chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anorexia; tachycardia; chills; sweats; temperature 100.8; slight nausea; fatigue; weakness; This is a spontaneous report from a contactable physician (patient himself). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm left on 01Feb2021 at 09:00 (at the age of 76-years-old) as dose 2, single for COVID-19 immunisation at Other. Medical history included hypertension, chronic kidney disease, coronary artery, malignant melanoma and drug hypersensitivity to penicillin and Cephalosporins. Concomitant medication(s) included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN) and ergocalciferol (VIT D). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received cephalosporin nos and experienced drug hypersensitivity and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiry date was not reported via an unspecified route of administration in arm left on 11Jan2021 at 09:00 (at the age of 76-years-old) as dose 1, single for COVID-19 immunisation at Other. On 17Feb2021, the reporter stated that the patient experienced temperature 100.8, chills, sweats, anorexia, tachycardia (102), slight nausea, fatigue, weakness. Fever stopped after 48-60hours. weakness persists to day5. covid rapid antigen test, covid PCR, and Flu negative. Much improved by day 4. No known contact with sick individuals. Always wore a mask, social distancing. Since the vaccination, the patient tested for COVID-19 on 18Feb2021. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient underwent lab tests and procedures which included body temperature: 100.8, influenza virus test: negative on 17Feb2021 and sars-cov-1 test: negative (Nasal Swab), sars-cov-2 test: negative on 18Feb2021 (Rapid antigen test and PCR). The outcome of the event temperature 100.8 was recovered on an unspecified date in Feb2021 and other events was recovering.  Follow-up attempts completed. No further information expected.
Confusion, Dizziness, Headache, Fever, NauseaVomitin, All symptoms started within 30 minutes of vaccine administration Narrative:
patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a non-health care professional or consumer via social media.  This case is linked to case 2020SA350303 (same reporter).  This case involves a 73-year-old female patient who laid down and never woke up (death), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, vaccination, past medical treatment(s) 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 and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, cause of death was not reported, it was unknown if autopsy was done.  Information on the batch number was requested; Sender's Comments: This was a poorly documented social media case involves 73-year-old female patient who died (death), after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)
Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
PT REPORTS FEELING PALPITATIONS AND "HEART BURNING" 24 HOURS AFTER RECEIVING HIS FIRST COVID-19 VACCINE.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching like crazy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 13, 2021, patient experienced pruritus (itching like crazy). The patient treated with Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency. At the time of the report, pruritus (itching like crazy) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications.
Pt. was faint appox 10 min following inj.  Vitals monitored.  Pt's FsBs was 63 - gave juice & crackers resolved within 30 min.  Pt instructed to eat breakfast, especially prior to visit.
PATIENT HAD COVID-19 VACCINE PFIZER Dose 1 date: 01/07/2021,     Dose 2 date: 01/28/2021, AND TESTED POSITIVE TO COVID.
Red rash around injection site. Instant bruise and a large bubble-like knot. Flushed face.
Patient had shot on thursday afternoon-friday night he woke up screaming.  When I got to him his body was red and hot took temperature 102.  Before I got his diaper hooked he had a seizure.  Called ambulance.  Baby was out of it for 2 hours.  MD said febrile seizures from vaccine.  PCP said not related to shot.
Breakthrough case of COVID-19: I got COVID-19, I had to quarantine, I did not require any treatment. I had a headache and sore throat for three days; and felt very fatigued.
On 09/13/2022 I received my Covid-19 vaccine. On 02/22/2023 I was experiencing sore throat and chest cough. I reached out to my doctor and was prescribed amoxicillin. Cough lasted 3 weeks.
Sore arm for both of her arms; Runny nose; Cold/chills; Cold/chills; But she is not sure if she is going to get it; This is a spontaneous report from a contactable consumer or other non hcp.  A 7-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 07Jun2021 (at the age of 7-decade-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified day in 2021, the patient experienced sore arm for both of her arms, runny nose, cold/chills, but she is not sure if she is going to get it. Caller is a consumer, did not share their first and last name, nor their age or zipcode. After getting her 1st dose up until today (1 month after getting the vaccine), she still felt sore arm for both of her arms, runny nose and cold/chills. In line with this, she would like to know if this side effect are normal side effects being experienced after a month of getting the vaccine. She reported she was having a problem with the arm that she got her injection in but also the other arm hurts.  She is supposed to get her second dose today (it has been 30 or 31 days since the first dose) but she is not sure if she is going to get it because she still has pain and she has heard the side effects after the second dose can be worse. Patient was willing to provide her first name and city and stated and said she was in her 60s. However, the patient did not want to see a physician, instead she wanted to speak to a manager or someone higher than the person speaking to her to confirm the information. In line with this, she is concerned as to what would happen if she would not get her 2nd dose due to this side effect she is experiencing after the first one. The patient is concerned that the adverse effect had lasted so long. She wanted to know if she decides not to get the second one, would she be protected. She also asks if she did not get it today, would it still be okay to get later.  Outcome of the event Circumstance or information capable of leading to medication error was unknown and outcome of the other events were not recovered.   Information on lot/batch number has been requested.
Information has been received from a Licensed Practical Nurse concerning a 64 year old male patient who on 16-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663672/1709X). It was reported that on 21-JAN-2009 the patient presented in office with rash under left arm. It was diagnosed to be shingles. A ZOSTRIX and NEURONTIN were prescribed. Additional information has been requested.
Infant was given DTaP, IPV, Hib (Acthib), PCV7 on 6/6/03. Approx 16 hours after injection baby started to cry constantly over 2 hours, had low grade fever 100.2 degrees F.
This is a spontaneous case received from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL3248) via an unspecified route of administration administered in Arm Left on 30Mar2021 15:30 (at the age of 52-years-old) as single dose for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL3248) via an unspecified route of administration administered in Arm Left on 09Mar2021 15:15 (at the age of 52-years-old) as single dose for COVID-19 immunization and allergies to medications, food, or other products with amoxicillin. The patient's concomitant medications included loratadine (CLARITINE). It was reported that the patient became aware of the AE on 31Mar2021, she reported it in the system on the day after she became aware since she was not able to get out of bed to report it until then. The patient experienced extremely tired, extremely sore at injection site, body aches, joint pain, fever and chills on 31Mar2021. The patient did not receive any treatment for the events. The outcome of the events recovered. Follow-up attempts are completed. No further information is expected.
Moderna Booster dose was given instead of Moderna Bivalent as the booster dose. No reactions noted.
the patient only received the DTaP-IPV liquid portion of Pentacel; the patient did not receive the HIB powder portion, no AE; Initial information received on 14-May-2021 regarding an unsolicited valid  non-serious case from a other health professional and physician via Media Information (reference number 00601852).  This case involves a 15 months old male patient who received only dtap-ipv liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and did not receive the hib powder portion (lot UJ402AAA,UJ413AA and expiration date :09-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination on 06-May-2021 (product preparation issue).  The patient's past vaccinations included first, second and third dose of Pentacel (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on 12-Mar-2020, May-2020 and Jul-2020 respectively.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included a dose of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination .  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  Caller stated that a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion and wants to confirm that counts as a full dose of DTaP-IPV and was looking for guidance on documentation. Also Caller states a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion; there was some confusion about giving both vials, so only the liquid portion was given to the patient. Referred caller to the Pentacel Reconstitution Video. Caller reported that they checked in with the patient's mom and the child was doing great; they recommended to patient's mom to get the HIB component.    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 the 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.
On 01/08/01 13:30, the vaccinee received the third  dose of DTaP, the first dose of Prevnar, the third dose of haemophilus b conjugate vaccine and third dose of IPV. the vaccinee was prophylactically treated with acetaminophen. Approximately 3.5 hrs post-immunization, he became fussy. On 01/09/01 05:00, he was hot and developed a fever of 104 degrees F. He recovered that day at 09:00. As of 04/10/01, the outcome of the adverse event is resolved.
Patient stated she was having chest pain and that her chest was getting tighter and tighter. Pulse and blood pressure were normal. ambulance was called and they took pulse and blood pressure as well it was normal. they preformed more tests (unknown to me in the ambulance) she did not leave with paramedics
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use in August 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 26-Apr-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided.  No treatment information provided.  Lad data reported was ultrasound on 21 Sep 2020 with no result. Patient had glucose test scheduled on 18 Jan 2021. Estimated date of conception was 03 Aug 2020.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Started period first time since February. Heavy bleeding and headache everyday since. Had a fever on 2nd day of shot ranging from 99.3-99.8.  Also, had a sore arm.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (Merck), (lot # L016124 expiration date: 06-MAY-2017 and lot # reported as L024253 expiration date: 01-JUL-2017) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complain was involved. This is one of several reports from the same source (MARRS: 1511USA014712; 1511USA014713; 1511USA014714; 1511USA014715). Additional information has been requested.
little itchiness; round redness about a size of a penny (centavo) that has just ruptured; slight swelling in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (little itchiness), ERYTHEMA (round redness about a size of a penny (centavo) that has just ruptured) and VACCINATION SITE SWELLING (slight swelling in the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A016VALA) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRURITUS (little itchiness), ERYTHEMA (round redness about a size of a penny (centavo) that has just ruptured) and VACCINATION SITE SWELLING (slight swelling in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (little itchiness), ERYTHEMA (round redness about a size of a penny (centavo) that has just ruptured) and VACCINATION SITE SWELLING (slight swelling in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Swelling on (R) delt at site of MENACTRA - 9 cm reaction red, warm to touch. Swelling on (L) delt at site of tdap - 6.5 cm reaction red warm to touch. Prescribed BACTRIM oral suspension 10 ml bid x 7 days.
Patient presented with red, swollen, puffy under arm where vaccine (ZOSTAVAX) was administered. I (staff Rph) received OTC treatment with antihistamine and hydrocortisone cream.
Pt developed tightening of throat s/p vaccination. Denies trouble swallowing or breathing. Breathing even and unlabored. Benadryl 25mg PO x 1 given. Pt discharged home in stable condition with family. ER precautions given.
Pain, swelling and rash/redness at injection site. Fever and headache.  All symptoms continued throughout evening and following day.
Vaccine site cellulitis; initial red/warmth started on 1/3/2021, initially started to resolved, but reappeared worsened on 1/8/2021, PCP contacted and was given Tylenol/Benadryl for vaccine reaction/response with little improvement; was evaluated in ER 1/9/2021 and diagnosed with cellulitis, treated with course of oral antibiotics.
This is a spontaneous report from a contactable consumer. This is second case out of two split cases. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 11Jun2021 (reported as yesterday) at around 14:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jun2021, after the second shot, the patient was very ill today (as reported), had dizziness, very sore, fever and chills. Reporter inquired that patient cab be given with Aspirin or something for the events. The outcome of all the events was unknown. Information about batch/lot number has been requested.
severe pain back of head near head and neck first 24 hours flashing in both eyes like aura migraine still ongoing. Cloudy vision left eye, still ongoing Fatigue, still ongoing
A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 52 year old female vaccinee who experienced redness, swelling and moderate itching at the injection site on the same day as receiving Fluvirin on 10 October 2003. On 10 October 2003, the vaccinee experienced redness, swelling and moderate itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 2 hours, and had resolved at the time of follow up report. No follow up pending.
hand tingling, itching all over, chest feels hot or flushed, nausea, rash Went to the ER after advised by staff -treated with benadryl 50 mg IV solu medrol 125 mg IV/zofran 4mg IV/Pepcid 20 mg IV/Tylenol 975 mg po  stable after IV meds,  discharged home with epi pen and steroid dose pack
She experienced dry mouth and fatigue. Her arm hurt very bad. These symptoms resolved 11-6-21. Arm has a hardened spot at injection site. She reported on 11-7-21 entire arm down to fingers is feeling numb and has tingling pins and needles. Her PCP wanted her to wait longer before getting the second dose of Pfizer and monitor the situation because it spread to her feet and calves.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states within 18 hours of immunization a bump had formed at the injection site the size of "an egg", it was warm, itchy, pink, sore, and hard. Patient also felt "ill" within 24 hours of immunization.
Vaccine was given in subcutaneous tissue and not in the deltoid as recommended. Later that same day of injection (19 June 2018) the right arm injection site became red, swollen, and painful. Over the next couple of days the redness area became larger, remain swollen and painful and the area became warm to touch. Noted temp 99.5. The site remain sore, red, swollen and warm today 21 June 2018.