chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fast heartbeat and that is what I witnessed when I was sitting and waiting for 5 to 10 minutes; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, "I was reading on the website about the Pfizer vaccine (unspecified vaccine) and I noticed that it says certain things about the fast heartbeat and that is what I witnessed when I was sitting and waiting for 5 to 10 minutes or whatever and I notice that so. I'm schedule to go for my second shot and I kind of worried about going, so with this fast heart beat I don't think I should go for the second vaccine." Onset date of the event was unknown. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
pain in arm; swelling and pain under left arm; Fever; pain in her body; Tiredness; body was shaking; swelling under arm, I could not lift it; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 15:15 (Batch/Lot Number: ER8736; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lack of iron and left knee problem. They did MRIs. It was reported that she will be going for surgery on her left knee. The pain was much less now, she had been doing physical therapy for the same. Concomitant medication included FERROUS SULFATE taken for iron deficiency, ATORVASTATIN taken for blood cholesterol increased, B12 VITAMIN, VITAMIN D3, and CALCIUM. The patient experienced vaccination site pain, vaccination site swelling on 28Apr2021. She had pain after the shot about 2 hours after and swelling. She said that it increased more and affected her more until now. She said she took the vaccine and didn't feel much, then it was gradually increasing 1-2 hours after getting the vaccine. On 29Apr2021 she experienced fever, pain in her body, tiredness, body was shaking, swelling under arm, could not lift it. It was reported that after she slept because she felt tired and then woke up. Her body was shaking around 03:00PM, she took two Advil, she thinks they were 250mg or 300mg. On 30Apr2021 she experienced swelling and pain under left arm. On an unspecified date she experienced pain in arm. The outcome of fever was recovered on unspecified date. The outcome of pain in her body, vaccination site pain, vaccination site swelling, swelling and pain under left arm, Tiredness, body was shaking, swelling under arm, I could not lift it, and pain in arm was unknown. The patient underwent lab tests and procedures which included blood test which showed normal results in 2021. Therapeutic measures were taken as a result of fever.  No follow-up attempts are needed. No further information is expected.
fever; very painful muscle and joint pains over whole body and especially both arms, shoulders, neck, hips, legs, and calves; dehydration; suspected but unconfirmed kidney/bladder infection; ph imbalance Fever and muscle and joint pains lasted over two weeks. The ph imbalance has continued and was diagnosed by my physician on 01/13/2022. I am currently following the prescribed regime which will complete on 01/18/2022.
--7/18 -- Immunizations received approx. 12pm --7/19  -- Fever started approx. 7-8 am; T 99; Tm 102 that evening; fever lasted 3 days; took Tylenol/Children's Motrin --7/19  -- Also with decreased energy/appetite; increased fussiness, runny nose and nasal congestion - slowly resolving --7/19 -- Also with looser stools -- fouls smell;  not going more often; nonbloody; darker green stools --7/27 -- Erythematous rash started with few spots on face and abdomen; increased fussiness --7/28 -- Rash spread to more of trunk --7/29 -- Rash spread to more of body; more concentrated on trunk, also scattered on limbs and more on face; no new fevers; still having loose stools.
Patient started taking Paxlovid same day as positive test.; Patient started taking Paxlovid same day as positive test.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 24Feb2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing); "Previous DVT" (unspecified if ongoing); "Joint replacements" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: 12Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient started taking Paxlovid same day as positive test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive; (04Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient took other medication with in 2 weeks of vaccination. It was reported that patient received COVID-19 treatment from 24Jul2022 to 29Jul2022. It was also reported that patient started taking Paxlovid same day as positive test. Patient completed 5-day course without incident. Patient did not test negative until 04Aug2022 (approx 7 days after completion).   No follow-up attempts are possible. No further information is expected.
Migraine mild in intensity; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine mild in intensity) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (Migraine mild in intensity). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine mild in intensity) outcome was unknown.            Concomitant product used was not provided by the reporter.
Lar,ge red circle at injection site. Swollen, red, itchy arm, warm to the touch still occurring 10 days after injection
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. Patient stated that she has a history of headaches which worsened after receiving the first dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received contains NNI: The reporter answered the call and said she was not the patient and disconnected the call.
This spontaneous report was received from a physician via company representative concerning a 17 year old (at the time of event) (also reported as 18 year old at the time of reporting) patient of unknown gender. On 03-OCT-2012, the patient was vaccinated with single dose of GARDASIL (lot number, expiry date, dose and route unspecified). However it was unspecified if this dose constituted the first, second or third dose for the patient. No concomitant medications were reported. On 12-OCT-2012, the patient developed bruising and idiopathic thrombocytopenic purpura (ITP). It was unspecified if the patient sought any medical attention. The patient was referred to a hematologist however no follow up was taken place. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of the events were unknown. The relatedness for the events was unknown for GARDASIL. Upon internal review, the event idiopathic thrombocytopenic purpura (ITP) was considered as medically significant. Additional information has been requested.
Within 8 hours of the shot, patient developed Chills, severe headache, fever (101-102) and vomited four times between 12am-7am.  Note that he has had COVID infection in April 2020
Numb lips, metal taste, headache, itchy throat, tongue swollen, sores in my mouth, sick to my stomach both nausea and diarrhea.
blocked colon; shot arm to go icy cold; cold sensation through her arm, "icy veins"/shot arm to go icy cold and travel down to thumb and hand and stay cold; tingling in her arms and legs; gastrointestinal issues; This is a spontaneous report from a contactable Other HCP (patient). This 48-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose, and second dose on 23Jan2021 at single dose in arm for COVID-19 immunization. The patient medical history included severe reactions to some things. The patient's concomitant medications were not reported. Patient wanted to ask if some of her symptoms were an effect of the vaccines. She was having problems locally being able to differentiate problems. In her case, since she had a history of severe reactions to some things, she was observed for both for 40 minutes. Patient reported to have experienced a cold sensation through her arm; "icy veins", tingling in her arms and, reported having a "blocked colon". Mentioned that the gastrointestinal issues may have been caused by the diphenhydramine hydrochloride (BENADRYL). Her problems worsened even after diphenhydramine hydrochloride and she wound up at the ER on Wednesday when she woke up. She did not want someone to think later that her symptoms were related to it if they are not. Maybe some would be related. The doctor told her if her symptoms don't get better in two weeks, then she needs to see the Immunologist.  She then described tingling in her arms and legs. She did not want to wait until then. If it is expected, she can live with it. She wanted to know if it was common for shot arm to go icy cold and travel down to thumb and hand and stay cold. That was what they were ignoring.  She also said she wound up with a blocked colon. Outcome of the events was unknown. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limitedly available information and drug's safety profile, the blocked colon is unlikely related to suspect vaccine BNT162B2 administration. The detailed clinical course would be helpful for further assessment.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.
Death less than 24 hr after receipt of Pfizer #1 covid vaccine: 43 yo reportedly received her first Pfizer covid vaccine on 7/2302021.  Her agent received a call from Staff to inform  her of this sudden death.  She was reportedly found on her couch deceased on Friday evening, 30 JUL 2021 and law enforcement had her transferred to a Funeral Home pending determination on Autopsy and Family wishes. Presumed cause of death is Heart Failure with Autopsy pending for etiology of Dilated Cardiomyopathy and death. Patient had 1.5 yr hx of  dyspnea on exertion, intermittent chest pain at rest, and palpitations. She was evaluated here for a LBBB and long QT in 2018. Echo at the time was normal and she was cleared.   BP: 118/72; HR: 71; RR: 16; T: 98.6 °F (37 °C); HT: 66 in (167.64 cm); WT: 155 lbs (70.31 kg); SpO2: 98%; BMI: 25.02; BSA: 1.795 square meters; Tobacco Use: Yes; What type of tobacco product?: menthol; Amount of tobacco product used per day: 2 per day;
The day of the injection I had zero issues. I felt fine until the second night after the injection. At 2am I was awaken by what felt like a massive charlie horse cramp in my right arm. I was up the rest of the night trying to calm the cramping. I used Tylenol  and topical sore muscle creams but nothing worked. I had limited use of my arm. The next day I was able to get my arm to move and some of the pain subsided.  The next night I was awaken 2 hours after I finally went to sleep by the same cramping pain. This has occurred every night since I received the injection. Starting the week of February 19th the cramping pain became more aggressive and would additionally last throughout the day.  My Dr prescribed a pain med which ended up not working. Currently I am taking Tylenol or Excedrin extra strength every 4 hours to try to get some receive so I can go to work. On 2-22-22 I saw a neurologist who has requested that I get a deep tissue mri. This is due to the fact that not only do I have cramping in my bycep, but there is a 4 inch diameter area where the injection went into my arm that is numb. The skin surface is numb and has been since the 3rd day after the injection. The neurologist if investigating this as SIRVA.
Approximately 16 hours after receiving the vaccination chills/shivering with a low-grade fever (100.0 F) started. Symptoms lasted approximately 12 hours. Mild pain with  some redness occurred at the injection site, starting about 24 hours after injection and lasting for approximately 48 hours.
Rashes on both arms and back with itchiness, appeared 30 minutes after injection. Referred to Dr @ clinic. Advised to see ER.
Death Narrative:  Patient was previously tested COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted with afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more times over the next two months for cardiac symptoms with last hospitalization occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure. Patient never recovered and transitioned to hospice before passing on 4/16/21. Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2 2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic foley
normal vaccine type irritations at injection site, went away. five days later started to hurt again, had pain there, a nodule started that was hard and came to a point. feels shoulder to arm is impacted: has spasms, twitches, snappy and crackling all the way down to elbow. no current nodule pain. feels its affecting range of mortion
a minute or two after receiving the vaccine felt a Hot flush feeling and a metallic taste on the; and a metallic taste on the mouth; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (a minute or two after receiving the vaccine felt a Hot flush feeling and a metallic taste on the) and DYSGEUSIA (and a metallic taste on the mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. can't read it) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, ESCITALOPRAM OXALATE (LEXAPRO), METOPROLOL, PANTOPRAZOLE, TOPIRAMATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LIRAGLUTIDE (VICTOZA) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HOT FLUSH (a minute or two after receiving the vaccine felt a Hot flush feeling and a metallic taste on the) and DYSGEUSIA (and a metallic taste on the mouth). On 01-Mar-2021, HOT FLUSH (a minute or two after receiving the vaccine felt a Hot flush feeling and a metallic taste on the) and DYSGEUSIA (and a metallic taste on the mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medications provided by the reporter.
fever/100.1/99.6; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever/100.1/99.6) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/100.1/99.6). At the time of the report, PYREXIA (fever/100.1/99.6) had not resolved.    Caller reports they received the second dose of Moderna around 11:00am on 13Sept2021 done in the left arm. Caller reports first dose was done in left arm as well.  Caller experiencing  fever and just wanted to know if it's safe to take Tylenol or Advil.  Concomitant medications was not reported.  Treatment medications was not reported.
Patient arrived for COVID-19 vaccine (Moderna vaccine). Patient was  under dosed given 0.05mL, waited for 15 min and then left and no acute reactions were noted. Leadership was notified. Patient was brought back 3 days later for accurate dosing. No adverse event noted
3MAR93 mom reported that pt had t106 R starting 8 hrs p/vax; states temp stayed between 105 - 106 x/would come down to 103 R for approx 48 hrs; mom contact PMD who adv cont w/APAP q 4 hrs;
A day after my second vaccination, there was difficulty breathing and my heart rate was up. It felt like I had a blood clot coming, and so I went to the ER and everything was fine, however I was still having trouble breathing. I had bloodwork done for signs of a stroke  that were unremarkable. I continued to have trouble breathing and the next day I had a lot of mucous and saliva build up and choking on it. This lasted about an hour in duration. I did experience this multiple times since. No trouble breathing post episode. After receiving booster shot, 11/02/2021 at the doctor, Pfizer, I experienced trouble swallowing and mucous build up within 45 minutes, and was sent to the ER again where I was given Benadryl and Steroids. Symptoms began to subside and everything however I began to have another episode the day after with Choking on mucous buildup. I went and got an endoscopy and eosinophilic esophagitis. I was told by doctors that pfizer does aggravate this condition. No episodes have come up and am on a strict diet for improvement and have seen great improvement in quality of life.
pt recvd vax 12JAN; sx of pain @ ball of lt foot began 13JAN; was difficult to walk; became feverish later in the wk & noticed red streaking @ lt foot; went to see MD on 15JAN & was started on med;
Patient came in 7/06/21 to get a Pfizer Covid-19 vaccine. He explained that even though he had a J&J vaccine in March, he would like to get the Pfizer too.
this is one of three pts who devel severe local rxn;no other info was available @ the time of the call;
headache; stuffy nose; cough; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case is linked to case 2019SA158639.  This case involves a 63 years old female patient who experienced headache, stuffy nose and cough, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5875AA and expiry date: 14-Feb-2020) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious headache, stuffy nose (rhinorrhoea) and cough following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was cough, stuffy nose and headache.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovering / Resolving for headache, stuffy nose and for cough.  Documents held by the sender: none.
No symptomatic AEs / No additional AE; Patient was given PEDVAX HIB at 5 weeks 4 days instead of 6 weeks. No symptomatic AEs. No additional AE details or PQC.; This spontaneous report has been received from a nurse, concerning a 5-week and 4-day-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 08-JUN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T042014 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and confirmed as 23-JUL-2023) (dose, route of administration, and anatomical location were not provided) as prophylaxis. The patient was vaccinated at 5 weeks 4 days instead of 6 weeks (Product administered to patient of inappropriate age).  No symptomatic nor additional adverse events were reported.
(R) arm swollen, warm and red 48 hrs after vaccination Dx cellulitis vs vaccine reaction Rt upper arm on Augmentin 400 mg 1 5 ml-tsp BID x 7 days per ER report
Chronic mild pain in left arm above elbow, still continues. Aggravated when reaching behind the back or lying on left side. Not noticeable 90% of the time. Has been continual since a couple of days following the second injection. No similar reaction experienced after first injection.  Two days ago (5/15) a rash became apparent on the left arm between the elbow and wrist. No swelling, pain, or itching associated with the rash, merely skin discoloration. No known potential other causes. Condition unchanged today; picture available.  Neither condition appears to be serious enough to warrant medical attention.
pt recv vax 19DEC96 & devel flu-like sx & yellow phlegm which persisted @ the date of this report;also devel an inj site rxn which resolved p/a couple of days;
Chest pain, inpatient therapy 4-17-2021 to 4-19-2021. Discharge diagnosis of myo -pericarditis