chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event:  Involuntary musclejerks started on 4/14/21.  Muscle jerks started with shoulders and now affects arms head, shoulders, and sometimes whole body. Outcome:  diagnosed with myoclonic jerks involving head, neck, and extremities. Treatment:  low done Keppra trial advised
Severe headache, high fever, rigors, severe muscle and joint aches, tender lymph nodes, severe fatigue.  Symptoms started within 12 hours of receiving vaccine and lasted 2 days.  Tender lymph nodes started about 1 month later and lasted several months.  Tylenol and Ibuprofen were used.   Severe fatigue, muscle, and joint pain continue today. Have since been diagnosed with rheumatoid arthritis.
RAPID HEART BEAT; VERTIGO (CAN'T WALK AROUND); TINGLING IN RIGHT SIDE OF HEAD; NUMBNESS IN RIGHT SIDE OF HEAD/NUMBNESS TO THE RIGHT BODY; SEVERE MIGRAINE; BRAIN FOGGINESS/COULD NOT THINK CLEARLY/COULD NOT SPEAK CLEARLY; FLU LIKE SYMPTOMS/CHILLS/FEVER/NAUSEA; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced flu like symptoms/chills/fever/nausea. On 13-APR-2021, the subject experienced brain fogginess/could not think clearly/could not speak clearly. On 14-APR-2021, the subject experienced vertigo (can't walk around). On 14-APR-2021, the subject experienced tingling in right side of head. On 14-APR-2021, the subject experienced numbness in right side of head/numbness to the right body. On 14-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced rapid heart beat. Laboratory data (dates unspecified) included: Heartbeats increased (NR: not provided) 70 bpm, and MRI brain (NR: not provided) Normal. Treatment medications (dates unspecified) included: vitamins nos, and metoclopramide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine, and the outcome of flu like symptoms/chills/fever/nausea, vertigo (can't walk around), brain fogginess/could not think clearly/could not speak clearly, rapid heart beat, numbness in right side of head/numbness to the right body, loss of appetite and tingling in right side of head was not reported. 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.
Headache; Muscle ache; Diarrhea; Sudden feeling of like being really hot like I have a fever without having one; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 02Apr2021 as dose 1, single, (Lot Number: EW0169) via an unspecified route of administration on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation Assessment was done. Consumer stated, like many people (Further clarification was unknown) have side effect within the first 48 hours and then they went away but then about a week later the side effect hit him again later and they have been kind of like on and off for a week and then Saturday was the last day he felt them so, it has gone two days now without feeling it anymore but talk to somebody yesterday, he saw a nurse and she said that she has seen this before so, in other words had this same side effect on and off for two weeks now and it was an extreme headache, muscle ache and diarrhoea. He had that after the first shot within 48 hours and after second shot within 48 hours which is a little bit more severe and about a week later he had exact same symptoms even little bit more severe and then on Saturday this past Saturday probably the worst and then it was improved, a day of doing terrible and then he go a day or two doing great and then it again came back and then the only other symptom he could report was just this sudden feeling of like being really hot that was the best he can describe it, like have a fever without having one. Consumer stated that had actually got blood tested on Thursday of this past week. Consumer stated, just like Ibuprofen for the aches and got a Vitamin infusion from his doctor after the second dose. Vitamin C and things like that. Consumer stated that he got a COVID antibody test and then also got antibody and then got a complete metabolic panel. The patient underwent lab tests and procedures which included blood test: no results, metabolic panel: no results and Covid test: no results on 13May2021. Therapeutic measures were taken as a result of headache, muscle ache and diarrhea. The outcome of events headache, muscle ache and diarrhea was resolved on May2021 and event sudden feeling of like being really hot like I have a fever without having one was unknown.  Follow-up attempts completed. No further information expected.
A week after vaccination felt miserable.  Severe headache; exhaustion By May excessive leg swelling
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.51.  Concomitant products were not provided.  On 03-Apr-2021, excursion time was 09 AM  and temperature was 34 respectively, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic on 03-Apr-2021. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Right upper lateral arm is swollen pink and warm, pruritic rash, no lump at site of injection, no axillary adenopathy.
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
Immediate symptoms included blotchy skin on face, arms, and chest.  The next day my menstrual cycle began ten days early with extreme cramping and excessive bleeding - cramps and heavy bleeding have occurred with every cycle since (no pain and normal level of bleeding prior to vaccine). Severe adverse reaction includes on-and-off heart palpitations and severely increased anxiety to the point of weekly panic attacks (attacks non-existent previously) with physical representation in the form of pain in chest/neck/left arm.
Headache; A spontaneous report was received from a consumer concerning a 57-years-old male patient , who received  Moderna's COVID-19 vaccine(mRNA-1273)  and experienced event headache .  The patient's medical history  was not provided  . No relevant concomitant medications were provided .  On 02 Feb 2021, prior to the onset of events , the patient received their first of two planned doses  of  mRNA-1273(Lot/batch: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 03 Feb 2021 , patient experienced event headache .   No lab reports  were provided. Treatment information provided were not provided .  Action taken with mRNA-1273  in response to the events was not reported .   At the time of the report , outcome of the event headache was unknown .
pruritic diffuse with papules & urticaria treated with Medrol Dosepak, Aveeno bath & cream, diphenhydramine
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients (3 or 4) of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with PNEUMOVAX23 intramuscularly (lot # M032635, expiration date: 05-MAY-2018; dose was not reported) for prophylaxis. On an unknown dates, the patients experienced adverse reactions that were not further specified by the reporter. The outcome of adverse reactions was unknown. No causality assessment was provided. Reporter additionally stated that these adverse events were reported from pharmacy to Vaccine Adverse Event Reporting System (VAERS) about a year before the report's date. No Product Quality Complaint was involved. Additional information has been requested.
The wife called us and stated after the vaccine at some unknown point the patient passed out and has been hospitalized. The patient waited for 15 minutes in the store and was talking like normal. He walked out of the store on his own. The wife states she found out today he may have had multiple mini strokes.
Developed rash, hives on body, itchiness, swelling to face and abdomen,c/o of difficulty in breathing, mom unsure of time frame for when rash started, several minutes after last injection. Did not notify clinic, waited to return to school and asked nurse what to do. Sent to Urgent Care. Received Prednisone 20 mg x 3 days, Benadryl 25 mg q 4-6 hours x 30 tablets
The needle came out on her arm / received half of the dose; The needle came out on her arm, thus wasting part of the dose; The needle came out on her arm, thus wasting part of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional information was provided as follows: This case was reported by pharmacist for herself. The pharmacist reported that she received the 2nd dose of Shingrix and the needle came out on her arm, thus wasting part of the dose, which led to accidental underdose, exposure via skin contact and Inadvertent exposure to vaccine. The patient received half of the dose. The reporter consented to follow up.
Numbness in left arm; Tingling in left arm; This spontaneous case was received on 17-Sep-2020 from a pharmacist via agency [reference number: SEQW20-01846] and concerned a 48-year-old female patient.  The patient's medical history and concomitant medication were not reported.  On 16-Sep-2020, the patient was vaccinated with Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm] for influenza prophylaxis. The batch number reported was 276534 and expiry date was 06-Jun-2021.  On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced tingling and numbness in the left arm where she had received the vaccine. No corrective treatment was given for the events.  At the time of initial reporting on 17-Sep-2020, the outcome of the events 'localised numbness' and 'tingling of extremity' was not reported.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Additional information was received on 28-Sep-2020 from Group: Suspect vaccine was changed from Fluad Quadrivalent to Flucelvax QIV. The narrative was amended accordingly.  Company comment: On 16-Sep-2020, a 48-year-old female patient was administered Flucelvax QIV vaccine. On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced paraesthesia and hypoaesthesia in the left arm where she had received the vaccine. The patient's medical history and concomitant medication were not reported. Based on provided information, causality is assessed as possibly related for both events.; Sender's Comments: On 16-Sep-2020, a 48-year-old female patient was administered Flucelvax QIV vaccine. On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced paraesthesia and hypoaesthesia in the left arm where she had received the vaccine. The patient's medical history and concomitant medication were not reported. Based on provided information, causality is assessed as possibly related for both events.
Diarrhea, after booster.; she was feeling ill/she was very sick and has no health conditions/deathly ill.; Fever over 100 degrees, after booster; Dry heaves, after  booster; Headache, after booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 09:30 (Lot number: 30135) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL3246, Site: left arm), administration date: 25Jan2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Lot: EL9262, Site: left arm), administration date: 15Feb2021, when the patient was 65 years old, for COVID-19 Immunization, reaction(s): "chills", "Bad headache", "Ached all over", "felt a little tired". The following information was reported: PYREXIA (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Fever over 100 degrees, after booster"; RETCHING (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (16Oct2021), described as "Dry heaves, after  booster"; HEADACHE (non-serious) with onset 15Oct2021 21:30, outcome "recovered" (17Oct2021), described as "Headache, after booster."; DIARRHOEA (non-serious) with onset 16Oct2021, outcome "recovered" (16Oct2021), described as "Diarrhea, after booster."; ILLNESS (non-serious) with onset 15Oct2021 21:30, outcome "not recovered", described as "she was feeling ill/she was very sick and has no health conditions/deathly ill.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient states that she got the booster at 9:30AM and by 9:30 in the evening she was feeling ill. She had a fever over 100, dry heaves, headaches, and diarrhea. And by the next morning, she was still on the bathroom floor. She was not sure she will ever take it again, she was very sick and has no health conditions. Patient stated that she would not take another Covid vaccine in the future.   No follow-up attempts are possible. No further information is expected.
Loss sense of smell 3/27/2021 tested due to known exposure /3/24/2021 tested positive for covid-19,  3/29/2021 and 3/30/2021
MISSED A DOSE OF VIVOTIF ON THE SCHEDULED DAY AND TOOK IT THE NEXT DAY; This spontaneous case report (PVX2019-1829) was received from a pharmacist on 15-Jul-2019. It describes a consumer who "missed a dose of Vivotif on the scheduled day and took it the next day" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif a day late. It was reported that the consumer missed a dose of Vivotif on the scheduled day and took it on the next day though, the consumer completed Vivotif course.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed a dose of Vivotif on the scheduled day and took it the next day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose of Vivotif on the scheduled day and took it the next day" was considered as not applicable.
PATIENT EXPERIENCED SWELLING AT INJECTION SITE, NO PAIN OR ITCHING OR REDNESS.  PATIENT WAS ASKED TO BE OBSERVED FOR 40 MINUTES AND THE SWELLING DECREASED SLIGHTLY.  PATIENT WAS CONTACTED 2 HOURS LATER, THE SWELLING HAD SUBSIDED SLIGHTLY MORE.  PATIENT WAS ADVISED TO USE COOL COMPRESSES AT THE INJECTION SITE AND TO TAKE BENADRYL AND OR TYLENOL.  PATIENT'S PRIMARY CARE PHYSICIAN  (MEDICAL NURSE) WAS INFORMED OF THE REACTION.  THE DR. WAS FAXED THE COPY OF THE VACCINE ADMINISTRATION CONSENT FORM.
11:15am - shortness of breath, rash on face and neck, HR 148, BP150/100 - EMS called 11:16am - increasing shortness of breath, rash on face and neck - Epinephrine EpiPen dose 1 given IM (Lot: 9GM432 Exp: 2/2021 11:17am - HR 152, BP, 170/82, O2sat 100% on room air 11:18am - HR 152, BP 180/90, O2sat 100% on Room air 11:22am - BP 170/98. Rash improving 11:26am - EMS transport arrived.  patient walked to ambulance with 2 assist. Patient transported
Swelling, redness and warmth 3cm x 3cm and mild redness several inches down arm and around injection site.
h/a, dizziness a/immun; pt fell w/LOC for 15-20 secs w/syncopal attack- C vasovagal type; lost balance & fell down; LOC momentarily, stiff, rolling of eyeballs, crying, BP dropped 100/60, vomit, bruise on lt temple p/hit head; poss allerg r
Patient developed rash on 9/27/18 in the evening on the anterior aspect of his neck, which spread to his neck and face, including cheeks and bilateral upper eyelids. He was seen on 9/29/18, and was diagnosed with petechiae. No prior history of trauma, vomiting, or coughing. He was seen on 10/1/18 for follow-up and the petechiae were still present but not spreading.
Patient presented to clinic for 2nd dose of COVID vaccine after being unable to receive 1st dose.  Patient advised he had one COVID vaccine  for 1st dose.  After injection by the nurse and entry into -it was discovered that patient had Covid vaccine for 1st dose-not other.  After explanation to patient-he insisted that he still had COVID VACCINE.  Called call center  and they advised nothing else for patient to do-no further vaccination required.  Patient monitored for 30 minutes and no reaction.  Patient called 1 hour post injection and still no reaction.
From telephone correspondence received on 12/26/02, it was reported that 69 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/08/01. The patient developed generalized hives about 1week later. She was seen in physician's office 3 weeks later, treatment of Benadryl and Prednisone was prescribed. Patient was seen by physician on 11/27/01, symptoms still persists she was prescribed Atarax as treatment. The patient was seen by allergist in December, 2001 then seem by a dermatologist in January and February 2002. Intermittent hives still persist.
At 15 minutes post injection, started with shortness of breath, severe itching, headache, flushing, chest tightness, lightheadedness, dizziness, angioedema
Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead.; Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead.; not being able to walk unattended; Double vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left), administration date: 16Aug2021, for COVID-19 immunization. The following information was reported: DIPLOPIA (hospitalization) with onset 19Sep2021, outcome "recovered with sequelae", described as "Double vision"; DIZZINESS (hospitalization), VISUAL IMPAIRMENT (hospitalization) all with onset 19Sep2021, outcome "recovered with sequelae" and all described as "Extreme dizziness to the point of not being able to walk unattended. Double vision, left eye not able to look straight ahead."; GAIT DISTURBANCE (hospitalization) with onset 19Sep2021, outcome "recovered with sequelae", described as "not being able to walk unattended". The patient was hospitalized for dizziness, visual impairment, gait disturbance, diplopia (hospitalization duration: 10 day(s)). Therapeutic measures were taken as a result of dizziness, visual impairment, gait disturbance, diplopia.  Clinical Course: Patient administered other vaccine same date vaccine date i.e 08Sep2021. No other vaccine in four weeks. Other medications in two weeks were Humira for Rheumatoid Arthritis. AE had treatment. 5 infusions of steroids after 2nd hospitalization. No COVID prior to vaccination. COVID dose not tested post vaccination. patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.