chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FELT LIKE CRAP; FEVER; TIRED; HEADACHE; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, felt like crap, fever, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, tired, headache and felt like crap was not reported. This report was non-serious.
Pt was discharged from post observation and in parking lot and became nauseous with  emesis .  States nausea onset occurred when he exited the clinic.  Pt was observed by RN inside clinic and quickly exited the building to assist pt and provide chair to be seated.  1050EMTS called and 1052 arrived. Pt continuing to have emesis and be lightheaded.  Denies trouble with breathing.  1100 BP 162/92 HR 70  O2st 98 . Pt  monitored and assessed denies nausea and without emesis.   1105 BP 168/palpable HR70 O2sat 97, 1115 Pt standing without vertigo nausea and released by EMTS and escorted to car by wife.
Information has been received from a physician assistant (PA) concerning an approximately 86 year old male patient with sulfa allergy and no other pertinent medical history who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not provided). There was no concomitant medication. The PA reported that approximately 2 weeks after the vaccination, the patient developed shingles. It was given VALTREX as a treatment for the adverse event. The patient went to the physician's office for medical attention. No lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Shingles were considered to be disabling to the patient's vision by the reporter. Additional information has been requested.
Rash underneath the breast and I didn't think much of it. I was helping my sister-in-law move and I talked to my mom, and she said that that has happened to her before. As you get older you get hotter underneath there. My grandmother also has gotten them there and she suggested creams. But it progressively got worse. It was on Monday that I woke up, I noticed that it was not getting any better and it had spread. I sent a photo to my gynecologist, and she said that it was Shingles. I went to visit her, and she confirmed it was Shingles and prescribed medication for 10 days. I had a hard time with the booster because I also had a problem with the first vaccine as well. I also had aches and pains with that first vaccine as well as this booster. I can't say that I got this from the booster, but I can't rule it out as well.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and was brought to the hospital ER on 3/7/21 after suffering cardiac arrest where he could not be revived. He was on warfarin for a fib and had CKD and CHF. Recently presented to the ED on 2/8/2021 with some chest pain which the attending concluded it was a low concern for an ACS.
Wrong dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot number AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided. This case contains information for the 2nd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 29-OCT-2014, patient was vaccinated with an improperly stored doses of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Shortness of breath; Dizziness; Nausea; Fever; Shakiness; Pale to the face; Body aches; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 16:15 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCODONE; GABAPENTIN; IBUPROFEN. The following information was reported: DYSPNOEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Fever"; TREMOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Shakiness"; PALLOR (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Pale to the face"; PAIN (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Body aches"; VOMITING (non-serious) with onset 13Jan2022 19:00, outcome "not recovered", described as "Vomiting". The events "shortness of breath", "dizziness", "nausea", "fever", "shakiness", "pale to the face", "body aches" and "vomiting" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dyspnoea, dizziness, nausea, pyrexia, tremor, pallor, pain, vomiting.  Additional Information: The patient did not received other vaccines within 4 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No Relevant concomitant medications was reported.  Treatment information was not provided.
After receiving the second dose I had 4 nights of nights terrors.  Since the 13th, the night terrors have ended but dreams are very vivid and bizarre.  I thought this was important to share because someone living alone may leave their residence and be harmed.
Stroke; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingix (1st dose received on 20th April 2019).   On 20th July 2019, the patient received the 2nd dose of Shingrix. On 23rd August 2019, 34 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.  Additional information was reported as follows: The patient wanted to know, could a 3rd dose of Shingrix would safe on blood thinner.
(1st) shot - began to get rash next day (have had this with reactions to molds, smoke, preservatives in flu shot several yrs ago); rash tends to be all over body milder on face and hands and feet; stomach felt "off"; sickish no energy for 3-5 days - felt as if "lost" 5 days or could do little. (2nd) shot took BENADRYL as per PCP - rash developed later but extremely dizzy and lightheaded 1st AM (took no more BENADRYL!); (better after 6) - began sore throat (extreme) within hrs; cold began - still have remnants. Assume cold was due to shot "sapping" immune system making me vulnerable - rash lasted 3 days or so in this time have on legs and thighs and overall - generally during after experience with the rash - it is more spotty - i.e. where I am warmest, etc. Again very uncomfortable feel off - stomach off - no energy; again rash is not unfamiliar but was significantly worse with these 2 shots. Am wondering what, if any, ingredients is similar in the flu shot preservatives of 45 yrs ago and this shingles shot - (I have been getting preservative free flu shots).
Patient reports having numbness and tingling going down her arm radiating to R hip after injection. No pain or weakness.  VSS.  Upper extremity and lower extremity strength and sensation 5/5 bilaterally. She was observed for approximately 45 minutes and during this time she notes symptoms improved. She was advised to continue to monitor symptoms, warm compress to area. Follow up as needed
Patient reported itching almost immediately after getting vaccine.    Patient was taken to ER via wheelchair but left AMA before being evaluated.
Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
ULCERATIVE COLITIS SYMPTOMS WORSENED OR FLARE UP; SUSPECTED CLINICAL VACCINATION FAILURE; DRUG EFFECT DECREASED; INCREASED TENDENCY FOR INFECTION; SUSPECTED COVID-19 INFECTION; PILONIDAL CYST RECURRING; This spontaneous report received from a patient via a company representative concerned a 19 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pilonidal cyst. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown. expiry: Unknown) dose was not reported, 1 total, administered on 30-SEP-2021 for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  The patient had pilonidal cysts before initial treatment of Humira. on 03-Dec-2021, patient had pilonidal cyst removal, this was a recurring cyst that had previously had a removal due to this patient thought he had a ulcerative colitis flare up, but Humira was no longer working well. The patient was on pain killers for relief, patient was more prone to these infections being on Humira, but, symptoms have just worsened. Patient had Covid positive diagnosis after receiving first vaccine. (Suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected clinical vaccination failure, and suspected covid-19 infection, was recovering from drug effect decreased, and ulcerative colitis symptoms worsened or flare up, had not recovered from increased tendency for infection, and the outcome of pilonidal cyst recurring was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207067.; Sender's Comments: V0.20211230093-covid-19 vaccine ad26.cov2.s -Ulcerative colitis symptoms worsened  or flare up. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211230093-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Right inner ear whooshing coinciding with heartbeat began 6d post 1st Covid shot (had on April 15, 2021). Persistent and constant. Coupled with extremely high blood pressure; atypical for patient.  Ear whooshing went away 2 weeks after 2nd Covid shot. Intermittently returning 3+ weeks after 2nd Covid shot.   Three days post 2nd shot (May 9th), awoken at night with repeated intense 'adrenaline' rushes/panic attack like feelings, which prevented sleep. The events seemed to occur at the moment the patient was about to fall asleep, then would jolt patient up. These INTENSE events continued for 4.5 hours. Patient tried deep breathing exercises to no avail. Patient eventually rose from bed and did multiple 'full body shakes' to try and relax. Finally was able to sleep.   Patient experienced 2nd menstrual cycle in one month. Atypical for this person, who had never had any anomalous or difficult cycles in her life.  May 29. This night again experienced same adrenaline rush/panic symptoms overnight, again wholly preventing sleep. Patient took ibuprofen to relax muscles, to no effect. Patient again tried full body shakeout 2x. After 2nd time, was able to sleep after 4-5h of insomnia--complete inability to fall asleep.
Information has been received from a health professional concerning a 72 year old male with no known drug allergies and no previous medical history who was vaccinated with PNEUMOVAX (lot # 659487/1960U) (route and site not reported) between 24-Jun-2008 and 27-Jun-2008. There was no concomitant medication. The physician had indicated that the patient had experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain had occurred a few hours after administration and resolved within 24-48 hours later. No further information is available. Additional information has been requested.
Report 20010266381 describes elevated liver function tests in a 35 year old female who received hep B vaccine recombinant (Engerix-B). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history reportedly included hypertension. Concurrent conditions were not specified. The vaccinee reported that she received unspecified medication to treat hypertension. The vaccinee reported that she received a booster dose of Engerix-B on 08/22/2001. This booster dose "did not take." She then received another injection of Engerix-B on 10/05/2001. On 10/23/2001, during routine blood analysis to monitor her antihypertensive medication, it was noted that her liver function tests (NOS) were elevated. Liver function was reassessed on 10/26/2001 and 11/05/2001. The vaccinee reported that the liver function was "getting progressively worse with each measurement."
Patient stated approximately 2 days after vaccines experienced vertigo, excessive sweating, vomiting, loss of stability. So much so he went to the hospital, and he was there from Sat to Tues. He said from the tests ran etc certain things were ruled out and it seemed that he was experiencing these symptoms due to the vaccines.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003528, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Client had vasovagal response after vaccines were given which lasted a few seconds. 5-10 minutes later developed itchy red rash on arms, legs, and torso. Given 50mg BENADRYL by mouth observed client for 45 minutes. Rash resolved, no respiratory problems.