chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full blown migraine; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (since she was 2 years old). Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]), CLONAZEPAM, HYDROCODONE and INSULIN for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea). The patient was treated with UBROGEPANT (UBRELVY) for Migraine, at a dose of 4 tablets max a week. At the time of the report, MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.            Patient state 1-2 hours after getting the vaccine she had a headache and then by 5pm she had a full blown migraine. Patient wanted to note she has suffered from migraines since she was 2 years old. Patient reports she only had 3 to 4 severe migraines a week every week and started to go to a neurologist. Patient reported nausea after the first dose as well.   This case was linked to MOD-2021-288803 (Patient Link).
I have a large itchy hive at injection site. It is larger 2.5 days after getting injection than before.   Had 102 fever, chills, shakes, stomach pain, muscle and joint pain, rapid heartbeat, dizzy,
I started to become ?itchy? on my legs a few minutes after the 2nd vaccine but then a few hours after got a few red patches on my chest and back and had some ?hives? on my left arm.  They have faded mostly  but I still have had a few rashy patches still visible .  (I also had fever and body aches for 2 days,  and moderate to severe headache for 1 week.  Also developed a very minimal slight dry cough. ) The one symptom that has been a bit worrisome and not gone away since receiving the 2nd vaccine is an ache/pain that radiates from my left arm up through my shoulder and neck and into my jaw and ear  (all on left side) It is still present daily and gas not improved so will check in with my primary care doc this week.
Delirium, mumbled speech,inability to stand or walk inability to eat,vomiting, loss of bowel and bladder control
pt recv vax & the following morning pt devel nausea & regurgitated clear fluid; dx lasted for approx 30 mins; pt vaccinated w/ a 2nd & 3rd dose of vax; exp a recurrence of sx following each vax; No further details were provided;
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a female patient of unknown age. The patient had no medical history, current illness and prior vaccinations. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M036059, (dose provided as 0.0) intramuscular in the left arm (indication not provided). Concomitant therapies included multivitamin (VITAMINS (UNSPECIFIED)). It was reported that patient developed swelling at site of vaccine injection on right arm(vaccination site swelling), swelling on left arm(peripheral swelling) found to have a left brachial vein deep vein thrombosis (DVT), ultrasound doppler abnormal and white blood cell count increased . In Lab test, Duplex of both upper extremities were performed which showed DVT right extremity; WBC 17(units not provided). The patient had emergency room visit and was hospitalized. The outcome of the events deep vein thrombosis, white blood cell count increased, vaccination site swelling, ultrasound doppler abnormal and peripheral swelling was reported as recovered/resolved.  Causality assessement was not provided. The agency considered the events to be serious due to life-threatening. Additional information is not expected because no further details can be obtained from the Agency.
pt recv vax 16JUN95 & devel exanthem all over the body on 27JUN95 w/t101;
chest pain developed 6/21, admitted to the hospital with diagnosis of myocarditis 6/22
Post vax, the pt developed rash throughout body which started out on legs and spread throughout areas on back, arms, trunk, and neck. Dx with atopic dermatitis. Treated with Atarax, Eucerin cream, and Cetaphil skin cleanser.
No appetite or thirst, nervous, lost weight, pain in arm, yellow soft stools, swelling in arm and neck, vertigo, metal taste in mouth, salty taste in mouth. 06/09/2000 Letter and consent sent. 07/18/2000 call to MD's office re: status of request. Receptionist said they see norequest. Will fax the letter and consent today. 07/26/2000 Records received. All findings are NL. Seen 07/14/2000 and felt to be improving. Problems are chronic low back pain and anxiety. Case complete.
After 2nd dose, immediate shaking and chills. Had to lay on the floor of the car on the way home. 30 minutes drive and once home projectile vomited green and yellow bile.  Has been in end stage liver disease since April 2022.
My mom was difficult to awaken and took 35 minutes for her to respond.  Increased confusion (did not know me, nor did she know her own name). Extremely unsteady on feet.  She had slept  from 5pm to 9am.  After breakfast and an hour she regained her knowledge of her name and mine and could correctly recite her DOB.  She continues to have difficulty ambulating complaining her legs ache.  She is also extremely tired.
The patient experienced a high fever, over 103F for about 1 1/2 weeks.
fatigue; chills; pain in the injection site after getting the 1st dose; right arm soreness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 02Feb2021 09:30 (Batch/Lot Number: EL9264, Expiration date: Not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications were none. The patient historical vaccine includes Flu vaccine would stay sore for a while with Flu shots, she would generally get flu shot annually. It was reported that onset time was probably about 11:00, by the time she got home after being administered the first dose of Pfizer COVID-19 Vaccine around 09:30 that day. She had onset of painful injection site area of right arm, fatigue and some chills but that was the extent of it. The right arm painfulness was a little surprising. She expected soreness in the right arm but it was painful that first day. It has gradually. The majority is finally improved since then. To raise her arm up she can still feel something there, not what she would call pain or anything now, probably just soreness gone. On the second day the right arm soreness and pain moved down from the injection site and kind of stayed in that area for a while. It was apparent the soreness was still bothering her but yesterday was when she was finally improving.Took a Tylenol for side effects: taken before she heard the news cast. She took 1-500mg Extra Strength Tylenol caplet for adults on 02Feb2021 for side effects. Taken around 10 hours after she was administered the Pfizer COVID-19 Vaccine, so around 19:30, so that she could sleep. She was reluctant to do so because she does not normally take anything like that unless she really feels she needs to. She just thought she did not know how she was going to sleep with that arm pain radiating. No other vaccines were received within 4 weeks prior to the vaccination. Therapeutic measures were taken as a result of fatigue, chills, pain in the injection site and sore arm. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
FLU LIKE SYMPTOMS; BODY ACHE; FEVER; This spontaneous report received from a health care professional concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced flu like symptoms. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, body ache, and fever on 28-MAR-2021. This report was non-serious.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 58 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 01-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 01-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Influenza vaccine administered at 3:10, right deltoid, patient had a vasovagal reaction within 5 seconds. Team Alert called, patient moved to reclining chair, blood pressure and monitoring ensured. Team Alert team monitored patient, Patient transported to ED via ambulance about 20 minutes later due to dropping blood pressure.
Extreme stomach pain; extreme back pain; high fever 101+; night sweats; delusions and dizziness.
The pharmacist, injected the vaccine into my right shoulder instead of my deltoid at 8:30 pm.  At 1;30 am I woke up screaming in pain and with a frozen right shoulder.  My shoulder did not begin to improve till 1//28/2020.  The injury is now fully resolved and I now have full range of motion.
Information has been received from a physician concerning a 9 year old female with asthma who on 30-MAR-2007 was vaccinated with Gardasil (Lot # 65503/0012U). Concomitant therapy included montelukast sodium. On approximately 02-APR-2007, within three to four days of vaccination with Gardasil, the patient experienced itchy, papular rash on face, extremities and body. The patient sought unspecified medical attention. The patient was treated with Benadryl. As of 10-APR-2007, the patient was recovering from itchy, papular rash on face, extremities and body. This is one of two reports from the same source. Additional information has been requested.
Big lump; Numbness in arm; Swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20A) for COVID-19 vaccination.     Concomitant products included Blood Pressure for Blood pressure, INSULIN DETEMIR (LEVEMIR), INSULIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm). At the time of the report, VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) 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.   No treatment information was provided.
Vaccine given at 11:50am. Patient waited in pharmacy 15 minutes after vaccine given. At 12:15pm, pharmacy received call from front of store that patient was having a reaction. Upon reaching the patient, she complained of being hot, light-headed, and weak. Gave her water, crackers/chips, wet papertowel, and ice pack on pack of the neck along with a blowing fan. She cooled down but remained light-headed and weak. After 15-20 minutes, she called her daughter to pick her up. Approximately 15 minutes after that, her daughter came to the store and stated that she probably had not eaten or drank very much that day and that was probably causing her issues. After a few more minutes, She decided to leave the store and go home with her daughter where she could rest. She stated she had not had any reaction with her first two doses of Moderna. We called for follow-up check but patient's phone went straight to voicemail without being able to leave a message.
Migraine Throbbing headache since day after vax Ringing in ears sporadic Very sore breasts nonstop since the day following vax including painful nipples Diarrhea intermittent seems to have resolved
Flu vaccine given 10/05/01, came in 11/5/01 - Check out tenderness, pain at injection site. Area noted to be red/indurated.
slight/brief cheek numbness and tingling tongue (about 3 hours after the vaccine) and again about 1 week after the vaccine.  Lasts for 15min or so.
Reaction to Influenza immunization. Left arm is swollen and red. Started after Flu shot on 9/13/2012, fever, chills. Naproxen 500mg 1 tablet 2 times daily as needed. Ice 10 minutes 3-4 times a day.
Swollen lymph node and injection site, radiating to breast. This was so bad that I was not able to move my arm without a severe ache/pain and went on for several days. Also uncontrollable  shivering caused me to lie in bed  and under covers for about 8 hours. If I moved any part of my body the shivering would return.  Headache, loss of appetite were not too bad none
Chills woke me up at 5am, kept me up for at least an hour. Headache, pain in eyes, fever continued through the day. Muscle pain in back significantly worse than previous days
painful fingers/painful arm; inability to take deep breaths; flu-like symptoms; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in fingers in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-SEP-2023, the patient received Arexvy. On 14-SEP-2023, less than a day after receiving Arexvy, the patient experienced pain in fingers (Verbatim: painful fingers/painful arm), difficulty breathing (Verbatim: inability to take deep breaths), influenza-like symptoms (Verbatim: flu-like symptoms) and headache (Verbatim: headache).  On 18-SEP-2023, the outcome of the pain in fingers, difficulty breathing, influenza-like symptoms and headache were resolved (duration 4 days).   It was unknown if the reporter considered the pain in fingers, difficulty breathing, influenza-like symptoms and headache to be related to Arexvy.     It was unknown if the company considered the pain in fingers, difficulty breathing, influenza-like symptoms and headache to be related to Arexvy.   Additional Information: GSK receipt date: 26-Sept-2023 The patient who received Arexvy vaccine and experienced the following symptoms: painful arm, inability to take deep breaths, flu-like symptoms, headache and painful fingers.  The patient stated that the symptoms all appeared later the same day as the vaccination and they were all gone in 4 days. No consent to contact physician, the patient did not want to involve him. Did not consent to follow-up.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 408 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
I HAD EVERY SIDE AFFECT POSSIBLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced i had every side affect possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i had every side affect possible was not reported. This report was non-serious.
Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient). On 26-Aug-2021, ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient) had resolved.        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.   The reported wanted to know if should re administer. No concomitant medications provided. No treatment medications provided.
Chest pain and discomfort with inhaling, nausea and leg fatigue. Happened 3 days post vaccine. No injection site pain
Patient was seated in front of the pharmacy after her vaccines were administered. A few minutes after receiving the vaccine, I heard some heavy breathing noises and checked on her.  She said she was having a hard time breathing and she was experiencing shooting pains.  I stepped outside of the pharmacy to examine her more closely and she was shouting about pain that kept throbbing in her lower right back area. She was breathing very heavily and was in severe pain.  She remained seated but her condition worsened and her breathing was more forced/labored and she was in significant pain.  It was at that time we initiated calling 911 and to administer diphenhydramine liquid. She continued shouting and jolting her body due to the severe pain she was experiencing in her lower back (on the right side). There was no swelling or redness at the injection sites.  The paramedics arrived and brought her to the ambulance for further observation.
This is a spontaneous report from a contactable Pharmacist. A 79-year-old female patient received PREVNAR 13 (Lot # Q02071, Expiry Date Jan2018, NDC # 00005197102) via an unspecified route of administration at 0.5 ml single on her right deltoid muscle on 28Dec2016 for immunization, not prescribed by a physician. She had never received it before this vaccine. Medical history was none.  There were no concomitant medications. At the very end of Dec2016, 2 to 3 days after injection, she had an injection site reaction: a red spot that appeared and she said that it itched at the beginning and then the redness had gone down but it was not as red as it used to be but now its spreading, it was getting bigger and there is a lump. It has been about a week so, the Pharmacist was just wondering how long does the reaction usually take place and when should it go away. The outcome was not recovered.
Prolonged body soreness, temp 101.3 degrees nausea. Lasted 3 days. Heavy bleeding @ injection site
This spontaneous report was received from a registered nurse referring to a 2 month old patient of unknown gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On 12-MAR-2019, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # N021308 and expiration date: 05-MAR-2019) orally for prophylaxis. No adverse effects reported.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving Moderna vaccination,  she immediately awoke, and I helped to chair where she immediately fainted again, myself and tech caught her and helped her to the floor.  She recovered immediatly and we called 911. We stayed with the patient where she was responsive and talking till EMT arrived.  EMT checked her out and left.  She was feeling much better and was able to leave on her own strength.  Patient had a history of fainting after a blood draw, and with penicillin inj
I have had hives all over my body for the past two weeks .. they don't seem to be going away and I am concerned about getting the 2nd dose.  I am miserable
muscle pain, joint pain, stomach discomfort, extreme fatigue, symptoms of Irritable Bowel Syndrome
ROTATEQ vaccine dose #1 given at age 8 mos. No reactions occurred/anticipated.