chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Later that evening, around 7:30pm "I" noticed what appears to be a rash that has developed on the top of "my" left hand.; It's a small, isolated, area with around seven bright red spots in varying sizes that has not spread; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 18Apr2021 at 10:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history included adult attention deficit hyperactivity disorder(ADHD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 24Mar2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 19:15, later that evening the patient noticed what appeared to be a rash that was developed on the top of his left hand. It was a small, isolated, area with around seven bright red spots in varying sizes that was not spread. The patient reported that there had been no itching, pain or sensitivity. It also appeared to be fading and it had been more than 72 hours at the time of this report since receiving the second dose. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash that has developed on the top of left hand and small, isolated, area with around seven bright red spots in varying sizes were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
I started my menstrual period 2 weeks early, 4 days after COVID-19 Vaccine dose #1. Since it started, I have been bleeding for 3 weeks straight with drastic variations in blood volume every day. This is abnormal for me since my birth control has regulated my periods.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. It was reported total 69 administered doses of these, 68 doses were booster and 1 dose was a first dose.
I had a low grade fever, chills, aches, sore throat, ear ache, cough that lasted a week. Loss of smell and taste for 2 days.
Received vaccine in right deltoid--3 to 5 minutes later developed hot sensation in rt shoulder radiating into middle of rt chest. Pain developed across chest and persisted to some extent until evening, then moved more into rt axillary area. Was sore with every position change. Developed palm size swelling in rt axilla that remains soft. No rash, no breathing difficulties, no fever. Rx consisted of ibuprofen for soreness.
NO KNOWN ADVERSE EVENTS HAVE BEEN REPORTED TO FACILITY.  HAVE TRIED TO CONTACT INDIVIDUAL BY PHONE AND EMAIL TO VERIFY DOB UNDER 16 YEARS AND HAVE NOT BEEN SUCCESSFUL.  WILL CONTINUE TO TRY TO CONTACT.
female patient received one dose of pre-exposure prophylaxis then and,on Day 21, came to pharmacy for the second dose; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient who was vaccinated with one dose RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection, Information on the batch number was requested) via unknown route in unknown administration site.  It was reported that the patient received pre-exposure prophylaxis and she is now at Day 21 and has not received the second dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate schedule of vaccine administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; I had a metallic taste in my mouth; This is a spontaneous report from a contactable  consumer.  A 65-years-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number= EL9262, via an unspecified route of administration, in the right arm, on 22Jan2021 at 14:00  (at the age of 62 years-old) as a single dose for COVID-19 immunization. The vaccine administration was given at a hospital. The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor was diagnosed with COVID-19 prior to the vaccination. Medical history included being a breast cancer survivor.  Concomitant medication included montelukast sodium (MONTELUCAST) daily, received within 2 weeks of vaccination. The patient previously took LEVAQUIN and LIVALO and experienced an allergy.  On 22Jan2021 at 14:45, at forty minutes after the vaccination, the patient reported that the top of her shoulders were a little achy - across the back and also experienced a metallic taste in her mouth. This lasted around one hour. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events was not reported. Since the vaccination, the patient has not been tested for COVID-19.
After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt like it was ripping out of my left arm and it was tender. The lymph node subsided after two days of the vaccination. I also had two menstrual cycles back to back which was out of the ordinary for me since I am regular on my periods.  I saw my gynecologist due to my menstrual symptoms. I was regular up to that point of my vaccination. One week ago I had better range of motion to my left arm.
13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge) . The Moderna Vial did not have an expiration date on it. However, the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021. The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document contains no new Information.
pt recv vax 2MAY96 & 9MAY96 pt devel a fever of 106 x 24hr & vomiting;pt taken to ER dx w/acute fever of undetermined origin & a viral synd;lab eval revealed WBC count 22.8;UA revealed large ketone;
Pt Deceased - Breakthrough 1st Dose 3/4/2021 - Pfizer - en6202 2nd Dose 3/25/2021 - Pfizer -- en62077
Bad headache, consistent high temperature, nausea, dizziness,  severe muscle pain , weakness etc
Injection Site got big and bigger (Ping Pong Ball size); Red Mark on the Injection Site/ Red injection site; Raised Injection Site; Itchy Injection Site; Sore Arm; A spontaneous report was received from a 37-years-old female patient  concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event sore arm. On 1 Feb 2021, the patient experienced the events red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site.  Treatment details included Augmentin.  Action taken with mRNA-1273 in response to the events was not reported.  On 27 Jan 2021 the outcome of event, sore arm was resolved. The outcome of events, red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site was unknown.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced tinnitus, which started getting very loud tinnitus 3 days after the first shot. It improved slightly a few weeks later but got worse again after the second dose. Even after 5 weeks, it did not resolve. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and was sought saying that there was no treatment. On an unknown date, the patient underwent audiogram and the result showed that there was no hearing loss in the tested frequencies. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe joint pain; Low grade fever; Severe diarrhea; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 45-year-old female patient received BNT162B2 (PFIZER- 1, single for COVID-19 immunisation. Medical history included High blood pressure, high cholesterol, GERD, and anxiety. Concomitant medications included lisinopril; rosuvastatin calcium (CRESTOR); pantoprazole; celecoxib (CELEBIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration, administered in the right arm on 07Feb2021 13:15 (at the age of 45-years-old), as doseXA [CELECOXIB]); acetylsalicylic acid (BAYER ASPIRIN) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Severe joint pain, Low grade fever, Severe diarrhea , and Tiredness on 08Feb2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 27Jan2021. No treatment was received as a result of the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pharmacist initially tried to inject the dose in my left arm and the fluid ran down my arm and he said something was wrong with the needle and gave me the second injection. No pain or other problems
Within 16 hrs experienced severe lower back pain, lasted couple days, still experience intermitant light headaches, intermitant upset stomach, intermitant pain in side, (prior to flu shot had no symptoms),  have not sought medical help.
TINGLING IN THE FEET/TINGLING RADIATED UP THROUGH HER BODY; This spontaneous report received from a pharmacist concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: 21-JUN-2021) .5 ml, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced tingling in the feet/tingling radiated up through her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in the feet/tingling radiated up through her body. This report was non-serious.
low grade fever; rash with itching on his upper abdomen that resembles chicken pox; rash with itching / Rash; rash with itching /  itching; This case was reported by a consumer and described the occurrence of chickenpox in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in his 30s).   On 12th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th March 2021 18:00, less than a day after receiving Shingrix, the patient experienced fever. In March 2021, the patient experienced chickenpox, rash and pruritus. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chickenpox, rash and pruritus were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chickenpox, rash, pruritus and fever to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix in left deltoid. Three to seven days after receiving Shingrix, the patient noticed a rash with itching on his upper abdomen that resembled chicken pox. The patient had seen his healthcare professional and was treated with Prednisone and Benadryl.  Rash and itching had gotten progressively worse since onset.  The patient also experienced a low-grade fever at 6 pm the night of the vaccine but was gone the next morning. The reporter did not consent to follow-up.
Information has been received from a physician concerning a patient who was vaccinated on an unknown date with a pediatric dose of hepatitis A virus vaccine inactivated. Subsequently the patient experienced an adverse event. There were no details to the adverse event, just that one occurred. The outcome was unknown. Follow-up information has been received from the physician concerning a 16-year-old male student with no pre-existing allergies, birth defects or medical conditions who on 05-Jul-2007, at approximately noon, was vaccinated in the right arm with an intramuscular first dose of hepatitis A virus vaccine inactivated (lot# 657304/0246U). Concomitant vaccination included a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the left arm. There was no illness at the time of vaccination. On 05-Jul-2007 at 2 PM an adverse event occurred which required a doctor visit and emergency room (ER) visit. Unspecified diagnostic tests and laboratory data were performed in the ER. The patient recovered on 06-Jul-2007. Additional information has been requested.
Vial was initially opened on 12/8 and was not discarded by staff. Nurse gave dose to staff from vial--after suggested 12 hour timeframe. No adverse events occurred. I called Moderna and they said it was fine given the proper storage, dose did not need to be repeated. They said there could be concerns with sterility given it is preservative-free. I relayed this information to the nurse who administered.
Pt came in to the pharmacy to inform us that she believes the vaccine was given to high in the arm. She said she went to her uncle who is a Dr. and he said it was given in the bursa and she may have bursitis. She said she has limited mobility of her arm now and will need therapy.
Approximately 7 hours after the vaccine, the patient states that her blood pressure and pulse were higher than normal. BP 150/97 and pulse 100 for a couple hours. She eventually felt better and did not seek medical attention.
In the evening of 4/1 around 7:30pm or so, I felt the left half of face becoming kind of numb/tingling and feels not normal. It felt like after the dental work when you get pain killer shot in cheek/mouth.  The condition improved with time but did not go away fully.  In the morning of 4/2, it felt better but still there somewhat and I felt the left eyelid droopy.  The left eye wept some in the morning.  My husband thought my left cheek felt a lot softer than right side.
Patient developed a rash over his body approximately 12 days following the booster. Treatment consisted of oral prednisone and antihistamines. Treatment is ongoing, but patient has improved 85%. Patient continues to treat with topical steroid cream and antihistamines. Symptoms at this time are significant skin sensitivity that cause flare ups that generally fade within an hour.
Pain and swelling in joints, esp hands and fingers, (primarily joints at base of index fingers and in right index finger) also shoulders, knees, neck, hips and feet hard bumps on top of both feet, but esp right foot. General malaise, tired easily for a couple of weeks
Hospitalized (12.8.21 - 1.12.22);  COVID positive (12.30.21);  Fully vaccinated  Admission date:  12/8/21 (from ED)  Discharge date: 1/12/2022 (transferred to Facility) PRESENTING PROBLEM: Hypoventilation  Acute respiratory failure  Acute on chronic respiratory failure  Acute and chronic respiratory failure (acute-on-chronic)   CHIEF COMPLAINT: Acute on chronic respiratory failure with hypoxia and hypercapnia  ASSESSMENT / PLAN: COVID-19 infection Likely hospital acquired No obvious symptoms, patient has stable respiratory failure Currently does not meet criteria for Decadron, remdesivir or monoclonal antibodies due to lack of change in hypoxia from baseline and no active symptoms of COVID Acute on Chronic hypercapnic respiratory failure, resolved OSA/OHS Severe pulmonary HTN Multifactorial respiratory failure in setting of OSA, OHS, pulm HTN Intubated 12/8-12/23, if he needs re-intubation he will need a trach Currently on 2-3L NC during the day and bipap at night(baseline).  Goal to maintain oxygen saturations at 88-92% PE/DVT 1/2021 Continue Xarelto  Paroxysmal Atrial fibrillation  Holding home Diltiazem 2/2 soft bps.  Continue metoprolol Continue xarelto S/P IV amio, continue maintenance dosing 200 mg daily PO Chronic diastolic HF Not in exacerbation Continue home Torsemide Daily weights, I/Os Hypertension, essential Holding home Losartan, diltiazem due to soft bps Continue Lopressor Shock, resolved Morbid obesity Body mass index is 51.7 kg/m². AKI on CKD 3, resolved.   Depression/Anxiety Continue Buspar, Effexor, Trazodone
Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: left arm numbness prior to becoming unresponsive
I had chills, body aches and a fever 16 hrs after the vaccine. I took Ibuprofen 3 times every 6 hrs of 400 milligrams. the area vaccinated was red, hot and very itchy. I had to leave work early.
Breakthrough case admission after 2 vaccines Janssen 4/6/21 Lot# 042A21A;  Janssen 11/18/21 Lot# 213D21A
My symptoms started on 06/09/2022 with a crashing headache, fatigue, runny nose, sore, my eyelids swelled, became hot and itchy. I would wake up and could not see because my eyelids would be so swollen. On June 10, 2022 I went to pharmacy and had a COVID-19 antigen test that came back negative. The Nurse Practioner felt that with all my symptoms I needed to get a PCR COVID-19 Test. I went to Urgent Care on June 11, 2022 for a PCR COVID-19 test done. On June 13, 2022 the doctor from Urgent  Care called to let me know that my PCR  test was positive. I was contacted by the IU high risk center and they prescribed Paxlovid that I started taking on the evening of June 13, 2022. I still have a bit of a sore throat, croaky voice and fatigue.
Can't stretch/lift right arm above head. Unable to reach left side with right arm. Sharp lightning pains down right arm to elbow to leg and toe. And toward my neck and back. Sharp pain wake me up during the night. Need to sleep in chair to relieve pain. Pain occurs when sleeping on back, left or right side.
migraine , blurred vision, extreme fatigue, arm pain for days could not move arm at all