chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; worst flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu vaccine once. That year, the patient experienced the worst flu. The patient neither had the flu nor would again. It was all for money. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
No Additional AR reported; 19 months old infant was accidently administered a dose of both PROQUAD and VARIVAX; This spontaneous report was received from a nurse referring to a 19-months-old patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.   On 15-DEC-2021 the patient was accidently vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, Lot# and expiration date were not provided) for prophylaxis on same day (accidental overdose). Nurse unwilling to provide any more information. No further information provided. No additional AE or PQC reported.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 08-MAY-2012 the patient was vaccinated with first dose of GARDASIL (0.5ml, intramuscular) (lot number unspecified0. The patient would receive her second dose of GARDASIL on the reporting day, on 06-MAY-2013. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
patient has a history of fainting. He received the covid shot and fainted approximately 7min afterwards. blood pressure was 138/88 pulse 59. He recovered fully after sitting down for 20min
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
dizziness; weakness; fatigue; muscle pain; nausea; stomach ache; loose bowl movements; arm hurting at injection site; red arm; tender arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), VACCINATION SITE PAIN (arm hurting at injection site), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided
Patient called office on 11/21/2017 stating she was experiencing " extreme tendon/ligament fatigue" of her right arm. She stated  "It is like when you paint or rake leaves...but it is not a muscle soreness".  She said pain radiated from injection site to right elbow. She stated injection site "did not have a lump or heat".  Patient denied any skin discoloration of her right arm.  She stated discomfort started 2-3 hours post injection, and became worse during the night. She said she took 650 MG of Tylenol X1. Patient  stated " I don't know if the Tylenol helped or kept the pain from getting worse." She said ice helped. She said she was able to perform good ROM this am. She said arm felt better this am but became sore with movement. I asked if she had any other side effects. She stated "I felt like I could not get warm last night, but I didn't take my temperature". I recommended that she call her MD this am. She stated "I'm not going to call my MD over a boo boo". I told her she experienced an unusual response and that it is best for her to contact her MD today. Patient gave me permission to contact her for follow up. 11/23/2107 10:30 am. I contacted patient. She stated she " felt much better now". She stated she was experiencing "better range of pain free motion". She reported she still has some discomfort with reaching and twisting her right arm while putting it into a sleeve. She states she felt tired and achey yesterday. She continues to deny any discoloration or raised areas at injection site. She states she did not notify her MD of right arm pain, stating she felt "silly". I said she had an unexpected reaction and that she should notify her MD today.
During monitoring post vaccination, pt reported reddened hands.  Pt assessed BP 140/83, HR 88, pox 97%  Symptoms progressed to itchy throat and tongue, itching on her head and body No obvious hives on chest/ back. Discussed with pts PCP given oral diphenhydramine 25mg x 1. BP 124/63, HR 78, Pox 97%   Given at 1015 for persistent symptoms of itching. By 1030, pt reported improvement in symptoms and VS remained stable.  BP 126/ 64, HR 79, Pox 96% RA @ 1040.Pt went  home with her son, who purchased Benadryl to have at home and pt will follow-up with PCP next day. Pt did have 2nd vaccine on 06/05/2021 without difficulty
No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02476362). No additional AE/PQC. Product Name: PROQUAD-- SUPPORTED Lot: X014622 Exp: 11/1; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 15-SEP-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X014622 and expiration date 18-NOV-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 4 Hours 15 Minutes 0 Seconds in temperature -14 Celsius degrees (°C) up to-10°C and for 7 Hours 45 Minutes 0 Seconds in -8.33C / -10°C up to 8°. Total duration was 12 hours.
Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transported to nearest ER.
Initially, sides of tongue felt numb.   Then, while driving home, at about 20 minutes (9:05 am), my face felt numb and weak and possibly swollen.  Most of the numbness went away after about an hour.  Tongue felt normal at about 1.5 hours.  I took a benadryl and some tylenol at about 1.5 hours post-vaccine.
Chills, muscle pain, hard to raise my arm,  terrible headache then I got shingles. Went to urgent care and taking generic for Valtrex for 10 day supply. The shingles is on the same side as the shot. On my shoulder, collar bone and chest, on my back. The doctor even said it stops in the middle of my back. It's very uncomfortable and painful.
Pt hospitalized with COVID19 on 9/5/21.  Transferred to another Hospital. She initially presented with SOB on 9/2, and was found to be COVID-positive. Currently hospitalized on BiPap.
Left arm - noted severe redness, erythema, tenderness & swelling Recommended ice packs to area & MOTRIN
He had the vaccine, had gravely scratchy sounding voice that does not go away, and swollen glands which he felt was due to allergies on the right side and lump on the right side of his throat which appeared on 4/25/21.   He has called an ENT and has an appointment tomorrow to see about that nodule that he has.
Injection received 8/24/21 around 1600. On 8/25/21 at 0700, chest pain and tightness (3/10) begins and anxiety begins to set in. 0830,  anxiety is significantly increased, palpitations noted. Chest tightness is 5/10, tachycardia, back pain 5/10,  lymph nodes to left axilla and clavicle are large and tender. 0930, now in Emergency room. Back pain 7/10, chest tightness increased to 6/10.  From 1100-2100, (post discharge from hospital), fever 101.9, fatigue, weakness, and lymph node swelling and tenderness. From 8/25/21-9/3/21 lymph node swelling continues, difficulty raising left arm without causing significant pain, as well as fatigue.  8/25/21- 10/31/21- significant shortness of breath upon mild exertion resulting in difficulty performing  normal tasks.
Pain at injection site - right arm deltoid region. Began after injection on 10-23-12 until reported 11-7-12. Referred to primary care physician for treatment.
Patient called me Friday evening  and she her arm was really sore. I said it's a possible side effect and to put ice on it and use a pain reliever of your choice. I also told her I know it hurts but try to move it around as much as possible. I told her I would follow up with her on Monday. I called patient on Monday and she said that it was better than it had been on the weekend but still really sore and it hurts so bad to move that she has limited range of motion. She said if no better she was going to call her provider on Friday. She was concerned I gave the shot too high up and I told her I did give it in her deltoid. She was also concerned I hit a nerve. I told her I would follow up with her on Friday.
SHINGLES facial:  requiring oral acyclovir and ophthalmological abx.
Autoimmune hemolytic anemia was the admission diagnosis to the PICU.  Patient needed a blood transfusion due to a hemoglobin of 5.5 in the ER which dropped to 4.5 prior to the blood transfusion and admission to intensive care unit.  He started getting "run down" a few days after his MMR vaccine.  I can't remember the name of the doctor at the time of vaccination but this can all be verified by his current pediatrician.
had flu shot 27OCT92 had difficulty walking & facial paralysis on 16NOV & was hospitalized; initial dx GBS;
body aches, fatigue for 24 hrs; body aches, fatigue for 24 hrs; This is a spontaneous report from a contactable Other HCP. A 26-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL/284), via an unspecified route of administration on Right Deltoid on 11Jan2021 (Age at Time of Vaccination: 26 years) at single dose for COVID-19 immunization at hospital. The patient Medical history included ongoing allergies to Augmentin, strawberries, bananas from 2002. It was reported that patient was not deceased.Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as not applicable and there was no events following prior vaccinations. Family Medical History Relevant to adverse events was reported as not applicable.The concomitant medications included Cryselle from Mar2014 (daily dose and regimen including Formulation, Route, Frequency: Daily Tablet) for menses regulation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EJ/685), via an unspecified route of administration on Right Deltoid on 21Dec2020 at single dose for COVID-19 immunization. On an unspecified date after second dose, the patient experienced body aches, fatigue for 24 hrs. It was reported that reaction recurred on re-administration of product. The events resulted in Emergency Room or Physician Office. The relevant lab tests was reported as none. The patient was not required any treatment for the events. The outcome of the events was resolved.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to a pediatric patient of unknown age. On 22-APR-2013 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported) rather than VARIVAX (Merck). On 22-APR-2013, the pediatric patient was inadvertently administered ZOSTAVAX rather than VARIVAX (Merck). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Shortness of breath; Coughing up bright colored phlegm; Feels terrible; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SPUTUM DISCOLOURED (Coughing up bright colored phlegm), FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), SPUTUM DISCOLOURED (Coughing up bright colored phlegm), FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), SPUTUM DISCOLOURED (Coughing up bright colored phlegm), FEELING ABNORMAL (Feels terrible) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Episode of rapid ventricular rate  in the setting of known paroxysmal atrial fibrillation
Caller reports that people she knows got sick from moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Caller reports that people she knows got sick from moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ILLNESS (Caller reports that people she knows got sick from moderna vaccine). At the time of the report, ILLNESS (Caller reports that people she knows got sick from moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.     This case was linked to MOD21-070412, US-MODERNATX, INC.-MOD-2021-068360, US-MODERNATX, INC.-MOD-2021-068394 (Linked Report).; Sender's Comments:  MOD21-070412: US-MODERNATX, INC.-MOD-2021-068360: US-MODERNATX, INC.-MOD-2021-068394:
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (lot# not reported).  Subsequently the patient experienced injection site reaction after GARDASIL vaccine was given.  The patient had redness, swelling and tenderness for two days.  It was unknown if the patient sought medical attention.  At the time of the report, the outcome of the patient was unknown.  No further information is available.
31 year old female who presents with right lower abdominal pain that started last night and radiates into her right flank. She states she has "passed out" a couple of times at home due to dizziness and lightheadedness. She c/o headache, nausea, diarrhea, vaginal bleeding, and generalized malaise. Her periods have been irregular for the last couple of months and has been doctoring with OB/GYN without answers. She has had frequency, urgency, dysuria, and odorous urine for at least days with associated flank pain. She has tried to increase her fluid intake without improvement of symptoms and has not seen anyone for this. She took ibuprofen 800 mg approximately 4 hours ago.   Sent home with meclizine for the dizziness.    Reason for Visit  Abdominal Pain  Diagnoses  0 Strep pharyngitis 0 Dizziness 0 RLQ abdominal pain 0 Nausea 0 Malaise 0 Sore throat
Systemic: Swelling in Armpit area around lymphnodes about the size of golf ball. Start 48 hours after shot-Medium, Systemic: Lymph Node Swelling-Medium
child fussy on 24NOV98 p/vax given & then had fever 25NOV98 brief sz;pt got blood cult & urine cult;pt was wheezing so given med;sent home but came back w/another sz & adm 25NOV98 until 26NOV98;came back later w/fever-looked good sent home
One day after my vaccination, I have bounding,  fast heart rate of 102-106 BPM.  It's more than 24 hours now since I was vaccinated.
Inflammation; Have to stay in bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    The patient's past medical history included Inflammation (Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot) and Pain (Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot).   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed). At the time of the report, INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed) outcome was unknown.     Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot. Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with her joint pain.   No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624992, MOD-2021-624995 (Patient Link).
eyes weepy, runny nose, sneezing, welt on rt arm size of nickle not where shot given; t102 underarm mom giving APAP, fussy but quiets when picked up; no appetite; called MD about taking Robitussin for runny nose-threw up this AM diarrhea;
injection site redness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had injection site redness. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Information has been received from a registered nurse and a consumer concerning a 10 year old male with no pertinent medical history who on 09-JUL-1998 was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 625047/1574E). On 15-OCT-2007, the patient developed chickenpox. On 18-OCT-2007, the parent of the child contacted the school nurse stating the child had chickenpox lesions on the back, abdomen, face, arms and legs, which the nurse described as severity level 1 (50-100 lesions) (reported by nurse as varicella outbreak post vaccination with varicella virus vaccine live (Oka/Merck). It was unknown if the child had a fever. Treatment was also unknown. On 02-NOV-2007 via follow-up the child was noted to be recovering and had less than 50 lesions. There was no product quality complaint. This is one of four reports from the same source. Additional information has been requested.
Soreness in that arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in that arm) and FATIGUE (Fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0032C (L or I) A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced MYALGIA (Soreness in that arm) and FATIGUE (Fatigue). On 11-May-2021, MYALGIA (Soreness in that arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE  PROVIDED.