chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain, headache, diarrhea, dizziness, fatigue (2 days). Started period 2 day early and had very heavy period with bad cramps.
11:55 AM - PEDIARIX, Hib and PREVNAR vaccines given. Almost immediate localized red reaction around every injection site. Hives noted above diaper line on lower back, red blotchy area noted (R) lower leg. No treatment given resolved on its own. Evaluated by MD (L) thigh erythematous areas. 1 inj. site about 6cm 1 inj site about 4cm (R) thigh injection site abt 4cm.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the patient underwent antibody test and the test result was 4.12, but according to patient's physician it should have been 9.9. The patient had confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210537468-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Lower back spasms, leg spasms, back pain. Unable to sleep, headache. Going on 5 days.
8 hours after the vaccine I had a low-grade temperature, chills, nausea, body aches, and fatigue. That lasted for 24 hours. Interestingly enough, my Covid symptoms started the same way my symptoms started after getting the vaccine. That lasted for 24 hours too. After that I started with a runny nose, low grade temperature for 4 days, watery eyes. Lost of taste and smell on day 7. Fatigue. Irritable stomach. Sneezing and congestion in my nose, sinuses, and ears. I got a COVID test on 09/09/2021 and it came back positive. I contacted my doctor as soon as I got the positive test result. I worked with my homeopathic doctor to take natural remedies for treating COVID. I tested again last week on 09/23/2021 and I tested negative. I still have stomach issues.
Nausea; Abdominal pain; A spontaneous report was received from pharmacist on 16NOV2023 regarding a 40-year-old female patient who experienced "abdominal pain" (PT: Abdominal pain) and "nausea" (PT: Nausea). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: 3003851) for an immunisation.   The patient's medical history, concomitant medications, or allergies were not reported.   It was reported that patient experienced abdominal pain and nausea after taking the first dose of Vivotif.  The outcome of the reported events was unknown.   The action taken with Vivotif with respect to the reported events was unknown.   No additional information was reported.  Company comment: It was reported that a patient experienced abdominal pain and nausea after taking the first dose of Vivotif. Further information regarding the events is limited. Hence, in view of strong temporal association, the causality of the above events is assessed as possibly related to Vivotif.; Sender's Comments: It was reported that a patient experienced abdominal pain and nausea after taking the first dose of Vivotif. Further information regarding the events is limited. Hence, in view of strong temporal association, the causality of the above events is assessed as possibly related to Vivotif.
Developed hives on lower exremities, improving after taking 50mg Benadryl at home, no mouth swelling, no respiratory distress, BP102/66, pulse 72
Had a dizzy reaction to the Pfizer Covid 19 Vaccine; Has had a very bad time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time.". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Had a dizzy reaction to the Pfizer Covid 19 Vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Has had a very bad time".  Additional information: Two years ago caller received three doses of the Pfizer Covid-19 Vaccine. Had a dizzy reaction to the Pfizer Covid 19 Vaccine. Ever since, has had a very bad time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018904 same reporter/patient/AE, different dose;US-PFIZER INC-202300018910 same reporter/patient/AE, different dose;
Had COVID-19 for 2 1/2 weeks. PCR test date 1/30/2021. After this vaccine(my1st vaccine), experienced body aches, headache, fever, chills and fatigue for approx 36 hours from onset.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old female patient who experienced fever, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2018, the patient received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ051AB, expiry date: 05 Jun 2019 via intramuscular route in the left deltoid. On an unspecified date, the patient developed a non-serious fever (pyrexia) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data not reported. Final diagnosis was fever. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for fever. List of documents held by sender: none.
6/1 visual disturbance  6/4 ED visit for vision loss, dizziness  6/11 ED visit for dizziness, confusion, hazed vision, generalized weakness ? CT SCAN - unremarkable 6/18 opthamologoist appt to check ? all normal  6/21 dizziness still present, tingling in left fingers and toes 6/23 mri scan  6/25 PT visit for ?vertigo? 6/29 neurologist visit
Report persistent/intermittent chills began day 1 post vaccination. Treatment: none, Outcome: Does not interfere with ADLs. Advised to follow-up primary care doctor.
Pt fainted after receiving BOOSTRIX and VARIVAX vaccines. LOC < 30 sec.
Eczema flare up from just a spot on my hand to my torso and legs and arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 14:00 (Lot number: FF2589) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "MTHFR gene mutation" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: if covid prior vaccination- Yes; "eczema" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; FLONASE [FLUTICASONE PROPIONATE]; XYZAL; METHYL CPG. Past drug history included: Hydrocodone, reaction(s): "known allergies: hydrocodone", notes: known allergies: hydrocodone; High doses of steroids, reaction(s): "known allergies: High doses of steroids", notes: known allergies: High doses of steroids The following information was reported: ECZEMA (non-serious) with onset 20Oct2021, outcome "recovering", described as "Eczema flare up from just a spot on my hand to my torso and legs and arms". The event "eczema flare up from just a spot on my hand to my torso and legs and arms" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eczema.  Additional information: Dose received: 2, product: COVID 19, Brand: Pfizer, brand unknown:False, lot number: 30135BA, lot unknown: False, administration date:25Oct2021, administration time:03:30 PM, dose number:2, vaccine location: Right arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received as Triamcinolone Acetonide Cream 0.025%. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
One week after vaccine I developed and itchy raised bump at injection site. By the next day the pitching became worse and a 3 X 3 inch hive had developed.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 13-MAR-2023, the patient received Bexsero. On 13-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-MAR-2023 The reporter consented to follow up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who was inadvertently vaccinated with an expired 0.5 mL dose of suspect DIPHTHERIA -2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (frequency once) lot UI648AA via intramuscular route in the right arm on 24-Jun-2019 after having a cat scratch.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.  It is an actual medication error case due to expired vaccine used.  It was unknown whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Pt recvd a series of 3 Engerix-B (dates unk) & pt was a non-responder following the series of injections; pt recvd 2 booster injects & still did not respond;
"I work in the ED in behavioral health. I got my Covid vaccine at 12/23 1930 and I got super sick 24 hours getting my covid vaccine, I had chills and fever which I know is a normal side effect. But I had some shortness of breath which I thought was weird, I feel totally fine today"
SHINGLES IN ARMPIT, BACK, AND CHEST; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shingles in armpit, back, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles in armpit, back, and chest was not reported. This report was non-serious.
Headache, Myalgia, Arthralgia, chills, injection site pain, dry sinuses The morning after receiving the first dose of the vaccine, the patient reported soreness at the injection site, headache, joint pain, chills, and dry sinuses. She took three doses each of ibuprofen 400mg and acetaminophen 650mg over the course of that day.
Day 1: Left arm had DTaP and IVP vaccinations (right arm had MMR). Day 3: We noticed considerable swelling, redness and very hot left arm and shoulder (onset may have been much sooner - with the cold winter weather our son had on long sleeved shirts and pajamas at all times - we discovered because son was complaining of pain in the arm). Left arm was 20-25% larger than right arm. Returned to doctor immediately (48 hours after vaccinations). Dr. prescribed Cefadroxil 250MG/5ML Susp 100ML - 6ml twice/day for 10 days. No change for first 24 hours, but after 24 hours redness and swelling was reduced somewhat. Day 5: Dr. requested re-check visit. Swelling/redness/warmth down considerably. Day 8: (today) arm appears normal. Will have final Dr. visit 3/16/07 (Day 12) to verify complete recovery.
more than 36 days have passed since the first dose and patient did not receive the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and patient did not receive the second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-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 36 days have passed since the first dose and patient did not receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and patient did not receive the second dose) 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.   No concomitant and medication information provided.  No treatment information provided.   Reporter did not allow further contact
Information has been received from a licensed nurse practitioner referring to a 65 year old male patient. On 17-MAR-2015, the patient was vaccinated with the first dose of ZOSTAVAX (dose, frequency, route and lot number not provided). On 31-OCT-2015, the patient was vaccinated with the second dose of ZOSTAVAX (dose, frequency, route and lot number not provided) (extra dose administered). No adverse effects were reported. There was no product quality issue (PQC). Additional information has been requested.
Aches; chills; fever of 104.4; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient). A 21-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 26Feb2021 (at the age of 21-year-old) as dose 2, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No known allergies were reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date (at the age of 21-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other vaccines within 2 weeks of COVID-19 Vaccination included unspecified vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Feb2021, the patient experienced aches, chills, fever of 104.4 the following day. The patient underwent lab tests and procedures which included body temperature: 104.4 on 27Feb2021. No treatment was received for the events. The outcome of the event was reported as resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient became dizzy/diaphoretic during 15-minute post-vaccination waiting period in pharmacy waiting area; patient reported feeling unwell to pharmacy staff; this pharmacist escorted patient back to vaccination room with assistance of pharmacy manager; cold compress applied to patient's forehead, water offered- patient experienced brief loss of consciousness and became unresponsive to verbal commands for approximately 60 seconds; pulse strong; upon regaining consciousness determined patient had worked an overnight shift and had nothing to eat all day prior to vaccination; provided food/water/direct observation for at least 30 minutes, and indirect observation for additional 15 minutes- symptoms fully resolved
Difficulty breathing, muscle aches, headache, fatigue, dizziness, pain at injection site
chills,nausea,anorexia,h/a,erythematous @ vax site;tx APAP,IV NaCl,heparin lock
Severe shoulder pain; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Sep2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to avocado, kiwi, banana, mango and latex. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEK); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took measles vaccine; mumps vaccine; rubella vaccine(MMR) and experienced drug allergy. On 08Sep2021 at 17:00, the patient experienced severe shoulder and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder and arm pain was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for(RA). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 3 doses of Engerix-B on 19FEB90, 4APR90, & 16AUG90 & was found to be a non-responder;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # K011562, expiration date: 08-APR-2017 (dose, route of administration and anatomical location were not reported). It was administered prior to its expiration date. The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1707USA000769: US-009507513-1706USA008487: US-009507513-1707USA000768: US-009507513-1707USA000794.
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.       On 07-OCT-2021, the patient was vaccinated with the improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA) (PROQUAD) (lot # U019287, expiration date: 15-DEC-2022) 0.5 ml/once (strength and route were not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 5.7 Fahrenheit (F) for 6 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported (no adverse event).
Approximately 5 minutes post injection, Pt experienced syncopal episode lasting 10 seconds. BP 90/62 at episode. After orientation X 3 was re- established, Pt reported feeling better. BP 96/64 at discharge. Discharged in the care of her mother. No injury noted. Physician aware.
On 06/11/2021 had heart attack complete blockage on RCA which resulted in chest pains, shortness of breath, profuse sweating. Was admitted to a local hospital and procedure through the right arm was used to clear blockage and place a stent at the site of blockage. This occurred even being completely healthy and with no history of heart disease of under laying condition, and very minimal blockages in other part of this artery and others, less than 20% blockage. Recovered and sent home day later with lifetime of medications.
She had trouble breathing within days of the second vaccine. She went to the hospital 9 days after the vaccine. Her breathing continued to decline where she had to be placed on a ventilator. She stayed on that for almost 3 weeks. The doctors had no hope of her recovery and we chose to end life support exactly one month after her second shot.
9:45 Client experiencing itching on the back of her neck. No rash, swelling, redness or hives noted. Slight itching on face on right eyebrow and right side of nose. No redness/rash noted. BP 190/96  9:50 BP 182/86 10:00 refused ambulance dispatch, itching resolved. States she feels well enough to leave and wants to go home. Client ambulated without difficulty. No s/s distress. Ambulated with husband to personal vehicle accompanied and driven by husband.