chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both my mother and father had their shots on the same day.  Mother (77) had mild fatigue the day after the shot with some arm soreness.  She was fine after about a day.  My father reported  arm soreness and fatigue that lasted about three days after the shot.  He thought he was rebounding from the shot and continued his usual activities.  Though, he started complaining of being "winded" and difficulty breathing.  He slept a lot and continued with fatigue and shallow breathing.  A week after his shot he felt he needed to go to the ER because of difficulty breathing and being exhausted after walking up a flight of stairs (we live in a raised ranch style house).
FELT LIKE HAVING HEART ATTACK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced felt like having heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like having heart attack was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Redness around arm in a area of about 9 cm long and 5 to 6 cm wide. It is tender and painful. Used BENADRYL but not helping her. Also using Ibuprofen for pain.
Two days after receiving second vaccination came down with illness; headaches, fatigue, ear pain, nasal congestion, eyes swollen/red, face pain
Administered adult dose of Hep A instead of Pediatric. No noticeable reaction after injection. Informed parents VAERS completed for purpose of monitoring.
Weakness began after first dose and was accompanied by malaise.  Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
pt recvd vax & 21AUG93; 23AUG93 pt exp neck pressure, heartburn & BP 210/110; 24AUG93 recvd Bentyl & prilosec 25AUG93 exp palpitations & dizziness; 27AUG93 exp grossly distended neck;
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site arm stiffness in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. On 15 February 2014 the subject received a dose of BOOSTRIX (unknown details) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was 34 weeks. The date of last menstrual period was reported as 21 June 2013. The estimated date of delivery was reported as 3 April 2014. On 15 February 2014, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced injection site arm stiffness (also described as "stiff shoulder"). Relevant test results included ultrasound examination in 2013: on 7 August, 4 September, 1 October, and 18 November. There was no evidence of defect from prenatal testing. At the time of reporting the event of injection site arm stiffness was resolved. Per the subject, the "stiffness resolved within 24 to 36 hours." At the time of reporting, the pregnancy was ongoing. The subject documented another case of vaccine exposure. See case A1062376B for details on the other case. Follow-up information was received on 18 March 2014 via consumer who reported she received BOOSTRIX injection 0.5ml ON 15February 2014 with authorization to contact her physician. No other information was provided. Follow-up information was received on 24 June 2014 via healthcare professional. The pregnancy was by normal conception, not by in-vitro fertilization. On 02 April 2014, at calculated 40 to 41 weeks gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by normal vaginal delivery, weight 7 pounds 10 ounces; length, head circumference and Apgar score were not provided. No other information was provided.
Client received pediatric dose of Hepatitis A; rather than adult dose of Hepatitis A. on 04-09-2019. Client notified of pediatric administration on 04-10-2019 and referred back to office for adult dose of Hep A to be administered in 6 months.
The day after the flu shot, he had arm muscle pain when the arm is moved up and back. Was better after 8 days of prednisone 20mg  on 10/18/21. Then, it returned after off the prednisone and continues currently.
10 hours after receiving the vaccine I developed an acutely swollen, painful right knee,  I required prednisone 20mg and symptoms subsided in about 10 hours
A physician reported that his 2 year old son developed fever after vaccination with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 21MAR2003, approximately 24 hours post-immunization, the subject developed a fever of approximately 103 degrees Fahrenheit. At an unspecified time post -immunization, the subject developed an injection site reaction characterized by induration and erythema. The subject was treated with unspecified antipyretics. As of 25MAR2003, the events persisted.
tiredness; muscle aches; fever; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced tiredness, muscle pain and fever. On an unknown date, the outcome of the tiredness, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient had a Shingrix vaccination day before reporting in the evening and experienced muscle aches, tiredness and fever.  The patient asked how long should these symptoms last.
chills, nausea, headache, severe pain in right arm difficultly lifting right arm on day of second dose
16-year-old Received Heplisav-B; Initial Report Received on 18-Oct-2019 and 07-Nov-2019 (non-significant)  A pharmacist reported that a 16-year-old patient (unknown gender and race) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history and concomitant medications were not provided.   On an unknown date, the patient received a dose of Heplisav-B (lot #, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe. The pharmacist stated he did not have any other information to provide.   On 07-Nov-2019, the reporter confirmed that additional information was not available.   At the time of the report, the outcome of the event was not reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI and IB.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Insomnia" (unspecified if ongoing), notes: Other medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: very first positive test; (Dec2022) Negative, notes: around day 7; (Dec2022) Positive, notes: on day 11; (Dec2022) very positive; (Dec2022) Positive, notes: until 3 weeks. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details included COVID 19 Treatment i.e., Paxlovid for Treatment of COVID-19 (Treatment start date 12Dec2022 and Treatment stop date 16Dec2022 by oral route. Clinical course: Symptoms (fever, chills, cough, sore throat, fatigue, mm / joint aches) improved after Paxlovid, with negative rapid COVID test x 1 around day 7, then returned on day 11, along with very positive rapid test; symptoms resolved by 2.5 weeks since the infection first started, positive rapid COVID test persisted until 3 weeks since the very first positive test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035145, expiration date 30-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit ( >14 but <16 degreesFahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursionn of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006257: US-009507513-1703USA006256: US-009507513-1702USA010414: US-009507513-1703USA006255:
High blood pressure  with lower number 90 and above at times. Ringing on right side of head, high pitch hissing that various in level from low to moderate to high
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 1 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006259, 1210USA006260, and 1210USA006261) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt presented to vaccine clinic to receive second dose of COVID 19 Moderna vaccine. Pt did not have his COVID vaccine administration card. When Pt presented to this writer to receive vaccine, he had already been checked in and verified and provided his informed consent form that was completed and signed. Pt reported that he had no adverse events from his first dose of Moderna. This writer verified Pt's name, DOB, and reason for visit to vaccine clinic. Pt was informed of potential adverse events and offered appropriate education. Vaccine administered and Pt observed for 15 minutes post injection. No adverse event noted and Pt left vaccine clinic ambulatory. Upon return to the clinic, Pt's second dose of Moderna vaccine was documented. This writer became aware that the Pt had received his second dose of the Moderna vaccine one week too early when verifying the schedule for an upcoming vaccine clinic. A telephone was made to the Pt to inform them of the event that occured and explain that Pt would not need to receive an additional dose, however, there was no answer and there was no voicemail available to leave a message.
Rash to front of neck and back of neck and chest at 1140 am Benadryl 50mg injected IM to right deltoid. T 99.8, P 80, B/P 106/70. 1155 - T 99.1, P80, R20, B/P 110/60. 1220 - T98.8, P80, R20, B/P 110/80. 12:00pm rash was cleared up.
Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x 2 days.
left sided flank pain and itching, patient was diagnosed with shingles; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 28-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered severe left sided flank pain and itching. Then, she was diagnosed with shingles (herpes zoster). As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe, serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  The reporter considered shingles as disabling.
Two red spots on both upper thighs, blanching. Reaction to PEDIATRIX - left thigh. Flu - right thigh. Patient presents with rash since yesterday. Child received vaccines 2 days ago - 6 month plus flu shot. No other symptoms, no fever. Patient accompanied by mother.
My left side of my throat started hurting out of the blue around a month after my booster Covid-19 vaccine. My throat  is very painfully, I had a ultrasound done and my lymph nodes are swollen on the left side of my throat causing a lot of pain.
Patient presents at pharmacy on 3/15/21 with 3 or 4 red bumps at the injection site,  The reaction was about the size of a quarter.  Patient states that she noticed when she removed bandaid about 24 hours after the injection on 3/12/21.  RPh asked patient any history of reactions to adhesives/bandaids in the past?  Patient said no. Talked with patient on 3/19/21 patient states the area is dry.
TOOK SECOND DOSE LATE; This spontaneous case (PVX2019-967) was received from a nurse on 23-Apr-2019. It describes a female consumer who "took second dose late". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 17-Apr-2019 and forgot to take second dose. She took the second dose on 21-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose late" was unknown.  Company's Comment: The causality of the event "took second dose late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose late" was considered as not applicable.
died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034315, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR034315:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
weigh loss of 20 pounds; increase in blood pressure; chest pain; shortness of breath; headache; dizziness; nausea; myalgia; weakness; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 91-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LP9HK, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for an unknown indication.   On 30th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness. On 1st January 2021, the patient experienced weight loss. On an unknown date, the outcome of the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness were not recovered/not resolved.   It was unknown if the reporter considered the weight loss, increased blood pressure, chest pain, shortness of breath, headache, dizziness, nausea, myalgia and weakness to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's daughter. The patient received the Fluarix vaccine the doctor's office.  Two days later, the patient experienced weakness, myalgia, nausea, dizziness, headache, shortness of breath, chest pain, increase in blood pressure, and a weigh loss of 20 pounds after 93 days. The patient went to the emergency department two days after the injection. There was nothing found that was abnormal and the patient was not admitted.  Subsequently, the symptoms continued till the day of reporting. The emergency room visit was required. The patient had blood work, X rays, computerized tomography scans, and electrocardiograms done, and all came back normal. The reporter consented to follow up.
Fever on 03/17 (rectal); vomit, diarrhea on 03/17, hoarse cough on 03/16.  eye discharge at injected 03/07-started on Tehytrim eye drops
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/31/21 2nd dose01/21/21 Diagnosed covid positive:09/01/21 Symptom onset:09/01/21 Exposure:home Symptoms:Cough, fatigue,sore Throat,HA
p/vax pt exp swelling of cervical lymph nodes, sharp pain in head & rt ankle pain w/no edema;pt devel a red rash on face, neck, chest, abd & back;T98;eyes wee noted to be very weak & very tired;
Within 5 minutes after receiving vaccine patient became somewhat light headed. Laid down, vital signs stable 100/82 P=80 R16. After 10-15 min had juice and crackers-felt better-went back to office. Called school nurse approx 30 min later complaining of funny feeling in right lower leg. (constricting feeling) weak/numbness also right arm from elbow down fingertips slight limp noticed. Rescue called vitals stable - no worsening of conditions. Pt called family Dr. - advised to go to ER. Declined transport by rescue. Father came to drive pt to ER/home - before leaving pt called family Dr again & was awaiting call back before going to ER. 11/25/09 11:15pm spoke with pt. Did not go to ER. Said he spoke with CDC last evening. Feeling better today but still with symptoms. 12/12 Patient called back. It took 48 hours to feel better. He had experienced (R) sided "constriction" from elbow to wrist & from knee to foot which caused limping. Back to work without residual.
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
I have Ulcerative Colitis. It has been in remission for a long time. But it is in a severe flair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591).  A 69-year-old female patient received tofacitinib citrate (XELJANZ), at 10 mg; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing), notes: remission for a long time. The patient's concomitant medications were not reported. Past drug history included: Covid-19 vaccine for Covid-19 Immunization, notes: Primary Immunization Series completed; Manufacturer Unknown. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "I have Ulcerative Colitis. It has been in remission for a long time. But it is in a severe flair". The action taken for tofacitinib citrate was unknown. Clinical course: Patient has ulcerative colitis. It has been in remission for a long time. But it is in a severe flair. The reporter thought that the Pfizer Covid-19 booster was what triggered this flair. The patient was also prescribed Xeljanz 10 mg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better after standing up. stayed 30 minutes. Felt better and left. Narrative: