chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case is linked to case 2018SA237938, 2018SA237937, 2018SA237939. This case involves a [19 years] female patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT. (Batch number: UI982AC, expiration date: 30-Jun-2018, site of administration left arm and route was not reported) on 20-Aug-2018. It was an actual medication error due to incorrect product storage as FLUZONE QUADRIVALENT given to 4 patients after shipment of vaccine shipped on Saturday and not received until the following Tuesday/improper storage these doses cannot be counted as valid. It was unknown if any 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
I woke up to my heart racing mildly, very cold, headache and marked nausea. Symptoms onset 11 hours after injection,.
On August 8th I was taken to the Emergency Room via ambulance because I suddenly went in to Atrial Fibrillation RVR. After receiving electrolytes, and diltiazem I was released. I was still in afib. I was prescribed Diltiazem and baby aspirin that I have been taking daily for two weeks. I have undergone a stress test, currently wear an event monitor called MCOT (mobile cardiac outpatient telemetry). I have a caravan scheduled for 10/21, and a cardiac ablation scheduled for 10/28.
Muscle cramps in thighs. These were not aches such as caused by flu, but actual spasms.
Patient received a vaccine not indicated for 16 years of age. Patient felt a little tired on 3/22 and then this morning she was ok, per mom.
Swollen red left arm. Diagnosed with blood clots in all his veins in left arm and spent 4 days in hospital on blood thinners and had 2 surgeries to remove them
localized extreme reaction for her arm; deltoid is very sore, she is in pain; numbness, tingling radiating all the way down to her hand; numbness, tingling radiating all the way down to her hand; her arm is now severely in pain; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (Covid vaccine) via an unspecified route of administration in arm (deltoid) on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a 42 years old dentist who had Pfizer vaccine on 04Jan2021, she had extreme reaction just localized extreme reaction for her arm, her deltoid is very sore, she is in pain, numbness, tingling radiating all the way down to her hand on unspecified dates. The concern is should she get another Covid vaccine, she is already past the window to get it and she is still having extreme arm pain raiding down her hand and so the question is the patient thinks she needs to get the second vaccine and the reporter is not so sure that's a good idea and she is still having this reactions so she reported this to the VAERS system but the reporter just wanted to know how to treat her. The patient was given two rounds of steroids as treatment, both have helped which means better but now she is worse again her arm is now severely in pain. The reporter talked to an orthopedic surgeon who wasn't sure about giving her an injection into the shoulders because she will probably get the vaccine again. The patient had not recovered from the events.  Information on Lot/Batch number has been requested.
urticarial type rash first noted 32hr p/vax;rash started on neck & spread to trunk, arms & face accompanied by fever up to 100.9;fever lasted until 6/20/99 AM;Rash & fever first appeared 6/18/99;pt taken to ER;
Chief Complaint  Difficulty breathing, cough, n/v/d x 3 days. Has received one covid vaccine. C/o generalized body aches. Zofran PO en route.  History of Present Illness  52-year-old gentleman presents to the emergency room with acute shortness of breath cough nausea vomiting.  He has been sick for 2 days.  His symptoms are progressed to the point that it is worse and had a come in to get checked out.  He has had associated nausea vomiting 2-3 times over the past 24 hours nonbloody nonbilious, and a couple episodes of diarrhea as well.  He is having some low back flank pain without sciatica and also a headache that is moderate in nature.  Is feeling quite fatigued rundown and has had one Covid shot about a mont
extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vaccine/histamine reaction; left side of his face swollen and puffy in lips, chin and cheek; left side of his face swollen and puffy in lips, chin and cheek; left hand swollen and itchy/forearm swollen; left hand swollen and itchy; allergic reaction to the vaccine/histamine reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23May2021 12:50 (at age of 45 year old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient not had medical history and family medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02May2021 12:50 (at age 45 years old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as single dose for covid-19 immunization.  Patient had the second dose of the Pfizer COVID-19 vaccine last Sunday (23May2021). Since then, he thinks he had an allergic reaction to the vaccine. On 26May2021 (Wednesday late morning, early afternoon), he woke up and the left side of his face was all swollen and puffy in the lips, chin and cheek. It started out in the lower cheek and then kind of spread through out the day. It eventually went down to the lower lip on the left side and moved up to the upper lip on the left side. His face was still swollen but to a much less degree. He took Benadryl and it kind of went away and was getting better. His left hand was all swollen and itchy now. It started after but was simultaneous with the face swelling. On 27May2021, he woke up this morning and his right wrist and forearm was swollen. Not really a rash but was red and swollen, and looks like a histamine reaction. Right wrist and forearm swollen was reported as worsened. He had been extremely congested the past 2 days. Was extremely congested with 99 percent blockage. He took Afrin which knocked it out. It was better but he was still very congested. No physician office visited. He was at Urgent Care right now. The outcome of the events "left side of his face swollen and puffy in lips, chin and cheek; extremely congested" was recovering. The outcome of other events was unknown.  Information on lot/batch number has been requested.
Onset of Facial numbness and flushing on R periorbital region. Spread to lateral periorbital area near R eye. Peaked and began to resolve in 15 min. Mild residual  numbness.
Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 23-APR-2007 was vaccinated with a first dose of GARDASIL vaccine(yeast) ( lot # 656051/0244U). On 23-APR-2007 after getting the injection the patient developed serious injection site reaction that lasted for two weeks. She returned to the office and the injection site appeared red, inflamed, swollen, and there was a lump there. The events improved for two weeks and then returned and lasted for a week. The patient would not receive the second and third doses of Gardasil. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a Rgistered Nurse (R.N.) concerning a 26 year old female with Crohn's disease for which she took steroids daily, who on 23-APR-2007 was vaccinated IM in to right deltoid at 10:00AM with as first dose of GARDASIL vaccine (yeast) lo# 656051/0244U. On 23-APR-2007 after getting the injection the patient developed serious infection site  reacton that lasted for two weeks. She returned to the office and the injection site appeared  red., inflamed, swollen, and there was a lump there. The events improvedfor two weeks and then returned and lasted for a week. The patient would not receive the second dose and third dose of GARDASIL vaccine(yeast). Unspecified medical attention was sought by the patient.. In follow up the reporter reported that on 23-APR-2007, patient had bleeding with injection and had quarter size lump with ecchymosis for two weeks. On 02-MAY-2007, patient was seen  in the office. She was seen in the office again on 17-MAY-2007 and the site was tender and there was alump at injection site again. In follow up it was noted in the office note that the patient bleeding with the injection and had some echhymosis that was quarter sized. Tha paitient recovered. Additional information is not exptected
some side effects from 2nd dose that lasted a day and half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half). At the time of the report, VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half) had resolved.            The treatment history was not reported. The concomitant medication was not reported.
vomiting sunday and monday (day #2-3)        vaccine 2nd dose sat afternoon 3pm        took a nap - which is unusual for him sunday FEVER , FATIGUE , AND ongoing intermittent  DIARRHEA
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 24-MAY-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours; not feeling well; not feeling normal; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024693 (Moderna), 149362 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "cipro antibiotics" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergy:morphine", notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine. Vaccination history included: BNT162b2 (DOSE 1, -1st dose Pfizer 22Jan2021), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours", "not feeling well", "not feeling well", "feeling tired". The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "not feeling normal"; FATIGUE (non-serious), outcome "not recovered", described as "feeling tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, feeling abnormal, fatigue.  Additional information: Caller received her fall booster on 09Sep two weeks and 2 days ago. Patient is still running a low grade with temperatures below 100 degree F since the day after receiving the Moderna shot -on 10Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201194742 same patient, different vaccine dose/event;
Pt. states that after receiving the 2nd dose of Moderna 03/02/2021, started experiencing symptoms 03/03/2021 of left arm pain *numbness, whole body aches, headaches, and weakness. Primary visit 04/2021, Blood Work (B12 High) recommendations for Pain Management *Gabapentin, 05/2021 Follow-Up with Primary *Gabapentin dosage raised. Still experiencing symptoms.
grand mal seizure; This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th April 2019, the patient received Menveo (intramuscular). On 24th April 2019, 10 days after receiving Menveo, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant). The patient was treated with antiepileptics nos (Seizure Medication). On an unknown date, the outcome of the grand mal seizure was unknown.   It was unknown if the reporter considered the grand mal seizure to be related to Menveo.  Additional details were provided as follows: The reporter was patient's mother. The patient had no prior history of seizures. Approximately 10 days after receiving dose of Menveo, the patient experienced a grand mal seizure, which required hospitalization.    At the time of reporting, the patient was taking anti seizure medication. The reporter consented to follow up and provided name and phone number for physician.
83-year-old woman has a history of dementia who was brought in by family due to increasing weakness and slight change in her mentation.  She does have fairly advanced dementia but they states she was talking significantly less today and hardly spoke to him at all which is unusual for her.  She also was profoundly weaker today than her baseline.  It difficulty getting her up without significant assistance and typically she does not use any assistance device to ambulate throughout their home.  She was diagnosed with COVID on 01/27/22 with an at home test and was prescribed Paxlovid by her PCP.  However due to the continuing weakness she was brought to the ED.  In the ED she was not very talkative but was otherwise stable.  She did have significant weakness in family felt unsafe returning back home due to her increasing weakness.  Admission was requested.  During my evaluation the patient was alone and did not speak with me.     PT IS CURRENTLY INPATIENT.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound COVID - symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Within 24 hours post vax, the pt developed pain and soreness at the injection site. This is one of two pts from this facility who experienced an injection site reaction following receipt of vax.
Cried/screamed for 4 hours during the night.  Vomited x 1.  Pt seems well on 7/1/2010 per mom.  Afebrile.
Patient was given an expired dose of Menactra. No adverse reaction or medical treatment required at this time.
On 5/16/00 mother phoned to report the pt was "really cranky" and fever for 2 days. Also reported she had not given her Tylenol or Motrin. Mother reeducated on fever reducers. Mom brought child to clinc. Mother was concerned about infection etc. On 5/17/00 mom called clinic and reported and ER visit and that MD found "nothing wrong" temp of 105.1 and pt sent home. Had visit scheduled later with PMD and found "nothing wrong". On 5/12/00 a home visit was made to check thermometer. Temp of 102.6 after Motrin given.
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue;  2/27 extreme fatigue; nausea; diarrhea; headache
Had a set of strokes, was hospitalized, Thromlectomy preformed as well as Biomarker device implanted into heart.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-501575 (Patient Link).
Chest pain/pressure and palpitations, paroxysmal hematoma on fingers, joint stiffness in knuckle, tender lymph nodes, anxiety, weakness symptoms in arms
Patient reported outbreak of chicken pox began on 9/4/2011. Patient did not see a Dr.
Muscle pain near injection site, inability to raise arm for 3 days. Mild headache persisting for 5+ days; Pain, redness,  and tenderness at injection site for 5+ days.
Medication/Administration Error- Patient was given 0.2mL of Pfizer COVID-19 vaccine without diluting  (6-10 times higher than recommended dose). Patient observed at home by parents. Mother denied any localized reaction at the injection site or any other adverse effects.
PATIENT RECEIVED EXPIRED MODERNA COVID VACCINE 03/27/2022 ON 4/5/22.
Several hours after the vaccination, my back started itching.  The itching lasted that evening and into the next morning and then subsided - no treatment done.  No rash.  Also had fatigue the entire day after the vaccination.  My right arm was sore.
Itchy red patch on the injection site; Soreness in the arm; Itchy red patch on the injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old 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 arm left on 28Aug2021 at 14:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included melatonin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Aug2021 at 14:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the patient experienced itchy red patch on the injection site and soreness in the arm. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy red patch on the injection site and soreness in the arm was not recovered at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
11/16 approx. 2 days after shot had chills - No fever - Aching in shoulder and legs - Slight cough. TC to CL. 11-16-09 PM - feels better - Just feels tired. She will contact her PMD if gets concerned.