chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STARTED BEING SICK; FELT DISORIENTATED; STAYED IN BED; WHOLE BODY FELT WEIRD/FELT SO BAD; FEELING HOT; FELT LIKE ACHY IT'S HARD TO EXPLAIN; PRETTY MUCH ASLEEP; CHILLS; NAUSEATED; FEELING TIRED; HIGH FEVER; REALLY DID NOT FEEL WELL; FEEL COLD; HAD NOTHING TO EAT, DRANK GATORADE, AND WATER/UNABLE TO EAT; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 167 pounds, and height was 71 inches. The patient's past medical history included: couple knee surgeries a couple years ago, and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced had nothing to eat, drank gatorade, and water/unable to eat. On 16-AUG-2021, the patient experienced really did not feel well. On 16-AUG-2021, the patient experienced feel cold. On 16-AUG-2021, the patient experienced feeling tired. On 16-AUG-2021, the patient experienced high fever. On 17-AUG-2021, the patient experienced started being sick. On 17-AUG-2021, the patient experienced felt disorientated. On 17-AUG-2021, the patient experienced stayed in bed. On 17-AUG-2021, the patient experienced whole body felt weird/felt so bad. On 17-AUG-2021, the patient experienced feeling hot. On 17-AUG-2021, the patient experienced felt like achy it's hard to explain. On 17-AUG-2021, the patient experienced pretty much asleep. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced nauseated. Laboratory data included: Body temperature (NR: not provided) 101 to 102 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, really did not feel well, whole body felt weird/felt so bad, felt like achy it's hard to explain, felt disorientated, feeling tired, nauseated, started being sick, feeling hot, stayed in bed, feel cold, and pretty much asleep, and the outcome of high fever and had nothing to eat, drank gatorade, and water/unable to eat was not reported. This report was non-serious.
neck pain; light reaction (little pain) he had on his shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027420A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
No other AE/PQC reported; patient was administered VAQTA after expiration date; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 28-JUL-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (1 milliliter, lot # S007265, expiration date 07-JUL-2020; route was not reported) for prophylaxis after expiration date (expired product administered). The reported was also inquiring if the dose was valid. No other adverse event (AE) or product quality complaints (PQC ) were reported. The product was not available for investigation (Obtain was false). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
In less than 2 hours  I became very dizzy and nauseous.  At 3 p.m.  I vomited once.
no additional AE or side effects/symptoms; she was was accidentally given the GARDASIL 9 vaccine today and consumer is currently in 3rd trimester of pregnancy; medical assistant inadvertently administered GARDASIL 9 to a 28-week pregnant patient, because they thought it was a different medication; This spontaneous prospective pregnancy report as received from a physician and from the patient refers to a 28-week pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-NOV-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscular (lot # and expiration date were not reported). The administering medical assistant thought it was a different medication (unspecified). No other adverse event was reported.  The last menstrual period (LMP) was estimated to 06-MAY-2020 and estimated date of delivery (EDD) to 10-FEB-2021.  The pregnancy outcome was pending.
Pt was given all 4 vaccines and the HPV was given last an right after it was administered the pt stated he felt to faint then started having a seizure arms stiffened and legs extended and stiffened eyes rolled in back of head lasted about.
now a week late in receiving the second dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and consumer/non-health care professional. This case involved an unknown (age and gender) patient receiving a week late second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (inappropriate schedule of product administration)   The patient's past vaccination(s) included imovax on 31-Aug-2021 with first dose.  Relevant medical history, medical treatment(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a week late second dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (inappropriate schedule of product administration) and would like to know how to proceed with administration  It was reported "She states that the patient is receiving dose two today for pre-exposure prophylaxis. She would like to know when they need to come in for their third dose".  This case was an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  At the time of reporting, no adverse event.  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.  There will be no information available on the batch number for this case.
Tightening of throat, itchy eyes, watery eyes, swollen eyes. Pt went to the Emergency Room and was treated with Tylenol, Benadryl, Prednisone, and Zantac.
Pt. started vomiting the evening of the immunizations & seemed to stop breathing.  Taken by ambulance to E.R.  Pt. was watched in ER & discharged home the same night.
pt recv vax & 1 day later pt devel rash on the lt leg w/swelling @ inj site;
Itching , redness and swelling at the injection site . Hydrocortisone cream .
This case was reported via other manufacturer. This is a pregnancy case. This female subject was enrolled in a study. the subject received FLUARIX on an unknown date. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received: Reporter stated that, she was at a clinic and overheard that prefilled syringes are administered to pregnant women from GSK.
11OCT91 11AM pt recvd immun; 1230PM sl fever, APAP given; 5PM t105F; 9PM t104F; Taken to ER;  12OCT91 2PM returned to normal;
Pt recvd DTP/HIB & devel a fever to 104 during the evening; the following morning fever was 102;
TENIVAC been administered post excursion to a patient with no reported adverse event; Initial information received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA214932(CLUSTER).  This case involves an unknown age and unknown gender patient who was administered tenivac  post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7927AA expiry date:13-Oct-2025 for immunization via unknown route and unknown site (strength, dose: unknown),  tenivac been administered post excursion with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event poor quality product administered.   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 complaining of itchy round slightly swollen red area about 3 inches in diameter. On examination, provider noticed, R lateral thigh with 2 inch raised blanching red circular area with no excoriations, slightly warm. Patient given Benadryl and ibuprofen.
I normally do not sleep very long; I was having a very hard time staying awake. When I was awake, I felt like I needed to lay down and sleep. I had a low-grade very of 101F. Once it broke, I was coughing of phlegm of various color, there were times my oxygen got below 94. At times you could her gurgling in my lungs near the end of February. My doctor put me on an antibiotic to help clear up the lingering infection. I was unable to take the Paxlovid when I tested positive in early February for COVID-19, it took three weeks for me to recover. I am functioning but I cannot say that I am totally recovered. I do not feel right.
pt recvd 3 doses of Engerix-B & did not respond when titer was checked; booster vax will be offered;
Arm has a nodule that formed where the injection site was. 1 inch x 1 inch
Employee noted left deltoid redness, pain, swelling 1 day after receiving influenza vaccine.  Came to Emp Hlth Office and then was referred to the ED.  Diagnosed with "local allergic reaction to influenza vaccine".  Contacted employee on 10/3/11 and she stated she iced her arm over the weekend and it's "feeling much better and red area had decreased".
fainting multiple times, significant drop in blood pressure, sent in ambulance to  ER, returned home that evening but remained very physically weak and had spurts of fever for several days following
This spontaneous report was received from a nurse referring to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route of vaccination were not reported, lot # K016132 with expiration date: 24-SEP-2016, lot # L003774 with expiration date: 04-FEB-2017, lot # L007225 with expiration date: 03-MAR-2017, lot # L012036 with expiration date: 07-APR-2017, lot # reported as L018001 with expiration date: 19-MAY-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
My smell and taste has been strange ever since. I can almost always smell a metallic or sickly sweet smell. Its like everything I smell or taste has to pass through a sort of blanket of metal or formaldehyde. I can really only smell really strong things like white vinegar. But not subtle things like candles or when food is cooking. My taste is nearly gone, and I really only get texture, things that are really spicy or really sour. It started within a day or so from when I got my first shot and has been the same since.
On 03/20/2019, a 22 month old patient received an adult dose of VAQTA.; No known adverse effects.; This spontaneous report was received from a nurse referring to a 22 month old patient of unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On an unknown date, the patient received an adult dose of hepatitis a vaccine, inactivated(VAQTA)((strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis(product administered to patient of inappropriate age). No known adverse effects. The causality of the event was not provided.
body aches, hot ans cold spells, diaphoretic, nasal drainage, sore throat
Chest pain, myocarditis. Troponin level of 14.753.2pg/ml. TX: Ibuprofen 200mg every 8 hours.
Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol.  4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol.  Was still feeling poor at 1am but coherent and talking, not thinking  that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache.  At 6am, he was found blue/dead in his bed.
Bells' Palsey; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication. On or about 30-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for Bells' Palsey . As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   Upon internal review, the event Bells' Palsey was determined to be medically significant.
A next day after the vaccine late in the evening an extreme tired feeling just came over me.  I sleep real good.  The next day was ok but later that day that same extreme tired feeling came over me again.  10/29 I got a runny nose and developed various cold like symptoms.  I started feeling a little congested.  10/30 while working outside I was fine, but later in the afternoon while talking I noticed I had a developed a bronchial crackly voice sound.  My upper chest began feeling funny of a congested like feeling.  10/31 I reached out to my PCP and advised I thought I had bronchitis due to the symptoms I was having, but I got no response so I called the Urgent care and advised of my symptoms and was advised to come in.  I went to the Urgent Care where a COVID-19 test was performed.  That Monday following my Dr's office finally reached back out to me later and did hear the crackly sound of my voice and advised if the symptoms got worse to seek additional care.  On 11/3 the Urgent Care's office and my Dr's office received the COVID-19 positive test results and called me and now wants to do the Monoclonal Antibodies injection for the COVID-19 positive status.  I still have a lot of nasal stuffiness in the back upper throat chest area.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient thought a spider had bit him/her, but it was shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
fever; chills; rash on her breast; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer in one breast treated with radiation). Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in early June 2019, refer linked case US2019172899).   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced fever and chills. In August 2019, the patient experienced generalized rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the fever, chills and generalized rash were unknown.   It was unknown if the reporter considered the fever, chills and generalized rash to be related to Shingrix.  Additional information received were as follows: The patient's medical condition included hyperimmune system. The patient experienced fever and chills which started later the day of vaccination. The patient missed work the following day but these symptoms resolved and she was able to go to work on 14th August 2019. Within 2 weeks of the 2nd dose, the patient experienced a small triangle size rash on one of her breast. The patient kept an eye on it and it continued to get bigger.  The patient was given cortisone cream which helped but at the reporting date it had come back and spread to her other breasts and parts of her body. The reporter consented to follow up. Emergency room visit required.
I slept for 4 days n hardly ate anything; I slept for 4 days n hardly ate anything; Been sick since I got the, Flu shot; I came down with a terrible cold n still have it; Got the flu shot, five hrs later I was so weak I could barely get to bed; Initial information was received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who  got the flu shot, five hrs later i was so weak i could barely get to bed, i slept for 4 days n hardly ate anything, i came down with a terrible cold n still have it and been sick since i got the, flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 06-Dec-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On 06-Dec-2022 the patient who got the flu shot, five hrs later i was so weak i could barely get to bed (asthenia)(latency: 5 hours) following the administration of influenza vaccine.  On 12-Dec-2022 the patient came down with a terrible cold n still have it (nasopharyngitis) (latency: 6 days) following the administration of influenza vaccine.  On an unknown date the patient been sick since i got the, flu shot (illness) and i slept for 4 days n hardly ate anything (hypersomnia), (Decreased appetite) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered for the events i came down with a terrible cold n still have it and been sick since i got the, flu shot and Unknown for rest of the events.
Patient received flu shot.  A few minutes later while waiting to check out at register, she fainted.  When she fell she bumped her head above her eye.  She was unaware she had fainted, but she immediately regained consciousness.  She then claimed to feel "queezy". Patient was brought into back and laid down for around 30 minutes.  Was given water and an ice pack for her head wound.  Her pulse was normal and her blood pressure was normal.  She later explained she felt a pain in her arm before fainting.  She was planning to go to an urgent care facility to be checked when she left.
Shouder began to ache, motion limited, severe pain at injection site, high on the shoulder. Still painful to move, worse at night, revisited PCP 1 week later after having called a couple day after shot.  Used heat, ice, Naproxen, with no noticeable improvement. Was switched to Meloxicam on 12/15 to combat inflammation noted on MRI (along with rotator tear and arthritis appearing). After following instructions for rotator cuff exercises and taking the NSAID, aching during the day subsided, but still limited motion and night pain now after 3 days of this treatment.