chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 minutes after shot, I was dizzy and headache. Starting at midnight until 9am my heart was racing between 114-124 bpm all night long while laying still in bed.  Normal sleeping heart rate is low 60's.  Chest pain and racing was obvious.  Extreme headache, pain in legs, etc. lasted for 2 days.  Fever hit 100.5
Patient reported on 11/26/14 that she had bruising along arm where immunization was given. She had consulted her Dr and was given a "sulfa" drug.
herpes zoster ophthalmicus; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 73 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster ophthalmicus. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster ophthalmicus. The outcome of the event herpes zoster ophthalmicus was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event herpes zoster ophthalmicus was determined to be medically significant.  Additional information has been requested.
When the vaccine was given it may have been given subcutaneously rather than intramuscularly (the provider tented the skin before inserting the needle).  The patent had the expected mild arm soreness for 2 days following the vaccination with no systemic symptoms.  She was subsequently without symptoms until 8 days after the when she noted some itching at the injection site.  That evening the injection site had a 7 cm by 5.5 cm area of erythema, induration, and warmth.  There was no adenopathy and no associated systemic symptoms.The next morning the erythema was slightly larger, but by that evening was starting to decrease.  By the next morning the induration, warmth, and erythema were resolving and she had no further itching.  This has continued to resolve throughout today.  This appears to be a delayed reaction to the Moderna vaccine that may have been exacerbated by a possible subcutaneous injection.
Complained of pain at injection site ; left deltoid where she got her DTaP that day. Woke up with redness, swelling, itching and pain in the area. Seen in office to eval.
Marked swelling of entire upper arm from shoulder to elbow; erythema & tenderness as well;
I experienced numbness of my face, starting in my lips, working through my jaw, up my cheeks, up into my eyes, and to my forehead. The numbness / tingling lasted for 30 minutes and then dissipated with no other adverse effects.
Developed Pulsatile Tinnitus in right ear which lasted for 3 weeks, causing difficulty sleeping. After 3 weeks, symptoms became intermittent and then stopped after 4 weeks.
Headache 4 hr after injection Elevated temp with body shakes  15 hr after injection Body aches and physical tiredness for 2 days following injection Treated with fluids, Tylenol, rest
''I'' got a fever blister on ''my'' lower lip; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 11:45 (at the age of 56-years-old) and a second dose of BNT162b (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The medical history included slightly elevated cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included cholesterol medication (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) for immunization on an unknown date. On 15Mar2021 at 17:00, the patient got a fever blister on his lower lip within 24 hours of the first injection and and also experienced same within 24 hours after the second injection. The patient reported that it was not occurred since he received shingrix (shingles vaccine) when he turned 50-year-old. So, for over 6 years, the patient did not have a fever blister and this leads to speculate him that this vaccine (suspect) may had reduce the efficacy of the shingles vaccine and this warrants further investigation. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported event which included treatment with docosanol (ABREVA). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever blister on lower lip was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Eye blinking progressing to twitching or tics that began within 1 day of the vaccines
stored improperly; No adverse effect; This non-valid spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' relevant medical history, concomitant medications and concurrent conditions were not known.  On unknown dates, the patients were vaccinated subcutaneously with an unknown number of doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R013302, expiration date 08-MAY-2020 and lot # R017946 expiration date 24-JUN-2020 (strength and dose were not reported)) and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R003293, expiration date 31-JUL-2019, lot # R022572, expiration date 04-FEB-2020, lot # R011217, expiration date 15-OCT-2019 (strength and dose were not reported)), both for prophylaxis. It was unknown if sterile diluent was stored properly. No adverse effects were reported. There were previous temperature excursions. Data logger was not involved.
3 - 4 days after this infants vaccinations, the mother stated the child developed RSV and almost had to be hospitalized. Since then he's probably only had about 5 healthy days of his life that he hasn't had URI's. 60 day follow up states patient has persistent ear infections and skin is broken out. The follow up received on 7/3/01 states, "6/15/01 Augmentin susp 400mg/5ml 2.5ml bid x 10 days then re check."
Arm became red and very warm this the shot was given Saturday night and the redness started on Monday.
fluarix vaccine was give to a patient on 2 separate days; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3na4m, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 27th October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The flu fluarix vaccine was given to a patient on two separate days, which led to extra dose administered. The reporter consented to follow up.
Patient is a 66 y.o. male, a prior medical history of lung cancer s/p right pneumonectomy, gout, dyslipidemia went to urgent care for evaluation of shortness of breath.  Patient found to have hypoxia, not on oxygen at baseline, sent to ER, tested positive for Covid.  Patient was initially placed on ceftriaxone and Zithromax, which were discontinued due to negative procalcitonin.  Treated with dexamethasone during hospital stay.  Patient has history of smoking in the past, possible undiagnosed COPD.  Discharged on prednisone taper.  Patient was on 2 L of oxygen, discharged on home oxygen.  Patient was stable at the time of discharge, recommended to follow-up with primary care provider within a week.
Started end of 04/2023 with increased breathing problems and pedal edema.   Made doctors appointment to find out I had significant EKG changes.  Was referred to a Cardiologist, and was sent for a stress test.   Results from test revealed that I was in cardiac heart failure.  Ejection Fraction was at 20%(normal for my age is about 70%).  I had an echocardiogram in 2019 with the results being normal.
Covid 19; This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (Covid 19) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. The patient got the Moderna Bivalent booster last week on Thursday. It was reported that the patient had a cough that was not going away with their inhaler. No treatment medications were reported.
Pt given 0.5 ml of Fluvirin. Made for 4 years and older. Warning on box but no warning on vial.
My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.
AM of 20AUG91 red streaks developed elbows, collarbone area; streaks rose pink color; tenderness in collarbone area; c/o rt upper thigh fatigue; T 97.5; c/o nausea & dizziness; referred to ER for eval., but didn't go; illness lasted 48 hrs;
It's like puffy at the injection site; It hurts; Top of her arm swollen; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It's like puffy at the injection site), PAIN IN EXTREMITY (It hurts), PERIPHERAL SWELLING (Top of her arm swollen) and VACCINATION SITE PAIN (Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 31-Aug-2021, the patient experienced VACCINATION SITE REACTION (It's like puffy at the injection site), PAIN IN EXTREMITY (It hurts) and PERIPHERAL SWELLING (Top of her arm swollen). At the time of the report, VACCINATION SITE REACTION (It's like puffy at the injection site) and VACCINATION SITE PAIN (Soreness) outcome was unknown and PAIN IN EXTREMITY (It hurts) and PERIPHERAL SWELLING (Top of her arm swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
My period is normally very regular and was not due for 12 days at the time of the vaccine. However, I unexpectedly started my period the day after my first vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced irregular periods. The patient reported that her period was normally very regular and was not due for 12 days at the time of the vaccine. However, she unexpectedly started her period the day after her first vaccination. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event irregular periods was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reported a sore throat and neck, a headache, and she had a fever (100 degrees) and chills (shaking). We treated with ibuprofen. On 10/29 her symptoms had mostly resolved.
History of mild seasonal depression. Not medicated. First dose on 12/26, mild ?blues?. Felt it was strange given how excited I?d been to get the vaccine. Slowly dissipated. Second shot 1/16 with mild expected fever. Within 15 hours developed severe depression and new presumed anxiety that has yet to dissipate despite being medicated. Compulsive suicidal ideation, obsessive thoughts, sobbing and generalized anhedonia without any history of experiencing these thoughts during prior depressive episodes.
Hives all over and more lethargic. Swollen hands. Was given Benadryl and then Atarax was started.
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
In the evening of the dose she had pain & inflammation at injections site, couldn't sleep on that side.  The following morning around 5 am she started to experience viral type symptoms with hot and cold flashes and very foggy head which continued for about 36 hours. No other person she knew experienced these symptoms, except a coworker that also received a SHINGRIX vaccination from the same lot number.
have had them two times after I had the vaccine/Suspected vaccination failure; Shingles/it was internal; felt like worms crawling around; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: have had them two times after I had the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/it was internal), crawling sensation (Verbatim: felt like worms crawling around) and rash (Verbatim: rash). The outcome of the vaccination failure was unknown and the outcome of the shingles, crawling sensation and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, crawling sensation and rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, crawling sensation and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles three times and two times after he/she had the shingles vaccine. The reporter stated that one time it was all internal and felt like worms crawling around the same area that broken out in the rash. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads.
Hospitalized (11.15.21);  COVID-19 positive (11.10.21);  Fully vaccinated Admission Date: 11/15/2021 Discharge Date: 11/17/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus HOSPITAL COURSE: This is a 65-year-old female with a history of obesity, body mass index 41, obstructive sleep apnea not on CPAP, coronary artery disease ischemic cardiomyopathy EF 63% in March 2021, history of stenting, hypertension, hypothyroidism.  Patient states that she initially tested positive for COVID on November 10th, states this was ordered by her primary care provider but she was asymptomatic at this time. For the last 5 days she has had increasing weakness, nausea, loose stools up to 3-4 day (none today). Patient denied any chest pain or shortness of breath.  She states she received a Moderna vaccine in March in April of 2021. On arrival to the emergency department patient was noted to be hypoxemic, requiring 2 L of oxygen to maintain sat 94%. Her blood pressure was soft but stable, she had a temperature 38.9°.  On exam she was diaphoretic, obese, ill-appearing. Lungs show diffuse crackles heart regular rate and rhythm abdomen was benign.  Extremities showed trace to 1+ edema bilaterally. Sodium 131 potassium 3.2 chloride 95 CO2 25 BUN 15 creatinine 0.91.  Liver enzymes normal.  Glucose 124 lactic acid 2 procalcitonin 0.08.  White blood cell count 4 hemoglobin 9.9 platelet 365000 segs 83 lymphs 11 D-dimer 700. Chest x-ray showed typical COVID findings bilaterally. Patient was admitted and started on dexamethasone and Remdesivir. Patient's symptoms improved. She was able to be quickly weaned off of O2. She wears 2L at baseline qhs. She was discharged home in stable condition.
I have a rare immunocompromised disease called Lymphangioleiomyomatosis. I had COVID-19. I had a low-grade fever and symptoms of a cold. I had a scratchy throat and runny nose. It was really like a mild cold. I tested at home and then I went to a clinic, and it came out positive. I was put on antibiotics. I recovered really quickly.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications was reported.  The patient received half dose of Moderna vaccine. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications was reported.
Body aches, Headache, Fever of 100.4.  Took 2 Tylenol.  Still Fever of 99.8 6 hours later.  Took 2 more Tylenol.
Numbness/tingling on the whole left side of my face starting days after the  and continuing at this time. No treatment has been given.
Within 2 days of shot, she developed chills, nasal congestion, weakness, and loose stools. Beginning approximately 11/27, she developed elevated pulse and dyspnea. Went to ER 12/2/21 and diagnosis with new onset Afib with RVR, palpitations, pulmonary edema and acute hypoxic respiratory failure. Given IV cardizem in route to ER. Required diltiazem drip at ER. New oxygen requirement of 4LPM while inpatient - required 2LPM on discharge - not required prior to this. Back to ER 12/9/21 for symptomatic Afib/RVR. Admitted 12/10. Discharged 12/13. Required new meds of lasix, digoxin, amiodarone, apizaban and metoprolol.
Pt vaccinated with MMR 5 days after MMR developed fever to 103-104 & continued to have fever x3 days followed by rash generalized including scalp which was itchy. Pt irritable with restless sleeping & mild ataxia all of which resolved.
Fatigue, some chills, head hurt all day long.  Would have been unable to go to work but it was a weekend so I didn't have to.
Pt recv 1st dose of Hep B vax/HIBTITER & devel urticaria;
Patient recieved the Moderna Booster, no 2nd dose of Moderna Vaccine was located in Alert. This booster is now documented as the 2nd dose, rather than the booster in alert