chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test which was negative, 1/22/21 still has fever drive thru at hospital covid drive thru pt had PCR and it was also negative, went back to same drive thru on 1/24/21 and had another PCR which was negative, 1/25/21 urgent care visit, pt was tested for flu-Negative, lab work was done which showed CBC all counts were low  resulted in ER visit, admitted 1/25/21 afternoon with panside apnea and sepsis and patient stayed in hospital for 9 days 2/2/21 pt was released to go home. Lots of labs and test were done while patient was inpatient, Pt is still weak and has no energy.
FLU LIKE SYMPTOMS; NOT FEELING GOOD; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced not feeling good. On 19-MAY-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine  was not applicable. The outcome of the flu like symptoms and not feeling good was not reported. This report was non-serious.
Narrative:  87yo male patient died on 9/26/2021. Pt had received covid vaccines from agency on 4/5/21 & 5/5/21. Pt had limited medical care from agency- only opthalmology. No info given regarding pt's death. Also no medical history available in agency records. This death is likely not related to the vaccinations due to advanced age, and length of time from vaccine administration.
Vaccinee experienced cramping (gastrointestinal) & diarrhea p/all 3 doses of Engerix-B.
MIDDLE OF NIGHT FRIDAY NIGHT, CHILLS, FEVER, NAUSEA, NOT FEELING WELL, BODY ACHES.  LASTED ALL DAY SATURDAY UNTIL EVENING HOURS SATURDAY NIGHT.
Approximately 4-5 days after the vaccine, I developed small itchy patches on my shoulders. Since then, I have developed more spots on my shoulders, lower back, hands, right arm. Yesterday, April 20, I developed patches on both calves about two inches below the knee.
After pfizer second dose in March and after booster in Novemeber of 2021 - having tachycardia upon standing and heart rate staying well over 100 for a long time, and increase is over 30-40 beats like POTS - it does come back down in the 80s-90s when setting .
COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive; COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EK9231), in left arm, on 12Feb2021 at 08:00 as dose 2, single (Lot number: EL9261), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180), in right arm and on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "primary immunodeficiency (Hypogammaglobulinemia)" (unspecified if ongoing), notes: I have primary immunodeficiency (Hypogammaglobulinemia) and asthma; "asthma" (unspecified if ongoing), notes: I have primary immunodeficiency (Hypogammaglobulinemia) and asthma. Concomitant medication(s) included: PREDNISONE, start date: 31May2022, stop date: 05Jun2022; TESSALON, start date: 31May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: testing positive and finishing paxlovid. Therapeutic measures were not taken as a result of drug ineffective. Clinical course information: No known allergies reported. Patient received Anti viral treatment of Covid 19 from 30May2022 to 03Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 days after injection, injection site got red, hot, inflamed. I wasn't sure what was going on so I went to Immediate Care on 01/12/21 where they put me on antibiotics and an antihistamine. I followed up with primary care on 01/15/21. By then my arm was almost back to normal. He told me to stop taking the antibiotics and antihistamines and report the reaction. I did as instructed and by 01/17/21 the redness, warmth and swelling had returned. I restarted the antihistamines and my arm has gone back down to normal.
Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 at 19:30 as dose number unknown, single (Lot number: Ep6955) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not received any other medication in two weeks. Patient received treatment of Paxlovid for covid 19 from 15Aug2022 to 17Aug2022.
Patient was given 2nd dose of Moderna vaccine too early. First dose given 3/16/2021 and second dose on 3/29/2021. Patient monitored onsite x 30 minutes with no s/s of adverse reaction and advised to notify PMD of any problems
Received shot at 2:45pm. Sore/stiff arm started around 6pm. Went to sleep and woke up at 1:00am shaking with a fever and chills. Severe headache, throat sore with swollen glands, could barely walk/move or get out of bed. Also experienced nausea. Took tylenol around 1:00am and again at 5:00am.  Could not move from bed on Wednesday and had to call out of work Thursday with a bad headache, weakness, and overall body pain/discomfort. It is now Friday and I am still having very bad joint and muscle pain when I walk and move and still have a headache and fatigue/weakness.
No adverse event. Moderna Booster for 18 years of age or older given. Moderna bivalent booster should have been given.
Pt vax w/ 3 hepta B,  3rd dose given on 03May90.  Pt failed to produce adequate antibody titers.
No additional AE; administration of improperly stored vaccine; This spontaneous report was received from a registered nurse referring to a 10 years old female patient. There were no concomitant medications, concurrent conditions, medical history or drug reactions/allergies reported. There were no other vaccines within 4 weeks prior to the vaccine administration.  On 18-MAR-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was improperly stored, 0.5 milliliter once in the right deltoid (strength and route not reported, lot # u008316, expiration date: 15-AUG-2023) for prophylaxis (product storage error). There was no illness at time of vaccination. The operator was fully trained, followed all direction and administration was cleared. The temperature excursion occurred when there was a unit malfunction, and the refrigerator worked out of range for 20 minutes or less before the vaccine was moved to a different unit that was in range. All vaccines were cleared as viable, no issues, no harm reached the patient. All vaccines were cleared for use. No measures need to be taken. The refrigerator was replaced. No additional adverse event was reported.
The screening and consent form had the wrong date of birth. The person wrote they were born in a specific year, when they were born in a different year. They did not meet the age eligibility per FDA to receive this vaccine.
Not sure if seizure; body muscles started shaking; Pain in lower spine on back; Pain in lower spine on back; This is a spontaneous report from a contactable consumer (patient).   A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in Arm Right on 07May2021 13:00 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunization. Medical history included type 1 diabetic, allergies to severe peanut, "tree but", shellfish. Concomitant medication included insulin lispro (HUMALOG) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in right arm on 16Apr2021 13:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. The patient experienced Pain in lower spine on back and body muscles started shaking uncontrollably, not sure if seizure on 08May2021 02:00. No treatment received for the events. The outcome of the events was recovered. The event seizure was considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number is requested.
Patient had new acute areas of infarction involving the anterior periinsular cortex and left posterior temporal-parietal cortex.
Fever; Headache; Chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/10/21 2nd dose02/07/21 Diagnosed covid positive:08/24/21 Symptom onset:08/23/21 Exposure:Home Symptoms:SOB, FATIGUE, COUGH, MUSCLEACHES, SORETHROAT, DIARRHEA, CHILLS, RUNNY NOSE,HEADACHE.
Get so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Get so tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Get so tired). At the time of the report, FATIGUE (Get so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history and concomitant medications were provided
mom states pt had a high pitched cry;gave pt APAP @ 2PM;when pt arrived @ ER was happy, smiling & eyes bright;
Patient fainted in her chair ~2 minutes after administration of the vaccine. Patient informed me ahead of the immunization that she is a fainter and she faints after every immunization and that she brought her mother to assist. Patient was resolved by putting her head down for several minutes. She left after the incident after approximately 20 minutes. Patient reported feeling fine and back to normal.
The pt developed a fever, irritability, and rash within 24 hrs post immunization. The physician describes rash as "measles-like."
Provider summary "This is a 77 yo male, with PMH significant for Afib, DM2, CKD3, HFrEF (EF 35-40%), CAD, bilateral nephrolithiasis s/p multiple recent urological procedures with bilateral stent placements, who presented to hospital ED today for complaints of back and stomach pain. Earlier today, pt reportedely had a large emesis and lost consciousness following with reported faint to no pulse from SNF. He was transported to the ED via medic. EMS reported that pt was unresponsive upon arrival, but had spontaneous respirations. Dr. with urology was notified, and felt that bilateral stent exchange might be indicated, as stents were placed beginning of the month. While in the ED, he became increasingly hypotensive and required initiation of pressors. ICU was contacted for admission for further resuscitation prior to Urological intervention. In the ED, pt was alert and orientated. He agreed to continuation of pressor support and further OR procedures if necessary.  Of note, he is a DNR/DNI and has had multiple ICU and hospital admissions over the last few months related to urosepsis or urological procedure needs. His niece is POA.    Patient with a complicated urologic history, here with septic shock from multi-drug bacteremia/pyelonephritis, obstructive uropathy/infected stone. Initially it was MDR ESBL Klebsiella, and subsequently Enterobacter found in urine. Patient was treated with Invanz and course was extended to two additional weeks from date of last negative Bcx (6/27/22) for which he did receive a midline. He was started on a midodrine course from the CCU, but weaned off. He has a frequent history of urinary retention which is alleviated by straight catheterization per the recommendations of Urology. He underwent bilateral stent exchange while admitted and will follow up with urology for a R ESWL after discharge tentatively on 7/20/22. Hospitalization was prolonged several days due to incidental covid-19 positive test though patient was and remained asymptomatic, thus postponing both R ESWL and discharge back to facility.  He was advised to remain off of ASA, Plavix until after the procedure and off of Eliquis until follow up with Cardiology occurred. For this reason, he was kept on a heparin gtt while hospitalized due to chadsvasc of 8.
body aches; fever; Chills; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via an unspecified route of administration in left upper arm on 02Mar2021 10:15 (age at vaccination was 45 years) as DOSE 1, SINGLE for COVID-19 immunisation at Hospital. The patient's medical history included she got sick with the flu shot. She did not know the exact date that she got the flu shot it was over 15 years ago. The patient's concomitant medications were not reported. She did not receive other vaccines prior vaccinations within 4 weeks. Her history of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer suspect were none. The patient experienced body aches and fever on 02Mar2021 20:00 and chills on unknown date. She was asking if those were normal, how long should they last, and when should she go to the doctor. She was getting scared because she was never sick. The patient did not visit emergency room and got an appointment. The outcome of events body aches and fever was not recovered and outcome of event chills was unknown.  No follow-up attempts were possible. No Further Information was expected.
Information has been received form a nurse practitioner concerning a 16 year old female patient who in 2007 was vaccinated with the three doses of GARDASIL (Lot numbers not available). the last month(September 2008), the patient developed abnormal pap smear after receiving all 3 doses of GARDASIL vaccine. the patient sought unspecified medical attention. Additional information is not expected.
Pt recvd a series of 3 doses of Engerix-B & exp no adverse exp, however did not convert; plan to revax;
pt recv vax; arm became swollen & there was inject site redness; MD thought it looked like cellulitis;
hallucination-like symptoms; confusion; dilated eyes; felt like he was "going to die", worried parents might hurt him,; vomiting; head pain, booboo inside his head; fever; night terrors; This case was reported by a other health professional via call center representative and described the occurrence of hallucination in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and ondansetron (Zofran) for product used for unknown indication.   On 8th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Zofran at an unknown dose and frequency. On 8th November 2021, 3 hrs after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vomiting, headache, fever and night terrors. On 10th November 2021, the patient experienced hallucination (serious criteria GSK medically significant), confusion, pupils dilated and impending doom. The patient was treated with paracetamol (Tylenol) and ibuprofen. The action taken with Zofran was unknown. On 8th November 2021, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the hallucination, night terrors, confusion, pupils dilated and impending doom were unknown and the outcome of the vomiting was recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the hallucination, vomiting, headache, fever, night terrors, confusion, pupils dilated and impending doom to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 8th November 2021, the patient received Flulaval and experienced vomiting, head pain, fever 3 hours after the vaccination.  The patient went to the emergency room on same night and received Zofran. On 8th November 2021, less than a day after receiving Flulaval and Zofran, the patient experienced night terrors. On 10th November 2021, 2 days after receiving Flulaval and Zofran, the patient experienced confusion, hallucination like symptoms, and dilated eyes. The patient stated that he felt like he was going to die, and was worried that his parents might hurt him and there was a booboo inside his head. On 11th November 2021, the patient experienced another fever (100.6 degree F). The patient was altering between Tylenol and Ibuprofen as a treatment for fever. The reporter stated that, emergency room visit was required. No additional information was provided. It was unknown if the reporter considered the hallucination, fever, night terrors, confusion, pupils dilated and impending doom to be related to Zofran. The reporter consented to follow up.
He died within 5 minutes of getting the morphine.; hospitalized for a severe UTI; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (father).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took Morphine and experienced allergic to morphine. It was stated that, the patient was older but very healthy. On an unspecified date, the patient experienced complicated severe UTI and was hospitalized, within 4 days he went from a nasal cannula to a BIPAP. He kept pulling at his BIPAP so the doctor used Morphine (for which he was allergic). He died within 5 minutes of getting the morphine. The vaccine started killing him and then the morphine finished him off. Therapeutic measures were taken as a result of the events. The seriousness of the events was serious and hospitalized. The outcome of the event was death and for complicated severe UTI was unknown. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Follow-up (21Sep2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Reported Cause(s) of Death: He died within 5 minutes of getting the morphine.
Breakthrough COVID infection. Only symptom noted is cough. Unknown symptom onset.  Positive test collected 09/17/2022 prior to admission.
26 y/o male who reports this morning to clinic for assessment of redness around left shoulder and swelling in axillary area for last 4 days. Patient received smallpox vaccination on 11 May 2018. No concerns have been raised about progression of site reaction on left deltoid. Patient has been caring for lesion as instructed and has experienced no other rashes. He denies headache, chest pain, shortness of breath, fatigue, fever or chills. Patient does have some discomfort in left axilla when raising arm over head. He asks how soon he may return to his usual work in the gym. He has otherwise been able to go about his activities of daily living without difficulty.
Pain at the injection site that woke him up; Some soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020 04:00, the patient received the 1st dose of Shingrix. On 11th August 2020, 4 days after receiving Shingrix, the patient experienced injection site pain. In August 2020, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around 4:00 pm and experienced some soreness in his arm that resolved but last night the day of reporting he had a pain at the injection site that woke him up.  The patient took an Advil which helped.  At the time of reporting the pain resolved. This case linked with US2020159616, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159616:same reporter