chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got shot on 10/09, said still very painful at injection site today 10/24/23.  Said 10/20/23 put some topical arthritis cream on his arm, following day large bruising all over front and inner bicep, yellowing at deltoid, no bruising past elbow.  Still terribly bruised at presentation.  Bruising itself doesn't hurt.  Advised to go get it looked at, going to urgent care now.
Patient reported itching at 6:00PM then redness (red blotches) at approx 8:30PM. Patient called pharmacy at 9:00PM and used diphenhydramine to treat. Itching returned occasionally, but resolved (all symptoms) after two days.
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever,  chills ,muscle aches, brain fog.  1 week post Facial paralysis, fatigue,  vocal cord weakness, feeling of unwell.
Dizzy every day/ lightheadedness every day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy every day/ lightheadedness every day) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Thyroid cancer (Removed Thyroid), Lupus anticoagulant, Menopause, Sleep disorder and Syncope vasovagal (all life). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) for Anticoagulant therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease and Thyroid cancer, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Sleep disorder, MAGNESIUM and VITAMIN D NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIZZINESS (Dizzy every day/ lightheadedness every day). The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form,(taken 2-3 times). At the time of the report, DIZZINESS (Dizzy every day/ lightheadedness every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had seen all their regular doctors including a syncope cardiologist. The patient received her second dose of vaccine on 02-Feb-2021.   This case was linked to MOD-2021-074949 (Patient Link).
Patient experiences local swelling and redness around the injection site. The swollen area is red, tender and a bit warm. It is not painful or itchy. The redness has faded a little since the day after the injection, but the area has moved down to her elbow and below.
3 x 5 cm red area at site of injection of MMR 48 hours after receiving vaccine.
Doses were kept in room temperature for greater than 12 hours; Thought they had been newly drawn and administered them; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-352687 (Patient Link).
Fainted 5 minutes or so after receiving vaccine for unknown amount of time. Seizure-like head bobbing  and hand numbness.
Reports some discomfort in r shoulder with rom from 100-180 degree rom. Denies limitations in rom to r upper extremity or r shoulder. Denies instability to r shoulder. Offered visit and declines this option.
Patient develop painful and itchy rash on left arm (same arm as the vaccine) that tested positive for varicella zoster. Interestingly, patient had shingles on left arm in the 1980s.
No issues at first, but around 4pm I started getting hives on my chest. Very red and bumpy. I'm not having any difficulty breathing, so I think I'm fine.
Pain, swelling and redness at injection site Headache Chills Fever  (Temp 100.6) Muscle Aches Fatigue
DIARHEA AND SORENESS IN LEFT SHOULDER (INJECTION SITE) 2ND  DAY FROM INJECTION.
due to the COVID Pandemic, she never got her 2nd dose of Shingrix; received 1st dose via intercostal route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2019, the patient received the 1st dose of Shingrix (intercostal). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 10-OCT-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received 1st dose via intercostal route). On an unknown date, the patient experienced social problem (Verbatim: due to the COVID Pandemic, she never got her 2nd dose of Shingrix). The outcome of the intramuscular formulation administered by other route and social problem were unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter was the patient. The patient did not have any further information about the first dose of Shingrix, no lot or the location of the administered dose. The reporter consented to follow up. Due to covid pandemic, the patient never got 2nd dose of Shingrix, which led to social problem.. The patient received 1st dose of Shingrix via intercostal route, which led to intramuscular formulation administered by other route. The case had been linked to US2023069450, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023069450:Patient's husband report
This non-serious spontaneous case, initially received on 17-Sep-2018, reported by other non-health professional and concerns a female elderly patient of unspecified age. It was reported that in the past (3-4 years), the patient administered influenza vaccine and developed soreness and redness in the arm. The patient's historical condition included asthma (on an unspecified date). On an unspecified date, the patient administered INN Flu vaccine seasonal (dose, route of administration, anatomical location, manufacturer, batch number and expiry date: not reported). On unspecified date, after vaccination, the patient experienced soreness and redness in the arm. At the time of this report, the outcome of the events was not reported. Follow up report received on 25-Sep-2018: The patient's date of birth was added in the tab. Non-significant follow-up received from other non-health professional on 14-Nov-2018: No new information was received. Hence, no changed were made to the case.
Client stated blurry vision.  Checked her frequently (every 5 minutes approx.)  Spouse claimed she also has macular vision.  Did not clear completely.  She was adamant about going home.  b/p 170/82 Spouse stated that she is very anxious and b/p increases with her anxiety.  Kept for 50 minutes to monitor
Shingles shot and had shingles few years later / had another 2 shots for shinkles/Suspected vaccination failure; Had shingles few years later; Still have nerve pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles few years later and still had nerve pain.  The patient stated that he/she had another 2 shots for shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
ON 08/04/2022 I RECEIVED PCV20 PNEUMOCOCCAL CONJUGATE VACCINE PVC20 ON MY RIGHT SHOULDER AND THE DOCTOR ASSISANT INJECTED IT INTO MY TENDON. 08/08/2022 WENT TO EMERGENCY ROOM FOR SEVERE PAIN. 08/15/2022 WENT TO ORTHOPEDICS AND WAS ORDERED A MRI. 09/06/2022 MRI WAS GIVEN. 09/23/2022 TO SEE MD WAS RECOMMENDED TO SEE A ORTHOPEDIC SURGEON. HAVE A APOINTMENT ON 01/31 2023 9:30 AM  TO SEE DR. TO DISUSSED SURGERY.
He woke up could not walk; dizziness; lots of difficulty walking; This is a spontaneous report from a contactable consumer (patient's daughter)   A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 13Jan2021 at 15:00  at single dose via an unspecified route of administration  on right arm for COVID-19 immunization. Relevant medical history included borderline diabetic. It was also informed that patient had a little bit of cognitive decline predating the vaccine and he didn't drive. Concomitant medications were not reported. On 14Jan2021 the patient woke up and could not walk. On the same day (14Jan2021) the patient also experienced dizziness and lots of difficulty walking. He was admitted to hospital on 14Jan2021. Reported the CT was clean, chest x ray was clean and blood work was fine. Patient was planning to receive the next dose of vaccine on 03Feb2021. At the time of the reporting the patient was recovering from dizziness and had not yet recovered from other reported events.   Information about lot/batch number has been requested.
No additional AE; an expired dose of VAQTA to a patient on 10MAR2023; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 10-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #U021561, expiration date: 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). The reporter confirmed the product was not involved in a temperature excursion and was stored according to the recommended storage range until administration. No additional adverse event was reported.
Area red, swollen, and hot to touch. She can't pick up her arm due to pain, also felt dizzy.
Palpitations, dizziness, nausea, diaphoretic, hypertension, tachycardia.
Diarrhea; Dizziness; Sluggish; Cold sweat; Going to passout things were turning black; going back to bed and couldn't make it (too weak)/had to sit on floor; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat) and PRESYNCOPE (Going to passout things were turning black) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor) outcome was unknown.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient received 5 year old immunization(DTaP, MMR, IPV) on 07/14/2006 at 2:30pm.  Left office and within approximately 10-20 minutes developed a cough.  Also had one episode of diarrhea prior to eventually breaking out in diffuse red rash pruritus rash (macular on face, extremities and chest) No wheezing. Also had eyelid edema when seen by me at 4:30pm.  Phone follow up 07/17/2006 rash resolved.
Information was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 17-JUL-2018, the patient was vaccinated with VAQTA for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On the same day, after the pre filled syringe needle was pulled out of the skin, there was amount of leakage at the injection site (injection site leaking); however, no side effects were reported. The outcome of injection site leaking was unknown. The relatedness between injection site leaking and VAQTA was not reported.
Patient described reaction to first dose as follows:  almost immediately after her first Pfizer COVID injection, she states that she felt nauseous and short of breath, then vomited.  Per pt, EMS said her blood pressure was ?through the roof? (no exact vitals given).  She was observed for 30 minutes, stated she felt much better and went home voluntarily.  At no time was epi administered per patient.  Today, patient gave her vaccination history from 4/14/2021, stated that she felt fine today and that she wanted to proceed with her second Pfizer dose.  It was determined that there was no contraindication and the vaccine was given at 3pm.  Within 3 minutes, patient stated that she was having difficulty breathing and was nauseous.  EMS arrived immediately, pt  coughed up some sputum, vitals as follows: 144/97 105 98% initial temp 101.7, but pt was in the back of a car with engine off and the warehouse was a little warm.  EMS repeated vitals 140/88 100 98%. Pt was able to ambulated out of the car to a chair, eyes closed, but at no time did she appear SOB or in any distress, RR remained 16-18 bpm.  Final by 128/88.HR 99 SaO2 99%., blood glucose 140, repeated temperature out of the car 99.1.  EMS stated that she appeared to be stable, but pt insisted that she did not feel good, was nauseous and SOB, and that she wanted to be transported to a hospital.  Pt taken to Arizona General by ambulance, with stable VS and in NAD, AOx3.
PATIENT WAS GIVEN A STATE VACCINE WHICH IS MEANT FOR CHILDREN 18 YRS OLD AND UNDER.  PATIENT HAS NO SYMPTOMS OR REACTIONS TO THE VACCINATION. PATIENT HAS BEEN NOTIFIED OF THE ERROR. PATIENT DOES NOT NEED TO BE RE-VACCINATED.
Received 2 Doses of Heplisav-B At The Same Time; Initial Report Received on 28-Feb-2023  A registered pharmacist reported that a 36-year-old male patient (race and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at the same time in a combined dose.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On an unknown date, the patient received two doses of HEPLISAV-B vaccine (Lot # 937230, expiration date Sep-2023, NDC # 4352800  305) at the same time in a combined dose intramuscularly (injection site unknown). The person administering the vaccines misread the prescription and combined two doses of HEPLISAV-B into one prefilled syringe and administered them to the patient. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
23JUL92 fell face foward on floor; body rigid, eyes rolled back, pules 50, resp 14 & shallow pt became very combative for approx 1 min; pt suffered a convuls as a result of allergic rxn to vax;
Developed headache, nausea, dizziness. Did not feel well enough to remain at school and was picked up by father. PCP was contacted by parent, told to "keep an eye on her."  Still felt bad on 12/08/09.  Returned to school on 12/09/09.
pt has swelling & soreness since 3MAR93; extreme itching, swelling & redness of the lt arm; There is induration, erythema of the upper arm w/in about 4 cm of shoulder & elbow;
Pfizer 4/2/21, 4/26/21, 1/13/22. Positive on 2/9/22
Initially sore arm, tiredness, achy body - went away in 24 hours. 5 days later very itchy rash/hives on arms and legs and at injection site  - very difficult to manage discomfort. 12 days later welt/hive appeared on injection site, with additional hives appearing on face/neck.
Moderna vaccine: Migraine, nausea, couldn?t touch left arm due to pain.  Light and motion sensitivity. Stabbing pain all throughout scalp.
Fatigue; fever; headache; This is a spontaneous report from a contactable nurse.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:Ek9231, via an unspecified route of administration on the left arm on 08Jan2021 22:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paroxetine (PAROXETINE), finasteride (FINASTERIDE), testosterone (TESTOSTERONE) and rosuvastatin calcium (ROSUVASTATIN VIAL). The patient experienced fatigue, fever and headache on 09Jan2021 11:00 with outcome of recovered.
Large local reaction with 1cm x 2.5 cm area of tender erythema to left upper arm which appeared 9 days after vaccination given.
testing Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (testing Positive for Covid) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (testing Positive for Covid). At the time of the report, COVID-19 (testing Positive for Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 18-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 08-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported.  No treatment information was provided.
three patients who got 6 doses injected at one time and overdose; localized reaction of pink, warm, tender swollen arm; localized reaction of pink, warm, tender swollen arm; Fever; Nausea; This is a spontaneous report from a contactable physician. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO187; Expiration Date: 31Aug2021) via an unspecified route of administration on 17Aug2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. Medical history included obese (patient was morbidly obese prior to hospitalization at 269lbs in Mar and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), ongoing alpha-1 antitrypsin deficiency , lung disease, COVID-19 from 20May2021 to an unknown date (had Covid 19 around 20May2021 and was hospitalized for 10 days). Concomitant medication included alpha-1-antitrypsin (PROLASTIN C), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), ipratropium bromide, salbutamol sulfate (DUONEB), bupropion (BUPROPION), dupilumab (DUPIXENT), fluticasone propionate, salmeterol xinafoate (ADVAIR), furosemide (FUROSEMIDE), glycopyrrolate (GLYCOPYRROLATE), ipratropium bromide (ATROVENT), levothyroxine (LEVOTHYROXINE), metformin (METFORMIN), omeprazole (OMEPRAZOLE), all taken for an unspecified indication, start and stop date were not reported, alprazolam (ALPRAZOLAM) taken for lung disorder, start and stop date were not reported; azithromycin (AZITHROMYCIN) taken for lung disorder, start and stop date were not reported. The patient experienced as, three patients who got 6 doses injected at one time and overdose on 17Aug2021, localized reaction of pink, warm, tender swollen arm, fever, nausea on 2021. Baseline O2 status was 6-8 meters a minute and was on bipap. For the overdose event, HCP reporter suspects full vial of diluted vaccine was administered. The patient underwent lab tests and procedures which included oxygen saturation: 6-8 on May2021 (baseline O2 status was 6-8 meters a minute and was on bipap), weight: 245 lbs on an unspecified date (patient was morbidly obese prior to hospitalization at 269lbs in March and 266 in May. She lost a lot of weight in the hospital and was 245 lbs at discharge), weight: 269 lbs on Mar2021, weight: 266 lbs on May2021. Outcome of the event localized reaction of pink, warm, tender swollen arm was not resolved and unknown for fever, nausea.  Follow-up attempts are completed. No further information is expected.
On 2/1/2023, patient presented to the emergency department from his assisted living facility for evaluation of chills, dry cough, rhinorrhea, and generalized weakness. He was given a COVID-19 NAA test which resulted positive; His chest x-ray showed some vascular congestion, and right basilar opacity which may be atelectasis or infiltrate. Patient was diagnosed with COVID-19 virus infection, cellulitis of right lower extremity, and congestive heart failure exacerbation. He was treated with IV Lasix and started on antibiotics. Patient was admitted to the hospital for further evaluation and treatment.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital