chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pressure; nerve pain; headache; chills; fever; numbness in thumb; nausea; dizziness; joint pain; tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0777), via an unspecified route of administration, administered in left arm on 09Jun2021 at 03:00 PM (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history included arthritis and high blood pressure and had no known allergies. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and venlafaxine HCL ER (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 19May2021 at 03:00 PM (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not a pregnant at the time of vaccination. 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 09Jun2021 at 03:30PM, the patient experienced chest pressure, nerve pain, headache, chills, fever, numbness in thumb, nausea, dizziness, joint pain, tired and sore arm. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours; Doses administered more then 1 month apart; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment medications were not provided.
Death - 13 hours after Influenza A administration. Spouse had evidence of febrile event when found. spouse had been exposed to son with H1N1 (swine) continuously for 5 days in preceding 8 days before death. It was unknown at time that son had H1N1 and only became known to us 6 weeks after patient's death.
Patient had a six by six red rash, warm to touch. Patient is also experiencing chills.
Headache left side where she had Bell's palsy, severe pressure, dizziness, pain, trigeminal nerve pain.
The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called and he states he would return in in 2 months time to get the Bivalent vaccine.
received the two doses of Shingrix a couple of years ago/ she got shingles last year/ suspected Vaccination failure; she got shingles last year; starting to get sores; experience itchiness; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a kid). Previously administered products included Shingles vaccine (received the one-dose shingles vaccine 7 to 8 years ago from the reporting date).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin ulcer and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the skin ulcer and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin ulcer and pruritus to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. A couple of years ago, the patient received the two doses of Shingrix. In 2020, last year the patient got shingles. In 2021, this year at the time of reporting, she was starting to get sores and experienced itchiness. The patient recently received the Pfizer covid vaccine, which she reported had made her feel crappy, she further described this crappy feeling by saying that she was tired and it felt like it was dragging like she was pushing herself. The patient did mention that her medications were causing other problems (unspecified). The patient declined to give her address or email address. The reporter consented to follow-up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. No further information was reported.
Six months after Shingrix injection I still have some pain, no more like a pain spider web under the injection site spreading down my arm. It is not debilitating but very annoying.  I did have several episodes that felt like a wasp sting at the injection site for about 3 weeks after the shot, one of which was so painful that I almost dropped to my knees, each of those  episodes  lasted about 20 seconds. I've been to see my doctor and she seems to think the injection may have into the dura of the muscle.
On 12/15/2021, my daughter developed a severe case of diarrhea more prominent than usual. I watched her symptoms closely and we saw the doctor on 12/17/2021 to check to see if it was a parasite. On 12/18/2021. the diarrhea stopped so we stopped doing the panel for parasites.
35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fingers and toes. Went to nearest Emergency room, 8 minutes away. Treated with IV Solumedrol, Benedryl, and Pepsid.  Stabilized and discharged after 2 hours. Minor symptoms for 2-3 more days. Back to normal now.
Pt vaccinated with DTP/OPV/PPD started Hallucinating - seeing bugs, shakes 105. Gave Tylenol.
No adverse events at time of vaccination on 1/14/201 and 2/11/2021.  Reporting a positive Covid-19 breakthrough case.
I was unable to perform any usual daily activities. I had a severe headache,  joint aches, chills and extreme fatigue. I slept for 36 hours. I'm reporting this because I had the same reaction to my first dose. I had COVID in December but I'm otherwise very healthy.  I would not be willing to receive another dose of this vaccine.
soreness in each arm after each vaccine dose; Found a crack in a tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Found a crack in a tooth) and MYALGIA (soreness in each arm after each vaccine dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Migraine headache. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN 81), PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]) and ZINC for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced TOOTH FRACTURE (Found a crack in a tooth). On an unknown date, the patient experienced MYALGIA (soreness in each arm after each vaccine dose). At the time of the report, TOOTH FRACTURE (Found a crack in a tooth) and MYALGIA (soreness in each arm after each vaccine dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) blood testing showed had antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 16 Mar 2021 , the patient reported gave a blood transfusion donation and was told blood testing showed had antibodies.  No treatment information was provided.   This case was linked to MOD-2021-222516 (Patient Link).
Severe muscle and joint pain 24 to 36 hours after the injection. 48 hours afterward, still having muscle and joint pain but not as severe. Pain in my left armpit, and slight swelling in the glands.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On 16-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K008078/exp. 03-SEP-2015) (dose, route and frequency were unspecified). Concomitant therapy was not reported. No adverse symptoms and no product quality complaint were informed. Additional information has been requested.
Mild induration approximately 8 cm, circumventing right deltoid injection site.  Erythema anterior upper arm shoulder to near elbow.  First noted 06/02/2005 AM.  Arm movement not restricted.  Affected area swollen, warm to touch .  Treatment:  ice compress/elevation/motrin or tylenol.  Will return if temperature develops, symptoms worsen, any lesion develops.
On the two initial vaccinations I had no adverse affects except pain at the injection site. With the booster I have been sick for three days. I am an extremely healthy, physically active 108 lb 68 year old female. I have been achy all over with very sensitive skin. I go from being too hot to uncontrollable shivering. I also haven't slept well which I'm guessing is because of the discomfort. I haven't had an appetite at all which has probably contributed to my overall weakness. I wanted to report my adverse reaction so you were aware of it. Hopefully you will add it to your statistics.
No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an administrator referring to a 5 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 12-OCT-2019, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(lot number S022568 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 04-FEB-2020)(exact dose and route of administration were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent(STERILE DILUENT)(lot# and expiration date was unknown). The vaccine was exposed from 6 degree Fahrenheit (F) to 14F for 420 hours and from 15F to 46F for 106 hours. The previous temperature excursions was from 6F to 14F for 200 hours and from 15F to 46F for 18 hours . A "data logger" was involved. No adverse effects reported.; Sender's Comments:  US-009507513-1911USA000877:
wasn't feeling good at all; had 102degF temperature; really bad headache; next day, I was so sick; burning up; felt like I was freezing inside; had to call out from work; whole day I didn't eat anything; was in bed all day; arm hurt so bad; could not even lift up my arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work) and EATING DISORDER (whole day I didn't eat anything) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad) and LIMB DISCOMFORT (could not even lift up my arm). On 31-Mar-2021, the patient experienced ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work), EATING DISORDER (whole day I didn't eat anything), FEELING ABNORMAL (was in bed all day), PYREXIA (had 102degF temperature) and HEADACHE (really bad headache). On 01-Apr-2021, the patient experienced MALAISE (wasn't feeling good at all). At the time of the report, ILLNESS (next day, I was so sick), FEELING HOT (burning up), FEELING COLD (felt like I was freezing inside), IMPAIRED WORK ABILITY (had to call out from work), EATING DISORDER (whole day I didn't eat anything), FEELING ABNORMAL (was in bed all day), MALAISE (wasn't feeling good at all), PAIN IN EXTREMITY (arm hurt so bad), LIMB DISCOMFORT (could not even lift up my arm), PYREXIA (had 102degF temperature) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported  No treatment was reported
Jaundice, high liver enzymes, fatigue, tea colored urine. Stomach pain
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; varenicline tartrate (CHANTIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history included cardiac disorder. The patient's concomitant medications were not reported. On an unknown date, the patient experienced myocarditis. The patient has a heart condition and need to quit. It's something that's going on around the heart. Patient stated that the heart is fine and everything's fine, have scar tissue and they were calling it myocarditis. The action taken in response to the event for varenicline tartrate was unknown. The outcome of the event was unknown.  Follow-up attempts are completed, information about lot/batch number cannot be obtained.
Feeling tired; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231) via an unspecified route of administration on the right upper arm on 30Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril (LISINOPRIL) for high blood pressure. The patient experienced feeling tired, nauseous and a little headache on 30Dec2020 08:15. Outcome of events was not recovered.
PATIENT HAD REDNESS, SWELLING, AND BRUISING THAT APPEARED THE DAY AFTER THE VACCINE WAS GIVEN. PATIENT CAME TO PHARMACY TO ASK WHAT THEY NEEDED TO DO. WE RECOMMENDED THAT SHE FOLLOW UP WITH AN URGENT CARE PROVIDER OR PRIMARY CARE PROVIDER. SHE WAS TREATED WITH AN ANTIBIOTIC AND STEROID PACK.
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
3cm area of induration on both deltoid with erythema, warmth and tenderness.
no adverse event; HCP calling for re-vaccination information for MMR II and VARIVAX administered via IM route on 9/20/22. No further information provided, no additional AEs, no PQCs reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age an gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 20-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5ml/once, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength, lot #, and expiry date were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/once, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength, lot #, and expiry date were not provided) . No further information provided, no additional adverse events, no PQCs reported.  This is a non-valid case due to lack of patient's identifiers.
Broke out in bad rash and had severe itching. Rash went away after about a week, but continue to itch.
Information has been received from a physician concerning a female who a couple of years ago was vaccinated with 0.5 ml of GARDASIL (Lot # was not provided). The patient developed Lupus after receiving GARDASIL. No dosing information was provided. The outcome of the patient's Lupus was unknown. The patient sought unspecified medical attention. Upon internal review, Lupus was determined to be an other important medical event. Additional information has been requested.
1st dose went in and out of AFib; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 05Jan2021 17:00 (Lot number: EL9261) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "svt" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Bees stings" (unspecified if ongoing); "asthma (now)" (ongoing). Concomitant medication(s) included: DILTIAZEM; FLECAINIDE; XARELTO; LASIX [FUROSEMIDE SODIUM]; POTASSIUM [POTASSIUM CHLORIDE]; TRIAZ [AZITHROMYCIN]. Past drug history included: Morphine, reaction(s): "known allergies: morphine"; Keflex, reaction(s): "known allergies: Keflex"; Levaquin, reaction(s): "known allergies: levaquin"; Xanax, reaction(s): "known allergies: Xanax", notes: breo versed; Aspartame, reaction(s): "known allergies: aspartame"; Metoprolol, reaction(s): "known allergies: metoprolol"; Erythromycin, reaction(s): "known allergies: erythromycin". No Other vaccine in four weeks. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 05Jan2021 19:00, outcome "unknown", described as "1st dose went in and out of AFib". The event "1st dose went in and out of afib" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation included Cardizem drip. No Covid prior vaccination.; Sender's Comments: The event Atrial fibrillation is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
MILD ALLERGIC REACTION AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an elderly male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced mild allergic reaction at the site of injection. The action taken with covid-19 vaccine  was not applicable. The outcome of mild allergic reaction at the site of injection was not reported. This report was non-serious.
Patient claimed he had a sore at injection sites then throbbing pain on his left arm & his left shoulder & his arm can't move so he went to emergency.
Patient started sweating, blood pressure dropped, blurry vision, and was shaking. We gave him water and a snack and he stated that he felt better.
Patient reported presyncope approximately 15-20 minutes after vaccination. She was assessed by this provider with nursing support, and found to have intermittent presyncopal sensation. A history was obtained, which patient reported good breakfast, one caffeinated beverage, appropriate fluid intake. Allergy to amoxicillin (hives and swelling). Only medication was OCP. Vitals were 140/90 by manual cuff, SpO2 100%, RR 16, HR 66. Cardiopulmonary auscultation and neurologic exam (cranial nerves) were within normal limits. She was moved to a partitioned section of the vaccine site, and reported feeling slightly better, however continued with presyncope. She was noted to have mild 2 beat nystagmus on quick head motions, and syncopized. She returned to consciousness quickly, however at this time EMS was called due to prolonged nature of symptoms and limited resources at vaccine site. She was transitioned to a stretcher with assistance, and EMS arrived. She reported chills and was covered with her jacket. She syncopized again during EMS assessment, and was easily arousable, but at this time reported chest tightness. EMS applied 3-lead EKG which appeared normal on the monitor, SpO2 was 97% and respirations continued normally, and heart rate was in the 80s, with blood pressure 141/85. She was taken by EMS to the nearby Emergency Department.
Breakthrough case admission after 3 vaccines Moderna 1/22/21 Lot# 069F21A;  Moderna 2/1/22 Lot# 012H21B; Moderna 6/29/22 Lot# 01722A
Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department reporting worsening headache for three months. Diagnosed with dural venous sinus thrombosis, admitted to hospital, anticoagulated, and discharged to home stable with symptom resolution.
pt recv vax 19MAR97 & 8hr p/vax pt exp a fever to 103.4;