chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unevaluable event (her brother is dying because of the Moderna vaccine); This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) (seriousness criteria hospitalization and life threatening). At the time of the report, UNEVALUABLE EVENT (Unevaluable event (her brother is dying because of the Moderna vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was dying because of the company vaccine. Patient was admitted to a hospital.  No relevant concomitant medication information was provided. No relevant treatment medication information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Patient had a breakthrough case of Covid 19.  Positive covid test was 8/19/2021.  She received regencov the same day.  She had previously received her moderna covid vaccines on 2/25/21 & 3/26/21
Noted in Incident Report - patient sitting up in chair @ 11:40am - approx 15 minutes after vaccination. Stated - did not feel well, noted patient was pale, shallow breathing, drooling at mouth slightly... LOC. Patient placed in Trendlenberg position, O2 applied, V/S taken. See below. EMS called. Patient taken to hospital for f/u.
Had dT on 08/25/03 and she developed papular itchy rash over abdomen, chest (upper extrants), no involvement of palms. Mild erythema. No oral involvement. Seen today and gave Benadryl 25mg PO.
I had a fever of 99.6, sinus congestion, sore throat, headache, fatigue,  and cough. I had a telephone visit with my doctor on 1/19/2021. I took a COVID test on 1.17.2021 that came back positive. My symptoms lasted 2 wks. I used a Nebulizer, Mucinex, Azithromycin, Ibuprofen to help alleviate my symptoms.
tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself).  A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
Received vaccine on Nov 5, 2015. Two+ weeks later developed double vision, slurred speech, unsteady gait, numbness. L.P., MRI done - both abn. Tx'd with IV SOLU-MEDROL, oral steroids.
2.5 inch (at time of report) red, raised, hot to the touch, hard bump which has increased in size.
Red and swelling at the injection site on her right arm that caused arm immobility. Redness and pain continued to move down the arm to patients wrist and has since extended to her breasts as well. Went to the doctor on 11/6 and started on Benadryl and ibuprofen as well as cold compresses. Since that time she has had slight improvement but is still in a lot of pain.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 at 15:00 as dose 1, single (Lot number: EH9889), on 10Jan2021 at 07:00 as dose 2, single (Lot number: EL3302) and on 30Sep2021 at 18:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16May2022 at 18:00 as dose 4 (booster), single (Lot number: O59M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Menopausal" (unspecified if ongoing); "Gilbert's syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13May2015, stop date: 06Jul2022; PREMPRO, start date: 07Jun2021, stop date: 06Jul2021; MOTRIN [IBUPROFEN], start date: 21Jun2022, stop date: 30Jun2022; ATORVASTATIN, start date: 12Aug2015, stop date: 21Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
shingles; shooting pain in her head; shooting pain in her head, ear and jaw in the left side; shooting pain in her head, ear and jaw in the left side; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 82, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history was and concomitant medications were not reported. On 22Jan2021, the patient experienced a shooting pain in her head, ear and jaw in the left side which is the same side where she got the shot. Two days later on 23Jan2021, the patient broke out in shingles, her doctor told her that the vaccine may have triggered the shingles. She may receive the second dose of the vaccine on 27Feb, she would like to know if it's okay for her to receive the second dose of the vaccine due to the shingles. The outcome of the events was unknown.  Information regarding Lot/Batch number requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2022 at 9:08 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Mar-2022 at 9:08 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. The patient ethnicity was White. A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg. Exp. date of 04-Apr-2022.
Patient received her flu vaccine at the flu clinic and within a minute, patient started with a dry cough then complained of shortness of breath and was extremely red all over. Patient complained that her throat was starting to close up. Patient was administered 50 mg BENADRYL IM and EMS called. Continued to monitor patient who stated she was starting to feel better within a few minutes after receiving BENADRYL. EMS arrived and monitored for 30 minutes. Patient signed AMA not going to hospital and EMS left clinic. RN continued to monitor patient until patient's husband picked her up an hour later.
Pt fainted shortly after vaccination and remained unconscious for approximately 30 seconds to 1 minute.  Was fine afterward.
1330-Patient relates her mouth went dry and she became dizzy.  Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA.  Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
Rash all over face and front of neck starting the night of immunization. Patient took Benadryl
Information has been received from a physician concerning an 8-year-old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658594/1330U). On an unspecified date (post vaccination) the patient experienced an injection site reaction. The office suspected the diluent and disposed of all diluent of that lot number (lot number unavailable). At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Low grade fever.(highest 100.1) Headache. Nausea. Cold sweats. Body aches.
Muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The patient asked about remedies for muscle pain that occured after shingrix vaccination. No other information reported.
Information has been received from a physician concerning a 12 month old patient who on 8/13/04 was vaccinated SC with a dose of varicella virus vaccine live. On 8/18/04, five days later, the patient developed vesicles on the hand. Two days later, 50 to 100 atypical vesicles appeared on various dermatomes. No fever was present. The child was being observed with no treatment. Unspecified medical attention was sought. The patient was reported as recovering. There was no product quality complaint. Additional information has been requested.
Patient received flu shot in right deltoid on 10/18/2010. She presented to pharmacy again on 10/21/2010 with redness (about golf ball size), slight warmth & a small nodule at site of injection. It was not sore (per patient) & did not look infected.
One week after first dose, I began to experience slight muscle twitching in legs, arms, and torso.  The symptoms are not severe and I typically only feel them when at rest.  I'm submitting in an effort to continue tracking data.  Unless I hear otherwise, I plan to receive second dose next week.
Sweated; shaking; chills; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Triglycerides" (unspecified if ongoing); "High Triglycerides and lipids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "Sweated"; TREMOR (non-serious), outcome "recovered", described as "shaking"; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body pain".  Reporter by: Consumer  Event description: I sweated, have shaking chills and body pain after 15 hrs of vaccination. The symptoms last for 8 hrs. 48 years old. Female. 65kg, 165 cm  Optional Information: High Triglycerides and lipids.  Name of product: Pfizer covid-19 vaccine. Batch: FJ5683  The event happened during the use of the product.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Apr2022): Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SEVERE NECK STIFFNESS, UNCONTROLLABLE HEADACHE DIFFERENT FROM USUAL MIGRANE.  I CAN NOT GET THIS UNDER CONTROL WITH MEDICATION.  I HAVE RECEIVED BOTOX INJECTIONS AND PAIN HAS NOT GONE AWAY.
p/vax pt immed started gasping was limp, turned white was transported to ER & then was transferred to hosp;
Rec'd 5 yr. immunizations 6/13/16 at office. Pt with S/S beginning 6/14/16 -> (Rt) upper arm with edema, erythema and warmth. Afebrile. Seen for S/S 6/16/16. Supportive care recommended - Ice packs, PRN BENADRYL and return PRN if increased.
Initial induration, tenderness - 48 hours marked induration, erythema, warmth & superficial edema.
Pt called stating she experienced nausea, whole body aching, injection site warmth, redness and soreness.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/14/2022 ACUTE RESPIRATORY FAILURE
rash growing around the injection site. Taken Benadryl and steroid ointment application.
THE PATIENT'S ARM HAS BEEN TWITCHING EVER SINCE SHE RECEIVED HER FLU SHOT IN THE FALL. SHE HAS A DOCTOR'S APPOINTMENT SCHEDULED, AND WILL LET US KNOW WHAT THE DOCTOR SAYS.
Developed fatigue, body aches on 4/19/19. Had dry cough and one loose stool and headache. On 4/22/19 developed maculopapular rash across chest, arms and legs, back and feet. Had fever 101 on 2/18/19.  referred to dermatology who did biopsy which showed urticurial-allergic eruption. He had also taken codeine for cough night before erupton occurred.
joint pain everywhere; MENTAL FOGGINESS; NOT FEELING GOOD; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain everywhere), FATIGUE (Fatigue), FEELING ABNORMAL (MENTAL FOGGINESS) and MALAISE (NOT FEELING GOOD) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included METHOTREXATE SODIUM (METOTREXATE) for Joint pain.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 28-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (joint pain everywhere), FEELING ABNORMAL (MENTAL FOGGINESS) and MALAISE (NOT FEELING GOOD). At the time of the report, ARTHRALGIA (joint pain everywhere), FATIGUE (Fatigue) and FEELING ABNORMAL (MENTAL FOGGINESS) had not resolved and MALAISE (NOT FEELING GOOD) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of JOINT PAIN, MENTAL FOGGINESS and NOT FEELING GOOD was not provided. The reporter's causality for the event(s) of FATIGUE with RINVOQ(UPADACITINIB) was a reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Day 1 very sore arm. Day 2-4 sleepy and tired all the time. On day 15 I woke up with sore body, headache, fatigue, progressed into uncontrollably chills that turned into a fever of up to 101.8. Felt very dizzy, no appetite and had a couple of hours of Heart Palpitations of 110 bpm. That 1 day was terrible. Woke up the next day and I was fine, since then Im mainly tired and have no appetite.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. In October 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The nurse reported that, 5 to 6 weeks before the time of reporting the patient received SHINGRIX. At the time of reporting, the patient appeared to had shingles on their abdomen. The reporter wanted to know the information about on outbreaks post vaccination. The reporter was agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure, as the details regarding vaccination schedule and exact time to onset for the event were unknown.
Heart rate went up to 182 resting rate reported 12 hours after vaccine , was taken to hospital for monitoring .; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 05Mar2021 10:00 (at the age of 33-year-old) as 2nd dose, single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266) on 12Feb2021 at 08:00 as a single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced heart rate went up to 182 resting rate reported 12 hours after vaccine, was taken to hospital for monitoring on 05Mar2021 22:00. The patient visited emergency room and was treated with IV (intravenous) medication (unspecified) for the event. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab) was negative and heart rate went up to 182 on 05Mar2021. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Terribly painful menstrual cycle after the 2nd vaccine. Very painful was the description by patient.  Since the cycle is coming to an end she indicated she was beginning to manage better but we don?t know what this means for future cycles.
pt was colicky and drew up legs for several hours after vaccination also he didn't have a bowel movement for 48 hours after vaccine was administered
pain; fever; This is a spontaneous report from a Pfizer. A non-contactable consumer reported for a male patient (friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and fever on an unspecified date. Reporter was reported about elderly friend that she was taking care of. Patient had 1st dose of covid vaccine after vaccine had pain and fever. Patient was supposed to get 2nd dose but caller was concerned about getting covid virus and wanted to know what she should do in regards of taking care of elderly person. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech-Dose 1, Dose 2/Moderna-Dose 3, Dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6203), in left arm and on 22Mar2021 as dose 2, single (Lot number: Ep7534) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 037c21a), in left arm and on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: fish" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE, start date: 16Aug2016; VALSARTAN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Dec2021, outcome "unknown", described as "Pfizer / BioNTech-Dose 1, Dose 2/Moderna-Dose 3, Dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
After a month of getting this vaccine I developed a lump on my right collarbone area.  My physician at the time wanted to just to monitor it and not do any testing.  I went to clinic and they sent me into  Radiology to scan the bump and then they withdrew the fluid out of it.  They didnt feel it needed to be tested.   I have also had joint pain and stiffness and fatigue since this vaccine.  The day after the shot I had severe leg pain and didnt want to move just sleep for 2 days.