chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 29-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Rash and soreness developed on right shoulder. Vac. administered 1 inch apart.
Parent reports arthus type local reaction - large, red, hot, indurated response beginning app. 2 hours after administration and last 4 days.
This spontaneous report as received from a health care worker refers to 2 unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (unspecified lot# and expiration date, route, dose not reported). No concomitant medications were reported. The reporter states that she remembers reporting this to Merck "years ago" and requesting a lot# check because the unspecified patients developed fever and redness and swelling at the injection site after receiving PNEUMOVAX 23. The outcome of the events and causality is unknown. This is one of the 3 cases reported by the same reporter (same reporter link: 1409USA010810 and 1409USA012530). Additional information has been requested.
24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number:EW0168; Expiry date: unknown),via an unspecified route of administration, in the Left Arm on 15May2021 at 13:00 as a single dose for COVID-19 immunization. The patient's medical history included disability due to back injury and nerve damage in both legs. The patient reported No allergies. The patient's concomitant medications included buprenorphine (BUPRENORPHINE); oxycodone (OXYCODONE), etodolac (ETODOLAC); baclofen (BACLOFEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 06Jun2021 at 12:00, the patient reported for both doses, 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine that lasted 2 days for 1st dose, and so far, half a day for 2nd dose. No treatment was received for the events. The clinical outcome for the events was not recovered/not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
pain in her right eye; eye was irritated; sore arm; A spontaneous report was received from a consumer  concerning her wife, a 71-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in her right eye, sore arm/vaccination site pain, eye was irritated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 02AL20A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events,  pain in her right eye, sore arm, eye was irritated. Thursday, she went to the HCP who says her eye was irritated and it might or might not be related to the vaccine. HCP prescribed her an antibiotic ointment. On Sunday and Monday, she forgot to use it, but remembered Monday night and Tuesday the pain in the eye came back.  Treatment details included antibiotic ointment.  The patient received both scheduled doses of mRNA 1237 before the events, therefore, action taken with mRNA-1273 in response to the events was not applicable   The outcome of event, pain in her right eye, sore arm, eye was irritated was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Severe headache, fever 101, body aches, fatigue lasting about 1 day.
Pt recvd plague vax sometime during 19DEC91; @ about 2300 that day, pt was noted by roommate to be reading in bed, healthy & in no distress; about an hr later, roommate awoke to go to bathroom & find pt dead on floor;
Patient given adult dose Hepatitis A vaccine instead of Pediatric dose of stated vaccine. No reaction / adverse event. Talked to RN - form faxed - she stated it is not necessary to call manufacturer unless our facility requires us to do so.
Noticed about a week after first dose a red circle appeared around the injection site.  Skin at site was slightly itchy and had a noticeably higher temperature than surrounding skin.  As of today the circle is still there, though more blotchy and less defined and temperature is still slightly higher than surrounding tissue.
One hive on my L side of my neck. Itchy, red, hot for at least 30 minutes. RN gave me Allegra after 30 minutes of no new hives and no other symptoms.
TINNITUS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine bnt 162 (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, start therapy date was not reported for prophylactic vaccination. On an unspecified date, following vaccination with booster of bnt 162, the patient experienced tinnitus. (Dose number in series 2). The action taken with bnt 162 was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
June 28, 2021 - pt. was diagnosed with Walking Pneumonia.  Aug 6, 2021 - seen in local ED for chest pain. Sep 9, 2021 - seen in local ED for severe right lateral abdominal pain.  Sep 10, 2021 - diagnosed with Leukopenia, acute kidney injury. Sep 14, 2021 -  Dr. indicates dropping White Cell Count, Red Cell Count, Hemoglobin, Neutrophil.  Sep 17, 2021 - 2nd Dr.  saw him for rt knee pain/swelling.  Sep 18, 2021 - Medical team sent him to hospital for lt knee pain/swelling and neutropenia.  Knee was aspirated. Oncology drs felt he could go home.  Sep 21, 2021 - 3rd Dr. did a procedure for kidney stone (RIGHT ESWL).  Sep 29, 2021 - 1st Dr. admitted pt. for chemotherapy for Acute Myeloid Leukemia Bone Marrow Biopsy was done. He was discharged on Oct 2, 2021.  He was admitted on Oct 9 2021 and discharged on Nov 2, 2021.  1st Dr. retired from Oncology and pt.'s care is now under the direction of a 4th Dr.  Since this visit, pt. has been making 2 visits a week, or more, to the hospital for blood draws and infusions/shots.  He would be readmitted every six weeks or so for more chemo therapy.  He never achieved remission.  During his May 29 - June 25, 2022 admission, he developed multiple blood clots in both legs (right leg had 5, left leg had 3).  He also developed an infection called c. diff and fluid retention overload. He almost died in this visit.  He has received more chemotherapy in an outpatient setting and is being set up for a stem cell transplant.
turned pale, eyes rolled back, broke out in a cold sweat, passed out, laid down on table, jerking movement over entire body only out for a second; nauseated, got dizzy 18JUL95 pc no problems x/arm sore
Everything was fine until 9 days later I had severe flu and went to a 24Hr clinic who advised I had covid.
No additional AE reported; patient received the 3rd dose of GARDASIL 9 too close to the 2nd dose; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 07-FEB-2021 and 02-APR-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (doses, routes of administration, lot numbers and expiration dates not reported) and on 27-JUL-2022, the patient received the third dose of the vaccine,1 dosage form, lot number 1780876, expiration date 09-NOV-2023 for prophylaxis (route of administration not reported), that was administered too close to the second dose (inappropriate schedule of product administration). No adverse event was reported.
Redness in his arm; swelling  in his arm; rash the size of a ball around the injection site/ rash was not raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm). At the time of the report, VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised). At the time of the report, ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       concominant and treatment medication were not provided
patient experience general flu-like symptoms after time of vaccination (chills, nausea, headache) but then experience muscular stiffness and muscular symptoms the following day. recommended that patient follow up with her pcp (she mentioned she hadn't discussed the rxn with them due to their views on the vaccine); she mentioned she will try to reach out to her pcp or a specialist that she sees
Sarted at 1245 co HA, BP 166/83 HR 78, 1310 bp 175/87, hr82.  Pt stated took morning dose nifedipine not scheduled for losartan until evening.  to ED for eval.
Could barely get her balance; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and BALANCE DISORDER (Could barely get her balance) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Rheumatoid arthritis, High cholesterol and ADD. Concomitant products included PRIMIDONE and PROPRANOLOL for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced BALANCE DISORDER (Could barely get her balance). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and BALANCE DISORDER (Could barely get her balance) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient also takes ADD medications, statin low dose, Rheumatoid arthritis medications and high blood pressure medications.
pt recv vax 2DEC96 & 3mo p/vax lab eval revealed vaccine failure;it was also reported that the pt was attempting pregnancy;No further details were provided;
I was diagnosed with osteoarthrosis in my right hand knuckle (primary hand) on 01/25/2023. My symptoms started about a month after I received my COVID vaccine. The pain stated about May/June 2022. I initially thought that I had jammed my finger in my sleep. It wouldn't heal and kept persisting. I eventually went into a walk-in clinic to have my hand x-rayed and I was diagnosed with osteoarthrosis.   I don't know whether or not this was a direct result of the COVID shot, but the timing is suspicious. I decided to report this to VARES just in case.
Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved my arm, No Treatment. But, not as sore as it was after 1st injection. 3/17 Day after injection, very tired all day. Went to bed at 7:30pm. Arm soreness waning. No Treatment. 3/18 Noticed slight dizziness, sometimes. Not as tired. Arm pain almost gone, just a bruised feeling at injection site. No Treatment. 3/20 Dizziness more noticeable, today. My head feels like it's full of cotton. No Treatment.
Swollen lymph nodes in neck; head feeling "foggy"; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not included. The patient was allergic to fish and seafood. Concomitant medications included omeprazole magnesium (OMEPRAZOLE), vitamin c (MANUFACTURER UNKNOWN) 20Mg and multi-B Vitamin (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:30 the patient experienced swollen lymph nodes in neck and head feeling "foggy" going on 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. On 11Nov2020, the patient underwent nasal swab and the result was negative. The clinical outcome of the event swollen lymph nodes in neck and head feeling "foggy" were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Breakthrough positive case of COVID 19; Breakthrough positive case of COVID 19; This is a spontaneous report from a contactable other healthcare professional. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, SINGLE and 2ND DOSE, SINGLE, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. Medical history included atrial fibrillation (A-fib). It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. The patient's concomitant medications were not reported. It was reported that the patient experienced breakthrough positive case of COVID 19 on an unspecified date. It was noted that the patient was tested positive to COVID test post vaccination. The event resulted in hospitalization. Treatment was received for the adverse event (unspecified medication). The event was considered serious due to Caused/prolonged hospitalization. The outcome of the events was recovered.   Information on lot/batch number has been requested.
1620: After receiving COVID vaccine, pt c/o tingling on lips and face; hx same s/s w/food allergies inc rash/hives 1624: Benadryl 25 mg po given  1628: BP 168/98 HR 88 RR 24 SpO2 100% 1634: States tingling improved but left cheek feels "numb" 1635: DS 109 1638: States numbness feel improved 1647: BP 162/90 HR 88 1652: Discussed elevated BP; suggested f/u w/PCP. Pt driven home by husband.
Deltoid tight, soreness, ?sterile abscess, marked tendonitis, cervical m. spasm, medial epicondylitis;
MMR II Live Inj vaccine adminstered 6/25/16 and expired 6/11/2016, no known ADR, waiting to call manufacturer Monday 6/27 (currently closed), per CDC revaccination is advised unless serologic testing indicates a response to the vaccine.
Guillain Barre Syndrome that lasted for 4 weeks.  Prickling, pins and needles sensations in arm, fingers, leg, feet numbness/loss of feeling in arm and hand for weeks Difficulty with facial movements, including speaking, chewing or swallowing Severe pain, achy, shooting or cramplike  Rapid heart rate Difficulty breathing
Covid 19; Covid 19; This is a spontaneous report from a contactable healthcare professional (patient, self-reported). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an intramuscular route of administration, in Right arm, on an unspecified date, as single dose for COVID-19 immunization, at Nursing Home/Senior Living Facility. Medical history included Mild congestion. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has been tested for COVID-19 on 15Jan2021 and the result was positive. The outcome of the event was resolved on 23Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Covid-19 and the suspect drug BNT162B2.
Patient receiving RABIES vaccine series after being scratched by a raccoon that jumped into the family's car. After receiving the third dose in the series, patient developed a rash 1 day after the third dose was administered. Rash is described as a vague maculopapular rash to the inner thighs.  No urticaria or papules. Administration of BENADRYL prior to last injection advised.
Patient administered vaccine on 9/23/2021. Vaccine expiration was 9/21/2021. No adverse events reported by individual.
Developed annular erythema and edema and pain inferior to injection site 2 days after vaccination which increased in size on day 3. Referred to primary MD. To be seen by doctor on 10/19/07.
FLUZONE HD QIV was administered to children under 18 years of age with no adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 6 years old female patient and Nurse was administered Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to children under 18 years of age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2023, the 6 years old female patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (expiry date: unknown, strength: standard, frequency: once and lot U8138CA) via intramuscular route in the right deltoid as Immunization (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  US-SA-2023SA317318:01802208
This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 24Mar2021 (at the age of 38-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Other Vaccine as second dose (Batch/Lot Number: EWO 15800 Formulation: Unknown) via unspecified route of administration on 24Mar2021. The patient medical history and concomitant medications were not reported. On 14Aug2021, the patient reported that she did Covid test and was positive and experienced very bad symptoms and had fever, cough, body pain, and lost smell and taste. Patients feel very frustrated. Patient though being vaccinated she would not experience this nightmare. The patient underwent lab tests and procedures which included COVID-19 test, positive on 14Aug2021. Patient had Covid tested post vaccination and Covid prior vaccination was reported as yes. The patient took Tylenol as treatment for the event. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Patient reported high fever since getting shot on 04/07/21 and still on 04/13/21. She had  headache and body ache. She said she even did covid test that showed negative.