chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wasn't able to move his neck or have a full range of motion in his neck/back problems; Ache in his right foot; sinus issues and pressure in his face; mucus which he states is a sign of infection; Sore neck; eye socket hurting; Nose dripping; A sore throat; Foot cramps; He is smelling an offensive smell; back problems, sore neck and back; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (wasn't able to move his neck or have a full range of motion in his neck/back problems), PAIN IN EXTREMITY (Ache in his right foot), PARANASAL SINUS DISCOMFORT (sinus issues and pressure in his face), SECRETION DISCHARGE (mucus which he states is a sign of infection) and NECK PAIN (Sore neck) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (wasn't able to move his neck or have a full range of motion in his neck/back problems), PAIN IN EXTREMITY (Ache in his right foot), PARANASAL SINUS DISCOMFORT (sinus issues and pressure in his face), SECRETION DISCHARGE (mucus which he states is a sign of infection), NECK PAIN (Sore neck), EYE PAIN (eye socket hurting), RHINITIS (Nose dripping), OROPHARYNGEAL PAIN (A sore throat), MUSCLE SPASMS (Foot cramps), PAROSMIA (He is smelling an offensive smell), BACK PAIN (back problems, sore neck and back) and CHILLS (Chills). At the time of the report, MUSCULOSKELETAL STIFFNESS (wasn't able to move his neck or have a full range of motion in his neck/back problems), PAIN IN EXTREMITY (Ache in his right foot), PARANASAL SINUS DISCOMFORT (sinus issues and pressure in his face), SECRETION DISCHARGE (mucus which he states is a sign of infection), NECK PAIN (Sore neck), EYE PAIN (eye socket hurting), RHINITIS (Nose dripping), OROPHARYNGEAL PAIN (A sore throat), MUSCLE SPASMS (Foot cramps), PAROSMIA (He is smelling an offensive smell), BACK PAIN (back problems, sore neck and back) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient was reported to use sinus medications and vapor machine as treatment for the events. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient fainted after vaccine but walked out of store after ambulance was called. Patient stated that she faints due to needles.
Pt developed fever to 101.4 w/ generalized tonic clonic seizure 48hours after administration.  Evaluated in emergency dept - no treatment required.  Fever resolved after this incident.  1 wk later (total of 9d following MMR administration), pt developed new fever to 101.4 w/ no focal symptoms or infectious etiology identified.  Had generalized tonic-clonic febrile sz lasting 10min.  Evaluated in emergency department - cultures of blood, urine, CSF negative.  All work-up was normal including basic metabolic panel, urinalysis, complete blood count, csf studies (glucose, protein, cell counts), CT head, chest x-ray with the exception of elevated wbc of 15.9 (poly 62,band 2, lymp 29). Pt received no treatment and was discharged home.
Client states that the vaccine site became very itchy 45 minutes after the shot was given, as well as "tingly" feeling.  The next day she noted a very sore, half dollar sized red raised area that was very hot to the touch.  She felt a definite lump under the general area of the vaccination which was given SC.  Today the area remains as reddened and as large as she noted last night, but not as hot to the touch.  She is still feeling sore in that area.
Box 17 - Varicella  Chills, body aches, swollen throat (hard to breath, swallow, talk). Seen at Emergent Care. Tested for strep, negative. Advised to stay home for 5 days, rest, take Advil every 4-6 hours. Denied relation to Varicella vaccine. Planning to follow up with PCP on 7/21/20.   Box 23 - Experienced flu after taking MMR vax
feels weak; fever; chills; headache; slight discomfort to injection site; This is a spontaneous report from a contactable consumer (patient herself) received from Pfizer-sponsored program. An 82-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021 she experienced fever, chills, headache, slight discomfort to injection site, on 05Feb2021 she felt weak, caller received an appointment for her second dose on 03Mar2021 which is 4 weeks out rather than 3. The outcome of all events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fatigue; Chills; Inflammatory marker increased; Sickness; Uveitis flare up; COVID-19 virus test positive; COVID-19; This is a solicited report based on the information received by Pfizer. A contactable physician reported that a 39 year old female with events of non-serious POSITIVE COVID-19, UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, COLD, BAD COLD, INFLAMMATION MARKERS HIGH and SICK with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD, INFLAMMATION MARKERS HIGH and SICK. In January 2020, the patient experienced COLD. In January 2020, the COLD resolved. In December 2020, the patient experienced POSITIVE COVID-19. On unknown dates, POSITIVE COVID-19, UVEITIS FLARE and SICK resolved. COVID-19 VACCINE was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events  of POSITIVE COVID-19 and SICK with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of UVEITIS FLARE and COLD with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD and INFLAMMATION MARKERS HIGH was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the batch/lot number requested.; Sender's Comments: As there is no indication of the time interval between the administration of the drug and the onset of events and based on known drug safety profile there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.   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.
Itchy rash all over face/neck/belly; Red rash all over face/neck/belly; Fatigue; Joint pains especially in the thigh and knees; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and was unknown if ongoing. The patient did not receive any medication within two weeks of vaccination. The patient was allergic to fruit allergy(pineapple), allergy to animal dander(fur from animals), perfume sensitivity(some perfumes), cosmetic allergy(some powders and some soaps) The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6201) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced itchy red rash all over face/neck/belly, fatigue, joint pains especially in the thigh and knees. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events itchy red rash all over face/neck/belly, fatigue and joint pains especially in the thigh and knees were all not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Pt reached out to the pharmacy on 12/3/21 stating that after receiving Pfizer booster on 12/1/21, she began experiencing symptoms on the night of 12/2/21 including rash which presented on the left side of her face moving to the right which was resolved after taking benadryl, pt also experienced chest tightness as well which did not resolve.
was given with the regular flu vaccine Fluzone QIV rather than the Fluzone high dose flu vaccine with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Elderly patient of an unknowm age and gender who was given with the regular flu vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv] rather than the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown expiry date, lot number, strength) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient was given with the regular flu vaccine Influenza Quadrival A-B Vaccine rather than the Influenza Quadrival A-B High Dose Hv Vaccine with no adverse event (wrong product administered) (latency: same day).  It was reported, A Pharmacy Director/ Pharmacist said they have a patient on one of their site who is over 65-years-old and was given with the regular flu vaccine Fluzone QIV rather than the Fluzone high dose flu vaccine. Inquirer asked if they have to revaccinate the patient with the high dose flu vaccine.  She does not have any information on the lot number or the age or gender of the patient, but states that since it was a flu shot clinic, no other vaccines were given. They will contact the patient and refer them to their HCP to determine follow-up actions, if any. Pharmacist states that she instructed staff on duty to fill out a VAERS report.   Action taken: not applicable  Outcome: Unknown    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 the 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.
patient received the 4th dose of ActHIB at 11 months old (instead of the recommended 12 months), no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00457196) and transmitted to Sanofi on 02-Feb-2021. This case involves an 11 months old male patient who received the 0.5 ml 4th dose of HIB (PRP/T) VACCINE [ACT-HIB] VACCINE (lot UJ327AA, expiry: 30-Jun-2021) via intramuscular route in the left thigh at 11 months old (instead of the recommended 12 months), for prophylactic vaccination on 29-Jan-2021 (Inappropriate schedule of product administration)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), INFLUENZA VACCINE (FLU) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of an actual medication error due to drug dose administration interval too short (latency same day)  The caller stated that a patient has received the 4th dose of ActHIB early and would like to know how to proceed in caring for the patient. The actual day of the month was not available. The patient was supposed to receive the 4th dose of Acthib. The patient's birthday was 26-jan-2021 in the computer and his actual birthday is 25-feb-2020. He received his dose weeks early.  At the time of report, no adverse event was reported.  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.
Developed high blood pressure, which was textbook 120/80 prior to getting vaccine.  Now have to take two different medications (Metaprolol and Amlodipine).  Also currently being checked for atrial fibulation.
This spontaneous report was received from a health care professional concerning a 1 year old patient of unknown gender. On 05-JUL-2013, the patient was vaccinated with expired dose M-M-R II first dose, 0.5 ml, subcutaneously (lot # 1025AA exp 30-JUN-2013). No adverse effects were reported. Additional information has been requested. This is one case of several cases reported by the same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Jan2023.  Additional information: Known allergies reported as NA and Other medical history was NA.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I received my first dose exactly a week ago, and today my arm became inflamed and rashy at the injection site. It is hot to the touch and just uncomfortable. It's been this way for about 7 hours so far. I've been treating it with ice packs which helps the heat sensation feel better, but the rash is still red and visible. I'm not super concerned but still felt that I should report it, as it's weird it took a week to show up.
got exposed to their niece who has lymphoma and who also tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient (her sister-in-law).A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number), via an unspecified route of administration as 1st Dose Single Dose for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number), via an unspecified route of administration as 2nd Dose Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got exposed to their niece who has lymphoma and who also tested positive for covid. She wants to know if they can still be infected with Covid even if they received both doses of the vaccine.The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
approx 10 pts exp fever to 104 w/in 24 hrs of immun; unk if immun were given from the same vial;
chills, headcold,skin sensitive to touch, woke-up the next day after vaccination with feeling of being very warm and sweaty. symptoms resolve and only feels tired today 2/3/2021 for lack of sleep last night.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786.). Sender's Comments: US-009507513-1712USA008050.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.  concomitant details not provided.    This case was linked to MOD-2021-009003 (Patient Link).
Patient experienced dizziness, little shakiness with-in 5 minutes of vaccine administration. She lost consciousness twice for about 2 to 3 seconds. I made patient laid on the floor mate, and she felt much better.
Hospitalization for COVID-19 infection with hypoxemia, failure to thrive, abdominal pain/elevated lipase, acute on chronic kidney disease, diastolic congestive heart failure on dates 8/22/2023- 9/18/2023. Treated with dexamethasone.
Pt fainted shortly after vaccination. Sudden loss of BP suspected. Pt recovered from lifting legs above head for 5 minutes. Issue did not persist. Always faint from blood draw.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Medical history was not reported. On 22-NOV-2014 the patient was vaccinated with ZOSTAVAX approximately 0/7 ml, subcutaneous, in the arm (unspecified arm) (lot number and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified)(Manufacturer unknown) administered in the other arm on the same day. Concomitant therapy was not reported. The pharmacist informed that on 22-NOV-2014, in the evening the patient developed a red, swollen and itchy rash in the injection site of the arm that ZOSTAVAX was administered. There were not laboratories diagnostics performed; The patient sought medical attention calling to the pharmacy. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
On 2/22/22, administered expired Proquad vaccines. Vaccine expired 2/15/22. Writer did not document the Lot, manufacturer.
I had a sore arm after receiving the vaccine for about a day. My husband passed away on 07/05/2022.  It was recommended that I see my doctor for a checkup after he passed away. I was diagnosed with hypertension on 10/02/2022. I am on medication to control the hypertension. It is not ideal, but it is better.
Redness 30 min after the vaccination admin. Redness and swelling at injections site. Darker redness 1/2 dollar size inner circle with light redness over the entire deltoid region. Warm to touch.
patient passed out after vaccine. said she felt dizzy and her vision was a little blurry and then she fainted. Mom and patient refused for ambulance to be called and mom said she would monitor patient. called mother later in evening (7:50pm) to check on patient but had to leave voicemail and did not receive a call back with an update.
For informational purposes, I am a health care provider myself. I have been experiencing severe episodes of vertigo, starting approximately 1 week after receiving my first dose of the Pfizer vaccine, and only when lying in bed. They occur a few times per night, and have occurred essentially every night since they started. They are very intense, but also very short in duration, of about 3-5 seconds. When I called my primary care physician to see if she had any thoughts, or suggestions, or if she thought it could be due to the vaccine, she informed me that she also had the same reaction, severe vertigo, while lying in bed, at about the same time period, 1 week after her first injection, although she just had 2 isolated episodes of it, and she had the Moderna vaccine. Neither of us have seen any published information listing this as a side effect of the vaccine.