chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was sweating a lot; cold shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "Covid", start date: Dec2020, stop date: Dec2020, notes: Caller stated his brother had COVID back in December. The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "was sweating a lot"; CHILLS (non-serious), outcome "unknown", described as "cold shivering". He had COVID back in December and was tested negative on 10Jan2021.  Additional information: It was reported that the brother who received the first dose of Pfizer's COVID vaccine yesterday, 15Apr2021, and was sweating a lot with cold shivering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticarial lesions face, extremities, trunk 12-24 hrs. after vaccine administration. No respiratory distress. No dysphagia. No vomiting. No fever. No angioedema. Transient and resolved totally with oral dosing diphenhydramine.
26 you male patient reported "lightheadedness" about 15-20 seconds after receiving IM injection. He then lost consciousness for approximately 30 seconds. Patient was seated in a chair and supported by RN until he regained consciousness. He became diaphoretic upon regaining consciousness, but otherwise reported "feeling better" over the next 1-2 minutes. His vital signs were assessed & wnl. BP 100/55, 99% O2 sat, HR 58, RR 16. Patient stated he's an athletic trainer and had come directly to the vaccine clinic from a workout. He stated he had eaten earlier in the day and believed he was well-hydrated. He was offered additional fluids and walked to another area about 5 minutes after syncope, where he remained in observation for an additional 10 minutes. He then transferred to the general observation area for another 10 or so minutes before feeling well enough to leave. He reported no further symptoms.
Moderna COVID-19 vaccine EUA Vomiting, headache, achy all over, dizzy, weak Lasted just that evening On second vaccine, vomiting next day, very sore arm, headache, dizzy Have been feeling sick to my stomach many days lately...haven?t vomited
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 26-year-old female patient received who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016). Previously administered products included ENGERIX B adult (dose 1). In January 2014, the patient received the 2nd dose of ENGERIX B adult 20 ug. In January 2014, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
arm began to swell-pt treated w/ice packs & APAP-arm cont to swell from neck, fingers, chest area;swelling/pain cont to persist;
Breakthrough case of Covid sx began - 05/23/2022 Home test ? 05/28/2022 Urgent Care Test ? 05/28/2022 ? 05/30/2022 Positive test Sx began as what felt like typical sx of sinus infections that I always have. Sore throat, stuffiness, nasal drip, slight cough, body aches, fever at it?s highest 99.9. The stuffy coughing situation got worse. I had a bit of taste and smell off for a few days. No chest or breathing issues. Home test on 06/01/2022 came back negative.
Patient woke in am 4-3-17 with rash all over. Had vomiting and diarrhea over weekend (so did other family members). Grandmother states patient had low grade fever on 04-02-17.
Patient died 8/27/2021 at the Hospital with diagnosis of Pnuemonia caused by SARS-CoV-2
This study case was received from the investigator in a trial on 22 February 2012. A 32 year-old male subject whose medical history was not available was found to have "other, chest pain" 14 days after the subject had received the following vaccines on 24 February 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Mumps (manufacturer, lot number, route and site of administration not reported) and Varicella (manufacturer, lot number, route and site of administration not reported). On 25 January 2009, the subject had Anthrax 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 09 March 2009, a normal ECG and a normal Echocardiogram on 11 March 2009. Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
flu like; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had got hit with bad flu symptoms. The patient asked would feel the same after second shot.
This spontaneous retrospective pregnancy report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The reporting nurse stated that on an unspecified date the patient, who was pregnant (last menstrual period and estimated delivery date were unknown), was vaccinated with a dose of M-M-R II or VARIVAX (Merck) (it was not clear which one did the patient received) (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The nurse reported that the patient experienced an abortion spontaneous on an unspecified date. The outcome of abortion spontaneous was unknown at the time of the report. The reporter did not provide a causality assessment for the event of abortion spontaneous. Additional information has been requested.
Employee came to Employee Health to report about a week following flu shot started having rash on back of neck and swollen lymph nodes. Was prescribed a cream that was put on rash.
sudden death 36 hrs after administration... classified a a sids by medical examiner... no history or evidence at autopsy of any site reaction, symptoms or fever reported by parent. no evidence of encephelopathy or inflamatiobn of brain at autopsy. pt. had bilat cleft of lip and and cleft palate, muscular vsd. evaluated by ped cardiology and ent at 2 wks of age.. vsd felt to not be significant. Autopsy Report received which stated patient experienced sudden cardiac death and acute angle of origin of coronary artery.
Profuse menstruale bleeding for a prolonged time.  Not at scheduled menstraul time.
patient given vaccines about 5 minutes earlier, and was waiting in office for 15 minutes Heard dad holler for help. fount pt. unresponsive and rigid in siting position. helped to floor. unresponsive for about 15 seconds. grey in pallor. some posturing and seizure like movement in upper extremities. 30 seconds after waking up - alert and oriented x 3. Hot to touch. BP 100/50; HR 84; Pulse ox 100% RA. transported to ER
Patient was feeling a little tired; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 10Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient was feeling a little tired. Clinical outcome of the adverse event was unknown at time of this report. The case was assessed as non-serious.   The lot number is not available despite follow-up attempts made. Follow-up attempt have been completed and no further information is expected.
20 scattered vesiculo-pustular lesions on neck and back. Approx. 20 lesions on torso.
Hives present within a few hours on stomach, chest and back Were still present 3 days later but did not irritate.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No known conditions.     On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant and treatment medication were provided
G62.9 NEUROPATHY 4/11/2023 RIGHT HIP JOINT PAIN G62.9 NEUROPATHY 4/11/2023 RIGHT HIP JOINT PAIN G62.9 NEUROPATHY 4/11/2023 RIGHT HIP JOINT PAIN
went today to get a COVID-19 vaccination (Johnson & Johnson) today.  She is here for seizures.  Apparently she was fine shortly after the shot and then this afternoon started having chills and fever and then had with the family said was a 30-minute seizure before EMS was called.  EMS found her postictal and during the transport they had she had another seizure in route.  In the emergency room she had a fever of 101 and was postictal
got sick on both of them; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (got sick on both of them) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick on both of them). At the time of the report, ILLNESS (got sick on both of them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-428271 (Patient Link).
At 3:10 pm pt c/o lightheadedness.  Vitals were checked by Paramedics: 138/88; P- 120; Blood Sugar 207.  Pt was encouraged to relax and take deep breaths.  She denied any hx of HTN but did state that she has a heart murmur.  Lungs sounds were clear per Paramedics.  Vitals were repeated at 3:27 pm: 118/78; P-120.  Pt stated that she was feeling better and was encouraged to go home and rest instead of returning to work.  Also encouraged pt notify her PMD of what had occurred, especially as her pulse was still elevated.  Pt agreed to do so.
Redness, swelling (some) and warmness, redness started at top of arm and moved down the arm.
Injection 5/30/06 swollen lips, hands 05/31/06 Benadryl given 6/1/06 rash (red whelps, itching) extremities 6/2/06 rash and swelling cleared. Did not seek medical care.
A couple of minutes after receiving vaccine pt began having sx's of vertigo(room spinning, nausea).  She was still at the administration desk at that point and was assisted to a stretcher for observation.  During her observation, she stated to the department nurses that she frequently gets vertigo.  She thinks her ear had popped causing this episode as she has been having allergy sx's recently.  Pt was observed for approximately 50 minutes until a ride arrived to take her home.  She states she had medication at home for the nausea and was comfortable treating this there. Pt was taken via WC to her family member's vehicle and assisted into the vehicle.  Pt tolerated Moderna #1 dose w/o any signs or sx's of acute allergic rxn.
J96.00 ACUTE RESPIRATORY FAILURE 4/10/2023 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 HTN (HYPERTENSION) R09.02 HYPOXEMIA 4/9/2023 HTN (HYPERTENSION)
Our pharmacist provided a booster dose to an individual under the age of 18. Patient was 14 at the time and it is unclear whether their card was presented. The pharmacist should have confirmed which dose in the state immunization registry.
shingles after receiving the second dose; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient develpoed shingles after receiving 2nd dose. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
pt fainted and slipped of the chair. She was coherent and 911 was called they stayed with her until she was ok and she walked out fine
Information has received from an administrator referring to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-JUN-2015 the patient was vaccinated with an expired dose of VAQTA (0.5 ml, lot # 0532AE, expiration date 25-JAN-2015, intramuscular). Information regarding concomitant medications was not reported. No adverse reactions had been reported. Additional information has been requested.
Large red area-painful-itchy-raised area. Approx 3inches in diameter. Immunization possibly given in sub Q tissue. Large part leaked out of site when given. Given closer to inner thigh.
Reaction; A spontaneous report  was received from a consumer, regarding herself, a female patient of unspecified age who received Moderna's COVID-19 vaccine and experienced an unspecified reaction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Dec 2020, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 05 Jan 2021, after vaccination, the patient had unspecified reaction for which she had questions.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, reaction was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Initial unsolicited report received from pharmacist on 27-Oct-2017. This case involves 71-year-old female patient who was vaccinated with 0.5 ml once dose of FLUZONE HD (Batch number, expiration date, dose was not reported) via intramuscular route in right deltoid on 26 Oct 2017. Medical history was not reported. Stated patient has no known allergies. Patient did not receive any other vaccines. On 26 Oct 2017, same day following the vaccination, the patient experienced oval shaped, red spot that was around injection site and on 27 Oct 2017, one-day post vaccination, the spot is extending lower on arm. Lab data and corrective treatment were not reported. The patient's event outcome was unknown. List of documents held by sender: none.
Communication Comment: "Patient present in clinic for COVID-19 vaccine. Patient reported feeling something" going up and down her neck" about 15 mins after vaccines was administered. Blood pressure reading was obtained, elevated at 188/100, HR 100. She reported new symptoms of dry throat causing tightness sensation and numbness in tongue. Patient was given Benadryl 25mg PO and water and observed for an additional 40minutes. Her symptoms resolved including throat dryness, tongue tingling, throat tightness. Denies dizziness, rash, difficulty swallowing, hoarseness, chest pain. Vital signs improved.  She reports she has blood pressure medicine at home that she was advised to take only when needed. She did not take medication today. She does not know the name of medication. Declined prescription of blood pressure medication today, agreed to take medicine she has at home and return to clinic for appointment Friday, 2/12/2021. Patient given strict ER precautions if her symptoms continue, worsen or if she develops new symptoms."
Under 24 hours after first vaccine dose, menopausal patient who hasn?t had period in over a year, began heavy flow period. Also reported pain in right leg, but unclear if related at this time (will monitor).
Had rash arm, neck, face 5/21 told to give Benadryl-(did not give) called phone nurse 5/23 and stated-now face is swollen and neck red-eyes swollen -Tx ER Benadryl and orapred with tapered dose
Information has been received from a pharmacist concerning a 61 year old female patient with no known drug allergies who on 10-NOV-2008 was vaccinated with one dose of ZOSTAVAX (Merck) (lot number not provided).  There was no concomitant medication.  On approximately 10-NOV-2008 the patient developed soreness, redness, swelling and pain at the injection area.  At the time of reporting, the patient did not recover.  The patient sought medical attention by consulting pharmacist.  Additional information has been requested.
Roughly 3 inch bruise like discoloration on the inside of the right forearm mainly yellow to brown with areas of reddish purple tinge and 1 - 1.5 inch bruise - like discoloration of left upper inner bicep (mainly yellow/brown tinge small area of purple), fever of 101 degrees Fahrenheit, and generalized body aches.
At 11:41 am client said that he thought he blacked out. He looked pale and was sweating. At 11:43 he had crackers and water. At 11:47 his oxygen saturations were 97% and his heart rate was 69. At 11:49 his blood pressure was 122/78. He felt better and left around 12:00 pm.
h/a-sore throat, aching body-fever;coughing-congested;
BRUISES OCCURRED EASILY; HEADACHE; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bruises occurred easily, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bruises occurred easily was not reported. This report was non-serious.
Mother reports child had an episode of "reflux" poss. d/t milk allergy and went to ER in Resp. Distress and had possible seizure activity. Mother also reports child may have had  3 additional seizures while in hosp.  9/7/07 Reviewed hospital medical records which reveal patient experienced possible seizure activity when found foaming at the mouth & nares, pulling his knees up to chest, flailing arms in rhythmic manner.  Face was red & patient was grunting & having difficulty breathing..  Was lethargic afterwards which slowly improved.  Had recently changed formula & spitting up had resolved approx 3 days prior.  Low grade fever noted since vax.  Admitted 8/9-8/11/2007.  Had several starring episodes w/eyes deviated while in hospital.  Tx w/anticonvulsant & was d/c to home on that.  To f/u w/peds neuro in clinc.   FINAL DX: Seizures & GERD.
Patient had a large red and warm area near the injection site about 6 hours after shot.  she also got a rash around her neck the next day, about 20 hours after shot
bacterial infection; This is a spontaneous report from a contactable consumer (reporter's wife) via Pfizer-sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 18Feb2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history included battling a bacterial infection. The patient's concomitant medications included series of antibiotics. The reporter stated that she and her husband are both due to get their second dose tomorrow 11Mar2021. Her husband had been battling a bacterial infection since January and he had been on and off antibiotics since then. He just started another series of antibiotics, and his bacterial infection which leads him to take Amoxiclav. Since Sunday he was taking 2 tablets a day, 875 mg per tablet. They want to know if it was ok, if that was possible. He started taking that Sunday and she doesn't know if that interfered with anything with the vaccine, she wanted to know if there are any known interactions with those 2 things. She said it has been 3 weeks tomorrow since the first shot, but she does not know if they should extend that period until he stops taking the antibiotic, his last day on it the antibiotic would be Saturday. She clarified her husband had been dealing with an antibacterial infection since before this first dose of the Pfizer COVID 19 vaccine. She also reported that, they are fine after the 1st dose of the vaccine last 18Feb2021 but, she had a little rashes in her lower eye that going to her cheek. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Resident has significant edema to LUE. LUE red and hot to touch. Resident c/o significant pain throughout arm.
spreading erythema, induration w/tender erythematous proximal lymph node 3 days p/vax; rxn vs cellulitis DTAP site;
App. 15 minutes after immunizations were given, patient broke out in hives all over body. No respiratory symptoms or distress. No facial swelling or mouth swelling. Benadryl (Diphenhydramine 12.5mg/5ml) in the amount of 4 ml was given to the baby by mouth and the hives went away with 15-20 minutes.