chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm very sore and itchy starting 2 days after injection. Rash appeared  later in the 2nd day. Injunction site red, swollen to size of golf ball, and hot. Reaction gone  5 days after injection.
pain throughout right arm lethargy/exhaustion for 2 days mild fever insomnia headache
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
PASSED OUT AND HAD 2 GRAND MAL SEIZURES LOST CONTROL OF BLADDER X 2.
redness/swelling, itching @ inject site lightheadedness, & fluttering heart are reported in pt receiving fluogen vax; pt exp immed redness & swelling @ site w/c/o lightheadedness & heart fluttering; itching;
red rash covering upper arm after 2nd dose.  red swollen painful rash one week after first dose also at injection site (left arm)
Booster shot on 10/23/21 - on 11/3/21 woke with red itchy scalp took Claritan which helped - on 11/4/21 woke with red, raised hives.  Took Claritan again -  a few hours later it had gotten worse.  Seen at doctor's office given 8 day course of prednisone - hives continued throughout the 8 days - seen by allergist.  Allergist did not believe it was in response to environmental or food cause given the length of hives and believed given my auto-immune history and history of getting hives likely due to something else that my body was reacting to such as stress or possibly the booster shot - but not able to be certain.   Today is 11/11/21 - I am currently taking pepcid and Zyrtec with hives still occuring but not as severe - I would still get the booster again if deemed necessary.
This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route were not reported), lot # M025192 and expiry date: 21-MAR-2019, lot # M020102 and expiry date: 08-MAR-2019, lot # M025194 and expiry date: 22-MAR-2019. No concomitant medications were reported. The vaccine was exposed to a temperature frame of 34.5 Fahrenheit for 100 minutes. A data logger was involved. There were no previous excursions. No adverse events were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Headache, overall all body pain, muscle pain, tiredness all worse than when I had Covid in august.
Delayed redness/warm to touch around injection site worsening on Day 8 post vaccine with itchiness. 2.25 inches by 2 inches in size
R thigh redness swelling minimal pain no induration 1 day after immunizations. Lesion on DTaP and varicella site. Likely from DTaP.
sore arm; mild headache; This is a spontaneous report from a contactable consumer reporting for himself. A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202 (EN6200: as reported in field)), via an unspecified route of administration, administered in Left Arm on 05Mar2021 at 11:45 as single dose for COVID-19 immunization. The patient's Medical history included High blood pressure, and overweight. The patient did not have COVID prior to vaccination. The patient did was not tested for COVID post vaccination. The patient did not take any other vaccine 4 weeks prior to COVID vaccination. The patient's concomitant medications included paracetamol (TYLENOL), ibuprofen, tadalafil (CIALIS), probiotics, and lisinopril. On 05Mar2021 at 13:00, the patient experienced sore arm, and mild headache. Therapeutic measures were taken as a result of events: treatment included Tylenol and Ibuprofen. The outcome for the events was resolved approximately on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 10-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from  6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter; Sender's Comments:  US-009507513-2001USA009007:
About 14 hours after vaccination, broke in a rash with a high fever of 102. Rash was at the top of both thighs. Went to a dermatologist and was prescribed Triamcinolone Steroid Cream. After using for 2 months rash went away.  Noticed that I had gotten some sun the day before in the exact places I had the rash. Three days before this vaccine  my new doctor had a heart monitor placed because I was starting to feel some heart fluttering, and I had Atrial Fibrillation 20 years ago. While my heart was being monitored I felt my heart fluttering every once in a little. Doctor said Premature Atrial Contraction was detected.
Initial report was received from another manufacturer, who received the report from a health care professional on 22 February 2012 (Service Request Number 1-4889096556). A patient (age, date of birth and gender not reported) had received an injection of ADACEL, sanofi pasteur Ltd. (lot number, date, site and route of administration not reported) and an unspecified amount of time later developed tachycardia and swelling. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Unfortunately, he contracted the virus; Unfortunately, he contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Unfortunately, he contracted the virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2-3 hrs post vax, exp abdominal pain, tiredness, HA, nausea. Transported to local hospital.
Severe bilateral swelling in both feet / ankles to shin Severe body aches x2 days Slept x 17 hrs. Saw Cardiology- Attached consult pt still suffers from leg edema  HPI: I had the pleasure of evaluating patient at your kind request. As you know, she is a 78 yr old female with a history of edema, rheumatic fever as a child, back problems s/p multiple interventions.  Swelling of b/l lower extremities occurred within week of first COVID vaccine. Seemed to slightly improve. After second dose of COVID vaccine, swelling re-occurred and lasted for months. She still has some swelling, but it's much improved. She wears comression stockings every day. She also takes furosemide.  Denies dizziness, lightheadedness, fatigue, syncope, chest pain/pressure/tightness, palpitations, fluttering sensation, pounding in chest, dyspnea, DOE, PND. Denies hematuria, hematochezia, melena, or nosebleeds.
Erythematous with pruritis.; Erythematous with pruritis.; Golf ball size swelling at injection site after first jab; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab) 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, 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 experienced VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab). At the time of the report, VACCINATION SITE ERYTHEMA (Erythematous with pruritis.), VACCINATION SITE PRURITUS (Erythematous with pruritis.) and VACCINATION SITE SWELLING (Golf ball size swelling at injection site after first jab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information of patient was provided. Patient's treatment information was not provided. Patient had no Adverse Reaction to second shot of Moderna Vaccine.
A report has been received from consumer. The report concerns a male patient, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. It was reported that the patient experienced quite sick which started on 09-Nov-2015, slight runny nose which started on 08-Nov-2015 and product quality issue. The outcome of the event of slight runny nose, quite sick and product quality issue was unknown. The report was considered to be non-serious.
Patient woke up in the middle of the night. Aprox 12 hours later with flu like symptoms. Felt tired next day, developed rash on neck, hot flashes, throat tightness around 24 hrs later. Went to ER around 6 pm. Received fluids and BENADRYL.
Severe neck pain, originated from site of injection on L arm, lasted 1 day; severe small joint pains on 11-16-09.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to -MODERNATX, INC.-MOD-2021-060769 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-MAY-2021 and outcome of the include recovering.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-060769:Mother
Information has been received from a registered nurse concerning a 6 year old child with no known allergies who in November 1996 was vaccinated with varicella vaccine. On 06/16/2001, the child presented to the physician's office with a chicken pox/rash breakthrough characterized by an itchy rash on back, and 60-100 lesions. It was reported that the child's classmates have chickenpox. It was noted that the child was afebrile, but that his mother had given him Tylenol. Follow-up info has been received and indicated that the registered nurse does not have any additional info. No further info is available.
vaccine in the freezer moved to the refrigerator on 06JUL2022 and Beyond use date was 05AUG2022; No adverse event; 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)), PRODUCT STORAGE ERROR (vaccine in the freezer moved to the refrigerator on 06JUL2022 and Beyond use date was 05AUG2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine in the freezer moved to the refrigerator on 06JUL2022 and Beyond use date was 05AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)), PRODUCT STORAGE ERROR (vaccine in the freezer moved to the refrigerator on 06JUL2022 and Beyond use date was 05AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)) and PRODUCT STORAGE ERROR (vaccine in the freezer moved to the refrigerator on 06JUL2022 and Beyond use date was 05AUG2022).    No concomitant medication were reported.  Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and Beyond use date was 05-AUG-2022. 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19-SEP-2022 until 09-NOV-2022. 9 Boosters 3rd dose and 3 second doses. No previous excursion. The vaccine was administered to 6 Patients on 19-SEP-2022, 2 Patients 04-OCT-2022, 1 Patients 06-OCT-2022, 1 Patient on 09-NOV-2022. No treatment information was provided by the reporter. This case contains information about Patient 8th out of 12 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
redness; pain in the injection site; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced ERYTHEMA (redness) and PAIN (pain in the injection site). At the time of the report, PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
slight fever; slight arm pain at vaccination site.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53 (units: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine yesterday. The patient took Tylenol due to slight fever on an unspecified date. She also reported having slight arm pain at vaccination site. Otherwise she reported feeling great. She would like to know if it was okay for her to take Tylenol. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
sensitivity of teeth; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (sensitivity of teeth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERAESTHESIA TEETH (sensitivity of teeth). At the time of the report, HYPERAESTHESIA TEETH (sensitivity of teeth) had not resolved. Not Provided          Patient stated that she experienced teeth sensitivity a few days after receiving her second dose of vaccine which was ongoing at the time of call. Patient stated that the symptom was like nerve sensitivity to touch affecting both top and bottom sets of her teeth, and is scheduled to meet her dentist.
Feeling like a vegetable; Sick; My body was a bit upside down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down) in a 55-year-old patient of an unknown 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down). At the time of the report, FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down) outcome was unknown. Not Provided          It was reported that the patient took the second dose 2 months ago and body was a bit upside down but since 2 weeks now the patient had sick feeling like a vegetable.  No Concomitant medication were reported. No treatment medication were reported.
Knot in arm on inner bicep facing body towards armpit. Painful to touch and not exactly at injection site but near
VACCINATION WAS GIVEN IM INTO MY UPPER ARM. THE ARM HURT VERY SLIGHTLY AT THE INJECTION SITE, AS EXPECTED. HOWEVER, THE NEXT MORNING I AWOKE TO HAVE THE INSIDE OF MY BICEP MUSCLE VERY SWOLLEN, RED AND HOT. I WENT TO A URGENT CARE FACILITY, AND THE DOCTOR INFORMED ME THAT I WAS HAVING A SEVERE REACTION TO THE VACCINATION, PROBABLY BECAUSE I HAD ANTIBODIES IN MY SYSTEM FROM THE PREVNAR 13 THAT I GOT ON 01/29/15 AND A PREVIOUS PNEUMONIA VACCINATION I GOT APPROXIMATELY 10 YEARS PRIOR.
Breakthrough case admission after 2 vaccines Moderna 11/8/21 lot# 071F;  Moderna 12/3/21 lot# 030H21B
pt recv vax & father called 230 w/inc temp -T193 ax;given Ibuprofen dec temp to 101.9 p/30min;
Sore arm. fatigue. eyes tired. Nausea. Chills. Feel feverish but normal temp.  General malaise.
This spontaneous report has been received from a nurse reporting on a 7 month patient of an unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 07-FEB-2017, inadvertently the patient was vaccinated with an intramuscular dose of PNEUMOVAX 23 (lot # M037669 and expiration date 09-MAY-2017) (dose and frequency were unknown) instead of been vaccinated with PREVNAR (lot #, expiration date, dose, and frequency were not reported) for prophylaxis. There were no adverse effects reported. The reporter confirmed that this was not related to a product confusion and that it was due to a human error. There was no product quality complaint (PQC) involved. Additional information has been requested.
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
Headache, Myalgia, Fever, CoughWheeze, Diarrhea, NauseaVomiting FATIGUE Narrative:
Pain in injection arm chest and neck. Swelling in the arm neck and chest, rash in armpit and chest. Shortness of breath and difficulty in breathing.  Elevated heart rate and blood pressure.
Redness and itchiness on the site of injection, small vesicular rash resembling zoster rash on and around the site of infection.
10 days post vaccine head to toe uticaria, no history of hives or new exposure. Globus sensation.  Treatment with oral steroids, high dose antihistamine
Patient experienced lightheadness, racing heart and feeling of impeding doom upon standing up after receiving a TWINRIX vaccination. Patient exhibited dystonic-like symptoms and posturing after being re-seated.  No LOC, no chest pain, no breathing difficulty, no nausea/vomiting, no urticaria.  Patient treated with 50mg of Benadryl with symptoms resolving within 30 minutes.  Patient diagnosised with a vasovagal induced panic attack with dystonic like symptoms after receiving a TWINRIX vaccination.
Fever of 101 by the night of the vaccine. Severe chills.  Next day- low grade fever 99. Exhaustion, foggy/hazy feeling.  Day 3- back to normal. Still a bit sleepy.