chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per clinic nurse: Localized redness and warmth to left deltoid, neck and earlobes red. patient with excessive crying and voicing "it hurts" at injection site. Caregivers at bedside giving comfort and cool rags. Patient monitored for 15mins and vital signs remained stable and at 1540 redness improved with cool rags. Patient no longer crying and appears pleasant and smiling.
Received flu shot at 07:30 - 08:00 both eyes red and c/o nausea. 08:45 to Employee Health - shivering nausea vomit. Zofran 4 mg orally, went home.
Day after 1st oral typhoid dose, developed sx of mild diarrhea and episodes of SOB with activity lasting 5-7 mins in duration. Had about 15 episodes of SOB/day. Took 2nd dose and symptoms became more frequent. Took 3rd dose and no further incident. Will stop at 3 doses.
Severe asthma attack that started 5 days after the 1st dose of the vaccine.
PARENTS REPORT INFANT REFUSING TO MAKE EYE CONTACT, NO LONGER COOING, OR TALKING AS MUCH AS BEFORE. MOM FEELS HE IS NOW GETTING BETTER- BUT NOT TO THE LEVEL HE WAS PRIOR TO VACCINES.
Breakthrough case admission after 2 vaccines MOderna 2/19/21 Lot# 015M20A;  Moderna 3/19/21 Lot# 015M20A
Pt recv vax on 6/4/98; 1 hr post vax pt exp stiff jaw & difficulty swallowing
Morning following vaccine had nausea, chills, dizziness, weakness. Cleared by late afternoon.
Information has been received from a licensed practical nurse concerning a 79 year old male with penicillin allergy who on 10/21/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine, in the right arm deltoid area.  On 10/21/2004, in the evening, the patient developed warmth, redness and slight swelling of right arm.  The patient was treated with diphenhydramine hcl and ice pack as needed.  It was also reported that the patient's wife also had an adverse experience and was vaccinated in the same lot.  The reporting nurse requested a lot check.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  Additional information has been requested.
Pt fainted after receiving a flu vaccine injection, feel to floor, hitting her forehead on the floor.
A report was received from a health care professional on 6 January 2003, concerning a male vaccine of approximately 30 years of age who experienced Guillain-Barre Syndrome, and was hospitalized approximately 2-3 weeks after receiving Fluvirin on 20 November 2003. On an unspecified date in 2003, 2-3 weeks after receiving Fluvirin the vaccinee experienced symptoms of GBS. The vaccinee was hospitalized on an unspecified date. The vaccinee experienced symptoms of GBS primarily in the lower extremities. The symptoms had not resolved at the time of the report. The vaccinee had received influenza vaccine (brand unspecified) in the past without any adverse events occurring. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; fluzone quadrivalent np administered to a patient that has been exposed to a temperature excursion with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a Nurse. (Agency Inquiry Number: 01228367)  This case involves a 21-year-old female patient who has been administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after being exposed to a temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunization; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunization; and Varicella Zoster Vaccine (Varicella Vaccine) for Immunization.  On an unknown date, reportedly fluzone quadrivalent np has been exposed to a temperature excursion with no reported adverse event (product storage error).  On 09-Aug-2022, the patient has been administered fluzone quadrivalent np at dose 0.5ml once via intramuscular route in the left deltoid (lot U7684BA, expiry date: 30-Jun-2023) after being exposed to a temperature excursion with no reported adverse event (poor quality product administered) same day latency. It was not the first-time vaccine was administered.  Action taken: Not applicable. The patient was not using the product at time of report.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for both events.     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.
Patient received 1st dose of Moderna on 4/24/2021. At a vaccine site on 12/16/2021, he received the Pfizer vaccine. Today, 12/17/2021, patient indicated he felt sick.
This patient was given a booster dose when he is not 18 years of age, he was 17 at the time of immunization. Not immunocompromised per screening paper.
Covid19 breakthrough.  Vaccine received on 05/28/2021.  40 y/o PMH of bipolar and DM presented to ED with 1 week history of being Covid + and attempting to treat at home.  Pt c/o progressive SOB, Cough, Fever.  Room air sat 88%, pt placed on O2 at 5L NC.  CXR with extensive Bilat Bronchopneumonia.  Pt treated with IV ABX/ IV Steroids and Remdesivir.
Friday Sept 10, 2021, I went to clinic where I had got my first two and received the 3rd jab of Moderna (full strength).  I had headache and body aches.  That evening I had chills.  In the morning, when I felt better I took my temperature and it was 3.5 deg above normal.  Four days later on Sept 14 I had a tired feeling, chest pain, etc.  I had Myocarditis, caused by a virus, when I was 17, and this felt exactly the same.  Pain in Heart. Feeling like my lungs had concrete in the bottom.  Unable to take a full breath of air.  Weakness.  9/19/2021 Low O2 Sat Morning 84. Evening  74.  95+ since then. 9/20/2021 Prednisone to reduce inflammation.  I have been on bed rest for more than 2 months.   10/8/2021 Negative Covid Test.  I have never had Covid.  Every day I feel better.  Less Angina, less tired,   Moderna First Dose 1/27/2021, Second Dose 2/24/2021.
This spontaneous report was received from a pharmacist via Pfizer refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. On an unknown date in 2017 (reported as 2 years ago), the patient did not receive the second dose of PNEUMOVAX 23, when the patient was supposed to get vaccinated.
Pneumonia due to COVID-19 virus; Shortness of breath; Acute respiratory failure with hypoxia
Fever, fatigue, muscle aches, joint pain, headache, and swollen lymph nodes.
Large Swelling in left arm upper muscle tissue. Warm to touch. Describe by urgent care physician (3/1/21) as "grapefruit size". Pain and limited mobility lasting for 5 days. Initially treated with ice compress and Tylenol.  Large mass is still present 6 weeks later.   When I went for my 2nd dose, the doctor on site recommended seeing physician.  I saw my doctor 3/31/21. She recommended tests listed below. The recommendation from MRI results is surgical removal of the mass which measures 7.6x8.0x10cm
My arm  started hurting pretty much right away after I got the shot on Tuesday and hurt badly all day Wednesday.  When I woke up Wednesday morning, I felt nauseated and light headed.  My rectum and anus felt like they were on fire when I passed stool at 8:30 AM on Wednesday, then I almost fainted walking  from the bathroom back to my bed.  My skin hurt and I felt feverish all day, although I didn't actually have a fever.  I was awake for fewer than 6 total hours on Wednesday, all of them lying in my bed.  On Thursday I had some joint pain and muscle soreness, but was otherwise ok.  By Friday morning I felt fine.
2 days after gettin first shot, I experienced fever, swelling, itchy, rash at injection site, chest pain over my heart, and could not lift my arm very high. The chest pain caused difficulty taking in deep breaths. I was advised by my dr to head to minor emergency asap. I went in, they ran a few lab tests and a catscan on me and determined that when I had been injected, the sciatic nerve in my left arm had been impacted and was causing all the pain I was experiencing. The rash itchy and swelling was from the covid vaccine. A urine sample determined that I also had the beginnings of a UTI but the dr was unsure if that had any relation to the covid vaccine. I was prescribed antibiotics for the UTI
I started feeling like I had a bad cold, stuffy, coughing, but no fever, and my eyes hurt.  The next day I was running a fever, coughing more, and felt overall sick.  I got really sick and I was worried about my self with same symptoms with body aches, coughing, fever.  I just hurt all over.  I contacted my doctor office as soon as I tested positive for COVID-19.  I was short of breath but I never felt like I was struggling for a breath.
Narrative:  Patient completed Pfizer COVID-19 vaccination series in Feb 2021. Had a persistent cough for 6 weeks before presenting to hospital and tested positive for COVID-19. Admitted and treated with oxygen, dexamethasone, and remdesivir. Discharged home 8/21/21. History significant for multiple myeloma and taking lenalidomide 21 days on, 7 days off May 2020 to present previously with dexamethasone which was stopped April 2021.
Patient's son, called PCP office at Healthcare and reports that patient was given an erroneous, extra booster dose of Pfizer on 10/21/21 at her rehab facility. He said that the rehab facility called him and asked for his permission for the booster dose and he gave permission, not realizing that patient received a booster dose on 10/11/21 while an inpatient at Healthcare Hospital.
sore arm; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PAIN (achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PAIN (achy). At the time of the report, PAIN IN EXTREMITY (sore arm) and PAIN (achy) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-057817 (Linked Report). This case was linked to MOD-2021-057817; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057817:2nd dose case
PCR test Positive; PCR test Positive; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 29 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EL3247) as dose 2, single and administration date 02Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 01Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "PCR test Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Ag test; Test type: Unknown; (05Jan2022) negative, notes: neg AG; Test type: Unknown; (02Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: The seriousness of the case was reported as non serious. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
I had frequent Premature Ventricular Contractions (PVC's). I have worn a monitor for that a long time ago. I started noticing the PVC's again around January 2022. I started wearing a monitor again and was getting PVC's again along with Ventricular Tachycardia (VT). It was NSVT, very short bursts of it. The doctor ran more tests. I wore the heart monitor again on 04/28/22. The PVCs were less but the VT was not less. I started taking Metoprolol 25mg extended release. I take half a tablet in the morning and half a tablet in the evening. The next plan is to go see an Electrophysiologist in June 2022.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unspecified dates on 1999 the patient was vaccinated with two doses of RECOMBIVAX HB. Doses, routes, frequency, lots numbers and expiration dates were not provided. No other suspect or concomitant therapy was reported. The pharmacist stated that the patient would like to receive a third dose now. No adverse symptoms were reported. Additional information is not expected since there is no contact information.
This case was reported by a other health professional via call center representative and described the occurrence of tingling of extremity in a 59-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity, numbness of upper extremities and muscle pain. On an unknown date, the outcome of the tingling of extremity and muscle pain were unknown and the outcome of the numbness of upper extremities was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, numbness of upper extremities and muscle pain to be related to FLUARIX QUADRIVALENT. Additional detains were provided as follows: The age at vaccination was not reported. The patient experienced tingling of extremity, numbness of upper extremities and muscle pain in left arm after receiving FLUARIX QUADRIVALENT on left deltoid. No other information was provided by the reporter.
Arm hurt; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Eczema and Anaphylactic reaction (anaphylactic experiences). Concurrent medical conditions included Rheumatoid arthritis and Allergy. Concomitant products included ADALIMUMAB (HUMIRA) and EPINEPHRINE (EPIPEN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and HEADACHE (Headache). On 01-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-044581 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received on 22/Jul/2021:Does not contains ant new information
Patient presented to the vaccination site on 12/27/21. Patient stated to vaccinator that she had a severe allergic reaction to her first dose COVID Pfizer vaccine. Vaccinator alerted RN. Patient stated that her PCP prescribed her 25mg oral benadryl TID 12/06/21-1/03/21 and was given an epi-pen to bring with her for COVID second dose vaccine. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer second dose. Per CDC guidance, approval to proceed with COVID vaccine Janssen second dose was obtained from medical consult team, Vaccine Operations Lead, RN via text message. Client received COVID vaccine Janssen Lot# 1855191. Patient was asked to stay in observation for 30 minutes. Patient alerted EMT and stated that her throat felt tight and she felt warm. EMT alerted RN and other RN. EMT took patients vital signs. BP:136/86, HR: 103, O2: 98%. Patient stated that she felt warm and that her throat felt dry and tight. RN called EMS at 1709. EMt retook patients vital signs at 1714. BP: 136/80, HR: 79, O2: 98%. EMS arrived at 1716. EMS assessed patient. Patient signed AMA form at 1722. EMS left vaccination site at 1722. Patient was asked to stay an extra 30 minutes for observation. EMT retook vital signs and reassessed patient at 1735. BP: 138/86, HR: 91, O2: 99%. Patient still felt like her throat was dry but it did not feel as tight. Patient stated that she no longer felt warm. EMT retook vital signs and reassessed patient at 1745. BP: 132/86, HR: 85, O2: 97%. Patient stated that her symptoms are improving. Patient stated that she is no longer hot. Patient completed her extra 30 minute observation. Patient left vaccination site at 1746 with her husband unassisted and with a steady gait.
CAUGHT A COLD OR SOMETHING SIMILAR; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR). At the time of the report, NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR) had not resolved.            No concomitant drugs were taken. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  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.
Miscarriage; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, NDC number, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jun2021 (Age at vaccination: 37- years-old) as dose 2, single (patient partner got both doses) for COVID-19 immunization. No medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine which the patient partner took was BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that the stated that she was not sure if it was a reportable event, but her partner got both doses of the vaccination and she got pregnant after he was fully vaccinated (03Jul2021) and she miscarried (14Aug2021), she did not get the Pfizer COVID-19 vaccine but her partner got both doses, she did not have her partners vaccine card to provide the NDC/LOT/EXP or dates of vaccination from it. She says she believes her partner got both doses of the vaccine and was fully vaccinated in Jun (unspecified date). She was experiencing the miscarriage/miscarrying now (14Aug2021), which started Saturday, and she just left the doctor's today (unspecified date) and she confirmed that it was dead. The patient underwent lab tests and procedure which included pregnancy test: positive on 03Jul2021. The event miscarriage was considered as serious (Medically Significant). The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness, hypertensive immediately after vaccine. By. 9/20/21 pt has been having ongoing headaches, dizziness, blurred vision, nausea, difficulty performing well at work
Vaccine administered at 1500. Fever began at 2100, vomiting at 2200. Profuse vomiting for the next 18 hours with fever to 102.8 degrees F. The fever resolved to return the next day to 99.5.
Information has been received from a doctor and mother of a consumer who reported that she had read medical literature of a similar case to her daughter. She did not have details to report and was concerned her case might be an additional case for this literature report. The medical literature reported that there was an associated case of a patient with asthma that had rhabdomyolysis after receiving GARDASIL of unknown dose at an unknown time on an unknown day. It was unknown if the patient sought medical attention. The action taken and the status of the patient were unknown. Upon internal review, rhabdomyolysis was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient. This is one of several reports received from the same source. The case of the reporter's daughter was captured in WAES# 1109USA00548. Additional information has been requested.
According to daughter, pt was incoherent almost immediately (a day later) after receiving shot; and still "not right". Apparently pt was taken to hospital where test were run but nothing came back.
11$0am Patient completed getting vaccine and walked to Post observation. Patient sat down and right after he sat down, he immediately felled head first on the floor. Nurse sat patient up and vital signs were taken. AOX3. B/P 120/78. P86. Patient was cold, clammy and sweating. Assess patient noted left bruise on head, posterior left side abrasion of head. Pt. stated that he has not eaten today. History of fainting.  Pt. continued to sit on floor and evaluated for additionally twenty minutes. Gave patient protein bars and water.  Pt. stood up upon completed time and states he will make appointment with doctor.