chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
got localized pain for a few days on my left arm from injection site,  I developed malaise, headache, a fever 101.8 the day after the injection, fever subsided that night.  Headache went away the 2nd day of vaccination.
Patient came to pharmacy today 10/1/13 and showed me a red, flat rash approx 6" long and 3 1/2" wide. It was hot to touch. Injection site was still painful. Pt did go to hospital ER 10/1/13 and saw Dr.
The first day body discomfort, arm pain, today vomiting and diarrhea chronically, mild stomach pain. Discomfort all day from the morning and vomits and diarrhea from 3 in the afternoon. Body pain.
Awoke with cough and complained of leg pains for 2 days. Taken to dr.'s office to investigate the leg pains, and physician observed that he was having difficulty taking breaths following the coughs. Breathing worsened throughout the day. 4pm - appointment at pediatrician with a nebulizer treatment. 5pm - sent to ER for further observation, and treatment. 5:15pm - 2nd 15 minute nebulizer treatment. 6-7p - one hour nebulizer treatment with prednisone. 7-8pm - additional one hour treatment with magnesium  sulfate. 9pm - admitted for overnight observation and additional nebulizer treatments.
lab work came back abnormal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LABORATORY TEST ABNORMAL (non-serious), outcome "unknown", described as "lab work came back abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter stated that the patient had recent lab work came back abnormal after took the Pfizer COVID-19 Vaccine. The reporter wanted to know if the clinical trial showed these types of results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was found at home Saturday afternoon passed out. Patient was rushed to the hospital where it was discovered he had a blood clot. He is going to hospitalized for a few days per patients mother.
Patient had her left arm swollen/red/warm to the touch from her elbow to her wrist. No reaction site of injection. Patient did not have any other symptoms. Reaction started about a day after her injection. She came to the pharmacy on the second day to help treat her condition and itchiness. Patient took OTC BENADRYL over the weekend and symptoms improved and disappeared per phone conversation 3/20/13.
My son?s shoulder ( when the shot has been administered) tripled in size, was extremely hard and hot to the touch. He hasn?t slept in a few days complaining of ?being very itchy?  We called the pediatrician this morning ( 03/26/2022) and were told it was normal and to give him Benadryl and Tylenol. I don?t think this kind of reaction in a toddler is ?normal?
Pt. experienced swelling in her left arm and complained of pain from "the top of her head to her fingers" on her left side.  She also felt knots at the injection site.
L Deltoid area Cyst like lesion 0.5 x 0.5cm + tenderness 5 wks after vaccine placed.
I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT). At the time of the report, CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
MENSTRUAL PERIOD HAS BEEN ALTERED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of reporting and do not have any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-JUL-2021, the patient experienced menstrual period has been altered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual period has been altered. This report was non-serious. This case, involving the same patient is linked to 20210819939.
Mom states baby sleep a lot, when she woke up was very warm, took the temp 102. Called Dr was advised to go to ER. Complete work up was done. Blood and spinal tap and urine was given Tylenol temp came down was sent home.
back pain; cough; felt like she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), COUGH (cough) and PYREXIA (felt like she had a fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 immunisation.     No medical history was reported.  Concomitant products included METFORMIN HCL, LISINOPRIL, AMLODIPINE, CEFIXIME (FLEXERIL [CEFIXIME]), SPIRONOLACTONE, FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LINAGLIPTIN (TRADJENTA), SIMVASTATIN, LORATADINE, LINACLOTIDE (LINZESS), MAGNESIUM, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), INSULIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced BACK PAIN (back pain), COUGH (cough) and PYREXIA (felt like she had a fever). At the time of the report, BACK PAIN (back pain), COUGH (cough) and PYREXIA (felt like she had a fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 97.6 f Inconclusive.         Treatment medication included cough drops (unspecified).
all of joints are in pain/bad joint pain; unable to walk or stand up; This is a spontaneous report from a contactable consumer or other non hcp (patient) communicated to Pfizer sponsored program. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 59-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included knees were in pain before receiving the vaccine. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 59-year-old), as single for covid-19 immunisation. On an unspecified date in 2021, the patient experienced all of joints were in pain/ bad joint pain and unable to walk or stand up. The clinical details of the events as follows: The patient took both doses in Feb2021 and Mar2021, however after a month and a half, she experienced bad joint pain, was unable to walk, or stand up. Before receiving the vaccine, her knees were in pain. She was also taking Meloxicam prior to getting the vaccine. Now all of her joints were in pain. She needed to take it every day instead of before, she would just take it when her knees were in pain and now needed it every day. She wanted to know if there had been any complaints with the same scenario as hers. She just had a general inquiry. She did not want to make any problems. After receiving the vaccine, it was suddenly like in the morning when she woke up, she was fine and after 1 hour, she just started to walk and could not stand up the pain was on both knees. Patient was taking Meloxicam before getting the vaccine only when her knees were hurting her. Now, she has to take it every day. She had an appointment with her doctor on unspecified date on Friday and maybe she would do blood test or give stronger pain medication. She stated she did not want to take Meloxicam every day as she is now. She did not wish to create report. Investigation Assessment was not Provided. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
urticaria @ inj site 7 days later;rx atarax;no prior hx egg allergy;
Initial and follow-up information has been received from a physician and a Registered Nurse (R.N.) concerning a 19 year old female who on 05-MAR-2007 was vaccinated IM in her left deltoid with a first dose of Gardasil. Patient developed immediate swelling and erythema at the injection site. No other symptoms appeared. No prescription medication was provided. The patient recovered within the time she was in the office. Additional information is not expected.
This spontaneous report was received from a healthcare student refers to a 23 year old female patient. No concurrent condition or medical history was reported. On 30-MAY-2015, the patient was vaccinated with VARIVAX, dose 1, (lot # K002050, dose and route of administration was not reported). No concomitant therapy was reported. On 02-JUN-2015, the patient developed a varicella like rash. It was also reported that the patient had blisters on her arms and hands that look like chicken pox. The patient sought medical attention and contacted pharmacist. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
I started experiencing dizziness, I was diagnosed with Vertigo after it. I'm scheduled to see an ENT to address the vertigo.
I thought I had a cold, but I tested for COVID-19 test at home and the line was really fate. I went to the clinic the same day to get tested again to make sure and I test positive for COVID-19. I had a slight sore throat and cough, stuffy nose, and body aches. I took NYQUIL and ibuprofen for my symptoms. I still have a bit of a cough.
leg was swollen & red w/approx 4x6 inch erythematous region; warm to touch; pt mom was advised to use ice, take ibuprofen suspension;
12:35PM STATES SHE IS LIGHT HEADED; FOREARMS RED - PLACED ON FLOOR WITH FEET ELEVATED.12:40 MOVED TO COT PER WHEELCHAIR. A/O, PINK, W/D, RESP REG WITH EASE. 12:48 'FEELS BETTER'.  1:50PM FEELS BETTER - HUSBAND HERE TO DRIVE PT HOME. NO REDNESS TO ARMS; NO ACUTE OR OBVIOUS DISTRESS NOTED.
A little off or funny feeling for first two hours.  After that, flu like symptoms for about 20 hours.  Headache, chills, fatigue, ringing in ear,  night sweating (possibly due to fever), minor body aches.  No soreness at injection site.  A little fatigue on second day after the shot, and am now back to normal.
received a dose of Menactra, March 2016 / 4 months later (07/13/2016) / dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Menactra for prophylaxis.   On 13th July 2016, the patient received Menveo. In March 2016, the patient started Menactra at an unknown dose and frequency. On 13th July 2016, unknown after receiving Menveo, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.  Additional details were reported as follows: The patient received dose of Menactra and 4 months later the patient received a dose of Menveo which led to interchange of vaccine products. All patient identifiers were reported.No Batch number or Expiration date reported when asked. No further clarifications. Consented to follow up. No further information was reported.
The first shot of Moderna gave me side effects within 6 hrs. I had excruciating migraines for two almost three days that caused me to lose time from work. I had severely swollen neck glands, nausea, very mild temp 99 degrees, ringing in ears, and my taste buds changed to beef. My smell was still fine. I went and got tested for COVID because my taste changed and tested negative. Also had body aches, fatigue and had to ice my arm it hurt so badly. The headaches were the worst piece. They were so incredibly painful that I could not work. I am not comfortable taking the second shot now because of my experience with the first. I drank extra water ahead of time and took Tylenol after for the headaches. Nothing worked. I just had to suffer through it. I do not want to take the second shot when I hear it is worse than the first based on those headaches. I cannot handle double the strength in second shot.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
liquid portion of Pentacel given without reconstituting with the lypoholized HIB powder portion/ No reports of side effects; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 28 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided. Concomitant vaccination included Hepatits A and MMR vaccines.   On 09-May-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ACT-HIB) lot UJ108AA, expiry date 24-Jul-2020 via intramuscular route in right thigh (R vastus lateralis).  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that liquid portion of Pentacel given without reconstituting with the lypoholized HIB powder portion.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender- none.
a patient received expired PNEUMOVAX 23; No additional adverse effects reported; 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, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot S026366 was confirmed to be valid, with expiration date 17-SEP-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effect reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness to area. Swollen. Sore. Area grew 3" to 6 1/2-> 5 in height
Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilirubin slightly elevated; Glucose and bilirubin slightly elevated; Extremely rapid heart rate; Elevated blood pressure; Dry mouth; Lightheaded; Shakes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of BNT162B2 via an unspecified route of administration at arm left on 25Mar2021 13:15 (age at 49 years old, Batch/Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC); vitamins nos (MULTIVITAMIN); fish oil; all as supplement. About 5 mins after injection (25Mar2021 13:30), the patient developed extremely rapid heart rate and elevated blood pressure, dry mouth, lightheaded and shakes. The patient went to emergency room (ER), heart rate stabilized after about 60 mins. Blood work and EKG were normal on 25Mar2021. Next day on 26Mar2021, the patient developed extremely lethargic, erratic heart rate, no appetite. The following evening, the patient had another the same episode as post injection, rapid heart rate, chills, elevated blood pressure. The patient went to ER, EKG/Chest x-ray/blood tests all normal (glucose and bilirubin slightly elevated) on 26Mar2021. 4 days post injection (29Mar2021), heart rate still erratic and significant fatigue, heart rate spiked with little effort. The events required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received iv fluids as treatment. All events were not recovered.
experience arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain that still persistent. The patient was asked whether the had a hand in developing the vaccine. The reporter did not consent to follow up.