chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shot took place on 7/6/2021, and I had flu-like symptoms for the entire day on 7/7/2021. My ear ache began on 7/11/2021. It started as an ache, but grew gradually worse. I had made an appointment to talk with my doctor about the ear ringing I have had since testing positive for Covid on 3/16/2021. The appointment on 7/15/2021 ended up being an appointment about diagnosing ear pain, which was attributed to an ear canal infection. The doctor prescribed ear drops and an antibiotic, but the ear pain continued to worsen.  On  7/27/2021, I saw an ear nose throat specialist who found a hole in my eardrum. I am currently taking more drops and waiting for results of an ear culture. The ringing is still present, as is the pain, as of today, 7/28/2021.
Pneumonia; coughing up blood; A spontaneous report was received from a consumer who was also a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia and coughing up blood.  The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.  On 19 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient began to cough up blood and was seen and treated by a healthcare professional. A chest x-ray was done and revealed pneumonia. Treatment for the event included doxycycline, prednisone and an inhaler.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, pneumonia and coughing up blood, were unknown.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious unexpected event of Hemoptysis. The events occurred one day after the first dose of the mRNA-1273 administration. Treatment for the event included doxycycline, prednisone and an inhaler. Since Pneumonia has insidious onset rather than acute onset, the event was possibly related to underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Hemoptysis, a causal relationship cannot be excluded.
When I got the booster shot it activated my   Eczema   extremely it became more painful and went more places and my period has been coming and going for the past 10 days
I, the patient, had full body hives approximately 16 hours after having the first shot of 2.  No history of ever having hives.  I went to urgent care and met with Dr., as he prescribed a 5 day dose of Prednisone.  After taking the steroid for five days, the hives were completely gone.
6/7/19 7am: diarrhea, Fever of 100 F. , Flu-like (achy, headache, chills). Upper left arm at injection site very red and sore 6/7/19  11am  diarrhea, Fever of 101 F. Continue with Flu-like symptoms.  Upper half of left arm is red, swollen and very sore. 6/7/19  Continue rest of day and evening with fever 100 to 101 F , Flu-like symptoms and swollen red upper arm.  6/8/19  Temp down to 99F. Arm continues as before with swelling, redness.  6/9/19  No fever. Arm redness,. soreness and swelling diminshes.  1.5" strip of redness remains around middle of arm.
Chills, fever, severe aches/pains, gastrointestinal pain, nausea, throwing up, swollen glands on right side of my neck and under my right arm, severe headache, severe fatigue.
Patient with a history of Graves disease, well controlled on methimazole 2.5 mg every other day.  She developed symptoms of Graves in April 2021 (approximately 2 weeks after second dose).  In May she was found to be floridly hyperthyroid and methimazole was increased.
Fever, chills, body aches, nausea, headache, gall stone attack
A female, now 54 years of age with a history of allergy to eggs since childhood, reported that she received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed a fever of 104F and generalized hives. She also developed an injection site reaction characterized by "severe" swelling and redness. She was seen by the physician and treated with an injection of an unidentified medication. She recovered.
MOUTH DRYNESS/THRUSHY FEELING IN MOUTH; ACHES; PAIN; FATIGUE; HEADACHE; SKIN BURNING ESPECIALLY ON THE FACE, ALSO ON BACK; EXTREME SENSITIVITY ON SKIN; HYPED-UP FEELING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced skin burning especially on the face, also on back. On 13-MAR-2021, the subject experienced extreme sensitivity on skin. On 13-MAR-2021, the subject experienced hyped-up feeling. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced mouth dryness/thrushy feeling in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, pain, fatigue, and headache, and the outcome of skin burning especially on the face, also on back, extreme sensitivity on skin, hyped-up feeling and mouth dryness/thrushy feeling in mouth was not reported. This report was non-serious.
SYMPTOMS: RUNNY NOSE/SINUS PRESSURE/JAW PAIN/LEFT EAR PAIN/FLUID IN LEFT EAR/GREEN DISCHARGE FROM PT SINUS/BODY ACHES AND FATIGUE. STARTED 11-4-14 AND CAME IN TO SEE DOCTOR 11-7-14. ANTIBIOTIC GIVEN TIMES 7 DAYS AND EAR DROPS.
COVID-19; Chronic heart failure with preserved ejection fraction; Elevated brain natriuretic peptide (BNP) level; Fatigue; Hypokalemia; Hyponatremia; Need for vaccination
It spiked my pulse to 125 sitting down and it stayed in the 120s-130s for thrre solid days with no break. I had a racing heart, shortness of breath and dizziness. I had throbbing headaches, and joint pain. It all lasted periodically for 2 weeks. I have a diagnose of 1st and 2nd degree AV Block.
The following patient received a Moderna dose approved for 6-11 years of age on 10/07. This vial was originally approved as a booster dose for patients 18+.  So technically, they received a monovalent booster.
Around April 22, 2023, around certain times of day, I would get dizziness then it would go away. I did not have any other symptoms, just dizziness. Not long after this started, I was diagnosed for COVID-19, I was not given medication. I cannot really tell you when COVID-19 was gone, as I am now experiencing, muscle fatigue, weakness, the dizziness. poor balance. My doctor had prescribed medication to help me with the dizziness.
Sharp back pain radiating into chest. EMS called. Lasting 1 hour. This 66-year-old female patient presents with sharp back pain. Patient was seen in and given vaccination for pneumonia and influenza in her bilateral deltoids this morning. States she was feeling fine otherwise. She went shopping afterward, and had sudden onset of sharp pain across her entire back which radiated forward into her chest. She said the pain was severe enough that it "took my breath away," and doubled her over. EMS squad was called. By the time they arrived at the scene the patient says her symptoms were beginning to let up. They gave her 324 mg of aspirin, as well as sublingual nitroglycerin. She says that the sublingual nitroglycerin resolved her back pain. Patient does have a history of smoking although she quit a number of years ago. She also has a history of GERD and is on a PPI. Family history of coronary artery disease. Re-eval/course of visit: Concern for acute coronary syndrome or other intrathoracic pathology, as well as possible aneurysm. Patient had some tenderness in the right upper quadrant on exam, plan will be to evaluate her with a right upper quadrant ultrasound as well. Labs to include CBC, CMP, cardiac troponin, d-dimer, magnesium level, hepatic function panel. Patient will be evaluated with a EKG. Patient had an elevated d-dimer. We will proceed with CT angiogram of the chest thoracic aorta protocol. Patent's laboratory studies were largely unremarkable. She remained vitally stable throughout her emergency department course. She remained asymptomatic.
Patient received first dose of Moderna on 10/9/21 at age 14. She received her second dose of Moderna on 11/19/21 to complete her series.
tested positive for covid-19; tested positive for covid-19; This is a spontaneous report received from a contactable consumer (Patients brother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history was not reported, Family history included: father has high blood pressure and diabetes. The patient's concomitant medications were not reported. Reporter initially stated, his brother (patient) only had three serious days of this, and it was from the vaccine. He had actually had covid-19. Mentioned he tested positive for covid-19, was quarantined for 2 weeks. He had three days of serious effects from the virus itself. He later confirmed it was from the virus itself, not the shot. The outcome of the events was unknown.
21APR93 mom states pt had high pitched cry & inconsolable for 3 hrs beginning p/immun was given; MD felt poss reaction to DTP; irritability ceased 3 hrs p/shot given; t101;
Generalized rash mild on trunk, fever 3/7/03. Satellite lesions 3/9/03.
STOMACH PAIN; DIARRHEA; BURNING FEELING IN STOMACH; HEADACHE; FATIGUE; MILD REDDISH BRUISE ON RIGHT HAND; RIGHT CALF A LITTLE SWOLLEN VERY MINUTE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous gastric issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced right calf a little swollen very minute. On 06-JUL-2021, the subject experienced mild reddish bruise on right hand. On 06-JUL-2021, the subject experienced fatigue. On 07-JUL-2021, the subject experienced stomach pain. On 07-JUL-2021, the subject experienced diarrhea. On 07-JUL-2021, the subject experienced burning feeling in stomach. On 07-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild reddish bruise on right hand, and fatigue, and had not recovered from right calf a little swollen very minute, stomach pain, diarrhea, burning feeling in stomach, and headache. This report was non-serious.
Pt. states that after receiving the 3rd dose of Moderna 12/13/2021, started experiencing symptoms 12/26/2021 of itchiness throughout the body with "welps" and nausea. Emergency room visit 12/26/2021, Steroid Injection. Self-treating with 25mg Benadryl, still experiencing symptoms.
Headache, Arthralgia, chills, fatigue, exercise intolerance. Narrative:
Information has been received from a registered nurse and a 26 year old female with no pertinent medical history and no history of known drug reactions/allergies who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (therapy site unknown, lot # not reported).  On 17-OCT-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 mL IM (therapy site unknown;  lot # not reported).  On 17-FEB-2009 the patient received the third dose of GARDASIL 0.5 ml IM (therapy site unknown) (Lot# 661044/0548X).  There was no concomitant medication.  On 01-APR-2009, a nurse reported that after the third dose, the patient developed varicose vein on her legs, headaches, chest pain and shortness of breath.  The patient was seen by her primary care physician.  The nurse reported the patient was recovering.  On 02-APR-2009, the patient reported that "a few days before receiving the third dose:, she started to experience leg pain, chest pain, headaches.  After receiving the third dose, the patient still had the same symptoms.  The patient reported she had a Magnetic resonance imaging (MRI) done and had seen a knee doctor, a spine doctor and her primary care physician.  The doctors were still unsure what was causing her symptoms and she will soon find out the results of the MRI.  At the time of this report, the patient had not recovered.  Additional information has been requested.
17-year-old received first dose of Moderna. Patient will not turn 18 until July 2022. Received 0.5mL dose. No immediate adverse events. Patient and parent were informed of the error.
Onset of continual menses for 4+ weeks after none for previous 6 months; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 29Apr2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; MENSTRUATION IRREGULAR (non-serious) with onset 11Dec2021, outcome "recovering", described as "Onset of continual menses for 4+ weeks after none for previous 6 months". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: The patient had no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
3 inch dark red circle with hard lump (same size as circle) at injection site. 72+ hours from injection and still present and not changing
Information has been received from a healthcare worker (office manager) referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L039297, expiration date 19-JUN-2016; dose and route were unknown). No symptoms were reported. The vaccines were stored under 1 degree Centigrade for 6 days in November 2015, 1 degree Centigrade for 20 days in December 2015, 1 degree Centigrade for 16 days in January 2016, 1 degree Centigrade for 20 days in February 2016 (totally 62 days). No other excursions were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported that she has anxiety and some medical procedures make her feel lightheaded. Administered flu (FluBlok) and COVID-19 (Pfizer bivalent) vaccinations to patient. Patient was ok after vaccinations and moved to waiting area. after a couple minutes, patient stated she was feeling lightheaded and moved to floor in counseling/vaccination room. provided patient cool compress and bottled water. she also reported her throat feeling tightness but acknowledged it was anxiety. patient did not show other signs of anaphylaxis and was able to breath, talk, and drink water without difficulty.  after ~15 minutes patient moved to chair in counseling room. after ~5 minutes patient moved to chair in waiting room. after ~5 minutes, patient left pharmacy area to shop in store.
Patient complaint of excessive soreness on the site of vaccination that lasts for more than 5 days. Patient also complaint of longer than 4 days of dizziness and tiredness.
Initial report was received from another manufacturer on 22 February 2012 (Service Request Number 1-4886311402). A female patient had received a dose 3 injection of DTAP (manufacturer, lot number, date, site and route of administration not reported) and an unspecified amount of time later went into respiratory distress. The patient was taken to the emergency room and released. The patient also developed hives and swollen lips with other vaccines (unspecified). Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Pfizer-BioNTech COVID-19 Vaccine: COVID-19 case resulting in Hospitalization / Death. Received Pfizer-BioNTech Vaccines on 8/2/2021 and 8/24/2021. Presented to outside facility 1/24/22 with SOB and COVID positive, c/b PE w/cor pulmonale and right popliteal non-occlusive DVT. Tx'd w/tPA and IVC filter. Initially improved until 2/1/2022 decompensated w/cardiogenic shock and respiratory failure requiring intubation. Transferred to Hospital. Impella placed 2/3/2022 to 2/8/2022. Received antibiotics for MRSA bacteremia and CRRT for acute kidney injury. Tx'd methylprednisolone, anticoagulation, and pressor/ionotrope. Transitioned to palliative care 2/15/2022, expired same day.
Patient administered Zostavax 0.65mL SQ instead of Varivax. Parents informed of event. No reactions at time of administration or yet reported.
Difficulty  breathing; multiple red, hot, itchy lumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included WARFARIN, ATORVASTATIN, METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site). At the time of the report, DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) was resolving.            Concomitant medications taken were Heart medication No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable
9:45pm- approx 12 hours after injection I got chills and uncontrollable shaking, lips turned purple, it lasted overnight.  Severe exhaustion and headache and Chest tightness occurred which lasted for 36 hours post injection.
being sick; This is a spontaneous report received from a non-contactable reporter (consumer), Program ID:. The reporter is the patient. An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: ILLNESS (non-serious), outcome "unknown", described as "being sick". Additional information: The reporter considered the event was caused by the suspect drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Feb 14, 2021 at 9 am I noticed a red blotch where I got the shot.
Patient became fussy after administration of vaccine and developed a red, hot area on his upper left thigh where the vaccine had been administered.
pt recv vax & w/in 35 days of vax pt devel nausea, elevated body temp, backache, weakness in the lower extremities, & diff urinating;dx of transverse myelitis was allegedly made on 13DEC88;pt exp pain & permanent paraplegia;
Patient in vaccine clinic 05/17/2021, parent stated child patient was given 1st dose of Pfizer Covid - 19 for 12 years and above lot # Ew0176, Returned to Vaccine Clinic 6/8/2021 to receive 2nd Pfizer Lot number EW0176.  No issues noted after vaccines.   3/26/2022 Patient and parent to returned  vaccine clinic  to receive booster , Mother stated she lied about patients age with 1st and 2 doses and when ask why she  lied she stated she wasn't sending him back to school unvaccinated and then was told that  staff would need to change everything from those 1st 2 vaccines in computer and correct DOB  dates and paperwork incidents / reports  and she stated she didn't care.  Also lead nurse ask parent why patients Vaccine card had correct correct DOB she said she changed date on vaccine card with correct date DOB year had been whited out and correct date inked in.  Corrections made and booster given to child patient and new correct card given to mother
Mom call on 1/15/01 and complained that pt cried on 1/13/01 about 20 minutes, inconsolably and then could be consoled but fussy. Seemed to be in a 'daze' with minimal interaction with mom and siblings X 5 days. Decreased breast feedings X 5 days, low-grade fever <101F with ? starring spell-eye looked glazed per mom. Recovered from these symptoms by the 6th day.
neck was tightening, and it hurts to move it from side to side; hasn't slept since since she's gotten it; headache; neck was tightening, and it hurts to move it from side to side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 14:00 (Lot number: EN6205) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing),  "Arthritis" (unspecified if ongoing), ; "high blood pressure" (unspecified if ongoing); " SARS virus", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious), NECK PAIN (non-serious) all with onset 08Mar2021, outcome "not recovered" and all described as "neck was tightening, and it hurts to move it from side to side"; INSOMNIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "hasn't slept since since she's gotten it"; HEADACHE (non-serious) with onset 08Mar2021, outcome "recovered" (09Mar2021), described as "headache". Therapeutic measures were taken as a result of muscle tightness, neck pain. Her headache was really bad the first day. The next day was bad but it went away.For the neck tightness and pain Was told to take Prednisone, it helped ease it up, it is working a little bit.States it is a lot better than what it was with the prednisone, she is not crying. Stated seems to be working. No Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.