chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed Reactions 7-14 days after vaccination; Delayed Onset Pain on the Injection Site; Delayed Onset Redness a little lower than the Injection Site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Delayed Reactions 7-14 days after vaccination), VACCINATION SITE PAIN (Delayed Onset Pain on the Injection Site) and VACCINATION SITE ERYTHEMA (Delayed Onset Redness a little lower than the Injection Site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed Reactions 7-14 days after vaccination), VACCINATION SITE PAIN (Delayed Onset Pain on the Injection Site) and VACCINATION SITE ERYTHEMA (Delayed Onset Redness a little lower than the Injection Site). At the time of the report, VACCINATION COMPLICATION (Delayed Reactions 7-14 days after vaccination), VACCINATION SITE PAIN (Delayed Onset Pain on the Injection Site) and VACCINATION SITE ERYTHEMA (Delayed Onset Redness a little lower than the Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Information has been received from a 72 year old female concerning herself who was vaccinated with PNEUMOVAX 23 (name and manufacturer unspecified) about a year ago and went into a shock. The caller had to go to the emergency room and her blood pressure was really high. The patient is 72 years old and stated she is not allergic to any medications. She gets a flu vaccine every year and has no reactions. Her blood pressure is still a little high. Upon internal review, shock was determined to be other important medical events. This is one of several reports from the same source. Additional information has been requested.
redness, swelling- induration of 5 cm x 6 cm.  Warm to touch, severe itching tenderness
Patient developed a DVT (deep vein thrombosus) in left leg which was diagnosed on 3/6/21.
Left arm, back, buttocks, leg pain including left hip & knee joint pain which started on 10/2/10 & last approx. 1 wk. Took Prednisone dose pk which relieved the symptoms.
Information has been received from a registered nurse concerning to a 16 weeks old male patient. On 21-AUG-2012, the patient was vaccinated with 2 mL of the first dose of ROTATEQ, oral. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, WAES # 1108USA02150, WAES # 1108USA02151, WAES # 1108USA02152 and WAES # 1108USA02153). Additional information has been requested.
Left shoulder pain, pain and burning pain in left shoulder, went to orthopedic walk-in clinic and they said xray was normal and referred her back to her primary.  Primary physician had her start prednisone (6 day course) states diagnosis bursitis, finished up prednisone pack and is having pain again.  Rating pain a solid 5, reports that she has range of motion but is very uncomfortable with ROM.
5mins post vaccination pt reported dizziness and chills Vitals: 15:00 128/67, 85, 17, 100% -- > 15:10 121/68, 85, 17, 100% Pt placed in supine position and was given fluids.  Pt's symptoms resolved.  Pt stable and released from the vaccination site w/ steady gait
I experienced heavy acute epistaxis. (4 in the past 3 days); This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (I experienced heavy acute epistaxis. (4 in the past 3 days)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (I experienced heavy acute epistaxis. (4 in the past 3 days)). At the time of the report, EPISTAXIS (I experienced heavy acute epistaxis. (4 in the past 3 days)) outcome was unknown. Not Provided          No concomitant and treatment drug information was provided. Patient reported that with the booster shot patient had experienced heavy acute epistaxis(4 in the past 3 days).
Patient felt nauseous almost right away and proceeded to vomit.  She then felt better and after waiting in the store for a while felt better and went home with her parents.
Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; This is a spontaneous report received from a contactable consumer (Patient). A 79-Year-old female patient (Pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The relevant medical history included pre-diabetic, high Cholesterol, shingles (many years had gone by) and allergies: Penicillin, Statins, Hazelnuts, all from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL3247, right arm) on 15Feb2021 at the age of 79 years old for Covid-19 immunization. On 20Mar2021, within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab on 09Mar2021 and 10Mar2021, both showed negative. The outcome of the event was recovering.  No follow up attempts are needed. No further information is expected.
PATIENT EXPERIENCE A RASH STARTING TO DEVELOP ON HER RIGHT ARM AND HER BACK HAD STARTED TO ITCH APPOXIMATELY 10 MINUTES AFTER HER SECOND DOSE OF MODERNA. PATIENT WAS ANTICIPATING THIS REACTION BECAUSE SHE ALSO EXPERIENCED A MILD FULL BODY RASH AFTER HER FIRST DOSE THAT LASTED FOR 24 HOURS.  PATIENT REQUESTED BENADRYL. SHE RECIEVED 25MG/10ML ORAL DOSE OF BENADRYL 12.5MG/5ML CHILDREN SYRUP. PATIENT HUSBAND WAS WITH PATIENT TO DRIVE HER HOME. PATIENT IS ALSO A PART OF A  TRIAL STUDY FOR AUTOIMMUNE RHEUMATOID ARTHRITIS  TO SEE HOW THEY MOUNT ANTIBODIES TO THE VACCINE. PATIENT SAID SHE RECEIVED PERMISSION TO CONTINUE MODERNA SECOND DOSE.
To clarify I had tested positive for COVID 1/4/2021 was sick with symptoms for 16 days.  Received vaccine on 3/1 experienced within 24 hours fever high as 102.5, exhaustion, aches in legs, pain in back and a severe headache these lasted for about 24 hours. After the 24 hours I experienced 2 days of complete malaise.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. 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 administration, and batch number: unknown, expiry: unknown) dose not reported, dose number in series 1, 01 in total administered, start therapy date were not reported 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 reported that "reporter had a relative that lost both of his parents within 2 days of the jab. On an unspecified date, the patient was died from an unknown cause of death. They were among the official death counts attributed to the jab". (dose number in series was 1). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220112752.; Sender's Comments: V0: 20220112398-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I developed a rash on my arm several inches below the injection site 12 days after the first dose of the vaccine.
tenderness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness in the arm). At the time of the report, VACCINATION SITE PAIN (tenderness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a male patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # was unknown) on unknown date. On an unknown date the patient experienced redness and tenderness at injection site that subsided after few days. The patient did not seek medical attention. No treatment information was reported. Additional information is not expected.
Vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered as if it had a preservative) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered as if it had a preservative). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered as if it had a preservative) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Vaccine was administered after 14 days from the first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant FU document received on 29-Sep-2021 included no new information.
vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 16:45 as dose number unknown, single (Lot number: FM9992), in right arm 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 16Jun2022, outcome "recovering" and all described as "vaccine_brand=Pfizer / BioNTech, product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (16Jun2022) 100.5, notes: Fever; SARS-CoV-2 test: (15Jun2022) negative, notes: Returned afternoon of 6/15, tested negative at 3pm; (16Jun2022) Strong positive, notes: Strong positive Thursday the 16th at 7am; (21Jun2022) positive, notes: took at-home test the 21st afternoon. Very faint line of positive; (23Jun2022) positive, notes: Thursday 23rd took PCR/antigen test locally, tested positive; (25Jun2022) positive, notes: Tested VERY strong line positive Saturday morning 10am (fever). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional reporter: Paxlovid Rebound. Attended a Business Trip 13Jun2022- 15Jun2022. No one was wearing masks in planes/airport/casinos/restaurants. Patient wore an N95 mask 75% of the time (except at customer dinners and mixers). Returned afternoon of 15Jun2022, tested negative at 3pm - Symptoms Wed Evening (phlegm, congestion, slight fever, headache, fatigue, body aches). Strong positive Thursday the 16Jun2022 at 7am. Fever 100.5. Took first dose of Paxlovid Thursday the 16Jun2022 at 6pm. Last Dose Paxlovid Tuesday the 21Jun2022 at 8am. Started improving, took at-home test the 21Jun2022 afternoon. Very faint line of positive. Continued improvement with some symptoms (congestion, cough). Thursday 23Jun2022 took PCR/antigen test locally, tested positive. Friday throughout the night symptoms increased. Saturday am 25Jun2022, woke up with body aches, congestion, headache, fatigue/brain fog. NO fever. Felt like the original symptoms. Tested very strong line positive Saturday morning 10am (fever). Still sick Monday 27Jun2022.
kidney issue left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 3), for COVID-19 immunisation. The following information was reported: RENAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "kidney issue left side". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I noticed immediately that I had pain in area of shot. After a couple of days, I called chiro for adjustment and ultrasound to calm pain. After 4 or 5 treatments, I called med Dr. for XRAY and they gave cortisone shot - followed by P.T. 2x a week for 3 wk. The pain was bad so I quit P.T. Another cortisone shot on May 5.
Fever of 103.5 the following morning after vaccine. continued to have fever up to 103.8 through the weekend. Improved with scheduled tylenol and motrin. Evaluated at Pediatricians on the Monday following vaccine. dx with ear infection but very faint rash noted on hair line at appointment. awoke the morning of the 27th a flat red rash to face, neck, trunk and back.
My daughter experienced extreme thinning of her hair after having the GARDASIL vaccine about 5 years ago. It has not grown back. Thyroid testing was normal. Her hair was very thick before the vaccine, and now you can see her scalp.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Mild, Additional Details: Approx 5 min after vaccine adminstration patient reported burning/itching sensation in throat, racing heartbeat, dizziness and anxiety regarding vaccine.  BP and HR were elevated (144/90, 91). Throat, tongue, face negative for swelling. Patient declined difficulty breathing, tongue feeling swollen/heavy. Patient reports that burning/itching sensation in throat persists and took 25mg benadryl. Also reported swelling/tender lymph nodes. Monitored x45min and called in afternoon - symptoms resolved
Swollen, erythematous 10.0cm x 6.5cm on left leg. Large localized reaction treated with Benadryl and cool compresses and Motrin.
I thought I a sinus infection. I had chills on my body. I had four days of consistent sneezing. After 10 days I went to see my doctor and he wanted to make sure I had no lung problems.
p/vax pt devel fever of 102.6 w/4 red lesions on face, 6 small lesions on chest 7 1 lesions on back;pt visited the MD & by that time temp had dropped back to 98.1;MD dx pt w/chickenpox;
Client called complained of swelling at site of injection, redness and small pimple in center of lump on arm
Rash all over the body; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JAN-2023, the patient received the 2nd dose of Shingrix. In FEB-2023, 3 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rash all over the body). The outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Pharmacist reported to VEARS that 3 weeks after Shingrix second dose the patient developed rash all over his body.  Patient´s doctor indicated a treatment with steroid, but the rash was still present with no improvement. Patient was not immunocompromised, and he was a Doctor as well. The reporter consented to follow up. The reporter did not have lot number, expiration date and patient´s DOB information were not available at the moment of reporting. HCP was driving to her work. The reporter was consented to follow-up by email.
Information has been received from a certified medical assistant concerning a 26 year old female with no drug allergies and no medical history, who on 13-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658488/0930U).  There was no concomitant medication.  Subsequently, "within a few days" the patient developed small bumps all over her back.  It was not itchy.  The patient picked at it and thought they were pimples.  She treated the bumps with PROACTIVE.  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  It was reported that the bumps had gotten worse over time.  No product quality complaint was involved.  Additional information has been requested.
Patient would like it to be noted he has had joint pain within 2 weeks of receiving the vaccine. It became more prominent within 1 month after vaccine I had to get medical attention due to the progressing pain in joints after 2 months  pain is so severe at this point once again I seen medical. Now it's constant throbbing pain. I have been prescribed several meds to no avail. I know this is a direct affect to this vaccine as I never had such pain prior to vaccine.
MOP presents with 12 month of female with diffuse rash to body, fever, N/V/D since Friday. MOP advised her dtr received routing 1 yo vaccine (PROQUAD, Hib, PCV13) on 10/11/2018. The next day she was cranky and fussy and began experiencing diarrhea (watery). On Saturday, she had a fever and mom was treating with TYLENOL. Mom advised infant taken to ER Sunday am 0745 for fever 103, n/v/d, fussiness and not sleeping x2 days. Mom advised child vomited x 2 but can keep small amounts of formula down. ER diagnosed with viral gastroenteritis and released home. Mom advised on Monday, day 4 post vaccines, she noted a red rash begin on infants chest that progressed to her back,  forehead, arms and legs. Mom has been using MOTRIN as instructed, and child's temp today w/pediatrician was 96.8 F. Mom advised child still has episodes of watery diarrhea today but no further n/v. Mom states rash has not spread, but appears more pronounced today. 10/22/2018 rash almost resolved, afebrile and acting normally.
expired dose was given/PEDIARIX: maladministration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The reporter stated that, an expired dose of pediarix was given to the patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Pediarix, which led to expired vaccine used. This case is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066909:Same reporter US-GLAXOSMITHKLINE-US2022066910:Same reporter
4 to 5 patients received shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.  No concomitant medication reported.  Reporter stated that patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363703, MOD-2021-363708, MOD-2021-363709, MOD-2021-355809, MOD-2021-351064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Contains no new information.
Herpes Zoster, Right chest and axilla, T2 Dermatome.  Mild itching, not painful.  Patient noted rash on the chest, axillary lesions found during exam.  Patient presented for previously scheduled skin exam and brought up the rash wondering if it was poison ivy.
Severe abdominal pain, nausea, and vomiting, with back pain. These events started in November and then returned in Jan, and repeated an additional 5 times, getting more frequent as time went on. Ultrasound revealed gallstones.  I have lost abut 35 lbs since my last vaccine.