chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 an unspecified date, the subject experienced body aches, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and headache was not reported. This report was non-serious.
Breakthrough case admission after three vaccines 2/3/21 Moderna Lot# 038K20A;  Moderna 3/5/21 Lot# 030A21A;  11/10/21 No manufacturer or lot # available
Dizziness, fast heart rate, nausea, fatigue Call Kaiser they said not to worry about the severe reaction.
Pt with R lower leg pain on 30 Apr 2021.  Duplex U/S on 04 May 2021 showed deep venous thrombosis from ankle to mid femoral vein.  Initiated on rovaroxiban
Itchy eyes red swollen  eye lids  and swollen around eyes and face . Skin is red and splotchy. Condition  is with both eyes.
Over the time period to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Large area that is red & raised around injection site. Site looks like little bumps on entire thigh. (Rt thigh - where PREVNAR 13 was given) - Advised to apply cool compress, mark area of redness, CB should sx worsen.
This spontaneous report as received via social media refers to a consumer of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient was affected from the vaccine. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Began itching about 1/2 hour afterwards; Woke up next morning with hives on left forearm and up left arm; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration on 05Jan2021 12:15 at a single dose on right arm for COVID-19 immunization at workplace clinic. Medical history included anxiety, attention deficit hyperactivity disorder (ADHD), and seasonal allergy from unknown dates. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported that she began itching about 1/2 hour afterwards on 05Jan2021 13:00 and she woke up next morning with hives on left forearm and up left arm. The events were non-serious. Antihistamine was given as treatment for the events. Outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Diagnosed with multiple sclerosis. Right side numbness and weakness  from head to toe, loss of vision , double vision
from time of administration to present March 16, 2023. Pain is present and consistant with swelling increasing and decreasing periodically over past 15 moths. Patient is continuously aware of inflammation and mild to moderate pain at site that does not radiate or restrict movememt. Pain increases with palpation of site.
Fever greater 100.4; profuse night sweats; horrible head ache; severe joint pain throughout; nausea greater than 2 days now; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 immunization; Bnt162b2 (Dose Number: 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "Fever greater 100.4"; HEADACHE (non-serious) with onset 19Apr2022, outcome "recovering", described as "horrible head ache"; NAUSEA (non-serious) with onset 19Apr2022, outcome "recovering", described as "nausea greater than 2 days now"; NIGHT SWEATS (non-serious) with onset 19Apr2022, outcome "recovering", described as "profuse night sweats"; ARTHRALGIA (non-serious) with onset 19Apr2022, outcome "recovering", described as "severe joint pain throughout". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, night sweats, headache, arthralgia, nausea.  Additional information: Batch/lot numbers were not available/provided to reporter at the time of report completion. Hospitalization Prolonged was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event with unspecified medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1. Chills for 4 hours 2. Fever & extremely hot for 4 hrs. 3. Aches all over body 4. Extremely tired 5. eyes had mucous accumulation.
patient is complaining of all over neuralgia that started the day after administration. patient is able to control pain with tylenol regular strength
PATIENT STATED THAT THE DAY AFTER THE VACCINATION WAS ADMINISTERED THAT IT WAS EXTREMELY SWOLLEN AND TENDER TO THE TOUCH FOR OVER A WEEK. HE SAID THE SWELLING STARTED GOING DOWN BY THE SECOND DAY AND SEEMED ALL GONE BY THE END OF THE WEEK, BUT IT WAS STILL A LITTLE SORE. THEN ABOUT 3 WEEKS AFTER THE VACCINATION, BRUISING STARTED IN THE AREA THAT WAS DARK PURPLE, YELLOW, AND GREENINSH IN COLORING AND SEEMED TO SPREAD OVER THE ENTIRE DELTOID AREA WHERE VACCINE WAS ADMINISTERED BUT THAT IT DID NOT HURT UNLESS OF COURSE YOU POKED ON THE BRUISE.
I have had progressive pain in my right arm and shoulder since having the 1st Covid Moderna shot. This is why I did not get the 2nd. I have had debilitating pain in my shoulder and arm getting worse throughout the months. I got a steroid shot in the shoulder joint on Aug. 9 and helped for about 6 weeks. Pain is back. Went to Dr. and he thinks that the injection was not given correctly. A fireman gave mine, which is not used to giving vaccines. He believes it went too deep or too high. So he ordered an MRI on my right shoulder and I have a torn supraspinatus tendon and torn labrum , which Dr. told me can happen if not given correctly into muscle. That has set up terrible inflammation in my shoulder joint with fluid, progressive arthritis and chronic pain, esp. at night. I have been told the only remedy is a total shoulder. this vaccine has devastated my shoulder.
within 1 hour of shot arm had a large dark bruise.  Bruise gradually faded but it has been 40 days and there is still a bruise there.  It is light in color, but still noticeable.  Is only painful when lightly pushed, just like a bruise.
Resident was given a flu shot by home care RN. That night he had a fever which increased his BS to 160. The next am his blood sugar was 197 at 7 am, 199 at 11 am, and 4 pm 159 blood sugar. MD increased HUMALOG by 8 units. FBS on 10/24 = 136 mg/d FBS 10/25 = 145 mg/dl FBS 10/26 = decreased 100 back to usual BS range by 10/26/2013.
Vaccine administered 1/3/2012 at 1450. Initial symptoms pain, soreness and unable to raise arm, then redness and swelling on 1/4/2012. Fever 101.6 1/5/2012. (ALEVE) OTC and TYLENOL OTC.
patient c/o light headedness and itchiness. a few hives appeared around her mouth. patient was given 10 ml of benadryl oral liquid and waited 30 minutes. itchiness and hives subsided.
body aches; tongue was numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue was numb) and MYALGIA (body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included METFORMIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (tongue was numb). On 16-Mar-2021, the patient experienced MYALGIA (body aches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, HYPOAESTHESIA ORAL (tongue was numb) had resolved. At the time of the report, MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-Jun-2021 contains significant information. Outcome of the events were changed to recovered/resolved.
On 4/20/99, the pt experienced arm pain. It was noted that the pt was absent from school because of the arm pain. On 4/22/99, the pt recovered and returned to school with no further complaints. Additional information has been requested.
Swelling of about 5" in diameter area, redness, hot to the touch, pain in area and arm pain. FYI: Flu shot was also given, but on other arm.
few bumps - small area on vaccine site - left arm; itches occasionally - small area on vaccine site - left arm; rash - small area on vaccine site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A2A or 001A2H) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm). At the time of the report, VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of vax w/in an hr following the vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
Vertigo spells 4-5 x daily each followed by wave of nausea          Primary  MD & Pharmacist recommended hydration with Pedialyte Brain Fog Confusion Blurring vision Severe Fatigue All symptoms continue daily from 9/28/20023 to presently 9/24/2023
Extreme headache / neck pain 2 days following injection. Both have continued since then, but are starting to subside. Suspect fever for days following the onset of symptoms.
The patient was administered a vaccine that expired on 2/28/2022 and had not been reconciled out of inventory.  The patient was made aware and asked to report any adverse conditions or symptoms.
Fever 102, local erythema/swelling, diffuse myalgias & joint pain, headache.
No immediate complications on first shot other than a day of arm pain at injection site. At 2 wks out from dose 1 injection, I developed right L1 shingles. I?m only 48 and healthy with no underlying health conditions
did not sleep; body aches/Twinge in one side; fever; chills/shivered under the covers all night; Withdrawal from the methadone; Excessive thirst; Mouth was really dry; Injection site reaction characterized by a bit of burning pain in the gluteal muscle; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep), PAIN (body aches/Twinge in one side), WITHDRAWAL SYNDROME (Withdrawal from the methadone), THIRST (Excessive thirst) and DRY MOUTH (Mouth was really dry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NALTREXONE (VIVITROL) for Opioid type dependence.    The patient's past medical history included Opioid type dependence (Methadone) and Hepatorenal failure.   On 13-Apr-2021, the patient started NALTREXONE (VIVITROL) (unknown route) 380 milligram once a month. On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced WITHDRAWAL SYNDROME (Withdrawal from the methadone), THIRST (Excessive thirst), DRY MOUTH (Mouth was really dry) and INJECTION SITE REACTION (Injection site reaction characterized by a bit of burning pain in the gluteal muscle). On 27-Apr-2021, the patient experienced INSOMNIA (did not sleep), PAIN (body aches/Twinge in one side), PYREXIA (fever) and CHILLS (chills/shivered under the covers all night). At the time of the report, INSOMNIA (did not sleep), INJECTION SITE REACTION (Injection site reaction characterized by a bit of burning pain in the gluteal muscle) and CHILLS (chills/shivered under the covers all night) had resolved and PAIN (body aches/Twinge in one side), WITHDRAWAL SYNDROME (Withdrawal from the methadone), THIRST (Excessive thirst), DRY MOUTH (Mouth was really dry) and PYREXIA (fever) had not resolved.            Treatment information was not provided. No concomitant medications were reported.   On an unknown date, two weeks prior to starting Vivitrol, the patient stopped methadone.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, diarrhea, queasy, chills and fever. On an unknown date, the outcome of the headache, diarrhea, queasy, chills and fever were unknown. It was unknown if the reporter considered the headache, diarrhea, queasy, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient experienced headache, chills, fever with body temperature of 99.2 degrees F, queasiness and diarrhea. The patient had denied permission to contact their physician.
Lymphadenitis-swollen lymph nodes just below injection site on (R) arm. Mild erythema/warmth/pain.
incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect). At the time of the report, WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse effect) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL).    No concomitant medication information was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up received that contains significant information that includes new reporter, patient details, event details, suspect product route of administration, indication and batch lot no. with expiration date.
pt was given a flu vax on 13OCt93 & returned to the clinic 15OCT93 & had a small area of redness @ the inject site; pt states arm hurts;
Patient sat down for the 15 minute observation period, after about 3-5minutes fainted, falling face forward.  Episode lasted less than 2 minutes, sat up and stated felt better.  Patient stated they have fainted before and tasted blood however mouth had no signs of bleeding.  911 was called and came within 5 -10 minutes.  Patient left with first responders
approx 22 hours: Extreme arm pain; acute headache; chills; sweats; fatigue; slept almost entire time, then dissipated except for extreme sore arm.
Patient had significant pain, redness, and swelling on left arm approximately 4 inches below administration site (mid bicep to just past the elbow) that occurred 1 day following administration and continued for >5 days following the shot
gave her a flu shot and another SPIKEVAX shot inadvertently; The last two nights she has had prickly itching; She felt a little funny but otherwise she was fine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (The last two nights she has had prickly itching), FEELING ABNORMAL (She felt a little funny but otherwise she was fine) and EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3917B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 (it was mild. She took the other drug that was Paxlovid. She tested positive for two weeks but she was better in a day.) from 01-Feb-2023 to February 2023. Concurrent medical conditions included Seasonal allergy.   On 20-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Oct-2023, received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In October 2023, the patient experienced PRURITUS (The last two nights she has had prickly itching) and FEELING ABNORMAL (She felt a little funny but otherwise she was fine). On 26-Oct-2023, the patient experienced EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (The last two nights she has had prickly itching) had not resolved and FEELING ABNORMAL (She felt a little funny but otherwise she was fine) and EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently) outcome was unknown.            It was reported that patient had received other vaccines in the four weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient receives a Spikevax vaccine on 20-Sep-2023. On 26-Oct-2023 patient receives a flu shot and another SPIKEVAX shot inadvertently. She felt a little funny but otherwise she was fine. The last two nights she had prickly itching and took Benadryl which had helped. She had not changed her diet or done laundry so she was wondering if this was from the second shot. This morning she still felt it in her lower legs and a little on her belly. Her doctor told her to keep taking the Benadryl. She did have the other lot numbers for her previous vaccinations.
Patient felt light-headed within a few  minutes post vaccination. She was transferred by EMT to the hospital for observation.
ACUTE RESPIRATORY FAILURE 11/26/2021 HTN (HYPERTENSION)  HYPOXIA 10/26/2021 HTN (HYPERTENSION)
Left deltoid itchy, redness, some swelling, prednisone 60mg, Diphenhydramine hydrochloride 50mg.
Started getting chills, fever, body aches, and pain in ribs similar to when I had costochondritis several years ago. Nine days later I am still experiencing fever, chills, chest pain, and nausea and vomiting.
A few minutes after receiving the vaccine, I became light-headed. Those present noted I was flushed and then the color left my face and I was shaky. I also had a cramp-like feeling in my left cheek/jaw. The nurses monitored my condition during the 15 minute waiting period. I felt better after about 10 minutes, though still weak and nauseous for about 30 minutes after. Aside from a sore arm at the injection site for a couple days, I felt okay thereafter.