chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIGHTNESS IN CHEST; Shortness of Breath; FEELS LIKE DRUGGED,FELT EXTREMELY WEIRD,FEELS LIKE A ROBOT SHUTTING DOWN; RANDOMLY FALLING ASLEEP; WAKING UP FEELING RESTED; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, thyroid issues, irritable bowel syndrome, latex allergy, and penicillin allergy, and other pre-existing medical conditions included patient was allergies to anything you can think of in Kansas could not name them all. The patient experienced allergic reaction when treated with nitrofurantoin for urinary tract infection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 03AZ1A, and 03A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 15:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tightness in chest. On 24-MAY-2021, the subject experienced shortness of breath. On 24-MAY-2021, the subject experienced feels like drugged, felt extremely weird, feels like a robot shutting down. On 24-MAY-2021, the subject experienced randomly falling asleep. On 24-MAY-2021, the subject experienced waking up feeling rested. On 24-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness in chest, shortness of breath, and extremely tired, and the outcome of feels like drugged, felt extremely weird, feels like a robot shutting down, randomly falling asleep and waking up feeling rested was not reported. This report was non-serious.
Narrative: Patient received two doses of covid vaccine. Patient reportedly passed of of cardiac arrest/respiratory failure. Unclear if any relation to covid vaccination as complex medical history including HTN, hyperlipidemia, CKD stage 3, CAD s/p bypass grafting in 2016, MI Sept 2016, BPH s/p TURP 2013, gout, hypothyroidism, TIA, glaucoma, vitamin D deficiency SCC of the mandible (2012) and right buccal SCCA (2017) s/p Wide Local Excisions, radiation and Split Thickness Skin Graft, depression, h/o right foot pressure ulcer and concerns for CHF. Reporting per network instruction.
More than 42 days have passed between first dose and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache occurring several hours after receiving vaccine and is still present. Left sided neck and ear pain started 4 days after receiving vaccine and are still present.
for a few days his body didn't feel too good; This case was reported by a consumer via licensee and described the occurrence of feeling unwell in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient did not have medical history. It was reported that the patient was healthy person, he was doing exercise and lot of things. The patient did not took any recent vaccines or any concomitant medication. The patient took flu shot after certain age and for few days his body did not feel good. The patient was taking flu shot for about 8 years and stated that it did not happen when he gets them, he must have gotten used to them. The reporter consented to follow up.
Dizziness  Heavy/weak legs progressing to arms and hands Tingling in legs and arms and now face Occasional exhaustion  Heart palpitations  Started 3 hrs after vaccine with cramping calves and then progressed to these signs 6 days after
Almost immediately after the vaccine I developed SOB, chest pain, headache and severe fatigue just seemed as if the symptoms just continued over from dose 1.  I developed a postnasal drip and my sinuses congested real bad.
Bumps on hands and elbows itching pain 5/10 when bumped or touched. She was seen at the ER 3/18/09. Diagnosed General Vaccinia, treated with LIDEX cream bid prn.  5/26/09 Medical records received DOS 3/18/09 to 4/27/09. FINAL DIAGNOSIS: Erythema Multiforme, Adverse Drug Effect of Vaccines Smallpox. Post vaccination presented dermatitis with red papules, crusted, fingers/elbows, itching, pain when touched or bumped.
1 x 1 cm area of erythema and 4 small vesicles over the right lateral brow. Small eschar noted 2 cm area of induration extends beyond vesicles laterally. There is mild edema near the (R) upper lid but no periorbital cellulitis. Pt. has appt 26 Jul 11.
3/21/2022 around 3:20 pm pt noticed redness and swelling in both hands. Both legs were itching and burning. Pt said legs felt like they were on fire. Then she noticed generalized hives all over body including face. She said her neck, face, and both ears were red. Her ears were red, swollen and hot to touch. Pt said she felt tired. She felt like she had fever but did not take her temperature. Denied swelling of lips, tongue, or throat. Denied having any SOB. Took Benadryl around 3:30 pm and all symptoms went away around 4 pm. Pt did not see a doctor for signs or symptoms. Father said they took child to ER but her symptoms were getting better so they did not stay to see the ER doctor. Pt showed me a picture of the hives on her arms and a picture of her neck and face that appeared red and inflamed. Referred pt to see her PCP regarding possible adverse reaction to vaccines. Pt received first set of childhood recommended vaccines on 3/10/2022. Father said child had not received childhood recommended vaccines before due to her brother had an anaphylaxis reaction to vaccines and nearly died. Father plans to take child to see APRN who is child's PCP.
Left upper arm turned red, hot to the touch, then the whole body was covered in a non-itchy rash. Child's arm hurt very badly. Took her to hospital and to her doctor, who diagnosed her with cellulitis from the flu shot.
Had a couple of PEs (pulmonary embolism); This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient had a couple of PEs (pulmonary embolism) on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the pulmonary embolism and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Systemic: Tinnitus-Mild, Additional Details: Patient reports mild ringing in her left ear and that she can't hear as well. She first noticed symptom at 4:30pm (about 3-4 hrs after 2nd dose of Moderna)
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional and concerned 9 patients. The weight, height, and medical history were not reported. The 9 patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported) dose, Batch number was not reported and has been requested. Start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. It was reported that, nine other people at doctor's office had low antibody levels (suspected immunological vaccine failure) post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210540152.; Sender's Comments: V0.20210542105-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine 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: SPECIAL SITUATIONS.
8JAN96 mom called in w/ c/o hard knot size of a marble & small bruise @ site of inj still present;denies any pain, redness or inc of size over last few weeks;
This EE received two Covid vaccine, Pfizer. But he became Covid Positive on Juy 12.
Body Ache; Fever (100.7); Extreme chills/Shiverning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Ache), PYREXIA (Fever (100.7)) and CHILLS (Extreme chills/Shiverning) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (Body Ache), PYREXIA (Fever (100.7)) and CHILLS (Extreme chills/Shiverning). At the time of the report, PAIN (Body Ache), PYREXIA (Fever (100.7)) and CHILLS (Extreme chills/Shiverning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I have suffered from tinnitus for 20 years however 2 days after taking the first vaccine my hearing loss increased and the ringing in my ears got much louder.  It is currently 4 weeks later and it is still very loud.  I just received my second shot to day and am praying that it doesn't get worse.
The day after the injection I got a burning sensation around the front outside of my left underarm (arm of the injection site). Not in my armpit. It is not severe and I can ignore it, but it has not subsided.
Exhausted! In bed all day. Nightmare sweating in sleep. Shaking bouts.
A dose of moderna vaccine was administered to a 16 yo; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo) in a 16-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Approx. 30 minutes after injections began ruritic episode with erythematous rash on inner arms, One area on chest with slight edema of eyes. Sent to M.D., M.D. sent to E.R.
At 2 am, I woke up to severe chills and body aches, and horrible migraine. I checked my temperature and it was 100.7. It continued to climb to 102.8. I took Tylenol and Ibuprofen all night and all day and could not get relief.  I missed a day of work because of this. I am still with fever as of 5:55 pm and the body aches and migraine. This was not explained to me. I feel like I did when I had Corona on the worst days. I am really praying that this ends so that I can go back to work tomorrow.   I thought that someone was supposed to call and check on us each day....
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients on an unspecified date received improperly stored MMR II (lot no, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
Patient experienced itching raised rash red to touch. Came into doctor on 5/11/15 had spread down to pash elbow. Started on antibiotic Keflex bid for 10 days at this time.
Swelling, redness right arm. Patient received steroid shot at clinic. Given Prednisone 10mg and AUGMENTIN 875 scripts to be filled.
MIGRAINE; CHILLS; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On 11-MAR-2021, the subject experienced migraine. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, migraine and dizziness was not reported. This report was non-serious.
kept sleeping/I slept about 12 hrs, I think; no appetite; body aches/ still have body aches, but they're half better.; real tired; chills really bad; fever of 101.4°F; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired) and CHILLS (chills really bad) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concurrent medical conditions included Heart disorder.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F). At the time of the report, SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F) outcome was unknown and MYALGIA (body aches/ still have body aches, but they're half better.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Body temperature: 101.4 (High) 101.4°F.         No concomitant and treatment medication were reported. On18-Nov-2021, (that morning)  the patient felt real tired kept sleeping. Later on the patient had a fever of 101.4°F, body aches, chills really bad and no appetite. That night, the patient slept about 12 hrs. On 19-Nov2-021, the patient still have body aches, but they're half better.   This case was linked to MOD-2021-392019 (Patient Link).
got sick but was ok now/also had COVID after COVID vaccine; got sick but was ok now/also had COVID after COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: her youngest child has asthma and several underlying conditions. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got sick but was ok now/also had COVID after COVID vaccine".  Clinical course: It was reported caller wanted to share her experience with COVID vaccine and say thank you for the privilege of having a vaccination. Caller declines to complete a report for her daughter or other family members, unable to confirm if caller meant her daughter or mother also had COVID after COVID vaccine, at risk report filed for caller's daughter and mother. No further details captured, reported, or documented at this time. COVID vaccine was a Pfizer product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received an additional booster dose, is not considered immunosuppressed.  Pt did not remember having received a booster dose on 4/22/22  at a local pharmacy and had not recorded this dose on his CDC card. Registry record of outside dose did not transfer into pt's chart until after dose was administered.  Staff member was reminded to check state registry prior to each vaccine administration.
Pt had vaccinations administered - remained in office for 30 mins after vaccination waiting for other family members to complete their appointments. AT 1:00 am received phone call from mom that pt reported feeling funny and was passing out on her. Advised to return pt to clinic - pt was lethargic, unable to move extremities to clinic. Transferred to ER. 9/16/08-records received for DOS 7/7/08-presented to ED with C/O feeling faint, weak and unable to move, felt flushed and had brief erythema all over. DX-presyncopal episode. Prolonged weakness following number one. Transient weakness status post immunizations.
the back of my neck became occasionally tender/painful to the touch.; I had pins and needles/tingling feeling in my right arm all day Friday./ There was a brief time I thought it was on the right side of my face as well.; This is a spontaneous report from a contactable Consumer (patient). A 56-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6202) via an unspecified route of administration on 04Mar2021 at 15:00 (Thursday) in the right arm as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Penicillin allergy, Cutaneous T Cell Lymphoma, Mal de debarquement Syndrome. The patient's concomitant in two weeks included Zyrtec Allergy. Prior to vaccination, no other vaccine in four weeks and did not had COVID. On 05Mar2021 (Friday), patient had pins and needles/tingling feeling in her right arm all day. There was a brief time she thought it was on the right side of her face as well which went away the next day. On 06Mar2021 (Saturday evening), the back of her neck became occasionally tender/painful to the touch. The patient was unable to tell whether it was swollen. Patient stated that It was feeling better today (Monday). No COVID post vaccination. No treatment received for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THREE COVID-19 VACCINE.
Had both vaccines, got shingles again/ Suspected vaccination failure; Got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had shingles, then patient got both the Shingles vaccines and got shingles again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.