chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up 48 hours after injection with itchy palms(hives) and both lips burning. Very anxious and agitated, light headed. History of  anaphylactic results requiring medical intervention in the past. Drank a lot of water and took a Zyrtec then laid down and slept 2-3 hours. Exhausted for over a week.
Heart Attack / trauma; mysterious ring around the site that has grown larger and larger; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack / trauma) in a 50-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. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cerebral palsy.    On an unknown date, 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. In 2021, the patient experienced VACCINATION SITE REACTION (mysterious ring around the site that has grown larger and larger). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack / trauma) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack / trauma) and VACCINATION SITE REACTION (mysterious ring around the site that has grown larger and larger) outcome was unknown.            No concomitant information was reported. Patient with cerebral palsy received COVID-19 vaccine. Patient had a mysterious ring around the site that had grown larger and larger and patient ignored it until October 31. Patient had a heart attack and had stints placed in heart. Patient blame Moderna and Moderna's vaccine. Patient can take action against Moderna for the trauma as patient have been through.  Company comment: This spontaneous case concerns a 50-year-old female patient, with no relevant medical history reported, who experienced the unexpected serious (Medically significant) AESI of Myocardial infarction that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and onset date of event was not available. Patient experienced heart attack and had to have stents placed. No further information on risk factors, relevant medical history, clinical course, investigations and details of treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5  vaccine is not affected by this report.
This report concerns a 24 month old male who on 01-DEC-2000 was vaccinated with a dose of Comvax. Concomitant therapy included a dose of Infanrix. On 01-DEC-2001 the pt experienced moderately severe pain at an unspecified site and fever. The next day, he recovered, with out treatment. the reporter considered the pt's experiences to be related to Infanrix administration. No further information is available.
hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.
This spontaneous report was received from a healthcare workers refers to a 19 years old female patient. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route, lot# unknown) respectively on 15-MAR-2012, 30-MAY-2012 and 15-AUG- 2012. No other co-suspects were reported. The healthcare worker stated client got the patient's third of GARDASIL early. No adverse effects reported. Additional information has been requested.
Dizziness and lightheartedness that was not treated with medications. 20 min later patient reported mild dizziness. Patient drank 2 bottles of water.
This case was considered medically important. Information regarding PREVNAR was received from a consumer, and verified by a healthcare professional regarding a male patient who experienced autism. The patient received a dose on an unspecified date. The patient's younger brother developed autism in May-2005, see related case: US-WYE-H03437408. Product was administered on an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced autism. The patient's outcome is unknown. See related case(s): US-WYE-H03437408 (adverse event, expedited). No additional information was available at the time of this report.
Pt states that he received Johnson and johnson COVID vaccine last year. Never received a booster. Admitted with chest pain and possible MI. Tested possible for COVID upon admission
12/4/06 14 year old female received flu vaccine within 2 min patient starts to seize which lasted approximately 1.5-2 min and then throws herself on her Mom and collapsed.  EpiPen 0.3 mg given right leg IM.  ER notified.  Patient transferred to ER via wheelchair.  12/15/06 Received ER records from hospital which reveal patient began to shake & turned pale within 5 min of flu vax shot.  Admin Epi Pen w/good results but patient felt weak & vision turned black prior to epi.  Taken to ER for observation for 4 hours.  Patient d/c to home on steroids, benadryl & given epi pen for prn use.  Referred for allergy testing. Final Dx: possible allergic reaction to flu shot.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.21 for dose administered on 15-Apr-2021 No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 6-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment; vomiting; stomach problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 30Apr2021, outcome "unknown", described as "vomiting"; ABDOMINAL DISCOMFORT (non-serious) with onset 30Apr2021, outcome "unknown", described as "stomach problems"; PRODUCT DOSE OMISSION ISSUE (non-serious) with onset 30Apr2021, outcome "unknown", described as "scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment".  Additional Information: Patient got the first dose on 09Apr2021. She was scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA297470, 2018SA297469, 2018SA297471, 2018SA297472, 2018SA297473 (same reporter). This case involves a 6 years old patient (unknown gender) who received single 0.25 ml of vaccine FLUZONE QUADRIVALENT (Suspension for injection) (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the right thigh on an unknown date (reported Sep-25 - Oct-12) for Immunization. Patient's medical history was not reported. No concomitant therapies was received by patient. It was a case of actual medication error due to vaccine underdoes. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Received different vaccine doses; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she received Pfizer vaccine for the second dose mistakenly.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains non-significant information (updated patient initials).
felt queasy 31NOV but not debilitated; diarrhea 1NOV @ 902Am; had cough & generally felt lousy until 8NOV: felt like a cold but no runny nose, etc;
Fever, chills, sore throat, headache, swollen glands. Broke out on mouth, cheeks and chin open lesions. 10/2/02 Still has swollen glands and cough. Mother became ill on 9/29/02 with similar symptoms. Referred to PCP by PHN on 10/02/2002.
Pt received DTP noon 31-JUL-90 slept most of next 9 hrs; occasional high pitched scream; Temp 101.  awokened by mother for feeding; Drowsy, fed poorly leg red & swollen initially.
her husband dose not; This is spontaneous report from a contactable consumer (spouse). An 80-year-old male patient (husband) received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported herself and spouse received their second dose of Pfizer COVID vaccine on 28Jan2021. They have both been subsequently tested for antibodies, stated that she has antibodies present but her husband does not in 2021. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Tongue and lips started to feel "prickily" and then became numb.  The next two or so days pain in my right kidney area.
Swollen fingers; rash all over body; hurts to bend fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 13:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XANAX; WELLBUTRIN; LEXAPRO. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "Swollen fingers"; RASH (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "rash all over body"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "hurts to bend fingers". The events "swollen fingers", "rash all over body" and "hurts to bend fingers" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of peripheral swelling, rash, pain in extremity.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events swollen fingers, rash all over body and hurts to bend fingers occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Amendment: This follow-up report is being submitted to amend previously reported information: narrative updated to reflect that patient had no relevant medical history  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (20Aug2021): This is a follow up spontaneous report received from a contactable consumer. This consumer reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity
Started running fever 1 day post vax- fever lasting 3 days; arount 103-104(ax); Taken to ER;
I lost my hearing in my left ear 3 months later after getting my dose 3 booster vaccine. I went to the ENT doctor 3 times. he wants me to get an MRI before coming back to him.
On July 13, 2017 it was discovered that there was an excertion on July 9 at 60.6F for 12.10 hours. Refrigerator went out of range.
Case previously recorded as MA2009-5719. Initial case report received from a healthcare professional on 20 NOV 2009. This 3-year-old male child was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 10127801) on 20 NOV 2009. No adverse event appeared. Reference no. NA09-008676.
The very next morning after the vaccination around 7:00 AM , my right arm was hurting, it was not red, or there wasn't any bruising.  I had tightness in my throat, it was pretty much like an anaphylactic  shock is how the doctors described it. I had white bumps, like welts,   on the back of my throat and tongue. And the roof of my mouth and my tongue, my lips everything in my mouth was swollen. My eyes were almost swollen shut. On 12/27/2021,  I had a doctor video visit. He advised me to take Benadryl, and Tylenol,  I used my albuterol  inhaler several times because I couldn't breath. So around 3:00 pm I went to the Emergency Room because I was still having a hard time breathing and the swelling wasn't going down.  The doctor immediately gave me an Epi pen. and told me i had an allergic reaction to the vaccination. The doctor advised me that it was up to me to take the 2nd vaccination . He said it was up to me.
Patient reported to ER on 4/27 with 6 hours of chest pain radiating to left arm.
My arm started feeling tender later in the day of the shot; swelling under my armpit.  It looks like a lump; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via an unspecified route of administration, administered in Right Arm, on 26Mar2021 at 11:00 (at the age of 49-year-old) as DOSE 2, SINGLE for covid-19 immunization in Workplace clinic.The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL 12 HOUR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date: not reported), via an unspecified route of administration, administered in Right Arm, on 05Mar2021 at 11:00 (at the age of 49-year-old) as DOSE 1, SINGLE for covid-19 immunization.The patient was not pregnant at time of vaccination.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 29Mar2021 at 11:00, the patient's arm started feeling tender later in the day of the shot, that continued, but patient thought nothing of it as patient was told that should be expected. Now the patient saw there is swelling under her armpit. It looked like a lump. The patient waited to see if it would get better. It had, but it was still noticeable. The patient hoping it would continue on the path of feeling better and the swelling/lump going away. No treatment was received for the adverse event. The outcome of the events was recovering at time of report.  No follow-up attempts are needed. No further information is expected.
STRANGE SIDE EFFECT IN LA SKIN; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced strange side effect in la skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strange side effect in la skin was not reported. This report was non-serious.
The pt had a rash all over body about 4 weeks after shot was light red and itchy for pt-seen my MD.
Information has been received from a consumer concerning her 13-14 year old daughter who approximately 2 months ago, November 2007 (exact date not reported), was vaccinated (route and site not reported) with the second 0.5ml dose of Gardasil (lot# not reported).  On 02-JAN-2008 the patient developed a rash on "her leg and on her shoulders".  The patient did receive unspecified medical attention.  Per the patient's mother, the patient has not recovered.  No additional information is expected.
vertigo; headaches; 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 VERTIGO (vertigo) and HEADACHE (headaches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) and HEADACHE (headaches). At the time of the report, VERTIGO (vertigo) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
IgA nephropathy relapse following COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as unk, single (Batch/Lot number: unknown) for covid-19 immunization.The patient's relevant medical history included: "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown", described as "IgA nephropathy relapse following COVID-19 vaccination". Therapeutic measures were taken as a result of iga nephropathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tachycardia, weakness, Pain in arm vaccine administered radiating into head and neck, nausea.