chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Back soreness; red blood in urine; Shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
No adverse event; Gave Moderna COVID-19 vaccine after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had acute and chronic illnesses at the time of vaccination.     On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date).    No concomitant medication was reported by reporter.  A total of 7 doses were used post expiration date. Vial did not undergo any temperature excursion.  It was also unknown whether patient seek medical care.  No treatment medication was reported by reporter.
Headache, fevers, nausea, chills, vomiting, bodyaches.
Fever/Chills. Treated with Tylenol and recovered in 1 day.
At 10:25 pt. was administered HPV #2 on right deltoid IM and BEXSERO on left deltoid IM. Did not mention not feeling well therefore taken to lab for thyroid function testing due to history of hypothyroidism. At 10:30 am pt. was at the lab when the lab tech ask for help, feeling lightheaded, fainted. I helped laying her down to the bed and check her BP was 100/60. 15 minutes later her BP was 98/58 and she was shivering. She stayed there for 10 more minutes. Per mom Pt fainted before with blood flow draw 6/9/17.
extreme fatigue and extreme migraine starting 9 hours after vaccine and lasting 24 hours, slightly sore arm for 24 hours
About a few hours after vaccination, patient reported itching all over the body, swelling at the injection site. Her arm was sore. We followed up with patient and patient felt sick and achy up to today after almost 3 days. Patient used Benadryl cream to help with the itching and Ibuprofen to help with the soreness. However, no signs of fever, difficulty breathing. After almost 3 days, the itching at injection site is described as "a ball size"; other areas itching has gone away. Patient is still tired and feels sick.
Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm is sore; Chills; Headache; Fever; Tired; First it started of with I think it was tiredness, 'jerking' and then fever."; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0217) via an unspecified route of administration in Arm on 11Jun2021 as second dose, single for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin d, paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, since patient had the shot. Consumer stated Dose of Vitamin D as it for High blood pressure medicine further clarification was unknown. It was reported that the patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via unspecified route of administration on 18th May 2021 as 1st dose, single for covid-19 immunization. It was reported that the patient did not receive any vaccine within 4 weeks prior to the COVID 19 Vaccine. Consumer stated she was calling regarding a side effect that she noticed after she had her shot-on Friday the 11th of this month (11th june2021) and stated she had all the symptoms except for a few started Saturday on 12jun2021, her arm was sore and she had the chills and when she went to bed, had headache. First it started off with she thinks it was tiredness, jerking and then fever and still experiencing. On 13jun2021, she noticed that her arm being swollen but underneath the arm in her armpit she noticed it was pretty swollen under her arms and confirmed the name of the vaccine as Pfizer Covid 19 vaccine and patient stated no treatment was received and took Tylenol before vaccination. Reporter seriousness for all the reported events as unspecified. There was no investigation assessment. The outcome of the events was not recovered.
Not himself, grandmal seizure at 2:35pm lasted 7mins afterwards had gotten severe chills and very nauseas the entire day and very tired but NO FEVER. Has had flu shots since 1996 has never had a reaction.  His Grandmal seizures only come on LATE at night not during the day ever and this one was different then his other ones.       This was done at my husband place of employment we always go there. They have nurses come in. you will have to talk to someone at office at that phone # I Gave you if you need more information.  Tell them it was done at office she is there contact person.  Or call me .
Itchy rash that started on arms and has migrated to legs, ears, and a few dots on face
Patient with known seizure disorder, had loss of consciousness, possible seizure, for the first time in 2 years.
I had a sinus infection and the Dr. called it allergies and I don't feel like it's just allergies. It feels like a respiratory infection, I've had 3 asthma attacked in the past 3 weeks, and I haven't had one since childhood. I feel like I'm drowning in mucus. I have pain in my right shoulder where my lung is and it will hurt so bad and my right arm will tighten up real bad and I didn't do that before the vaccine. I have had a lot of cloudily memory since I've had the first vaccine.
Patient received BAM therapy on 12/10/2020 and received Moderna vaccine on 1/23/2021. Acute STEMI after BAM therapy
meningioencephalitis; Severe headache; severe nausea; migraine; small subarachnoid hemorrhage postulated; This is a spontaneous report from a contactable Physician (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 07Jan2021 at 02:30 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included hypertension, hypercholesterolemia, hypothyroidism and dust allergy. Concomitant medications in two weeks prior to the vaccination included levothyroxine sodium (SYNTHROID), chlorthalidone and rosuvastatin calcium (CRESTOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 PM patient experienced severe headache with severe nausea requiring emergency room (E R) visit and intravenous (I. V) morphine, toradol and ondansetron. Computed tomography angiography (C T A) of head performed on unknown date was normal. Pain unbearable. Lumbar puncture (L P) not done. Pain persisted four days later, though diminished. Diagnosis (Dx) uncertain but possible migraine with right (r) eye preference or small subarachnoid hemorrhage postulated. Another troublesome possibility could be vaccine reaction (meningioencephalitis). Events resulted in Emergency room/department or urgent care. Treatments received included IV morphine, zophran (as reported), ketorolac tromethamine (TORADOL) and metoclopramide hydrochloride (REGLAN). Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient recovered with sequel from the reported events.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events meningoencephalitis, headache, nausea, migraine and subarachnoid hemorrhage. 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.
PATIENT REPORTED "WEIRD SENSATION IN HER THROAT" VITALS OBTAINED, respirations even and unlabored, airway clear to auscultation, o2 sat 100%, shortly after patient reported difficulty breathing. Respiration 24, HR 120 02% 100. patient stated "i can't breath", airway clear to auscultation, respiration 28, o2 sat 100% HR 140. patient swallowing without difficulty, EMS called. 25 mg benedryl administer by nursing. Nursing did coaching breaths with patient to assist in lowering respirations. HR 80, R 18 EMS arrived patient declined transport to hospital. patient stayed 30 minutes for observation and discharged home. Refused allowing staff to call family or friends to drive her home.
an expired dose of ACTHIB was administered with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  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 (DAPTACEL) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), both for Immunization.  On 01-Nov-2022, the patient received 0.5 mL of Booster (dose 4) of suspect HIB (PRP/T) VACCINE (lot UJ594AAA and expiry date: 26-Oct-2022) via intramuscular route in the left thigh for prophylactic immunization.  On 01-Nov-2022, (latency: same day) an expired dose of acthib was administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Was not due for a cycle for another 11 days.  Taking same vitamins as normal, no new foods, etc.  Started to feel heavy in stomach and uterus at 0900 on 08/28/2021, spotting notice twice on 08/29/2021 while using restroom, spotting noticed again on 08/30/2021 while using restroom.  Full menstrual cycle started 9 to 10 days early in the night of 08/30 and 08/31/2021. Lasted one day more than normal with total cycle being 5 days.
FEVER (100.8 ORAL), CHILLS, BODY ACHES STARTED ABOUT 10-12 HOURS AFTER INJECTION- RESOLOVED IN 12 HOURS. REDNESS, PAIN AND SWELLING IN RIGHT ARM ABOUT 1- 2 INCHES BELOW INJECTION SITE.  HAS INCREASINGLY  ENLARGED IN PAST 4 DAYS, RED, WARM TO TOUCH AND ITCHY. TOOK BENADRYL 25 MG PO ON FRIDAY EVENING  WITH SOME RELIEF OF ITCHING. STILL REMAINS RED, SWOLLEN AND WARM TO TOUCH. HAVE NOT SEEN PCP OR MEDICAL PROFESSIONAL AS OF THIS DATE.
Moderna 1/12/21, 2/9/21, and 3/10/21. Positive on 1/21/22
"Covid Arm". One week after getting the shot, my arm became red, itchy and hot at the vaccine site. It is still like that 48 hours later. My arm was sore for a couple of days after getting the shot, but then was fine for 4-5 days before these symptoms appeared.
Patient was administered COVID vaccine in R arm and Flu vaccine in the L arm.  This was the 1st vaccine in COVID series, but has received Flu vaccine several other times.  Approximately, 15 minutes after receiving vaccines, developed an erythematous rash along the thumbs of both hands.  Patient was given 10mL of Benadryl at 1638 and Vanicream was applied to the rash.  She was re-examined at 1700.  Rash had not spread.  Patient has having no difficulty breathing.
Mild chest pain (soreness and discomfort) lasting 10 days after receiving a Moderna booster shot. The soreness would flare up throughout the day for several hours at a time.
On 1/19/10 patient came to pharmacy wanting to tell us about her arm pain. She has had chronic arm pain since vaccine administered which is relieved by Ibuprofen. She has seen a Dr. The pain started about 2 hours after administration.
Edematous area upper 1/2 of the leg from knee to mid upper leg. Tx: Benadryl every 6 hours prn, ice, rest, elevate.
made them fell weak and lose their apetite; made them fell weak and lose their apetite; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "made them fell weak and lose their apetite".  Additional information- Patient did not want to take their weekly dose of Ozempic that week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm was red; swollen; painful arm; red circle around the site of injection; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (painful arm) and VACCINATION SITE ERYTHEMA (red circle around the site of injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the site of injection). On an unknown date, the patient experienced ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen) and PAIN IN EXTREMITY (painful arm). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (painful arm) and VACCINATION SITE ERYTHEMA (red circle around the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up Information was received on 24-MAY-2021 : updated patient demographics, concomitant medicines, 2nd dose details updated, added new event Erythema, pain in extremity. updated outcome of events injection site erythema, peripheral swelling from unknown to Recovered
TWITCHING OF THE EYES; NUMBNESS IN HIS MOUTH; PAIN IN HIS FACE AND JAW; NUMBNESS ON LEFT SIDE OF FACE; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: enlarged prostate, high blood pressure, non alcoholic, and smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage at the time of vaccination. Doctor prescribed anti-viral for numbness on the left side of his face thinking possible bells palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included finasteride for enlarged prostate, morniflumate for enlarged prostate, and losartan for high blood pressure.  On 26-JUL-2021, the patient experienced pain in his face and jaw. On 26-JUL-2021, the patient experienced numbness on left side of face. On 07-OCT-2021, the patient experienced twitching of the eyes. On 07-OCT-2021, the patient experienced numbness in his mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on left side of face, pain in his face and jaw, numbness in his mouth, and twitching of the eyes. This report was non-serious. This case, from the same reporter is linked to 20211016889.
Experienced stroke symptoms and was taken by ambulance to the ER.  Speech was altered and couldn't communicate thoughts.  Was admitted to the hospital for 2 days. After 4 weeks of post TIA, speech is coming back but memory has deteriated.
pt was cranky & irritable for about an hr & cried on & off;fell asleep for about 1hr;pt seem lethargic & was moaning;pt vomited;pt was limp;T101 & pale;shaking hands, body & jaw about 1hr or so;
Information has been received from a licensed practical nurse concerning approximately nine female patients who were vaccinated intramuscularly with a 0.5 ml dose of Gardasil. Subsequently the patients became dizzy. Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of two reports received from the same source.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date were not reported) which was frozen then thawed. The patient medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. There were no side effects or treatment. 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. List of documents held by sender: none.
Patient experienced muscle pain, feeling tired and weak, and headache. Symptoms resolved after resting.
Patient is under the age of 18 when he was given the Moderna vaccine.   Patient had no side effects to the vaccine.
Pt recv vax on 5/2/99; 1 hr post vax pt exp painful/ swollen/ pink/ warm/ limited movement of upper arm, tired, sore feeling
Case number PHEH2014US014770 is an initial spontaneous report received from a consumer on 22 Jul 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. On 11 Oct 2012, she was vaccinated with FLUVIRIN (batch number: 120581, expiry date: 01 Jun 2014). It was reported that immediately after the vaccination, she had a reaction in her arms. She stated that they swelled up to the "size of a football" with a severe burning pain and then she started having shortness of breath due to throat swelling. Following the events, she was hospitalized on an unspecified date. She reported that she had been hospitalized multiple times through the years, for the same symptoms her doctor stated that the events were due to flu shot. The outcome was reported as condition unchanged.