chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 month child was given the flu vaccine intended for an over 6 month child, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (Reference number- 00473707) and transmitted to Sanofi on 12-Feb-2021.  This case involves a 4 months old patient was given the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date (product administered to patient of inappropriate age)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  The consumer had not experienced any adverse reactions and that he was aware of and wanted to know if there were any studies about possible effects later on. He would be  needing to do an Impact Study before contacting the parents as this even though occurred 2 months ago it was just brought to his attention.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
My arms swell and I had a fever. My glands were swollen and the fever lasted 4 days. On the 4th day, the swelling went down but it didn't look right so that's when I went to the Emergency room where they did the EKG. They let me go and got in touch with my doctor which I got an appointment on the 29th. I am experiencing heightened senses and pain. The pain is really bad in my forearm and elbow. It feels like it is weaker than what it was. I can't lift my arms over my head. It is more intense after the vaccine was administered.
After 2nd dose of Pfizer 4/25/21, by 5/6/2021 complaining of severe headache and showing major symptons of something neurologically wrong- extreme memory fog, confusion, headache.Was hospitalized on 5/31 for about 10 days after a 911 call complaining of a headche. Released in a worsened state. Spent 10 days at home, regressing daily. On 06/19/2021 hospitalized again, doing tests eliminating possibilities.Rapidly regressing, unable to speak full sentences, Myoclonus, loss of motor skills, Pyramidal & extrapyramidal symptoms as well as akinetic mutism. After 3 weeks undiagnosed, on 07/12/2021 LP results confirmed positive for CJD. Was released to hospice on 07/19/2021 and death on 07/22/21.
On 1/1/2021 I developed a large, red, itchy, hot area approximately 3 inches by 5 inches on my left deltoid area, over the injection site.
Patient describes pain at injection site, starting the day after administration and continuing on for 12 days now. Patient has only taken aspirin for the pain and will be trying ibuprofen per recommendation. Also recommended patient see his primary care physician for evaluation.
terrible itching; magnesium was low; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching) and BLOOD MAGNESIUM DECREASED (magnesium was low) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (terrible itching) and BLOOD MAGNESIUM DECREASED (magnesium was low). At the time of the report, PRURITUS (terrible itching) and BLOOD MAGNESIUM DECREASED (magnesium was low) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood magnesium: Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were shot to stop itching. Treatment details included shot to stop the itching.
I became pregnant shorty after receiving my COVID 19 booster, and miscarried 9 weeks later.
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On an unknown date, multiple unspecified patients were vaccinated with a dose of GARDASIL 9 (dose and route were not reported) (lot # L040054, expiry date 26-DEC-2017 or lot# M007764, expiry date 30-JAN-2018) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
Rash on (R) deltoid, fever, swelling at injection site, body aches, chest tightness, headache. Pt seen by PA at Medical Clinic on 1/22/09. Recommended Ibuprofen and Benadryl prn.
Patient received the Pfizer COVID vaccine instead of the Pfizer Bivalent COVID vaccine.
Pt. developed fever about 100. Felt very tired. Rt. arm sore still 6 days later. States arm is not warm, red or swollen.
Severe nausea; Difficulty swallowing; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included ehler-danlos syndrome type III. The patient had unspecified long list of allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified nutrients vegetarian enzymes for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced severe nausea and difficulty swallowing. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea and difficulty swallowing was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
a bad cough ever since the first covid shot 11May2021; This is a spontaneous report from a contactable consumer (patient) or other non HCP  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 (Age at the time vaccination 49-years) as first dose single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus and cardiac failure congestive. Concomitant medication included levothyroxine sodium; pantoprazole; solifenacin taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took vasotec [enalapril maleate] and experienced hypersensitivity, thera flu 24 and experienced hypersensitivity. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. It was reported that patient have a bad cough ever since the first covid shot 11May2021, I called they said it will go away in a few days it did not, I got my second shot 01jun2021 my cough has gotten worse they keep telling in a few a day it will go away it is not going away I have a sore throat, my right ears hurts bad and I an running fevers. Patient did not receive any treatment for event. The outcome of event was not recovered
Itchiness the next day followed by red raised area roughly 2 to 3 inches in diameter on bicep starting about 1/2 inch above elbow. No visible reaction directly surrounding the injection site.
Cold; Headache; Shivering; 4 hours after first shot developed sickness; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (4 hours after first shot developed sickness), NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN B12 [VITAMIN B12 NOS], SUCRALFATE (CARAFATE), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (4 hours after first shot developed sickness). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering). In April 2021, ILLNESS (4 hours after first shot developed sickness) had resolved. At the time of the report, NASOPHARYNGITIS (Cold), HEADACHE (Headache) and CHILLS (Shivering) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.  The patient had the worst headache of her life and feeling so cold felt like ice in veins.   This case was linked to MOD-2021-358836 (Patient Link).
Face swelling about an hour after injection- Lasted for a couple of hours. Severe dizziness and nausea all day today (the day after injection).
Pt has taken flu vax for 10 years with no problems. By night did not feel right, was bloated, had nausea, tad of diarrhea. 30 minute later when got home, had chills, fever, felt freezing, was moaning in pain because felt muscles constricted. Had headache took ADVIL and also pill for nausea. Fever did not break until AM. For 24 hours felt weak, had heavy breathing. In the morning called the doctor but was too weak to go. Still had some diarrhea on AM but was able to keep some food down. Friday morning felt better but was still slow to get going. Today feels fine.
Started out as tiny red bumps on back and by 8/29/2011 AM it had spread to stomach, chest, legs, face, groin area. On back the tiny red bumps are now raised red welts/bumps. Doctor said just to treat the itchy symptoms with hydrocortisone cream.
chest congestion, cough, sore throat, fever, dizziness, chills steroid pack, cough medicine, antibiotic, cough drops, throat numbing medication Sickness persists through date of form.
Immediately after vaccine injection site red, itching and small circular area around injection site.  Left arm and chest rash and itching.
PATIENT HAS REDNESS, SORENESS ON THE ARM AND RASH OVER HER BODY
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 07-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The patient did not develop any late occurring adverse events.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Patient received first dose on 19Feb2021 in left non-dominant arm. Patient experienced a sore arm. Patient is scheduled for a colonoscopy. Wants to know if this will affect the second dose vaccine
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Shaky feeling, dizziness, tingling in bilateral upper extremities. Dr at bedside examined and monitored for 15 mins then discharged in stable condition
Treatment of COVID-19; Treatment of COVID-19; vaccine_brand_other=moderna/vaccine_dose_number=4; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: gj5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), in left arm, on 30Jan2021 at 12:00 as dose 2, single (Lot number: en5318), in left arm and on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ew0191), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Apr2022 at 11:00, outcome "unknown", described as "vaccine_brand_other=moderna/vaccine_dose_number=4"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative tests on day 7 and 9; (2022) Positive; (2022) Negative, notes: Negative tests on day 7 and 9. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Rebound COVID symptoms on day 10 with positive test after w negative tests on day 7 and 9.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and interchange of vaccine products and BNT162B2.
Initial report was received from a health care professional on 09 October 2012. A 35-year-old female patient, whose medical history and concomitant medications were not reported, had received FLUZONE (batch number: UH713AB) intramuscularly in left deltoid on 08 October 2012. On 08 October 2012, the patient received FLUZONE at 11:45AM and by 3:30PM broke out in hives on left wrist, right wrist and on feet. Skin was reddened, hives present that was itchy, and skin in these areas feels tight, also there was slight swelling. The patient received BENADRYL and symptoms were begun to clear. The laboratory investigations were not done. The events resolved on an unspecified date. Follow-up information received on 02 January 2013: Patient's concomitant medications, risk factors and medical history and illness at the time of vaccination were none. Patient had not received any other vaccine. Patient had no other medical condition. It was reported that the swelling was not at vaccination site. Event cessation date was 11 October 2012.
This spontaneous report was received from a certified medical assistant regarding a 6 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Post vax, child was admitted to hospital after history of 3 episodes of eyes rolling back, followed by arm then leg shaking. Observed by parents. NO episodes during admission. Dismissed 02/28/2000. Final dx was possible seizure, bilateral otitis media, possible asthma. MD recommended no pertussis vax in the future.
Information has been received from a physician concerning a 21 year old female who in August 2007, was vaccinated with the second dose of GARDASIL (no lot# reported), 0.5mL injection. In October 2007, the patient experienced nasal symptoms, coughing and congestion. Unspecified medical attention was sought. Additional information has been requested.
Pt son verified dob and when processed the insurance rejected. The correct dob was 3/16/2010 not 3/16/2009 making child 11 years old and not 12. when tried to verify dob again with parent they refused.
Arm pain, intense head, nocturnal tertians and what has me worried is an edema in the right hand. (Inoculated arm)
Strong pain in left arm. Flare-up of all the issues on left side of body, which had been at bay until vaccine: bursitis, pain left hip, sciatica, plantar fasciitis, leg pain
Initial and follow-up information has been received from a physician and an other healthcare professional concerning an 18 year old female who on 14-JAN-2008 was vaccinated with a second 0.5 mL dose of Gardasil (659439/1267U). At 10:30, on 14-JAN-2008, the patient experienced fainting (she passed out and fell to the floor) and head injury (contusion). The patient reported that she felt flushed then doesn't know what happened. Post incident the patient was oriented and alert x3 and sustained a reddened area to left side of forehead (previously reported as head injury (contusion). Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint.  This is one of several reports received from the same source. Additional information is not expected.
shaking chills (rigor) 12H post shot; muscle aches; headache; fatigue (slept all next day); brain fog; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3247 and expiry date: unknown), via an unspecified route of administration on 28Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included mild asthma and mild hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and had unspecified medications within 2 weeks. The patient experienced shaking chills (rigor) 12H post shot, lasted 3 hrs; also has muscle aches, headache (3days), fatigue (slept all next day), brain fog on 28Jan2021 23:00. Outcome of the events was recovering. Patient took ibuprofen 36 hours after shot as treatment for the adverse events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Bad rash.   Fever.  Puking.  Diarrhea. Sore.
Pt states that he developed hives 1 1/2 hours after administration of Tetanus shot. Reported to the clinic next day, no visible evidence of rash at this time. No treatment necessary.
A week after Pfizer injection, I got a raised, red area about 2 or 3 inches by five inches on my arm.  It was hot and very itchy.  Over the net two weeks it got larger, but less red.  It was gone about the time I received the second shot,  After the second shot, I got the rash sooner, but it was larger and not raised or hot  It lasted several weeks.  I took antihistamines and tried Cortisone cream.  They didn't seem to help
The patient received the Moderna vaccine before turning 18 years old. She didn't have any symptoms.
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult.  Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
I received the 2nd shot Friday morning and early evening my arm started to ache.  The aching continued throughout my body and during the night I could hardly lift my arm.  Saturday I came down with chills and felt like I had a fever though I didn't take it.  My whole body ached with my arm aching worse and felt totally wiped out.  I felt so unwell I stayed in bed and took advil every 6 hours or so and woke up that evening with night sweats.  I continued to feel just as bad Sunday with the same symptoms.  On Monday I felt better.  It seemed the chills and aching had subsided and I was on the mend.  Sometime during Monday my right eye was starting to feel uncomfortable.  I also was sneezing all of a sudden, my nose was running, and I had a cough.  Tuesday my right eye was inflamed, the eye itself was painful and tearing and the area around my eye red and swollen.  I also had diarrhea that day.  The next day my eye was worse and I went to urgent care and got a PCR test worried somehow between shot 1 and 2 I was exposed to Covid-19.  They also gave me antibiotic drops for my eye.  The PCR test came back negative I'm thrilled to say but my eye infection was worse and more painful with the drops.  I made an appointment with the eye doctor on Friday.
SEVERE HEADACHES AND NAUSEA FOR 2 WEEKS AFTER THE 1ST DOSE.
On 9/13/17 patient presented with slightly raised red area that is about 2 in. below the vaccination site. The vaccination site itself has no bruise, no soreness or any markings. The site that is red is hot to the touch and measures about 2.5 in. by 5 in.  The area affected is not itchy. The patient also reported that several years ago when she received a ZOSTAVAX vaccination 4 years ago, her arm swelled up significantly but did return to normal after several days.