chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax in spring of 1990 & pt developed sx highly suggestive of MS; had numbness in the extremities & loss of balance that worsened & improved unpredictably; single MRI of the brain was inconclusive; addt details are being requested;
Right thigh rash 24 hours later. First pruritic like hives, then blisters 3 days later.
Patient reported she started to cough very hard and then having difficulty breathing. This was later in the day after receiving Flu shot. Her daughter gave her BENADRYL and she was fine this morning.
No additional AE was reported; an expired PROQUAD vaccine that was administered to a patient; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 02-NOV-2021, the patient was vaccinated with the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # T013541, expiration date; 17-OCT-2021) used as directed for the prevention of Measles, Mumps, rubella and varicella (expired product administered). No additional adverse event (AE) was reported.
I was the pharmacist who gave patient(pt) a PREVNAR 13 ON MONDAY and Thursday, I just happened to counsel the same pt and she told me she got itching since monday. She tried benadryl but it did not resolve so pt went to emergency thursday and ER gave her prednisone. Patient did not call us but pt was fine. I called doctor who wrote pt a presciption but office is closed today, so i will leave the note for manager to call dr. office monday to let doctor know
patient received a dose of Tenivac on 22nd of Oct that had expired on the 12th of October2020, No AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from an other healthcare professional.  This case involves a 18 years old male patient who was administered with0.5 ml expired first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U6091AA and expiration date: 12-Oct-2020) via intramuscular route in left deltoid for prophylactic vaccination on 22nd of October 2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included INFLUENZA VACCINE ; HPV VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.
Lack of response - information has been received concerning a 25 year old male who in August 1997 and october 1997 was vaccinated with the first and second doses of varicella virus vaccine live .  In 2000 laboratory evaluation revealed a lack of response.
Patient said injection site was inflamed and sore for a few days. For a few weeks now the pain goes away during the day and shoulder pain occurs again later in the day.
Patient reported chest pressure/tightness to center of chest with difficulties taking a deep breath.  Per pt, completed 30 mins of observation after receiving Pfizer booster and left the building to go to Bank. Developed chest tightness there and drove back to building. Vitals obtained and patient evaluated by MD.
The pt experienced a cellulitis reaction to the vaccine site. The pt sought unspecified medical attention. No further details were provided.
blood pressure is higher than normal; heart rate is higher than normal; mild headache; soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), HYPERTENSION (blood pressure is higher than normal), HEART RATE INCREASED (heart rate is higher than normal) and HEADACHE (mild headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and COVID-19 in September 2020. Concomitant products included ERGOCALCIFEROL (VITAMIN  D) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (soreness) and HEADACHE (mild headache). On 02-Feb-2021, the patient experienced HYPERTENSION (blood pressure is higher than normal) and HEART RATE INCREASED (heart rate is higher than normal). At the time of the report, PAIN (soreness), HYPERTENSION (blood pressure is higher than normal), HEART RATE INCREASED (heart rate is higher than normal) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
t101.8 mom says on 10DEC94 & was seen in hosp ER; mom says was told nl react to shots & needs to cont shots;
Normal chills and chills where my body was uncontrollably shaking; Stomach pain; Body aches; Sore arm; Fever highest 103.6; Diarrhea; Normal chills and chills where my body was uncontrollably shaking; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 07:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to sulfa medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allium sativum (garlic) (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and colecalciferol (VITAMIN D3); all on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 18:00, the patient experienced chills both what patient said were normal chills and chills where her body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm. On 29Apr2021, the patient underwent body temperature and the result was 103.6 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, and 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 normal chills and chills where body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Large red, itchy welt on arm just below injection site of Moderna vaccine appeared 12 days after vaccination
Vaginitis; This is a spontaneous report from a contactable healthcare professional.  A 22-month-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm from 23Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced vaginitis on 24Dec2020 13:00 which was reported to be treated with an unspecified OTC. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient was recovering from the event.   Information on the batch number has been requested.
4 mo imms 3-20-17. Woke with fever to 102.1 - fussy. No other sx.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Immediate numbness on left side of my body (arm, face); burning sensation in my face; face felt droopy; lightheaded; nauseous
Booster vax w/ hepta B given on 01Dec90; Feb91, titer results borderline.
4/28/08 bruises, petechiae-no fever. 06/20/2008 MR received for DOS 4/28-30/2008 with DX: ITP-responsive to 2 doses IVIG.  Mild anemia-etiology?. Infant presented from local hospitala generalized petechial/purpuric rash and marked bruising, mostly on bony prominences. Tx with IVIG. F/U 5/16/08 with continued bruising on arms and and shins, few petechiae on soft palate. Will f/u as outpt.
extreme immune? reaction, starting around 11 pm the same day of reaction, including high subjective fever, delirium, repeated episodes of syncope, extreme weakness lasting 2-3 hours.  overall -  flu like symptoms that  lasted 36 hours post injection.
On 01/09/2002 pt stated rash to entire body onset on 01/08/2002. Pt was referred to ER for evaluation. On 01/17/2002 pt seen in clinic she was told rash/itching could have been due to TD.
Injection site rash,  ~3 inches long and ~1 inch tall. It is warm to the touch and slightly raised. Rash not present after first injection. Slightly lethargic, no body aches, arm is not tender. Started this morning, 8/25.
a patient that received an expired dose of the Moderna booster (3rd dose) vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) vaccine) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a patient that received an expired dose of the Moderna booster (3rd dose) vaccine) had resolved.      No concomitant medications were reported.  No treatment information was reported.
Pt states that 1 week after Immunization was given he noticed achy elbows bilaterally. Both forearms also had muscle aches. Additional information from 12/23/02: Bilateral elbow aches have resolved. Additional information from 01/27/03: Forearm pain continues without change.
first night i had rapid pounding heartbeats ,trouble sleeping, four bathroom trips in a half hour. later in the day flu like symptoms ; aches, chills, etc.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe
Patient reported not feeling well about 5 minutes after injection and became unresponsive for a couple minutes as I was talking with patient.  Patients eyes were open but was unable to respond to a verbal question for a couple of minutes .  After that she said she just didn't feel well. We called the paramedics and they checked her and released her. Husband also was called and ended up driving her home. Pt felt much better by the time she went home.
Expired vaccine administered to 10 patients (Patient 6 out of 10); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was stored in refrigerated condition under 38 to 40 Fahrenheit. On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality detected during visual inspection. No temperature excursion or no puncture had been happened.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Per mother patient had a fever 8/22 in the evening she noticed that her left arm was swollen, red and hot. She gave her TYLENOL. On 8/23 and 8/24, she felt warm. On 8/24 area was itchy - she applied anti-itch cream. 8/25 - area still red, hard, and hot. Approx 1 1/2" diameter. "It's getting better" 8/27 per mother.
First sign was a headache and nausea.   Several hours later, I received chills, sweats and body aches for two days.  One the second day, in the late evening I had a fever of 101,   The chills, sweats and body aches continued,   On the third day, I started feeling better, but very tired.
Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with GARDASIL that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Arm pain; tiredness; body aches; flu; chills; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 10:45 AM, single dose for COVID-19 immunisation. The patient's medical history included Clindymycin sulfas allergy and she was diagnosed with COVID-19 Prior to vaccination. The concomitant medication was not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not disclose other medications which she received within 2 weeks of vaccination. The patient experienced Arm pain, tiredness, body aches, feel like I have the flu, chills on 31Jan2021. She did not receive any treatment for adverse event. The outcome of events was reported as unknown. Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt received flu vaccine in left deltoid and then Menactra in right deltoid;immediately after Menactra given as bandaid about to be applied,pt became very pale and faint.Pt was assisted to a supine position and then noted to be very red in the face,eyes staring,unresponsive,arms and legs tonic for approx 10 seconds.Immediately afterwards pt talking and responsive.examined by Dr. Pt given juice and crackers and remained supine for approx 20mins then allowed to sit but pallor returned slightly so he reclined again.After further 20 mins pt gradually acheived a sitting position.Eventually able to leave office in a wheelchair expressing acute hunger for lunch.
arm and leg convulsions; Shaking; sweating; eyes were getting blurry; dizziness; the patient had to go to the toilet for an immediate bowel movement; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONVULSIONS LOCAL (arm and leg convulsions) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue syndrome and Immune disorder (NOS).    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced CONVULSIONS LOCAL (arm and leg convulsions) (seriousness criterion medically significant), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea). At the time of the report, CONVULSIONS LOCAL (arm and leg convulsions), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Lab details were not provided. No relevant concomitant medications were reported.  Company comment: 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.
After taking this vaccine, Patient suddenly had an allergic reaction all over his body. He broke out in hives and had shortness of breath. He continues to have hive reactions ever since that day. He developed eczema and itches until he bleeds.
Reaction to first dose of Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (Reaction to first dose of Moderna Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction to first dose of Moderna Vaccine). At the time of the report, ADVERSE REACTION (Reaction to first dose of Moderna Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concominant medications were not reported.  Treatment information was not provided.
A report has been received from consumer concerning a 42 years 6 weeks 5 days old, female patient, height 63.0 inches; weight: 131.0 pounds. Patient relevant history and concurrent diseases were not provided. Concomitant medications included acetaminophen for flu symptoms. Patient recent nasal FLUMIST (Intranasal), 0.2 milligrams, once/single administration during 2015. She was diagnosed with the flu via nasal swab on 06-Mar-2016. She was then on TAMIFLU 2 pills daily for 5 days. FLUMIST Quadrivalent was continued. At the time of reporting, flu was ongoing. The company physician assessed flu to be non serious.
"Bruise or a red rash" at the injection; "Bruise or a red rash" at the injection; Peeling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number M57C5, expiry date 9th April 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 10 days after receiving Shingrix, the patient experienced injection site bruising, injection site rash and injection site exfoliation. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved and the outcome of the injection site rash and injection site exfoliation were unknown.   It was unknown if the reporter considered the injection site bruising, injection site rash and injection site exfoliation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the left arm and developed a bruise or a red rash at the injection site 1.5 weeks later. She stated the site looked better but was peeling. The reporter did not consent to follow up. The reporter did not have further information.