chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; This spontaneous report received from a consumer via company representative via social media concerned a female of unspecified age, 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 were not reported) dose, 1 total administered start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was died, as per the reporter stated that, my wife died from the Johnson and Johnson vaccine. On an unspecified date, "the patient died from unknown cause of death. It was unknown if an autopsy was performed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20220256305- COVID-19 VACCINE AD26.COV2.S- Died. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Raised 2" red area in L arm. Lightheadedness, dizzy, joint aches, diarrhea. Pt states he gets pains in his chest at times. Also stated chills on 9/30th. Pt with weakness and swelling in his joints, hard to move. Also feeling sore in his joints. Rx for Tylenol and Motrin 800 given.
Information has been received from a nurse concerning a female patient who on unspecified dates was vaccinated with the first and the second 0.5 mL doses of GARDASIL. "Within a day" after receiving the first and second dose of GARDASIL, the patient experienced fatigue for about a week and then the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; felt like the flu" for 2 days; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number G537F, expiry date unknown) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema, swelling arm, headache, fatigue and pain were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient exerienced flu like symptoms for 2 days.  The patient also expereinced red, swollen arm, sore arm, headache, fatigue and achy. Arm ache still persisted after 10 days. This case linked with US2019AMR232164, US2019AMR234116 and US2019102453, reported by same reporter.
Two days pot vax, this 6-month-old child experienced a rash. By the next day it had extended "from head to toe." The pt was seen in the ER. No further information is available.
Pain injection site; Dizziness; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain injection site with outcome of recovered on 09Dec2019 and dizziness on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test on 09Dec2019 but results were unknown.    The information on the lot number has been requested.
0.5ml HPV administered in the right deltoid. Within one minute the patient went pale & states that he did not feel well. Pt placed in supine position and a sip of water given. Color came back to the patient's face, heart rate 56. Dr to bedside. Vasovagal reaction. Three minutes later patient experienced two episodes of emesis, pale. Dr evaluated patient. Dr advised patient to stay in clinic longer for monitoring. Mom and nurse or dr at bedside entire time. Patient sat up, color good, states feeling better. Drank a sip of water. No further emesis. Patient sat on table with legs down for 5 minutes, states feeling fine. Slowly stood up. Walked slowly toward door, turned around and went pale. Started to faint against wall, slowly went down with mom and reaching for him. Did not hit head. Laid patient supine on floor. Yelled for help and AED. Dr at side. Attached AED, no shock advised. Heart rate per Dr auscultation of heart in 30s. Pt talking, aware of surroundings, asking what happened. Reassured patient he is being taken care of. EMS called by another staff member. BP 98/64 oxygen 100%, Heart rate per palpation by myself at 60. Pulse ox registered 47 for HR. Patient color pale, talking and responsive to location. EMS arrived, I gave report of vitals, no family history of syncope, though patient and mom report patient has experienced 4-5 episodes of near syncope-syncope in past. Reassured mom. EMS took over care and patient transported to ER.
10/21/2006 Pt c/o redness, warm, swelling from shoulder down to wrist left arm. Resolved by 10/25/06, Denies hives or dyspnea.
Patient developed hives within 2 hrs of vaccines being given. Rx BENADRYL PO. No tongue/lip swelling/wheezing.
Pt had fever at home an 30 seconds of generalized tonic clonic activity about 24 hours after vaccine (a little less).
severe burning while the medication was being injected; This spontaneous report was received from a medical assistant referring to a 12 year old male patient, with no pertinent medical history and no known drug reactions/allergies.    Concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (right arm, different location).     On 01-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1614897, expiring on 20-SEP-2021, dose 2, intramuscularly,y in the right arm, for vaccination.    The patient experienced severe burning while the medication was being injected into the right arm (injection site pain).   Burning resolved a few minutes after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered.  No treatment was provided.  Not any lab diagnostic test was performed.  The patient did not seek for medical attention.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event.  This is one of two reports from the same source (1908USA002441).
Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87306), via an unspecified route of administration, administered in left arm on 25Mar2021 at 21:27 (at the age of 50 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced Anaphylactic reaction. The patient visited emergency room on 25Mar2021 and and was released from the emergency room on 26Mar2021. The patient received treatment for the events. Caller stated from her understanding from her doctor she was not anaphylactic to anything in the shot but she had an anaphylactic reaction. Caller stated she wanted know since the vaccine is federally regulated and mandated and she has health insurance but her (Services name) and deductible is high and her being anaphylactic to the shot and receiving care and now receiving bills does Pfizer offer any help with that. Anaphylactic reaction: Caller stated this ended the next morning because it was overnight when she was released from the hospital. Caller clarified she was brought to the emergency room and was released from the emergency room. Treatment: Caller stated she was provided medication at the site of the (Name) and then put in an ambulance and was given medication then transported to the hospital. Caller stated the COVID vaccine she received was the first dose and last dose. Caller stated the physician office was not open and the hospital she wanted to go to was approximately 30 minutes away and she was transported to the nearest hospital to the facility location. The patient did not undergo any lab tests and procedures. The outcome of the events was recovered on 26Mar2021.
Patient received Pfizer Bivalent vaccine on 9/14/22 and 11/11/22.  No symptoms noted at this time.
devel nausea, dizziness, h/a, fever; pt was treated w/Mortin & advised to drink clear liquids & was placed on SIQ for f/u the next day;
Soreness in arm/difficultly moving arm. Lasted until 10/19/16. Resolved.
shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering.  The information on the batch number has been requested.
Beginning Saturday (day after administration), she had redness and swelling (and muscle soreness) at injection sight. Sunday the swelling seemed to move down and around her arm as well as the redness. It has continued to progress each day. Currently her arm is very dark (almost looks like a very dark bruise all over it) and swollen to her wrist. Her hand looks a normal color. She states she bruises very easily anyway due to Plavix.
EXTREME LETHERGY, NAUSEA, FATIGUE, WEAKNESS, ELEVATED TEMP, ELEVATED HEARTRATE, SENT TO THE HOSPITAL FOR EVALUATION, FLUIDS ADMINISTERED AND MONITORED, THEN RETURNED TO FACILITY
Information has been received from a nurse practitioner via a company representative referring to an approximately 65 year old female patient. Information about patient's current condition or medical history was not reported. On 21-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose not reported) subcutaneously. Concomitant medications were not provided. On 22-MAR-2013 the patient experienced a rash all over her body. The patient was referred to a dermatologist and diagnosed with Lupus in June 2013. The nurse practitioner reported that the patient still saw a Rheumatologist as of April 2015 and outcome of Lupus was reported as not recovered. Upon internal review, Lupus was determined to be medically significant. Additional information has been requested.
p/vax pt woke up w/swollen eye; rash under arms & back of neck; low grade temp; tx-DPH
Got sick every time; Initial information received on 02-DEC-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (unknown demographics) reported got sick every time (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick every time (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Patient presented with confusion.  ABG showed acute on chronic respiratory failure with hypoxia and hyp patient was treated with ceftriaxone and azithromycin for possible superimposed bacterial pneumonia as well as COPD exacerbation with IV methylprednisolone and duo nebs.  Patient self extubated on 11/7/2021 but was able to avoid reintubation as oxygen levels were weaned down. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  An adult female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Lot number: EL1284), on 20Jan2021 as dose 2, single (Lot number: EL9262) and on 17Aug2021 as dose 3 (booster), single (Lot number: EW0191) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 23May2022; IBUPROFEN, start date: 23May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". 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.  Based on product investigation results, the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL1284, fill lot EL1282, the bulk formulated drug product lot EL1280. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.  Based on product investigation results, the complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL9262 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9262, fill lot EL9253, and the formulated drug product lot EL9244. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Suspected Covid 19 cannot be completely excluded.
Within one hour, I felt dizzy, completely drained, headache, body aches, fever, chills, stuffy and runny nose, sinus congestion, sensitivity to light and sound, swollen and sore throat, chest congestion, increased heart rate of 120-140BPM, decreased O2 sat of 95% and earache pain. I did not lift my head or been able to get up until 11/4 @7:15PM.
She said arm was swollen from bicep to her back. It was real red. It is a lot better now
Initial information received on 16-Oct-2018 regarding an unsolicited valid serious case received from a other health professional and live additional information received from same reporter on 17-Oct-2018. This case involves a 54 years old female patient who received 0.5 ml vaccine FLUZONE HIGH DOSE (lot UJ042AA and expiration date 19-May-2019) via unknown route in the right deltoid on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had urinary tract infection. It was a case of actual medication error due to inappropriate age at vaccine administration. No side effects 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.
Patient started noticing dark stools the day after vaccination (4/15) and began vomiting blood on 4/16. One episode of vomiting resulted in a syncopal episode in which the patient hit their head, causing a laceration which required staples. The patient does report intermittent abdominal pain over the course of the past few weeks, but today is more severe and the first time he has experienced bloody emesis. Upon presentation patient was tachycardic, hypotensive, and pale. Patient reports he does not frequently consume alcohol. Patient received a pantoprazole bolus and drip, an octreotide drip, and PRBC. Patient also received several doses of ondansetron. Patient is being admitted for care.
This report was received from an agency and was assigned manufacturer report number (5581814), refers to a 84 year old female patient. On unknown date the patient was vaccinated with PNUEMOVAX 23 (lot # H014196, expiration date was 19-MAR-2014). On 04-FEB-2013 the patient came into the office and complained of swelling. The doctor thought it was fine and was a mild local reaction and she was doing okay on 11-FEB-2013. The original reporting source was not provided. This is one of the several reports from the same source. Additional information has been requested.
Rapid heartbeat that lasted for 6 to 10 seconds; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat that lasted for 6 to 10 seconds) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat that lasted for 6 to 10 seconds). At the time of the report, HEART RATE INCREASED (Rapid heartbeat that lasted for 6 to 10 seconds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
Pain at site progressing to numbness & tingling in left arm extending to wrist day 1 & 2- fatigue, nausea, head & neck pain day 1 & 2.
My arm was very sore after the second dose of Pfizer. A few weeks later I noticed the pain in my muscles still persist. Now, I'm continuing to have elbow pain and pain in my upper shoulder
Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TESTOSTERONE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired for a couple of days). At the time of the report, FATIGUE (Tired for a couple of days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills, Fever middle of the night, headache, sluggish. No appetite.
Passed out at one time; Having COVID symptoms; Massive headache; A spontaneous report was received from a consumer concerning a 68-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced massive headache, passed out at one time/syncope and having COVID symptoms.  The patient's medical history was not reported. No relevant concomitant medications were not reported.  On 26 Feb 2021, approximately two days prior to onset of the events, the patient received their dose of mRNA-1273 (batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient had a massive headache. On an unknown date, the patient passed out at one time (medically significant event) and overall just having COVID symptoms. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events massive headache, passed out at one time and having COVID symptoms was not reported.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of syncope along with nonserious events of unexpected COVID-19 and expected headache.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.