chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was here for first influenza vaccine. Pt noticed 2-3 small hives around abdominal tube a few minutes after flu vaccine. No wheezing/SOB/cough; no lip/tongue swelling. Pt notices an aura and informed MA she thought a seizure was impending. Pt became unresponsive and body was stiff; pt informed us of where her rescue medication was Midazolam 5 mg/mL, 1 mL was administered by me intranasally Pt transferred to the bed. Within about 15 minutes pt because responsive. Hives remained small and few on abdomen; pt given 25 mg diphenhydramine via G-tube. Pt was checked on multiple times and was back to normal before being she left our office (spent over 1 hour in our office being observed before pt left). I have discussed many times with the pt about her ability to safely drive herself; pt tells me that she is more than able to drive safely since she does always get an aura before her seizures and also seizures come in clusters usually within an hour and pt has only had one sz here and was observed for over 1 hour before being released from our care. Pt reports she is able to drive herself safely home and promises to not drive if she develops symptoms that make it unsafe for her to drive.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored PNEUMOVAX23 injection (lot # M040004, expiration date 20-MAY-2018) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013631: US-009507513-1701USA013821:
Patient is a 31 year old female with a benign medical history who presented for her 2nd SARS CoViD-19 vaccine (Phizer BioNTech) at approximately 1330. After waiting in an observation room for about 14 minutes, she developed a headache and asked to be medically evaluated. At 1345 her vital signs were as follows:   Pulse 109 Respirations 18 SpO2 97% on room air Temp 97.8F BP 140/80 pain 2/10, headache  She reported no prior reaction to her previous vaccine dose. She also endorsed not having anything to eat prior to this vaccine. After resting for 5-7 minutes she developed nausea and vomiting and decided she would like to be evaluated at the ED, but not taken over by ambulance. She was taken by wheelchair accompanied by this provider, a Certified Medical Assistant, and Security to the ED and assisted to check in, and then report was called to the ED Provider on. No medication was administered during this interaction. Patient's headache and nausea persisted though her vomiting subsided. She remained alert and verbally interactive throughout the transport. She was transported at 1355 and report was called at 1424.
Sore arm, quarter-sized rash at injection site first 3 days; on day 5, rash had grown to 3 times original size, plus very hot & slightly itchy (no soreness remaining).
Temperature of 100.4 for 1-2 hours, about two hours after symptoms began. For at least 12 hours since symptoms began, persistent moderate headache, generalized muscle aches, fatigue, and occasional chills. Early symptoms felt similar to a moderate hangover.
1 day p/vax in lt deltoid c/o pain in area, red raised firm area developed; seen in this office the next day @ which time an area cellulitis 2 1/4" x 2 1/2" noted approx 1/2" below inject site;
Pt recvd 3 doses of Engerix-B & failed to convert; Booster dose administration planned;
After vaccine administered became aware booster dose was given too early. Contacted his mother and no ill effects reported, advised her vaccine was given too early but does not need to be repeated.
The product was refrigerated on 18OCT2021 beyond expiration date 13Oct2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 18OCT2021 beyond expiration date 13Oct2021 ) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 18OCT2021 beyond expiration date 13Oct2021 ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 18OCT2021 beyond expiration date 13Oct2021 ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It mentioned that the vial was placed in the refrigerator on 18-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medications were reported.
No reaction 1st 24 hours, swelling and redness 48 hours later. 60 hours later increased redness, swelling and tenderness at injection site.
The day of the vaccine: fever, nausea, chills, fatigue , etc which lasted about 26-48 hours  ONE WEEK AFTER: MARCH 26: SEVERE VERTIGO WHICH CAUSED AN  INABILITY TO WALK, RAPID AND UNCONTROLLABLE NYSTAGMUS, NAUSEA, VOMITING.  The SEVERE NATURE OF IT LASTED AT LEAST 36 HOURS AND WENT AWAY SLOWLY OVER THE NEXT FEW WEEKS.
On January 28th, shortly after I woke up in the morning I started feeling very itchy on my neck/behind ears/hairline. I was normally scratching this area and began to feel small bumps appear, figuring out after looking in the mirror that they were hives and my neck area where I was scratching was extremely red. As the day went on my itching would move to different areas of my body, mostly my armpits/groin/neck area. These areas were also breaking out in hives and extremely itchy, and would turn very red when I itched there. The next day, January 29th, I was still very itchy throughout the day, and hives/red blotchy spots would appear on different parts of my body and begin to itch randomly. On January 30th, I began taking one generic Zyrtec (10 mg Cetirizine) per day and my itching throughout the day has been much less frequent since beginning this treatment. However, even if I am not itching at times throughout the day, I will often see areas of my skin have red blotchy areas appear and then disappear a short time (about 20 mins) later. Additionally, if I scratch an area of my body, shortly afterwards the area that I just scratched will have a red line/lines appear. I have noticed this mostly on my face after touching/scratching it, but this happens anywhere on my body if scratched. I have tried to hold off on taking the 10 mg Cetirizine some days, but I have started feeling itchy if I wait too long, so I have kept taking it. I have been taking one tablet of 10 mg Cetirizine each day since January 30th.
felt ill after the first injection I don't want the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient felt ill after the first injection and did not want the 2nd dose.
No adverse effects; one patient received one dose of improperly stored ROTATEQ; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.         On 27-JUN-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R025713, expiration date 20-JUN-2020; dose and route were not reported) for prophylaxis (improper storage of product in use). No additional doses were administrated. No adverse effects were reported.   The administrated vaccine experienced the following temperature excursion: total time and lowest temperature below 36 degree Fahrenheit (33.9 Fahrenheit) for 40 minutes. The digital data logger was involved. Previous temperature excursions included total time and lowest temperature below 36 degree Fahrenheit (30.3 Fahrenheit) for 90 hours and 7 minutes, total time and lowest temperature below 36 degree Fahrenheit (30.5 Fahrenheit) for 1 hour and 45 minutes and total time and lowest temperature below 36 degree Fahrenheit (35.2 Fahrenheit) for 2 hours and 5 minutes.
Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration. In light of this, patient elected to receive additional dose of Moderna vaccine on Feb 1, 2022.  On March 6, 2022 he was admitted to the hospital with infective endocarditis complicated by aortic and mitral valve failure and septic cerebral infarcts. On March 19, 2022, he passed away. He had risk factors for developing endocarditis and we don't believe there is an association between the improperly stored vaccine or revaccination.
HEADACHE; CHILLS; FEVER; MUSCLE ACHES; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18005022, and batch number: 18005022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, muscle aches, and tired. This report was non-serious.
breathing funny; got the second shot and he has a knot on his cheek; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER COVID 19 VACCINE) on an unspecified date as dose 1 for Covid-19 immunization and he had a small knot on his cheek. Caller states he was calling about the Pfizer shot. Caller later reclarifies the Covid 19 shot. Caller states he got the second shot, and he has a knot on his cheek. Caller reclarifies, that with the first shot, he had a small knot on his cheek, but with the second vaccine the knot was bigger. Caller also states he was breathing funny today. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
1/8/23 chest pain, palpitations, tachycardia and dyspnea.
MILD CHILLS; MILD ACHES ALL OVER; TIRED; 10% OF WHAT I FELT WITH J&J VAX; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. (dosage number in series 1)  On an unspecified date, the patient experienced  10% of what I felt with j&j vax (unspecified adverse events). (dosage number in series 1)  Non-company suspect vaccine included: mrna 1273 ( form of admin, route of admin, and batch number were not reported), 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.(dosage number in series 2)  On an unspecified date, following vaccination with mrna 1273 booster dose, the patient experienced mild chills, mild aches all over, tired, the patient reported this events started after 27 hours post jab. (dosage number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the mild aches all over, tired, mild chills and 10% of what i felt with j&j vax was not reported.  This report was non-serious.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two female patients (one 70 and one 90-year-old). This is the second of two reports. A female patient of an unspecified age received PREVNAR 13; lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization, and influenza vaccine (FLUZONE; reported as HD flu (pending clarification)), via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patients received both HD flu vaccine and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), and both experienced significant systemic reactions. This patient felt ill enough to seek medical attention for her physician. The outcome of the event felt ill was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018414465 same reporter/drug/event, different patient.
Deep dark purple bruise on her left inner thigh. Muscle in left leg was swollen and very sore and had a burning feeling. She also had little bumps on her outer thigh. Cramps and pain on her left ovary area and on her lower left back. Pain in her lung area and also her neck broke out in hives which caused her to have itchiness in her eyes and ears.
Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.            Reported that on an unknown date, the patient experienced Humira did not work well by itself. Moderna covid-19 vaccine (Elasomeran) was also considered suspect.  Reported Causality for Drug effect incomplete (Humira did not work well by itself) for Moderna COVID-19 vaccine reported as Possible.  It was unknown whether patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was reported.
Hard lump in muscle of arm, spreading rash, white spots, itching. Swelling had gone down is now returning. Rash covering most of top of arm is spreading. Lump happened within 24 hours of vaccinations. Arm in pain two weeks later.
Incorrect vaccine administered to underage infant. Had mild rash about 24 hrs after vaccine given.
This spontaneous report as received from a nurse practitioner refers to an unspecified patient (age and gender unknown). The patient's concurrent conditions and medical history were not mentioned by the reporter. On 20-JUN-2016, the patient was vaccinated with an expired dose of GARDASIL 9 of batch# K023432, expiry date: 18-JUN-2016; (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effect was reported. No further details were provided. Additional information is not expected as the reporter did not have time to participate in the filing of this Adverse Event report.
It started with trouble breathing when I exert myself that lasted a couple months. Then at night I would develop a raddle in my chest. It was only about mid 30% range of my breathing cycle where it didn't occur. I would also have the raddling during the day but not as bad. Can not wear the CPAP because the air pressure from the CPAP was greater than the air pressure when I exhale.
The customer said the patient's mother reported that the patient had GERD; Projectile vomited everything after the dose of ROTATEQ; This spontaneous report was received from a registered nurse (also reported as a costumer, conflicting information) and refers to a 9-week-old female patient. The patient did not have any medical history, nor drug reactions/allergies. Concomitant medications included pneumococcal vaccine, polio vaccine, HIB vaccine, and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccine.  On 03-APR-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, taken orally as rotavirus vaccination. Lot #1917915 has been verified to be a valid lot# for rotavirus vaccine, live, oral, pentavalent, expiry date was not reported but upon internal review it was established was 22-MAR-2024.  On the same date, the patient's mother reported that she developed gastroesophageal reflux disease (GERD), and projectile vomited everything after the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The patient sought medical attention; however, no treatment was given for the events. At the time of reporting, the outcome of the events was unknown.  The causal relationship between both events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Left arm swelling and erythema at deltoid. 13.5 inch circumference vs 12.5 inch circumference on right deltoid.
Pain in my neck and rt shoulder almost immediately. Pain extremely intense all over my body. Lasted over 24 hours. Dizziness, too. Felt like I had been run over by a TRUCK!
Never felt sicker in my life; Vomiting; chills; sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: ILLNESS (non-serious) with onset 06May2022, outcome "not recovered", described as "Never felt sicker in my life"; VOMITING (non-serious) with onset 06May2022, outcome "not recovered"; CHILLS (non-serious) with onset 06May2022, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 06May2022, outcome "not recovered", described as "sweats". Therapeutic measures were not taken as a result of illness, vomiting, chills, hyperhidrosis.  Additional information: Patient did not have known allergies. Patient did not receive any other vaccine within four weeks. No covid prior to vaccination was tested. Patient did not test covid post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myopeicarditis - patient had chest pain, SOB, had to go to ER, was given Rx medications. Currently all symptoms are resolved.
INJECTION SITE PAIN, FATIGUE, BODY ACHES, ITCHING AT INJECTION SITE Narrative:  65 yo female with PMH sleep apnea, depression, GERD called triage line on 3/24/2021 to report flu-like symptoms (fatigue, body aches, and injection pain site with her second dose of covid19 vaccine. Pt received her COVID19 vaccine on 3/19/2021. Pt stated that symptoms started on 3/20/2021. Tylenol OTC helped with her symptoms. She described injection site as painful, itchy and feels that it's not getting better. Pt was followed up with a provider via phone and was given prednisone 40mg x 2 days, 30mg x2 days, then 20mg x 2 days, then 10mg x2 days since the the location rxn did not resolve on its own and it's been 4 days since she first saw the reaction (per progress notes). Other symptoms have resolved. Per patient, she experienced similar symptoms with the first Moderna vaccine.
facial swelling; This is a spontaneous report from a contactable other health professional. A 34-years-old non pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685), via an unspecified route of administration, administered in arm left on 08Jan2021 at 15:30 as 1st single dose, for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included iodine allergy, drug hypersensitivity, food allergy, covid-19 and concomitant medication included prednisone (Other medications in two weeks). On 08Jan2021 (after the first dose) the patient experienced facial swelling within a couple hours of the vaccine that lasted for several days. On an unspecified date in 2021, the outcome of the events recovered.  Follow-up attempts are completed. No further information is expected.
Fever and exhaustion began the next day.  Fever was intermittent through 10/27.   Exhaustion ended  by 10/27. Extreme dizziness and diarrhea began on 10/15.  Unable to walk, just laid on the bathroom floor for a couple of hours. So weak, I was unable to place a phone call, but was able to text my sister in another state.  Problematic dizziness and diarrhea continued through 10/24.   Still feeling a little dizziness occasionally, but greatly improved over 10/15 onset.