chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient was received expired QUADRACEL vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (MI) (Reference number- 00800771) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 5-year-old male patient who was received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 25-Aug-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA, expiry: 13-Aug-2021, formulation: injection) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error expired vaccine used (latency same day).  It was reported "Caller states that a patient received an injection of QUADRACEL in her office on 25AUG2021 that had expired on 13AUG2021. Caller states that she was unsure what the protocol was and called the number that was provided from the package containing QUADRACEL. Caller asked how she should proceed with regard to the patient."  No other adverse event was reported.  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.
Arm/muscle soreness that had initially gone away after 48 hours, but reappeared at the 7 day mark, much more intense with a quarter size red bump at the injection site
5" long, 3" across left fore arm red bumpy rash that itches, this showed up third morning after second dose
I took a test because my wife came down with COVID. I had mild symptoms; I think they were even milder with the Paxlovid. I felt a little more tired than normal. I did not have a fever and did not have any other symptoms. The only way I knew I had COVID was due to the fact I tested positive. I cannot recall any other symptoms. My doctor was very responsive. The vaccine and Paxlovid helped me. Dr. increased my inhaler to 200mg while I had COVID. She had me continue that for a month.
Shot administered 11/20, 12/14 patient came in and said arm still hurts. According to her due to Flu shot. Stated its getting better and performed push ups at the store show she's strong.
Outbreak of hives approximately 2 hours after administration of vaccine. No anaphylaxis. Benadryl 25 mg PRN advised.
Systemic: Vomiting-Mild, Additional Details: PATIENT COMPLAINED THAT SHE IS ABOUT TO FAINT AND THEN SHE HAD VOMITING. SHE STARTS TO FEEL BETTER AFTER VOMITING.
This spontaneous report as received from a pharmacist refers to a 61 year old patient of an unknown gender. On 15-JUN-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 lot # K009809, expiration date: 16-MAY-2015, 0.5 ml, intramuscular. No adverse effects was reported. Additional information has been requested.
Within 30-min: Muscle pain across shoulder and arms. Joint pain: shoulders, elbows, fingers, knees, and toes. Mild swelling and redness in hands. Next day; mild swelling of face.
Information has been received from a consumer who read on a online blog that a male patient with Parkinson's disease on a date not reported, was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles two weeks after he got vaccinated with ZOSTAVAX (Oka/Merk). This is one of several reports received from the same source. No further information is available.
Fever, myalgias, muscle weakness, headache, blurred vision, memory impairment.
Information has been received from a Licensed Vocational Nurse (L.V.N.) who reported that, on multiple unspecified dates, multiple unspecified patients were administered improperly stored GARDASIL (lot # K011325, expired date 08-APR-2017, dose and route not reported). No adverse effect was reported. The vaccines were at temperature 33 F for 74 hours. There was no previous temperature excursion. This is one of the several reports with the same reporter. Additional information has been requested.
I had fever of 99° after taking ibuprofen 600 mg throughout the day on June 3. I had chills and sweats alternating from the evening and throughout the night. I woke up completely drenched in sweat I had to change my clothes. The chills were so severe that I could barely move (also because my bones hurt). All of this was over the course of approximately 6 PM until the next morning around 5 AM.   More significantly, I experienced severe bone, joint and muscle aches all throughout my body.  I had severe pain especially in my ankles, feet and knees. I also experienced pain in my spine, hands, arms, stomach, ears, and eyes. I felt mild nausea and a very mild  headache.   I am also nursing an infant, and my milk production was reduced from 30 ounces a day to approximately 15 ounces on the day of June 3.
pt recv vax & skin began to blotch w/in 10min of vax;24FEB97 mom states pt is fine;MD feels pt reacted to pertussis;
Administered dose to 17 years old 2 male patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (two 17 year old males) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Received a flu and a pneumonia shot at the same time from local doctor after a brief checkup, shots given on 10/20/2012. Shortly thereafter went into cardiac arrest and was revived and a ICD has been planted. I now have atrial flutter that will not subside. I was and am in good physical health for my age, had no indications that there was an imminent heart problem.
One nurse also had the same symptom as she had/ Started with a headache; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; This is a spontaneous report from a contactable consumer via a team. This is 2nd case of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, her daughter got her first dose of the Pfizer Covid 19 vaccine last April. Three days later she experienced horrible headache all the way down to her body. Also added that she experienced nerve twitching, nerve touching in her legs and left arm that went to her right arm. When she went to her doctor, they said that they don't even think that the side effects she is experiencing is from the Pfizer COVID vaccine. That it's all in her head. One nurse (patient) also had the same symptom as she (daughter) had. The patient experienced the similar events of headache, pulsating tinnitus, General body pain, Twitching of limbs, Tingling sensation.The outcome of the events was unknown.  Information about lot/batch number has been requested.
vaccine exposure during pregnancy; sore arm; headache; fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (fatigue) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Previously). Concurrent medical conditions included Drug allergy (Allergic to Morphine and Dicloxacillin).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-May-2021. On 12-Feb-2020, the patient experienced FATIGUE (fatigue). On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), MYALGIA (sore arm) and HEADACHE (headache). On 12-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Ultrasound abdomen: normal (normal) good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is pregnant and is also taking prenatal medication. Treatment information was not provided. patient was tested positive for pregnancy in September.
Fever, chills, nausea, headache, body aches, shortness of breath from 11am until 8pm the next day.  Shortness of breath and persistent cough when speaking at length since 1st dose.
Pt received Hep-B to left arm at school. Noticed redness to injection site, within 30 minutes and also redness to face and a reddened area to chest. No elevated hives, no respiratory difficulties. BP and pulse stable, declined Benadryl by father and discharged with father, 30 minutes later. Called pt at home on 8/29/00 and grandmother stated "pt was not seen by doctor, he is doing fine and no complaints.
Coughing, rhinorrhea and several red urticaria on trunk, scalp and all extremities. No breathing difficulties.
patient was resident on the rehab floor; an expired dose of PNEUMOV AX 23 was administered; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 13-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (1 dosage form, lot #: T010639, expire date: 31-AUG-2021; strength, route and anatomical Location  were not reported) for prophylaxis (expired product administered). The pharmacist stated that the dose was properly stored up through the time of administration. The patient was resident on the rehab floor (ill-defined disorder). No further information was provided.  The outcome and causality assessment for ill-defined disorder were not provided.
pt recv vax 26NOV96 & 9DEC96 pt exp chickenpox-like rash on back (1 lesion), face (4-5 lesions) & stomach & 1-2 lesions);
At first, waking up with  difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache.  Very fast heartbeat.   Took a lot of effort to walk, especially down stairs.  Took Tylenol (around 5:00 AM) , went back to bed.  After  7 hours of sleep, had no appetite. Headache.   Symptoms faded after a couple more hours.
Information was received from a nurse concerning a male who "many year ago, as a child" was vaccinated with a dose of MMR.  It was reported that subsequently the patient had a reaction and became "very sick".  Unspecified medical attention was sought.  The patient;s outcome was not reported.  It was also reported that the patient's son had a similar experience following vaccination with MMR.  Additional information has been sought.
No adverse symptoms reported.; The patient was vaccinated with improperly stored ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 20-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number R033255 and expiration date of 26-JUN-2020 orally for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature below 36°F / 2°C FOR 6 hours. There was no previous temperature excursion. A "data logger" was involved.
Approximately one hour after injection patient became dizzy, nauseated and pale. Symptoms lasted approximately one hour then resolved no specific treatment was required.
Moderna COVID-19 Vaccine EUA Chills, headache, sore left arm the following day. Headache lasted through 2/27/21.
Rapid pulse/High heart rate -137; Nausea/Severe Nausea; Hives; Fatigue; Palpitations; Chills; Sweating; Fever; Severe joint pain; Dizziness; Headache; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE; Lot Number: EWO167; Expiration Date: 31Aug2021), intramuscular, in right arm on 17May2021 15:45 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing conditions of juvenile idiopathic arthritis from 1969, Raynauds from 1966, Hypertension from 1991, Scleroderma from 1990, Sjogren from 1975, Gallbladder disease from 1994, Graves disease from 1996, Chronic tachycardia from 1993, Congestive heart failure from 2013, Type 1 Diabetes from 2013, neuropathy - 3 kins from 2013-2014, Chronic Infections from 2013 and psoriatic Arthritis. Concomitant medications included ursodiol and ursodeoxycholic acid (ACTIGALL) taken for gallbladder disorder from 1992 and ongoing, diltiazem (CARDIZEM) taken for hypertension from 1991 and ongoing; ciprofloxacin hydrochloride (CIPRO) taken for infection, metronidazole (FLAGYL) taken for infection, tedizolid phosphate (SIVEXTRO), propylthiouracil (PTU) taken for graves disease, spironolactone taken for cardiac failure congestive and metoprolol taken for tachycardia. The patient had unspecified allergies. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; LOT number EW0181), intramuscular in right arm on 20Jun2021 for COVID-19 immunization. The patient experienced hives on 17May2021 14:40, rapid pulse/high heart rate -137 on 17May2021 15:55, nausea/severe nausea on 17May2021 15:50 and palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue on on 17May2021. Therapeutic measures were taken as a result of rapid pulse/high heart rate -137 and nausea/severe nausea. The events high heart rate and hives resulted call to physician. The outcome of the event rapid pulse/high heart rate was recovered on 20May2021. The outcome of the event hives was recovered on 22May2017. The outcome of event severe nausea was recovered on 19May2021. The outcome of event palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue was recovering.   Follow-up attempts are completed. No further information is expected.
Rash; itching; hives; Tingling in legs and feet; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 73-Year-old female patient first dose of BNT162B2 (PFIZER BIOTECH, COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration in upper right arm in the muscle on 05Jul2021 09:15 (age at the time of vaccination 12-years-old), as a single dose for COVID-19 immunization. The patient's medical history included she had 2 heart surgeries, irritable bowel syndrome, she took Fosamax for osteopenia and she had muscle cramps in her legs and feet and an upset stomach and nausea, osteopenia, Lipitor causes her muscle cramps and stomach pain, Dicyclomine for irritable bowel syndrome it was 10 mg that one she only took for a couple of days, she had the first shingles vaccine quite a few years ago and she had no side effects from that, and She has flu vaccines every year. Other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medication included vitamin D. Patient has trouble with the statins and She does take a statin now, is okay with it. On an unspecified date 2021, patient experienced allergic reaction; on 05Jul2021 Tiredness; on 05Jul2021 14:00 Tingling in legs and feet; on 05Jul2021 18:00 rash, itching, and hives. On an unspecified date, the patient underwent lab tests and procedures which included bloodwork, blood test: Unknown result. Patient did not visit emergency room or physician office. Upon consultation with her family doctor, she was advised not to get the second dose of vaccine and that she is "80% protected" already. Caller wanted to verify the information that her family doctor said, she asks if that is correct. The outcome of the evets allergic reaction was unknown; and all other events were recovered on 05Jul2021.  Information about batch/lot number has been requested.
swelling, redness, hot, inflammation;temp x 2 days, T101 tapering w/chills, aches & pains;extreme fatigue & weakness-arm cont to be red;splotchy, itchy x 1wk post vax;migrated towards elbow;
FIRST NOTICED SHORTLY AFTER 1ST DOSE ON 7/31/21. WAS TOLD BY URGENT TREATMENT PROVIDER TO "HOLD OFF FOR A WEEK OR SO TO GET 2ND DOSE" PER PATIENT.  PATIENT STATES THAT SHE EXPERIENCED "WEIRD PAINS" IN FEET AND LEGS, NEUROPATHY IN LEGS, WAS DEHYDRATED AND BLOOD PRESSURE WAS EXTREMELY HIGH.
Pt recvd TD Booster on 17-ARP-89, after stepping on a nail, returned to office on 19-APR-89, complaining of temp 99.5, pain at site of injection, radiating upper arm to neck; had swelling, redness, tenderness at site of injection.
I was told by front staff that the patient had fallen down and was exhibiting signs of seizures. This was about 5 minutes after receiving the vaccine. I rushed up there and found patient conscious of her surroundings and following verbal instructions. There were no signs of anaphylactic reactions. She had a bump on the back of her head as a result of the fall. I applied ice on it while waiting for EMT to arrive. EMT arrived with 5 minutes and took her away
Elevated heart rate within couple of minutes of receiving vaccine and extreme fatigue. Visited emergency room 4 times within two months after receiving vaccine and had abnormal EKGs. Followed up with a neurologist, cardiologist, gastrologist, and primary care physician to receive more follow-up tests but have not received any official diagnoses yet. As of July 7th, I still have rapid heart rate, low blood pressure, shortness of breath, bone cracking, and back & stomach & neck pains that all started since receiving the second dose of vaccine.
shivering started about 15 minutes after the shot and continues for 5 hours Nausea began about 15 minutes after shot and continued for 24 hours headache began about 15 minutes after shot and continued for 24 hours
Patient stated, her doctor  inform her to have a different vaccine d/t side effects. Tingling of lips after both shots, slightly decrease with Pfizer. Swelling of the face both times x2 days. Some difficulty of swallowing. No shortness of breath. Took benadryl both times with positive results.
Patient had received two full doses of Moderna on 4/7/21 and 5/5/21, then a booster of Pfizer on 12/17/21. Patient came in for Hep A booster on 3/28/22, but was instead, mistakenly given another Covid Booster--this time a 0.25ml dose of Moderna
This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age. On an unknown date in November 2013 (reported as on either 01-NOV-2013 or 02-NOV-2013), the doctor of pharmacy administered an expired dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date were reported as 1073AA and 11-OCT-2013 respectively), intramuscularly in the right deltoid to the patient. The reporter could not remember which date. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Immediate pain , twitching in upper left arm area. Onset of fever and extreme fatigue for several days. Continuing pain in lower neck and numbness/tingling/pain in fingers. Particularly left hand.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA, a single dose of MCV4 (manufacturer unknown) and a single dose of quadrivalent flu vaccine, all on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a bad headache. Clinical outcome of the event was unknown at time of this report. Follow-up (19DEC2015): Follow-up attempts are completed. No further information is expected.
Date of Admission:  3/17/2022   Chief Complaint:  Hypoglycemia   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 59-year-old male with past medical history significant for chronic pancreatitis, EtOH abuse, hypertension type 2 diabetes mellitus and medical noncompliance, presented to the hospital with complaints of hypoglycemia. Multiple episodes of emesis was reported with POC glucose noted to be 39 by EMS. Vitals on arrival of T 96.9°F, BP 111/85, HR 87, RR 20, SpO2 97% on room air. Labs on arrival remarkable for Bicarb <5, mag 1.6, phos 5.7 on initial BMP and Hgb 12.1 on CBC. Elevated lactic acid 15.7 since downtrended since admission to 11.0 with ABG 7.37/19/100/10 on RA.  Elevated beta hydroxy 3.07 and ethanol 227, toxic alcohol screen in process. UA positive for ketones, 30 Protein, >20 hyaline casts, 1+ bacteria w/ no WBC/LE/Nitrites. Found to be COVID +.  Transferred to ICU for continued monitoring.
The patient developed cellulitis 2 days after receiving the vaccine. She was treated at urgent care on 8-6. She received AUGMENTIN 500-125 BID.
Pt was given the injection low in the left upper arm.  The site was bruised, red, swollen and hot.  Dr checked the site and instructed patient to use ice and if it got worse to contact her PCP.