chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is here today for a possible vaccine reaction. She was seen two days ago for her well visit, at which time she received ProQuad in her RT and Quadracel in her LT. Mom states that she has a half dollar size raised red bump on her left thigh. She c/o pain when it is touched as well as a low grade fever. Her fever peaked at 101.2, but she has been afebrile today. Mom denies known exposure to illness. ,  Above documented HPI reviewed and verified. Additional history obtained by MD: confirmed that area of redness larger today than yesterday. Redness started within 24hours of immunizations. had a little limp the first day but has resolved. had temp 101.2 after vaccines but has been afebrile for over 24hours.
this is one of four patients to devel an inj site rxn characterized by pain, swelling, & redness following vax;pt recovered p/being treated w/DPH & a Celestone inj;
Patient developed pain in right arm on 11/5/2021 with soreness that crossed over to left arm.  Red big square noted and was raised and swollen.  Referred to personal doctor or urgent care.  Daycare sent her to Urgent care facility. She was evaluated and placed on Septra 800/160mg one tablet every 12 hours by mouth x 7 days.  She was advised to drink plenty of fluids and take medication with food.
Raging headache all thru the night until 11am, weakness like I am going to pass out if I stood up much longer, severe muscle aches in back, legs, and arm
Moderate pericardial effusion. Asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 12Jan2021 10:00 (Lot number: EL1284) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergies. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), (administration date reported as "22Oct2020"), when the patient was 61 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. He had not been tested for COVID-19 since the vaccination. The following information was reported: PERICARDIAL EFFUSION (medically significant) with onset 01Feb2021 16:00, outcome "unknown", described as "Moderate pericardial effusion. Asymptomatic". The event "moderate pericardial effusion. asymptomatic" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pericardial effusion with antibiotic, NSAID, omeprazole, and colchicine.; Sender's Comments: Based on the currently available information the possibility of causal association between the event pericardial effusion and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received regarding a case in litigation from a consumer concerning her son who on an unspecified date was vaccinated with PEDVAX HIB (OMPC) (lot #646153/0342N), VARIVAX (Oka/Merck) (MSD) (lot # 648751/0447P) and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD) (lot #645522/0780P).  Subsequently the patient was diagnosed with autism.  Upon internal review, the patient's autism was considered to be an other important medical event.  Additional information is not expected.
Started with skin rashes on multiple locations with itching. There is no respiratory reactions.  Treated with over the counter Benadryl 2 tablets total of 50mgs once a day, skin rashes and itching recurred everyday until today 02/11/2021. No other symptoms. No doctors visit.
onset of symptoms around 1:19pm (shot administered at 1:04pm), lightheadness. dizziness, chest tightness, fast heart beat, cold extremities, shakiness on extremities
Fever; chills; soreness and swelling at injection site; headache; Lt. side neck pain; fatigue / achy.
Redness; This case was reported by a physician via call center representative and described the occurrence of erythema in a 63-year-old female patient 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 erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness for three days after receiving Shingrix and it was getting larger, not recovered. The batch number and expiration date were not available since the physician did not call from the facility were the vaccine was administered.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.  No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The Dose administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022. The vial did not undergo any temperature excursions. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, contains reporter details was updated.
Hospitalization for TIA, and tested positive for COVID-19 on dates 8/25/2022-8/27/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Severe skin rash covering the entire torso (stomach, chest, neck, back, shoulders), and both forearms that started 1 week after the 2nd dose. Two different doctors diagnosed it as Pityriasis rosea, and prescribed a 12-day regimen of Prednisone. Rash looks like red, raised bumps all over the skin.
Case fully vaccinated with Moderna. Second dose administered on 4/23/2021. Tested positive for COVID on 10/12/2021. Admitted to Medical Center on 10/21/2021 and expired on 10/27/2021 while still hospitalized.
Patient was seated in post-vaccination area and informed RN of severe dizziness.  RN referred patient to EMTs and patient was taken to observation room for further evaluation and care.  Patient was placed in stretcher in a semi-Fowler's position and was given water to drink by EMTs.  Vital signs were obtained:  HR 105, RR 16, BP 121/76 mmHg.  Patient was awake, coherent, but complaining of severe dizziness and nausea.  She felt her condition was worsening and agreed to be taken by ambulance.
incomplete administration of QUADRACEL; Initial information received on 18-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves a 4 years old female patient who experienced incomplete administration of quadracel while receiving vaccine diphtheria-15/tetanus/5 hybrid AC PERTUSSIS/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 16-Mar-2022, the patient received suspect diphtheria-15/tetanus/5 HYBRID AC PERTUSSIS/IPV (MRC5) vaccine at an unknown dose once (lot C5862BA, expiry date: 01-Apr-2023, strength, form: not reported) via intramuscular route in the left vastus lateralis for Immunisation.  On 16-MAR-2022 the patient developed a non-serious event of incomplete administration of quadracel (incorrect dose administered)(latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was reported that she said that the needle detached from the hub during administration so they were unable to know the dose that was given.  Action taken: not applicable.  Outcome was Unknown for the event incomplete administration of quadracel.   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.
Significant local swelling and Erythema. Immunization about 10cm dia induration from erythema.
sick; Initial information was received on 15-OCT-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via media.  This case involves a patient (age and gender unspecified) who was sick (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient reported that, a year ago, It was mandatory to take it where consumer worked, had to be out sick for a week every year.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments:  SanofiPVPortal20210218000264: SanofiPVPortal20210218000293: SanofiPVPortal20210218000303: SanofiPVPortal20210218000328: SanofiPVPortal20210218000339: SanofiPVPortal20210218000353: SanofiPVPortal20210218000372: SanofiPVPortal20210218000382: SanofiPVPortal20210218000399: SanofiPVPortal20210218000423: SanofiPVPortal20210218000436:
Breakthrough case admission after 5 vaccines Moderna 2/11/21 Lot# 015M20A;  Moderna 3/11/21 Lot# 044A21A;  Moderna 10/27/27 Lot# 032F21A;  Moderna 4/15/22 Lot# 033K212A;  Moderna 10/24/22 Lot# 050D22A
t103 18 days p/vax 16MAY97 hives over body/non itchy began when afeb 19MAY97 PM;DPH has dec urticaria, cont to have visible flat red rash;
Pt c/o dizziness.  BP 103/84, HR 90, RR 16.  Pt stable and released from the vaccination site.
I had a cold, congestion, runny nose. The reason I went to urgent care, it turned into a pretty harsh cough. Needed treatment for relief. Physician said my lungs sounded fine. She said prescribed Prednisone and Benzonatate. Those are helping me with symptoms. I am still taking those meds at the time.
States that she was feeling dizzy and nausea. Patient states has a history of Vasovagal syncope and usually gets like this after having a shot, and that she was a little anxious getting the second shot since so many people told her is makes them sick. Patient was assessed by nurse and EMT, BP 86/39, P74, R22, was put in lying position on stretcher and BP was monitored closely. 16:19 BP 118/78 P64 R20 patient states feeling well and is ready to go home., was escorted by nurse and EMT to vehicle at 16:25, no problems noted.
Runny nose; Achy; A stuffed nose; Patient felt run down, Tired; Received a bivalent booster dose instead of a Moderna monovalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine). At the time of the report, RHINORRHOEA (Runny nose), PAIN (Achy), NASAL CONGESTION (A stuffed nose), FATIGUE (Patient felt run down, Tired) and WRONG PRODUCT ADMINISTERED (Received a bivalent booster dose instead of a Moderna monovalent vaccine) was resolving.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received a bivalent booster dose instead of Moderna monovalent vaccine. Patient had not received any other vaccines and no previous vaccine received within 4 weeks prior to COVID-19 Vaccine.  Treatment information was not reported.
starting friday april 9th 2021, after patient recieved vaccination she has had a headache on the left side of her head. the headache has been continuous and is not relieved by pain medication
The pt received vaccines on 10/10/00. On 10/16/00 the pt ran a low grade fever of 100.9, and developed hives and urticaria. No other symptoms were noted.
Fever, headache, neck pain, lethargic, confusion, dizziness, weakness.
Eleven year old patient was given 2 dose adult Pfizer instead of pediatrics Pfizer.
dizziness, Nausea, Heachache, muscle spasm at injection site.
Body aches and pains progressing to fever that peaked on 02/05 at 11 PM. Aches persisted as well as a low grade fever for three days. Extreme pain on the injection arm was also present for nearly two weeks.
Patient was given Covid 19 vaccine at approximately 1730. Patient notified us that "my throat feels itchy". I went into the patients room to take vitals while contacted Rapid Response Team. They responded immediately and patient was assessed and taken to Urgent Care to be further evaluated. Patient administered Benedryl and discharged.
Headache; Chills; Sore lymph node in breast on the side vaccine was given in arm.; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Dec2021 at 16:00 (Lot number: unknown) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 15:00), administration date: 06Apr2021, when the patient was 58 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 16:00), administration date: 27Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 at 16:00, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Chills"; LYMPH NODE PAIN (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Sore lymph node in breast on the side vaccine was given in arm". Therapeutic measures were not taken as a result of headache, chills and lymph node pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; Mild headache; Nausea; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer COVAX US Support study programme (CEP ID: 159558). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173/Batch number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 on an unspecified date in Jan2021 (when probed if consumer had COVID before taking the COVID-19 Vaccine, consumer stated, "Yes, before getting the shot in January"). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8735/Batch number was not reported), dose 1 on an unspecified date, for covid-19 immunisation. On an unspecified date, the patient experienced fever, mild headache and nausea. The consumer stated that: he is experiencing symptoms starting yesterday, it's fever, mild headache and nausea. He is just asking if these are the possible reaction from the second dose or if he has COVID-19 Vaccine again. He was wondering it's because he had the second dose about 15 days ago and he was wondering if it's possible that the symptoms are due the reactions of that vaccine or is more because he had COVID before when he got two shots so, reporter wondering if it's possible to that he gets COVID again (Consumer was unsure) or it's just a reaction from vaccine". Consumer wanted to know if it is possible that it's a reaction from the vaccine since he got the second dose 14 days ago but he hasn't seen anything online that states that you can still get reactions far away from when you get the shot. The consumer did not provide product details (Expiration date, NDC#, UPC#) and other details were unknown. The outcome of the events was unknown. Limited information was available over the call.
Blood in Urine; Chills; High fever; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded  No Concomitant Medicines were provided No Treatment medicines were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-076605 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient Demographics updated. Added four New Events Arthralgia, Fatigue, Chills, Pyrexia. Added Details of Second dose. Action taken with the drug was Updated from Unknown to No Change.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-076605:First dose
Very odd deep muscle pain in different parts without moving, walking or anything.  Primarily happening in my right leg, my right hand and my left hand.  The pain is strong but lasts half a second.  It is a strong deep pain in the muscles but in small area.   Strange sensation.   THis started today which is the second full day after the shot.   THe first day until today I had pain on the vaccine site but that I expected.  It has diminished substantially from the first day.    Hopefully, the deep muscle pain in different parts will go away soon.  Just reporting it because it is a very odd sensation and very unexpected when not even in doing any movement.
Approx. 5-10 minutes following injections as pt was leaving in hallway, mother brought pt back to clinic area for concerns of skin flushing and coughing.  Pt states she feels itchy.  Taken back to patient room for assessment.   Pt coughing hard, tries to vomit, facial cheeks, arms and upper chest reddened.  Area around mouth pale white in color, no shortness of breath, pt alert, oriented and able to speak.  Dr. made aware and orders Benadryl 25mg IM stat.  Administered to right thigh IM as ordered.  Pt calming down, less coughing, breathing normally, rests on bed with cool cloth on forehead with mother at bedside.  Pt reports she is feeling better.   Monitored by Dr. and nurse.  Pt released feeling better with no further symptoms of reaction.  Strep test positive today.  Mother aware to give Benadryl 25mg po or Zyrtec 10mg po if pt begins to have rash again.  She is to bring pt back if concerned.   She states agreement.
w/in 1-2mo of vax pt was walking w/mom & noted to pass out;pt was unresponsive for 30 sec, incontinent of urine,threshing pulse, poor perfusion & a very brief 10sectonic posture w/eyes rolling back;w/in 5min was alert;vagal faint;
reports fussiness/crying w/in hr of vax;temp of 102.5 R in ER that evening around 9:00 or 10PM;mom gave 2-3 doses of APAP;leg became swollen/reddened;would only comfort when held;given doses of Ibuprofen in ER;t101 range next day;