chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having headaches; I am nauseous; body aches; chills; A spontaneous report was received from a Consumer concerning 27-year-old, Female patient, participating Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program headaches, nausea, body aches and chills.   The patient's medical history, is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 18JAN2021. The patient received their first of two planned doses of mRNA-1273 in(Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced headaches, nausea, body aches and chills.   No lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events headaches, nausea, body aches and chills were unknown.   The reporter did not provide an assessment headaches, nausea, body aches and chills.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Body aches; Severe headache; Chills; Both of arms are sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 2 months and 1 week ago, refer linked case US2019AMR163388).   On 5th September 2019, the patient received the 2nd dose of Shingrix and FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced general body pain, headache and chills. In September 2019, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the general body pain was not recovered/not resolved and the outcome of the headache and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, general body pain, headache and chills to be related to Shingrix.  Additional information received were as follows: A day before reporting date, the patient received Shingrix on unknown arm and Fluzone. At night before the reporting date, the patient started having body aches, a severe headache and chills overnight. The patient was still experiencing body aches at the reporting date. Both of his arms were also sore, where he got Shingrix and Fluzone. The Shingrix arm ached more than it did after the first dose.  The Fluzone arm ached more than he usually experiences after a flu vaccine. It was unknown if the reporter consider the events body aches, a severe headache, chills and arm aches to be related to the Fluzone as well. The reporter consented to follow up.
Initial report received from a healthcare professional on 24 August 2012. A female patient (age not provided), whose medical history and concomitant medications were unknown, received third dose of IMOVAX rabies vaccine (lot number: unknown, route of vaccination was not reported) in the arm on an unknown date. The patient had received Immunoglobulin and third dose of rabies vaccine in last 4 weeks of the IMOVAX rabies. It was reported that dose 3 was not given in the arm muscle but given in the skin or the lower part of the muscle as the shirt sleeve was too tight. On an unknown date, the patient experienced slight pinkness at the injection site in the upper arm. Corrective medications and laboratory investigations were not reported. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
36 hours later noticed pain right deltoid rash on right arm, also back, no energy, flushed, slight body aches, no sob, (D+C after miscarriage m month ago). T96.8, BP 100/70, Lung CTA BL BS.
injection in upper arm at 2pm with no pain. after 30 minutes patient began to report severe pain radiating from shoulder all the way down to wrist. pain has been constant for the last 48 hours and patient went to hospital for treatment.  the pain has been very severe and unrelenting etc and patient is distressed at how her arm is feeling.
Dizziness, lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient's  medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate (ADDERALL) and lamotrigine (LAMICTAL) all from an unknown date for an unknown indication and was unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Mar2021, the patient experienced dizziness and lightheaded. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and lightheaded was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath that might be because I'm scared), PAIN IN EXTREMITY (Arm pain), BACK PAIN (Lower back pain), PAIN (Body aches) and CHILLS (Experiencing awful chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient was hospitalized with COVID in 2020.) and Pneumonia (The patient had pneumonia). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath that might be because I'm scared), PAIN IN EXTREMITY (Arm pain), BACK PAIN (Lower back pain), PAIN (Body aches) and CHILLS (Experiencing awful chills). At the time of the report, DYSPNOEA (Shortness of breath that might be because I'm scared), PAIN IN EXTREMITY (Arm pain), BACK PAIN (Lower back pain), PAIN (Body aches) and CHILLS (Experiencing awful chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Shortness of breath and pressure on chest - difficulty breathing. .Symptoms lasted about 3 hours
she was recieved her HEP A on 1st dose 7/19/22, 2nd dose on 2/14/23, then recieved a 3rd dose by mistake on 7/20/23
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Day after the vaccine I had body aches, fatigue , headache  and temp of 101.5
Received first dose on 01-Mar-2021 and second dose on 20-Apr-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Mar-2021 and second dose on 20-Apr-2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (phenytoin), Tuberous sclerosis, Seizure and Lung nodule (Multiple lung nodules).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Mar-2021 and second dose on 20-Apr-2021). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Mar-2021 and second dose on 20-Apr-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   This case was linked to MOD-2022-472153 (Patient Link).
Left side of body became extremely itchy 7 minutes after vaccine was administered. Itch started at the injection site and  continued to spread but only on my left side of my body. I have no difficulty breathing or any known issues. Clinic notified and self-treat at this time per Nurse.
I contracted Coivd, chest pains, sever cough, heart palpitation, hands shaking, anxiety, heart racing, lethargy. I had several incidents where I suddenly could not breath or stop shaking and needed assistance.
Extreme soreness of her right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "ductile carcinoma of the left breast in site 2", start date: 2021 (unspecified if ongoing); "She completed 6 weeks of radiation followed by a year later" (unspecified if ongoing). The patient's family history included: "metastasis of melanoma" (unspecified if ongoing), notes: mother passed away from metastasis of melanoma; "congestive heart failure" (unspecified if ongoing), notes: father passed away at 100 from congestive heart failure. The patient's concomitant medications were not reported. Past drug history included: Tamoxifen, notes: she started a 5 years regimen of tamoxifen. Vaccination history included: BNT162b2 (Dose 1, Single; Lot: EP7534; Expiry: unknown; NDC: unknown. She felt lethargic after the first 2 rounds of the vaccine but nothing earth shattering.), administration date: 15Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "felt lethargic"; BNT162b2 (Dose 2, Single; Lot: EW0151; Expiry: unknown; NDC: unknown. she felt lethargic after the first 2 rounds of the vaccine but nothing earth shattering.), administration date: 05Apr2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "felt lethargic"; BNT162b2 (Dose 3, Single; Lot: FD0810; Expiry: unknown; NDC: unknown), administration date: 25Oct2021, when the patient was 69-year-old, for COVID-19 immunization; Shingles shots (She also had the singles shots a year ago affect her for 24 hours), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Extreme soreness of her right arm".  Additional information: Caller reported that she had extreme soreness of her right arm after the 4th dose, the 2nd booster. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional vaccines administered on same date was reported as no. Reporter said that she has never had an allergic reaction before. No relevant lab tests.  Follow-up attempts are completed. No further information is expected.
Tinnitis, called patient today and it did subside after a couple of hours, she still has intense pressure. Advised pt to check with her physician.
Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, less than a day after receiving Shingrix, the patient experienced headache and general body pain. On 7th February 2021, the outcome of the headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix on left arm and experienced headache and body ache for 1 day. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038376:Same reporter
jittery feeling; fingers and lips tingling; fingers and lips tingling; heart racing; blood pressure really high; This is a spontaneous report from a contactable consumer (patient) reported for self.  A 64-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unknown date in Apr2021 as DOSE 1, SINGLE (at the age of 64), dose 2 of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE (at the age of 64) both for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced jittery feeling, fingers and lips tingling, heart racing, blood pressure really high all on an unknown date in Apr2021. Patient reported that she got the first dose of the Pfizer Covid 19 vaccine three weeks ago and received her second dose and noticed the symptoms on same day of the first dose or the next day, said it went away after two weeks, it happened again a couple of hours after the second dose and was asking if taking Benadryl would be helpful. Her cardiologist said she could take it and it would be like an antidote and when probed it was reported that they don't have information on if Benadryl was helpful for others or not. The events were reported as non-serious. The patient underwent lab test includes blood pressure: really high. The outcome of events fingers and lips tingling was recovered on an unknown date on 2021 while the other events was recovered with sequel.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
FELT LIKE HAVING THE FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no new changes in lifestyle within the last two weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 17-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced felt like having the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like having the flu. This report was non-serious.
Erythema and edema of right deltoid area w/mild edema approx 2 cm x 1 cm, not tender.
Patient fainted right after receiving all vaccines,  became pale and disoriented ,patient was monitor for about 20 minutes and was able to walk out with mom with no problems.
Gross hematuria after received the booster dose.  Hematuria started between 3-4 hours after the vaccine.  I was in Emergency Room on 12/12/2021.  U/A was obtained which showed RBC, Protein in urine.  Ultrasound of kidney and catscan of abdomen were performed.  Follow up with PCP is required after ED visit.   This incident happened with the 2nd dose of Moderna and spontaneously resolved within a week.
I noticed pain in my arm as I was leaving the park lot.  My arm began to swell withing the first two hours after getting the vacine.  My arm was red and swollen down to the elbow.  It itched for a week.  It stayed swollen for 4-5 days.  I had to take benadryl the first night so it would stop swelling and hurting.  I sent a picture of my arm to nurse on site at clinic.  She told me it was a bad reaction and needed to be reported.
Severe muscle and joint pain, headache, nausea, tiredness, mild fever. Starting  evening April 7 and lasting through April 10
Fine macular rash on trunk, arms, chest and back. Conjunctivitis. No fever.
PATIENT CALLED IN TODAY TO REPORT AN ADVERSE REACTION TO THE MODERNA VACCINE. SHE IS HAVING REDNESS/IRRITATION IN THE ARM SHE GOT HER VACCINE. THIS SEEMS TO BE A VERY DELAYED REACTION. SHE GOT HER VACCINE OVER TWO WEEKS AGO, ON JANUARY 4, 2022. SHE SAID SHE STARTED NOTICING THE REDNESS ABOUT A WEEK AGO. IT ISN'T CAUSING HER PAIN. SHE SAID IT LOOKS JUST RED AND IRRITATED BUT DOESN'T APPEAR TO BE INFECTED IT LOOKS MORE LIKE SOME WELTS/APPEARS TO BE MORE ALLERGIC REACTION. SHE WAS WONDERING ABOUT TRYING BENADRYL. I TOLD HER THAT WOULD BE A GREAT PLAN TO START WITH SOME BENADRYL AND THAT SHE COULD ALSO TAKE IBUPROFEN IF NEEDED. DISCUSSED SIGNS OF CELLULITIS TO WATCH FOR REDNESS THAT STAYS AROUND OR SPREADS/HEAT/PAINFUL. ADVISED TO CONTACT DOCTOR IF HER SYMPTOMS SEEM TO WORSEN OR DO NOT IMPROVE AT ALL. ALSO TOUCHED BASE WITH HER DR OFFICE AND SPOKE TO EMPLOYEE WHO SAID SHE WOULD REACH OUT TO THE PATIENT.
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
9/16/09 1630 patient was in her usual state of health when she received the flu vaccine from the Clinic located inside a supermarket.  Approximately 30 minutes later she began complaining of nausea and that she felt clammy.  An RN then called 911.  EMS arrived at the scene at 1536, patient was found lying on floor on left side complaining of severe nausea and dry heaves.  Vital Signs taken by EMS, HR=80, skin was pale, temp=95.8 F, glucose=179, SaO2=98% on room air.  Patient was transported to Emergency Room.  At 1610 patient arrived in ER and was complaining of back pain and abdominal pain.  By 1735 the patient had developed persistent hypotension requiring pressors for blood pressure support.  She went into respiratory failure requiring intubation, and developed metablic acidosis.  As of 9/18/09 @1500 the patient has been weaned from all pressors. Medical Records and Discharge Summary received 10/12/09.  Date of Admission:9/16/09-9/29/09.  Primary Diagnoses:  Anaphylactic shock secondary to flu shot.  Acute respiratory failure secondary to shock on admission.  Hypokalemia.  Hypomagnesemia.  Acute renal failure. Dehydration.  Malnutrition. Anemia. Assessment:  Patient was admitted to ED 30 minutes after receiving a flu shot c/o abdominal and back pain 9/10, and nausea.  In the ED she was found to be hypotensive and required triple pressors.  BP 84/48, systolics in the 60's, 70's, 80's. Her temperature was 92.7.  Patient was somewhat somnolent, but responsive to verbal commands.  Admitted to the ICU for stabilization.  Patient was transfused 2 units of packed red blood cells.  The patient went into respiratory failure requiring ventilator support secondary to shock. While on the ventilator, the patient was sedated. Pt. noted to be weak and hypocalcemic, she was given 1 gram of calcium IV, hypomagnesemia also present as well as thrombocytopenia.  She had severe metabolic lactic acidosis and profound acidemia and was on a bicarb drip being hyperventilated.  As BP normalized, she was weaned off two pressors.  Urinary output was decreased, but improved.  A central venous line was placed. Noted to have moderate cardiomegaly.  Pulmonary critical care, cardiology and nephrology consults were obtained.  In the ICU patient received supportive care including vent support, pressors and electrolytes as well as IV antibiotics.  As her condition stabilized, the patient was extubated, was doing much better and became stable.  Patient was discharged to a skilled nursing facility for further care.