chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Develop a swelling in the lymph node area; Armpit was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Armpit was tender and sore) and LYMPHADENOPATHY (Develop a swelling in the lymph node area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Armpit was tender and sore). On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Develop a swelling in the lymph node area). At the time of the report, VACCINATION SITE PAIN (Armpit was tender and sore) and LYMPHADENOPATHY (Develop a swelling in the lymph node area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.
Pt. presents with intermittent dry cough that began 24 hours after vaccine administration. Mother also reports green nasal discharge since onset of cough. He has been irritable and feeding less than usual.
I had a headache around 9:30 am, but I did not think too much about it. I began feeling tired and started getting mild body aches in my ankles in legs. I woke up at 1:30 am with severe body aches from my head to my toes. I was experiencing nausea and sweating and cold chills. I could not sleep at all. These symptoms lasted 6 hours. I had a fever of 107 degrees Fahrenheit at 6am. I could not move without being in severe pain. Today, I woke up with a swollen face. I feel very weak and fatigued. I am experiencing body aches, headaches, and tiredness.
Moderna COVID-19 Vaccine EUA Received vaccine at 9am. By 1pm extreme fatigue and pain in back of neck. Some muscle pain at site of vaccine. Then at 8pm high fever (99.5 - very high for me - I always record low temps.) Severe joint and muscle aches. Sweating. Couldn't sleep.  Muscle weakness. Nausea, vomiting at about 2am. Severe pain at vaccination site.  All continued until about 5am, when I finally slept for a couple of hours. Today, 10am on the 10th - pain at vaccine site, extreme fatigue and exhaustion. Just a terrible, terrible night.
I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. During the morning I started becoming disoriented and very tired. I was at work. I sat down and slept for 3 hours not hearing anyone. When I woke up my coworkers said I moved about 10 things around where they didn't belong. Like a cactus in the fridge along with a soap dispenser. I don't remember any of it. I felt better when I woke up. When I got home I slept for 11 hours. I was a little groggy the next day. I was fine 2 days later.
This spontaneous report was received from a medical assistant (also reported as office manager) regarding unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On 02-JUN-2017, 05-JUN-2017, 06-JUN-2017, 07-JUN-2017, 08-JUN-2017, 09-JUN-2017, 10-JUN-2017, 12-JUN-2017, 13-JUN-2017, 14-JUN-2017, 15-JUN-2017, 16-JUN-2017, 19-JUN-2017, 20-JUN-2017, 21-JUN-2017, 22-JUN-2017, 23-JUN-2017, 24-JUN-2017, 26-JUN-2017, 27-JUN-2017, 28-JUN-2017, 29-JUN-2017, and 30-JUN-2017, the patients were vaccinated with improperly stored M-M-R II lot # M039913 (expiration date 26-SEP-2018) (route and dose unknown) for prophylaxis. No adverse effects were reported. There was no previous temperature excursion. The temperature excursion was from 32 degrees Fahrenheit (F) to 35 degrees F (34 degrees F) for 300 hours and 47 degrees F to 77 degrees F (52 degrees F) for 250 hours. This is one of two reports from the same reporter (1708USA008995).
Client reported shortness of breath. He states he has had SOB 1 other time. History is HTN on BP meds but did not know name. Client denied being clammy high heart rate or any other side effects. Client monitored for about 30 minutes. He stayed alert and oriented. Denied any recent vaccines.
Two lesions on cheek; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Two lesions on cheek) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN LESION (Two lesions on cheek). At the time of the report, SKIN LESION (Two lesions on cheek) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient had two lesions, one on right cheek and the other on left for a week in 2021. Prescription was delayed due to this.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Headache CHILLS, LEFT ARM SORE, AXILLARY GLANDS UNDER LEFT ARM SORE Narrative:
Information has been received from an office manager concerning a male patient who during the time period of 11-OCT-2006 through 17-OCT-2006 was vaccinated with Pneumovax 23 (lot #s 651437/0899F, 651404/0352F, 651401/0619F and 651328/1046P), intramuscularly.  Subsequently, "within the last 7 to 10 days" the patient experienced swelling and pain in the injected arm.  The patient had swelling down to his wrist and he was being treated with antibiotics.  The physician requested a lot check.  The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory.  The lot met the requirements of agency and was released.  Additional information has been requested.
Red rash on arm almost to elbow, itches, 03/09/2021 Redness gone by 03/10/2021 AM   No treatment
Feb 6th pain in  right calf. Feb 9th 2021 had ultrasound of leg and diagnosed with blood clot.
Patient reports on 4/27/21, she got her first dose of the Pfizer Covid vaccine (County vs outside location?) and 2 days later she noticed red patches on her face, arms, shoulders, chest and back. Not associated with pruritus or other symptoms. Rash eventually cleared up after few days. She was scheduled for her 2nd vaccine dose 5/18. Advised her not to get the 2nd Pfizer vaccine. Discussed her option is to get J&J vaccine 28 days after her last or 1st dose (4/27).  Recent illness:  peritonsillar abscess developed 5/7 requiring drainage 5/10.  Pt given clindamycin and ibuprofen starting 5/10-5/20.  Of note, COVID vaccine is not recorded on vaccination site.
Extreme Pain, swollen area 3-4 inches in diameter and 2 inches out, fever 100, achy joints.
patient was mistakenly given Kenrix instead of Dtap last Oct when the Dtap was due with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via Medical Information (Reference number- 00469719).  This case involves a 15 month old male patient who was vaccinated with DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID VACCINE) [KINRIX] (batch no, expiration date and other dosing details were unknown) for prophylactic vaccination on 20-Oct-2020 and reported that a dose of KINRIX was administered instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] last oct when the dtap was due (wrong product administered).   The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   It was a case of actual medication error due to wrong vaccine administered (wrong product administered, same day of vaccination).   It was also reported :That caller contacted GSK (GlaxoSmithKline) who referred them here. Caller stated the patient was in the office and the doctor wants to give the Dtap but they want to make sure was it ok. Transferred to MIS (management information system).MIS informed a 15-month male, was given Kinrix in error on 20-Oct-2020 (patient was not 18 months as indicated). The Daptacel was ordered, however accidentally gave Kinrix instead. The Dr(doctor) told the mother that the Kinrix vaccine was too soon but should not hurt the patient. The patient was back in the clinic again and getting ready for the next vaccine and they are questioning if the patient should get the Kinrix or the Daptacel. The Daptacel was never used. The HCP (health care professional) just decided to switch to Daptacel to complete the series, despite standard information.  The patient did not have any AE (adverse event) as a result.  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. 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.  There will be no information available on batch number for this case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 48 years, in left arm 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 included: "Diabetes Type 2" (unspecified if ongoing), notes: Other medical history: Diabetes Type 2. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: 4 days after final dose of Paxlovid; (14Jul2022) Negative, notes: negative antigen test; (16Jul2022) Positive, notes: Positive test result 2 days after negative antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
symptoms stated on 9/19/23 of HA, cough, congestion, temp
My son was accidentally given the Hib vaccination at 1 month of age because the medication was confused for the HepB vaccination.  He had no adverse reaction to the vaccination. Per the CDC website, giving the vaccination before 6 weeks can decrease it's efficacy. He is going to complete the vaccination series normally and then we are going to test his titers 6-8 weeks after the last vaccination in the series.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose number unknown, single (Lot number: GJ6665) at the age of 77 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05May2022 as dose number unknown, single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "Supraventricular tachycardia" (unspecified if ongoing), notes: Other medical history: Supraventricular tachycardia; "Knwn allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, including Paxlovid.
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
pt recvd vax & 40 mins following vax was lightheaded, exp tingling & fuzzy vision, & was nauseous & was flushed & warm; sx were treated w/DPH;
Immediately following adminstration of vaccines, patient became pale.  Patient was assessed by physician and was given water and was instructed to remain in the facility for awhile.  After about 15-20 minutes patient was reassessed and was cleared to go home.
Tested positive for Covid-19 after receiving Pfizer Covid-19 vaccines/sore throat and running nose and real bad dry cough; Tested positive for Covid-19 after receiving Pfizer Covid-19 vaccines/sore throat and running nose and real bad dry cough; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 28Jul2021 at 12:00 as dose 1, 0.3 ml single (Lot number: EW0150, Expiration Date: Jul2021), in left deltoid and on 18Aug2021 as dose 2, 0.3 ml single (Lot number: EW0169, Expiration Date: Aug2021) at the age of 56 years, in left deltoid for COVID-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. Past drug history included: Lisinopril for high blood pressure; Atenolol for high blood pressure; Nifedipine for high blood pressure. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "unknown" and all described as "Tested positive for Covid-19 after receiving Pfizer Covid-19 vaccines/sore throat and running nose and real bad dry cough". The events "tested positive for covid-19 after receiving pfizer covid-19 vaccines/sore throat and running nose and real bad dry cough" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) Normal; CSF culture: (unspecified date) Normal; Culture: (unspecified date) Normal; Magnetic resonance imaging: (unspecified date) Normal; SARS-CoV-2 test: (unspecified date) Negative; (09Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PF-07321332, ritonavir (PAXLOVID). Clinical course: she worked on Tuesday (09Aug2022) and Thursday (11Aug2022) and tested on Tuesday (09Aug2022) and Wednesday (10Aug2022) was her day off and had sore throat and running nose and real bad dry cough and she thought was strep throat and they did a rapid Covid test was negative and she was diagnosed having bronchitis as they assessed her. She was given ceftriaxone sodium (ROCEPHIN) 1g IM and a steroid and she said deco and she is unsure of which steroid and she was prescribed levofloxacin (LEVAQUIN) 500 mg once a day for 7 days. She got home had received a message from the Employee health Nurse to call back and the COVID test on Tuesday 09Aug2022 and said she has COVID and she called the doctors office and she had a video appointment and they prescribed PF-07321332, ritonavir.; Sender's Comments: Vaccination failure depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Information has been received from a practice manager and a 38 year old female licensed practical nurse concerning the nurse with no pertinent medical history or no drug reactions or allergy who on 18-MAY-2010 was administering VARIVAX (Merck) (lot# 666693/1707Y, expired date: 04-DEC-2011) to a child and some of the vaccine got into the nurse's right eye. There was no concomitant medication. On 18-MAY-2010, the nurse experienced burning but recovered after the eye was washed out with water. The nurse sought unspecified medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
It's been 5 months since my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow up appended. Which includes First dose start date added and new event is updated i.e.,  It's been 5 months since my first vaccine.
Headache, Myalgia & NauseaVomiting  Narrative: Myalgia, headache, nausea; taking Tylenol; no reaction to previous, no recent vaccines
hives; itching; itchy feeling tongue; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LEK5230), intramuscular  at the right arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization at a hospital. Medical history included allergies with latex, sulfa., and penicillin (PCN). Concomitant medications were unspecified. The patient previously took erythromycin (ERY) and experienced allergies. The patient experienced hives, itching and itchy feeling tongue on 18Dec2020 09:30. Patient took 50 mg of diphenhydramine (BENADRYL), 20 mg famotidine (PEPCID) and 10 mg of cetirizine (ZYRTEC). The patient has not been tested prior and post vaccination. The patient was recovering from the events.
Parotitis-right parotid gland swelling and pain better on antibiotics. Started 6/14/15 MMR given 6/5/15. Had MMR #1 5/5/15.
Information has been received from a nurse practitioner concerning her 17 year old sister who on approximately 17-AUG-2008 was vaccinated with a first dose of GARDASIL.  The patient received a 0.5 mL third dose of GARDASIL while she was pregnant.  Her last menstrual period was in December 2008 and her estimated delivery date will be on approximately 07-SEP-2009.  Laboratories studies performed include a pregnancy test.  The patient sought unspecified medical attention.  Follow up information received from an initial pregnancy questionnaire stated that it was a foreign patient with scabies, with no known medical history and concurrent conditions.  On 09-FEB-2009 the patient received the third dose of GARDASIL (lot # 661531/1311X).  Concomitant therapy includes ELOMET.  It was also reported that the patient's LMP was at the end of January.  Her estimated delivery date is 07-NOV-2009.  Follow up information has been received from the nurse practitioner who reported that on 27-OCT-2009 the patient delivered a male infant (WAES 0903USA02327B1) (weight 7 lb, length 20 inches, head circumference 13 3/4) with umbilical hernia and hypospadias which upon internal review were considered to be congenital anomalies.  There was no complication during pregnancy, complication during delivery or infections/illnesses during pregnancy.  This is an amended report.  The field of pregnancy outcome screen was fetus normal now reads No instead of Yes.  Additional information is not expected.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Adverse event did not occur right after the vaccination. It was a year later. I caught Covid at that time.
This patient began feeling achy within 5 hours after receiving vaccine. The patient also noticed headache, chills; within 2 more hours hands felt tingly, and hands and feet felt cold. Her temperature was 100.5 the next AM and then 2 days later 101.3 in the AM, it resolved by the 3rd day. The patient still felt drug out and fatigued.
shingles/ zoster episode; Vesicle torso; This case was reported by a nurse via sales rep and described the occurrence of herpes zoster in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (multiple episodes of zoster).   On 26th March 2019, the patient received the 1st dose of Shingrix. On 5th April 2019, 10 days after receiving Shingrix, the patient experienced herpes zoster and vesicles. On an unknown date, the outcome of the herpes zoster and vesicles were recovered/resolved.   It was unknown if the reporter considered the herpes zoster and vesicles to be related to Shingrix.  Additional details were provided as follows: The patient developed minor zoster episode with vesicles torso.  In April 2019, the event resolved within several days.  The reporter gave permission to contact for follow up.
Thrombocytopenia presumed DX ITP onset of petechial rash within 24 hours of vaccine admin. Medical records state epistaxis, otitis, melena, ecchymosis, raised skin lesions.msv.  60 day Follow-up Information 06-JUL-2006: Thrombocytopenia resolved after Rx with IVIG.