chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a patient-himself on 17-Nov-2017. This case involves a 76-year-old male patient, who was vaccinated with a dose of FLUZONE HD intramuscularly once (Batch number: UI877AB, expiration date: 17-May-2018, dose, dose in series were not reported) in the arm on 17-Oct-2017 and again on 25-Oct-2017. The medical history and concomitant medication was not reported. On an unknown day, following the vaccination, the patient developed very painful in arm which extending from shoulder to elbow, unable to lift arm. It was a case of actual medication error due to extra dose administered. Lab investigation was not reported and corrective treatment was Ibuprofen/TYLENOL as needed. The outcome of mobility decreased and painful arm was recovering. 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 and Module 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. Documents held by sender: none.
03/02/11 after the vaccinations he woke up really upset in the night (not typical of him at all, he's always been a really good, calm sleeper).   2 weeks after that he had to be taken to the ER for a high fever and crying a lot. They suspected something was wrong with his throat, but apparently found nothingWe went home with no answers.   10 days after that visit to the ER we were back in the ER in the middle of the night for a 106 fever that was rising and I rushed him in. He had a throat infection that had been festering for weeks.   1 day after that visit, during the night, he was SO hot that he actually woke me up from the heat (co-sleeping here). He was really upset and really tiredthe only thing I could think to do was put him in a lukewarm bath. He screamed and cried and sat there saying "momma, momma"
This spontaneous report has been received from a nurse, refers to 3 unspecified patients. Concomitant therapies included sterile diluent(manufacturer unknown).  On 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as "N00068" for prophylaxis. No adverse event were reported. This is one of several reports received from the same source. Lot number N00068 is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments: US-009507513-1709USA002520:
Patient was found unconscious without a pulse. Patient remained in asystole without pulse or respirations despite CPR.
The patient developed a local reaction, 2 1/2" swelling and erythema of the left deltoid two days post vax. The patient's mother is to monitor and apply warm compresses. The patient was treated with Benadryl.
A report has been received from a Health Professional concerning a 6 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that patient was administered expired FLUMIST Quadrivalent vaccine on 30-DEC-2014. The outcome of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
Swollen, hot red injection site. Fever of 102 next day. Went to ER. Diagnosed with COVID-19.
Local reaction with redness and swelling at injection site on right arm noted on 03/27/2002 and the injection was given on 03/25/2002.
Patient did not experience any adverse events after receiving an additional dose of Moderna having already received J&J and a Moderna booster previously.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (lot no UI998AD and Expiry date not reported) via unknown route in unknown administration site instead of FLUZONE HIGH DOSE on 30-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No AEs have been reported by the patient. 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.
Flu vaccine (FLUVIRIN) was given to patient on 11.02.09 Rt arm. Pt noticed swelling, pain local site on 11.3.09 was seen by one doctor 11.6.09. Lt w swelling, erythema, pain local site and previous BCG scar adjacent to vaccine site 5-6 cm away from flu vaccine site is swollen, erythematous.
13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; 13 days after each vaccine had swollen tongue, gums and cheek and lips; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via unspecified route of administration in the right arm on 07Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via unspecified route of administration in the right arm on 28Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to unspecified products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021, 13 days after each vaccine, the patient experienced swollen tongue, gums, cheek and lips. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen tongue, gums, cheek and lips was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at the vaccination site). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding at the vaccination site) outcome was unknown. Not Provided          Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up information was received from the initial reporter: The reporter stated that the internist indicated that the vaccinator most likely hit a vein but most of the vaccine should have gotten into the muscle
10 minutes after vaccination had a large localized site reaction. Was kept at the hospital to be watched for approximately 45 minutes.  12 hours later night sweats, headache, site reaction cleared up.  8 days later (1/14/21) site became red, hot, and very inflamed. I had a similar reaction to the pneumococcal vaccine in September so I immediately contacted my allergist. I immediately took prednisone as instructed by my doctor and went in for an appointment. About 4 hours after the new site reaction, joint pain and malaise began. I'm continuing on a steroid regimen for treatment.   Today 1/16/21 I am still having joint pain and swelling. Site on my arm is mostly cleared up.
Delayed allergic rxn w/tender swelling of inject site 6cm diameter, erythematous, hives on back, fever; hx of sterile abcess requiring incision & drainage p/DTP 1986; DT w/o incident 1988;
Patient received a 3rd full dose of Moderna due to hx of breast cancer. Patient has no hx of adverse reactions in the past with other doses or vaccines. Patient administered vaccine at 9am in her right deltoid, IM. Patient goes to her office and returns 15-20 min later with cc that she is hot, itchy and has vomited a few times. Patient presented with red blotches on her neck face and bilateral ears. Injection site is red, swollen and warm to the touch. Nurse on site administered EPI in patients right thigh per protocol at 930am. EMT is called to come to site since EPI was administered. Patients vitals are checked before and after EPI. Patients BP is elevated but does have hx of HTN and takes meds for it. Patient leaves site where clinic is being held by ambulance for further observation.
pt. vax'd w/ 1st dose of hepatitis B & exp. tingling in arm. vax'd w/ 2nd dose and exp. tingling in arm and developed right unilateral conjunctivitis.
unable to stand or walk; tremors in her legs which as the days progressed spread to her whole body, arms, head, and; reaction may have been a heightened extreme immune response to the second dose of the; lot of sleepiness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (lot of sleepiness), GAIT INABILITY (unable to stand or walk), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Reported Past Medical History.) on 15-Mar-2021.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced SOMNOLENCE (lot of sleepiness) (seriousness criterion hospitalization). On 18-Mar-2021, the patient experienced GAIT INABILITY (unable to stand or walk) (seriousness criterion hospitalization), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) (seriousness criterion hospitalization) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 25-Mar-2021 due to ADVERSE REACTION, GAIT INABILITY, SOMNOLENCE and TREMOR. At the time of the report, SOMNOLENCE (lot of sleepiness), GAIT INABILITY (unable to stand or walk), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) outcome was unknown.            No concomitant medications were reported.  No treatments were reported.  During hospitalization, patient underwent numerous tests such as MRI and Xrays to rule out other diagnoses.  All tests came back negative. Pt has been in rehabilitation facility since 26MAR2021. Her tremors are lessening in frequency and intensity.  She is able to walk for short periods of time and use a walker as well.; Sender's Comments: This case concerns an 88-year-old female hospitalized with serious unexpected events of adverse reaction, somnolence, tremor and gait inability. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on 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.
Patient described all over joint pain and no appetite starting evening of booster dose and continuing four days later with no improvement.  Patient is taking Naproxen and Acetaminophen for the joint pain and trying to stay hydrated. Patient stated he experienced similar symptoms after second dose in April and continued to feel poorly all summer. Patient has no autoimmune disorders diagnosed at the present time.
HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
It was reported that a 19 year old female pt received a Menomune A/C/Y/W-135 vaccination in the left deltoid on 11/02/2000 at 2pm. One hour post injection the pt complained of itchiness. At 3:30pm the pt has a 4x5 1/2 inch area of erythema and swelling of the injection site. Reportedly the pt health services were notified and the pt recovered. No additional info was given from the correspondence received on 02/16/2001. No further info is expected; this case is closed.
expired dose of Quadracel was administered with no AE; Initial information received on 11-Nov-2019 regarding an unsolicited non-serious case received from health-care professional.  This case involves a 5-years old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] (lot: C5248AA, expiry date: 21-AUG-2019), via intramuscular route in unknown administration site on 02-Oct-2019.  The patient's past medical history was unknown.  List concomitant: flu vaccine and MMRV  It was an actual medication error due to the expired product administered.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received vaccine 9/30/09. On 10/01/09 had large reddened area on L upper arm - painful. Heat to trunk also experienced generalized achiness throughout body 8 hours after vaccine injection.
Extreme chills; fever (102+); night sweats - drenched bedding level of sweat; joint and muscle pain; nausea; headache; fatigue; painful injection site.  Most adverse events resolved in a few days. Still have night sweats, though not as severe as the first few days; some residual fatigue, and joint pain. Injection site only mildly sore.
had COVID symptoms and tested positive for Covid; had COVID symptoms and tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US Support.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date not provided) on 28Dec2020 17:30 at single dose in the left arm via an unspecified route of administration for COVID-19 immunisation .  There were no relevant medical history and no concomitant medications. The patient took the first dose of the vaccine on 28Dec2020 and by the end of that week she had COVID symptoms. She got tested on that Saturday (02Jan2021) and it was negative, so she went to an urgent care to get tested again on 04Jan2021 and she was positive. She was not visit physician office or emergency room. She was out of quarantine on 14Jan2021, and was due to go get her second dose of the vaccine on 18Jan2021. She was calling to make sure if it's okay to get it. The outcome was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event "had COVID symptoms and tested positive for Covid" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
Persistent headache. Taking acetaminophen with no relief. Advised to continued acetaminophen and try caffeine.
8/3/2021 Patient presented to Urgent Care with worsening shortness of breath, body aches and headache. She had been experiencing cold symptoms: nasal congestion, rhinorrhea, sore throat for the prior 9 days and now was also reporting chest tightness. 1st Covid vaccine 8/2/2021. Submitter does not have access to any further records of treatment or outcomes. Please contact the admitting hospital for this information. Hospital.
2 1/2 yo female with no PMHx, no previous allergies. Had fallen behind on immunization schedule OMUCC. Pt had vaccines given 1 week later pt developed fevers up to 102 degrees F then developed swelling on (L) cheek, nose & eye with erythema/induration x 4 days then slowly is resolving. No treatment given.
Fever 102, Chills, Headache, All symptoms lasted 36 hours.
In addition to having shortness of breath and racing pulse for weeks after having the vaccine, resulting in an ER visit and cardiology exams, I have had erratic menses since the first vaccine.  The length between cycles was shortened from my usual 27 days to every 10 to 14 days.  In November I bled for over 14 days.  A usual amount of time is 3-4 days for me.
Warmness at injection site; Redness at injection site; Itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (Itchiness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A red large oval occurred at site of injection a few hours later. Lasted for about 10 days. Occasional itching.  Main issue- I went for scheduled mammogram and  breast ultra sound (Jan 26) and 2 axillary  lymph nodes were enlarged. (same side as injection). Biopsy was suggested a week later. When I went a week later the nodes had gotten smaller almost normal so no biopsy was needed. It was attributed to the vaccine.
On 10/14/2022 I had an anaphylaxis reaction that was treated with 125mg solumedrol and 100mg benadryl at approximately 0940. The provider I saw had suggested I take another 100mg benadryl that same evening.
This spontaneous report as received from a registered nurse refers to an approximately 5 year old patient unknown of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J005177, expiration date: 03-NOV-2014) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005559, 1404USA005560, 1404USA005561, 1404USA005562, and 1404USA005563) from the same source. Additional information has been requested.
Fever and myoclonic jerks the day after the vaccines were given. The jerks quit after his fever was treated and he recovered.
Muscle aches; fever; This is a spontaneous report from a contactable physician. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot numbers EL0140 and EK9231), first dose via an unspecified route of administration on the left arm on 19Dec2020 at 08:00 and then via an unspecified route of administration on the on second dose via an unspecified route of administration on the right arm at 08:30 at a single dose, all for Covid-19 vaccination. Patient medical history was not reported. The patient has known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID).  Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested. On 19Jan2021, The patient experienced muscle aches and fever. There was no treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
vaccine dripped out onto her glove and the floor , no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77 years old female patient who was being vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (0.5 ml pre-filled syringe, lot UJ536AD and expiration date : 30-Jun-2021, via unknown route in the left deltoid , prophylactic vaccination) and while vaccination the vaccine dripped out onto and over the  glove and the floor on 29-Oct-2020 (underdose).  Medical history was not reported.  No other medications or vaccinations were given to the patient.  It was an actual medication error case due to vaccine underdose (same day latency).  Case description: when she went to remove the air from the syringe, the plunger would push in, it felt like there was pressure preventing it. when taking out the needle cap off they were able to remove the air in the syringe. And while attempting to administer 0.5 ml of the vaccine in the left deltoid. The caller stated that she doesn't think any of the vaccine went in.  No adverse event reported at the time of reporting.  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.