chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscularly. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, fever, rash on neck, chest, arms, SOB. Went to ED for breathing treatment after inhalers didn't work.
This spontaneous report was received from a medical assistant and refers to 79 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-JAN-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain on injection arm, and has gotten worse over time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on injection arm, and has gotten worse over time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain on injection arm, and has gotten worse over time). At the time of the report, VACCINATION SITE PAIN (Pain on injection arm, and has gotten worse over time) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication and treatment medications was not provided.
Severe swelling and intense pain to her arm at injection site. Pt noted pain also to her entire body (skin,muscle) that was so intense she couldn't control her bladder at one point. Pt strongly considered going to ER but didn't.
Immediate metallic taste, (L) arm swollen x4 days, fatigue, fever, joint pain, nausea and diarrhea. Resolved by time of 2nd follow up (by phone) 12/5/17.
That night after receiving a flu shot in the right arm-and PREVENAR 23 in the left arm-my left arm from the almost top of the arm to my elbow was red, hot, swollen and I couldn't lift it. I had chills-didn't eat supper for two days-felt queasy.
I went to the Pharmacy to get Covid Shot. I waited 20 minutes and went home. I was doing ok and in the evening, I started getting sweaty and I started running a high Fever. I kept going to sleep and waking up in sweat. I was like that for about 3 days. I took medication during this time. After about 32 hours I started to feel better.
Vaccine given about 09:40. At 10:08 mother called from home and reported hives (?) (rest is unreadable).
Flublok was administered to a 17 years old- outside age indication/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 17 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of report no 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 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.  Information on the batch number was requested.
Patient received 2nd dose of Moderna and was under 18 years of age at the time.
Narrative:  99 yo patient receiving hospice care expired on 8/9/21 after receiving COVID-19 vaccine on 1/26/21
Sore arm  the next day after receiving first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose). At the time of the report, PAIN IN EXTREMITY (Sore arm  the next day after receiving first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  Treatment information was not provided.   This case was linked to MOD21-071940 (E2B Linked Report).; Sender's Comments:  MOD21-071940:crosslinked, reporter case
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Reaction/event as reported by primary source was COVID rebound, Date of start of reaction/event was 16Jun2022, Outcome of reaction/event at the time of last observation Not Recovered/Not Resolved, no hospitalization Prolonged. Patient administered Paxlovid for treatment of COVID-19, drug start date was 06Jun2022 and Date of last administration was 11Jun2022, Patient not administered any other medications/products within 2 weeks of starting COVID-19 treatment, patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a 39 year old who had been in is usual health when he received his non-primary (#3) smallpox vaccination on 01/17/2003. On 21 January 2003 at approximately 0230 hour he was awakened from his sleep with chest pain 8/10 without associated shortness of breath. He stated that the friction of taking a deep breath increased his pain. He took some Motrin 800 mg and Benadryl which eased the pain along with sitting straight up through out the night. He presented to the Emergency Department (ED) on 23 January 2003.  He reports at the ED he did not have any EKG changes and negative cardiac enzymes. He was diagnosed with clinical pericarditis. He was placed on Vicodin and Motrin 800mg TID. He states that he had recovered by 5-6 weeks following onset. He has not had any cardiac follow-up to date. He denies any recurrence of symptoms since the initial episode.
-Local reaction to (L) arm vaccine site including redness, swelling, itching and burning in (L) deltoid area.  -Treated with Elocon Cream & Cold compress application -Pt. also experienced redness/flushing of skin on chest
Extreme fatigue; Severe chills; Heart rate up to 130 while laying down; Severe headache; Injection site sore and swollen; Injection site sore and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 16Mar2021 15:45 (age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing High blood pressure , ongoing known allergies to bananas, ancef. Concomitant medication(s) included calcitriol; hctz; levothyroxine; lisinopril; estradiol; metformin; rosuvastatin; desvenlafaxine; colecalciferol (VIT D3); ascorbic acid (+) zinc; biotin and cyanocobalamin (B12-VITAMIIN). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) in the left arm on 24Feb2021 16:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 17:00, the patient experienced extreme fatigue with in 30 minutes of injection, severe chills in excess of 8 hours, heart rate up to 130 while laying down, severe headache, injection site sore and swollen. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since vaccination. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a 23 year old female patient. Medical history and concurrent conditions were not reported. In 2007, 7 year ago, the was vaccinated with the first dose of GARDASIL. Dose, route, lot number and expiration date were not reported. The second dose was on 19-SEP-2014, lot # K009202, expiration date 17-DEC-2016, 0.5 ml, intramuscular in the left deltoid. Additional information is not expected. No allowed to contact physician.
Sniffles and stuff like that ( not further clarified); She was going to get fourth dose but wasn't able to receive it; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included C-section. Concurrent medical conditions included Asthma, Multiple sclerosis, Allergy to antibiotic (Bactrim DS), Drug allergy (Cipro), Drug allergy (Sulfa), Drug allergy (Epinephrine), Drug allergy (Naproxen), Drug allergy (Tramadol), Pain, Fatigue and Numbness. Concomitant products included OCRELIZUMAB (OCREVUS), DULOXETINE, OXCARBAZEPINE, BACLOFEN, MODAFINIL, GABAPENTIN, FLECAINIDE and TOPIRAMATE for an unknown indication.   In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it). At the time of the report, RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it) outcome was unknown.            In 2022, the Patient started therapy with Moderna COVID-19 Vaccine for COVID and patient stated that patient was going to get the fourth dose. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Live Follow up received contained patient middle name were added.
Developed psoriatic arthritis flare after each dose of vaccine (lasting months). Muscle pain, joint pain and fatigue worsening well beyond the normal and expected side effect. Increased number of joints impacted.
This spontaneous report as received from a registered nurse via a company representative refers to a 65 year old female patient. Concomitant medication, medical history, drug reactions or allergies were unknown by the reporter. The patient was vaccinated with unspecified pneumococcal 13v conj vaccine (also reported as PCB13) one year ago (approximately March 2016). On 07-MAR-2017 (also reported as "within the last 2 weeks"), the patient was vaccinated with the suspect drug, PNEUMOVAX 23 (dose, frequency and route of administration were not reported, lot N003997, expiration date: 20-OCT-2018) as prevention of pneumococcal disease. Within one day of receiving the vaccine, the patient contacted her physician and stated that her arms were red, painful to touch and feverish (reaction started in approximately March 2017, exact onset dates were not provided). The patient received unspecified treatment for the adverse events. The outcome of the adverse events was reported as recovered in approximately March 2017. The relatedness between the adverse events and the vaccine was related. Additional information has been requested.
This case was reported by a nurse to a sales representative and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included family history of diabetes. On 24 August 2006 the subject received 5th dose of Infanrix in the left arm. On 24 August 2006, the subject also received measles, mumps and rubella vaccine, strain not specified (MMRII vaccine, Merck), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and hepatitis A vaccine (unspecified manufacturer). On 26 August 2006, 2 days after vaccination with Infanrix, the subject experienced swelling injection site, injection site warmth and injection site redness. At the time of initial reporting, 04 October 2006, the events were improved. The nurse considered the events were probably related to vaccination with Infanrix.
Patient has swelling of the injection site, the inflamed area is about 4 inch by 5 inches. Patient states that it is itching. Patient went to urgent care & received ROCEPHIN & AUGMENTIN Rx.
Sore throat, headache, body aches, fever & swelling of face, chin & eyes.
Fever; Chills; Malaise; Fatigue; Arm Pain; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161, expiration date not reported) via unspecified route of administration in Arm Left on 14Apr2021 10:30 (age at vaccination 50-years-old) as single dose for covid-19 immunisation. Facility where most recent COVID-19 vaccine was administered was other. Medical history included chronic diverticulitis, drug hypersensitivity to penicillin, augmentin, erythromycin and lactose intolerance. Concomitant medications in two weeks included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for hypersensitivity from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 AM, (at the age of 50-years-old) as a single dose for COVID-19 immunization. Patient did not have or was diagnosed for COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 20:30 the patient experienced fever, chills, malaise, fatigue and arm pain. The patient received acetaminophen as treatment for the adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
I was working at a facility and as I was leaving, I was supposed to sign out. I could not remember what month, date, or year it was. I also could not remember what locker I had placed my belongings in. I have had a dull headache in the left quadrant of my head. I sent my doctor a message and a nurse called me back. She said it could have been a TIA-transient ischemic attack, transient global amnesia or a small seizure and they asked me to come in. They checked me out and they indicated that they would complete an MRI which is scheduled for Monday. They listened to heart and corroded artery as well as checked my reflexes. The symptoms passed after about 15 or 20 minutes. I was able to drive home and since have not had any additional episodes to date.
Pt states recently started on 3 new BP meds. Had not,  eaten since lunch or drinking fluids (had soda at lunch) Pt stated he felt weak and grabbed a hold of the table, stated he felt better then loss consciousness for a few seconds (then came to). LOC happened second time for 15 seconds. Pt then moved to wheelchair and moved to EMS room.  Assisted to cot and pt stated he was okay.
Chest pain started upon waking at 10am, took to Urgent Care at 12pm, EKG administered (normal), sent home on Ibuprofen. Chest pain continued for 2 days, Ibuprofen administered throughout. Day 3 resolved.
Started to feel sick to her stomach. Everything went white! She passed out. She was driving her car at the time and ran into a tree.
Chills & Fever, sweating, widespread vascular and joint pain. Treated as if COVID, although two home tests, one outpatient test and one inpatient test were negative. Illness progressed Saturday evening through Wednesday night. Saw PCP Thursday morning, sent to ER and subsequently admitted to hospital. Treated for symptoms, 65 lab tests failed to identify the illness, closest match is Adult Onset Still Disease. Heart went into A-fib and will require medication going forward. Sent home to recover after 7 days in hospital.
pt recvd vax; pt devel slightly edematous, pruritic rash on legs, groin, arms & eyelid;
Vomiting and diarrhea that went on for 4 days. Had rash at HIB and Prevnar injection sites.
Headache, Myalgia, Angioedema, Rash, fatigue Narrative:  flu symptoms for 24 hours: headache, body aches, fatigue. sore arm, redness, swollen at injection site for 1 week. took Benedryl and relieved symptoms. prior diagnosis of Covid-19. Covid recovered at time of vaccine  Other Relevant History:
Expired vaccine administered. No adverse effects. Repeated dose per CDC and Sanofi Pasteur recommendation.
Night of shot experienced fever of 101, nightmares and slurred speech.  The following day experienced fatigue.  By the second day post vaccination memory impairemt.  By the third day post vaccination has gait unsteadiness and fell six times.  The 4th day post vaccination left arm weakness and could not use arm. accompanied by slurred speech.
Approximately 16 hours after the second dose, I experienced extreme chills and shakes. The effect was so dramatic I was unable to move. This lasted for a duration of around 2 hours. Once this symptom subsided I was unable to regulate my body temperature for 12 hours. From there I had a 102 degree fever. had a complete loss of apatite and a mild headache.
rash on chest and breast area; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient did not have any allergies to food, medications, or other products. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) , curcuma longa (TURMERIC), glucosamine (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN) all from an unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 04Apr2021 at 19:00, two days after receiving the vaccine the patient experienced rash on chest and breast area. The patient did not have any changes to her diet or medication in the past month, saved for the COVID Vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event rash on chest and breast area was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Mother reports that the evening that child received varicella injection that child developed a few fluid filled lesions at site of injection. The following morning the child had fluid filled lesions over her legs, back and to a lesser extent her arms. PMD called, who said that the symptoms were similar to chickenpox and said to stay home since child was not otherwise ill. Dr. advised client to not have #2 varicella. Child attends daycare and had no known exposure to anyone with chickenpox.
Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot# K005183, expiry date 10-APR-2016; dose and route of administration were not reported). Additional information is not expected as all the scheduled correspondence has been obtained. This is one of several reprots from the same reporter.
Information has been received from a licensed practical nurse concerning a 6 year old female who on 09/29/1999 was vaccinated with one dose of varicella vaccine. On 05/14/2001, the pt developed a fever and an unknown number of lesions. The pt was diagnosed with mild case of chicken pox and sought unspecified medical attention. The pt was treated with Benadryl, Zovirax, and Aveeno bath. Subsequently, the pt recovered. Also reported was another pt who was vaccinated with varicella vaccine and experienced similar events. Additional info has been requested.
Starting 10/25/2021: felt achy, sore throat. Her temperature was 101.3. She's had a very mild cough. She's had some body aches and chills.
This patient was given vaccine 24 hrs ago. She took a nap this afternoon, woke with a 102 temperature (2:00 PM). On 01/18/01, the PMD reported positive Influenza A culture. The patients temperature went to 104 she saw the PMD, who felt the incident was coincidental that the patient had the flu.