chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot given 11/1/10 in the afternoon, later that evening pt had uncontrollable chills (out-of-body experience), vomiting, headache that came & went, and dizziness. This lasted all evening through the early morning hours.
Nothing happened immediately but after a few days I felt tired, itchy, I went to see a doctor because I was going in a trip, and I have a mammogram, but since the vaccine I feel down all the time, blood sugar is high, cholesterol & glucose is high.
Sustained tachycardia from 0900 until 1800 on Feb 2nd while laying in bed or on the couch. Ranged from 97-109. The average was 103. Tightness in chest, sweating, generally feeling unwell. Additionally, standard symptoms were present. Pain at injection site, pain under the left arm (lymph nodes), body aches, headache, fatigue. No fever and no shortness of breath.
Pt states he had a little swelling, redness and tenderness to arm. Thought it was due to lifting weights but now believes it was related to the shot.
Had some reaction; A spontaneous report was received from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had some reactions.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date had some reactions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, had some reactions was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Small red bumps noticed on upper chest when pt was showering. This occurred one week after receiving small pox vaccine treated with Benadryl 25mg 1 PO QID.
Swollen where the shot was given.  Redness appearing noted once yesterday.  Itche but not painful.
Rash generalizado y ampolliter. Aproximadamete 5 min derperede adminestrada 1040am DPH IM 5 mg.
Headache, Fever, NauseaVomiting, malaise chills Narrative:
No adverse effects reported/No additional AE; TE with ROTATEQ, which was supported and also administered; This spontaneous report was received from physician and referred to a 3-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot number W026137 has been verified to be a valid lot number, expiration date reported and validated as 05-FEB-2024), 2 ml, administered as prophylaxis (strength, frequency, vaccination scheme were not provided) after a temperature excursion (TE) (product storage error).
My concern is that the series of the 3 Lymerix vaccinations have affected my memory and loss of words in conversations. I would like to know if there is any information that might or might not verify my problem.
URI SX and diarrhea x 3d, no temp, rash all over body and 1 area on cheek, itchy seen in office by DR, to use Benadryl or calamine. Seen in urgent care 2/25, edema to hands/feet, using Benadryl no improvement. No distress in breathing. If rash worsen to start Oraped. No 2/28 did not use oraped child better.
This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis. Previously administered products included ENGERIX B (1st dose received in December 2017). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and the 2nd dose of ENGERIX B. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving ENGERIX B, the patient experienced therapeutic response decreased and drug dose administration interval too long. On an unknown date, the outcome of the therapeutic response decreased and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient earlier had completed the Hepatitis B series (unknown brand) and had low titers for Hepatitis B. Thus, leading to therapeutic response decreased. The patient was told to re-start the Hepatitis B series again with ENGERIX B. At the time of reporting, the patient was returning for the 2nd dose of ENGERIX B which was late than the recommended interval. Thus, it would lead to lengthening of the vaccination schedule. No further information was provided. Lab Comments: On an unknown date, the patient's laboratory test for hepatitis B antibodies titer was found to be low.
the patient is immunocompromised and wanted to get an additional dose. She already received the booster dose on 7/19/2021. She received the additional dose today and the booster dose is getting reported as an error dose.
This is a spontaneous report received from a non-contactable other hcp via COVAES. A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) flushed sensation and diaphoresis. During her 15 minute waiting period after the injection, the patient began to experience diaphoresis. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included water. Response to treatment was excellent. Patient discharged she was stable to go home and follow up with PCP. Differential Diagnosis included Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Flushed sensation. Pt observed for 15 minutes. Symptoms resolved. BG good and patient able to ambulate without dizziness, lightheaded, sob, cp. The outcome of event diaphoresis was unknown and all other event were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
female who presents to the ED with complaint of lymphadenopathy in the L clavicle one day after getting her second dose of the Moderna COVID-19 vaccination on Wednesday 4/21. She notes that the lymph node and L arm are painful. Pt reports some itchy skin as well, which she thinks started after her vaccination. She was seen by her PCP and sent into the ED for further evaluation. Pt took Tylenol earlier this morning without mild relief. Denies fever, chills, and N/V.
Information has been received from an office manager concerning a 65 year old male patient, with no pertinent medical history, no drug reactions or allergies reported, who on 28-APR-2011 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot #: 668009/1174Z, Exp: 10-MAR-2011) (Dose not reported). Concomitant therapy included LIPITOR, PLAVIX and lisinopril. The office manager reported that on 28-APR-2011 the patient developed a rash two inches below the injection site after receiving PNEUMOVAX 23. On 29-APR-2011, the patient was seen in the office and prescribed and unspecified dose of AUGMENTIN. No lab/diagnostic studies were performed. There were no other adverse events to report. At the time of the report, the patient was still recovering. Additional information has been requested.
Patient described elevated/raised redness & soreness at injection site. Also severe flu symptoms following shot. Also HSV1 outbreak following shot.
I have had an uncharacteristic, splitting headache every day since injection of varying length. Sometimes OTC pain relievers take care of it. Today the headache was severe enough to warrant a 5 mg oxycodone.
High fever, chills, sweating, excruciating headache, body aches, nausea, vomiting
This case was reported by a nurse and described the occurrence of tight feeling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(Infanrix, GlaxoSmithKline) for prophylaxis. There was no concurrent medications. On an unspecified date on or before 24 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infanrix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at a physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
10-26-10 Broke out in sparse rash - vesicular over trunk - (L) arm swollen at site.
Patient called the lab yesterday and spoke to the receptionist and the message was passed along to me.  He said that his side effects started right after the vaccine.  He complained of GI upset, headache, leg cramping and a bump at the vaccination site.  I tried calling him back twice on 11/18/21 and twice 11/19/21.  The phone went straight to VM.  I left a VM, but I have not hears back yet.  The patient told the receptionist that he was going to see his PCP that day (11/18/21).  I was unable to speak to the patient directly at the time the report was written, despite 4 attempts at calling him.
Patient came in on 11/18 in the AM and showed me her arm and showed me the site of injection.  It looked infected and I suggested she go to her MD.  The MD prescribed her an antibiotic for cellulitis.
administering expired FLUZONE HIGH DOSE QUADRIVALENT to two patients with no reported adverse event; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via  (Global Medical Information-00829494) in a specific country. This case involves a 75-years old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 26-Oct-2021, the patient received a 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Oral solution, lot number UJ443AB and expiry date 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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 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.
myopericarditis chest pain, persistent tachycardia with ECG changes, elevated troponin
This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (on an unknown date, the patient received ZOSTAVAX). On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular), In April 2018, less than a month after receiving SHINGRIX, the patient experienced hives, pain, pruritus and shingles. On an unknown date, the outcome of the hives, pain and pruritus were not recovered/not resolved and the outcome of the shingles was unknown. The reporter considered the hives, pain and pruritus to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient reported that approximately 1 week ago from the date of reporting, he experienced hives on his arms and legs. The patient stated that spots are itchy and some are painful. The patient stated that hives was growing in number and some of them looked like they were healing. The patient stated that he has never had Shingles before. The hives look like the pictures of Shingles that he had seen on the internet.
Narrative:  Pt went to her car to pick up her thing and went back to the observation. Reported of feeling lightheadedness and dizziness and shortness of breath. noted pt is breathing faster like 25. Sat down and @1505 vs: BP 120/56 HR:90 O2 sat: 96 %. Pt said she hasnt ate lunch yet and she took 2 tablets of loratidine this morning before going to work which makes her sleepy. Offered some snacks, chocolates, verified she doesn't have any food allergies. Drink more fluids and ate some food and pt said she was feeling better. @1520 VS: HR:80 BP 116/73, o2: 98% - looks more comfortable said not feeling lightheaded anymore. At 60min observation checked her VS: HR-83, BP- 119/65, o2- 98%. Pt said she called her son and will picked her up in 30 min. Called transport and wheelchair to go to cafeteria and have waited for her son to pick her up VS are WNL.
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who received 0.5 ml third dose of ACT-HIB (lot UI908AA, expiry date: 10-Nov-2019) via intramuscular route in the right thigh (leg) on 23-Jul-2018, which was incorrectly reconstituted. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PEDIARIX for Immunisation; and PREVNAR for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that ACTHIB dose that was reconstituted with room temperature sterile water instead of the refrigerated diluent that comes in the Box. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
COVID+ 12/28/2022.  Vaccination status - pfizer x3 _ Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: PRIVATE MD Primary Care Provider: PRIVATE MD Admission Date: 12/30/2022 Discharge Date: 01/02/2023 Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE: The patient is a 73-year-old male with history of Pompe disease, ischemic CMP, CAD, systolic heart failure, Afib on Eliquis, COPD, HTN, and anemia who presented with nasal congestion, cough, and shortness of breath.  His symptoms started 12/26 and he tested positive for COVID 12/28.  In the emergency department his oxygen dropped to 84% with ambulation.  Chest x-ray was without an acute process.  He received 1 dose of IV steroids and albuterol.  He was admitted to the hospitalist service.  Steroids were continued on admission.  His symptoms improved and he was evaluated for home oxygen, but did not qualify as his oxygen saturation remained stable at rest and with activity.He had clinically improved on the day of discharge and was discharged home in stable condition. Decadron was stopped as he was on room air and he felt it was not allowing him to sleep at night. He was advised to follow up with his PCP within 5 days of discharge. He also will need to reschedule his infusion of Nexviazyme which he missed this am while hospitalized.
Receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Unknown medication was taken as concomitant   No treatment medication was provided.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 14-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
PT RECEIVED VACCINE AT APPROX 12:30 PM IN LEFT ARM. STATED HE STARTED HAVING LEG PAIN IN THE FRONT OF HIS LEFT LEG AR AROUND 6 PM. THE PAIN RADIATED FROM HIS LEFT KNEE UP TO HIS WAIST. HE STATED THE PAIN WAS WORSE WHEN SITTING DOWN AND REACHED A PAIN SCALE OF 9. HE TOOK NO MEDICATION FOR IT UNTIL 9:00 THE NEXT MORNING HE TOOK AN ALEVE WHICH DECREASED THE PAIN. THE DOSE WAS REPEATED AT 9 PM AND AGIN THIS MORNING AT 9:00 AM. HE STATED HE STILL WAS HAVING PAIN IN THAT AREA. IVO C/O PAIN OR FEVER ELSEWHERE. (CLIENT WAS ADVISED TO SEE A DR.)  NOTE: ALSO WENT LATER IN THE DAY TO HOSPITAL IN TO GET PPD SKINTEST.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 during a social event. I tested positive for COVID-19 in 04/2023. I felt pretty bad for a couple days. I took over the counter medications to help with my symptoms.
Patient got shot on 9-18-20.  He stopped in on 9-21-20 to report still very painful and having some difficulty moving it
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-NOV-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of atypical herpes zoster. About four days after being vaccinated, the patient begun to breakout in bilateral blistering vesicles on his lower extremities while on vacation. The vesicular outbreaks bread and worsened in severity until lesions had covered nearly his entire body. On or about 02-JAN-2016, upon returning home from travel, the patient was treated by a physician which affirmed the diagnosis of severe herpes zoster or shingles. The patient continues to be afflicted by neuralgia pain from his extensive zoster infections. The patient has been prescribed prednisone and phototherapy for treatment of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tasted medicine in mouth; Felt weak; Felt like throat was closing; Felt blurry; Hardly could breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Psoriasis (Patient takes the injection for Psoriasis).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Tasted medicine in mouth). an unknown date, the patient experienced ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath). At the time of the report, DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath) had resolved.            Two days before the vaccine, patient has taken injection for psoriasis.  No concomitant medications were reported. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded