chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given Adacel within a 18 month window without looking in chart; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA202425, same reporter.  This case involves a female patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided.  On an unknown date, the patient received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number, expiry date, route and site of administration were unknown).  It was an actual medication error due to Drug dose administration interval too short.  It was reported that given Adacel within a 18 month window without looking in chart.  It was unknown whether patient experienced any adverse reaction after the injection.   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.  Information on batch number was requested for this case.  List of documents held by sender: none.
I had a pounding headache; exhausted and my appetite was heavily suppressed; exhausted and my appetite was heavily suppressed; I typically run 40-50 miles a week and I was barely able to get down my stairs.; I lost 7 pounds in 2 weeks from these symptoms; Nausea; bedridden for 16-18 hours everyday; This is a spontaneous report from a contactable consumer, the patient herself and contactable physician. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730 EUA 4/21 SWY/ALB), via intramuscular route, administered in Left deltoid, on 05May2021 at 09:00 as dose 2, single (age at vaccination: 26 years), for covid-19 immunization. Medical history included ongoing HPV Positive from Jan2021 and Mild intermittent asthma from Dec2017; also had a history of Mild cervical dysplasia from Feb2019, unknown if ongoing. The patient had no known allergies. Concomitant medications included oral sumatriptan taken for headache, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (Lot: ER8730 EUA 4/21 SWY/ALB) as a single dose in Left arm, on 14Apr2021 at 10:00 AM (age at vaccination: 26 years), for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that, on 05May2021 at 18:00, she started experiencing a pounding headache which was still somewhat prevalent that was so severe that she was bedridden for 16-18 hours every day, also started feeling exhausted, her appetite was heavily suppressed and she typically ran 40-50 miles a week and was barely able to get down her stairs. She told that, she had prolonged side effects from the vaccine going on 4 weeks. She stated that, she lost 7 pounds in 2 weeks from these symptoms (onset date: May2021). It was also reported that, the patient started experiencing nausea since an unknown date in 2021. The seriousness for the events were reported as non-serious. The adverse event resulted in Emergency room/department or urgent care. For headache and nausea, both Emergency room and physician office visits were required. The patient underwent lab tests and procedures which included CT head (Computerized tomogram), CBC (Full blood count), U HCG (Human chorionic gonadotropin), CMP (Metabolic function test) and UA (urine analysis), all with negative results on 23May2021. The patient did not receive treatment for headache and nausea and for other events received a shot of Toradol, and an IV of Promethazine. The outcome for all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
At first knee pain. Then horrible right hip pain by April 3rd. By Monday, April 5, I was in a full blow fibro flareup. By April 22, the pain was so bad, I broke down and called my doctor for something to help me. I could not walk due to the pain. He prescribed Gabapentin that I have never taken before. I cannot function without the Gabapentin. I live alone and fear I will fall.
FEVER, FUSSY, DECREASED APPETITE FOR 2 DAYS TREATMENT TYLENOL AND MONITOR
Vaccine was given on 4/1 and the next day nauseated, dry heaves, cannot eat and lives on protein shakes and he's lost 20lbs and he's weak and been in the hospital twice and the doctors cannot find why. He has passed out four times. He is a cancer surivor but nothing shows that the cancer has returned.
flu vax was inadvertently injected into pt shoulder joint;following day joint became swollen;the swelling was worsening @ the date of this report;f/u info recv 7JAN97 indicated pt also exp arthralgia w/loss of motion, strength & grip ;
Patient forgot that he had completed SHINGRIX series. He received 2 doses 2 months apart, but forgot about the second dose. Pharmacist also thought patient is waiting for second dose to be available. Patient does not have any adverse effect from any of the SHINGRIX dose. Patient has no complains from SHINGRIX vaccine. 1 st dose: 04-06-2018, 2nd dose: 06-06-2018, 3rd dose: 09-22-2018.
Swelling, hardness, redness, itching at injection site 8 days following injection.
On May 18, 2022 I tested positive for COVID-19. I had returned from travel a day before. I felt very tired and had a fever so I tested myself and tested positive for COVID-19. I contacted my doctor right after I tested positive and they prescribed me PAXLOVID. I took the PAXLOVID for five days.
Sm lesion RT side abd three sm lesions back, sm amount erythema two heavy raised vesicles.
dizzy; This is a spontaneous report from a Non contactable consumer via Pfizer-sponsored program.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced dizzy on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2016, shortly after being vaccinated, the patient was treated at a physician's office for the onset of a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient has experienced persistent and uncontrolled shingles eruptions since being diagnosed, suffering from his infections for nearly one-year in duration. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Arm was very sore. Hurt enough to wake me from a sound sleep.  24 hours after injection, extreme fatigue and low fever. All symptoms managed with Tylenol and sleep. All symptoms resolved after 24 hours.
At 12 hours after application: Headache, left lobe. At 24 hours of application: skin rashes, with some burning, but remains 4 days later. No other effect.
Pt given vaccine at pharmacy 3/20/19. Was admitted to medical center 3/27/2019 for altered mental status and seizure.
Information has been received from a physician through the pregnancy registry concerning a 33 year old female with a history of sinusitis and no known drug allergies who on 4/29/02 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included acetaminophen/pseudoephedrine HCl that was used twice during the past month. On 5/8/02 it was reported that the patient is now pregnant with her LMP 4/8/02. Her estimated delivery date was determined to be 1/13/03. Unspecified medical attention was sought. On 5/10/02 it was reported that the physician will not be following the patient's pregnancy. On 5/13/03, it was reported that the physician did not have any pregnancy outcome information and had only seen the patient in the clinic one time. On 5/16/03 information was received from the physician who had spoken to the patient's husband (the patient was out of the country). It was reported that on 10/29/02 at 29 weeks gestation the patient delivered an approximately 3lb 6oz infant. It was reported that there was no infection and that the baby was hospitalized for 2 months to grow and is doing well now. Upon internal review, the patient delivered at 29 weeks gestation was determined to be an other important medical event (OMIC). No further information is available.
Patient developed rash and fever after receiving the MMR vaccination subcutaneous in the Right Vastus Lateralis.   Patient did develop Acute Otitis media of both ears,  1 week post vaccine.   Rash had also already started spreading before patient was diagnosed.   Per provider looking at the dates of MMR vaccine, start of symptoms, and fever, and then rash.  Provider felt  confident it could be effects from the MMR Vaccination.  Did not require treatment.   Rash did clear up as of 8/5/2021.
The patient went to five different free Flu shot providers and got the shot, no adverse event; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown age and gender) who went to five different free flu shot providers and got the INFLUENZA VACCINE shot (intentional extra dose administered).  The patient had no medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a five doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of actual medication error case due to extra dose administered (unknown latency).  It was reported "Flu Shot Fridays I went to five different free Flu shot providers yesterday and got the shot. My doctor told me NOT to get more than one shot but also told me it was 100 percent safe. So 5 is better than 1. 5 times the protection."  It was unknown if the patient experienced any additional symptoms/events.  At time of reporting, 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.  There will be no information on the batch number for this case.
Lip swelling. treated with Solumedro, Pepcid and Benadryl
Janssen Covid 19 Vaccine EUA Patient experienced sudden onset Dizziness and Nausea following her vaccination. Vitals recorded and the patient was placed in a supine position. Facility contacted and they responded to the location and patient was placed in the ambulance and a 12 lead was completed. At this point the patient felt improved, Hypotension had resolved and the 12 lead was negative. Patient decided to AMA and healthcare facility was contacted for the AMA. Patient was taken home by her husband
sore arm; fever this time but not much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever this time but not much) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy.    On 02-May-2022, the patient received fourth 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) and PYREXIA (fever this time but not much). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever this time but not much) outcome was unknown.            No concomitant medication was reported.  The patient got 3 previous Moderna COVID-19 vaccinations.  On 02-May-2022, the patient received Moderna COVID-19 booster vaccine. This shot did not seem to bother at all. The patient had a sore arm and fever this time but not much.  No treatment medication was reported.   This case was linked to MOD-2022-556947 (Patient Link).   Reporter did not allow further contact
morning after vaccination urine had a strong odor that smelled like bacon.  I don't eat bacon and had not had anything unusual to eat. urine was paler than usual during rest of day but returned to normal the following morning.  Also experienced the common soreness at injection site, tiredness, aches--like a  mild flu.  All reaction disappeared by third day following vaccination
Large swollen knot at injection site that was red, hit, and swollen.  Fever 101, chills, nausea, brain fog, Erythema and rash present. Rash is urticarial chest, stomach, back, neck, groin, scalp.  Sweating and low pulse.
Patient was given the wrong vaccination. Patient was to receive a season flu shot but the covid booster instead.
Tingling in hands and feet, ascended to elbow and waist.  Weakness in arms, legs.  Hospitalized x 1 day.  Still have residual tingling in hands and feel.  Diagnosed with Guillian Barre Syndrome.  Still with continual tingling hands and feet. The medical records received on 4/5/04 states headache, blurred vision, palpitation, and sweaty palms. discharge summary states viral infection. msv
Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
if by accident administered only the diluent; if by accident administered only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On 27th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 1-Aug-2022 Reporter's comment: The reporter asked how to proceed if by accident they administered only the diluent portion of Menveo. This was on 27th July 2022. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the diluent portion of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I have been having severe migraine headaches in the back of my head and blurred vision.  I also usually get my period on the 15th of every month but right after the shot my period came on and it was the heaviest period I ever had and clots and tissue bigger than I have every seen.  I had severe diahree to the point that I had to go to the rest room 30 times.  I am a liver cancer survivor and have been in remission for 8 years.
Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:30 as (At the age of 49-years) dose 2, single for covid-19 immunisation. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing both Controlled with medication. List of any other medications the patient received within 2 weeks of vaccination include Lisinopril, hydrochlorthiazide, and levothyroxine sodium (SYNTHROID) all was taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as (At the age of 49-years) dose 1, single for covid-19 immunisation. The patient experienced flu like symptoms, nausea, fever up to 101.7, achiness, vomiting (vomiting, influenza like illness, nausea, pyrexia, and pain) on 25Mar2021 05:00. Patient received treatment for the adverse event as promethazine 25 mg and ibuprofen 800 mg. The patient underwent lab tests and procedures which included body temperature: 101.7 on 25Mar2021 Up to 101.7. The events were assessed as Non serious by reporter. The outcome of events was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a couple of days after the vaccine, my lichen planus flared, it increased after the 2nd vaccine.  I started topical triamcinolone and over the next few months the flare dissipated.  I have had LP for over 10 years and haven't had a flare this bad.  I am back to baseline, and am thrilled to be protected by the vaccine! I had reported to Vsafe and thought the info was going into the VAERS.  After a call from vsafe was told to report to VAERS.
This spontaneous report was received from a licensed practiced nurse refers to a 4 month old patient. On 08-MAR-2013 (also reported as 11-MAR-2013), the patient was vaccinated with an expired second dose of ROTATEQ, (lot number reported as 0287AA, expiry date 15-NOV-2012, route orally). No adverse event was reported. Additional information has been requested.
A report was received from a health care professional on 12/5/03 concerning a 2 year old male vaccinee who inadvertently received 0.5ml Fluvirin vaccine on an unspecified date. On an unspecified date the vaccinee received Fluvirin. At the time of the report no adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
arm was red at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red at the injection site.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported. On 17-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 VACCINATION SITE ERYTHEMA (arm was red at the injection site.). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red at the injection site.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-407238, MOD-2021-407239 (Patient Link).