chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805469 was crossed linked to original case 201804863 due to same reporter.
Pain in neck and shoulders, heat & severe pain radiating through bicep down to elbow, tingling through finger tips in both arms and sudden itching on palms of both hands.  10/20 09:00: uncontrollable bowels.
Urticarial rash, abdominal pain and emesis for several days, requiring epinephrine x 3, BENADRYL around the clock, and hospitalization.
Information has been received from a physician concerning more than a dozen females who were vaccinated with the first dose of GARDASIL. Subsequently the patients experienced syncope after the injection. Medical attention was sought. Follow-up information was received from a nurse who reported that she did not have an exact number of patients but that is not more than 15 in the 3 months that they had given the vaccinations to their patients. Additional information was received from a nurse practitioner. She referenced the same group of approximately 15 patients which was previously reported by the physician and a nurse. She confirmed that over the past three months experienced syncope after immunization. She was unable to provide any further patient details or lot numbers. A licensed practical nurse states that they were not keeping track of lot numbers at that time. Additional information is not expected.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored  VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route were not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)". Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA003115: Original Case: 1710USA003115; US-009507513-1710USA003166: Original Case: 1710USA003115; US-009507513-1710USA003167: Original Case: 1710USA003115; US-009507513-1710USA003168: Original Case: 1710USA003115; US-009507513-1710USA003164: Original Case: 1710USA003115; US-009507513-1710USA003163: Original Case: 1710USA003115; US-009507513-1710USA003165: Original Case: 1710USA003115.
Administered shingles shot, patient developed rash and blister. Informed her the next day to apply ice, BENADRYL cream and pills. Saw her 10 days later looks like it healing. Scab where blister was.
Pain and swelling in the injection area. Entire arm had a lot of aches for entire day after. Took Advil for relief. Have a lump in the area. Pain went away for the rest of week, however came back one week after injection  with a lot of redness and hard lump. Burning and aching as well as itching.   First day after injection was very tired and dizzy.
On the morning of Feb 2, it felt like a switch went off in my head. I felt spacey and disconnected. I went for a walk and felt better but tired. I then started to feel anxious and tired the next day. The third day I not only felt anxious but agitated. This seemed very similar to being on Prednisone. That day I called my doctor and took Ativan. We waited another week to see if the aniety would go away. It did not and I am currently on Lexipro. I walk almost everyday and it really helped with the onset of anxiety after the shot. However, F Feb 14 I felt chest pressure while walking which I had never felt before. After returning home, I went to the ER. All tests were negative for a heart attack. I am hesitant to get the second dose. I am currently seeing a cardiologist to determine what may have caused the event.
Initial report received from Non-Health Care Professional on 06 April 2012. Local reference number: 12-0219. A female patient, whose medical history included undiagnosed episode of suddenly experiencing weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness in 2009 and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (lot number- MP081AA (invalid lot) and site of administration- not reported) on 08 October 2011. It was reported that, the patient was sick for 2 days with elevated temperature, wiped out and had flu symptoms. The symptom of weakness, exhaustion, fever, swollen and burning feet, woke up with sweats and dizziness reoccurred in February 2012. The outcome of events was reported as not recovered. Documents held by sender: none.
Left deltoid - warmer than surrounding area. Difficulty increasing with raising arm up, reaching behind and lifting problems have increasing since about 2 days after injection. Request pt to visit hospital.
Injection was inadvertently given in the subacromial bursa. Patient had resultant severe shoulder pain and decreased range of motion. Initially given prednisone.
She got her vaccine, had severe backaches, her legs were aching and there was not a part of her that did not hurt.  She felt nauseous, her neck hurt, her head hurt.  She had fever and chills.  They lasted for about 24 hours and they left.  She did not take anything for her symptoms.
Pt called on 10/30 at 10:15 AM to report she developed rash on bilateral and back areas of neck 4 days after vax administration. Notes itch at times - rash has lessened but still can feel bumps on skin. Denies problem at site of injection - Had gotten vax x 15 yrs without problems noted. Did not Tx or seek medical attention. Is recovering.
Diagnosed with Covid after vaccination; Diagnosed with Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Both caller and wife have COPD and emphysema; "emphysema" (unspecified if ongoing), notes: Both caller and wife have COPD and emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with Covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: Other conditions and Investigations were not provided. It was Unspecified that COVID-19 vaccine manufacturer unknown a pfizer product. number of COVID-19 vaccine not provided. Reason for no lot number of COVID-19 vaccine manufacturer unknown. Caller unwilling to complete the report. Expiry date of COVID-19 Vaccine was not provided. Other products were not provided. Question about the Booster shot. In may caller had Covid and took Paxlovid. Wife had Covid and got monoclonal antibodies. Are they able to get the new Covid-19 booster. Verified above information with the caller. Both caller and wife have COPD and emphysema. Declined to complete report. Additional lot number and sample of the product available to be returned, if requested that was not provided. Packaging sealed and intact that was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very sore arm for 24 hours post vaccine; within 1 week soreness returned with swelling/lump and rash
pt recv vax 14JUN96 & 3min p/vax pt devel 1cm hives-like rxn above the MMR vax inj site;DPH given & pt recovered from sx;pt lungs were clear to auscultation, & no other hives, wheezing, or resp diff;
right ear being completely deaf; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 28Jul2021 at 19:45 (Batch/Lot number was not reported) (at the age of 25-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The vaccination facility type was pharmacy or drug store. The patient had no relevant medical history, past drug history and concurrent conditions. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 31Jul2021 at 06:15, Saturday, the 3rd day after receiving the vaccine, the patient woke up with her right ear being completely deaf. This has never happened, and she was a regular at cleaning her ears. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination which included nasal swab SARS-CoV-2 test: negative on 31Jul2021. The patient did not receive any treatment. The outcome of the event was not recovered.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event deafness unilateral cannot be totally excluded/assessed.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Given MMR on 11/21/07 (volunteer worker). Presented to hospital ER 11/24/07 with T 101, C/S V/D. W/U: CXR negative, WBC 5.38 with 80 seg bands, BC/UC negative. Seen in f/u 11/27/07 - sx slowly resolving.
heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose;
Patient received a dose of Pfizer COVID-19 Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the Agency due to lack of stability data, it was advised to revaccinate the patient.
SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
pt recvd 3 doses of Engerix-B & 3DEC91 tested immune for Hep B; 12NOV91 devel pneumonia treated w/ATB; when retested for Hep B on JUN92 was found to be non-immune;
patient passed out; shot may him whoosy however he stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first 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. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out) (seriousness criterion medically significant) and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed). At the time of the report, LOSS OF CONSCIOUSNESS (patient passed out) outcome was unknown and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed) had resolved.            Concomitant and treatment information not provided.   This case was linked to MOD-2021-033479 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Right arm lymphadenopathy; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 28Apr2021 at 11:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 16:00, the patient experienced right arm lymphadenopathy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymphadenopathy was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case previously recorded as MA2009-4370. Initial case report received from a physician via Novartis Pharma, on 12 NOV 2009. A 2-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102041P) i.m., on 09 NOV 2009. No adverse events was reported. Agency reference no.: NA09-008119.
Worsened shortness of breath, feeling jittery like I had a large dose of steroids, fatigue and weakness.
He experienced the pain on the same day (9/4/2019). He noticed a bulging nodule or mass with dark bruises a month later after vaccination (10/2019).  He scored the pain at 5 while taking Norco 7.5/325mg, Doctor said he would need to get operation to get the mass out.
LARGE CIRCLE THAT IS FEVERISH (WARM) TO THE TOUCH SURROUNDING THE INJECTION SITE. CIRCLE HAS GROWN OVER THE PAST WEEK, HURTS WHEN SOMEONE TOUCHES IT, AND ITCHES SERVERLY.  PHYSICIAN WILL NOT SEE PATIENT BECAUSE THEY WERE NOT THE ONE WHO ADMISTERED THE SHOT
Pt recv vax on 2/12/99; on 2/14/99 pt exp red lump at vax site w/ pain & hot to touch; tx=hot & cold compresses
Child had shots 3/12/18 her reaction is has been super clingy since, will not fall asleep alone as before, seems fussy where as before my child only cried when hungry. She now randomly screams and cries at random moments even when feed, changed, and comfortable.
This case involves an unknown age and unknown gender patient for whom reported "temperature excursion for menactra & ipol (opened) that reached -0.43 Celsius for 3.5 hours in the fridge" while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and POLIOMYELITIS VACCINE (INACTIVATED) [IPV (VERO) [IPOL]]. The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) [Lot: T1D481M and expiry date: 25-Jul-2022] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date: not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date the, patient developed a non-serious event "temperature excursion for menactra & ipol (opened) that reached -0.43 Celsius for 3.5 hours in the fridge" (product storage error) (latency: on the same day) following the administration of IPV (VERO) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was reported that, "the temperature excursion was occurred due to unknown reason and this occurred a couple of months ago. Caller stated to disregard the freezer temperatures of 17.52 Celsius for 7.5 hours". Laboratory data was not reported. At the time of report no adverse event was reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe hives, joint pain and swelling; Started 1/12/22 at 5:10 pm; Still occurring 1/14/22 9:53 pm; Not responding to steroids and antihistamines.
Patient received flu shot in left arm and right arm rec'd Pneumovax, red swollen slightly raised, afebrile unable to left arm, redness went all around cold compress.
Arm was sore; Body pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PAIN (Body pain) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), PAIN (Body pain) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (Arm was sore), PAIN (Body pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Pyrexia: 98.2 f (abnormal) 98.2 F.         No concomitant medication reported. No treatment information reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-035348 (Patient Link).
~7hrs post vaccination I began feeling chills. Throughout the next 24hrs I developed a severe headache, nausea, muscle & joint pain, and abd/pelvic cramping. My peak temperature was 99.3'F (normal is ~97.5'F). I took some tylenol the next morning (~22hrs post vaccination) to alleviate some of the symptoms. Symptoms lasted until ~36hrs post vaccination.