chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. brought immigration form from civil surgeon with need for Td, PPV, Varicella (due to neg blood titer) and Zoster. I said Zostavax not needed because was neg for chickenpox.  Returned 5/18 with pain & erythema in left forearm. Said she had Zostavax at a pharmacy (against my advice) on 5/13. Pain, swelling & erythema began 5/17. Referred to Clinic for MD assessment due to pain.  MD called to HD & unsure but felt it may be Zoster from vaccine and put on an anti-viral medication.
Patient reported shoulder pain and inability to sleep on arm. Patient acknowledged location of immunization in deltoid. Recommendation was made to ice area, use naproxen, and check with physician.
Patient received the 2nd dose 20 days after their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose). On 20-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Diffuse red papular rash on face, upper extremities and trunk which appeared 3 days, post vax of Hep-B #2. Denies exposure to new foods or products. Treated with Prelone X 3 days and Atarax.
Blood clot; Pain all over; could not eat anything; She felt like she had a gas; Nauseous; headache; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache). At the time of the report, THROMBOSIS (Blood clot), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  The expiration dates for suspect drug were not provided. Patient was taking other medication. HCP was not aware of the side effects.  Company comment: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-404957, MOD-2021-404948 (Patient Link).; Sender's Comments: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Patient passed away 12/13/18. Per parent report he has a seizure and died.
arm/ injection site soreness, chills, body aches, headache, mild fever 99.6 Fahrenheit. Medications taken: extra strength Tylenol and ibuprofen 400mg once to twice daily for 2 days after second vaccine dose.
Dizziness, tingling of face and hands, blurry vision, weakness in limbs (couldn't walk or stand) shaking, felt like fainting.  Severe headaches.   She has had these symptons every day since getting the Gardasil shot.
On 2/17/2021 patient complained of not feeling well, noted to be hypotensive, was sent to  Medical Center  Emergency Department for further evaluation.  Diagnosed with COVID-19 infection.
09:12, PA-C  informed pt. was getting flushed right after receiving the second dose of Pfizer vaccine. Pt. immediatly assessed: AAO x 3 and in no distress. Pt. states hx. of this reaction with vaccines and allergy shots. Pt. states he had similar reaction after the 1st Pfizer vaccine. Pt. was given Benadryl on the 1st vaccine and symptoms resolved. Currently, no breathing or swelling issues but, remains flushed on face, upper chest and arms.  Does not appear to be hives.  At 09:15 Pt. given Benadryl 25mg liquid. VSS stable, 65hr, 96% O2. 09:20 flushing on skin almost gone and pt. reports feeling better with no complaints. 09:28 pt. discharged to leave clinic.
Administered injection to high; Dose was administered into shoulder joint;  Followed up with a OH clinic provider. Was referred to a specialist
I had swollen lymph nodes within 16 hours after the flu shot and a very bad headache. It lasted until Saturday morning at 4 am.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: other medical history: Migraine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Positive Covid antigen home test with reoccurrence of runny nose, sneezing, nasal congestion after 1 wk of discontinuing treatment and positive Covid test after 5 days of negative test   No follow-up attempts are possible. No further information is expected.
Administered the dose to a patient but some leaked out.; Administered the dose to a patient but some leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out). On 30-Mar-2021, UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter was a pharmacist who reported that they administered the vaccine dose to a patient, but some leaked out and wanted to know if the patient needs to be re- administered.  No treatment information was provided.
Cerebral edema/ Cerebral Ischemia; This literature-non-study case was reported in a literature article and describes the occurrence of BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cerebral edema. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Imaging procedure: Initially showed scattered cortical thrombosis. On an unknown date, Lumbar puncture: Elevated opening pressure.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) to be related.    No concomitant and treatment medications were reported.  24 hours after receiving first dose of the Moderna COVID-19 vaccine, the patient developed severe headache. Three weeks later patient was admitted with subacute headache and confusion. An external ventricular drain was placed, but patient continued to have elevated intracranial pressure.  Ultimately, patient required a hemicraniectomy, but intractable cerebral edema resulted in patient death.  Pathology was consistent with thrombosis and associated inflammatory response. Though correlational, her medical team surmised that the mRNA vaccine may have contributed to this presentation.  Company Comment: This is a literature non-study case concerning a 30-year-old female patient with no reported medical history, who experienced the serious (fatal, hospitalization and medically significant) unexpected event brain edema. The event occurred 24 hours after receiving the first dose of mRNA-1273 vaccine. 24 hours after receiving first dose of the Moderna COVID-19 vaccine, the patient developed severe headache. Three weeks later patient was admitted with subacute headache and confusion. An external ventricular drain was placed, but patient continued to have elevated intracranial pressure. Ultimately, patient required a hemicraniectomy, but intractable cerebral edema resulted in patient death. Pathology was consistent with thrombosis and associated inflammatory response. The reported cause of death was Cerebral edema. It is unknown if an autopsy was performed.  Relevant diagnostic tests included Imaging tests that initially showed scattered cortical thrombosis, and Lumbar puncture resulted in elevated opening pressure. No concomitant and treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Cerebral edema
NOT BEING ABLE TO BREATH; RIGHT LEG AND FOOT VERY SWOLLEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced not being able to breath. On JUL-2021, the subject experienced right leg and foot very swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not being able to breath, and right leg and foot very swollen. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 13-DEC-2013 at 17:30 ZOSTAVAX (Lot # J007858) was exposed to a temperature noted as equal to or >12 degrees C for an estimated total time out of range of 9.75 hours. On 13-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J007858, expiration date 28-SEP-2014) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
This spontaneous pregnancy report was received from a medical assistant refers to a approximately 19 year old female patient with no drug allergies/reactions. The patient's medical history included hypoglycemia, anemia, ovarian cysts and kidney cysts. The medical assistant reported that after the patient completed the three dose series of GARDASIL (lot# H021346, expiry: 01-OCT-2015)0.5 ml, intramuscularly and became pregnant. The reporter stated the patient received her first dose on an unknown date in November 2012, the second dose one month after (December 2012), and the third dose five months after the second dose (approximately on May 2013). No concomitant medications were reported. The LMP and EDD was not known. The pregnancy outcome was outcome pending. Patient had an unspecified pregnancy test: result not reported. Patient sought medical attention(office visit). Additional information has been requested.
itchy hives/rash "from head to toe" per patient who called over the phone to let clinic aware. Stated she has been taking Benadryl for this. No other concerns (denies throat itching, or difficulty breathing). Started on 5/2/21 and reporting on 5/4/21 which she still has hives per patient
It?s been 9 days n now the injection site is itching n puffy it?s weird no other side affects  I did scratch til it bled
01/14/22 presents to ED "after a fall". PMHx of "a. Fib-Xarelto, stroke with residual peripheral vision loss in R eye and LLE weakness"
PATIENT FELT LIGHTHEADED. PLACED ON SUPINE POSITION ON THE FLOOR  WITH ELEVATED LEGS. BLOOD PRESSURE WAS TAKEN WITH A NORMAL OUTCOME OF 110/70. PATIENT WAS OBSERVED FOR 30 MINUTES. SNACKS AND WATER WAS PROVIDED. ADVISED PARENT TO OBSERVE PATIENT THROUGHOUT THE DAY, CALL 911 OR VISIT THE NEAREST EMERGENCY ROOM IF ANT ADVERSE EFFECTS ARE PRESENTED.
Unilateral eyelid swelling (upper/lower) symptom onset 24 hr after vaccination
Onset of reaction at 11 hours after injection. Fever (100.8º F), body aches and pains.  Seemed to abate 24 hours after injection, but then, 48 hours after injection, a wave of extreme fatigue with back ache began, accompanied by a low grade fever (98.4º F). This lingered for the next 6 days, at which point I saw a physician.  He was not concerned. "You're building some very strong antibodies!" HA! In fact, on that day, my temperature fell below 98º F, which is normal for me and the extreme fatigue abated to mild fatigue. I asked if I should get a Covid test, but he saw no reason because I wasn't actually sick.  It's now 5 days since I saw the doctor. My energy is slowly returning but the back ache had morphed into back spasms, which continue to bother me somewhat.
pt devel hive type react w/in 5 mins of inject; had flushed cheeks w/itching & swelling of eyes; no difficulty breathing or body rash; rash limited to face & was consisting of generalized flushing w/small raised papules on cheeks;  redness
This case was reported by a non-health professional via interactive digital media and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included cancer (11 years ago) and immune system disorder.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were recovered/resolved. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient might of had the bad reaction from reduced immune system from cancer 11 years ago. The patient had 1st dose of SHINGRIX 2 months ago and had a bad reaction of aches and headaches. For tolerance effect after 2nd dose, refer case US2018GSK138651.
10 x 5 cm welt formed around injection site less than 24 hours after injection. also warm and itching. also had diarrhea night of injection. Treating welt with hydracortisone cream 1%, ice, and benadryl at night
Information has been received from a physician concerning a 6 month old patient who on 16-MAY-2007 was vaccinated with RotaTeq vaccine. On 12-OCT-2007, the patient was seen by the physician to received the second dose of RotaTeq vaccine. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Tested positive again 8 days after last Paxlovid dose; (2023) Positive, notes: Tested positive again 8 days after last Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (lot number: GG0127) from 01Sep2023 to 06Sep2023. The patient received another 5 day course of Paxlovid after testing positive again 8 days after last Paxlovid dose, and had symptoms.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Post injection site was sore for 2 days.  However, on November 8, 2022,  I had a small stroke, from which I have recovered completely. I heard on the news that strokes have been observed in women 65+ (I was 76 years old) after the Pfizer COVID Booster.   I have had Moderna vaccinations & boosters prior to this Pfizer booster.   I just wanted to enter my "data point" to your statistics.
annoying choking all day long; extremely hot to the touch; red patch on my arm; chills; The arm was extremely sore, not the usual pain; A spontaneous report was received from a consumer concerning a female patient of 65 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced redness, pain and hotness in arm, chills and choking.  The patients medical history included high cholesterol and blood pressure. Concomitant medications reported included Lipitor, Hydrochlorothiazide, baby aspirin and vitamins.  On 05 Feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030M20A ) vaccine intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, couple of hours later patient experienced soreness in arm.  On an unknown date, six days after the vaccination, patient experienced redness in arm and extremely hot to the touch.  On an unknown date, 1 to 2 days later after vaccination, patient started choking all day long and patient also got the chills.  Treatment for the event included Advil once or twice.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for unknown for redness and pain, recovered for feeling hot, not recovered for chills and choking.; Reporter'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.
After receiving the vaccine, I had a sore arm and fever for one day. On 08/23/2022, I was on vacation and was hiking and noticed I had a rapid heartrate. On 09/06/2022, I had an EKG, and I wore a Holter monitor for a week. In October 2022, I was diagnosed with rapid heart rate when not at rest. I am not taking anything to help with my symptoms.
A physician reported the occurrence of vomiting in a 22-year-old male who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt had no relevant medical history. Concurrent conditions and concurrent medications were unknown. The pt received injections of Twinrix on 10/02/2002 and 11/01/2002 without adverse experience. He received his third injection of Twinrix on 03/31/2003. 30 minutes post-immunization, the pt experienced flushing, 2 episodes of vomiting, and diarrhea. His vital signs remained stable and he did not experience anaphylaxis, stridor or hives. He was kept in the physician's office for observation.
Blisters and itching on fingers on the hand of the arm that received the vaccine. She also stated she had multiple red lumps on the arm and intense pain. Pain started the day of vaccine, red lumps, itching and blisters night of 1/9.
Significant pain in left upper arm radiating down arm and up neck. Painful within rage of most. Very intense 1st day. Currently rates 7/10. Said okay. Tylenol, Ibuprofen, Aleve, heat, ice
seizures 48 hrs p/vax; eyes rolled up & pt shook; 2 seizures next 24 hrs & 3 seizures w/in same time frame;