chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history did not included any pregnancy. The subject did not use contraception. On 1 may 2014, the subject received unspecified dose of BOOSTRIX 9.5 ml, intramuscular, unknown injection site). Subject's last menstrual period was on 28 September 2013 and estimated date of delivery was on 04 July 2014. The type of conception was normal. The subject was exposed to the vaccine during the 3rd trimester. The prenatal testing showed no evidence of a defect. At the time od reporting, the pregnancy was ongoing. This was one of the 3 pregnancies received from the same reporter. Follow-up information received on 22 July 2014: Subject's details, VAERS informations and vaccine responsible physician were provided. An unspecified number of pregnant women received BOOSTRIX. Follow-up information received on 01 October 2014: This pregnancy was a normal conception. On 10 July after 41 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by normal vaginal delivery. The infant had an Apgar score of (6-9), a weight of 3.223 kg. The mother did not experienced an adverse event. Follow-up information received on 06 November 2014: The delivery date was updated from 10 July 2014 to 09 July 2014. The baby's length and head circumference at birth were not available.
shingles; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 66-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-JAN-2016 (also reported as on about that date), the patient was vaccinated by the pharmacist with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced shingles and was treated by a healthcare provider due to that event. The patient claimed damages as a result of: injury to themselves; economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown.  The reporter consider the event of shingles to be related to the suspect vaccine.  The relatedness between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Painful nodules in arm and breast after 1st dose; Painful nodules in arm and breast after 1st dose; Arm warm after 1st dose; Arm swollen after 1st dose; Arm hurts after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Painful nodules in arm and breast after 1st dose), VACCINATION SITE NODULE (Painful nodules in arm and breast after 1st dose), VACCINATION SITE WARMTH (Arm warm after 1st dose), VACCINATION SITE SWELLING (Arm swollen after 1st dose) and VACCINATION SITE PAIN (Arm hurts after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) 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) 1 dosage form. On an unknown date, the patient experienced BREAST MASS (Painful nodules in arm and breast after 1st dose), VACCINATION SITE NODULE (Painful nodules in arm and breast after 1st dose), VACCINATION SITE WARMTH (Arm warm after 1st dose), VACCINATION SITE SWELLING (Arm swollen after 1st dose) and VACCINATION SITE PAIN (Arm hurts after 1st dose). At the time of the report, BREAST MASS (Painful nodules in arm and breast after 1st dose), VACCINATION SITE NODULE (Painful nodules in arm and breast after 1st dose), VACCINATION SITE WARMTH (Arm warm after 1st dose), VACCINATION SITE SWELLING (Arm swollen after 1st dose) and VACCINATION SITE PAIN (Arm hurts after 1st dose) outcome was unknown.        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.   No treatment information was provided. No relevant concomitant medications were reported.
This spontaneous report as received from a nurse refers to a 69-year-old female patient with no drug reactions or allergies. No concurrent conditions or medical history were provided. On 26-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection administered intramuscularly (lot # M006139 with expiry date: 13-MAY-2017; strength, dose and site of administration were unspecified). Concomitant therapies included PRADAXA. On an unspecified date in 2016, the patient developed redness and pain which radiated to elbow. No laboratory tests were provided. The nurse stated that the patient was treated with BENADRYL and TYLENOL for pain. The symptoms subsided after a couple of days and patient was fine at the time of this report. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Initial misuse report received from a healthcare professional (nurse) on 23 October 2013 and the case was received on 21 March 2014. A 26-month-old patient (gender was not provided) had received first dose of 0.5 ml of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
A few minutes after I got the 1st shot, body felt warm and tingly. Then I had a small seizure according to the tech, but did not lose consciousness. The whole incident was less than 10 secs. He said my eye movement rapid. 9 days later, felt the same previous symptoms, but did not have a seizure.
NONE Administration error - patient was given 1 ml of Moderna COVID vaccine instead of 0.5 ml
Post vax, the pt developed tachycardia, drowsiness, fatigue, malaise, vertigo, rash, flushing, nausea, and fever of 102. After the fever broke the pt developed a strep infection due to decreased immune system.
About a week after the second dose, he started a cough that grew worse and he still has the cough today. He's still seeing the doctor and needs more tests.
EXTREME NAUSEA & VOMITING LEADING TO DEHYDRATION AND BLACK OUT.  INJURIES FROM BLACK OUT CAUSED HOSPITAL STAY OF 2 DAYS
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age. It was reported that many patients came into the office later than recommended schedule in the GARDASIL prescribing information. Number of patients and lot numbers were unspecified. No adverse effect reported. Additional information has been requested.
Minutes after dose, client felt "tired."  Sat him down and gave him juice which he drank voraciously.   14:24 168/100-95-18-O2 sat 98% on room air 14:29 160/90-95-18- 99% Room AIr  Drank second juice. States he ate this am Coughing deep moist cough, laughing.  States he feels better. Encouraged to see PCP for BP.  States he was just at a clinic. Discharged ambulatory with steady gait.  Escorted to car in  clinic vehicle.  12:31
No inflammation at deltoid but very stiff neck & torticollis within 24h. Lasted 72 hour left trapezius & subscapular pain.
A little temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (A little temperature) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back discomfort (The patient has some back issue and the procedure scheduled on 25 Feb 2021.).    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (A little temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (A little temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt received moderna series and pfizer booster
Narrative: Patient received two doses of Pfizer COVID 19 Vaccine and one dose Moderna COVID 19 vaccine on 26 March 2022. The patient tested positive for COVID 19 on 27 April 2022. The patient presented to the ED on 27 April 2022 with chest pain and shortness of breath for one month. The patient was admitted to the hospital with elevated troponins (NSTEMI), acute kidney injury, pericarditis, and myocarditis. The patient was treated with steroids, antibiotics, and electrolyte replacement. The patient was intubated on 28 April 2022 due to respiratory failure and acute coronary syndrome. The patient started CRRT (dialysis) on 2 May 2022. The patent died on 12 May 2022. Reported per EUA.
Pt developed severe hives which began approximately 5-6 hours post vax lasting 4 days. Pt was treated with Benadryl and ultimately Zyrtec.
12cm x 15.5 cm indurated erythemtous tender rash around injection site with small purulent discharge from injeciton point
Immediate spike in heart rate and numbness in left side. Dizziness and headache. Since my shot i have Had persistent tachycardia above 100. Average heart rate is 130bpm. Full cardiac work up and diagnosed with dysautonomia
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
PATIENT GOT FIRST MODERNA DOSE 03/11/2021 AND SECOND DOSE 04/08/2021 AND PASSED AWAY ON 04/14/2021
surgery on leg; Pain in other leg; This spontaneous case was reported by a consumer and describes the occurrence of LIMB OPERATION (surgery on leg) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced LIMB OPERATION (surgery on leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in other leg). At the time of the report, LIMB OPERATION (surgery on leg) was resolving and PAIN IN EXTREMITY (Pain in other leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown dates, the patient had surgery on leg. The patient was recovering from surgery on her leg. It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  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.  Company comment: This spontaneous case concerns a 63-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of limb operation an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of limb operation an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chest pain, swelling of lymph nodes on left side, upper back pain, arm pain, Shortness of breath
PT RECEIVED JANSSEN ON 4/29/21. WHILE IT WAS BEING REPORTED INTO TENNIIS THERE WAS PREVIOUS DOCUMENTATION OF PFIZER 0.3 ML ON 4/9/2021 AT HOSPITAL.
body ache; fatigue; Lot of itching (mainly in the eyes, throat and face); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)) 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 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 (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)). At the time of the report, PAIN (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1st Vaccine 8-10  hours after the injection my arm was sore. I was tired.  7 days later I started itching. It is severe. I have to ice it to get relief. It wakes me up at night. It hasn't stopped.  Today is 3  1/2 weeks. 2nd vaccine  8-10 hours later sore arm, fever for 24-30 hours.
Ended up in the hospital with a d dimmer level if 5000 Massive headaches. Was checked out and did not have blood clots. Have had strange sensations in legs since the vaccine. Lost the use of my arms completely and wasn't able to do easy tasks like thread a needle. I'm still neurologically impacted acted with fine motor movements.
03/27/2001 had red dots on lips and back; on 3/17/01 and 3/18/01 had diarrhea.
Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm.  Also had diarrhea twice in between vomiting, and was shaking occasionally.
Initial report received from a pharmacist on 14 Sep 2010: This patient was vaccinated with FLUVIRIN (batch number 111799P1), 0.5 ml intramuscularly, on 14 Sep 2010. The reporter stated that the patient received an influenza virus vaccine (unknown manufacturer) a week prior at another pharmacy. No adverse events were reported since administration.
Vomiting at 10:30. Watery diarrhea until about 1:00 am
Patient received the Moderna COVID Vaccine on 29 January, at which time she was 7 weeks pregnant.  No other comorbities noted.  On 01 February she had a miscarriage. She also received the first dose while pregnant, first dose was given on 30 December 2020 and she was 3 weeks pregnant
Arm soreness and 3 red areas at injection site. Lasted 5 days. Fatigue lasted 4 days. Fever x 1 day. Malaise x 4 days.
long term side effect vomiting mucus; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (long term side effect vomiting mucus) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VOMITING (long term side effect vomiting mucus). At the time of the report, VOMITING (long term side effect vomiting mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (long term side effect vomiting mucus) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VOMITING (long term side effect vomiting mucus). At the time of the report, VOMITING (long term side effect vomiting mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
RASH ON LEFT SIDE AND CHEST STARTED ON 3/30 6 P.M.
Patient had a 2 inches long and 1 inch wide red spot on her arm and slightly raised.
tiredness; headache; muscle pain; chills; fever; nausea; swollen nodes; feeling totally unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the left arm on 13Mar2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 14Mar2021 at 00:00, the patient experienced tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell for at least 9 days so far. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 05-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcome of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Patient received Anthrax vaccine on 5/18/14. Experienced cold sweats, nausea and headache. Also stated an upset stomach. Went to hospital ER on 5-19-14. Was treated for flu like symptoms and released. Given TYLENOL, ibuprofen and ZOFRAN.
On March 9, 2021 I received my first dose of Pfizer.About 4 hours later I bent my left knee for about thirty mins and stood up. I couldn't even put weight on my left leg. My muscles were so tight and strained in my left leg. It felt similar like bruising around my knee and all the way up to my quads. The following day, I rested and iced my leg all day. I couldn't go back to my regular routine of working out until Thursday. However, I was limping until Friday morning. March 13th, my leg is still tight and strained. It hasn't gone back to normal.
Office Visit 10/18/2021 Family Medicine Chronic obstructive pulmonary disease, unspecified COPD type, Essential hypertension  Sinus congestion  COVID-19 Dx Sore Throat  1. sinus congestion and coughing    MAB Infusion Treatment Team 10/21/2021 O2 sats > or = 90%   Signs of potential reaction reviewed with patient.   Tolerated IV start and MAB infusion without complication.
The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.