chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore on the arm; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux, stomach relaxer, IBS (irritable bowel syndrome). Concomitant medications included hyoscyamine sulfate for stomach relaxer, omeprazole (PRILOSEC), Vitamin D2, omeprazole for acid reflux. On 23Jan2021, the patient experienced heart beat was high, she was having heart beat was fast and usually it's low, she just feel weird, and also experienced sore on the arm. No treatment received. Lab data included Height: 5ft 5 inches and weight: 140 pounds on unspecified date. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Redness, tender, warm to the touch, swollen for about 2-3 days
This non serious case was received on 11 March 2009 from VAERS (reference number 267304) via a search of the QScan database. A 32 year old female received Fluzone SV '2006-'2007 USP (lot number U2257AA) on 23 October 2006, An hour and a half later the patient developed chest tightness a "tickly" cough, red and burning eyes, congested ears, egg white rash, CBC (complete blood count) was completed. The patient was reported as recovered and required an emergency room doctor's visit.
Case number PHEH2013US021911 is an initial spontaneous report from the nurse received on 18 Oct 2013. This report refers to a 01-year-old female patient. She received a flu shot (manufacturer and batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) on an unknown date. On an unknown date, after vaccination she experienced a severe reaction to the vaccine. The outcome of the event was not reported. No other information was available.
pt recv vax 27FEB97 & 4MAR98 pt exp massive amounts of pruritic varicella-like lesions which were dime of nickel size located on scalp, extremities & trunk;pt also devel a low grade fever;
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 74 years old female patient received a 0.5 mL dose of FLUBLOK QIV (Batch number: QFAA1813, expiry date: 30-Jun-2019, for the first time) on 20-Nov-2018 and inadvertently second time on 30-Jan-2019 (batch number, expiry date not reported) via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. No adverse event was reported at the time of reporting. Reported as not aware of any adverse effects so far. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. Documents held by sender: none.
Information has been received from a medical assistant concerning a patient of unknown age and gender. On 26-MAY-2015 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # J006185, expiry date: 24-MAY-2015, dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Approx 3-4 minutes after receiving a HPV #2 and Tdap she fainted and twitching of facial muscles and extention of arms and legs for less than 5 seconds.  After episode was over and she set up she was oriented x 4, pale, Vital Signs within Normal limits.  Observed for 30 minutes with V.S. done every 10 minutes. V.S. remained WNL.  Mom was presented and escorted daughter home with instructions to take to ER if condition changed.
Rash on both thighs, both arms. Large raised and red bumps, itchy and painful if scratched.
Just days after the vaccine the patient woke up with the left side of his face numb and inactive. He was shortly after diagnosed with Bells palsy. And has been prescribed a steroid pack for the bells palsy.
blood clotting cancer; blood clotting cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), THROMBOSIS (medically significant), outcome "unknown" and all described as "blood clotting cancer". The reporter stated that one of her relatives, who received the vaccine developed blood clotting cancer but still took the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) form a Pfizer-sponsored program via Regulatory Authority. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (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: ERYTHEMA (non-serious), outcome "unknown", described as "Red Arm Immediately Upon Getting the Shot"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain". Additional information: A male patient of an unspecified age received bnt162b2 (BNT162B2) via unspecified route of administration. It was reported that the patient experienced adverse events within 3 days of his first dose of the Pfizer BioNTech Covid Vaccine. Reportedly the caller did not want to tell him any personal information and he will need to be transferred to Medical Information for questions. Call handler states that she will contact him with the Medical Information department to address his question. Call handler requests that call answer some additional questions about his experience before transfer about the adverse events he experienced. Caller states he had a red arm immediately upon getting the shot and he has had chest pains for the last 2 weeks. It was reported that the patient was upset and states he called to figure out the science behind the first shot and what was in it. Caller handler states is not call handler a medical professional, why cannot she tell him what is in it. Caller states each time he moved to another department; he loses more confidence in Pfizer. Additional information and details unable to be obtained. The reporter stated that he was recording this call as well and is going to show it to everyone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced sweating and a fever accompanied by nausea. Patient's wife called 911 and paramedics remained with patient until he felt better. transport to hospital was not required.
Erythema, flu-like symptoms, injection site reaction, swollen lymph nodes, muscular pain in neck and shoulders.
Dizziness, NauseaVomiting, HYPOtension, pallor Narrative: 1207 - felt dizzy, tingling, turned pale, felt nauseated. Laid down in chair, BO 107/70 HR 75 1225 BP 122/85 HR 71 standing, felt stead released back to work at 1223.
Worsening Left arm pain starting around day 3 after injection.  There was pain at the time of injection that was slightly worse than a usual flu vaccine.  The pain is a constant ache 8/10 at rest, only 2/10 when active.  It has a neuropathic characteristic in that there is no soreness or tenderness at the site anymore; it does not hurt more when I press on the site; it hurts constantly without provocation; ice does not make it better; heat makes it much worse.  It is very difficult to sit at a desk and do work; the pain intensifies the longer I sit.  It is much less intense when I am active and moving the arm.   It is not getting any better with time, in fact, it seems to be getting worse.  I am now almost 6 weeks after the injection.  I do not plan to get the second, booster vaccine since this seems worse than having the shingles.
nasal congestion feels like she has a head cold, headache starting 9/14/21. Note: husband also tested positive for COVID on same day, he also was vaccinated
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
Pt was given Covid vaccination for age 5 - 11 y/o. Patient should have received vaccination for age group 12+. Patient denies any signs or symptoms.
Patient has redness on the right arm and pain. The pain started late in the evening on 8/7/13. Pt has no temp. It was warm to touch.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients age and gender. On an unknown dates the patients were vaccinated with doses of ROTATEQ orally (dose, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
24APR98 c/o redness, soreness & swelling @ the site of inj instructed to ice area & take OTC ibuprofen PRN;28APR98 cont to c/o redness, swelling, soreness & now blistering @ site states did ice area on 25APR98 & 26APR98;pus from blister
Patient had typhoid vaccine/ IPV/ DT (decavac) vaccine on Wednesday the 6th.  She is traveling in Septemter.  On Sunday, August 10th,  she began to experience muscle aches that came on quite suddenly, she felt very weak, had "teeth chattering", chills, headache.  She also had abdominal pain and vomited on Sunday night.  Temp got up to 102.  On Monday she continued to run a fever of 102.8.  Today her temp is 101.8.  She states she is weak today and unable to sit up for more than ten minutes.  In review of side effects of typhoid vaccine - it is possible this may be a reaction to this vaccine. . .
Itching Injection Site; Itching on lower legs and scalp; Palpitations; Hypersensitivity reaction; Rash over inside of both arms, and chest, and mid-back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching Injection Site), PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Pollen allergy (sneezing, runny nose) since May 1966. Concomitant products included ACETAMINOPHEN, SILDENAFIL, METRONIDAZOLE and PROBIOTIC 10 for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site). The patient was treated with HYDROCORTISONE for Rash and Itching, at an unspecified dose and frequency. On 25-Apr-2021, VACCINATION SITE PRURITUS (Itching Injection Site) had resolved. In May 2021, PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back) had resolved.            Additional treatment medication included lotions (unspecified).   This case was linked to MOD-2021-033612 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Updated event details, outcome, suspect product details and concomitant medications.
lt arm edema, redness, pain seen by MD 21FEB w/o treatment;s/sx persist to 23FEB referred back to MD;s/sx involve the entire arm;GI distress 4hrs p/vax
At approximately 1030, RN administered the wrong COVID-19 vaccine to client (DOB: 07/18/1983). The client presented to vaccine site with an appointment to receive his 2nd dose Moderna vaccine, however, RN accidentally administered the Pfizer vaccine (lot# FF8839) in the L deltoid. RN reported administration error to Lead RN, stating that she realized it was a misdose when she went to write the Pfizer information on his vaccine card and noticed that he had received Moderna for the 1st dose. Lead RN informed client of the error and answered the client's questions. Client verbalized understanding and sat in observation for 15 minutes. No adverse reactions were noted while client was observed. Co-lead RN adjusted appointment to reflect the correct COVID -19 vaccine (Pfizer, Lot# FF8839) administered to the client. Lead RN provided education to all vaccinator staff to complete the 11 rights of medication before administering the vaccine and to receive verbal consent from the client regarding specific vaccine type before providing injection.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, non smoker, no alcohol use, pain, and allergy-sneezing, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergies-sneezing, ascorbic acid/thiamine hydrochloride for drug used for unknown indication, amlodipine for high blood pressure, and ibuprofen for pain. The patient had no adverse events after the vaccine. On 30-APR-2021, the patient underwent a swab test for COVID-19 which was positive. At the time of the report, patient was not feeling well with runny nose, light cough, light body aches and no appetite. She further reported that she felt warm and cold occasionally. Laboratory data included: Coronavirus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and confirmed clinical vaccination failure. This report was serious (Other Medically Important Condition).; Sender's Comments: 2021501889-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
The patient temporarily had blurred vision and loss of his central and peripheral vision. He had a headache, photosensitivity, and felt too ill to drive himself home from work. The following day, the patient was back to normal without any symptoms.
5/13/15 - evening of imms, pain, given ADVIL. 5/14/15 - AM - given ADVIL for pain. 5/14/15 - noon - given ADVIL and ice for pain, redness, swelling, warm to touch, itchiness.
a patient accidentally received the full 0.5ml of Moderna for her booster dose instead of the 0.25ml. The last vaccine (her second shot that finished off her primary series) was given almost a year ago on 4/20/2021. The patient was informed of the dosage error.
Moderna COVID-19 Vaccine EUA  Pt was diaphoretic and shaking post vaccination with the Moderna vaccine. Also became nauseous. Gave employee something to drink, monitored vitals, and had him stay in the monitoring area. Also gave employee 4mg ODT zofran for nausea. Employee's BP normalized and stated he was ok to go to work. Also stated he had never had this reaction from another vaccine and no known drug allergies.
Redness, swelling, and pain with blistering at injection site.  Fever to 101
Suspected Vaccination failure; Broke out again; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Broke out again) and pain (Verbatim: Pain). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a Shingle shot after he/she heard you could had it more than once. The patient stated that three years later he/she was in emergency room. The patient broke out again and it was worst pain ever. The follow-up could not be possible as no contact details were available.
1) Itchy torso without rash nor hives, started the date of vaccination 02/09/2021 to current 02/11/2021.  2) Right hand numbness, started the date of vaccination 02/09/2021 to current.
Pt recvd 1st dose of Hep B vax on 5DEC90 & on 12DEC90 pt devel hives on scalp & ears & then generalized all over body; pt recovered;
4 female school teachers c/o S.O.B. & wheezing to school nurse - treated with Ibuprofen.
Sore throat, headache, muscle aches, joint aches, chills, fatigue, nausea. Lasted 18 hours. Treated with otc ibuprofen and rest.
PATIENT COMPLETED PLASMA DONATION AT 14:46 ON 09/20/2011 AND RECEIVED A RABIES BOOSTER VACCINE POST PLASMA DONATION AT 16:21. PER CSL GUIDELINES, PATIENT WAS REQUIRED TO WAIT AT CENTER 20MIN AFTER VACCINE ADMINISTRATION AND RELEASED WITHOUT ANY SYMPTOMS OF REACTION AT 16:41. PATIENT STATES SHE FELT DIZZY AND LIGHTHEADED THAT EVENING WHILE SHE WAS AT HOME AND LASTED GREATER THAN 30 MIN BUT LESS THAN 1 HOUR. PATIENT UNSURE OF SPECIFIC LENGTH OF TIME OF SYMPTOMS. PATIENT STATES TODAY (9/23/11) THAT SHE IS FEELING BETTER AND HAS NOT HAD ANY FURTHER PROBLEMS.
redness, swelling, warm to touch at injection site. Pt also has low grade temps.
Pt had local redness and swelling around injection site that grew in size 4-5 inches in diameter.  Also, pt reports developing a cough after the injects. It has been 4 days since shot, and pt reports redness/swelling has started to decrease.
After 1st Lymerix, pt did not feel well. Pt was informed that this was normal and to go ahead with 2nd shot. After the 2nd Lymerix, pt was bedridden-could not function. She had memory loss, shooting pains, chills, cough, myoclonic jerks, headache, stiffness, lack of concentration, rib pain, burning in head and spinal column.
This literature marketed report has been received from the authors of the published article, titled as stated above and refers to an adult patient with a chronic renal failure on immunosuppressive treatment. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center for Health Statistics. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (exact dose, site of administration, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) within 1 month prior to death. The patient was confirmed to have vaccine-strain varicella-zoster virus (VZV). It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports derived from the same literature article (linked with MARRS # 1807USA012959 and 1402USA010964). Sender's Comments: US-009507513-1402USA010964: US-009507513-1807USA012959. Reported Cause(s) of Death: varicella listed as the underlying cause of death.
Dehydration, swelling, shivers, headache by 7am on next day, illness. Cellulitis from Bacterial infection.
Tachycardia. Baseline HR 80-90, has been around 120-130 since last night. No fever, rash, GI, HA, BA.
Caller has been having finger snapping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) support. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: FINGER DEFORMITY (non-serious) with onset 2021, outcome "unknown", described as "Caller has been having finger snapping".  Additional information: Caller received the first dose of the Pfizer covid-19 vaccine in Apr and the second dose in May. Caller has been having finger snapping and would like compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme chills while hot Teeth hurt/sensitive  Headache Stomachache, unable to eat Sluggish Very achey to the point where I cannot sleep Foggy brain Slow moving
Experienced viral type syndrome (sore throat, swollen cervical lymph nodes, fever, fatigue) within 48 hours of receiving DRYVAX (x2, no take). SM's symptoms lingered into development (July through Sep/Oct 2006)- headache, neck pain, decreased appetite, muscle weakness and decreased attention span. Around Sept/Oct 06, developed essential hand tremors. Also notes chronic fatigue and headaches. In Nov 2006 developed progressive dysphasia for 3 weeks which spontaneously resolved. Later diagnosed with periodic leg movement of sleep and restless leg syndrome.
mom called on 9MAR94 said pt had recvd vax on 22FEB94 & on the morning of 9MAR94 had some facial twitching about 3 times that morning wanted to know if this could be DTP react; advised to call MD;