chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started to get severe itching in the underside of the upper arm (left) the injection arm; There were hives present in that location only; I also felt tingling in my lips and a thick tongue; I also felt tingling in my lips and a thick tongue; I was tired for about 3 days after the injection; night sweats on the third night; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266) via an unspecified route of administration, in left arm, on 23Feb2021 (at the age of 74 years) as a single dose for COVID-19 immunization at Hospital. The patient medical history included multiple sclerosis, hives. The patient had no history of known allergies. Concomitant medications included glatiramer acetate (COPAXONE), hydrochlorothiazide. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) via an unspecified route of administration, in left arm on 02Feb2021 (at the age of 74 years) as a single dose for COVID-19 immunization. There were no other vaccines received in four weeks. Prior vaccination, the patient had no Covid. On 23Feb2021, 5 hours after receiving injection she started to get severe itching in the underside of the upper arm (left) the injection arm. There were hives present in that location only. She also felt tingling in lips and a thick tongue. she had an Epi-pen from previous hives (unknown origin) a few years ago. As she live only a mile from the hospital and she was a retired nurse, she just assessed the symptoms and kept the EpiPen by her side. After about an hour, the symptoms subsided. She was tired for about 3 days after the injection and had night sweats on the third night in Feb2021. There was no treatment received for the adverse events. Post vaccination, the patient was not tested for Covid. Outcome of the events was reported as recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Mar2022, outcome "recovered" (01Apr2022) and all described as "Paxlovid indication: Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events vaccination failure and covid19 cannot be totally excluded.
Presented with a large erythematous reaction today which does not seem to cause him any discomfort--Size to Left Leg is measured 120x190mm--appears no evidence of itching or pain and his mobility has not been affected--Mother to apply ice no more that 10 minutes and to elevate the leg as much as possible--To return to see MD again tomorrow 04/23/2017.
Patient experienced pain at injection site, overall joint/body aches,  fatigue, and severe chills that started the evening after vaccination.  Will apply ice to arm, rest and take otc pain medication of choice (tylenol/ibuprofen) if needed to help with pain and discomfort.  Will follow up with pharmacy or physician if symptoms worsen or do not resolve in 2 days.
Rash, UrticariaPruritus, injection site posterior and in more subQ tissue Narrative:  reported to EOH site was posterior arm, and had major inflammatory response. red, hot and tender for 3 days. resolved on own w/o further intervention needed. education provided to those giving injections.
Awoke 3/31 with pain to left jaw area, some sl swelling. No redness or warmth, no fevers or other adenopathy.
Patient seen in office with complaints of multiple bruises. CBC showed platelet count of 0. Referred to hematologist and hospitalized for Idiopathic thrombocytopenic purpura.
got a severe case of the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got a severe case of the shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023. This case was reported by a patient's friend via interactive digital media. The patient got the shingles vaccine and a week later got a severe case of the shingles. The follow-up could not be possible as no contact details were available. This case has been linked to the case US2023AMR067315 reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR067315:same reporter
Vaccine error: Incorrect immunization of varicella given. Pt did not need varicella vaccine.
I was vaccinated yesterday and woke up in horrible pain and nausea. I vomited and had to go back up so bed since I was so dizzy.
Symptoms began a full 15 days after my second shot and included: -- Intense body aches -- Completion depletion of energy -- Severe chills All the symptoms that were expected a few days after the vaccine, but I couldn't find anything anywhere about them showing up so long after the vaccine. The immediate effect of the vaccine was only a very sore arm.
Pt. developed flu-like symptoms which included chills, temperature, and body aches the day following the vaccination.
101 degree fever within 12 hours of receiving the first MMR vaccine.  Fever spiked again 6 hours after first fever subsided.
swelling from his elbow to wrist; now his right hand is swollen as well; hot to the touch; Can't use his hand; He has pain in every joint of his hand and fingers.; sore arm; felt like he had flu like symptoms; He was tired and had chills; He was tired and had chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well) and VACCINATION SITE WARMTH (hot to the touch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Obesity and Atrial fibrillation. Concurrent medical conditions included Hypertension and Penicillin allergy. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN "AGP") and SPIRONOLACTONE for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), CHILLS (He was tired and had chills) and FATIGUE (He was tired and had chills). On 07-Feb-2021, the patient experienced JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well), VACCINATION SITE WARMTH (hot to the touch), FEELING ABNORMAL (Can't use his hand) and ARTHRALGIA (He has pain in every joint of his hand and fingers.). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like he had flu like symptoms), JOINT SWELLING (swelling from his elbow to wrist), PERIPHERAL SWELLING (now his right hand is swollen as well), VACCINATION SITE WARMTH (hot to the touch), FEELING ABNORMAL (Can't use his hand), CHILLS (He was tired and had chills), FATIGUE (He was tired and had chills) and ARTHRALGIA (He has pain in every joint of his hand and fingers.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: negative Negative. On an unknown date, X-ray: negative Negative.         No treatment was reported. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR
No Adverse outcome  Recieved covid vaccine 6/6/22 amd 6/7/22
Redness 3"x4", hard to the touch, swollen and warm to the touch, Tylenol and cool compresses
Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157332 and 2016SA157340 (same social medica report). This case involves a two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed high pitch screaming, a high fever, vomiting and diarrhea. The patient also developed additional symptoms. Patient's mother contacted the pediatrician and decided to take her son to the emergency room. On an unknown date, patient died in the arms of mother on their way to the emergency room. It was not reported whether autopsy was performed or not. Laboratory investigations and corrective treatment were not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented social medical case where patient died after administration of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). No medical history, concomitant medications, lab/diagnostic or autopsy results accompany the case to help identify the cause of death. Investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.; Reported Cause(s) of Death: diarrhea; high fever; high pitch screaming; vomiting.
Erythematous papules with small vesicles on face and upper trunk and 12 lesions.
Patient received .25ml instead of .5 ml dose - I have a call out to her to return to receive .25ml more to complete
6cm x 4cm erythema.  Swollen R thigh at injection site (treatment-Orapred)
Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
Patient's arm was red, swollen and inflamed. MD checked his arm, told them to put cold compresses and if not better in a day or so come back.
Information has been received from a nurse practitioner concerning a 19 year old female who experienced fever a few hours after receiving the first dose of GARDASIL. The patient received the second dose of GARDASIL on 13-MAY-2009 and after a few hours, the patient's mother called in stating that the patient felt like her throat was closing that she couldn't breathe. Lot #'s were not available. Patient was brought to the emergency room but she was not admitted in the hospital. At the time of the report the patient's AE improved. Follow-up information has been received from a nurse practitioner who stated that the patient was treated in the emergency room. The patient was treated with BENADRYL IV and fluids. The patient was not admitted to the hospital. The patient had recovered. Follow-up information received from a medical assistant at the nurse practitioner's office stated that the patient's mother called the office and reported that her daughter felt as if her throat was closing. The physician then advised that the patient be taken to the hospital. Upon internal review, felt like throat was closing and couldn't breath, requiring treatment with IV antihistamine, were considered to be other important medical events. Additional information has been requested.
I am the epidemiologist reporting on behalf of 57 year-old male patient.  Patient received one dose of the Pfizer vaccine on 04/06/2021, according to immunization records.  The patient passed away on 4/09/2021 (3 days post first dose, hospital emergency room). The death certificate lists ?cardiac arrest? as the immediate cause of death. No additional information regarding underlying conditions that may have contributed to this death is available.
Developed atypical trigeminal; = This case was reported by a other health professional via call center representative and described the occurrence of trigeminal nerve disorder in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced trigeminal nerve disorder. On an unknown date, the outcome of the trigeminal nerve disorder was unknown.   It was unknown if the reporter considered the trigeminal nerve disorder to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were as follows: The age at vaccination was not reported. HCP reporeds that she herself received Fluarix in 2018 and She developed atypical trigeminal 6-7 weeks later.        The reporter did not consent to follow up.
Tinnitus, I now have a very high pitched sound in my left ear. It is high pitched like a dentist drill. That is the best I can describe it. It had a onset of approximately 24 hours after my first shot of Pfizer.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were inadvertently vaccinated with doses of improperly stored PROQUAD (dose and route of administration were not reported, lot # L003221 and expiry date 30-JUL-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial solicited report on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 24 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 10 November 2016. On 16 November 2016, 06 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The subject's lab data included, on 16 November 2016 ECG was normal. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 24-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Thu 4/1/21: 9:32pm: chills; 10:19pm fever: 101.7; 10:59pm fever: 102.7;   (note: no aches with fever but headache worse as fever rose, less as it diminished) Fri 4/2/21: 2:15am fever: 102.8; 12:10pm fever: 100.6; 3:12pm fever 100.6 3am: night sweats Sat 4/3/21: 9am: woke drenched but normal fever. Weak, tired. Strength returning slowly all day. 95% by evening, tho no reserves of strength. Sun thru Wed: night sweats every night so far.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M007963, expiration date 15-AUG-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003754.
Swelling, redness at injection site; muscle ache; incredible tiredness; vomiting; headache; weakness
got shot, Have it/Suspected vaccination failure; Have it; Still burning inside; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shot, Have it/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Have it) and burning sensation (Verbatim: Still burning inside). The outcome of the vaccination failure was unknown and the outcome of the shingles and burning sensation were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient had it and got his/her Shingles shot. The patient still had the burning inside. The patient stated that it was slowly killing him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Provider discharge summary states, "Reason for Admission: h/o  hx of Dm2, colon cancer presented with weakness. He was diagnosed with COVID on PTA ER presentation and was sent home. He sat down on the floor of his house and could not get up from weakness. Labs reveal elevated CPK. Admitted for weakenss from COVID and Rhabdo.    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Patient has been increasingly improving on IVF and conservative management   Problem list at discharge: Acute Rhabdomyolysis: improving - from prolonged immobilization at home - continue IVF - renal function stable   Acute COVID 19 infection - likely causing weakness - mild URI symptoms. Non hypoxic - symptomatic treatment     Type 2 diabetes mellitus without complications: SSI Benign prostatic hyperplasia without lower urinary tract symptoms: Flomax Essential hypertension: Norvasc, BB PSVT (paroxysmal supraventricular tachycardia)   History of TIA: ASA, statin History of Adenocarcinoma of colon s/p partial colectomy 02/23   Patient was accepted to inpatient Rehab for generalized weakness"
When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 in April 2022.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 14-Nov-2023, the patient experienced EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly). At the time of the report, EYE DISORDER (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly), HYPOAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) and PARAESTHESIA (When I woke up the next day my left eye was half closed and the left side of my face is numb and tingly) had not resolved.            Concomitant and treatment medications were not reported.
After the vaccine I felt sick including a splitting headache. I had hot/cold sweats. I hopped in the shower and I almost threw up. I did not have an appetite and experienced fatigue. I didn't take anything for the symptoms. After about 2 days I started coming out of it. On day 3 I went back to work. After about a month or two I started to experience Erectile Dysfunction. I decided to go to the doctor. I was prescribed VIAGRA. After the first cycle nothing has changed and I had to go back to get another prescription. It still affects me today.
Patient presented to the hospital on 9/25/22 with fever. Tested positive for COVID on 9/26/22. Patient expired on 9/28/22.
Broke out with rash on forearms (right & left arms) and from pelvic area down front & back of legs.  Did not itch but once noticed and would touch, then itch formed.  Not severe or irritating, just present.  No pain nor heat from rash.  Still present on legs today, Friday, January 22, 2021.  Cerave cream has helped relieve what itch is present.  Not uncomfortable, irritating or painful.