chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a 3rd dose of the Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a 3rd dose of the Moderna Vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012a21a, 037k20a and 011m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a 3rd dose of the Moderna Vaccine). On 15-Mar-2021, EXTRA DOSE ADMINISTERED (Received a 3rd dose of the Moderna Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of extra dose administered for mRNA-1273, lot # 012a21a with no associated AEs.   This case was linked to MOD21-054178, MOD21-054198 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 012a21a with no associated AEs.
Booster; Sluggish; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  The lot number for bnt162b2 was not provided and will be requested during follow up.
TENIVAC was administered to a patient and it was a few days expired with no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician and a consumer/non-health care professional via Regulatory Authority (Reference number- 00651546) and transmitted to Sanofi on 22-JUN-2021.  This case involves a 22 year old male patient who received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot number: C5638AA, expiry date: 17-Jun-2021] via an intramuscular route at the right deltoid on 22-Jun-2021 for prophylactic vaccination (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  At the time of report, list of concomitants was reported as no other vaccines.    It was case of actual medication error due to expired vaccine used (Latency: on the same day).  At the time of report, it was reported that, the TENIVAC was administered to a patient and it was a few days expired and reporter was wanted to know if the vaccine was good even if the vaccine was a few days expired or did the patient need to be revaccinated.   At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient felt fine after first dose on 2/3/2021 other than a sore arm and tiredness.  Approx, 2-3 days after the second dose, she started experience pain and swelling in both feet and legs.  Since then, she has been seen by her rheumatologist, vascular surgeon and primary care physician.  Her symptoms have included both legs being bright red and warm to the touch with significant difficulty walking over the past month.  Her right leg has completely resolved but her left leg remains swollen and painful. Patient states it looks like she suffered a burn - her leg is still very red and skin is peeling. Her PCP recently diagnosed her with cellulitis likely related to vaccination.
pt recv vax & devel allergic rxn w/localized itching & a hot spot the size of a saucer, became hypotensive 110/70 according to pt a hypertensive on med;the following morning pt devel malaise & felt poorly;
Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's sister-in-law) received via the Medical Information Team from the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Information has been received from a physician concerning a 4-month-old male with no pertinent medical history and no drug reactions/allergies who in February 2007, was vaccinated PO with a 2mL dose of Rotateq. There was no concomitant medication. Subsequently the patient experienced bloody stool Subsequently, the patient recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, the event was considered to be another important medical event. This is one of several reports from the same source. Additional information has been requested.
Information has bee received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 02-OCT-2015 the patient was vaccinated with a dose of expired VAQTA (lot # J007781, expiration date: 19-SEP-2015), dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever 99-100.6 for 72 hours after shot. Body aches for 48 hours. Mild headache for 36 hours
The evening of Friday January 29th my face began to experience itching and burning as well as hive like bumps. I did not take anything for that at the time. I woke up the next morning with my face extremely sensitive with red splotches and it was still very itchy. I then noticed the arm that had the injection was hard and was also experiencing the same symptoms as my face and increased soreness. I took Benadryl that evening and woke up Sunday with improved symptoms but still noticeable soreness in the area of the injection and it was still a little red and hot to the touch. It is now Monday morning and the reaction has continued to improve with still some soreness and a little hot to the touch.
Slight fever(100 rectally)2 days following 2nd administration of Rotavirus vax.4 months later, intusseption occured(11/10/99). Tx'd with 4 barium enemas. Admitted to hosp. 8 hrs. for observation. Pt. was fully recovered when discharged.
Had two shingles shots and still got shingles/ suspected vaccination failure; Shingles; Numbness outside hip area; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had two shingles shots and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), numbness (Verbatim: Numbness outside hip area) and pain (Verbatim: Pain). The patient was treated with magnesium, lysine, ascorbic acid (Vitamin C) and vitamin d. The outcome of the vaccination failure was unknown and the outcome of the shingles, numbness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, numbness and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, numbness and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two Shingles vaccine and still experienced shingles. The patient reported that physician stated that happened but it came in milder way. The physician stated three signs of shingles, 1. rash of any kind, small bumps, pimples, red spots and bumps. 2. Pain or flu symptoms and 3. numbness The patient stated his or her shingles felt like a sword went in through his or her back above his or her hip and through his or her colon and front below belly button it can effect the digestive system. The patient had numbness in the part of the outside hip area, the physician stated that was the tip off for him. The patient stated that no one knows how this shingles felt until you had it. The patient received magnesium gel which was applied to spot it was stings at first but will ease the pain for hours. Patient received lysine in large doses and vitamin c and vitamin d as a treatment. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
On 7th day after vaccine, rash appeared on inner forearms and upper legs, both left and right.  Symptoms persisted for about 5 days.  Rash looked like hives, minimally itchy. Headache upon standing which quickly resolved occurred repeatedly  during the same timeframe.
COVID arm - 4 inch circle on left arm after shot #2.  Vivid dreams continuing for three weeks as of this date.
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
fever started 10JUN96 cont until it peaked @ 105 12JUN96 early AM;mom gave APAP that did not bring down fever;MD gave Motrin & that kept it @ 104 for several hrs then it went to 105;
7:00 PM - 2 hours after the vaccination I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction  10:00 PM Left the clinic. Went home and slept. I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am unsure of getting the second dose.
PLAQUE PSORIASIS; BACK PAIN; ARTHRITIC PAINS; PAIN IN FINGERS; This spontaneous report received from a patient concerned a 4 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for covid-19 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.  On an unspecified date, the patient experienced plaque psoriasis, back pain, arthritic pains, and pain in fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from plaque psoriasis, had not recovered from arthritic pains, and the outcome of back pain and pain in fingers was not reported. This report was non-serious. This case, involving the same patient is linked to 20220251315.
Patient received flu vaccination at 12:30pm at Pharmacy. Left shortly after injection with no apparent concerns. Husband calls 2 days later to report that patient had symptoms consistent with a heart attack. Went to ER at 4:30pm that day and stayed in the ICU for several days. Patient has since been released and is back home.
Arm ache; Pain on the legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Event outcome updated
Redness at injection site, high pitched scream that evening for about 1 hour off and on and was inconsolable. Knot under skin where vaccine for given for about a month.
Moderna COVID-19 Vaccine EUA received on Jan 29, 2021.   "Covid arm" started on day 9 after vaccination.  Red, swollen, itchy circle, about 1 1/2 inch in diameter, 1 inch below vaccination site . . . spreading down and around arm on days 10 and 11.
Patient received high dose flu shot on September 30th, 2021.  He states that his arm is very sore and he can not move it that much.  He came to the pharmacy twice before and mentioned to it to the staff, both times they stated that the soreness is normal after getting a vaccine.  Today he approached the pharmacy stating that he went to the his dr for a regular visit and made the comment and the dr stated that it shouldn't be sore anymore and looks like it was injected too high.  I asked the patient to come into the clinical room and he pulled his shirt sleeve up and the injection site is still there and it looks to be too high.  The patient states that day the needle looked very long and the RPH that administered the vaccine to him kept pushing and pushing.
Child developed rash on neck and both arms to wrists day after shot was given (12/17/03) Mom called family Dr. who instructed to give her an antihistamine (over the counter)By next am rash was gone but child had a fever of 103 degrees - mom took child to Dr. on 12/18/03 then back to Dr. on 12/22/03 because still running temp. of 103 degrees. Dr. diagnosed child with pneumonia and treated with Zithromax and Aerosol treatment. no hospitalization required.
approx 24hr p/vax pt had episode of becoming limp, unresponsive, head falling forward-several seconds duration-adm overnight-normal EEG, home on monitor;has been fine since;poss infantile spasms;
Ringing in the ears - lasted approximately 24 hours (I sometimes have tinnitus); briefly lightheadeda couple of times the day of the vaccine
My daughter complained of leg pain the night of vaccine was administered.  She complained an increase in pain throughout the night. Next day she would not walk and I notice her feet and are a bit swollen and bruised then we went to ER at 2:20. In the ER her feet were swelling even more turning purple w bruises. She said the pain was terrible. And dots formed both feet up to calf.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jun-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  No treatment information was reported.
Had a root canal between first and second dose Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 25Apr2021 11:00 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Flu shot for immunization, reaction(s): "Muscle pain". The following information was reported: TOOTH DISORDER (non-serious) with onset 04May2021, outcome "unknown", described as "Had a root canal between first and second dose Vaccine". Therapeutic measures were taken as a result of tooth disorder.  Additional information: The patient had root canal treatment on 04May2021. During the root canal treatment he received a Novocain injection and Ativan pills. The patient later received second dose of bnt162b2 (BNT162B2), administration date 09May2021 at 11:00 as dose 2, single for covid-19 immunisation. Prior Vaccinations (within 4 weeks) were none.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sore arm after taking the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as an unspecified dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after taking the first dose on an unspecified date. The caller had a sore arm after taking the first dose and wanted to know how they can schedule their 2nd dose in their local area. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Chronic fatigue syndrome: Myalgias, arthralgias, migraine HA, cognitive dysfunction, unrestful sleep after AVA. Began in 1999 after AVA #1. Had 6 AVA vaccinations since 1999. No immediate worsening of sxs after each shot but pt reports sxs worsened as years progressed. Deployment out of country also involved with significant worsening of sxs in 2003. Symptoms: Joint Pain, multiple joints, Muscle pain, Fatigue, Malaise >60 Days, Memory Loss, short term, Headache, Migraine, Restless sleep.
Fever 101.3F, cranky but consolable. 3/4" firm, indurated area on both thighs, not warm. Right thigh tender. No rash, no meningeal signs. Symptoms resolved by 8/10/2000.
My upper/mid left arm, is very swollen. It has been since the day I received the vaccine-happened almost immediately. My arm is also very painful, tingly, all the way down to the fingers. This swelling and pain has not subsided at all, since I received the vaccine. I went to the hospital the same evening. I was given an antihistamine, Ibuprofen, and ice, and told there was nothing more they knew to do. A week later, I went to my former family physician, and was given an antibiotic for a week. (do not remember the name). Nothing changed after a week so on Tuesday, April 20, I went to the ER. They gave me a test to check for a blood clot, as well as a Percocet pill and an hour after a shot of Morphine. There was not evidence of a blood clot, and I came home. There is still swelling today, though now I have a course of  Wal-Dryl, 25 mg Allergy caps , 24 pills. 1 every 4 hours, a course of Prednisone, 20 mg, 20 pills, and oxycodone/Acetaminophren 5-325 mgs for pain, 18 caps, 1 every 4 hours. I have also called the County Health Department who advised to see an Infectious Disease Doc.  I am still in pain, and swollen. I haven't had a fever, but am feeling warm, tired and achy.
tested positive for Covid 16Mar2021; tested positive for Covid 16Mar2021; This is a spontaneous report from a consumer (patient) from the Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as single dose (dose 1) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine on 28Feb2021 and tested positive for COVID on 16Mar2021. She was in quarantine until 27Mar2021 but the second dose should be today, 21Mar2021. She cannot get her second dose today because of quarantining so she is now scheduled for 02Apr2021. The patient asked if the antibodies from COVID diminished the efficacy of the vaccine and if it will still be 95% effective. She stated her doctor said after 10 days of quarantine she has 42 days to get the second dose. The patient stated she is just going to get it and hope she gets the 94-95% efficacy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
approx 45 mins p/immun pt began to have welts raised under eyes; also difficulty breathing; EMS called, they responded & started nasal O2; mom transported to MD; MD discovered sl ear infection in rt ear;