chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling rundown; Sore throat; General fatigue; Queasiness; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer BioNTech Covid19 mRNA lot number ER8727) via unspecified route of administration in the left arm on 18Mar2021 as a single dose for COVID-19 immunisation. Concomitant medication details were not reported. It was reported that the patient was allergic to minocycline (MANUFACTURER UNKNOWN). It was reported that the patient did not take any other vaccines in four weeks. The patient was not diagnosed with COVID-19, prior vaccination. The patient has not tested for COVID-19 post vaccination. On 19Mar2021, the patient had sore throat, feeling run-down, queasiness, general fatigue. It was reported that the patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had mild arm pain and fatigue for about a day after receiving the vaccine. On 03/21/2023, I had a telehealth visit with my doctor for a sinus infection. I was prescribed amoxicillin for the infection. I tested negative for COVID-19 on 03/21/2023.
Patient fainted and vomited approximately 5 minutes after receiving her shot. Patient was extremely nervous prior to receiving her vaccine.
AFTER RECEIVING HER 2ND DOSE TODAY, SHE PASSED OUT AND WAS DIAPHORETIC. THIS DID NOT HAPPEN WITH THE FIRST DOSE OF COVID PFIZER VACCINE ON 4/23/2021. ON SITE EMS RESPONDED AND VITALS LISTED BELOW. SHE HAS PASSED OUT WHEN HAVING BLOOD DRAWN BUT NOT WITH VACCINES.  SHE FELT BETTER AND WAS RELEASED TO HOME
1127AM brought from class room to nurse with rash on both arms, face. Given BENADRYL with tap 2. Mom picked up child - told to watch for signs of wheezing/ rash or stress. Notified us. Wt 44 lbs.
calling to report the administration of an expired dose of a PNEUMOVAX 23 VIAL to a patient on 09/01/2023.  No symptoms or further details reported.  No other AE and no PQC; calling to report the administration of an expired dose of a PNEUMOVAX 23 VIAL to a patient on 09/01/2023.  No symptoms or further details reported.  No other AE and no PQC; Information has been received from an unspecified reporter, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-SEP-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 2,5 ml/ five dose vial, lot # U025499 and expiration date 07-AUG-2023 (administration route was not provided) for prophylaxis. No adverse effects were reported.
Initial summary report received from a non-healthcare professional on 14 October 2013. 148 patients (details not provided) received FLUZONE ID batch no UT4721BA (route, dose, frequency and exact site of information not reported) on an unspecified date in 2013. The patients had moderate redness, swelling, pain at the injection site. This was described second hand from the distributor who got the information from one of their customers. No further information was provided. List of documents held by sender: none.
Erythema with induration in RT deltoid, 8cm x 9cm. Diffuse erythema RT upper extremity and tender to palpation.
Fever of 101F at 6 am, progressed to 102F in the afternoon. Fever broke by 2/28/21.  Woke up with chills, sensitive skin, inability move the left arm due to painful injection site 2/27/21. The pain over the injection site progressed to itchy patch for 3-4 days. Stuffy nose, right sided migraine like headache that lasted 3 days. Started to have period like cramps 2/28/21, and had spotting to light period for 7-8 days, even though I have an IUD since August 2020.
no adverse effects reported; A 15 yeard old patient was adminitered a dose of PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a 15-year-old patient of an unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 24-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 milliliter (ml) (strength, vaccine schedule, and indication of use were not reported; lot number S008574 and expiration date 16-SEP-2020) (product administered to patient of inappropriate age). There was no adverse event reported.
Her shoulders and neck hurt to move or lay down; Her shoulders and neck hurt to move or lay down; Neck feels like it is more fused than it was before; Chills; Back pain; This is a spontaneous report from a contactable consumer (patient) via Support. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included ongoing fused spine. The patient's concomitant medications were not reported. The patient reported that shoulders and neck hurt to move or lay down and her neck felt like it was more fused than it was before. The patient received paracetamol (TYLENOL). After a week, the patient had lessened flexibility, and reported that chills come and go and she did not feel like doing much for a week. The patient also had back pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
red spot on left arm near vaccination site.  Approximately 2 inches by 1.75 inches.  Itchy and taut skin.  Doctor prescribed antibiotic for cellulitis--Cephalexin 500 mg, 4 per day for 5 days  Spot spread slightly but itchiness and tautness diminished.  Invisible by end of antibiotic sequence
Day 5, (L) arm at injection site was red, itchy, and tender.  By Day 9, redness was 3x3 inches, itchy,  swollen, warm and dense.  Email and called Employee Health.  Day 10 called primary physician, left message.  Day 11 took 1/2 tablet of Zyrtec10 mg.  Day 12  symptoms dissipated.  Day 13 called primary physician again.  Day 14 primary physician returned call and said OK to get booster second vaccine.
Moderna vaccine was administered outside of facility- reported by patient  EPILEPSY, UNSPECIFIED 11/23/2021 LATE EFFECT OF STROKE CRYPTOGENIC STROKE 11/10/2021 LATE EFFECT OF STROKE HYPOTENSION 11/10/2021 LATE EFFECT OF STROKE EPILEPSY, UNSPECIFIED 11/23/2021 METABOLIC ENCEPHALOPATHY CRYPTOGENIC STROKE 11/10/2021 METABOLIC ENCEPHALOPATHY HYPOTENSION 11/10/2021 METABOLIC ENCEPHALOPATHY EPILEPSY, UNSPECIFIED 11/23/2021 METABOLIC ENCEPHALOPATHY CRYPTOGENIC STROKE 11/10/2021 METABOLIC ENCEPHALOPATHY HYPOTENSION 11/10/2021 METABOLIC ENCEPHALOPATHY
Patient had blurred vision, clammy skin and dizziness.  B/P prior to immunizations 102/96.  When incident occurred B/P 98/50, HR WNL. Patient observed in office for 30 minutes after episode.  Left office without any adverse symptoms.
12 hours after receiving the vaccine I started to feel body aches and a headache. The body aches affected my legs shoulders and arms. Mostly the muscular parts of my body. My headache affected my temples and the top of my head. I did start to run a fever of 99-100 degrees. These symptoms lasted about 12 hours then stopped. I did not take any medications to remedy these symptoms. About a month after the vaccine I had about 80-85% hearing loss in my right ear. I called my friend who is an ear, nose, throat Dr., He checked me by doing an audiogram and put me on prednisone for about 2 weeks. I recovered most of my hearing in my right ear.
Pfizer shot  on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
WHILE PATIENT WAS WAITING IN STORE AFTER RECEIVING VACCINATION ON 2-13-21 WITHIN MINUTES SHE BEGAN TURNING RED IN FACE AND NECK. FLUSHING OCCURED ALL OVER FACE/NECK AND DOWN ARMS. HER NOSE STARTED RUNNING AND SHE BEGAN TO PRODUCE PHELGM - WHICH WOULD GET STUCK IN HER THROAT. SHE DID NOT HAVE ANY SWELLING IN TONGUE, LIPS OR THROAT.   AROUND 6PM SHE NOTIFIED THE PHARMACIST ON DUTY. SHE STATED TO ME THIS TYPE OF REACTION OCCURS WHEN SHE EATS GLUTEN OR MSG. WE CHECKED THE VACCINE INGREDIENTS AND DIDN'T FIND SUCH IN MODERNA.  SHE WAS THEN GIVEN A 50MG BENADRYL BY THE PHARMACIST. AFTER 10 MINUTES SHE SAID SHE STARTED TO FEEL BETTER.  ALL OF A SUDDEN HER CHEST STARTED TO FEEL HEAVY WHICH SHE WAS BELIEVED TO BE FROM ALL THE EXTRA PHELGM PRODUCTION. WE CONTINUED TO WATCH AND WAIT. AROUND 6:30PM SHE AGAIN SAID SHE  FELT WELL ENOUGH TO GO HOME.  I OFFERED HER AN EPI PEN. SHE DELCLINED. SHE WAS GIVEN 50MG BENDARYL TO TAKE HOME JUST IN CASE.  STATED SHE WAS OK TO GO HOME AND DIDN'T NEEDED ANY FURTHER ASSISTANCE FROM ME OR 911. I  CALLED  THIS AM 2-14-21 TO CHECK IN ON HER. SHE STATED THE RASH/FLUSHING RESOLVED LAST NIGHT AND SHE WAS MUCH BETTER TODAY. THE ONLY SYMPTOM SHE HAD TODAY WAS A SORE ARM.
Sore arm; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever ) and VOMITING (Vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever ) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever ) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 100.9 (High) Body temperature increased to 100.9°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided. Patient received the first dose of Moderna COVID-19 vaccine on March 24th  2021 and reported sore arm , fever (100.9° F) and throwing up. Inquired if can take Tylenol.
Patient is fully vaccinated. 28-year-old female presents to the ED complaining of fatigue, generalized weakness, dyspnea.  States that she was diagnosed with COVID 3 days ago.  Has been having symptoms for the last 4 to 5 days.  Also has a cough productive of yellow sputum.  Having mild generalized chest tightness.  On and off subjective fever and chills.  Also having on and off mild generalized abdominal pain.  No dysuria hematuria or polyuria.  Symptoms are moderate in severity.  She says that she was getting better and then worsened yesterday.  No leg pain or swelling.  No history of DVT/PE.BP 106/77  | Pulse 80  | Temp 98.4 °F (36.9 °C) (Oral)  | Resp 18  | Ht 177.8 cm (5' 10")  | Wt 77.1 kg (170 lb)  | SpO2 100% Troponin less than 0.01.  UA negative for UTI.  Hepatic function and lipase normal.  CBC and chest x-ray unremarkable.She was given IV fluids, Toradol Zofran and Robaxin. Discharged home.
mom states PT had T 103; would not dec w/Tylenol; T did dec temporarily w/Advil; mom states PT was irritable, crying most of night, no appetite; lt arm--that DPT was given in--was red, swollen & hot to touch; referred to PMD;
Tachycardia, fatigue, chest pain continued left arm. fatigue, neck pain left side, nose bleed right nostril. Blood-violet color bruises on both arms, both thighs and legs, bleeding from anus and urethra, extreme tiredness, swelling on both wrist and fingers and ankles and feet, dizziness, swollen lymph nodes left arm, both swollen breast, swollen face and neck
This spontaneous prospective pregnancy report as received from a 24 year old female consumer refers to herself. In 2011 the patient was vaccinated her first and second dose of GARDASIL intramuscular. The patient was scheduled to receive the third dose in February 2012. The patient became pregnant in January 2012. The LMP and EDD were not known. After became pregnant, the third dose of GARDASIL had never been received. The pregnancy outcome was outcome pending. Additional information has been requested.
Other nurse  was alerted to patient experiencing "seizure like" activity in the waiting area at approximately 1430. Per nurse patient appeared lucid and conscious upon her immediate response. Writer arrived for unrelated reason and saw other nurse was already tending to patient. Patient noted to have legs elevated, and a cool towel on head. nurse asked student nurse to get a snack and gatorade while writer was looking for cold compress on arrival. Writer provided nurse with a cold compress and she placed it on patient's chest approximately one minute after arrival. After 2 minutes of lying down with feet elevated patient stated he wanted to sit up in a chair. Writer and nurse assisted to chair. Writer observed patient for approximately 10 minutes. Patient stated he was feeling better. Patient's representative was instructed to have patient wait another 10 minutes in observation area. Both patient and patient's representative verbalized understanding.
Had some hearing issues; Did not get scheduled 2nd Moderna COVID-19 Vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot). At the time of the report, HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Daughter reported to this facility that patient had suffered a stroke and it was reported to her by the stated physician that the COVID-19 vaccine was the cause of her stroke.  Pt also received a Fluzone High Dose quadrivalent influenza vaccine on 09-29-2022 lot number UJ918AD, expiration 06-30-2022 by this agency via IM route.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age (reported over 65) received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. Three days after vaccination, the patient reported redness that would not go away. The patient was treated with antibiotics. The outcome of the event was recovered on an unspecified date. Information on the batch number has been requested.
3.5 hours after immunizations, patient had anaphylactic reaction while picking berries at home. Received epi, steroids, antihistamines in ER. Admitted overnight.  Nurse follow up on 08/04/04 states: "Weak, Diff breathing, Pale, Diaphoretic, Hives, Tachypneic."
Hives. Not itchy. Comes and goes. Hives will appear at night and leave in the morning. Area hives appear is on forehead and back left shoulder.
neuropathy in bottoms of both of my feet/toes- mild tingling and strong numbness are constant, slight pain sometimes off and on. Started in summer I think in July. I am not diabetic, moderately overweight (180 pds) and not an alcoholic. No known reason why this developed.
sudden loss of hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 19-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided).On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from sudden loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of sudden loss of hearing was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of sudden loss of hearing was considered to be disabling. Upon internal review, the event of sudden loss of hearing was considered to be medically significant.
Extreme case of cellulitis (according to Dr) that required an E.R. visit on Thursday or Friday 9/17 or 9/18 that progressed to require hospitalization. Pt called and spoke to dispensing pharmacist on Wed 9/16 to report slight fever and redness at site.  10/26/09:  ED Records received for Date of Service 9/17/09 and Medical Record and Discharge Summary received for dates of service 9/18/09 to 9/21/09.  Final Dx:  LUE Cellulitis, hypertension, hypercholesteremia, elevated transmainases.  Assessment:  Presented to the ED on 9/17 with fever, chills, swelling and redness that developed the day following flu shot.  Given ceftriaxone and Keflex and sent home.  On recheck on 9/18 the area of redness was greatly increased and patient was admitted with a low-grade fever and leukocytosis.  Started on IV Vancomycin, and swelling and tenderness decreased, pt. became afebrile.  AST and ALT were mildly elevated.  Blood pressure was fine while in the hospital.  Discharged on Bactrim DS with swelling, erythema, tenderness and warmth greatly decreased in the left deltoid area.  To follow up with PCP in 3-5 days.    ICD 9 Codes:  999.39, 682.3, 401.9, 272.0, 790.5, 530.81, E879.8, E849.6
Approximately 7mm on left arm.  Left arm swollen, warm to touch and area is red and itching.  Advised to apply ice pack and take Ibuprofen as needed, follow up with private MD if no change by 11-21-08.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 31-AUG-2017, the patient was vaccinated with M-M-R II, lot # M042846 with expiration date on 21-OCT-2018, for prophylaxis. Other suspect therapies included VARIVAX lot # N012488 with expiration date on 20-APR-2019 and sterile diluent (STERILE DILUENT). On 31-AUG-2017, 3 months 10 days after onset of therapy the patient experienced accidental overdose. No adverse effects were reported. Product quality complaint was not involved.
TEN MINUTES AFTER HAVING THE INJECTIONS SHE STARTING GETTING WEAK AND WAS LAID DOWN BECAUSE SHE FELT SHE WOULD PASS OUT. SHE VOMITED AND STARTING SWEATING.
Headache, tiredness, nausea, diarrhea, body aches, joints aching.
PNEUMONIA; TICKLE IN THE BACK OF HER THROAT; This spontaneous report received from a consumer concerned a female of unspecified age of unknown race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had tickle in the back of her throat and according to reporter patient was positive because patient work from home. Patient got hit hard and went to the doctor and had the start of pneumonia and almost ended up in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia and tickle in the back of her throat was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211007273.; Sender's Comments: V0;20211007486; -covid-19 vaccine ad26.cov2.s Pneumonia. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
It started with the soreness in my arm, then I started to get a headache like two to three hours after taking the vaccine, and then with the headaches I started to get floaters, like black dots in front of my eyes, and in my right eye the floaters never went away. I have been going to see continuous eye doctors, and the floater in my right eye kept getting bigger and bigger. I developed Retinal detachment in my right eye. This has been ongoing from the second dose of the vaccine and into the 3rd dose as well, I started the new year off getting Retinal Detachment surgery. The floaters are now gone, they all went away.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # M022402, expiration date 01-NOV-2017, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 1 hour and the data logger was not involved. Previous temperature excursion was exposed between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 1 hour. Sterile diluent (MERCK STERILE DILUENT) was not part of the temperature excursion. No adverse effects were reported.
Symptoms began roughly 29 hours after 1st vaccine injection.  -Symptoms include: Sore throat, stuffy nose/nasal drip, fever, chills, nausea, headache, arm soreness, fatigue, and body aches
1/2 p/vax pt appeared tired;pt slept 1hr & awoke crying;mom picked pt up form crib & pt began to shiver, then shook hard;breathing became labored; t100 ax;pt unresponsive to tactile stimulating;mom reports eyes rolled around;d, cold sx
p/vax pt felt fretful laid down in seat of the car; about 1-2 hrs later the sx began including fever & itching; By that noc fever was 103 w/swelling @ site, redness, body rash; 7OCT92 pt returned to be checked; edema, redness @ inject site