chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored VAQTA (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003015: US-009507513-1708USA003603: US-009507513-1708USA003604: US-009507513-1708USA003606: US-009507513-1708USA003605.
Chills, arthralgia, headache, and fatigue that resolved after 12 hours
popped into my eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (popped into my eye) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (popped into my eye). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (popped into my eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient who is a phlebotomist stated that a "spurt of the vaccine got in her eye" while administering the vaccine to a vaccine recipient.  Patient stated that for treatment, she rinsed her eye and applied a "cold compress to dab out the corner of her eye."  Patient stated that she has not had any symptoms since being exposed to the vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed flu-like symptoms after receiving initial dose. No further information regarding the patient's experience was available at the time of report.
Local reaction, redness 3x6 cm and tender to touch. Temp was 100.2 and stated just does not feel well. Denies shortness of breath and denies any chest pain. Alert and Orient x3. Lungs are clear and heart rate was 77 apical. O2 was 95%. Patient wanted to keep an eye on the redness and agreed to return to clinic or be seen in the ER if she developed any chest pain or worsening symptoms.
Diffuse body rash, concentrated on legs that began  the day after administration of KINNIX, MMR, VARICELLA and H1N1 vaccines.
side effect; chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis.   On 14th October 2020, the patient received the 1st dose of SHINGRIX . In October 2020, less than a week after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced adverse event. On an unknown date, the outcome of the chills and adverse event were recovered/resolved.   It was unknown if the reporter considered the chills and adverse event to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received SHINGRIX and had Chills. The reporter asked how long did the side effects last.
Patient had a syncopal event with mini seizure lasting approximately 15 seconds. Patient has fainted in the past with vaccines.
Patient came into office with parents.Patient needed COVID vaccine also his father. His father also mention patient wanted COVID Bivalent vaccine. I comfirm his age 11y but the Bivalent was only for 12y & up. After giving patient covid vaccine he waited 20 mins in lobby. Cofirim with patient parents that he was fine and no symthoms.
DTaP given 10:30 AM, 9/23/03. Inconsolable crying began at 1:00 PM and lasted through 4:30 PM. No fever. No local reaction. No other systemic reaction. Vomited at 1:00 PM. Anorexic afterwards.
Left arm 4cm. x 4cm. redness, swelling and warm to touch.
Swelling, itching, heat, redness at sight of injection that spread through rest of forearm about 8x4 in size
This spontaneous report as received from other health professional via company representative refers to a female patient of unknown age which was published in an article. No information regarding current condition, medical history or drug allergies were reported. On 02-SEP-2010 the patient was vaccinated with GARDASIL injection (strength, dose unit, lot number and expiry date was unknown). No concomitant therapy was reported. On an unknown date the patient experienced headaches, abdominal and joint pain, fatigue, sleepiness, cognitive issues, nausea and pain in her ears after receiving the first dose of GARDASIL. On an unknown date the patient received many different types of treatment (unspecified names, doses/frequencies and manufacturers), and also underwent blood tests, computed axial tomography (CAT) scans, nuclear magnetic resonance imaging (MRI) and other various unspecified labs and diagnostics testing. It was not specified if the patient received subsequent doses of GARDASIL. It was not specified if the patient received GARDASIL or GARDASIL 9. The outcomes of the events were unknown. The reporter did not provide the causality of events to GARDASIL. No further adverse event information was provided. Additional information has been requested.
Edema, redness, and warmth from elbow bend to shoulder. Patient's caregiver gave "antihistamine and NSAID".
I contracted Covid-19. My symptoms included coughing, fever, diarrhea, sore throat, brain fog, shortness of breath, reduced blood oxygen levels. I received the monoclonal antibodies treatment. I also received two different inhalers, Prednisone, aspirin, and an anti-inflammatory drug.
blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient learned about possible heart inflammation.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Very limited information regarding this event/s has been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.
Three months after vaccine was working in the garden and developed blisters on knees, that wasn't Poison Ivy. Over the next day or two started feeling extreme fatigue, which fever and chills. Felt better for a couple days, then had another extreme fatigue episode where I had to sleep. Felt better a few days later. Still feels strong episodes of debilitating fatigue and achiness.
No further AE/PQC reported.; MMRII was administered after expiration; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown day in October 2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # R028523, expiration date 04-OCT-2020, 0.5 milliliter, for prophylaxis (route of administration was not reported). No further adverse event reported.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Skin peeled off around injection site-Medium
The morning following the first dose on May 8, 2021 a patch of hairs about an inch in diameter was lost in beard and has not grown back. Several hours after the second dose on June 5, 2021 pain in chest began. Shortness in breath, tightness in chest and pain around the heart has continued.
DEATH; MASSIVE HEART ATTACK; This spontaneous report received from a consumer via social media concerned a 5 decade old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was fit and active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (one week after vaccination), the patient experienced massive heart attack and died from an unknown cause. The consumer reported that "I have an employee whose dad a week after the J&J shot had a massive heart attack and died, he was late 40s and was fit and active". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211020424-covid-19 vaccine ad26.cov2.s-Death, Massive heart attack. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Fever (100.5 degrees), body and joint aches, swollen armpit glands on arm of injection, and slight headache starting 4 hours after injection and lasting 24 hours except swollen glands which persist 1 week post-injection .
Patient had moderate local reaction to Acellular DPT vaccine.  Since then, has developed an itchy rash (described by mom as hives) at the site of the injection, that lasts for a few hours and then disappears.  Physical exam in the office today showed a small area of induration, with no visible hive.
staff members was administered an expired dose of the Flu vaccine with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA350309(CLUSTER).  This case involves a 44 years old female patient who was administered an expired dose of the Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2023, the patient received an expired dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot UT7680NA, Expiry date:  23-Jun-2023 with unknown strength) via intramuscular route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (Latency: same day).  It was reported "A pharmacist reported that two of their staff members was administered an expired dose of the Flu vaccine and would like to know if it is still counted as a valid dose. She reported that the expired vaccine was not sent out to the pharmacist as it should have."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had intense nausea/food aversion begin within 48 hours of receiving first dose. Lasted for 4 days. The day the nausea went away I began my menstrual cycle  a week early which has never happened to me before. I have a very consistent 28 day cycle and have never gotten my period this early.
TOOTH PROBLEM; JAW PROBLEM; FEVER; KNOCKED OUT; This spontaneous report received from a consumer concerned a female of unspecified age. 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, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced knocked out. On an unspecified date, the subject experienced tooth problem, jaw problem, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, knocked out, tooth problem and jaw problem was not reported. This report was non-serious.
Patient received the 3rd dose COVID vaccine in the left arm (Pfizer, Lot# FD0809) on 08/31/2021. At 1140, the client reported to RN Observer that about 5 minutes after receiving the vaccine she started experiencing mild dizziness. RN provided client with juice and snacks and notified Lead RN. Client drank 2 juices and finished bag of chips. Client denied transfer to zero gravity chair as she was more comfortable remaining in her locked wheelchair. RN Observer took client vitals while Lead RN assessed client. Client presented A&O x4, denied SOB, changes in vision, and chest pain. No swelling or rash observed. Client reported she has been experiencing dizziness often, occurring around 1200 due to her current medication regimen and has spoken with her provider regarding symptom management. At 1140 client vitals were BP 102/70 in L arm sitting upright, HR 48 Irregular, and RR 20. Client reported her baseline BP and HR runs low due to her current medications. Lead RN advised client to remain in observation for 30 minutes and client provided verbal consent. Client has medical hx of Coronary Artery Disease, Irregular HR, and Stent Placement.  Client's current medications include: Carvedilol (6.5mg, once daily), Eliquis (dosage unknown, twice daily), Benazepril (dosage unknown, twice daily), Aspiring (80mg, once daily), Potassium (dosage unknown) , Isosorbide (dosage unknown), and Metformin (dosage unknown). Client has a history of allergic reaction to Penicillin resulting in hives. At 1149 client reported she was feeling better and denied dizziness. Client denied experiencing any adverse reactions to the 1st and 2nd dose Pfizer COVID vaccines. At 1210 RN observer took vitals of BP 122/70 in L arm sitting upright, HR 52 irregular, RR 20. Client stated she "feels much better after having some sugar" and denied dizziness. Client drove herself to the vaccine site and denied having anyone available to pick her up. At 1215 RN educated on ER precautions, when to f/u with PCP, and reviewed V-Safe information. At 1220 RN observed client ambulating with even and symmetrical gait. Client left vaccine site at 1225.
Redness and swelling progressed to where the whole upper arm was deep red by 8PM on 2/18/15.  By 8AM on 2/19/15, the redness had spread and his right arm was swollen to twice the size of his left arm.
Head to toe body rash/ hives (including palms and soles of feet), temperature of 101.8 when first checked.
5-6 hives on right hand and forearm on 12/19 at around 1100, took 25mg of PO Benadryl and went away. Intermittent tingling to right foot/ calf and hand (more to foot and calf) started 2100 12/18. Tender right axillary lymph nodes.
Mild rash on thorax.  Lasted for 5 days.  No treatment necessary.
COLD; HIGH FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cold, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, and cold. This report was non-serious.
Beyond 42 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Large local injection site reaction itching/swelling, redness approximately 4-5 cm near vesicular. Covered with cephalexin for infection/cellulitis/OTC steroid.
pt was fussy in evening; parents administered APAP; pt felt hot  when turned pt over eyes rolled & tiwtched all over; parents called 911; sz had stopped when paramedics arrived; t101;
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M024261, expiration date: 30-JUL-2018 (dose and route of administration were not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion. No adverse effect was reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007888: US-009507513-1701USA007886: US-009507513-1701USA007887.
Patient stated  that 2-3 hours after taking the shot she got a rapid heart rate like her heart was going to beat out her body. Heart rate was 162. Patient stated that she took Aspirin with warm water. Patient stated that she had the same reaction with the flu Vaccine. Patient stated that the rapid heat beat lasted about  a day.
Patient received the first Moderna COVID-19 Vaccine dose on 6/25/21 and the second dose of Moderna COVID-19 Vaccine on 7/23/21. For unknown reason (not documented in chart) patient also received a third booster dose on 11/17/21 which is 117 days after the second dose. The recommended waiting period between booster and second dose is 168 days (7 days/week x 4 weeks/month x 6 months). There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
No adverse event; inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (inadvertently administered the bivalent booster dose to a patient who came in today, 17Apr2023, for the 2nd dose of the primary series).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  The patient had 1st dose on 30-Jun-2022, Lot number AS1414B expiration date 13-Feb-2023. No adverse evet was reported after the administration. No treatment information was provided by the reporter.
This spontaneous report as received from a pharmacist via company representative refers to a 46 year old male patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, dose and route not reported). The patient complained of pain and unspecified swelling at injection site of the ZOSTAVAX on an unspecified date. The outcome of "pain and unspecified swelling at injection site" was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.