chrisvoncsefalvay/vaers-outcomes huggingface dataset:
international travel neg Ag preflight 19Mar, then sx 20Mar and positive ag test; international travel neg Ag preflight 19Mar, then sx 20Mar and positive ag test; fever; cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 49 years as dose 3 (booster), single, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Mar2022, outcome "unknown" and all described as "international travel neg Ag preflight 19Mar, then sx 20Mar and positive ag test"; PYREXIA (non-serious) with onset 20Mar2022, outcome "unknown", described as "fever"; COUGH (non-serious) with onset 20Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Mar2022) negative; (20Mar2022) positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough.  Clinical information: The patient receive any other vaccines within 4 weeks prior to the covid vaccine was unknown, The patient has been tested for covid, since the vaccination and prior to vaccination, the patient diagnosed with covid-19 was unknown   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Since I received the 2nd shot I have constant pain in left arm where shot was administered.   Feel like a nerve was hit.   Hurts with any movement , lifting,  sleeping, etc.
I was a little tired the night of the vaccine. That lasted for three or four hours. I had an elevated PSA - and got a  Positive ID for cancer diagnosis Prostrate Cancer - they called it "recent score 6"  - no treatment as of yet. It's at a low level and doctor said there will be a follow up in 6 months. June 9th - phone conversation with the doctor.
Heart rate rose to dangerously high for two hours. Pharmacists monitoring me and continual taking of blood pressure. Was sick for a long time after vaccination day
Pt complains of shortness of breath over the last 2 days.  He started with fever, chills, and a productive cough.  Pt has COPD, but does not use home oxygen.  Pt has nasal congestion and generalized weakness.  He was admitted to the hospital for COVID pneumonia and hypoxic respiratory failure.
This spontaneous report as received from a doctor of pharmacy refers to a 65-year-old female patient with no pertinent medical history. Current conditions included allergy to penicillin, phenothiazine and clavulanic acid. On 09-JAN-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H018798. expiration date 15-JAN-2014, route not reported). Approximately on 09-JAN-2013 a patient developed injection site reactions after vaccination with live ZOSTAVAX. The patient had a red raised dime size area at the injection site. The patient had itching at the injection site which began shortly after vaccination, went away and then returned. The events did not resolve at the time of this report. No treatment was given for the event. The patient contacted the pharmacist and sought medical attention. Additional information is not expected.
This spontaneous report as received from a medical assistant referring to a 2 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 17-SEP-2015, the patient was vaccinated in right thigh with dose of improperly stored (Merck) VARIVAX (dose and route were unspecified) lot # L018001, expiration date: 19-MAY-2017. Concomitant therapies included MMR II vaccinated in left thigh and PENTACEL in right thigh. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
expired dose of ACTHIB being administered to a patient with no reported advesre event; Initial information received on 14-Mar-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 12 months old female patient who used expired dose of acthib being administered to a patient with no reported advesre event after receiving vaccine hib (prp/t) vaccine [Act-Hib].   The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On an unknown date, the patient received suspect hib (prp/t) vaccine (strength, dose, frequency, formulation, route, : unknown) (lot UJ649AAA, Expiry date: 05-Mar-2023) in unknown administration site for prophylactic vaccination (immunization).  On 13-MAR-2023 the patient diagnosed with a non-serious expired dose of acthib being administered to a patient with no reported advesre event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
16JAN91 grandma noted unusual high pitched cry at 6 hrs lasted 1 hrs; face turned beet red while crying; Pain at inject site, swelling/hardness 1 inch or less, redness & irritability; small purple area where inject given. See WORM
Bottom teeth pulled, as she has jagged teeth underneath the bridge; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (was hospitalized.) in November 2020 and Arm discomfort (Patient was attacked by some kinds on November 2019. Required surgeries and rehab).). Concurrent medical conditions included Blood disorder and Spinal disorder (Had a spine condition that didn't let patient put the hands in front of the body when falls. Patient went to see a lot of doctors: her general practitioner, but also a neurologist to check if she hit her head when she fell. Patient got a brain scan.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced CHILLS (Chills). On 18-May-2021, the patient experienced TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge). The patient was treated with Surgery (bottom teeth pulled) for Tooth injury. On 17-May-2021, CHILLS (Chills) had resolved. At the time of the report, TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The had other operations: knee cap replacement surgery, shoulder surgery, and a cataracts surgery, that had to be postponed due to the symptoms experienced after the second shot.   This case was linked to MOD-2021-297469 (Patient Link).
On 5/11/99, the pt experienced an injection site infection and mild varicella rash. On 6/11/99, the pt recovered.
Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No acute adverse reactions have been reported by the patient or guardian.  Due to the nature of the event, the causality between the events, "Expired product administered" and "Product storage error" and Vaxelis is not applicable.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "No adverse event".  No further information is expected.
Had meningitis shot 4/17/18, started to have mild swelling and redness 1-2 hours later 4/18/18 reports the redness and swelling increased in size. Reported to PCP office on 4/19/18 on exam site noted to be red, swollen, warm to touch no pus/drainage, "rash", reported "itchy" patient tried calamine lotion and BENADRYL 4/18/18 at home. No fever, no chills reported. Skin was noted to have large circular area of erythema to left upper arm/deltoid measuring, 10 cm in diameter. Skin is tense but not painful to touch skin was relatively warm no open skin or drainage. No limitation to movement of the arm.
Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. 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.
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless.  Patient was coughing and clearing throat.  Fluids were offered and patient was moved to a more private area, vitals were taken.  Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm.  Rapid response team was notified and took the patient to the hospital's emergency department.
Headache, Myalgia, Tachycardia, Chills, Injection site pain Narrative:  Took OTC ibuprofen and tylenol
Sore arm; Rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No relevant Medical history Reported.  Concomitant products included PREGABALIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). 01-Mar-2021, the patient experienced RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was provided.   This case was linked to MOD-2021-121565 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional  information was received on 11-May-2021 does not contain any information.
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt exposed to varicella exposure in MAY95 & mom recv vax 13JUN95 & 14JUN95 mom devel a pink rash & the area around the inj site was red & sore (WAES95080243);sx persisted for 3-4 days;27JUN95 son exp mild case of chickenpox w/50 lesions;
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Gave her water to drink, she was able to respond to questions and knew where she was. Was able to walk on her own.
Patient describes muscle aches in legs since receiving COVID Vaccine on 4/1/2021 that has not improved. (Physician encounter took place on 5/05/2021)
Initial vomiting, twice, then very pale and diarrhea following about three times.  Very sleepy.  Clamy, no fever.  Went back to bed around 11:15, no symptoms so far since going to back to bed.
Pt with 2 inch x 2 inch area of erythema & induration (L) thigh where site of injection occurred.
Flu like symptoms  Fierce headache Pain in joints Unable to lift right arm (not the site of the injection)
Started with a Scratchy throat on June 7.  June 8/9th sore throat, chills, cough, headache (neg at home covid test).  the morning of the 10th still a severe headache, sore throat, and worsening cough. On the morning of the 11th took another at-home COVID test and it indicated positive, I went to the clinic, and another test was administered confirming Positive COVID.  checkup indicated that my conditions seemed mild. Discussed Paxlovid with the health care provider, and took a blood test to determine kidney function.  GFR was good, health care provider prescribed Paxlovid.   I took my first dose at about 7 p.m. on the 11th, within two hours my symptoms were minimal, less coughing, released headache and sore throat, and even had a bit of nausea and it was relieved by the Paxlovid.  Today June 14, I am doing well,
Felt sick to stomach at 7:30am, went to bathroom, sat down, started getting hot and sweaty all over my body, tunnel vision started and ears started ringing, couldn?t see or speak, came to and was covered in sweat. About 15 minutes later it happened all over again
Extreme redness/swelling/pain at injection site. Treated with ice and ibuprofen ? lasted for approximately one week after symptoms appeared.
Oct90 pt vax w/ hepta B;  devel itchy hives w/in 1 day.  Tx w benadryl; hives resolved in 3 days.  No hypotension, laryngospasm.
The patient noticed a few days after the immunization that he was starting to develop small itchy red bumps on his legs. He didn't seek medical attention immediately because he thought they would go away. On 10/31/2017 he came to the pharmacy to report the rash and it had spread all over his trunk and in smaller amounts on his arms and legs. He denies any contact with new chemical substances other than the flu shot.
I am a third-year medical student. Since receiving the second dose of the COVID vaccine (Pfizer) on Tuesday 2/2, I have had persistent and worsening muscle spasms of the torso. I presented to the Emergency room on 2/6 due to worsening symptoms and was admitted until 2/7. The neurology team evaluated my condition was not able to make a firm diagnosis. They believe the vaccine has caused a dystonic reaction. I was given benadryl 25mg to continue for one week q6 hours prn. However, benadryl has provided minimal relief. They also strongly recommended that I be seen by a movement disorder specialist at hospital ASAP.  However, due to the fact that I have insurance I am not covered for care from hospital. My insurance said they will review the referral which will take another 5-7 business days from today 2/9. As a medical student, I have had to miss one week of clinic rotations and will continue to miss vital medical training as well as my board exam this Friday due to my worsening symptoms. It has created such a negative impact on my life including pausing my medical training, and physically being incapable of driving or performing many of my basic daily activities. I live alone and near hospital. I am urgently requesting if there is anyway CDC can help me, a medical student who has put in her all to fight the pandemic alongside you.   I am extremely concerned about my symptoms and the panic that it has created for my family and friends. I hope that a rapid response can help me and my loved ones find some answers during these challenging times.
fatigue  Narrative:  Initial vaccination completed on 2/12/21. He was at baseline that day and over the weekend. On Monday, 2/ 15, he went to the dentist to have some work done, which included local anesthesia. He has tolerated local dental anesthesia in the past w/ o issue. After the dental visit, he experienced extreme fatigue for 3x days (Tues/Weds/Thurs). This was described as feeling the need to sleep almost all day. He was able to get up to eat and use the restroom, but wanted to sleep for the rest of the time. This is described as being very abnormal for his as he is typically a very active person. As the fatigue improved on Thursday, 2/18, he and his wife noticed that he was having difficulty with his memory - which is very abnormal for him. This includes not being able to remember basic directions or grandchildren's names. There have been no changes to his medications, including no new OTC. He does not consume alcohol and there have been no changes to his home environment. Additionally, his wife (lives together) has been at her baseline health - with no reported memory concerts. Patient asks if he should receive the 2nd vaccine dose. Discussed the risk vs benefit of vaccination. Reviewed his age and problem list and noted that HTN may put him at an increased risk for severe illness 2/2 COVID. Also reviewed that 1x shot in series has limited protection. Patient still interested in obtaining 2nd vaccine. Memory concerns have slowly been improving. Discussed that this ahs been a seldom reported adverse effect of the vaccine - including reports of mental cloudiness - and that this + the fatigue could be related. Unlikely that the local dental anestheia contributed to situation, but it could have. Plan agreed upon at this time: - Push 2nd vaccination visit out to current 42 day cap, 3/26, to give more time to see if the memory concerns resolve- Advised to have future dental work done prior to next dose in order not to confused the clinical picture (next visit scheduled for tomorrow)
inc fever, unable to move, diarrhea;went to MD suspected bactersal ATB given;loss use of hands & legs;
Patient reported tingling of her lips, nausea and fatigue starting 1 hour after receiving injection.  She had the first Hep B injection on 9/25 with the same reaction, but she had a BCC removed that day and thought it was possibly from that, which is why she didn't report it then.  The same symptoms happened again after her second dose and she realized it was a reaction to the shot because it was the same exact symptoms.  Symptoms last about 1 day or so.
Panic attacks, chronic fatigue/weakness began on Feb 1st, less than 3 days after shot number 1 was given.
Body Aches, Soreness, Dizzyness lying down or rolling over in bed.  First two symptoms went away, but Dizzyness remains today.
Patient immediately felt lightheaded and fainted with head in lap for 5 seconds. We called 911 and he drank a lot of water and felt better and paramedics left.
The patient came to the pharmacy for her second dose of Pfizer Covid 19 vaccine. On the day of administration, the pharmacy was administering both Moderna and Pfizer. The wrong vaccine was grabbed and inadvertently administered to the patient.
Headache; This is a spontaneous report from a contactable consumer or other non Health Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN5318) as 1ST DOSE, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.This consumer reported she had her first dose of Pfizer-BioNTech COVID-19 Vaccine 03Feb2021. She has a headache and was wondering if it is ok to take Tylenol for the headache. While she was on hold she called the Health Department and they told her it was ok to take Tylenol for headache; but she wanted to verify if it was ok with Pfizer. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.