chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches and pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of PAIN (Body aches and pain) 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.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (Body aches and pain). At the time of the report, PAIN (Body aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose). At the time of the report, product dose omission issue (missed 2nd dose of Moderna vaccine/passed 42 days after the 1st dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Shortness of breath, pulmonary emboli, deep vein thrombosis (DVT) in leg
A nurse reported that a 14 month old female received either Acel-Imune or Tri-Immunol and MMRII vaccines on 12/16/1996 and developed "mental status changes" approx 1-2 hrs post-immunization. This event continued for approx. 7-10 days.
Patient complains of pain at injection site, pain with range of motion and limited range of motion left arm.
Post vacc, pt c/o dizziness, pale, advised to lower head, wet towel applies to head.  BP 78/p, transportated to table in wheel chair. 9:25, bp 88/p lying down. 9:30, bp 94/68, temp 95.6. 9:35 bp 104/84. 9:45 bp 120/70. 9:50 bp 104/64.
Severe headache, Hot flashes, Cold symptoms, High fever, Body Aches, Diarrhea, Vomiting, Dry heaving, Dehydration, Lack of appetite, and Suicidal thoughts. I am now seeing a therapist, who prescribed me anxiety and depression medication. I have never experienced suicidal thoughts before ever in my life.
This spontaneous report as received from a Nurse refers to a female child patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous unspecified which thigh that which was improperly stored. No adverse effects reported. No further information was provided. Additional information is not expected.
had side effects following administration; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that they had lots of friends who received Shingrix and some had no side effects and others had side effects following administration. No additional information was available. The case has been linked to the case US2020005553 and US2020005549 reported by same reporter.
HIB component of Pentacel was mixed with normal saline instead of the diluent it came with the box with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a unknown demographics patient who received HIB component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] mixed with normal saline (lot: not reported, expiry date: not reported), via unknown route, on an unknown date for prophylactic vaccination (product preparation error).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Wrong diluent used. It was reported that HIB component of Pentacel was mixed with normal saline instead of the diluent it came with the box and received by patient.  At the time of reporting, the patient had no adverse event.  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.
Within 3 hours, post vax, the pt developed urticaria and a low grade fever of 100.3F. The next day the urticaria was more extensive. Unspecified medical attention was sought. Additional information has been requested.
Previously healthy 4 month old infant had generalized tonic seizure approximately 60 hours after receiving Pediarix, HIB, Prevnar. Lasted about 5 minutes; resolved spontaneously. Afebrile at the time. Hospitalized 1 day. CT head negative, EEG normal, Blood chemistry was normal. Second seizure occurred 11/20/03 (5 minutes - tonic). Patient started on Tegretol. Next seizure occurred 1/14/04. Two more seizures occurred 2/29/04. Patient re-admitted to hospital. EEG again normal. Blood chemistries normal, metabolic work up negative. Patient seizure free since 2/29/04. Remains on Tegretol. To date, no definite etiology for seizures has been determined.  Nurse follow up on 06/18/04 states: "ADD: Arm stiff, vomiting, staring."
Developed flu-like symptoms, body aches, significant fatigue, fever of 100.6.
Headache, Myalgia, Fever, Chills, Fatigue, Injection site pain Narrative:
The arm that the patient received the shot in was a little sore (typically like a shot).  She had slight bodyaches on the morning of 10/6 and also slight aches in her legs.  She was okay on 10/6.
upset stomach; I am still dizzy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fall (had a history of falling in the last few years).   On 20th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced upset stomach and dizziness. On an unknown date, the outcome of the upset stomach and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix two days ago (from the day of reporting) and still felt dizzy and had upset stomach. The reporter asked if anything could do to cure the dizziness.
Vaccine FLUZONE 0.25mg, lot UT4159CA exp 6/30/12 administered 10/11/11 130pm. 3AM 10/12/11 mother heard child whimpering-seizure lasting 5 min. Temp 102. EMS called transported to med center for observation. No treatment, released to home.
Pregnant at time of shot, 26 weeks. Preterm Premature rupture of membranes happened on after shot. Contractions and labor started and baby was born at 26 weeks 3 days.  Hospitalized from 02/28/2021- 03/06/2021
Immediately after vaccination patient reported feeling lightheaded, diaphoretic.  Witnessed syncopal episode in bay (no head trauma),  assisted to recliner by vaccinator.   BP 90/80 at start of event.  Given Gatorade and crackers with minimal effect.  15 minutes after treatment BP 80/70 and administered O2 via nasal canula.  Transported via wheelchair at 12:06pm.
mom states closed eyes very tight, no movement of body, no facial expression as if not responding for approx 1 min; then very fussy for short time;
Had fever of 102 since 5:30pm yesterday. Headaches, chills, and body aches
Swelling in arm around injections site. Patient is going to take an ibuprofen and ice the area.
Fever (104) reduced with acetaminophen, but resumed, red/warm/pain at injection site, arm is swollen and slightly hard/firm to the touch.
Information has been received from a registered nurse concerning a 10 year old female who on 28-OCT-1996 was vaccinated with a dose of Varivax (Oka/Merck) (lot # 617908/0777D). On an unspecified date, the patient developed a generalized rash with 50 to 200 lesions. It was unknown if the patient had a fever or cough. It was unknown if the patient sought medication attention. No further information is available.
Redness and blistering at site of injection approx. 2 to 3 day after administration of vaccine.
After administration of ROTATEQ vaccine patient became dusky, cyanotic and pulseless. CPR initiated and this lasted for approximately 5-6 minutes before patient started breathing & had a pulse. Was transferred to PICU after the event. 2-3 drops of ROTATEQ given to right side of cheek prior to choking. The rest of the vaccination was disposed of.
I began experiencing itching in my hands and feet in the 2-3 days after the vaccine. Around the 4th day after the vaccine, I experienced all over body itching. The itching has not subsided.
Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001253: US-009507513-2104USA001254:
On 5/20/21 patient arrives to hospital via EMS for leg pain and numbness. Left lower extremity cooler to the touch.  Unable to palpate pulses.  Unable to Doppler pulses.  Cap refill is slow, around 3 to 4 seconds.  Patient reports he is unable to feel a sensation.  Able to wiggle toes. 5/20 CT angiogram reveals dissecting aneurysm. 5/20 COVID-19 positive 5/20 cardiothoracic surgery : MEDIAN STERNOTOMY for REPLACEMENT, AORTA, ASCENDING (HEMASHIELD PLATINUM 34MM), AND TEE Intubated or the surgery and of typical uration post-operatively On high flow NC oxygen  Critical care MD notes: Not symptomatic due to COVID No COVID treatment(s) were ever needed. Discharged to home
40 mins (3:10 pm) after injection, Hands started feeling like they were on fire, discolored, veins over thumb areas were enlarged and swollen. Swelling went up to forearms. Face was flushed and started to swell. Feet initially swelled and then became numb and cold. Went to ER as I'm anaphylaxis to Benadryl. Was given 125mg of IV steroid and 40 mg of IV pepcide @ 3:45pm. Allergic rxn symptoms subsided within 20 minutes of medication. Was given a 3 day dose  take 60 mg of Prednisone.
DTaP and MMR given right arm 6/8 IPV given 6/8 left arm. 6/9 at night, right arm red and swollen (shoulder to elbow).
3-24-21 6:20PM PT STATES SHE FEELS LIGHTHEADED, SWEATY, HEART RACING'. STATES SHE IS 'NERVOUS ABOUT GETTING SHOT AND WAITED AN EXTRA HALF HR' AFTER HER WAIT TIME. A/O, PINK, W/D, RESP WITH EASE.  6:25PM PT STATES SHE 'FEELS BETTER'. HUSBAND HERE TO DRIVE PT HOME. GAIT BRISK AND STEADY.
severe generalized burning type pain; occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "other autoimmune diseases" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back.". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: It was also reported that symptoms occurred 6-7 days after the injection on both occasions. Patient had minimal symptoms with the 2nd, 3rd and 4th doses. These symptoms are unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD). No concomitant medication was reported. It was unknown that the patient ever got COVID-19. BUD date was given as 23-Jun-22. No treatment information were provided. This case was linked to MODERNATX, INC.-MOD-2022-599989 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-599989:Master case
Episode of atrial fibrillation, heart rate 140, irregular at 1:00 AM. Called cardiologist and took metoprolol 25 mg at 2:00 AM.  Awoke at 7:00 AM and had converted to normal sinus rhythm, heart rate 58.
6.5 cm long  by 8 cm wide erythema & warmth ant/lad @ thigh.
pt recv vax 22SEP97 & the same day pt became irritable & was difficult to nurse;the next morning pt became limp & did not move any extremities;pt had a blank expression on face & father thought pt died;
My husband has tested positive for COVID-19 and I started having a sore throat, a headache, and fatigue. I took a COVID-19 home test, and it was positive. I did reach out to my health care provider but at that point it was too late for me to get on PAXLOVID. I did feel better in a few days but a few weeks later I was having the bad headache again which lasted about a month. This was accompanied with some extreme fatigue and dizziness.
drowsy; sore arm; abdominal pain; fever; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 29-years-old female patient received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:00 (Batch/Lot Number: EH5318, Expiry date was not reported) (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunization at hospital. Medical history included asthma. There were no known allergies. Concomitant medications included senna alexandrina leaf (BLACK FOREST HERBAL TEA, Herbal Tea for fertility), start and stop dates were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. The patient did not have covid prior to vaccination and has not been tested for covid since vaccination. On an unspecified date, the patient experienced drowsy, sore arm, abdominal pain, fever and chills. It was reported as the day the patient got the vaccine, she was drowsy and had a sore arm until Sunday. She was fine until Tuesday and started having abdominal pain and fever/chills. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
pt felt light headed and sat down on the floor. He was attended quickly by an rph , checked for signs and symptoms , pt was talking all the time,, paramedics were called. he was given fluid (gatorede) as he mentioned not having enough food / fluids through out the day, paramedics came and checked the vitals , he was alright and refused to go with paramedics. He sat for a while after, ate some food and left with an uber
Patient was given 2nd Hep A vaccine. Patient discharged from clinic however around 1230 mother called clinic reporting patient was having severe arm neck and back pain. Per dr, mother advised to return to clinic with patient. Imed on site within normal limits however patient continued to complain of severe pain. Patient was given ibuprofen 400 mg, lorazepam 0.5 mg po and observed in office for 3 hours then discharged home. Mother contacted next day on 8/8/15, stated still has pain however very minimal and doing much better.
I noticed a very large swollen Lymph Node under your right arm and I immediately went to Doctor after receiving email her (ask me to come in). She acknowledged that it was very large and said that it should go down but if it didn't go down she would need to see me again. My Doctor let me know that from some literature that it could be a side effect.
child received an expired dose of the IPOL vaccine with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who received an expired dose of the ipol vaccine with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot R1F971M via intramuscular route in unknown administration site.  On 25-JAN-2022 the patient received an expired dose of the ipol vaccine with no reported adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (child received an expired dose of the IPOL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event child received an expired dose of the ipol vaccine with no reported adverse event.  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 the 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.
I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the first covid vaccine moderna 29 may 2021 and the second dose 24 july 2021) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Admitted with COVID pneumonia. Treated with steroids, remdesivir, zinc, vit-c, singulair, O2, merrem. Discharged home with O2.
Case received from a healthcare professional in the USA on 14-NOV-2005 (MIS/VIS # 05-0660). A 10-year-old female patient had received an injection of FLUZONE with preservative (lot unknown) in OCT-2005. She developed (latency not reported) a local reaction with swelling, skin peeling and scaling. The patient had had three prior flu immunizations without any problem. Patient's recovery status not reported. Follow-up information received on 20-MAR-2006. Per the responsible physician the patient received FLUZONE, lot number U1846AA (expiry date 30-JUN-2006) on 10-OCT-2005. Patient recovered. No further information is expected.
C/O FEELING DIZZY, CLAMMY AND DIFFICULTY BREATHING; LOW POTASSIUM DIAGNOSED IN EMERGENCY DEPARTMENT OF LOCAL HOSPITAL; PT DISCHARGED ALIVE.
Headache, Myalgia, Fever & Syncope Narrative EH visit. She says she passed out 27 hours  after the vaccine. Fell out of chair, hit ribs.
started to have pain & severe soreness approx 1 1/2hr p/vax;by 5PM arm felt heavy & painful to lift;erythema & swollen lt deltoid involving entire upper arm by 730PM;ice applied;