chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BROKEN HEART SYNDROME TACHYCARDIA; HEART ATTACK; FEELING UNWELL; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sick, and covid-19 (was prescribed steroids and oxygen at home, cough medicine) and concurrent conditions included: diabetes, thyroid, fibromyalgia, chronic migraine, chronic sinusitis (was prescribed antibiotics), allergy to antibiotics, allergy to sulpha, food allergy, allergy to weed grass, allergy to dust, allergy to mould, and allergy to animal, severe anxiety, and panic attack. The patient experienced drug allergy when treated with codeine, and prednisone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: 25-MAY-2021) 1 total administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced heart attack around 11-12 pm, patient was screaming and hollering following a family incident, her son gave her some water hoping the chest pain would go away, patient's son took her to hospital and in emergency room was informed that having a heart attack. They took her for check up in an emergency room and was checked for clogged arteries [by opening up leg arteries and checking] and none was found. The doctor informed the patient that she had broken heart syndrome tachycardia. The patient was hospitalized for 1 day and was advised for complete bed rest for minimum 5 days. The patient was feeling crazy as never had anything like this before, suffered from severe anxiety and panic attack. The patient returned to emergency room on an unspecified date, as patient was feeling unwell. The doctor informed the patient, it would take months/weeks to recover from her heart attack. On JUL-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. Laboratory data (dates unspecified) included: Angiography (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart attack, and the outcome of feeling unwell and broken heart syndrome tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211115420 -covid-19 vaccine ad26.cov2.s- heart attack, broken heart syndrome tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Exhaustion, chills, body aches, headache temperature oral 101-102.8
She can't remember what her last name was, she was very removed from the reality of the world.; Confused state after third shot; lost cognitive faculties; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.), CONFUSIONAL STATE (Confused state after third shot) and COGNITIVE DISORDER (lost cognitive faculties) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 030M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID, CALCIUM, DILTIAZEM, DULOXETINE, GABAPENTIN, LETROZOLE, LEVOTHYROXINE, MODAFINIL, MELATONIN, INSULIN ASPART (NOVOLOG), OLMESARTAN MEDOXOMIL (BENICAR), OMEPRAZOLE, OXYCODONE, INSULIN GLARGINE (TOUJEO), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LIRAGLUTIDE (VICTOZA), RIVAROXABAN (XARELTO) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.) and CONFUSIONAL STATE (Confused state after third shot). 01-Sep-2021, the patient experienced COGNITIVE DISORDER (lost cognitive faculties). On 01-Sep-2021, MEMORY IMPAIRMENT (She can't remember what her last name was, she was very removed from the reality of the world.), CONFUSIONAL STATE (Confused state after third shot) and COGNITIVE DISORDER (lost cognitive faculties) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood test: normal (normal) normal. In September 2021, White blood cell count: high (High) Slightly high which returned to normal the following day..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant also included over-the-counter fiber supplement. No Treatment medications were provided by reporter.    This case was linked to MOD-2021-329105 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: updated medical history, outcome of all events to recovered and added new event (cognitive disturbance).
Left upper thigh was swollen and erythematous. Dx'd with cellulitis. Treated with Keflex (250/5ml) 4 ml q 6 hours X 10 days. Follow-up tomorrow.
Pt. was to receive Flu Vaccine. After vaccine was administered Pt. mother asked if there was egg product in the flu, because pt. has allergy to egg. Pt. was assessed by a ARNP. Heart rate and pulse were monitored, Pt. was kept in clinic for 20 minutes. Our LPN gave pt. mother instructions for BENADRYL if needed at home. Age of patient at time of event: 1 years 1 months.
Pt was treated in the ER following abrasions and contusions sustained to her forehead. Pt received injection at that time. Two days post vax the pt developed nausea and vomiting and felt weird. She was diagnosed with a drug reaction and recovered.
Initial report was received 27 August 2010 from a health care professional. A 47-year-old male patient with no reported medical history, had received a second dose of JE-VAX, lot number EJN234A (route and site of administration not reported) and one day later, he developed wheezing, swelling in his upper lip, and urticaria on his arms and legs. The event required a doctors visit; however, at the time of the report, information was not provided regarding corrective treatments and laboratory or diagnostic testing. On 18 August 2010, eight days prior to the event onset, the patient had previously been vaccinated with "TYPIM", TWINRIX and BOOSTRIX (lot numbers, routes and site of administration not reported). On 17 August 2010, the patient had received a first dose of JE-VAX (lot number, route and site of vaccination not reported) with no adverse event reported. The event outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Pharmacist administered COVID-19 Moderna 1st dose to white male 20 years old with no past medical conditions at 2:48pm. Pt was instructed to leave the vaccine booth and have a seat at the immunization observation area, pt sat down normally and lost consciousness at 2:50pm. Pt's dad caught him while fainting, shouted to pharmacy, code white was alerted to store management and pharmacist was at pt side right away. Pt regained consciousness after 2 seconds, rph started to manually monitor pulse on wrist right away, offered him cold compress for face, pt declined. Rph instructed pt to take deep breaths and remain in reclined position to maintain breathing and airway. Paramedics were offered and pt agreed, paramedics on site at 3:05pm. While waiting - continued to show signs of severe paleness, weakness and extreme shaking of the body, manual monitoring of HR never went above 90 bpm. Pt stated he had "lightheadedness and progressive tingling of the arms and fingers. Rph instructed tech to bring out emergency kit cart and was ready to initiate manual BP reading, however at that point, pt's father was getting in the middle and frustrated and stated "why do you keep telling him to breath like that!". With family around, store management on site, and paramedics en route, pharmacist laid hands off pt due to father's request/frustration and waited for paramedics to arrive (1 minute total). Paramedics checked pt vitals, explained that this can be a normal reaction to the COVID vaccine, pt understood and was of stable body and mind by 3:18pm. Client, of his own free mind and will, declined paramedics at around 3:20pm, store management recorded. Rph also spoke to family while paramedics were with pt and they reported no mention of media or legal action at this time, they were only glad that pt was okay after the reaction.
Rash neck, genitals, stomach; Convuls; believe to be grand mal in nature; Pt has hx of sz; No fever;
Keflex qid 500mg x 7 days, warm compresses, Bacitracin. Redness, soreness, slight swelling at site.
COVID 19 Treatment; COVID 19 Treatment; Pfizer 4 th dose: 15Apr2022/ Moderna 5 th dose: 09Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 032L2dA), in right arm, on 27Feb2021 as dose 2, single (Lot number: 022M2dA), in right arm and on 09Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "lumpectomy for breast cancer Jan2019", start date: Jan2019 (unspecified if ongoing), notes: lumpectomy for breast cancer Jan2019; "Known allergies: Sulfa drugs" (unspecified if ongoing); "lumpectomy for breast cancer Jan2019", start date: Jan2019 (unspecified if ongoing), notes: lumpectomy for breast cancer Jan2019. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer 4 th dose: 15Apr2022/ Moderna 5 th dose: 09Sep2022". Patient first felt ill the evening of 15Dec22. Presented with strong gastrointestinal symptoms and the following day, started having a runny nose and cough. Tested negative 2x until Monday, 19Dec when patient tested positive at home. Patient called the doctor and put her on Paxlovid starting that evening. All symptoms were completely gone after the first 2 doses of Paxlovid. Patient felt great during the entire 5 days. However, the day following last dose (24Dec), nose began running again, and upper respiratory symptoms all came back including a cough. On the 5th day after completing treatment (29Dec), again was Covid positive. It was now 02Jan2023 and cold symptoms are still not improving. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) negative, notes: Tested negative 2x until Monday; (unspecified date) negative, notes: Tested negative 2x until Monday; (19Dec2022) Positive, notes: 19Dec when I tested positive at home; (29Dec2022) Positive, notes: On the 5th day after completing treatment (29Dec), I again was Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Body aches; Cough; Cold; He could resume his vitamin or supplements; scheduled to have his second dose on May 14; Chills; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient called in to ask if he could resume his vitamin or supplements. The patient received his first dose of the vaccine on 22Apr2021. The patient was scheduled to have his second dose on 14May2021 (which was more than 21 days). The patient specifically asked about vitamins E, C, B, and echinacea, which he states that takes as an immunity booster whenever he feels sick. It was reported that his 37 years old brother received his first dose of the Pfizer BioNTech COVID-19 vaccine and states he has started seeing symptoms of a cold including cough, chills, body aches that continued for 3 days. It was stated that his brother reached out to his doctor who told him it may not be related to the shot but may be because he has come in contact with COVID-19 since his first dose. Caller states that his brother is waiting on a COVID-19 test but caller was concerned because he state that his oxygen levels are going down. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
2/2 vaccinated , 2/9 all around vaccination site round red/hot/itchy
Pt self reported receiving covid vaccinations (no vaccine info available) and was admitted to inpatient facility with covid infection
HYPERtension Narrative: Hypertension with no response to BP medication.Still with elevated BP, had to change BP medication.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1 of LIQUID PEDVAXHIB on 09-FEB-2012 (lot # and dose not reported) and 44 days after on 23-MAR-2012 was vaccinated with dose 2 of LIQUID PEDVAXHIB (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Patient's mother reported her son's right arm where he got his vaccine on 08/13/2014 got swollen and reddened on 08/14/2014. She reported the swelling went down on 08/18/2014. It was reddened in a 3 cm size area around the site of injection of the right arm. She was encouraged to ice the area and report any other signs or more swelling or redness. No fever.
Received the shot on 3/23/21 and on 3/24//21 I experienced a terrible headache in the left temple area, pain behind my left eye and double vision.  The headache and eye pain lasted approximately two and a half weeks and the double vision for approximately 5 weeks.  I saw my eye doctor on 4/8/21, my regular doctor 4/16/21 and an eye specialist on 5/4/21.  No conclusion determined, possibly related to an old eye injury or not, could be vaccine or not.  Vision seems to have returned to normal at this time.
diagnosed with a superficial venous thrombosis in my lower extremity; This is a spontaneous report from a contactable Nurse (patient). A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation, at 32 years old. The patient's other medical history was not reported. Patient has no known allergies. The patient is not pregnant. The patient previously received the first dose of bnt162b2 on 18Dec2020, administered in left arm (Lot number LH9899) for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no concomitant medications. The patient was diagnosed with a superficial venous thrombosis in the lower extremity on 19Feb2021. The patient has no known risk factor for the event. Therapeutic measures were taken which included ELIQUIS. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the event was recovered with sequelae (recovered with lasting effects) on an unspecified date.
chills and fever from 7pm Friday - 1pm Sunday hives like rash started Monday morning
Patient started having heart palpitations on 8/15/21-8/16/21. Then started having noticeable swelling of her feet on 9/6/21
I received my first Gardasil vaccine today. Within a few minutes, I felt a "rush" in my head, as though all the blood was draining from it.  Everything started to become blurry, then black dots, then just black when I became dizzy. I felt like I was going to faint. It was a very scary situation that caused me to panic. I became very hot and sweaty following the injection. I was told I was "pale as a ghost". The nurse got me a glass of water and put a cold compress behind my neck. I put my head down and tried deep-breathing techniques. I laid down on an examination table for a few minutes. I felt recovered within 15 minutes, but feel very traumatized over what happened. I do not at all look forward to my next vaccine of Gardasil. I was not told about the possibility of fainting or feeling as though I would faint before the vaccine was administered.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 77-year-old female patient received the 1st, 2nd and 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. "She had all her Pfizer COVID-19 vaccines including the booster and was surprised to get COVID-19 infection." The events required an emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr 14, 2022) positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Patient called to ask about side effect from Paxlovid. She had all her Pfizer COVID-19 vaccines including the booster and was surprised to get COVID-19 infection. She took her first dose of Paxlovid this morning and 3 hours later, she developed diarrhea. She went to the ER this morning and was diagnosed with COVID-19. The ER doctor prescribed Paxlovid for her, but her regular doctor does not know if she started taking it. Information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
pt  was given  the vaccination for COVID on friday the 18th ( 2 days ago)  had moderate aches and diarrhea yesterday and began to have rash on Saturday . Pt is a nurse where there has been a large number  of children with gastroenteritis.  Pt with h/o immune reaction (? Stills disease ) where she breaks out in a urticarial rash ,previously only with illnesses in the past  Now pt has a rash. However Pt states this rash  feels different to her normal  one and she has never had a reaction like this to vaccine befores.  The  rash began  similarly to how it usually  starts on upper ext  and then spreads to trunk  now she has swelling around eyes and rash is getting worse. benadryl ineffective   pt also has swelling around her eyes and overall with irritation  which she has not experienced before.  pt  was sent to the Emergency department  for full evaluation  concern  for  sjs type reaction with
pt recv vax & arm turned pink swollen & pain Saturday p/vax;pain radiating down to the arm pit;Thursday became sick to stomach, h/a, refused to move arm;parent called MD ordered rest, DPH, ice & rest;pinkness & swelling went away Saturday
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. there was no pertinent medical history, current conditions reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of LIQUID PEDVAXHIB were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 140USA012856, 1403USA012857, 1403USA012858, 1403USA012859, 1403USA005464 (same reporter link) Additional information has been requested.
Progressive weakness later diagnosed as Guillain-Barre.  Patient has been on ventilator since 10/31/2012 and is expected to remain on a ventilator for 6 months to 2 years.  She is expected to have a permanent disability.
collapsed and had convulsions, multiple episodes since the date of 2nd dose to present, persistent numbness and tingling in legs and feet, extreme chest pain and rapid heart beat at inappropriate times, brain fog, left leg gait, weakness and poor muscle control/coordination
body aches; low grade fever; a 12 years old female was administered a dose of Menactra on 05-Jul-2018 and again on yesterday; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 12 years old female patient who experienced body aches and low grade fever, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 05-Jul-2018, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot M17054, expiration date : 31-MAR-2019 and another dose was administered on unknown dates for suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Expiry date and lot number of this dose not reported).  On an unknown date, the patient experienced a non-serious body aches (pain) and low grade fever (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was an actual medication error due to extra dose administered. A 12 years old female patient was administered a dose of Menactra on 05-Jul-2018 and again on yesterday   (Other relevant tests included no lab data.)  Final diagnosis was low grade fever and body aches.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from low grade fever and body aches.  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.  Information on batch number of the last dose requested.  List of documents held by sender: none.