chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client was administered his first dose of Pfizer vaccine at 10:25am on 1/23/2023. A consent form/screening was filled out prior to vaccination of the client and there were no risks noted. After vaccination, the client was taken to the waiting room for his recommended 15-minute wait following vaccination. At approximately 10:28am, the client fell to the floor on his right side in the waiting room. Client was having spasms in the right arm and right leg. Glasses were broken and lying on the ground beside client. Ambulance was called immediately. The client's girlfriend was in waiting room screaming and alerted the staff of the incident. Blood pressure, heart rate, and oxygen saturation were taken immediately at approximately 10:30am. BP 125/80, HR 70 BPM, Oxygen Saturation 98%. Seizure began at 10:28am and ended at 10:29am. Was in post-ictal state until 10:32am. Client states he did hit his head on the ground as he was falling from the waiting room chair. Denied any dyspnea. Injection site non-inflamed. No signs of anaphylactic shock present. Client stated following seizure that he had a seizure in the past when little after immunizations and had been diagnosed with vertigo as an adult. Signs of hypoglycemia present such as cool skin, diaphoresis, and pallor. Unable to check blood glucose due to none being available nearby. Client stated he did not eat breakfast before receiving the vaccination. Was assisted to a sitting position in the waiting room chair and monitored once stable. Stated he had a headache, but denied dizziness. Ambulance arrived at 10:40am and report was given to the EMT/Paramedic. Transported to the local hospital.
Right deltoid swollen, red, and painful. Instructed to give Motrin Q 4-6 H PRN, ice on if swelling. Warm to  touch. Also to measure with a pen, if spreading continues come in to office. Benadryl also.
approx 2 hrs & 45 mins p/recvd vax pt began crying-mom picked pt up-arms & legs became weak; vomited x 1, c/o head hurting real bad-c/o feeling cold, t99 orally & became pale;
Significant arm soreness and tenderness to the touch on arm that pneumovax 23 was injected into.
Per patient: "I started my oral typhoid vaccine and had a bad reaction.  I woke up in the middle of the night between 11pm-1am to take the pills.  After the first pill, I had very watery diarrhea but it resolved with Imodium.  There was no reaction after the second pill (two days later) but I took the third pill Friday night and woke up very sick on Saturday.  I had severe diarrhea, vomiting, severe nausea, chills, achy and was basically "out of it" for 12 hours.  I slept all day and night.  I called the help line and spoke to the on-call nurse and she said to get IV fluids in the emergency room, if needed.  I was able to keep liquids down by afternoon so didn't go in.  I was supposed to take the last pill last night but just couldn't do it." When I spoke to patient ton 6/4/19 symptoms had completely resolved and she was back to normal.  She took her last oral typhoid vaccine on 5-31-19.
45 minutes post receiving vax pt broke out in hives over whole body. Pt given Benadryl and symptoms resolved.
Dizziness and light-headedness; Fatigue; Headache; Sore muscles; This is a spontaneous report from a non-contactable consumer or other non hcp. A 48 unknown unit female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 06Mar2021 (Batch/Lot Number: EN6198) as 1st dose, single for covid-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies. On 06Mar2021, after the vaccination the patient experienced Dizziness and light-headedness, Fatigue, Headache, Sore muscles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected
pt developed rash after vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 58 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; ZOLOFT; TRAZODONE HCL. The following information was reported: RASH (non-serious), outcome "unknown", described as "pt developed rash after vaccine".  Additional information: Adverse experiences: Date of event onset: Jul2021, Provide summary of ADE. Include description of severity: patient reports "Sinus infection in July" and that MD gave her antibiotic (Ceftin) at that time but did not have her hold/stop Xeljanz". MD aware. Provide summary of ADE. Include description of severity: Pt reported per MD instructions, Pt held Xeljanz dose 1 wk before covid vaccine. Pt developed Rash after vaccine and held Xeljanz additional 2 wks due to Rash. Pt confirmed Pain is worse while off Xeljanz. MD aware. List any medication(s) patient was using at or around the time of the adverse event and dates of therapy: Ativan 0.5 MG Tablet, Zoloft 25 MG Tablet, Trazadone HCL 50 MG Tablet. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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 completed. No further information is expected.
blood sugars became extremely high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugars became extremely high) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugars became extremely high). On 24-Mar-2021, BLOOD GLUCOSE INCREASED (blood sugars became extremely high) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
A pulsing pain on the left side of my head (on my temple) came and went for several hours after the injection.  It stayed on the left side of my head until the time of this report.
BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 vaccinated at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, chills, and headache. This report was non-serious.
Nauseous, with large area of redness in local area of injection (5cm X 6cm), after both shots. Pain radiated down arm to fingers and into shoulder blade. Fingers would tingle and arm too painful to lay on.
pt had a positive COVID test on 6/26/22 at Urgent Care; pt passed away at home on 7/28/22; no medical records; PCP unknown
Patient received Moderna vaccine for covid ( 1st shot). Patient waited for 15 mins and then went to her car where she started feeling sharp poke feelings on her back and legs, left side of  The face heat sensation and tingling. Patient wasa brought to Building 6 where she is laying down   BP 148/84, HR 87, RR 20, temp 98.1  10 mg Zyrtec PO given  25 mg PO benadryl given  Per Dr   10:30 25 Mg PO given to patient
Patient received Moderna Bivalent and Fluzone HD together on Friday 10/7/2022 around 10:15 am. She remained near the pharmacy for 15 minutes with no adverse effects reported. Patient stated she woke up around 1 am 10/8/2022 feeling very itchy. She noted a rash going down her front torso, hands, arms, and feet. Her husband took her to the ER as soon as she noticed the rash was quickly spreading. After reaching ER, within 15 minutes of first signs of rash it had spread across her body and was very itchy and painful.  She did not report breathing issues. At the ER, patient states she was given IV benadryl and an Epipen injection to treat assumed anaphylaxis. Upon treatment, patient reports the rash pain immediately resolved and the rash began to clear up. She came to our pharmacy on 10/8/2022 to report the event and pick up prescriptions of prednison and epipen to continue to treat the rash. Upon examination, I, the pharmacist, noted the rash is still significant across the torso, arms and legs. She noted she is feeling uncomfortable again but did self treat with some topical benadryl before the pharmacy opened this morning.
pt passed out turned while and grey stopped breathing received on dose of epi pen 0.3 mg came to and a sugar drink, emt called and came, blood pressure was good
I20.8 STABLE ANGINA 3/28/2023 ASTHMA, UNSPECIFIED T78.40XD ALLERGIC REACTION, SUBSEQ 1/10/2022 ASTHMA, UNSPECIFIED
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-NOV-2015 the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Injection given on 12/06/2001 in right deltoid IM. On Saturday 12/08/2001 arm was very swollen no pain. Went to Med Center and received IV and medication Keflex 500 mg QID. Returned on 12/09/2001 to ER due to swelling down to elbow and received another IV.
I received the Moderna Bivalent booster and the FluZone Quad 2022-2023 vaccine on 9/30/2022. On 11/8/2022, I began getting chills at work at about 8:30 AM. I asked my office manager to turn the heat up, because I thought it was cold. She told me that I was the only person who felt cold, so I put on a jacket and a mask. I had a low-grade fever of 99.9. I also developed a persistent headache, a scratchy throat, and a bitter taste in my mouth. I didn't have much of a cough, but whenever I did cough, it hurt in the area by my lower ribs. I left work early that day and went home. When I got home, I took two antigen tests and got positive results on both. I notified my doctor's office of the situation through a phone app the same day. They scheduled a telehealth appointment for 11/9/2022. When we had the telehealth visit, I was prescribed a 5-day supply of PAXLOVID. I began taking the PAXLOVID that day. I had the aforementioned symptoms for about 3 or4 days. The more water I drank, the less severe my headache became. About 3 or 4 days after taking the PAXLOVID, the pain in my ribs went away. By the late evening of 11/11/2022, I actually felt well enough to drive out of town on a trip that lasted 1.5 hours. I took another antigen test on the night of 11/13/2022. I got another positive result. However, the line on the stick was much fainter than the ones I had when I took the tests on 11/8/2022, when both of the tests had very bold black lines.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Additional Details: Patient briefly fainted post Covid vaccination, then vommited, stated that his head felt hot. Spoke to mother later in the evening. Patient felt much better.
The pt experienced pain at the injection site, followed within 3 hours by severe headache, muscle and joint pain, elevated temperature, fatigue. Symptoms gradually lessened over 72 hour period.
Headache, Myalgia, NauseaVomiting, FATIGUE/SORE THROAT/CHILLS/HOT FLASHES/AFEBRILE Narrative:
This spontaneous report was received from a nurse, via another unspecified reporter, and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, previously drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prophylaxis at age 11 (strength, anatomical site, lot number and expiration date were not reported). Then the patient missed his second dose and on an unspecified date, more than 12 months after the first dose, the same patient got a second dose of GARDASIL 9 for prophylaxis intramuscularly (strength, anatomical site, lot number and expiration date were not reported) (Inappropriate schedule of product administration). No adverse effects were reported.
pt recv vax 115PM 6APR95 & 315PM states pt was shaking & had saliva out of mouth; mom advised to call 911 immed;
This spontaneous report as received from a registered nurse refers to her daughter a currently 18 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 02-APR-1997, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1 (lot # was not reported) and on 08-AUG-2007, the patient was vaccinated with (Oka/Merck) VARIVAX dose 2 (lot # was not reported). Concomitant medication was not reported. On an unknown date, reported as "recently" the patient had titers drawn which showed less than 0.91 for varicella which was considered not immune. The outcome of had titers drawn which showed less than 0.91 for varicella which was considered not immune was unknown. Causality was not reported. Additional information has been requested.
This spontaneous report was received from a nurse referring to a 2 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 30-MAR-2017, the patient was vaccinated with a dose of M-M-R II lot # L009545, expiration date on 19-MAR-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis, however no adverse events reported. No product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
she has no taste or smell right now; she has no taste or smell right now; This is a spontaneous report from a contactable consumer (patient reported for herself) Pfizer Sponsored Program. A female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 24Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date at single dose for Covid-19 immunization. It was reported that, "caller, received her second dose last Wednesday (24Mar2021). She only had few and minor side effects from the vaccine. However, she had no taste or smell right now and wanted to know if she had Covid or if it was an effect from the vaccine. Tried to transfer her to different department but the call got disconnected. Interaction number was requested to document". Outcome of the events was unknown.  Follow-up attempts are completed. Information on the lot/batch number has been requested.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccinations 4 weeks prior to the COVID-19 vaccine. Treatment information was not reported.
experienced a high fever; sore throat; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experienced a high fever"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: Patient received 1st dose of Trumenba and experienced a high fever and sore throat for about 2 days. (Name withheld) told patient these were some of the expected adverse events found in the package insert. Event took place after use of product.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
1. Collapsed onto the floor within 15 minutes of vaccine administration and was unresponsive upon shout/tap shout and a sternal rub. 2. Pulse was elevated at ~133, her breathing did not seem altered.   EpiPen was administered and EMS called.
Information has been received from a licensed practical nurse concerning a 69 year old female with no known allergies, hyperlipidemia, and osteoporosis who on 19-DEC-2006 was vaccinated in the left arm with a 0.65 ml dose of Zostavax (lot#654604/1406F0. Concomitant therapy included simvastatin, lisinopril, alendronate sodium, estrogens, conjugated (PREMARIN), and multivitamins (unspecified). Within 24 hours, on 21-DEC-2006, the patient presented to the office with a localized site reaction of the left arm that swelled from her left elbow to the shoulder and was red. No treatment was received and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
The first three days after the injection, I was very tired, nauseous, dizzy and in a fog.  My arm was extremely sore and hot.  I used an ice pack to help with swelling and heat. On Thursday the itching started.  I took Benadryl, but that did not stop the itching.   On Friday afternoon, my upper arm was starting to turn red and and puffy.  I continued with ice.  On Saturday afternoon, I went to urgent care because my doctor's office was closed.  I was diagnosed with Adverse effect of vial vaccines, Cellulitis of left upper limb, allergic urticaria.   I was prescribed Doxycycline 100mg #20, 1po q12h AND Medrol Dosepack.
This spontaneous report was received from a registered nurse referring to a 7 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1712USA010085: US-009507513-1801USA002508: US-009507513-1801USA002514.
Green diarrhea every 1-2 hours, normally she goes every 3-4 days asleep for 16 hours, confusion, loud crying.
low grade temp on 15MAR93 PM given APAP; t104.2 on 16MAR93 (105.2 on thermoscan thermometer)
Patient stated she had not received a BiValent Booster however, after administration and during the process of entering into national data base, it was noted the patient had received a dose of Moderna BiValent on 10/5/2022 at the local Store Clinic.  Pt did have a COVID Immunization card in her possession.
Initial case received from a consumer, who is also the patient, on 16 September 2009. A 39-year-old male patient, with a history of penicillin allergy, received an injection of FLUZONE (lot number not reported) on 15 September 2009. Approximately four hours post-vaccination, he reported symptoms of occulo-respiratory symptoms, including red, teary eyes. He also reported muscle fatigue, tight throat, and chest congestion. Symptoms subsided, then became worse 13 hours post-vaccination. The patient reported photosensitivity, aches, and fatigue in addition to the symptoms previously experienced. The following morning the symptoms improved, and by 24 hours post-vaccination he reported only bloodshot eyes. Documents held by sender: None.
Headache, Myalgia, NauseaVomiting, inj site pain, itchy, swelling, chills, nausea x7 days Narrative:
Fever (unmeasured, but after fever improved temp was still 99.4F).  Myalgias, arthralgias, headache that started over the several days prior to the fever, but the fever was the most severe reaction.
PT PRESENTED TO MEDICAL C/O RASH AND SWELLING X 1 DAY. PT STATES THAT RASH STARTED APPROXIMATELY 5 HRS AFTER HE RECEIVED HIS ANTHRAX VACCINATION. PT STATES THAT HE WOKE UP AND RASH HAD SPREAD AROUND HIS MOUTH AND NOSE AREA. PT DENIES ANY AIRWAY OBSTRUCTION AT THIS TIME. PT STATES THAT HE ALSO HAD AN HEADACHE MOSTLY FRONTAL PAIN 7/10. PT DIAGNOSED WITH AN ALLERGIC REACTION TO ANTHRAX AND TREATED WITH PREDNISONE. MEDICAL RECORD ANOTATED WITH ALLERGIES AND NO MORE ANTHRAX SHOTS.