chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FLU- LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 49 year old male. The patient's concurrent conditions included: migraine, irritable bowel syndrome (IBS) and latex allergy. The patient was a health care professional (registered nurse). On FEB-2021 or MAR-2021, patient had lost sense of taste and smell prior to vaccination, even though the patient was tested negative for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to the left arm on 12-APR-2021 for prophylactic vaccination. Age at time of vaccination was 49 years old. No concomitant medications were reported. On 13-APR-2021 (the day post vaccination), the patient had experienced flu-like symptoms. The patient also felt tired and achy (flu- like symptoms) for a few days which got resolved pretty quick. On 22-DEC-2021 or 23-DEC-2021 (before Christmas), the patient tested positive for covid-19 via swab test at the hospital he works (confirmed clinical vaccination failure, confirmed covid-19 infection). The lost sense of taste and smell (covid-19 infection) resolved after covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu- like symptoms and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000232849.; Sender's Comments: V0:20220552926-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Woke up with severely painful muscles and joints from my left arm (where I got the shot), left shoulder, and across my back.  By 10/6/2012, my entire body was in severe pain.  The joints and muscles were aching to where I couldn't move, or sleep.  This lasted until 09/01/2013 after I changed my diet to exclude all inflammatory foods (gluten, corn, soy, sugar, chocolate, caffeine products, red meat, dairy products) on 08/15/2013.  As long as I do not consume any of these inflammatory foods, I do not have pain.
Very high fever 101-104; I have had the flu; very bad headache; stomach pains; very bad diarrhea; sore arm; muscle and joint pain; muscle and joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 14:30 as dose 3 (booster), single (Lot number: FM7553) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing); "oral lichen planus" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "had operation I March made worse" (unspecified if ongoing), notes: had operation I March made worse; "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergy"; Vicodine, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: Ew0173, Prev dose lot unknown: False, Prev dose administration date: 04Oct2021, Prev Administration time: 02:30PM, Prev dose dose number: 2, Prev Vaccine location: Left arm), administration date: 04Oct2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Ep7534, prev dose lot unknown: False, prev dose administration date: 17Mar2021, Prev Administration time: 02:30PM, Prev dose dose number: 1, Prev Vaccine location: Left arm), administration date: 17Mar2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "I have had the flu"; PYREXIA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "Very high fever 101-104"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Jun2022 at 02:00, outcome "not recovered" and all described as "muscle and joint pain"; LIMB DISCOMFORT (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "stomach pains"; DIARRHOEA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "very bad diarrhea"; HEADACHE (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "very bad headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, influenza, headache, abdominal pain upper, diarrhoea, limb discomfort, myalgia, arthralgia.  Additional information:The patient did not received other vaccine in four weeks.No covid prior vaccination.The patient had been covid tested post vaccination
Patient was accidentally given a dose from an expired vial. The vial had not been disposed of the night before and expired at 5:15am on 9/29. The technician administering believed that someone in the pharmacy had already opened a vial this morning but that was incorrect. The error was realized within 30 minutes of giving the vaccine.
Pt is claiming to still have muscle pain at the injections site as of 1/18/2021 from the injection given on 12/29/2020
Numerous vesicle like lesions upper chest/back. R shoulder area. Some on both arms, lower abd.
chills, body aches, low-grade fever, headache, muscle aches, pain at injection site
it was rpt from territory representative concerning pt who was vax & subsequently devel fever of 103f;
Pt recvd series of 3 Engerix-B & on 28AUG91 was exposed to blood & body fluids from a possible Hep-B pos source; 30AUG91 lab study was done for HBSAB; pt was found to be non-responder; 3SEP91 pt given booster dose of Hep-B & dose of HBIG;
The way he is acting is more like he had a stroke; eyes glazed over; disoriented; felt funny; very weak; can barely stand and barely walk without human assistance and his walker; can barely stand and barely walk without human assistance and his walker; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 12:15 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included vascular dementia; hypertension; hypothyroidism; malignant melanoma of back (resected/in remission); bladder cancer (surgery in Nov2018/in remission); prediabetic; chronic kidney disease stage 3 due to hypertension; and sleep related hypoxia. No known allergies. Concomitant medications included donepezil taken for an unspecified indication, start and stop date were not reported; memantine taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; lovastatin taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin tablet. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech COVID 19) on 26Feb2021 07:45 PM in the left arm for Covid-19 immunization. The patient has not received other vaccine in four weeks. The first day after the shot, there were not any adverse reactions. The next morning at approximately 11:00 am, the reporter found patient laying on the floor next to his bed, eyes glazed over, disoriented, and he said "he felt funny". The reporter got him sitting up leaning on the side of the bed and called. The EMT's came and checked his vitals. Within half an hour from  finding the patient laying on the floor, he seemed almost back to normal. However, since he is 89 years old, the patient was transported by ambulance. Blood was drawn, a urine sample was taken, a chest Xray, and a CT scan of his head and his spine were the labs that were run. All the labs came back normal. However, once patient got home after being in the ER for 5 hours, he is very weak, can barely stand and barely walk without human assistance and his walker. The way he is acting is more like he had a stroke. Onset of the events reported as 20Mar2021 11:15 AM. The events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. The patient used walker due to can barely stand and barely walk; for other events, there was no treatment given. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.
This is a 51y.o. female who presents to ER due to nausea, vomiting and back pain.  She has a longstanding history of chronic pancreatitis, alcohol abuse and marijuana use.  At the time of my examination the patient had received a dose of Ativan and was limited in her ability to provide a history.  She was asking for medications to treat her back pain and additional Ativan.   GI has already evaluated her, and has cleared her for a diet from their perspective.  Her COVID-19 test was found to be positive.  She denies any loss of taste or smell recently, and is unable to specify a time of onset for any typical Covid symptoms.
Patient experienced a large red injection site reaction. Was warm to touch. Mildly itchy. Covered about a hand sized area of the upper arm.
dizzy-jerking, staring, non-responsive lasting 30sec;brought back to MD to stabilize;
Within 6 hours, extreme headache, fever of 102.8, chills, aches, disequilibrium, mild disorientation, all lasting approximately 8 hours.  At about 10 days post vaccination, Tinnitus which has been mildly present at times became noticeable all the time and is unrelieved.  Prior to this, Tinnitus would come and go and could be easily ignored.  Tinnitus escalated to a level that cannot be ignored and is now interfering with my ability to consistently hear/understand soft-spoken words or whispers.
Immediately after administration of HPV patient fainted. Dr. reassessed patient for injury and reaction. Afterwhich patient was o.k.
Terrible dreams every night since receiving the vaccine, sleep disruption has been continuous, sleep paralysis the first couple day after vaccine, extreme arm aching and intense (entire arm into fingertips) for about 10 minutes after the shot
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Nurse practitioner called regarding a delay in the patient receiving the second dose of GARDASIL. The patient received the first dose of GARDASIL (0.5ml, intramuscular, lot#, unspecified) on an unspecified date in 2008. The second dose(lot#, dose, route were unspecified) was just administered today, 09-APR-2013. The outcome was unknown. Additional information is not expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.
Recurrence of painful right facial neuropathy, at the same site of previous post-herpetic neuropathy. Has lasted about 3 weeks, and is gradually getting better but not gone yet. Patient describes allodynia on the right cheek and right ear, very painful to even light touch.
Boostrix administered to 7 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Boostrix. On 20th April 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: Nurse reported a 7 month old baby was administered Boostrix, which led to inappropriate age at vaccine administration. No vaccine information was provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Information has been received from a nurse concerning a 17 year old female who was recently (exact date not reported) vaccinated (route and site not reported) with Gardasil (lot # not reported).  Seven to eight days post vaccination the patient's "entire arm swelled up".  The physician performed a test on the patient to determine it was not cellulitis or a blood clot.  A Doppler test was performed, results were not reported.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Brought a really heavy period; Shortened their menstrual cycle; Had an earlier period; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) in a female patient of an unknown age 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 HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period). At the time of the report, HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-148424, US-MODERNATX, INC.-MOD-2021-148762, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-149251 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148424:Reporter as a patient-1st dose US-MODERNATX, INC.-MOD-2021-148762:Reporter as a patient-2nd dose US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose
c/o mild squeezing throat/larynx area 2 min after vaccine. No hives , no rash, no swelling of uvula, BP 162/92 O2 sat 98-100% Pulse 78-87. Refused epi. Refused EMS. Gave 50 mg Benadryl po. Drove to Hospital 1-3 min drive, patient condition stable. HX of allergic reactions to "injectable meds" since 2018 after she took tx for cancer. Advised Allergist consult and PCP consult if chooses to attempt any further covid vaccine. Spoke to her 4-6-21, stated "feeling good" other than sore throat and upper shoulders ache. No rash/hives today. C/O headache since vaccination. Stated left ER at 8 00 pm because she was hungry but had been advised by ER to stay another 2 hours.  BP at home today is 130s/90s and heart rate 100 per patient report.
Ringing in left ear. I noticed on 2/7 but can?t be sure I didn?t have earlier.
After the first week of the second dose started developing stiffness and swollenness in ankles and left-hand finger joint pain. The pain and discomfort were manageable and lasted for about 2 weeks after the first dose. Then I got the second dose. After getting second dose, had fever, muscle and joint pain on second day after second dose. Then the fever and muscle pain went away but joint pain has been progressively getting worse. On day 12 after the second dose the joint pain reached a point of interfering with daily normal activities. Most of the joints have discomfort but the ankles and wrists have the most pain. The symptoms include joint pain, stiffness, discomfort, feel of swolleness, and heaviness.
Developed numbness in lower extremities about 2-3 weeks following the second dose of the Moderna vaccine.  Neurology work up in progress.  Left leg is much worse than right leg.   Doctor's working diagnosis is peripheral neuropathy, autoimmune - possible prediabetic
Extreme dizziness that is still ongoing; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EK5730, via an unspecified route of administration at the left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. The patient medical history includes migraine and known allergies to Latex and sulfa drugs. Concomitant medication included levothyroxine, gabapentin, calcium, colecalciferol (CALCIUM & VITAMIN D). On 05Dec2020 03:00 (pending clarification), the patient experienced extreme dizziness that is still ongoing. The patient was not hospitalized for the event, did not receive any treatment for the event and event was reported as non-serious. The vaccine was administered in the workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Dec2020-unknown results). On 14Dec2020, Nasal Swab (COVID 19) Result was Negative.  The outcome of the event was not recovered.
Initial report received from a physician on 29 Dec 2009. The patient took LEVAQUIN concomitantly. This patient was vaccinated with FLUVIRIN (batch no: 102138P1A) on 21 Dec 2009. The patient experienced with coughing, chest discomfort, diaphoresis, arthralgia, myalgia in lower extremities and bilateral myalgia in calves on 24 Dec 2009. These symptoms dissipated and the patient returned to work on 28 Dec 2009. The patient was examined by physician and it was found that the lungs were clear but the patient had nasal congestion from an unknown date. The patient had treatment with postnasal drip. The outcome of the events were reported as condition unchanged.
For my second and booster shot, they caused high fevers as well around 104 that lasted for 4 days. I was instructed to try and use Tylenol for my symptoms and Motrin. I am going in for a bone marrow transplant due to other health issues, I then need to get all of my shots that I had as a baby. I am hesitant on getting my COVID-19 shots.
Information has been received from a 57 yr old female who on 15Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649692/0371P). On 16Nov04 the pt called the office with fever, chills, headache and injection site pain. The report indicates that the office suggested ibuprofen (Advil) and ice as treatment. It was also reported that another pt (WAES0411USA031790) had a similar experience. Additional information has been requested.
pt recv vax 16SEP96 & 21SEP96 pt exp a rash @ inj site w/one larger lesion & a few small lesions @ the inj site which looked like varicella (according to the pt mom);
Symptoms: Diarrhea and throat constriction. Treatment: Diphenhydramine 25 mg once.
Body Ache (severe) Nausea Vomiting Headache (severe)
Injection site became very red, hot, hard and swollen, nine days after receiving the vaccine.  Applied ice off and on the entire day.  Made no difference. Saw a medical provider on 1/18/2021, have been put on Cephalexin 500 mg, once capsule by mouth three times a day for 10 days.
Patient developed myocarditis and required admission to Hospital 4 days after second dose of Moderna vaccine. An EKG obtained in the ER showed diffuse ST elevations versus early repolarization 6/7/21.  The troponin checked in the ER came back to be positive for an acute myocardial infarction.  He was emergently taken to cardiac catheterization lab 6/7/21 where his coronary angiogram was negative for significant coronary artery disease.  His pre-discharge LVEF was normal.
This patient experienced a low grade fever, light red rash starting on her face and progressed to her abdomen and extremities. Discomfort, runny nose, swollen lymph nodes, and pain in her ears. The rash spread for about 3 days.
Severe migraine headache Pain at injection site Vertigo (extreme dizziness) Nauseous
Vaccine given approximately 900 AM at school - patient had no symptoms of adverse reactions until 1015 PM - mom states symptoms occurred suddenly with severe itching, rash on back + arms.  Pt was taken to local emergency department.  Given steroid injection, BENADRYL cream, BENEDRYL po + prednisone rx x 9 days.  "Told by ER not to take Tdap again".
Exacerbation of Parkinson?s symptoms, trouble walking, speaking,  mental slowness, worsening balance
0910P (+) c/o warm, then sweaty. VS monitored - Pt denies SOB, denies dizzy or swelling, denies itching/swelling. Juice provided. Pt monitored 20 minutes. S/Sx resolved. 0930 3/10/10.
States that the day after vaccination her arm was sore. Three days ago, patient noticed a large rash under right breast then she noticed small rash at injection site. Recommended for patient to follow up with primary care doctor- patient agreed. Will also discuss with doctor if she should receive second dose.
missed dose; no adverse event; This spontaneous report as received from a registered nurse refers to a currently 17 years old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route and lot # not reported).   The nurse reported that on an unknown date, the patient missed the last dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) series and was now out of the range in the prescribing information as patient was 17 years old.
An extreme inflammatory response resulting in tinnitus in both ears/knee pain (both knees)/very sore neck on right side with movement & lying down?these side effects & fatigue remain.  I also had a band of muscles  across my middle back which hurt when lying down which has resolved.
pt began fever & 8PM 102 R; 25MAY94 began motrin, sponging in bath, fever cont during noc; began APAP & Motrin 26MAY94; 26MAY94 for fever 103 R; had sz @ 12Noon;
chills, minor body aches, minor headache, fatigue, pain/soreness at injection site
Patient stated he did feel some pain at time of injection, but pain has increased over the course of the week and he is having difficulty reaching and lifting his arm past his shoulder. Recommended follow-up with PCP at this time to further determine what is going on.