chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 023m20a and 028L20A) for COVID-19 vaccination. Patient has never tested positive or diagnosed with COVID-19. Concurrent medical conditions included Pollen allergy and Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away). At the time of the report, HERPES SIMPLEX (develop a recurrent herpes simplex infection/this happened the very next day, and it was severe and localize, and went away) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was taking concomitant medication (unspecified) for blood pressure. On 25-Sep-2021, patient received the booster dose (lot no: 062E21A) of Moderna vaccine. Patient was wondering about the odds which may happen with second booster, and if it happened can patient take the antiviral medication. It was reported that patient did not seek medical care and did not experienced similar event in past. No treatment medication information was given. This case was linked to MOD-2022-533600 (Patient Link).
Dizziness onset within 14 hours followed by unilateral tinnitus and hearing loss left ear.
Patient received the Pfizer vaccine 2nd booster dose 6 days after the beyond use date of 6/30/2022. The patient may not have adequate efficacy of protection from COVID from the dose they got.
Felt extremely tired and sore. As time went on, becoming lethargic. Large purple area formed at the injection site.  Arm began to swell. That night just wanted to sleep.  Next morning noticed that the arm, shoulder, shoulder blade, chest, and kneck all swollen.  Very painful to move and extreme pain in lower back.  Numbness and shooting pain in arm. Emergency room on 1/26/2014.
This case was reported by a nurse via sales rep and described the occurrence of itchy rash in a adult female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was about 60 to 62 years old. The patient called the office on day of reporting and reported an itchy rash on her hand and around her eye.
Dizziness; Loss of equilibrium,; Nausea; So dizzy "I" could not drive.; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9269) via an unspecified route of administration in the left arm on 25Feb2021 at 08:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. 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. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN) and multi-vitamins (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. On 25Feb2021 at 10:00, the patient experienced dizziness, loss of equilibrium and nausea. Since getting vaccinated, the patient had been dizzy and at times, so dizzy that could not drive and had a loss of equilibrium. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were 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 dizziness, loss of equilibrium nausea and so dizzy "I" could not drive was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Swelling redness welting around site. Ice pack applied and oral Benadryl given.
I21.4 ACUTE NON ST ELEVATION MI 11/24/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/24/2022 ATHEROSCLEROSIS OF AORTA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/24/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 11/22/2022 ATHEROSCLEROSIS OF AORTA
Signifigant rash- 6cm erythematous patch at site of shot, diffuse papular rash rest of body.Started 2-4 days after shot.
The morning after injection my left arm had the expected soreness but additional numbness, weakness, and poor coordination in my arm, hand, and fingers progressively moreso toward my pinky. It has been consistently the same for 17 days.
Fainting spells, mouth sores, swollen lymph nodes, nausea, eyes burning.
Redness over immunization site with swelling around 10cm in diameter negative systemic symptoms.
12-28-2020 body aches especially back pain, dizziness, headache and fatigue for 24 hours
Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 06-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Malaise; Headache; Chills; I feel down / Feel very down; Body heaviness / I feel heavy; Right ear pain; Throat pain; Tired; I feel heart burn; Sleepy all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy all day), MALAISE (Malaise), HEADACHE (Headache), CHILLS (Chills) and DEPRESSED MOOD (I feel down / Feel very down) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced SOMNOLENCE (Sleepy all day). On 15-May-2021, the patient experienced MALAISE (Malaise), HEADACHE (Headache), CHILLS (Chills), DEPRESSED MOOD (I feel down / Feel very down), DISCOMFORT (Body heaviness / I feel heavy), EAR PAIN (Right ear pain), OROPHARYNGEAL PAIN (Throat pain), FATIGUE (Tired) and DYSPEPSIA (I feel heart burn). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD & SINUS) ongoing since an unknown date at an unspecified dose and frequency and PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy all day), MALAISE (Malaise), HEADACHE (Headache), CHILLS (Chills), EAR PAIN (Right ear pain), OROPHARYNGEAL PAIN (Throat pain), FATIGUE (Tired) and DYSPEPSIA (I feel heart burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID; I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have taken all five of your Pfizer Vaccinations (Pfizer COVID-19 Vaccines); I got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on an unknown date. Clinical course: Patient took all five of Pfizer Vaccinations (Clarified as Pfizer COVID-19 Vaccines) latest being about a year ago and was waiting for the new one to come out and then sure enough, got COVID and now the patient was on Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311011 same patient/reporter, different product/event.;
Painful right axillary adenopathy developed upon waking on 1/4/21.  On 1/5/21, noted red itchy skin patch overlying injection site on right arm.  At time of submission of this form, both issues are still present and persist.
5 of 11 employees vaxed w/Engerix-B vax did not devel ATB to hepatitis B; THis sampling was taken in JAN94 & does not support the 95% development rate advertised;
No adverse event; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 13-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live recombinant human albumin (rha) (M-M-R II).   On 18-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliters (ml), administered subcutaneously (SQ) (lot number U024220 has been verified to be valid, expiration date reported and established as 04-AUG-2023; formulation, strength, and anatomical location were not provided) for prophylaxis.  The administered dose of the suspect vaccine experienced a temperature excursion of 41 degrees Fahrenheit (°F) for 8 hours, 20 minutes, and 0 seconds (product storage error). There was no previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).
Patient seen in the ED on 11/20/22 for elevated blood pressure. In the ED, she reported that since being diagnosed with COVID-19 on 11/14, she has had elevated blood readings accompanied by nausea, lightheadedness, headaches, and tremors. COVID-19 PCR retest done in the ED on 11/20 was also positive. Ultimately, patient was admitted 11/20 - 11/21 for acute on chronic symptomatic hyponatremia and COVID-19 infection, not pneumonia. The hyponatremia was felt to possibly be in part related to COVID-19 infection.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Vaccine was given too low in the arm causing arm pain, redness and swelling. Patient came into pharmacy 2 days after the shot to complain that it was given too low. The pharmacist on duty noticed the redness and swelling. 2 days after the patient came into the pharmacy to complain, the patient was called and checked on.
Abdominal Cramps after 2nd booster shot,She is still having abdominal pain.; Diarrhea after 2nd booster shot; Sore arm after 2nd booster shot; Body aches after 2nd booster shot; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (Abdominal Cramps after 2nd booster shot,She is still having abdominal pain.), PAIN (Body aches after 2nd booster shot), DIARRHOEA (Diarrhea after 2nd booster shot) and PAIN IN EXTREMITY (Sore arm after 2nd booster shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A and 025D21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder, Abdominal cramp and Diarrhea.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced PAIN (Body aches after 2nd booster shot) and PAIN IN EXTREMITY (Sore arm after 2nd booster shot). On 15-Apr-2022, the patient experienced ABDOMINAL PAIN (Abdominal Cramps after 2nd booster shot,She is still having abdominal pain.) and DIARRHOEA (Diarrhea after 2nd booster shot). On 16-Apr-2022, PAIN (Body aches after 2nd booster shot) and PAIN IN EXTREMITY (Sore arm after 2nd booster shot) had resolved. On 21-Apr-2022, DIARRHOEA (Diarrhea after 2nd booster shot) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal Cramps after 2nd booster shot,She is still having abdominal pain.) had not resolved.      No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-547078, MOD-2022-547107, MOD-2022-547108 (Patient Link).
Mild headache; pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Amoxicillin on unknown date for unknown indication and experienced drug allergy. 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 07Apr2021 at 11:45 the patient experienced mild headache and pain at injection site. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcomes of the event mild headache and vaccination site pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Reporter/patient's name amended. Facility type vaccine Pharmacy or Drug Store added.
1. Severe increase in Tinnitus, has continued and not really diminished at all.  2. changes in seminal consistency.  Slowly improved but is still not normal.
pt recvd vax 30OCT95 11AM & 31OCT AM devel hives around head, shoulders & hands, t99, severe itching, felt ill, h/a, fatigue, weakness, some joint pain, SOB, wheezing;1NOV saw MD;3NOV weakness, lethargy;bronchitis
Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
The patient has not had any adverse reactions; in October of 2020 a 19-year-old was given PROQUAD; This spontaneous report was received from a physician referring to a 19 years old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin)  (PROQUAD) lot # S035105, expiration date 03-MAY-2021,  0.5 milliliter for prophylaxis (patient route of administration was not provided).    On 29-OCT-2020, the patient experienced product administered to patient of inappropriate age.  The patient has not had any adverse reactions.
got the flu; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who got the flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 6/19/2022 &  7/6/2022  --  RECURRENCE OF SAME SYMPTOMS
Information has been received from a consumer concerning her 16 year old daughter with no drug reactions or allergies who on 09-Dec-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The mother reported that 7 to 10 days after vaccination, approximately on 16-Dec-2008, the patient experienced severe joint pains. Mother also stated the patient was brought to the emergency room but was not admitted in the hospital. Mother also reported that after some blood test done, the patient was diagnosed of "mononucleosis" Blood test was done 2 weeks after the patient received GARDASIL, approximately on 23-Dec-2008. The patient recovered at the end of December. Additional information is not expected.
swollen armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Feb2021 (Lot number: EN6201) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TAMSULIN taken for transurethral prostatectomy, start date: 28Sep2021, stop date: 28Oct2021. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer BioNTech Covid Vaccine, prev dose brand unknown=False, prev dose lot number=EL3302 30mcg/0.3ml, prev dose lot unknown=False, prev dose administration date=21Jan2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 21Jan2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling. Additional information: The first shot had no adverse effects. The second shot he had a swollen armpit for several days which went away. The third booster shot he received recently, he had a swollen armpit which was quite large and also the pain radiated to the front and back of his shoulder. It was quite painful and limited the use of his right arm in that he could not extend it without pain. This lasted for about a week and gradually decreased in severity. However, after more than two weeks he still had some shoulder pain and not full use of his right arm. The patient had no known allergies. Prior vaccination, the patient was not diagnosed with Covid-19. Post vaccination, the patient had not been tested for Covid-19. Patient not received other vaccine and medications in four weeks   No follow-up attempts are possible. No further information is expected.
11/19/13 pt came to Dr. c/o chin swelling/blister and rash. Pt had shingles injection in July 2013 and October 2013. 1/15/14 office visit at clinic - pt states new lesions on hands and wrists in Nov. No active lesions currently. Pt states facial outbreak approx. 3 wks after 10/13 vaccine.
Severe headache and fatigue followed by vision disturbances in the Right eye-like an occular migraine.  Taken a week to slowly resolve, but still have light flashes in the right eye.
I had flu,rash all over my body, pain and stiffness in my joints and swelling glands in my neck .It happened after 2 weeks that i took the MRR shot but i didn't use any medication because i read the booklet they gave me at the clinic.
One week after vac. I had pain and large sore bump in my left calf.  I began to run a fever and body pain on 11/13. Ambulance took me ER. Tests indicated I had septic thrombophlebitis in left calf behind knee. This happened even though I had been on warfarin for 15+years for DVT and PE (8/2003). There was never a problem until I got the vaccine. Hospitalized from 11/14/21- 11/19/21 on lovenox 120mg 2x a day now . Antibiotics IV and oral contained the infection. Now, numerous hematomas on my legs and abdomen, shortness of breath and extreme lethargy.