chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain; tiredness; legs weak knees felt like jello; weird feeling in leg; severe chills like shaking off the bed but no temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "legs weak knees felt like jello"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "weird feeling in leg"; CHILLS (non-serious), outcome "unknown", described as "severe chills like shaking off the bed but no temperature". Additional information: Event weird feeling in leg lasted about a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced shivering; Experienced headache; Experienced fever; Experienced myalgia; Experienced insomnia or restlessness; Experienced insomnia or restlessness; Experienced fatigue; Experienced slurred speech; Developed arm pain which has not resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Shingrix. On 8th February 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th February 2022, the patient experienced shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech. On an unknown date, the outcome of the pain in arm, shivering, headache, fever, insomnia, restlessness, fatigue and slurred speech were not recovered/not resolved and the outcome of the myalgia was recovering/resolving.   It was unknown if the reporter considered the pain in arm, shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. One day after receiving Shingrix, the patient experienced shivering, headache, fever, myalgia, insomnia or restlessness, fatigue and slurred speech. She explained that myalgia had mostly resolved but none of the other symptoms had resolved. The reporter refused to provide healthcare professional information. She would be seeing them in March and will call them on the day of reporting. The reporter did not consent to follow-up.
BRUISING UNDERNEATH WATCH ON ARM OR OTHER EXTREMITIES WHERE THERE WAS PRESSURE; SCRATCHES GET A RED TRAIL LIKE BLOOD BLISTER AND ONE SCRATCH OPENED  UP AND BLED AND DID NOT SCAB OVER IN A NORMAL MANNER AND WAS SLOW TO STOP; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was healthy with no comorbidities. 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 JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced bruising underneath watch on arm or other extremities where there was pressure, and scratches get a red trail like blood blister and one scratch opened up and bled and did not scab over in a normal manner and was slow to stop. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising underneath watch on arm or other extremities where there was pressure and scratches get a red trail like blood blister and one scratch opened up and bled and did not scab over in a normal manner and was slow to stop was not reported. This report was non-serious.
not feeling all that great; vein on their right leg above their knee was hard and purple; a massive swelling on their right leg; fell; Diagnosed with a blood clot in their right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with a blood clot in their right leg) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (20 years ago they had DBT(Diabetes). Patient state they do not take any medication regularly. ).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced THROMBOSIS (Diagnosed with a blood clot in their right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple), PERIPHERAL SWELLING (a massive swelling on their right leg) and FALL (fell). At the time of the report, THROMBOSIS (Diagnosed with a blood clot in their right leg), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple), PERIPHERAL SWELLING (a massive swelling on their right leg) and FALL (fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  Patients went to a HCP, vein specialist, who prescribe they take daily shots of blood thinners for 6 weeks.   Company comment:This case concerns a 68-year-old, female patient with previous relevant medical history of diabetes, who experienced the unexpected event of thrombosis. The event occurred 27 days day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-317836, US-MODERNATX, INC.-MOD-2021-317918, US-MODERNATX, INC.-MOD-2021-318381 (E2B Linked Report).; Sender's Comments: This case concerns a 68-year-old, female patient with previous relevant medical history of diabetes, who experienced the unexpected event of thrombosis. The event occurred 27 days day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested. US-MODERNATX, INC.-MOD-2021-317836:Same reporter and Patient but different event US-MODERNATX, INC.-MOD-2021-317918:Same reporter and Patient but different event US-MODERNATX, INC.-MOD-2021-318381:Same reporter and Patient but different event
24 hrs after immunization, the patient developed redness, pain and edema below injection site -over the next few hours, pain and swelling moved into her left fore-arm.
Patient received the first and second Pfizer vaccine for COVID. The lot that was pulled was for 12 years and older 0.3 ml. I interviewed the MA as she was working in the pediatric department and states she usually verifies with license vocation nurse  before  administering, but there is no documentation on vaccine that it was done. I checked with LVN and states if she is not available sometimes they verify  with provider. Medical assistant thinks it might have been a documentation error as she keeps lots written on a sticky. Medical assistant counseled on checking the lot on actual vial of medication given and documenting. Vaccines are only drawn by LVN  when a dose was needed, but we would leave some predawn.  Lot number that was documented was drawn and available during time frame of vaccine administered.  They were stored in medication room accessible to medical assistants. We have now started to lock and I continue to review chart prior to handing them a dose. LVN is drawing as needed.  Medical assistant has been counseled on seven rights of medication administration.
Deep Vein Thrombosis right leg.  Five days after being vaccinated I began to notice swelling in my right leg from my knee through my ankle-foot area.  There was an associated increase in pain in the knee.  I tried to shake it off hoping that the swelling and pain would go away, but I finally relented to the concerns of my family and sought care on the 6th of April at the emergency room because my doctor refused an in-person appointment.  The emergency room physician prescribed Eliquis which I have been taking.  The swelling seems to have leveled off, but my right leg still appears to be twice the size of my left leg
Pt received vaccines in the office and immediately felt hot and clammy. Was able to get to her car where she drank something cold and sat in the air conditioning and felt a little better. Cont to have headache and dizziness all afternoon. Approx 5 hrs after administration, pt fainted at home. She continued to have a headache all evening, vomited once but slept well and woke the next morning feeling well.
Pt recvd vax 7SEP90 & devel neuropathy, arthritis, extreme fatigue, enervation, & emotional distress; no further details were provided;
I have been having soreness in my left lower leg.. I am concerned it has to do with the vaccine
1st dose of Engerix B onset of induration, inject site swelling, events resolved
Patient developed a cold sore in mouth that did not disappear. Sore was biopsied and found to be oral squamous cell carcinoma. Patient is otherwise healthy with no history of smoking or tobacco use and no family history of disease. Patient has undergone two surgeries with a third scheduled.
Information has been received from a physician concerning a 29 year old female with no pertinent medical history or drug reactions/allergies who in July 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  In September and December 2007 the patient was vaccinated with a second and third dose of GARDASIL respectively.  The physician reported that on an unspecified date the patient was diagnosed with multiple sclerosis and it may be related to GARDASIL.  The patient has had optic neuritis and numbness on half of her body.  At the time of reporting the patient had not recovered.  No additional information has been reported by the physician.  The physician felt that multiple sclerosis was considered to be disabling.  Additional information has been requested.
I got a metallic taste in mouth; tingly tongue; a burning sensation in my throat; a tingly sensation in my throat; a burning sensation in my chest; a tingling sensation in my chest; so short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I got a metallic taste in mouth), PARAESTHESIA ORAL (tingly tongue), BURNING SENSATION (a burning sensation in my throat), PHARYNGEAL PARAESTHESIA (a tingly sensation in my throat) and CHEST PAIN (a burning sensation in my chest) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DYSGEUSIA (I got a metallic taste in mouth), PARAESTHESIA ORAL (tingly tongue), BURNING SENSATION (a burning sensation in my throat), PHARYNGEAL PARAESTHESIA (a tingly sensation in my throat), CHEST PAIN (a burning sensation in my chest), PARAESTHESIA (a tingling sensation in my chest) and DYSPNOEA (so short of breath). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (I got a metallic taste in mouth), PARAESTHESIA ORAL (tingly tongue), BURNING SENSATION (a burning sensation in my throat), PHARYNGEAL PARAESTHESIA (a tingly sensation in my throat), CHEST PAIN (a burning sensation in my chest), PARAESTHESIA (a tingling sensation in my chest) and DYSPNOEA (so short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported.
strange feeling in tongue; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW8733) via an unspecified route of administration in the left arm on 06May2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included minor depression and acid reflux (esophageal). The patient was allergic to penicillin and sulpha drugs. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced strange feeling in tongue and dry mouth which were continuing at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of events. The clinical outcome of the events strange feeling in tongue and dry mouth were not resolved at the time of this report.
Fever for 12 hours  General body aches  Large lump and heat at injection site
chills; nausea; felt like he had the flu; This is a spontaneous report from a contactable consumer. An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 11:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient received first dose of BNT162B2 on an unspecified date. On 21Jan2021 03:00 AM, the patient had chills, nausea and felt like he had the flu after getting the 2nd shot of the vaccine. No treatment received. Events outcome was unknown.   Information on the lot/batch number has been requested.
Fever, chills, muscle weakness, body aches, vomiting, loss of appetite.
About eight hours after the second dose of the vaccine I started to feel bad. My fever was 101 degrees and I could not get it under control. It got up to 104 and I went to the ER because I had already taken two Tylenol. I was given fluids and IV Tylenol and it still took 3 hours for my fever to come down. My Pancreatic Enzymes were very high and they did a CT scan. Some of other bloodwork was abnormal as well. I had night seats for a few days afterward. My arm was extremely red swollen and irritated where I got the shot. My blood pressure was low as well and I had to break my Blood Pressure medication in half for about one week. I also stopped taking my water pill because I did not want to become dehydrated. I returned to my doctor one week later and my pancreatic enzymes were back to normal.
30MAR93 pt exp sore arm w/shooting pain into the neck; 31MAR devel severe abd cramping; 2APR presented to ER w/severe chest pain radiating to neck & back & severe muscle spasm of entire body; EKG nl; also panicy feeling;
Rash on thighs, spread diffusely 11/21/09.  Ulcers in mouth.  Vomiting and diarrhea.  High fever (104.3).
Tachycardia, hypertension, flushing, vertigo started within 5-10 minutes of receiving shot, came in waves, was transported via ambulance to local hospital ED.
No adverse event; 4-year-old patient received Expired First Primary Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose).    No concomitant medications were reported.  It was reported that, patient received 1st dose of the Moderna primary series. Clinic staff then noticed that vaccine expiration was listed as 11-Feb-2023 and discarded remaining content. It was individual vials with vial size of 2.5 mL. On 10-Feb-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Covid arm Red raised rash; Itchy; This is a spontaneous report from a contactable other hcp (Patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 42-year) in left arm on 08Mar2021 at 10:30 AM as dose 1, single for COVID-19 immunization. Medical history included autoimmune problems (since COVID), and COVID-19 (prior COVID vaccination), both from an unknown date and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken in two weeks of COVID-19 vaccination, for an unspecified indication, start and stop date were not reported. The patient tested COVID post vaccination. The patient received no other vaccine in four weeks. The patient had no allergies reported. On 10Mar2021 the patient experienced COVID arm red raised rash, itchy. The patient underwent lab tests and procedures on 11Mar2021 which included SARS-COV-2 test: unknown results. The patient received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient, age 64 comes to site to be vaccinated. Patient came pre registered. During the registration process Patient is asked all questions and was hoping to receive Moderna. Patient was advised that we only had available Pfizer and Janssen. Patient then decides on Pfizer and states that this is his first dose. Patient then proceeds to get vaccinated and once seated in observation, Patient states that this is in fact his third dose of the Pfizer vaccine. Patient confirms lying about this being his first dose when we had asked prior to him getting vaccinated. Patient then states that based on his research, the CDC is about to approve a third booster shot and so he wanted to take actions ahead of time. Patient received his first and second dose of Pfizer back in January in which we have no records of in our system and did not show his vaccination card upon arrival.   Called to notify her about a patient receiving 3rd dose of Pfizer. Proceeded to take patients VS and observe for 30 minutes. Patient showed no adverse or abnormal signs and symptoms.
It was itchy; rash around my wrist, changes in size & location, comes & goes; headache; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It was itchy), RASH (rash around my wrist, changes in size & location, comes & goes), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired). On 15-May-2021, the patient experienced PRURITUS (It was itchy) and RASH (rash around my wrist, changes in size & location, comes & goes). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (It was itchy), RASH (rash around my wrist, changes in size & location, comes & goes), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.            No concomitant drug details were reported.
On 11/11/10, tingling lower legs, tingling in hands, numbness, mild headache, weakness feeling & getting progressively worse. To ER.
Supraclavicular lymph node - swelling, pain - left side (same side vaccine was administered)
3rd Dose Pfizer ? @ 1918 PT reported to Adult Daughter (Translating) tightness in jaw. ? No complaint of airway compromise, no difficulty breathing.   ? Safety notified. Escorted to Special Obs., Requested water.  ? @1920 PT reported sensation of heartburn, onset of headache, sore neck in back, stiffness in jaw.   ? PT HX Diabetes & High BP.   ? @ 1926 BP 200/96, PR 76.   ? @ 1926 Safety notified Site Director; SD initiated 911 call.  ? @ 1934 BP 209/103 PR 82.  ? @ 1940 EMS on scene.   ? @ 1942 BP 210/98.   ? @ 1945 EMS transport to Hospital
Passed out as soon as the vaccine given. I had nausea dizziness and blurry vision that lasted for 15 minutes
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The reporter stated that the patient received first dose GARDASIL on 24-MAR-2013. On 08-MAY-2013, the reporter administered second dose GARDASIL which was expired (Lot # was reported as 1271Z, expiry 11-DEC-2012). No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.