chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that he had some pain while receiving the injection.  A few hours after, he started feeling pain in his arm.  He says his arm felt stiff (but he still can move it), and has pain down his left arm and in his left underarm area and toward his upper ribs.  He did specify that it did not feel like chest pain.  He has some swelling at the injection site.  He is planning to use acetaminophen and ice as needed and will be notifying his pcp if it gets worse.   Patient stated that about 24 hours after the injection he did have some shortness of breath which was relieved by use of his rescue inhaler.  He denies rash.  He is unsure if the shortness of breath was due to the vaccine or his underlying respiratory issues.
Stiffness and Pain,  all over body more in shoulders and knees. Also Body aches. Right ankle swelling
I lost consciousness; I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I lost consciousness) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (I lost consciousness) (seriousness criteria hospitalization, disability and medically significant) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (I lost consciousness) and VACCINATION COMPLICATION (I had a terrible reaction to the booster dose of the Moderna vaccine,And I had a terrible time with both the other doses, but it wasn't as severe as this.) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company comment:This is a spontaneous case concerning a female patient of an unknown age with no medical history provided, who experienced the serious unexpected events of Loss of consciousness and Vaccination complication(seriousness criterion hospitalization). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). On 03-Jan-2022, the patient experienced Loss of consciousness and Vaccination complication. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-437625, MOD-2022-437619 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history provided, who experienced the serious unexpected events of Loss of consciousness and Vaccination complication(seriousness criterion hospitalization). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). On 03-Jan-2022, the patient experienced Loss of consciousness and Vaccination complication. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient presented to pharmacy 11/14/2019 with a pea-sized rash on right arm, claims it happened several days after flu shot administered. No sob/ct/wheeze/tenderness/pain; rash is itchy. Recommended topical hydrocortisone 1% cream to apply to area three times daily.
pt was counseled on the use of afluria b/c she marked allergic to eggs but was not sure of reaction and had a flu vaccine from her dr in 2018 with no issue or side effect and was not sure if that was egg free. pt agreed to afluria and was counseled to stay in vaccination area for 15 mins afterwards. pt agreed. Husband reached out on Feb 15, 2020 to report side effect of mild allergic reaction. pt did not go to dr and is fine but husband just wanted to get report in.
flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Also found out that particular strain was only 85 percent effective. I got the shot last week and so far I'm fine.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for flu.  There will be no information available on the batch number for this case.
This spontaneous report as received from a office manager refers to a 2 year old female patient. On an unknown date, the patient was vaccinated with M-M-R II lot # N009171, expiration date 30-MAR-2019 (dose, route and anatomical location were not reported) for prophylaxis. the vaccine was diluted with sterile diluent (MRK). On an unknown date, the patient developed a lump behind her ear on her neck and swollen glands. The outcome of the events was not reported. The relatedness between the therapy and events was not reported. Additional information has been requested.
sore arm for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm for 5 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 044A21A) for COVID-19 vaccination.  Concomitant products included NEFAZODONE HYDROCHLORIDE (SERZONE), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), DIAZEPAM (VALIUM) and VITAMIN C [ASCORBIC ACID] for an unknown indication.  On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 5 days). The patient was treated with MORPHINE for Pain management, at a dose of 1 dosage form. On 08-Mar-2021, VACCINATION SITE PAIN (sore arm for 5 days) had resolved.            Relevant concomitant products usage  reported by the reporter was supplements - vit c, d, k2, methyl folate, Methylcobalamin , cinnamon extract, chloryphyll, reduced gl. Relevant medical condition provided by the reporter was many chronic conditions.   This case was linked to MOD-2021-066392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: No new information received.
10-15 minutes after vaccination patient began moaning, became unresponsive, began posturing, slack jaw.  Patient was lowered to the floor.  Patient became alert/responsive x3 after 1-2 minutes.  IV access started and patient transported to hospital.
Vaccine was administered on 09/20/2021 with expiration date of 09/19/2021. Patient did not experience adverse effect beyond what is expected (specifically extreme fatigue).
Swelling of entire leg.  Happened in late morning / early afternoon and still continues to be swollen on 7/10/15. No treatment.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent). An 8-year-old female patient (not pregnant) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 8, in right arm, in 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included Zyrtec (cetirizine hydrochloride). The patient experienced ineffective drug/lack of efficacy in the vaccine (medically significant), and suspected COVID-19/reporter's daughters and husband contacted COVID-19 despite having their vaccination (medically significant), onset Jan 26, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan 26, 2022) positive; (Jan 26, 2022) unknown results. Therapeutic measures were taken as a result of suspected COVID-19. Treatment taken, reporter stated, "Tylenol." The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
had flu shot 14OCT95 & next day devel a fever, h/a, sore throat, aching joints & muscles, loss appetite-was sick for 10 days;
A non-serious spontaneous report of "a 56 year old received FLUMIST" was received from a nurse concerning a 56-year old male. On 11-Nov-2009, the patient was inadvertently administered FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
ARRIVED AT EVENT, CONSENT FORM COMPLETED, DID NOT REPORT HE HAD BEEN ILL, DID NOT REPORT THAT HE TOOK ANY FEVER REDUCING MEDICATIONS
11 year old female given Pfizer Grey cap instead of Pfizer Orange cap at school based clinic.
- Nausea, Headache, Nasal/Sinus Area Inflammation, and Sore Arm at Injection Site (5 day duration) - Fatigue and Excessive Sleeping (Diminishing as of today (day 11) but ongoing) - Loss of Smell, Loss of Taste (Continues Fully Today, Day 11)
Reddened area 2 cm right thigh and area of induration about 3.5 cm at site of immunizations.
lot of pain in the arm; her hand is very swollen and she cannot close it; her hand is very swollen and she cannot close it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:00 (Lot number: FK5618) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "lot of pain in the arm"; PERIPHERAL SWELLING (non-serious), MOVEMENT DISORDER (non-serious) all with onset Dec2021, outcome "unknown" and all described as "her hand is very swollen and she cannot close it".  Additional information: Reporter daughter got vaccinated yesterday she was 11 years old but her hand is getting swollen and she was seeing a lot of pain in the arm and the vaccine was done around noon yesterday 1 PM probably, no noon O'clock 30 but her hand was very swollen and she cannot close it.  No follow-up attempts are possible. No further information is expected.
Child developed small, red area at site of vaccine injection. Size of dime or thumbnail. No fever, etc. No treatment.
VOMITING; BODY ACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, 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. On an unspecified date, the subject experienced vomiting, body ache, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body ache, fever, and nausea. This report was non-serious.
Pt was give Gardasil shot June 8-Had positive preg. test June 21. U/S 2 months baby heart beating 2nd U/S no heart beat (7/17 d/c to remove deceased baby) at medical center
received dose from expired vial; second Moderna dose administered greater than 35 days from first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided. Vial opened on 30-09-2021.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received included patient characteristics, batch/lot number, anatomical location of vaccine and new event were added.
3 hours after vaccine hand got really hot and arm and shoulder became very sore and had a lot of pain.  After about 30 hrs the pain is subsiding and movement is becoming easier.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Joint pain, headache, temp of 100.8.  Onset day after injection, lasting ~12hr
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035145, expiration date 30-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit ( >14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006255: US-009507513-1703USA006257: US-009507513-1703USA006254: US-009507513-1703USA006256.
Improperly stored vaccine administered - recalled; RECOMBIVAX HB that was recalled; This spontaneous report has been received from nurse regarding a 10-week old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled improperly stored dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 mL, lot # T00798 for prophylaxis and expiration date 01-NOV-2022 (dose and route of administration were not reported).  This report is one from multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009823: US-009507513-2010USA009831: US-009507513-2010USA009853: US-009507513-2010USA010090: US-009507513-2010USA010095: US-009507513-2010USA010216: US-009507513-2010USA010884:
Child was walking out of immunization clinic and dad said child passed out and started vomiting. Dad went back to get RN's. Child was a little pale and said she felt a little dizzy. Child left clinic after a few minutes and felt better.
Redness, slight swelling, warm to touch, itchy, approximately four inch diameter, very irregular shape.  Persists since onset. No treatment.
Vaccines were administered at approx. 10:25, and at approx. 10:35 mother noticed rash on face and legs. Within a couple of minutes, rash became more profound and spreading to back. No respiratory distress. Patient was taken to treatment room by triage nurse at approx. 10:43 and vital signs taken, which were normal. At 10:55 administered IM BENADRYL 12.5mg per order of Dr. 11:05 hives resolving and patient was reassessed by Dr. 12:15 BENADRYL and PRELONE were ordered for home use as needed for rash. Patient was d/c'd home with mother in stable condition.
Suspected shingles after SHingrix; This case was reported by a other health professional via call center representative and described the occurrence of suspected shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 20th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The patient experienced a suspected case of shingles. The reporter did not consent to follow-up. The caller refused to give any further details.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; MILD FEVER; This spontaneous report received from a patient concerned a 38-year-old female, unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency one total administered on 30-MAR-2021 for prophylactic vaccination. After administration of the initial dose to the patient reported that her back and hip had been hurting for the last month on 22-JUL-2021. Her feet was hurting and it was very swollen after being on her feet all day on 29-AUG-2021 at the fair with her kids. She had mild fever on her first booster covid vaccine. Her cholesterol was a bit high in her last blood work. Physician told her to not concerned but keep an eye on it. Her L-5 on her spine had inflammation which was why she had numbing and pain going down her right leg and foot (all events occurred in dose number series 1). It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The patient was previously received upadacitinib (Rinvoq) for moderate to severe rheumatoid arthritis. The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (manufactured by Johnson and Johnson) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency one total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series 2). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 3) (manufactured by Johnson and Johnson) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administered (both event with dose number in series 3). 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 mild fever (event with dose number in series 3). Laboratory data (dates unspecified) included: Blood test (NR: not provided) cholesterol bit high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220117248. (Dose number in series 1).
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength,  dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. The reporter stated that the administered vaccines experienced two temperature excursions: the first one between 32F and 36F for 57 hours, and the other one between 46F and 77F for 24 hours. No previous temperature excursions were reported and the reported information was not registered in a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000341: US-009507513-1702USA005592:
Approximately 10 days post vaccination I developed symptoms of dysautonomia (lightheadedness when standing, global digestive upset). I initially visited urgent care due to concern of heart issues (had an EKG done that was normal) and strong symptoms of anxiety that are very unusual for me. These symptoms progressed over the course of the next 2 weeks to include postural orthostatic tachycardia syndrome. I have a sudden increase in heart rate of ~20-40bpm upon standing with a concomitant drop in systolic blood pressure of ~20mmHg.  I have lost 8lbs due to an inability to eat a normal amount of food without stomach cramping and diarrhea.