chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a reaction to VARIVAX immunization on 6/20/09 which was erythema but no induration or pain measuring 12.5 x 8 cm outer area and 5x3 cm inner area of erythema. Patient told to ice and take BENADRYL on 6/21 which helped. She was examined with above description on 6/22. She will return if worsens. 6/23/09 clearing of erythema, no tender, minimally warm. She will follow up if non clearing.
inflammation thru out the body, painful joints, swollen face, walking very slow and hunched, elevated TSH level , elevated Potassium level ,elevated other results Was put on thyroid medication and anti inflammatory meds for now. Getting better slowly Fear from the oncoming symptoms after the vaccine. Never felt this bad before
VACCINES WERE GIVE AROUND 09:38 AM ON 09/28/23. PT DID NOT EXPIERENCE EVENTS UNTIL AROUND  5:00 PM ON 09/28/23.  PT HUSBAND EXPLAINED  PT HAD SHAKING AND COULD NOT MOVE BODY OR TALK.  AMBULANCE WAS CALLED AND PT WAS ADMITTED. SHE ALSO WAS DIAGNOISED WITH A UTI AT TIME OF EMERGENY ROOM VISIT .ALSO HAD HIGH FEVER WHEN ADMITTED TO HOSPITAL. PT WAS DISCHARGED AROUND 10:00PM  09/28/2023.  EVENTS REPORTED BY HUSBAND PT EXPLAINED COULD NOT REMEMBER WHAT HAPPENED, PT ALSO EXPLAINED HX OF CHRONIC UTI'S.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 49 years 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 was none. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: He took a Binax home test on 19May that was strongly positive (had been negative before); (19May2022) Positive, notes: He took a Binax home test on 19May that was strongly positive (had been negative before). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not had other medication in 2weeks. Patient may have experienced rebound symptoms after completing course of Paxlovid. He finished last dose of Paxlovid on 12May2022. Before finishing, he had complete resolution of symptoms (sore throat, myalgias). He remained well until 18May, when he had rhinorrhea and nasal congestion. He took a Binax home test on 19May that was strongly positive (had been negative before). The patient did not had Known allergies. The other medical history was none. The patient received paxlovid (Treatment Start Date: 07May2022, Treatment Stop Date: 12May2022) as treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Based on information received on 24-Aug-2018, the report previously considered as non-valid and became valid: because 37 patients involved in this case (initially reported as multiple children's). Initial unsolicited report received from Consumer/ Non-Healthcare Professional in the on 23-Aug-2018. This case involves 37 children patients who were vaccinated with a dose of vaccines PENTACEL and ADACEL. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due temperature excursions which was reached -0.33C for 30 minutes for their PENTACEL and ADACEL(incorrect product storage). It was unknown whether patient experienced any adverse event following vaccination. It had been request that the reporter sent "something to fill out" to provide all children details. 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 and Module VI of the 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. Follow-up information received from a non-healthcare professional in the on 24-Aug-2018. Number of patients updated. List of documents held by sender: none.
Client came to observer 30 minutes post vaccination stating she felt light headed. Clinic lead staff assessed indicating client weak, dizzy, flushed and diaphoretic. EMS called. Epinephrine .3 mg administered by auto injector. EMS arrived,  assessed client, encouraged client visit walk in clinic for evaluation and released client. Client left clinic stating she felt fine and walked unassisted out of building.
patient presented to pharmacy reporting symptoms of chills, headache, fever of 102 F for 1 & 1/2 day, starting the day of the vaccines.
Initial misuse report received from a healthcare professional on 03 December 2013. Four patients had received doses from open vials/unstable FLUZONE, TUBERSOL and ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
She got her vaccine, did fine the day of it.  The next morning she had extreme tiredness, aching, soreness on the arm, which she expected, foggy brain and light nausea.  She started to feel better as the day went on.  The next day it was the same thing all over again, as well as Monday.  She had force herself to do things, but continued to have these symptoms, high level of tiredness and foggy brain.  She did not call her doctor as it said that it could last for 2-3 days.  She did go in for an annual blood draw on Tuesday morning and got back the results, and one of them was that her TSH level was really low.  She has a FU appointment on 2/14/23.  She is still having the same symptoms.  Every morning she feels that she is going to be better, and then continues to have the same symptoms.
STROKE; This spontaneous report received from a physician concerned an elderly female of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. 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 stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231110448-Stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Hives over 4 days time itchy and uncomfortable. Started on shoulders and back, consecutively spread to chest and then down legs.
Information has been received from an office purchaser concerning a female patient who in February 2007, was vaccinated with a dose of PNEUMOVAX 23. The same day after the PNEUMOVAX 23 was given, the patient experienced severe pain in the arm where the PNEUMOVAX 23 was given. It was reported the the patient claimed she had had pain in her arm since she was given the PNEUMOVAX 23. But the office purchaser stated she had claimed to have pain in her arm before the injection was given. The patient sought medical attention via office visit. At the time of the report, the patient was not recovered.  Additional information has been requested.
PEDIATRIC PATIENT RECEIVED SHOT WHILST FATHER PRESENT AFTER SHOT HE STEPPED AWAY, THEN CHILD CLOSED HER EYE SHE LOOKED LIKE HER LIMS WERE SHAKING PER FATHERS OBSERVATION, THIS OCCURED FOR NO MORE THAN 2-5 SECONDS TECHNICIAN GAVE VACCINE. HE ALERTED ME AND I CAME OVER WITHIN 30 SECONDS.  PATIENT WAS AWAKE LOOKED A BIT PALE AND HER PARENTS HAD LIFTED HER FEET UP. SHE TALKED TO ME EXPLAINING THAT SHE REMEMBERED THE BLOOD AND THE NEEDLED AND SHE DOESNT LIKE NEEDLES SHE THEN DOESNT REMEBER ANYTHING FROM WHAT SHE SAW THEN SHE DREAMED. SHE WAS ABLE TO WALK OUT THE CUBICLE AND SIT DOWN, AFTER 5 MINUTES SHE APEARED TO BE MORE SWEATY AND HOT LAYING ACROSS HER MOTHER , MOTHER GAVE HER SOME SODA-FLUID.  I THEN CALLED EMERGENCY SERVICES, THEY CAME BY 5:25PM TO 5:30PM TOOK HER IN THE TRUCK TO OBSERVE, AFTER 15MINUTES OR MORE THE PARENTS CAME INTO THE DRIVE THRU AND SAID THEY WERE TAKING HER HOME SHE WAS FEELING BETTER.
Narrative: COVID infection following COVID vaccine series 03/25, Pfizer, dose #1 04/22, Pfizer, dose #2 08/17 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending 08/19 pt cc: no symptoms exposure: unknown
patient experienced numbness on his right hand; he started having this sensation when he went to sleep and ended up having it during daytime as well which got worse over time; he developed extreme pain in his arm. He stated that his arm was "killing him" at 3 o'clock that morning; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as unknown, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness on his right hand. He stated that he started having this sensation when he went to sleep and ended up having it during daytime as well which got worse over time. During the last few weeks, he developed extreme pain in his arm. He stated that his arm was "killing him" at 3 o'clock that morning and diminished at 6 o'clock that morning. Patient used heat pads, vibrators and took paracetamol (TYLENOL) to diminish the pain. He claimed that other people have been reporting the same type of reaction as well. The patient was referred to his physician for treatment recommendations. The patient was recovering from extreme pain in his arm. The outcome of the event numbness on his right hand was unknown.  Information on the lot/batch number has been requested.
Patient sought out testing at outside clinic on 5/19.  On 5/20 she phoned Covid  that she tested Covid Positive.  Patient reports beginning having symptoms on 5/9 (cold like symptoms) but continued to work.  She is currently precepting an employee who tested Covid positive on 5/11.   worked with her on 5/6 and 5/7.       Patient had the vaccine.
The pt experienced a swollen right upper arm and redness from shoulder to elbow, with warmth to the touch. She stated she felt feverish, complained of body aches and malaise. Symptoms began 9/14/00 and subsided by 9/17/00.
excessive swelling, crying, convuls, shock-collapse, sleeping problems; adm to hosp dx w/sz; meds Phenobarbital & Dilantin 1984-1987;
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of GARDASIL 9 experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, times and temperatures of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012036: US-009507513-1701USA012038: US-009507513-1701USA012035: US-009507513-1701USA012037.
neuropathy on bottom of feet. I felt an intense heat and pins/needles sensation on the bottom of my feet for hours on the night of my vaccine. I couldn't sleep from the pain and heat.
Patient was given flu shot and immediately after patients injection started to bleed a little more than normal. A few seconds later the injection site swelled up into a hard knot. Patient put ice on the injection site and the swelling went down a little.
pt recv vax 26MAR96 between 11AM & 1145AM police called to notify clinic found dead on 27MAR96 in AM;autopsy revealed abrasion on face & thumb, lungs congested, pleural, thymic & epicardial petechiae, cerebral edema;final dx suffocation
6-25-14 Symptoms of fatigue, rash (started 3 days ago). Diagnosis: Herpes zoster. Treatment: VALTREX 1gm - 1 tab two times daily #14, 7 days, ZOVIRAX 5% cream - 1 app three times daily, 60 grams.
2/27 Patient presented to a Clinic with ~4 days of nausea, chills, muscle aches and fatigue. He was diagnosed with COVID-19. He continued to feel poorly and 3/1 was started on doxycycline as an outpt. 3/3 was started as outpt on dexamethasone. 3/6 Presented to ED w/ worsening symptoms including SOB. RA pulse ox was 88%. He was admitted for COVID/COPD exacerbation and was changed to IV azithromycin/rocephin and dexamethasone. He was maintained on oxygen. He was unable to be weaned off oxygen and was discharged to home on 3/9 on oxygen.
Patient (myself) experienced acute numbness  throughout entire body (head to toe), loss of vision, hearing, and extreme perspiration/sweating for approximately 1-2 mins immediately after receiving injection. Pharmacist provided cold water after 9 mins. All symptoms subsided within 15 mins.  The overall event was short but very intense.
Patient received 1st dose Pfizer, Lot # EN6198 in RA on 3/3/21 during a drive-to public health clinic. Subsequently, received Janssen as listed above at treatment facility. No symptoms or adverse reactions reported.
Received 3 vaccinations on 10/12/15 (PNEUMOVAX 23, MENVEO, TENIVAC) - for clinical trial. C/O fever, redness right thigh beginning 10-14-15 lasting approx 2 days. Developed pain (Rt.) lower back, (Rt.) hip on 10-17-15 and went to hospital emergency room. Also with burning sensation in her right leg, pain in her (Rt) groin area. Given pain meds. (Rt.) hip pain and burning sensation (Rt.) leg worsened 10-29-15. Patient seen in office and Rx'd LYRICA.
J96.00 ACUTE RESPIRATORY FAILURE 2/19/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/28/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 2/19/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Tinnitus. ongoing, no treatment, to the best of my knowledge there is no known treatment for tinnitus . symptoms just started one day and havent stopped since, it is literally all day every single day 24/7.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information was provided by the reporter.
A rash developed on hands and feet later in the day on the day  the vaccine was given .  On the following day it began spreading to lower extremities.
Two weeks after the injection, I went into atrial fibrillation with rapid ventricular response. My heart rate was over 140. It began at 8 AM Pacific time, by 9:30 I was in the local emergency room. After they spoke with my doctors in hospital, they admitted me. I was in A-fib until 6:30 PM. At around 10:30 AM they put me on an I.V. with medication to slow down my heart rhythm. But the medication did lower my blood pressure so I had to stay at the hospital for 24 hours. This same basic chain of events occurred two weeks after my 3rd dose of my COVID-19 vaccine and then again at 4 weeks.
On Oct 2, 2017, patient was given FLUARIX QUAD at pharmacy. Patient is complaining of pain down the left arm. Pain is still present today.
Precancerous polyps; Breakthrough psoriasis on ankle; soreness at injection site on arm; This is a solicited report from a non-Interventional study received from a contactable consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-4144451-00). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 vaccination, and she started to receive risankizumab (SKYRIZI), subcutaneous from unspecified date for moderate to severe chronic plaque psoriasis. The patient's medical history included moderate to severe chronic plaque psoriasis from unspecified date and ongoing. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient previously received BNT162b2, intramuscular on Mar2021 as dose 1, single for COVID-19 immunisation.  The patient experienced precancerous polyps and non-serious soreness at injection site on arm and breakthrough psoriasis on ankle with SKYRIZI (risankizumab). Pfizer-BioNTech COVID-19 vaccine was also considered suspect. It was reported that precancerous cells were present. The patient had minor breakthrough psoriasis on ankle. She had minor soreness at the injection site after COVID-19 injection. In Jun2021, she had precancerous polyps removed on colonoscopy. The patient underwent lab tests and procedure which included Colonoscopy (precancerous polyps removed on colonoscopy) on Jun2021. The outcome of the events was unknown.   The reporter's assessment of causal relationship of the events with suspect drug BNT162b was reported as possible while it was not reported with suspect drug risankizumab. The company manufacturer assessment of causal relationship with suspect drug risankizumab was reported as not assessable for precancerous polyps and as no reasonable possibility for injection site pain and psoriasis flare-up. The company (AbbVie) assessment of causal relationship of the events with suspect COVID-19 vaccine was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Precancerous polyps, Psoriasis breakthrough, Vaccination site pain and suspect drug BNT162B2 cannot be excluded.   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.
arm became really itchy around injection site; thought it be cellulitis; whole arm around injection site was swollen up like a balloon; whole arm around injection site was red; doses given 14 days apart; very nervous; became nauseas; ended up throwing up; very low fever 100F; just tired; This spontaneous report was received 10FEB2021 from a consumer which refers to a 78-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced nausea, vomiting, tired, itchy around injection site, arm swelling at injection site, arm  red around injection site, first and second dose were given 14 days apart.  The patient's medical history included current cancer, dermatomyositis (autoimmune disease), Concomitant medications included chemotherapy (Keytruda infusion).  On 15JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: 039K20A).  On 29JAN2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (Lot number: 028L20A). Doses were given 14 days apart, out of window 15 days early.  The event(s) were, " injection site soreness, fever  he became nauseas, "I never get nauseas", ended up throwing up, very low fever 100F, tired, the arm became really itchy around injection site, whole arm around injection site was swollen "up like a balloon" whole arm around injection site was red, first and second dose were given 14 days apart".  The action taken for Moderna COVID-19 Vaccine was reported as taking Tylenol after the first vaccine injection for fever and Amoxicilin after second shot, 1x1000mg.   The outcome of the events was reported as Resolved.; Reporter's Comments: This report refers to a 78 Y/O male with Inappropriate schedule of vaccine administered (second dose at 2 week interval) for mRNA-1273 (lot # unknown) with serious unexpected cellulitis 5 days after second dose and NS Vaccination site pruritus, vaccination site erythema, vaccination site swelling, fatigue, fever, nausea, vomiting.  Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came to the pharmacy on 9/18/19 indicating to the pharmacist on duty that their right upper arm had swollen from their shoulder to their elbow and it had been worse prior to coming into the pharmacy. The pharmacist on duty instructed the patient to take Benadryl for the swelling.