chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive.   Patient lying on side. Wearing portable NC o2.  Unresponsive to verbal/sternal rub. No pulse, No resps.   Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig.   EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given.   Pt transported by AMR/Fire to hospital.    Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin.  2. Possible aspiration pneumonia, present on admission.  3. Bronchiectasis, chronic, secondary to asbestosis.  4. Acute combined metabolic and toxic encephalopathy, present on admission.  5. Out of hospital pulseless electrical activity arrest.  6. Hyperkalemia.  7. Cardiogenic shock.  8. Acute kidney injury.  9. Lactic acidosis.  10. Acute diastolic congestive heart failure.  11. Severe protein-calorie malnutrition.
The night of receiving the vaccine I just got very ill with a fever and body aches and it triggered a migraine that lasted for several days.
he is frustrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program COVAX US Support.(159558). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 74 years as dose 2, single for covid-19 immunisation, prophylaxis. Relevant medical history included: "Rheumatoid arthritis", start date: 2005 (unspecified if ongoing), notes: diagnosed about 15 years. Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; ORENCIA taken for rheumatoid arthritis. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: EM9809, Dosage text: 0.3ml, injection in left arm, Expiry date: 30Jun2021), administration date: 11Feb2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "he is frustrated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A 75 year old male consumer who go his second dose of the Pfizer BioNTech Covid-19 vaccine in Mar2021; recently had bloodwork and had no antibodies. He is asking if he has to start the series over again.  Mentions he is frustrated with his doctor because he had the test about a month ago, and just got the results a few days ago, and that he's been walking around all this time and could have gotten the virus and he did not know. States he has a history of rheumatoid arthritis, and get infusions of Orencia once a month, and also takes methotrexate.  Asks if that would that have anything to do with him having no antibodies. His doctor told him that he needed to wait 2 weeks before getting another infusion after getting the vaccine; later told him a month, so he is not sure what to believe. Stated that antibody test result was a percentage of 0.85, and had to be below 0.79; unsure of the name of the test, caller said it, but it was not clear. Should have asked him to spell it, but did not at the time.  He asked if we knew about those numbers or what they mean. He recently had a blood test and had no antibodies in his system. Wondering if he will have to be revaccinated. He was asking if the medication he takes would have anything to do with it. Would he have to restart the series since he thinks he does not have antibodies. He thought he was protected from covid and had the antibody test done a month ago but received his results the other day. She is transferring him for a negative antibody test after the vaccine.  He had the antibody test on 01Sep2021 but did not find out about his results till this past Tuesday. He declined consent to contact rheumatologist since she is misleading him on quite a few things. He thinks he will find another rheumatologist. He does not have Orencia or methotrexate handy to provide details such as lot, ndc, expiration, or manufacturer.  No follow-up attempts are possible. No further information is expected.
no adverse event; received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose) and NO ADVERSE EVENT (no adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Pt recv vax on 8/13/98; on 8/14/98 pt exp red/ hot/ lump at vax site
Became light headed "don't feel good" Pale in the face and sweaty did not faint.
After receiving both shots patient felt extremely dizzy upon standing up. Patient was very pale. Her blood pressure dropped. Patient was checked out by paramedics and was discharged home.
Little diarrhea yesterday and little bit of soreness the next day on my arm.; Little diarrhea yesterday and little bit of soreness the next day on my arm.; I took the the vaccine the 24 of this month/I got it 24 and I go back. later on did the second; This is a spontaneous report received from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration in Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. Also had little infection in Mar2021. It was reported that patient got dose 1 on 24Mar2021 and went back. Later on did the second in Mar2021. There was, just wanted to know if it is alright to take it, had little infection. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a 3 month old patient. On 23-AUG-2017 the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. on 26-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot # L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored. No adverse effects were reported. This was one of several reports received from the same source. Additional information has been requested.
Vial was opened 02/04/2022.  Vaccination given 02/07/2022
Pt received vaccine on Friday.  Saturday night pt noticed site where he received the vaccine was itching and he had developed a rash that was about 5 in X 2 in with a darker red raised rash in the center that was about one inch in diameter.   Pt. noticed no other signs or symptoms other than itching and rash on back of (R) upper arm.
Patient presented to clinic with doctor's prescription to receive PCV-23 vaccine. Mom informed nurse that patient had multiple medical problems including an one day diagnosis. Mom states that patient's blood count are "fine." PCV-23 administered left deltoid IM. On Oct 22 School nurse calls nurse to state that mom concerned that site is red, no itching. She (school nurse) says that she will tell mom that redness is a mild side effect. No severe reactions were reported at this time. On Oct 24 mom calls to state patient went to ER and received IV antibiotics and sent home on PO meds for infection.
Initial unsolicited case received from a consumer (patient parent) on 28 Nov 2017. This case involves three-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history was not reported. It was reported as prior to vaccinations patient had been starting to talk. Patient family history was reported as his siblings also had cerebral palsy and who are also autistic but thought may not be related to vaccinations. Concomitant medications were not reported. On an unknown date, following the vaccination, patient developed autism. Relevant lab tests and corrective treatment were not reported. Outcome of the event was unknown. Upon internal review the company decided to consider the case as serious, due to important medical event: autism. List of documents held by sender: none.; Sender's Comments: This is poorly documented case as patient had Autism following DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. Time of onset is unknown, further information on patient's medical history, concomitant medications, any recent infection, birth history, previous immunization and its tolerance are needed further assess this case.
Information has been received from a physician concerning a 15-month-old male who in August 2006 (at the age of 12 months), was vaccinated with Varivax. In November 2006, three months after vaccination, the patient experienced a shingles outbreak. Unspecified medical attention was sought. No additional information is available. There was no product quality complaint. Additional information has been requested.
Chills, nausea, loss of appetite, low-grade fever, muscle aches, fatigue
Red irregular shaped rash at injection site. One week later a second irregular finger shaped rash occurred. Both have remained for 2 months.
Nauseated; Constipation; Chills; Tired; Weak; Sleeping like 12 to 14 hours a day; Not really feeling very good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) 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: NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CONSTIPATION (non-serious), outcome "unknown", described as "Constipation"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ASTHENIA (non-serious), outcome "unknown", described as "Weak"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping like 12 to 14 hours a day"; MALAISE (non-serious), outcome "unknown", described as "Not really feeling very good".  Additional information:patient stated,  I don't have a fever, I don't have swollen gland or anything because I have a 'sheer' with all that.I had been taking DayQuil and NyQuil and that seemed to help.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following vaccination, patient had typical shoulder pain in the evening.  She awoke at 0400 the next day with a fever for which she took advil.  In the morning, after she woke up she complained of stomach / abdominal cramping and diarrhea.  Daughter called concern about unusual side effect of abdominal cramping.  Review with daughter - does not believe related to advil since patient takes routinely without symptoms.
Heart Pain, Pain in left arm (shot in right), fatigue, lightheartedness, severe diarrhea, headache, sharp vision, rash, shortness of breath
Patient is a 56 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.   He was given the Moderna vaccination in the left deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience nausea and feeling hot.  He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt drank water and got to feeling better within a few minutes.
pain in her disc in her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her disc in her back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced BACK PAIN (pain in her disc in her back). At the time of the report, BACK PAIN (pain in her disc in her back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain at injection site; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Pain at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizziness). On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided.
pt recv vax 7NOV96 & 8NOV96 pt exp v;13NOV96 pt exp muscle pain in legs, back, shoulder, hands & fingers;exp numbness & tingling in fingertips only;pt dx w/severe CTS;diff performing daily activities;tested for GBS;
Swelling of left arm, left forearm and left elbow to three times the size of the right upper extremity within 24 hrs of receiving DTaP immunization in left arm requiring pediapred syrup and Zyrtec syrup to resolve the angioedema. Treatment began on 10/24/02.
Pt reports feeling "not so good" for a day or so after receiving vaccination, then 2 days after she had a bad episode of dizziness/vertigo. Husband called ambulance. Pt reports she was feeling better by the time EMT's arrived and was checked out, but they were unable to find anything wrong. They did not take her to the hospital. Pt reports feeling fine now (7 days later). When asked about other symptoms, pt reports no headache, fever, muscle aches, or nausea during time of feeling "not so good" or during the episode.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unspecified date in 2015, the patients were vaccinated with doses of GARDASIL (administration routes, lot numbers and expiration dates were not provided), which were exposed to a temperature outside of the recommended range since an unspecified date in "early February 2015". No concomitant therapies were reported, neither was any adverse effect. Additional information has been requested.
Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
Patient called to report hot rash and soreness of arm since day OF immunization...asked to return to Pharmacy to confirm info and determine if immediate/further medical attention was in order....patient returned 6/22/18 (6:28pm)...left arm had rash disseminating from lower deltoid,downward toward elbow (non-circular approximately 4-5 inches wide)...Patient stated rash was hot and arm sore.....denied limitation of motion or movemen and/or itch...advised cool compresses to area 4-6 times daily and seek further medical advice if worsens....proactively informed PCP of occurrence.
Patient received Bivalent Pfizer vaccine lot # GK 1657. Upon completion of vaccination  and patient departure, this nurse noticed that the vial did not contain the 1.3 ml sterile water required for dilution. Vial removed from used.  notified as well as Provide. Per vaccine error reported through.  Parent notified, no symptoms reported at this time. Parent will monitor and f/u if symptoms develop or have questions
States that he came into the office today and received both vaccines and in the last hour cannot stop sneezing. Mild sore throat. Denies rash, dyspnea, throat closure/swelling, fever, malaise, chills. No hx of vaccine reaction.
42 y.o. female AAO x4, CC nausea and difficulty swallowing.  Pt. had first dose of Moderna COVID 19 Vaccine Lot 007C21A.  Pt. was sent to 30 min lot for hx of allergies (unk. type, childhood).  Post vaccination approx. 15 min pt. signaled for assistance.  Pt. advised that she had some slight nausea, dizziness and slight difficulty swallowing, although she attributed difficulty with swallowing to the nausea.  During interaction with pt., she advised that she felt increase of swelling swelling in her throat.  Pt. had recent hx of HTN and vitals were as follows:  BP 178/132 (wrist cuff), pulse 95, RR 16.  Pt. administered 25 mg of Benadryl which relieved the discomfort in throat within 10 min.  Pt. second set of vitals was 182/115, P 100 R 16 unlabored.  Pt. talked to personal MD and advised for them to go to urgent care.  Pt. refused further tx/ hospital transport and was released to go direct to urgent care with husband per MD.
Directly after the vaccination, I developed a fever and chills for two days. I was fine after that. Around May 20th, I developed pain and increasing immobility in my right arm. Thinking it was sore from travel to location that week for my daughter's college graduation, I thought it would disappear, but it worsened, and became agonizing in a few days. My arm was completely immobile and I developed a fever of 101.8. When I saw the doctor the next week, I was sent for blood tests to check for RA and a blood clot. Those were negative. I was prescribed Bactrim and prednisone, and the situation cleared up, except for a large dark bruise and lump in the middle of my right arm. No doctor could explain the cause. On Thursday, June 10, I developed extreme sensitivity in my lower front gum. An x-ray shows that it is an unusual condition: internal resorption, or the tooth is destroying its own nerve chamber. There are also mysterious red puffy lumps under my eyes, on my cheekbones. These have NEVER shown up prior to this. I have had no problems of this nature, ever, and now I have to have a root canal to save this tooth.
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Pain in right arm and lymph nodes of right underarm; fever; raised circular rash at injection site/cellulitis; brainfog/dizziness; dark discoloration at injection site as of this report
Temperatures of 105 were recorded by a new ear thermometer at home.  A rash on the body developed.  When the fever was down, he was acting very normal.  He was seen on 4/21/03 in the clinic and shot given 4/9/03.  His rash was small and macular, no puritis.