chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown.   No follow-up attempts are possible. No further information expected.
got the vaccine and have had them/suspected vaccination failure; had them 5 times; This case was reported by a consumer via interactive digital 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient had got the vaccine and had shingles 5 times since the vaccination.  The reporter also said shingles vaccine did not help everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. No contact details were available.
Dad called to report about a month later the child was having  knee pain, she was seen in our office on 04/08/2022 and referred to orthopedics, and was diagnosed with Juvenile arthritis, Dad believes the vaccine caused it
Information has been received from a consumer concerning her 5 year old daughter with penicillin and foods allergies who on 16-JUL-1999 was vaccinated with the first dose of MMR (lot number 630109/0121J) and on 05-JUN-2003 was vaccinated with the second dose of MMR II (lot number 645267/0101N). Concomitant therapy included natural medications. Concomitant vaccination on 05-JUN-200 included DTaP (unspecified), poliovirus vaccine, OPV-MERIEUX and tuberculin purified protein derivative. On 09-JUN-2003 (also reported as 4 days later) the patient experienced a seizure. She was taken to the emergency room and had an MRI and blood tests. She was later released. She then saw a neurologist and continued with appointments for 2.5 years. No medication was required. No further seizures noted, however, she continued to have EEG's (electroencephalograms) which still showed seizure activity for 5 years after the initial episode. She was recently diagnosed with Asperger's Disease. The consumer also mentioned the patient had no adverse reaction after the first dose of the vaccine in 1999. On an unspecified date the patient recovered. Upon internal review, seizure and Asperger's Disease were determined to be other important events. Additional information has been requested.
PT WAS GIVEN TWO SHOTS OF JAPANESE ENCEPHALITIS VACCINE (10 & 17 DEC 2004) PRIOR TO KNOWING SHE WAS PREGNANT.  UPON DETECTION OF PREGNANCY, PT DID NOT COMPLETE RECOMMENDED THREE DOSE SERIES OF JEV VACCINATION. ON 25 JAN 2005, PT PRESENTED TO CIVILIAN ER WITH OB RELATED BLEEDING.  QUANT HCG SHOWED EVIDENCE OF A PREGNANCY AT 4 TO 6 WEEKS.  ULTRASOUND SUGGESTED A BLIGHTED OVUM.  D&C EFFECTED WITHOUT COMPLICATIONS.  ADVANCED MATERNAL AGE NOTED.  ASSOCIATION BETWEEN JEV VACCINATION AND MISCARRIAGE UNCLEAR BUT PT DESIRES SUBMISSION OF VAERS.
I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.
Patient recieved first COVID vaccine from clinic on 1/7/21, and second dose was administered as the Janssen vaccine because the facility social worker had filled out the COVID vaccine consent form and stated that the resident had not recieved any COVID vaccine. After Janssen vaccine was administered, another healthcare worker at facility said that the patient has already recieved the Moderna dose as their first shot.
Info has been received from an RN concerning a 31 month old male, with no pertinent medical history and no known drug reactions/allergies, birth defects, or medical conditions, who on 9/4/03 was vaccinated, SC in the left thigh, with a 1st dose of varicella virus vaccine live. On 4/11/05, also reported as 4/5/05, the pt developed scattered varicella lesions on the trunk and upper extremities. It was previously reported that the pt experienced varicella breakthrough, which began on his face only. When seen by the doctor, he had 12 lesions scattered on his side and back. He also had itching but was afebrile. Benadryl and Aveeno baths were prescribed. No relevant diagnostic tests or lab studies were performed. Medical attention was sought. No product quality complaint was involved. There was no illness at the time of the vaccination. The pt recovered. Additional info is not expected.
ON TUESDAY MARCH 23 2021 AT 7:30 PM - 2 DAYS AND 11 HOURS AFTER THE SECOND VACCINE - I SUDDENLY LOST ALMOST ALL THE HEARING IN MY RIGHT EAR AND SOME OF THE HEARING IN MY LEFT EAR. IT WAS LIKE A SWITCH WAS FLIPPED AND I COULD BARELY HEAR. ON THE NEXT DAY, MARCH 24, 2021, I SAW ENT AT THE FACILITY. I HAVE BEEN TREATED SINCE THEN BY DR AND HAVE HAD STEROIDS INJECTIONS AND HAVE TAKEN PREDNISONE BUT HAVE HAD LITTLE CHANGE IN MY HEARING. DR ARRANGED FOR AN MRI. THE MRI SHOWED NO PHYSICAL ISSUES. I CONTINUE TO HAVE A MUFFLED HEARING IN BOTH EARS BUT THE RIGHT EAR IS MUCH WORSE THAN THE LEFT.
soreness; little brown bumps; painful; itchy; inflamed; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness), NODULE (little brown bumps), PAIN (painful), PRURITUS (itchy) and INJECTION SITE SWELLING (inflamed) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness), NODULE (little brown bumps), PAIN (painful), PRURITUS (itchy) and INJECTION SITE SWELLING (inflamed). At the time of the report, TENDERNESS (soreness), NODULE (little brown bumps), PAIN (painful), PRURITUS (itchy) and INJECTION SITE SWELLING (inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
THE PATIENT  SLID OUT OF HIS CHAIR TO A SITTING POSITION. HE BLACKED OUT FOR A SECOND, BUT CAUGHT HIMSELF BEFORE FALLING OVER. HE FELT LIGHT HEADED. HIS BLOOD PRESURE WAS 140/86 AND A HEART RATE OF 73. AFTER 20 MINUTES HE WAS FEELING FINE AND WAS BACK TO NORMAL. HE REFUSED A CALL TO 911 STATING HE WAS FINE AND WAS RELEASED.
There is a rash at the injection site. Redfish in color and now it?s itchy.  I didn?t happen until a week after the 1st dose   Nothing severe, but it?s still there.   Covid Arm
1 hr and 15 minutes after receiving the shot I had a wave of dizziness come over me. Suddenly,  my heart rate increase to over 180 beats per minute. I laid on the couch for an hour to relax and try to get it to slow down. Heart rate did not. Checked heart rate multiple times on a blood pressure machine and it was in the 180's. After an hour I went to the ER.
She already received her initial 2 covid vaccines from Pfizer and had a little a tiredness that went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: She also claimed that she may had more arthritis now that she had before. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "She already received her initial 2 covid vaccines from Pfizer and had a little a tiredness that went away". This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Feeling miserable; aches; chills; dizziness; fever of 101.4 Degrees F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F). At the time of the report, FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F) outcome was unknown.       The patient received treatment information includes ice and Tylenol.     This case was linked to US-MODERNATX, INC.-MOD-2021-072781 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-072781:Dose 1
devel rash, itching epi & DPH given;rx DPH given;P84, T97.6, BP 102/70;
Common side effect occurred later in the day of vaccination date 3/29/21 which includes local redness, pain and swelling on vaccination site. It progressed to low grade fever, headache and body aches that evening.  Tylenol ES prn provided relief. However, around 5pm the next day, I started having nausea, vomiting, near syncope , weakness and headache.  My husband had to pick me up from work, drive me home. This lasted until midnight.  Day 4 still with nausea and localized pain and swelling on arm. No more redness on site.
uncontrollable chills; severe dry heaves; felt flushed; shoulder feels like a frozen shoulder; pain in my arm where I got the injection; Nausea; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (felt flushed), PERIARTHRITIS (shoulder feels like a frozen shoulder), ASTHENIA (weakness), RETCHING (severe dry heaves) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included COVID-19 on 16-Jan-2021. Concurrent medical conditions included Coronary artery disease. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FLUSHING (felt flushed), ASTHENIA (weakness), NAUSEA (nausea) and CHILLS (uncontrollable chills). On 12-Feb-2021, the patient experienced RETCHING (severe dry heaves). On 17-Feb-2021, the patient experienced PERIARTHRITIS (shoulder feels like a frozen shoulder) and INJECTION SITE PAIN (pain in my arm where I got the injection). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 11-Feb-2021, FLUSHING (felt flushed), ASTHENIA (weakness), NAUSEA (nausea) and CHILLS (uncontrollable chills) had resolved. At the time of the report, PERIARTHRITIS (shoulder feels like a frozen shoulder), RETCHING (severe dry heaves) and INJECTION SITE PAIN (pain in my arm where I got the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test (positive-negative): positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 4 year old female who was vaccinated with the second dose of MMR II. Suspect therapy included VARIVAX. On 21-JUL-2008 the patient experienced anaphylactic reaction after her second vaccination with MMR II and VARIVAX. Immediately after vaccination the patient started to cough excessively. She was sent to the ER, treated and later released. The patient's mother reported that she developed a severe allergic reaction. She reported that her daughter's face and eyes were swollen, she had trouble breathing, a rash on her arms and feet, coughing and sneezing and severe belly pain. The mother also reported that her daughter was given steroids, "BENADRYL" (manufacturer unspecified), and "epinephrine" (manufacturer unspecified). It was reported that the patient received the first vaccination for MMR II and VARIVAX at 12-15 months. Patient is going to see her allergist. No product quality complaint. Additional information has been requested.
Prior to receiving this booster, I had received the J&J vaccine in March. I got feverish in the days following the J&J, but it was nothing like the weeks following the Pfizer booster. Starting two days after receiving the Pfizer booster, I started getting extreme migraines through my right eye. Three days after getting the booster, the headache remained and I had a low grade fever. These symptoms persisted and only got worse. Five days after getting the booster, I started to get nauseous and I had difficulty eating. I went and got tested for COVID but the test came back negative. Eight days after receiving the Pfizer booster, I experienced the worst migraine of my life. I was unable to move and no OTC medication would make it better. At that point, I could also hear a ringing in my ears and had pain in my neck. The low grade fever also persisted. Approximately 13 days after receiving the Pfizer booster, I called my Primary Care Physician and was told to come in immediately. After describing my symptoms, I was  told that I likely had aseptic meningitis. I was prescribed Dexamethasone 6 mg and felt better immediately after taking the first tablet. I have not had any symptoms since.
Headache, Myalgia, Arthralgia, chills Narrative: Myalgia, arthralgia, headache, chills; took tylenol; resolved within 48 hours
Decreased number of feedings almost immediately; he seemed to want to drink more instead of eating. Was consistently given (Tylenol) every 4 to 6 hours after receiving the vaccines. Two days later, was fussier than usual, kept waking up crying that night Sep, 18, 2005 he felt a little warm to the touch and since he was so fussy, I decided to give him (Motrin) at 3:30 am. He kept waking up after a little sleep and at 5:47 am he stopped crying and he started breathing shallow and fast, he was picked up from his crib and was shaking, his whole body was jerking hard and he would not respond to his name. He did not want to open his eyes or couldn't his eyes were half-way closed, I couldn't see his eyes. His Head was very hot and his body cold and with goosebumps. This non responsive episode lasted about 8 minutes, in the trip to the emergency room he opened his eyes and looked into my eyes.  They took his temperature and was 101.85 at that time. The nurse gave him Tylenol. The discharge diagnosis was Febrile seizure. The doctors kept him for three hours at the emergency room and told me to continue giving him Motrin, 1 tsp by mouth evry 6-8 hours Alternating with Tylenol every 4 hours.
readness near injection site, did not appeared to be bruised, no warmth or swelling reported
After dose 2, in March of 2021, I can hear my pulse in my head as a high pitch sound all across my head.
Headache for the past 10 days since receiving the second shot of this vaccine.  The headache is ongoing and is not responding to general courses of treatment - over the counter medications throughout the day. This has interfered with her ability to go to school or to participate in her normal activities.
Pt was given the influenza vaccine with preservative. Box from the manufacturer was mislabeled.
No adverse events following the first dose on 02.05.2021 The second dose on 02.26.2021 : fever - highest 101.2 degrees; slight headache; nausea;  deltoid pain; anorexia; loose stools; fatigue  I was pleased to have a reaction suggesting to me that some immune response was being generated.
vaccine had a temperature excursion of 0.5 degrees high for 1 hour while stored at this facility.
fever; 2.5 cm diameter raised ciruclar lesion around the injection site; papules on the back; This spontaneous report was received from a registered nurse, referring to a 12 month old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included pneumococcal 13v conj vaccine (crm197)(PREVNAR 13), hepatitis a virus vaccine inactivated(HAVRIX) and sterile diluent.     On 24-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S013711, expiration date: 01-NOV-2020 (also reported as 02-NOV-2020), subcutaneously, for 1 year wellness visit vaccines (dosage information, route and anatomical site of vaccination were not reported).   On 31-JAN-2020, the patient experienced fever, raised 2.5 cm diameter raised circular lesion around the injection site, and papules on the back. The nurse reported that the patient sought for medical attention and on 01-FEB-2020, he was prescribed Benadryl every 8 hours and cortisone cream for a week.   The outcome of pyrexia, papule and skin lesion was unknown. The causality assessment was not provided.  The reporter considered the events pyrexia, papule and skin lesion to be serious since required intervention to prevent serious criteria.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001425: US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001496:
Lymph node pain; swelling; chest painful; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiration date was not reported), via intramuscular on 18Feb2021 at 11:20 AM as a dose 2, single for COVID-19 immunization. The family medical history relevant to AE(s) included cancer, lungs than entire body, father passed away: cancer, lungs than entire body and heart stents, mother: heart stents. The patient's medical history included blood pressure and cholesterol. The patient's concomitant medications included amlodipine, taken for blood pressure and simvastatin (ZOCOR), taken for cholesterol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), via intramuscular on 28Jan2021 at 11:15 AM as a dose 1, single for COVID-19 immunization. On 22Feb2021, the patient experienced lymph node pain, swelling and chest painful. The adverse events resulted in physician office visit. On 24Feb2021, the patient was better. Treatment was not received for the events. The patient underwent lab tests and procedures which included blood work: results not provided on 04Jan2021 and urine culture: results not provided on 05Jan2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Shot #1- mayalgia in hip joints lasted 24 hours  Shot #2- dime size knot at injection site.  Opposite arm injections site soreness returned.  Mild mayalgia in both knees which lasted 14 days.  Shot #3- dime size knot at injection site.  Red blotchy rash around injection site for 3days.  Severe pain in left knee when standing up or sitting down(6 hours)subsiding to mayalgia in both knees for 30 days.  This mayalgia manifested joint pain which required the legs to be stretched out every 15 minutes.  In other words I could not leave my legs bent at 90 degrees for more than 15 minutes without feeling the need to pop the joint.  After appoximately 30 days this subsided.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. A few days later the patient developed raised red papules. The patient had recovered. This is one of several reports received from the same source. Additional information is not expected.