chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/30/2021  I was having body pain,  head aches and  suddenly I had a hard time breathing.  I went to the ER, they did an ECG and x-ray of my chest. They diagnosed. They gave me Acetaminophen and Ondansetron. They sent me home.  On May 2,2021 I started having shortness of breath and I fainted. I was on the toilet, and I was conscious, but I could not sit up because of shortness of breath.  Then I went to Urgent Care. The doctor who saw me and said I had syncopal spells, shortness of breath, constipation and bradycardia.   They sent me to ER because they felt something was going on. No acute changes on the ECG. I had sinus bradycardia, Non-Specific T-Anomaly.   They referred me to a cardiologist. He did a vascular cleaning and said it was okay. Asked me to repeat a stress test and a complete echo. The stress test I got off very quickly, because I could not breathe. They saw nothing on either test.  Told me to repeat the tests after 6 months. I have to wait until June to get it done.   I tested positive for COVID on January 20, 2022.  After that, my blood pressure started going chaotic.  I have anxiety and blood pressure has not improved.
Covid-Arm: hard, swollen, red rash at injection site.  Appeared 9 days after vaccination.
Kidney infection; I had my shingles shot/ I have the shingles right now/suspected vaccination failure; I have the shingles right now; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure and  kidney infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included infection (patient had 3 infection) and surgery.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced kidney infection (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with non-drug therapy (Radiation Therapy) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the kidney infection, vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the kidney infection, vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had the shingles right now down with them on his/her last radiation therapy Friday. The patient also stated flat in bed do to the pain of them and kidney infection, during chemo and surgery. The patient had 3 infection and asked why not close out with this, and he/she also had shingles shot thank God for my special friend who has been there for he/she. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The follow up would not possible as contact information was not available.
Patient hadttonic-clonic seizure for about 10 seconds, 10 minutes after vaccines, then continual with jerk, movements for 30 minutes
Information has been received from a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil.  Concomitant therapy included antimicrobial (unspecified).  The reporter mentioned that patient's menstruation period stopped for 1 month then came back after she got the dose of Gardasil.  She also mentioned that the patient was not pregnant.  The outcome was unknown.  Additional information has been requested.
Received the vaccine subcutaneously; Received vaccine a little lower in the arm than the deltoid muscle; A spontaneous report was received from Healthcare Professional concerning a 40-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle   The patient's medical history was not provided. Concomitant medications were not reported.   On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) subcutaneously in the arm for prophylaxis of COVID-19 infection  On 25 Jan 2021, the patient experienced received the vaccine subcutaneously and a little lower in the arm  than the deltoid muscle.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event received the vaccine subcutaneously and a little lower in the arm  than the deltoid muscle was resolved on 25 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration and vaccine administered at inappropriate site for mRNA-1273 (Batch Number: 039K20A) with no associated AEs.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, indication, lot# and expiry date unspecified) instead of a dose of VARIVAX. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the reporting pharmacist did not grant permission to contact with him.
after 11 days, I still have a large (1/2 dollar size, red mark at the injection site that is warm to the touch and at times itchy. I had no other symptoms or reactions to the vaccine.
Rash to upper chest, flushed cheeks, lightheaded BENADRYL 50mg PO pt received DEPO PROVERA injection just prior to vaccine.
Bright red ?rash? appeared 9 days after shot. Appx 4?oval shape, noticed after showering. Moderate itching set in several hours after noticing, and fatigue. Read about ?covid arm? on several reputable news outlets, so reporting the reaction. Will seek medical attention if it persists more than a few days.
This spontaneous report was received from a nurse, concerning to a 13 year old female patient. Her medical history and concurrent conditions were not reported. On 03-MAR-2016 at 10:00, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Narrative:  COVID infection following COVID vaccine series 01/29, Pfizer, dose #1 02/19, Pfizer, dose #2 08/11 COVID swab, result: detected 08/11 pt cc: exposure: unknown 08/11 CXR impression: Peripheral airspace disease. Correlate clinically for pneumonia, including viral/atypical etiology and follow-up to resolution. 08/12 pt admitted to hospital dx: COVID 19 PNEUMONIA LOC: 2 DAYS 08/12 FIBRINOGEN result: 541 08/12 DDIMER result: <0.22 08/14 ESR result 26 08/12 SARS-COV-2 IgG result: 0.01 08/12 abg: i-pH result 7.48, i-PCO2 38.7, i-PO2 74, i-HCO3 28.5 08/12 strep pneumoniae antigen result: negative 08/12 legionella antigen, urine result: negative 08/12 quantiferon-tb result: negative 08/12 SARS-COV-2 TOTAL AB SPIKE result: >2500 08/13 FIBRINOGEN result: 503 08/13 DDIMER result: <0.22 08/13 ESR result 54 08/14 FIBRINOGEN result: 459 08/14 DDIMER result: <0.22 08/14 ESR result 61 09/20 CT CHEST Impression: 1. Nonspecific pleural thickening has resolved. Pulmonary nodules, recommend follow up with full inspiration chest CT scan in 12 months. Other findings as above.
Severe arm pain since I received the injection 12 days ago, limited mobility, lack of sleep due to pain from arm.
Child wen to public evening clinic on 11/4/09 received live nasal spray. Went home and broke out with itchy hives all over except for head. No SOB or wheezing per mom. She called he MD and TX with BENADRYL and hydrocortisone cream topically. Hives noted thru 11/5/09. No other c/o or problems.
Patient became sick aroun 8/5. Not tested for COVID, but quarantined. Came into ED extreme weakness, productive cough, dry heaves. Oxygen was 89% room air
He developed hysterical crying within 2-3 hours of vaccines. Could not console. Went to ER with work up negative.
Patient since received the vaccine had a frozen shoulder type reaction where she could not move the arm.  She had pain and swelling at the site.  Since then she has had about 40 physical therapy sessions for about 6 months.  Her arm is still not at 100%.
p/vax pt devel difficulty swallowing, and progressive weakness, could not walk;exp acute flu like sx;Dx=myasthenia gravis;devel steroid myopathy  & aseptic necrosis of hips;pred d/c & difficulty speaking, swallowing & walking  Doc # 197836 states that report was cancelled based on correspondance received from the vaccine provider.
COVID Positive >14 days post vaccine Narrative:  COVID Positive >14 days post vaccine
Started with a headache, nausea, progressed to severe cough and congestion, body/joint pain, spiked a fever of 100.5, continued for 24 hours.
I started to feel sick the next day of my vaccine. I took my Fosamax medication the next day and I started to feel worse. The Fosamax medication I take is concentrated.   I experienced dizziness and started having tachycardia and also ran a fever.  Right now I am in the ER due to my fever symptoms.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA. On 28-Feb-2021, PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a fever of 101.4 degree F. No concomitant medication were reported. No treatment information was provided.
bright fluorescent green urine; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 23Feb2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received her first dose of the vaccine yesterday and woke up today (24Feb2021), had bright fluorescent green urine. The patient stated that, she reached out to her healthcare professional and just left providing a urine sample. The patient had asked whether this was a common side effect of the vaccine or not. Enquired that, the caller was asked if Pfizer was still working towards getting approval for the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
metal taste in mouth 30 min after injection received, itching sensation on left arm 1 hour after injection received. Pt. evaluated by their in house medical team who administered a Benadryl injection to the right arm, unknown dosage. The pt. told me the nurse on staff measured her SPO2 at 86% and wanted to call 911 for transport to the ER. Pt. reports she refused and left work to come to the urgent care clinic where I evaluated her. She is concerned that she could be having a panic attack vs. allergic reaction. Her itching arm and metallic taste has resolved but she feels chest pains on the left side of her chest and her left arm feels heavy.
1 day after receiving vaccine, redness, tenderness, and swelling developed at vaccine site which resolved 48 hrs later. Then  8 days later, the vaccine site became red, swollen, and painful with a hard bump.  I was seen by my primary care office whom diagnosed cellulitis at the injection site and was placed on Azithromycin 250mg x 6 days and Prednisone 5mg taper for 10days.  24hrs after starting the medications, the redness and pain at the injection site started improving and after 96 hrs on medications, all symptoms had resolved. Vital signs remained stable throughout the entire event.
pt recv vax 5AUG95 & 3MAR97 pt exp t100.3;4MAR97 pt exp 32-50 lesions;pt was treated symptomatically;pt recovered;
Had shot years ago, have shingles now/Suspected vaccination failure; Have shingles now; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of 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 pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-Oct-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had shot a number of years ago but he/she have had shingles now. The patient stated was very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
1 yo child was given HIBtiter & tine test. Twelve hrs later felt feverish & then had 1-2 episodes of generalized sz. Seen in ER temp 104, post-ictal & was hospitalized-no treatment. A few hrs later was awake & back to normal.
Date of manufacture 10/2021. Vaccine was received and placed in fridge April 8th. Packaging was labeled with date placed in fridge but BUD was not calculated. BUD was on 6/17/2022 and this vaccine was administered on 6/20/2022. Pfizer was contacted and excursion report was filed with them. Will follow CDC recommendations for readministering dose .
8/11/06 Hep A- Hep B vaccination #1 given at SC 11:35 RA, SADR at that time for next hour. Approx 6:30pm that day pt took daily dose of Zyprexa 15 mg PO then 30 mins - 1 hour later had pain in opposite LA and had heard rate slow down and stay slow till next morning. LA pain deltoid remained constant till noon next day. States LA pain a 6 on scale of 10, Described as a pulled muscle pain.
Patient experienced itchy mouth/throat as well as tingling in their face an hour after their vaccine. Patient was seen at the ER, was treated with Benadryl and Prednisone, and told to follow up with their PCM.
Patient states she had nausea, pain and stiffness at the injection site, sniffles and vomiting.
When he got the shots he cried uncontrollably, about 6 pm he started crying uncontrollably and very high pitched.  This continued off and on the entire evening.  His fever spiked to 103.5 had a very hard time settling him.  Gave him Tylenol no movement on the fever. The uncontrollable crying continued for at least 24 hours. He was very unsettled and unhappy for about a week.  Prior to the shots he was a very happy boy that NEVER had cried like that!
Pt came to ER c/o weakness, cough, fever.  Felt weaker then normal for the past few days.
PATIENT RECEIVED VACCINE 5/20/2021, WITHIN 8 HOURS OF VACCINATION, PATIENT BEGAN TO EXPERIECNE COVID TYPE SYMPTOMS (102.7 TEMP, MUSCLE ACHES, CORE MUSCLES BECAME VERY TENSE, NAUSEATED, SKIN FEELING PRICKLY TO THE TOUCH, DIFFICULTY WALKING. SYMPTOMS PROGRESSED TO THE POINT OF HIM LOSING ABILITY TO CONTROL BOWELS. AT THIS POINT PATIENT WAS HOSPITLIZED AT HOSPITAL FOR 1 WEEK. THERE, STAFF TREATED HIS SYMPTOMS WITH PAIN MEDICATIONS, THINKING IT WAS DUE TO BACK PAIN AND NOT THE VACCINE. THIS DID NOT ALLEVIATE HIS SYMPTOMS, HE HAD A SPASM LATING 18 HOURS. HE CAME HOME, THEN WAS REHOSPITALIZED AT MEDICAL FACILITY, AND REMAINS THERE AS PATIENT. NEUROLIGICAL TESTING WAS PERFORMED, AND MEDICAL STAFF IS THINKING THAT HE HAS TRANSVERSE MYELITIS, THIS DIAGNOSIS IS PENDING SPINAL TAP. HE IS RECEIVING IV STEROIDS, WHICH HAS DECREASED HIS INFLAMMATORY MARKERS. HIS GAIN HAS IMPROVED, VERBAL COMMUNICATION HAS IMPROVED, HAND AND BODY TREMMORS HAVE INCREASED, PAIN IS UNDER CONTROL WITH PAIN MEDICATIONS.
Severe headache; Having a reaction with extreme pain and myalgia; Having a reaction with extreme pain and myalgia; This is a spontaneous report from a contactable physician. This Physician reported similar events for four patients. This is report three of four reports.  A 19-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA, lot number: S58878, Pfizer product), via an unspecified route of administration on 01Apr2019 at a single dose for immunization. There were no medical history and no concomitant medications. On an unspecified date, the patient experienced severe headache, having a reaction with extreme pain and myalgia. The outcome of events was unknown. The doctor stated this was getting ridiculous 50% of shot causing headache and myalgia. Something must be wrong.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event different patient
shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration in the left arm on 06Feb2021 at 11:30 (at the age of 71 years old), as dose 1, single for COVID-19 immunisation. The patients medical history was reported as known allergies to narcotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On Feb2021, the patient experienced shortness of breath. It was unknown if patient received any treatment for the adverse event. The clinical outcome of the event shortness of breath was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021312093 Same reporter, patient/ similar events/ different dose
vaccines were removed from the freezer on date of appointments to be used, and any unused; No adverse event; Dose administered after manufacturer date of expiry to  patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient) and PRODUCT STORAGE ERROR (vaccines were removed from the freezer on date of appointments to be used, and any unused).    No concomitant drug was reported. Number of dose or vials reported as 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. It was reported that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. Vial did not undergoes temperature excursion. No Treatment medications were reported.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Since December 2014 the patients were vaccinated with VARIVAX (Merck) (lot # J013907, expiration date 30-OCT-2015, dose, dose#, frequency and route not reported) which had been improperly stored. No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
This spontaneous report as received from a registered nurse refers to a male adolescent patient (age not specified). Medical history was not provided. On 05-AUG-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot number not provided). Concomitant medication was not provided. On 05-AUG-2013, within 5 minutes of administration patient passed out while sitting. The outcome of the SAE was not provided. Passed out while sitting was determined as medically significant upon internal review. Additional information has been requested.
This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX which had the lot # L037791, expiry date: 30-DEC-2016 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 41 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 45 minutes to an hour after receiving the vaccine she started feeling like she was having throat swelling and difficulty swallowing and  swelling on her right upper lip and right face. No difficulty breathing.
Mom stated patient was with dad day of vaccines given, when she picked her up the following day is when she noticed the redness and swelling on (R) right thigh. Next day got a little bigger.