chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day.  She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.
Developed fever 12/28/20, tested positive for SARS 12/29/2020.  Quarantine for 10 days from onset of symptoms, returned to work 1/6/2021
Myalgia body ache Narrative:  sore arm for 2 days. body ache for 1 day.
first injection with Shingrix on 11/19/2019 / has not yet received the 2nd shot in the series; sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia (Twice in fourth decade of age). Concurrent medical conditions included bronchiectasis and chronic lung disease.   On 19th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient s family history reported as mother had shingles twice. The patient's medical history reported as Pneumonia twice while in her forties and in April 2019, the patient diagnosed bronchiectasis after having third case of pneumonia. The patient experienced sore arm at the injection site which resolved after about 3 days. The patient not yet received the 2nd shot in the series, which led to incomplete course of vaccination. The reporter consent to follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates since 24-NOV-2015, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD therapy type: (recombinant human albumin (rHA), lot#L030586 and expiration date: 10-FEB-2017, lot# L033692 and expiration date: 28-FEB-2017 and PROQUAD therapy type: human serum albumin (HSA), lot#L004006 and expiration date: 05-AUG-2016, lot#K020747 and expiration date: 30-APR-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Arm muscle hurting and still hurting 04.06.21. This is one month later and I am finding it hard to lift my arm without it causing pain
patient was vaccinated with this vaccine after the excursion; No adverse event; patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetes and Hypothyroidism.    On 03-Oct-2022 at 10:24 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   Treatment medications were not reported.
Patient requested Covid-19 vaccine for Pfizer (Comirnaty) not knowing she already had Covid-19 vaccine for Moderna ( Spikevax) 7 days ago. She got two Covid-19 vaccine within 1 week apart.
tested positive for COVID/Tested Positive for COVID 19; tested positive for COVID/Tested Positive for COVID 19; This is a spontaneous report from a contactable consumer (patient's husband). A 76-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (BNT162B2), via an unspecified route of administration, administered at the rehabilitation center in left arm on 28Apr2021, at 76 years of age, probably around 10:00 am (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hip fracture after a fall from 05Apr2021 and ongoing, which required patient's hospitalization from 5Apr2021 to 10Apr2021 and a surgery (see cross-referenced case AER # 2021497286) and diabetes. She was currently in rehabilitation center and was improving. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 18Mar2021 (lot number ER2613) at about 10:00 in the morning administered in her left arm. The second dose was 6 weeks later because she was unavailable for the second dose, which was then administered at the rehabilitation center. Concomitant medications included metformin for diabetes mellitus from an unspecified date (she has been taking this for probably 10 years or more) and ongoing; paracetamol (TYLENOL) taken for pain from an unspecified date and ongoing; potassium chloride taken for an unspecified indication, start and stop date were not reported; lisinopril taken for blood pressure abnormal from an unspecified start date and ongoing; valproate semisodium (DIVALPROEX ER) taken for manic depression, start and stop date were not reported; furosemide (FUROSEMIDE ACCORD) taken for an unspecified indication, start and stop date were not reported; nitrofurantoin (NITROFURANTOIN MONO/MAC) taken for an unspecified indication (the reporter said the patient has been taking this medication for quite a while, she has diarrhea problems off and on, he thinks), start and stop date were not reported; levothyroxine taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (EUTHYROX) taken for an unspecified indication (reporter thinks for diabetes) from an unspecified start date, about 7 or 8 years before, and ongoing; alendronate sodium taken for an unspecified indication, start and stop date were not reported and Vitamin D taken for an unspecified indication from an unspecified start date, 2 or 3 months before, and ongoing. It was reported that at the rehabilitation center they check patients 2 to 3 times a week for COVID so the patient got a routing check and, on 30Apr2021, she was tested positive for COVID-19, but she had no symptoms. They are going to take the test again with the swab. The patient underwent lab tests and procedures which included SARS-CoV2 test (nasal swab): positive on 30Apr2021. The reporter said his wife said there are a few more patients that have COVID at the hospital and he doesn't know if it is spreading. The event outcome was unknown at the time of the report.  Information on the lot/batch number has been requested.
CLOT; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced clot after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139236 -covid-19 vaccine ad26.cov2.s- clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
About 2 minutes after shot was given she felt light headed and tried to get up from exam table and fell on the carpeted floor,provider responded in less than 5 seconds,she looked pale and sweaty but responsive to vocal command ,was laid down on the floor,checked BP,Heart rate(normal range) and she was breathing by herself with good color,was given  a glass of water to drink and when she started feeling much better,was transfered to exam table and was monitored for some time,was given candy to eat .she fell on her face down and got small superficial laceration on chin that was cleaned with antiseptic and applied bandage,and transfered to ER VIA AMBULANCE.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (FIRST BOOSTER; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Aug2022, outcome "not recovered", described as "sick". Additional information: Patient received second booster shot on an unknown date in Aug2022 and wanted to report that the patient had been sick going on five days. Patient was still sick. Event Awareness Date: 18Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One week after vaccine, I became incredibly dehydrated, began vomitting and within 2hrs spiked a 104.4 degree F fever. I had uncontrollable shakes, chills & hot flashes. Tylenol wouldn't reduce my fever. I was taken to the ER where I was given fluids, potassium and magnesium which eventually calmed my fever. My blood pressure was very low as well. I tested negative for COVID-19 and Mono. No clear indication of cause resulted from chest xray and CT scan. Later small nodules were detected in my lung. Doctor's referred this as a viral reaction but couldn't determine a cause. I was discharged from the hospital after being there about 6hrs. The next day I was lethargic but felt almost back to normal. Within 36 hours I felt 100% and like nothing ever happened.
Ten days after receiving the Moderna vaccine booster, I developed urticaria. I sought medical attention from an allergy specialist. The urticaria has not resolved yet and I am currently taking medications for it. I do not have any history of allergies.
June 3rd vaccines, June 5th pt ret to clinic c/o high fever and uncontrollable crying x2 days. (20 min after vaccine). Upon examination pt also found to have pharyngitis. SHe recovered within 12 hours- RTB given as well.
Having severe headaches that is more severe from when I had the first dose. Currently feel heaviness in my head that is affecting my activity performance. I am also experiencing more tiredness than in first dose that is worsening instead of getting better. I have been talking Tylenol with no relieve that I couldn?t sleep.
Patient was supposed to receive a second dose of Janssen vaccine as a booster. A dose of Pfizer was given instead. Patient was told to contact us with any adverse events or symptoms.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild
Rapid onset 6-6-12 muscle aches, joint pains general feeling flu like sx. Pain at injection site. Pt was advised MOTRIN, ice to inj. site, limit activity til feeling better & hold his CRESTOR til feeling better.
10-3-02 received flu, pnue and TDA immunization at approximately 4:15pm; state approximately 8pm right arm(pnue given) was warm, red; arm hurting and did not sleep well. RTC 10-4-02 at noon, temp 97.8, complained of chills. Right arm red/warm approximate 6in long and 7in around arm, bruise at injections site. 10-7-02 phoned client, state better (arm red) but over weekend red, high temperature, chills, right arm very sore, was very sick per husband also. 10-7-02 arm red only.
This is in follow-up to report(s) previous submitted on 9/8/2006. Information has been received from a pharmacist concerning his 14 month old son with no known medical history or allergies who on 7/26/06 was vaccinated in the right thigh with a dose of varicella zoster virus vaccine live (Merck) (lot # 652966/0623F) instead of a dose of varicella virus vaccine live (Merck). Concomitant vaccination included a fourth dose of PREVNAR in the left thigh. There was no concomitant medication. During the weekend after the dose, on approximately 7/29/06, the patient's grandmother noticed a "pock" and red spots on the child. She applied camphor + eucalyptus oil + menthol vicks vapor rub on the pock. Unspecified medical attention was sought. It was reported that the pock and the spots have resolved. The pharmacist was told that his son was administered an "adult dose of the chicken pox vaccine". There was no product quality complaint involved. Additional information has been requested. Additional information from the office manager indicated that the practice was not aware of the child experiencing a "pock" or red spots after vaccination. She explained that the patient has since switched to another practice and no further contact has been made to their office. The patient was supposed to receive PROQUAD (Merck) and not VARIVAX (Merck) as previously reported. She reported that the packaging for the ZOSTAVAX (Merck) and PROQUAD (Merck) were similar. The vaccine are now taken out of there original boxes and placed in individual trays labeled with the trade names and marked pediatric or adult vaccines. No further information is available.
Patient received Janssen vaccine around 10:30. He left the observation room feeling fine. once he got at his car and started to drive, he felt shortness of breath and some weakness. Then, he came back to the SR Vaccine site to get help around 10:50. We met him in front of the parking lot, he was having some trouble of breath and weakness. We put him in a wheelchair, brought him back to the Observation area. I asked him to lay down with elevated legs on a chair. He instantly felt better, no more shortness of breath. He did not need to use any Oxygen supply. Also, he drank some water, sit back in the chair and felt better ready to leave with his brother who came to help him just in case. At 11:10 he left the building with orientations about worsening of symptoms and when to call EMS.
1750- IM injection ot R Deltoid.  She was sitting, and felt short of breath without wheeze or tightness in the chest or throat.  She stood up, and then felt tunneling.  Assisted to chair and floor.  Pulse weak, skin flushed, sweating on torso.  Face and Neck remained flushed and red. She refused epi at first.  So we gave her benedryll 25 mg po with apple juice.  She said she just had a big meal 30 min prior, but we checked her blood sugar- it was 85.  10 min after the first SOB feeling, it returned.  BP was recorded as 160/100.
Had headache & mild fever (100 on forehead) evening of vaccine but woke up on 3rd day with chest pains. Complained of pain when taking a deep breath and would flinch in pain. By the time got to ER in the afternoon, pain had subsided. Not sure if vaccine related but never had chest pains before & considering report of myocarditis after 2nd shot for younger males. Wanted this documented in case there is a pattern.
fast heartbeat; dizziness; weakness; had trouble seeing; This is a spontaneous report from a contactable consumer(patient). A 35-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration at the age of 35-year old on 06Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that after receiving the vaccine he had an immediate fast heartbeat, dizziness and weakness, and had trouble seeing and it lasted about 12 minutes. He experienced no swelling of the face and throat. Symptoms resolved within 12 minutes. He did not seek any medical attention while at the vaccination clinic. He had spoken with his primary care doctor and his doctor said it was fine to take. He did however see online that his side effects could be contraindications for the second dose. He was calling for a second opinion. The outcome of events was recovered on an unspecified date in 2021. No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
soreness of the arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324806 Same reporter, suspect drug and event; different patient.
SOME OTHER SYMPTOMS; BRAIN HURTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced some other symptoms, and brain hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain hurts and some other symptoms was not reported. This report was non-serious.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grad, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Immediately felt weak and light headed the same as the first shot, but did not incur breathing difficulties. Gradually became weaker as the day went on. 13 hours later, at 3AM, awoke due to severe pain, chills, and fever that progressively worsened to about 103 degrees and did not drop below 100 for another 17 hours.  Resting heart rate elevated over 30 bpm and respiration rate doubled. Pounding heart made it impossible to sleep. Had to double beta blocker dosage to reduce heart contractility to prevent chance of further scarring of ventricular tissue due from any myocarditis caused by the vaccine. Could not leave bed and could barely stand to go to the bathroom. Lost 5 pounds in one day. Couldn?t eat. Felt nauseas. Contemplated going to ER but didn?t feel I?d make it without passing out.  Still having difficulty walking any distance without feeling like passing out more than 72 hours after vaccination absent any arrhythmia.  Experienced non-sustained arrhythmias after the first vaccine dosage doing normal household activities that required me to stop what I was doing to prevent a defibrillator shock. I have a feeling of brain fog, difficulty concentrating or sleeping. It was a struggle to drive a vehicle to restock of fluids and electrolytes today. I fear this vaccine is making my health worse.
APPROX 5 MIN AFTER VACCINE PARENTS REPORTED TO PROVIDER LEG RED AND SWOLLEN.  UPON ASSESSMENT PT WITH APPROX 4 IN ROUND, RED, WARM AREA AT INJECTION SITE.  PROVIDER DISCUSSED CARE WITH FAMILY. FAMILY INSTRUCTED TO CALL THE CLINIC TOMORROW WITH UPDATE ON PATIENTS CONDITION.  TO SEEK CARE WITH ANY EMERGENT ISSUES.