chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The area in which the vaccine was administered turned red, and became very sore.  A lump was present immediately after and never dissipated.  The lump still remains.
One week after receiving the vaccine the patient began to experience tinnitus in his bilateral ears, hypersensitivity
CHILLS, SEVERE HEADACHE LASTING OVER 24HRS, LOW GRADE FEVER, SORE ARM, SWOLLEN GOLF SIZE AREA AT SITE, REDNESS, PAIN 6/10
12/12/22 presents to ED for "SOB". PMHx of "HFpEF, CAD s/p CABG, PAF on Eliquis, CKD, and Hypertension"
Injection given SQ. Redness/swelling x 72 hrs Continue with minimal swelling
Myocarditis; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Comments: myocarditis, 4 patients.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event myocarditis. 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.,Linked Report(s) : US-PFIZER INC-PV202300060530 Same article/ drug/event and different patient;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: E89262), in right arm, on 05Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 27Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 30155887), in right arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No adverse reactions to COVID injections/boosters. Paxlovid treatment start date was 23May2023 and treatment stop date was 27May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 , and the events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300210419 Same patient, different vaccine doses and different events.;
Patient called to complain of: itching, tiredness. Redness on her chest. Being out of breath while performing normal daily activities.
The patient was given a Pfizer covid-19 booster vaccine less than 6 month after her 2nd dose of her primary vaccine series. The patient is also 13 years old and the booster was not approved for anyone under the age of 18 at the time of administration.
-Difficulty in moving arm; pain in arm, sometimes radiating to hands. -No pain if arm in resting position.
Information has been received from a nurse practitioner concerning a 10 year old female who on 10-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot#657620/0536U). Within 24 hours of vaccination the patient developed an injection site reaction that "grew to be about the size of a softball (about 5 inches in diameter)." It was noted that the reaction was "warm, puffy, and red." She sought medical attention and was treated with Benadryl and ice packs. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 16-OCT-2014 the patient was vaccinated with expired dose of ZOSTAVAX (strength was reported as 19400 PFU), expiry date: 28-SEP-2014, lot number, route of administration, dose, anatomical location was unknown). No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
became blind in his left eye; This spontaneous report was received from the patient's wife referring to her husband, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.     On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for shingles (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported).         On an unknown date in 2008, the patient became blind of his left eye. The patient's wife was inquired of the vaccine could have caused the blindness.   The outcome of blindness unilateral was unknown.  The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was not reported.       Upon internal review, blindness unilateral was considered a medically significant event.
Pt. was sent from training to Dialysis to receive 2nd dose of COVID vaccine. Pt. did not have vaccination card on hand, did not remember what brand vaccine he received nor did RN ask prior to departure. Pt. arrived at Dialysis and was administered Moderna vaccine. Pt. received initial Pfizer vaccine on 4/20/2021 at County Department of Public Health. Pt. aware of circumstances and states he told RN at Dialysis "I had Pfizer, my first dose was Pfizer". RN monitoring pt. is asymptomatic.
After the injection, patient reported she was feeling numbness and tingling down her arm. Met with doctor, assessment determined ulnar neuropathy. Symptoms improved with rest. Recommended no pressure to elbow.
Dose administration error - injection was given by RN on the top of the shoulder instead of the deltoid muscle.  RN first tried to administer shot but hit bone, calling it "scar tissue", then moved to the right 2 cm and gave it in the subcutaneous space.
After leaving the Dr's office I began experiencing weakness in my right leg and pain in my joints in general. The weakness in my right leg increased and I had to struggle to walk. I could not put any weight on my right leg. I had severe pain in the muscles above my right knee. I applied ice, but it did not help. I applied heat for about 30 minutes and was able to limp for a short period of time. The inability to use my leg completely lasted for over 48 hours. I am still experiencing severe joint pain in my shoulders, knees, ankles and wrists. I am taking Meloxicam and Tylenol. I am able to walk, but the weakness and pain is still lingering after 72 hours. I also had a headache, cognitive difficulty  and fatigue.
I took a 2 week group trip out of the country and my COVID-19 symptoms began on my flight home on 05/24/2022. I experienced symptoms of cough, sore throat, congestion, ear congestion, low-grade fever, myalgia, fatigue, chills, and headache. I was prescribed Paxlovid on 05/28/2022 when I went to the clinic. I began taking Symbicort and Flonase 05/25/2022. When I began taking Paxlovid I stopped taking my supplements to avoid any drug interactions. I was ill for 6 days before my symptoms began to resolve. I still have lingering congestion and cough at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 17:15 as dose 5 (booster), single (Lot number: GI3277) at the age of 59 years, in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment with Paxlovid from 03Jan2023 to 07Jan2023 and patient was not received other medication in 2 weeks.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
high temperature/fever up and down; lungs shutting down; could not breathe; body aches; chest keeps hurting; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer sponsored program. A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included autism. Concomitant medications were not reported. The reporter stated that the patient received the first dose of the Pfizer COVID vaccine on 09Apr2021 and has been having a fever up and down and body aches. Caller states she has taken her to the doctor and the doctor prescribed promethazine with codeine and prednisone. Caller states her daughter has also been complaining that her chest keeps hurting and the doctor prescribed albuterol with budesonide. Caller states she has been giving her Tylenol for the fever and it has been 72 hours and it still has not gone away. The patient began running high temperature, lungs shutting down and could not breathe caller contacted pulmonologist who gave albuterol, steroids, daughter is still having breathing issues. Caller states she has an appointment with the doctor tomorrow who will be making the decision as to whether or not she will be getting the second dose. Caller asked what if her daughter does not receive the second dose how will this affect her being able to travel and what will the vaccination site put on her vaccination card when she goes back on 07May2021 for second dose even if her daughter does not receive hers. Caller would like to know if she is exempted from the 2nd dose, can she still travel. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
left arm a little sore for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In SEP-2023, the patient received RSV vaccine (right arm), FLU VACCINE (NAME UNKNOWN) (left arm) and COVID VACCINE (left arm). In SEP-2023, an unknown time after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: left arm a little sore for 2 days).  The outcome of the pain in arm was resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 29-SEP-2023 The case was received from the patient interactive digital media. The got the new Covid, Flu and RSV all on the same day and that was 4 days ago.  The patient had zero issues, left arm a little sore for 2 days, but he/she went to the gym on the second day and had been daily since the shots. The patient know that everyones body reacts differently, but that was his/her input. The follow-up could not be possible as no contact details were available.
Bad neck pain started overnight 12/8 to 12/9 and hasn't gone away yet as of today 12/13.  I also had fever, chills, and horrible headache on 12/8. Fever and chills went away by next morning, headache improved but never went completely away, and neck pain won't go away.
On may 05/2021 woke up couldn't walk worse than after 1st vaccine, had to use a walker with seat to move around in my home. There were so much pain down my left leg, couldn't stand it call doctor. Had to sleep when I could with leg on pillow. My pain meds.  didn't help pain much it hurted all the time.  Walked with cane a week later still walking with cane still have pain in leg. Knee.& ankle.
Information has been received from a healthcare worker concerning a 66 year old female with no pertinent medical history or drug reactions/allergies who on 20-OCT-2007 was vaccinated with Pneumovax 23 (lot# 655765/0061U) 0.5 mL injection. There was no concomitant medication. On 22-OCT-2007, 2 days after being vaccinated the patient experienced swelling from her shoulder to elbow which extended to her chest area. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered. The reporter felt that swelling from the shoulder to elbow which extended to the chest area was considered to be disabling. Additional information has been requested.
Slight tachycardia feeling, mild dizziness, brief nausea and feeling flush.  Some symptoms within few minutes, but all developed within 15 minutes.  Patient embarrassed and didn't want to acknowledge them.  She felt she needed to take her mask off to help her breathe.
Stroke; shingles; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 13-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, the pt suffered a stroke and shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine,symptoms have resulted in physical limitations not present prior to vaccination. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt sustained severe and permanent personal injuries. At the time of the report, the outcome of herpes zoster and cerebrovascular accident were determined as not recovered. The lawyer considered herpes zoster and cerebrovascular accident to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be medically significant. Cerebrovascular accident and stroke were determined to be serious due to disabling.
PATIENT DID NOT INDICATE THAT SHE HAD A PREVIOUS COVID VACCINE MAKING OURS A MIXED VACCINE. PATIENT REC'D A PFIZER VACCINE 3/12/2021 AT ANOTHER FACILITY.
Fever of 102-103 for 40 hours; Chills for 40 hours; Body Aces for 40 hours; Nausea & Vomiting 40 hours after; administration of the vaccine; Tongue Swelling 34 hours after administration of the vaccine; Sore Arm continues today; Injection Site Warm to Touch and Red 66 hours after administration of the vaccine.
The morning following vaccination, patient reported a splitting headache and a severely sore neck. This persisted for 2 days. Patient's mother gave ibuprofen, which seemed to help. Upon follow up on Day 5, symptoms have almost completely subsided and now reporting a mildly sore neck.
Patient felt dizzy, light-headed,  nauseous, and was diaphoretic about 5 minutes after vaccine given.  Patient was assisted to the ground and legs were elevated.  It took patient about an hour until he was able to sit up without dizziness.  Juice and snacks given and VS were monitored.  Patient was evaluated by Dr. onsite and instructed not to drive.  Patient was picked up by his in-laws and instructed by Dr. to be checked out further at either Urgent Care or the ER due to prolonged dizziness after vaccination.  Pulse was 86 sitting to 99 standing.  BP stayed the same from sitting to standing.  Blood pressures with manual cuff were 160/80.  BP rechecked 30 minutes later and was 140/80.  Patient was assisted by staff to the car when in-laws arrived to pick him up.
The injection site, the day after the 2nd dose, started getting very red, hot, swollen, and sore.  The red spot was dime-sized, but in subsequent days, the injection site spot has quadrupled in size.  I received the 2nd dose on 9/9/21 and as of today, 4 days later, the area is still swollen, hard, and warmer in temperature than the rest of my arm and body.  I also experienced some chills and slightly elevated body temperature on 9/10/21, but that went away.   I have applied ice to the swollen injection site area and have taken benadryl at the advice of the pharmacist where I received the 2nd dose.  So far, the area is increasing in size, but is lighter pink in color than when it started.
Pt received vaccine and then sat for about 7-8 minutes. Upon checking out pt stated that she didn't feel right and fainted. Pt came around a minute later sat for awhile and was released
where she received the injection was black and blue; This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a 53-year-old female patient who received SHINGRIX for prophylaxis.   On 6th January 2020, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 9 months after receiving SHINGRIX, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX.  Additional details were provided as follows: The patient had reported the event for herself. The patient received 1st dose, she could not remember which arm. The reporter mentoned that, her arm where she received the injection was black and blue but she had no discomfort from the second injection. The permission to follow-up was denied. This case had been linked with US2020AMR197100 and US2020AMR197099, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197100:same reporter US-GLAXOSMITHKLINE-US2020AMR197099:same reporter
Sore arm; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: W0162) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clindamycin (MANUFACTURER UNKNOWN) for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took sulfur (MANUFACTURER UNKNOWN) for unspecified indications from unknown date and experienced drug allergy. The patient previously 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 26Mar2021 at 15:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. On 17Apr2021 at 16:30, the patient experienced sore arm, chills, fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, chills, fatigue was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected
SYNCOPE REACTION;  LAID PT ON BACK W/ FEET IN CHAIR;  PT LEFT UNDER HER OWN POWER & FELT FINE AFTER SITTING FOR ~30 MINUTES S/P VACCINATION
pt recvd vax & 3 hrs p/dose was nauseous; while in bed later that noc exp projectile vomiting & convuls; pt's sx subsided; 1 day p/dose exp severe h/a, fever 102.2 for 17 hrs, severe back pain & swollen gums;
little by little, she developed a cold; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 77; Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccine little by little, she developed a cold. The event was assessed as non serious. Patient second dose was scheduled on 05Feb2021 (reported as this friday). She enquired whether if it is okay if she receives the vaccine with a cold. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
pt sibling had chickenpox began 12MAY99 w/ T100-102,4;red spots & blisters noted on face, head, torso, arms, legs (45 lesions so far & still breaking out);
Patient complains of feeling nauseous and having hot flashes. EMT called. Vitals BP 122/84 HR 72 100% O2 sat. Patient drank water. After about 10 minutes, patient states feeling better. Refused EMT accompaniment to hospital.