chrisvoncsefalvay/vaers-outcomes huggingface dataset:
64M h/o DM, HTN, HLD, BPH p/w weakness that started yesterday midmorning.  He first felt weak during work, when he noticed that he could not keep a good grip on his handtools; he had trouble squeezing the trigger on the nailgun and using his screwdriver. The weakness was equal on both sides.   Morning of admission, the patient was feeling even more weak, and he fell once in his house because of weakness in his legs, R>L.  He has had a lot of problems walking and keeping his balance.  There have been no changes to his medication regimen.  He has not had any previous episodes of this type of weakness.  He says the weakness is equal on both sides.  He has not had any blurry vision or double vision.  Denies slurred speech, drooping or drooling out of one side of his face, problems swallowing/choking, or confusion/disorientation.  He recently got his flu shot 10/16 (about one month prior to  presentation).  He also had a stomach infection last weekend (seven  days prior to presentation) where he had a lot of liquid diarrhea,  especially on the day of onset of that illness.  He also had nausea and  vomiting that weekend, and was unable to keep any food down until  Monday.  Since Monday, there was complete resolution of his symptoms.   He did not try any new foods; he did not eat any old/expired canned foods; no one around him is sick.  No recent travels.   Patient was felt to have an acute inflammatory  demyelinating polyneuropathy (Guillain Barre Syndrome) and was treated with IVIG. Patient is currently in a skilled nursing unit, has a motorized wheelchair.  4/8/09 Received hospital medical records of 11/13-12/1/2008. FINAL DX: Guillain Barre syndrome; SIADH resolved; hypotension resolved. Records reveal patient experienced nausea/vomiting/diarrhea following flu shot & developed progressive distal to proximal weakness.  LP done & found to have high protein.  Admitted to ICU.  Tx w/IVIG x 5 days. Improved slowly & transferred to SNF for inpatient rehab.     4/21/09 Received additional hospital medical records including: EMG/NCS report; Neuro & Neurosurg consults; Derm, Dental Uro consults; d/c summary of 1/28-2/2/09 rehospitalization for UTI while in rehab; additional labs.
Patient felt lightheaded about five minutes after her shot and returned to pharmacy counter. We were informed she also often has low blood sugar so we provided water and sugar in the form of candy to help raise her blood sugar. She had no reaction with her first shot. She felt more dizzy after about five minutes of sitting so we had her return to the immunization room and sit down, where she passed out in the chair. She came to a few seconds later and we lowered her to the floor and called 911. She continued to feel dizzy and lightheaded, as well as cold to the touch, until EMTs arrived. On arrival they found her blood sugar to be 60.
Patient came to pharmacy 11/13/05 asked if swelling and pain (from underarm to breast side) was typical of flu shot. These symptoms occurred after flu shot and remained for past 10 days.
Later on the day of the vaccine, I developed difficulty speaking and walking. My son brought me to the ER the following day. They ran  tests and ruled out stroke and other known causes of my neurological problems. I showed improvement the next day so they sent me home. My symptoms continued and worsened over a few weeks. My children called the ambulance on March 17. My body temp was 88 when I arrived at the ER and heartrate in 30s. I stayed in the hospital for 7 days but have no memory of that or the week before. As the Drs could not find a cause or remedy to symptoms, I was discharged to hospice care. I have improved at home with a lot of assistance but am not back to my pre-vaccine strength, energy, or coordination.
Patient reported dizziness after injection. Given gatorade and pretzel. Still reporting head fogginess and dizziness with clammy hands. 12:33 pm head fogginess was better, no further clamminess in hands. Stood up and reporting feeling better. Increased observation time to 30 minutes. At 45 minutes patient feeling better. Care provided by RN on staff .
Slurred speech, drooping on right side of face, headache. Drs. Wanted to rule out a stroke so CT Scan, MRI, Echocardiogram and numerous of blood test. 48 hrs the symptoms can completely subsided
Vaccine was reconstituted with  sterile water instead of the diluent provided with it.
Headache, coughing, sore throat, tiredness and fatigue. I ended going to the doctor who did a check up and sent me home to rest and recover.
Patient came into the pharmacy stating she had extreme bruising from the injection site down to her elbow 24 hours after the vaccine was administered. When I saw her arm on  7/5/19, the bruising was yellowing.
approx 2 hrs & 25mins p/vax pt began w/high pitched cry which lasted greater than 4 1/2 hrs; mom phoned vax provider p/4hrs of pt's cries able to verify high pitched crying;
Vaccines given approximately 1:30pm. Mother brought to nurse's attention a red, blotchy rash on child's extremities and back, face also red; mother thought reaction started within 5-10 minutes of injections.  No respiratory distress, child taking a bottle.  Child given .25ml of Benadryl, 50mg/ml, IM, right thigh at 1:50 pm. Discussed with mother having child seen by medical provider. Mother planned to go to her family medical provider directly from the Health Department. Family left with child in stable condition at 2:05pm.  Nurse called family 8:10 am 5/1/12, mother reports child doing well; rash was completely gone by the time they arrived at the medical provider's office, provider would not see child but instructed to use oral Benadryl as needed.  No further rash occurrence.
Development of polymyalgia rheumatica 2 days after 2nd shot. Pain and stiffness in shoulders, neck, pelvic girdle.
injection site itching; tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (injection site itching) and FATIGUE (tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching). On 27-Feb-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) had resolved. On 06-Mar-2021, VACCINATION SITE PRURITUS (injection site itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medications or treatment details were provided.
No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received wherein batch/lot number was added.
This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patient's of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot # H021346, expiration date 01-OCT-2015; lot # J008423, expiration date 21-JAN-2016 and lot # K010574, expiration date 08-APR-2017) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Pt administered flu vaccine and 4 hours later developed hives/urticaria on back, chest, all 4 limbs.
developed lesions/sores on the inside of my vagina these lesions are still present at date of this report but are improving the last time I had lesions like this develop was approximately 20 years ago. at that time I was tested and the lesions were determined not to be herpes simplex 2.
My first trip to the emergency room for stomach pain after the shot. I was discharge and felt better. I went to the emergency room again the next day and had abnormal heart rhythm. I was discharged again. I went to the emergency room again a couple days later and went into atrial fibrillation, they got my heart back in rhythm and overserved me for a few hours and discharged me. I was prescribed metoprolol at the emergency room.
muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Muscle pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle pain) had not resolved.            Patient used heat packs to treat muscle pain. Concomitant medications were not provided. Patient has been experiencing ongoing muscle pain for about 3 weeks Tylenol and heat packs on his arm for treatment which has not helped to improve the symptoms.
It was reported that a male pt received an Act-Hib and a Tripedia vaccination on 5/18/00. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information requested.
Pt reports facial swelling for 7 days after her dose. Pt did not seek medical attention and let it subside on its own. Pt declined receiving second dose.
pt recv vax 10AM 9SEP96 mom related fever & gen rash started 1PM same day;states fever subsided 11SEP96 but never actually checked temp;rash cleared 12SEP96;also gen swelling 10 & 11SEP96;2hr episode of inconsolable crying 11SEP96; to ER
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). Later in 2009, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 66-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced hives, feeling abnormal, chills, burning sensation, rash and fever. On an unknown date, the outcome of the hives, feeling abnormal, chills, burning sensation, rash and fever were unknown. It was unknown if the reporter considered the hives, feeling abnormal, chills, burning sensation, rash and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient came into the pharmacy on the day of reporting and told the pharmacist that, in June, he experienced rash, hives, fever, chills, burning and general feeling of blah.
From telephone correspondence received at AP on 10/28/2002, it was reported that on 10/21/2002 a 31 year old adult female received TD ADS ADULT, Lot # U0819AA, IM in the left deltoid, at a hospital ER.  On 10/24/2002 she called physician's office with pain in her jaw on the left side of face, along with soreness, pain, numbness, and tingling in her left arm.  The doctor saw her on 10/25/2002 and prescribed Ibuprofen every 6 hours, with ice to the left arm and observation.  It was not reported whether the patient recovered.
On Saturday, by noon, patient had painful gas with grunting and vomited a little bit. By 8pm started with gas pain, grunting, weighing down, then became unresponsive.   Ambulance took patient to ER, given rescue breathing, CPR, and shocks were required.   At hospital patient was intubated, had arrhythmia, respiratory issues. Patient taken to air to Hospital were she is in ECMO now.   Patient is still at the hospital now. They are treating her for myocarditis or cardiomyopathy.  Patient has positive Adoneno virus screen test for some type of infection. Myocarditis is an adverse event to resuscitation.
feeling bad; Covid; Initial information received on 27-Feb-2021 regarding an unsolicited valid serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced feeling bad (feeling abnormal) and Coronavirus Disease (COVID-19), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  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 and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (afternoon), the patient developed a serious feeling bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious about a week later was in the hospital with Coronavirus Disease (COVID-19), (unknown latency) following the administration of INFLUENZA VACCINE. Eight days in the hospital and another couple weeks on oxygen at home.   It was also reported that Product name: Product name was not provided. Since this is a post on the Sanofi flu shot we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves patient (unknown demographics) who had feeling abnormal and COVID-19, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
she didn't die but she knows 2 people that did; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: DEATH (death, medically significant), outcome "fatal", described as "she didn't die but she knows 2 people that did". The patient date of death was unknown. The reported cause of death was "she didn't die but she knows 2 people that did". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information provided is limited for reasonable medical assessment.  There was no information provided regarding cause of death, autopsy results and diagnostic studies. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related to the suspect drug until the cause of death is clarified and re-assessed based on additional data. This case will be updated once additional information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she didn't die but she knows 2 people that did
Pt. got clammy and instantly started sweating. Blood drained from face and eyes glassed over. Pt. stated he was weak and got very quiet. BP dropped to 65/39.
Constant headache since 1/17. Intensity comes and goes. It sometimes feels like a migraine and sometime feels dull. She had tried caffeine, motrin, alka seltzer, vics with no relief. She says it sometimes feels like her sinuses. She had a runny nose. No sore throat. Imitrex rx'd. Followed by allergist. Toradol 60mgxl. Follow up with PCP on 02/20/20.
This case was reported by a pharmacist and described the occurrence of injection site pain in an unspecified number of subjects of unspecified age and gender who were vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subjects received a dose of FLUARIX (.5 ml, unknown route and site) which had possibly previously been frozen (incorrect storage of drug). The lot number was reported as AFLUA52NAA from the reporter; however based on a safety lot number review, the lot number was updated to AFLUA524AA. At an unspecified time after vaccination with FLUARIX, some of the subjects experienced injection site pain and injection site redness. The injection site pain and injection site redness lasted 2 to 3 days in some subjects. At the time of reporting the outcome of the events was unspecified. The pharmacist reported that some dose of FLUARIX were frozen, and an unknown number of employees were vaccinated with possibly previously frozen FLUARIX. The pharmacist stated that possibly over 100 employees received the vaccine, and some did experience pain and redness at the injection site that last 2 to 3 days in some instances.
Received the Moderna shot Swollen lymph nodes in the left arm pit redness in the arm where the vaccination was administered  Itchiness in ears
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-Significant Live Follow up: added reporter.