chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
Swelling, redness (L) arm and forearm, decreased range in motion, poor appetite, fatigue, color in the area, scab formation noted. Results in treatment: MEDROL dose pack.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current condition and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (strength, dose, route and indication not reported) of lot # L015048 and expiry date: 29-APR-2017. Concomitant medications were not mentioned. The vaccine was stored at 26 degree Fahrenheit for a time frame of 18 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Fever up to 102 F for 3 days, irritability, redness and swelling and injection site right thigh.
flushed 15 min post inj. tickle in throat then tongue tingling and raspy voice 20 min post inj.
Pt. received H1N1 vaccine at  a community church event between between 11:20 a.m.- 12 noon.  States at 9 p.m. her face began to feel itchy, felt clumps on face and redness around neck.  Went to pharmacy and got Benadryl which she took one dose that night (04/24/2010) and she took two doses on 04/25/2010.  Has not taken any today (04/26/2010).  She states everything has cleared up and she has no problems today.
Information has been received from a physician's assistant concerning her friend, a 25 year old female who on approximately 03-FEB-2010 was vaccinated with a first dose of GARDASIL. On approximately 04-FEB-2010, the next day of vaccination, the patient experienced rash on her chest and abdomen. The rash went away, and then came back in the same area. She did not develop an injection site reaction. Additional information has been requested.
nausea; dizziness; low grade fever; Left sided Numbness; tingling; Painful/Tingling Blemishes on Left side of face.; Blemishes on Left side of face.; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder. On an unknown date, the outcome of the nausea and dizziness were recovered/resolved and the outcome of the low grade fever, numbness, tingling, pain in face and skin disorder were unknown.   It was unknown if the reporter considered the nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received the dose of Shingrix on and experienced some dizziness and nausea. Last few days patient had low grade fever, left sided numbness and tingling. New onset of painful/tingling blemishes on left side of face. The patient wanted to know whether he/she had Shingles.
The pt presented to the physician's office with clusters of vesicles and erythematous patches over her right arm and hand. Dx'd with herpes zoster by MD. Pt has not had chickenpox. Mother did not have chickenpox during pregnancy.
hip pain; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 67-years-old female Non-Pregnant patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL8982), via an unspecified route of administration, in Arm Right on 19Jan2021 12:15 as 1st dose single, for a covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included naproxen (NAPROXEN) taken medications in two weeks, the patient did not receive any other vaccine in four weeks. The patient had not known allergies. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported, on 19Jan2021 12:15 The patient experienced hip pain. Patient had taken Tylenol before and after 1st dose. She also had some hip pain but according to her it's not because of her 1st dose. She took naproxen the day of vaccination she asking Does this decrease the amount of antibodies that I gave. No Treatment received. The outcome of event was recovered on unknown date of 2021.   Follow-up attempts are completed. No further information is expected.
sore arm; Fever; Chills; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 in Nov2020.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Pyrexia: 100.6 (Inconclusive) Patient developed Fever 100.6F.         No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Vx stopped his heart, still in therapies; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac failure in a infant male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced cardiac failure (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the cardiac failure was unknown.   The reporter considered the cardiac failure to be related to DTaP vaccine.     Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: This case was reported by a patient's parent via interactive digital media. The reporter reported that the patient received a dose of DTaP vaccine, and it stopped his heart. The reporter reported that he/she was already in the ambulance on his/her way to the hospital and stated if he/she was not, they would had listed his death as SIDS (sudden infant death syndrome). The patient was 13 (unspecified) now and that vaccine injury still had him in therapies one size did not fit all. Additional Supportive Information: This case was linked with US2023AMR023197 which was reported by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR023197:Same reporter
stool light colored; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product GLECAPREVIR, PIBRENTASVIR (MAVYRET) for an unknown indication.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient started GLECAPREVIR, PIBRENTASVIR (MAVYRET) (Oral) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's relevant concomitant medications weren't reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: NNI On 28-May-2021: NNI
sz x 2;grand mal type sz;IV valium given in ER;no further tx required;MRI brain:nl;EEG mildly abn,possible post ictal activity shown in EEG;doing well now;also some vomiting
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 22Aug2023 to 26Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290992 Same patient, different product, different event;
continuous vomiting; diarrhea; was so sick; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown demography who experienced continuous vomiting (vomiting), diarrhea (diarrhoea) and was so sick (malaise), after he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccinations, concomitant medication and family history were not provided.   On an unknown date in 1970 (Friday afternoon), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (until Sunday night), the patient developed non-serious continuous vomiting (vomiting) and diarrhea (diarrhoea) 2 days following the administration of INFLUENZA VACCINE. On an unknown date, the patient was so sick (malaise) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  Other case details: the patient reported that in 1970, flu shots did contain the virus. For a long time, the patient refused to take the shot and started taking it again after being in the hospital in December 2016 with a blood clot in each lung and pneumonia.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was not reported.
Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Malignant neoplasm of female breast, unspecified.    Concurrent medical conditions included Breast cancer female (Unspecified site of unspecified female breast).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Hot injection site; Itching injection site; Target shaped red reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM, TROSPIUM, ENALAPRIL, PANTOPRAZOLE, METFORMIN, AMLODIPINE BESYLATE, ATORVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) on 01-Feb-2021 for Itching, at an unspecified dose and frequency and BACITRACIN ZINC, POLYMYXIN B SULFATE (ANTIBIOTIC OINTMENT) on 01-Feb-2021 for Infection, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE ERYTHEMA (Target shaped red reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl to stop the itching and antibiotic cream (unspecified) because it looked like an infection.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain and swelling in left arm from 2-3-21 to 2-6-21. On 2-5-21 I woke up in excruciating pain the injection site was the size of a golfball it was hot to the touch and I had a rash covering my entire arm to my fingers. My arm was so stiff I couldn?t move it. I took IB Profen and called virtual care on 2/6/21. They said it was probably just a reaction or could have been a bacterial infection from an unclean needle. I was prescribed doxicycline for 10 days. There was gradual improvement but went away entirely on 2/15/21 like it was never there. I still have pain at the injection site today 7/28/21.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
On 3-11-08 patient presented in office with c/o ear ache and sore throat.  Her ears were WNL and rapid strep screen was negative for strep. Temp was 99.1. She received # 2 VZV vaccine into her right upper arm.  On 3-13-08 she presented in office with a circular 10 cm area of erythema and firm induration.  The site was warm and slighty painful to touch. Temp was 98.5.   Ibuprofen and cold compresses were recommended, with follow up as needed.
The patient left the exam room. Then the patient was walking in the lobby and he passed out. Pt was alert, oriented, pale and diaphoretic.  BS was 87.  Pt was moved to exam room and legs elevated. Pt was given apple juice and reported improved symptoms.  BP 1331- 92/59, HR 71, pulse ox 98%   Pt rechecked at 1346- pt continues to feel back to baseline. Pallor has resolved.  BP 105/64, HE 90, pulse ox 100%.
Patient reports swelling in upper and lower extremities to the point where she could not put on her socks and shoes or lift her arm.
Narrative: COVID infections following completion of COVID vaccine series 03/05/21 COVID vaccine dose #1 03/26/21 COVID vaccine dose #2 04/19/21 Pt presents to clinic c/o heartburn and stomach bloating/tightness x1 week; rx given for famotidine 07/28/21 Pt presents to screening reporting cough, loss of taste/smell, muscle pain runny nose, that started 07/26; COVID POSITIVE 07/29/21 Pt reports SOB that started 07/28 and headache; ex given for albuterol 07/30/21 Pt reports continued symptoms and fatigue 08/02/21 Pt continues to feel headache, fatigue, and cough 08/06/21 Pt reports improved symptoms of cough, fatigue, and headache
Three days after I had the vaccine, I broke out with a rash on my lower back. A few days after that I broke out with a rash on my right side. I called the doctors office and made an appointment on 11/14/2019. Doctor said it was Shingles. Prescribed Valtrex, Gabapentin, lidocaine  and calamine lotion. A few weeks after that I got a breakout all over my scalp and a month after that I got it in my left eye.
After receiving the second dose of the COVID vaccine my autoimmune disorder has gotten worse and the adverse effects of my Celiac are present without any exposure to Gluten.  Before the vaccine l exposure to gluten would case painful canker sores in my mouth and a growth on my tingur and gastrointestinal issues. Since the vaccine, I have not been exposed to gluten because I no gastrointestinal issues but I have had a very painful mouth with cankers that have not gone away for weeks. This is the only time this has ever happened. In addition I have some symptoms from additional autoimmune disorders buy I have yet to go to a doctor to verify this additional issue.
Subjective report of shortness of breath for 3 days (did not seek medical attention) and sense of something biting her or pinching her body followed by appearance of 3-4 pink dots on her upper chest wall. Denies lip or tongue swelling.  Resolved after 3 days.
According to medical report, Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day.  She received her COVID-19 vaccine on 1/9/21.  Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21.  Over the last few days prior to admission, she developed generalized weakness, SOB, loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission.    Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Pt died on 2/3/21. See Medical report for more information.
Within 1 minute of giving the injection, patient lost consciousness for approximately 10 seconds.  Woke up on his own, diaphoretic, pulse normal. Continued to observe him for an additional 20 minutes.
Patient was given does #1 of Moderna COVID-19 vaccine and dose #2 Pfizer. No adverse events noted
Right thigh swelling and redness. Local reaction vs. infection. Rx KEFLEX.
Sore Arm red and very hot.   Weak like when I had Covid  very little energy
pt recv vax 7JUN97 & 20JUN97 pt exp poss liver failure, severe hepatitis & was hosp;the reporter was unsure if the pt had prev exposure to hep b virus & stated that it is not known whether pt exp & r/t vax w/hep B vax;
patient had received only the adjuvant portion of Arexvy; only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient had received only the adjuvant portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist called to inform that a patient had received only the adjuvant portion of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.