chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LARGE EXTERNAL THROMBOSED HEMORRHOID (BLOOD CLOT); This spontaneous report received from a consumer concerned a 32 year old male of unknown race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient underwent surgery for a large external thrombosed hemorrhoid (blood clot). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of large external thrombosed hemorrhoid (blood clot), surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-large external thrombosed hemorrhoid (blood clot) . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Immediate severe nausea and neck swelling sensation on injection side. About 30 minutes later experienced vasovagal response (typical for me), including lightheaded/passing out, turning A certain color, increased body temperature, severe nausea.  I laid down for about 20 minutes and was given an anti-nausea pill before sent home. About 1 -1.5 hours after my shot, I was standing at my sink and felt like I had the wind suddenly knocked out of me. I then experienced severe heart pain - it felt like someone had scooped a chunk out of my heart. I am a young health avid runner and I have never experienced such severe pain in my life. My entire right arm (injection arm) also became numb and tingly, and I was unable to get a pulse-oxy reading for about 30 minutes from my finger on right hand. My severe pain, heart pounding/rapid and strong palpitations, numb and tingling arm lasted for about 2 hours until it subsided. I failed to go to the hospital when I should have in that moment (in hindsight I should have). About 36-48 hours after my shot, I started to develop other symptoms over the course of two weeks. It started with what felt like loss of bladder control and excessive thirst. I also had constant eye twitching in my right eye for about 10-12 days, numbness along my lower right side extremities (my right leg and foot were numb for a few days), bad episodes of mental brain fog, and more.  About 3-5 days after my shot I woke up in the middle of the night grasping for air, heart rapidly pounding, and eyes rolled back. Again, something I have never experienced before. For about 3 months after my shot I had random episodes of rapid heart palpitations (especially when laying down in bed), brain fog, light headiness, right ear pain, and swollen lymph nodes in right side of neck.
Few pimple like lesions around immunization site (LAT) noted 1/29/03 parent.
Dizziness, lightheadedness, nausea, tinnitus, mild throat constriction, rapid heart rate, clammy sweaty skin, and redness around injection site.
received 1st doses while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received 1st doses while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 23-Aug-2021. On 15-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received 1st doses while pregnant). On 15-Feb-2021, EXPOSURE DURING PREGNANCY (received 1st doses while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 3/9/21 woke up with slight injection site swelling, erythema, localized red rash circular about 2x2 inches, very tender with injection site puritus.  Took 400mg PO Iburpofen at 0700. 0830am applied caladryl cream and ice compress to the arm. Resembles a smaller " moderna arm" type appearance.
swollen feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen feet) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PERIPHERAL SWELLING (swollen feet). At the time of the report, PERIPHERAL SWELLING (swollen feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was  provided by the reporter.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that vaccine was administered to total of 24 patients including 15 males and 9 females. HCP reported administrations were mostly for booster shots. No side effects reported. No treatment information were reported.
achy; Feel, tired; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish). At the time of the report, PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous report as received from another health professional (Market Research Agency: Barriers to ZOSTAVAX Co-administration) via a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection). Dose number, dose and lot number were not provided. The pharmacist administered the vaccine. The reporter believed the patient was on other medications, but was not sure what those medications were. On an unknown date the patient experienced really hard lump where the vaccine was administered. The outcome of really hard lump where the vaccine was administered was reported as recovered/resolved, a couple months after initial onset. The reporter considered really hard lump where the vaccine was administered to be related to ZOSTAVAX. Additional information is not expected.
After 2 years in menapsuse, started uncontrollable and unstoppable uterine bleeding which, at time of this notice, is essentially nonstop in varying severity for most of five months.
This spontaneous report was received from a medical assistant, who was also the patient's mother and refers to a 17 month old male patient. The patient's concurrent conditions included asthma and drug reaction or allergy to OMNICEF. The patient's other relevant medical history was not reported. The patient's concomitant medications were unknown. On 13-JUN-2016, the patient was vaccinated with a dose of M-M-R II (route and site of administration, dose, lot number and expiration date were not reported). Other suspect therapies included unspecified hib vaccine, 3 doses administered (dates of vaccination, route and site of administration, dose, lot number and expiration date were not reported) and DTAP (administered on 13-JUN-2016, route and site of administration, dose, lot number and expiration date were not reported). On 14-JUN-2016, the patient began vomiting and was taken to an unspecified hospital. While in the hospital, he was diagnosed as having a "cyanotic episode with severe apnea". When asked if the patient was admitted to hospital, the reporter stated that he "was in the hospital for 1 day". It was unknown if any lab diagnostic studies were performed and if any treatment was given for the event. The outcome of the events was considered as recovered on an unknown date in 2016, as the reporter stated that the patient "seems to be doing fine". The relatedness between the events and the vaccination with M-M-R II, unspecified hib vaccine and DTAP was not reported. Upon internal review, severe apnea was determined to be medically significant. Additional information has been requested.
Patient developed pretty severe dizziness, headache, generalized joint and muscle pain, chills, temperature of 99.9, nausea and weakness that continued for the next 24 hours.
Swelling around injection site with itchy rash with ring around injection site 5 days after injection.
Massive migraines lasting hours at least 3 or 4 times a week.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included dupilumab (DUPIXENT), escitalopram oxalate (LEXAPRO) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the  left arm on 19Mar2021 at 17:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. On 10Apr2021, the patient experienced massive migraines which lasted for hours at least 3 or 4 times a week. She used to have migraines only 2 or 3 times a year. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of massive migraines and included treatment with Sumatriptan (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event massive migraines was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Full body muscle pain, injection arm severe pain as well can't lift arm, headache, nausea, dizzy and brain fog.  Feel like I have the full body flu.  Hurts to move.
07/15/08 vaccine given at 14:20, with slight redness after 15 minutes. Mother called later that day to say daughter having reaction; red, warm and patient has slight fever. Instructed to follow "after shots paper recommendations" & read pamphlet to her. Apply cool cloth & APAP, if worse call back or go to ER. 07/16/08, mother here with patient. Left arm SQ site red, swollen, more. Seen by doctor given antibiotics by physician.
Arm soreness, tired draggy feeling a couple days after then progressed to wheezing drop in oxygen level. Dropped to 89 but with med came back up
Information has been received from a licensed practical nurse concerning a 15 year old female with a history of ear tube surgery as a child and with no known drug allergies who on 08-MAY-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 654540/1161F). The patient fainted 7 to 10 minutes after receiving the vaccine and sustained a laceration of her lower lip. The laceration was repaired in the office by placement of 4 sutures. On 14-MAY-2007, the sutures were removed, the laceration was completely healed without complication and the patient fully recovered. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
diarrhea; runny nose; sneezing; arm soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right (right arm/right shoulder) on 08Feb2021 at 14:50 pm (at the age of 84-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included bad/sore back from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that after receiving the first dose of vaccine the patient experienced diarrhea, runny nose, sneezing and arm soreness on 09Feb2021. The patient stated that received his first dose of vaccine and stated that he got up in the next morning feeling very good. His arm was sore. Then, he started sneezing a little bit and he got diarrhea. He didn't see that was a side effect on the sheets he received. He was wondering if the sneezing and diarrhea are part of the COVID-19 vaccine and wanted to ask if these are the side effects. He further mentioned that He didn't feel the shot and didn't feel any soreness last night after receiving the vaccine. He confirmed that the arm soreness started in the next morning. He can move his arm, and it was not hurting. However, after touching right on the spot he was injected, it was still sore. Overall, he confirmed that the soreness has improved. He had breakfast and he clarified that he had some cereal this morning and the sneezing started after that. The sneezing was not continuous. In fact, all afternoon, he hasn't sneezed. He did have a runny nose though. He declined to include healthcare professional for this report. He stated that he doesn't see a Lot number on his vaccine record card. The card has his name, date of birth, and a date. The patient was recovered from the events of sneezing and arm soreness on an unspecified date in 2021 and was not recovered from the events of diarrhea and runny nose.   Information about Batch/Lot number has been requested.   Follow-up attempts completed. No further information expected
Fainted 10 min later with tonic/clonic movements x 15sec. Vomiting x 1. 24 hours of headache, vomiting, dizziness. Treated with Phenergan, Tylenol, rest, clear liquids
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Medium, Additional Details: after the first pfizer covid vaccine, patient was lightheaded and seemed on the verge of fainting
Fever 103.7  for over 24 hours Dizzy Weak Severe Headache Euphoria feeling Nausea Severe Body Aches Fatigue Lethargic
Case number PHEH2013US013245, is an initial spontaneous report received from a nurse on 14 Jun 2013, with a follow-up received on 09 Jul 2013. This case refers to a 14-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014). at a dose of 0.5 ml intramuscularly into left deltoid on 07 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013. No adverse event was reported following this administration error. Follow-up received on 09 Jul 2013: Patient demographics, vaccination date and site were updated.
severe headache, nauseous, fever, aching, weakness, frog in throat, chills, blood shot/matted eye
Got shot on the 14th of March about 2:00 am that night got aches, pains , cold chills and head ache. These all lasted until  around 10:00 pm  the 15 of March.
Pt called office to report approx 12 hours following vaccine administration she developed widespread, intense muscle spasms, vomitting, hands and feet itching, throat felt swollen but could breathe.
Date the vial was initially stored in the refrigerator 26Jan2023; No adverse event; Bivalent vaccine was administered to a patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023).    No concomitant medications were reported.  There was Individual Vial of size 2.5 ml.  The vial was initially stored in the refrigerator on 26-Jan-2023. The vial did not undergo any temperature excursions.  No treatment details were reported.
had shingles shot still got shingles/suspected vaccination failure; Shingles; 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.   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: had shingles shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and did not have chicken pox still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
no adverse event; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer, referring to a 75-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W027449, expiration date reported and validated as 25-SEP-2024) as prophylaxis, that experienced a temperature excursion (product storage error). The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F temperature on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023. Worst case scenario of 46.7F was used for the full 72 hours of the weekend per direction of the Health Care Professional. No adverse effects were reported.  It was reported that the vaccine experienced a temperature excursion of 46.7F for 77 hours. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA002750: US-009507513-2304USA002694: US-009507513-2304USA002667: US-009507513-2304USA002746:
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date in 2016, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # M000756, expiry date 06-JAN-2018) dosage regimen and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of several reports received from the same reporter. Additional information has been requested.
Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt recovered and left.
Severe shingles like dermatitis with painful prickly itchy skin on my neck and upper back. Skin was red and itchy at first. The first symptoms (red and itchy skin on upper back and neck) started 24 hours after receiving 2nd dose of Pfizer COVID-19 Vaccine and lasted over 72 hours. Urgent Care Physician prescribed a cream for it.
Vaccine 12/17, developed palpitations and narrow complex tachycardia on 12/22. No elevated inflammatory markers and no evidence of myocarditis on cardiac MRI.  Underwent ablation of atrial ectopic focus on 12/28.