chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got deathly sick after receiving this vaccine. I was in touch with the pharmacy that administered the vaccine regarding how sick I was. I was lethargic with fever. I was tired with nausea and diarrhea like I had the flu. I could not get out of the bed. I had to crawl to the bathroom and lye on. I was sweaty. These symptoms lasted about 3 and a half days. On the 3rd day it subsided and I was able to leave to go see my kids after that. This was worse than getting the flu. Also in December, I went to my daughters house and I contracted COVID-19. I had a fever of 104 with the same symptoms. It lasted for one and the next day I was fine. I was tested at a drive thru clinic and the test was positive.
syncopal episode; Initial information was received regarding an unsolicited valid serious case from a nurse via The agency (Reference number- 00344229) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 12-year-old male patient who had a syncopal episode (syncope), after he received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL).  The patient had no history of seizures. The patient's past medical treatment(s), vaccination(s) and family history were not reported.   Concomitant medications were not reported.  On 29-Oct-2020, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6874AA and expiration date 21-Feb-2022) via an intramuscular route in the left deltoid and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (dosing details, batch number and expiration date not reported) for prophylactic vaccination.  On 29-Oct-2020, the patient developed serious syncopal episode (syncope), 20 to 25 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. The patient had a possible seizure following administration of the vaccines. The patient visited to emergency department for this event where Electrocardiogram and magnetic resonance imaging done, and neurology dismissed the event of syncope.  Other relevant laboratory test were not reported.  No corrective treatment were given.  At the time of reporting, the outcome of the event was unknown.  The reporter wanted to know whether the patient should avoid this vaccine in the future.; Sender's Comments: This case concerns a 12-year-old patient who had syncope, 20 to 25 minutes after vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported.   No treatment information was provided.  This case contains information for the 11th of 104 adult patients described by the reporter.
Information has been received from a registered nurse concerning a one year old patient who on 10-JUL-2007, was vaccinated IM with a first dose of PNEUMOVAX 23. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
pt stated that she a delayed painful 3 X 6 rash appear at the injection site.  It was raised, hot, and itchy.  Pt states that he symptoms  are getting better at this time and she has not contacted her PCP.
Reaction on 06/18/2003 in AM. Patient presents with swollen thigh left (knee to thigh crease). 12 x 10 cm light red area, warm and tender to touch. May treat with ice for 10 min q 4 hours and Children's Motrin PO q 6 hours PRN.
Information has been received from a physician concerning a patient who was vaccinated with a first oral dose of Rotateq. It was reported that 3 days post vaccination; the patient developed vomiting, refused to eat and was hospitalized. Diagnostics, treatment, and current patient status were not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and loss of vision, Nausea and Vomiting, Severe Fatigue
SORE ARM; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included ischemic stroke, and ischemic stroke. 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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Chills, aches, sleeplessness evening and day after (reporting this on 1st day after vaccination).
Fever; Dizziness; Nausea; Heart Palpitations; incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of pyrexia (received 1st dose about 5 to 6 years ago from the day of reporting (2015 or 2016) and experienced dizziness, nausea and heart palpitations, refer case- US2021AMR073266).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, several days after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced fever, dizziness, nausea, palpitation and incomplete course of vaccination. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the fever, dizziness, nausea and palpitation were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, dizziness, nausea and palpitation to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After 1st shot, the patient received 2nd dose of Hepatitis B vaccine as scheduled and started feeling dizzy, fever, nausea and heart palpitations, a few days after. The patient did not receive the 3rd dose of Hepatitis B vaccine as per the vaccination schedule, which led to incomplete course of vaccination. The patient went to the emergency room for a doctor visit, a few days after the 2nd dose and was not admitted. The patient did not take the 3rd dose as scheduled due to the previous complications and precaution.  The patient do not remember the location of the shots and had no details about the vaccine lot number, expiration date or dosage. The patient was recovered from the events. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073266:Same reporter
Woke up sick at stomach @ 4:00 AM. Went to kitchen to get something to eat to sooth it. Felt faint. Tried to make it to couch but passed out and fell before I could get there. Bruised chest in fall.  Blood pressure bottomed out. Stayed low throughout ER stay.
Patient reports a sore right arm. "Streaking redness" on right deltoid, dizziness and headaches.
Booster shot after a dose of Jannsen was given in August. Since vaccination, I have had a headache, nausea, and abdominal pain
was sick as hell; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via media.  This case involves a patient (age and gender unspecified) who was sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Vaccine was administered during a drive through vaccine clinic.  During the waiting period she had some facial flushing and felt nervous and dizzy.  She was given Benadryl 50mg po.  Symptoms resolved.  She was monitored for an extra period of time after resolution of symptoms.  She was dismissed to home with instructions to monitor carefully for any further symptoms and to seek medical attention should they occur.
Itching at shot site on left arm red about 1 1/2" below site. Applied ice to site.
In November when temperature change started having burning in chest shortness of breath and phlegm coming up diagnosed as upper respiratory infection. Lasted until 1st December. Prescribed doxycycline. Symptoms returned 12/12/2020 positive for Covid.
Pt presented with reaction to vax vs. cellulitis. Pt experienced 4 X 4 cm induration at site with 7 X 7 cm erythema surrounding it. Pt treated with Keflex.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 05ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) were 216, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 12-NOV-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
my nose stuffed up; my bottom lip swelling up; soreness in my arm; weird petroleum jelly kind of taste on my lips; bumps on inside the bottom lip; bumps tongue; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution of injection), dose 1 via an unspecified route of administration on 20Mar2021 11:30 (at the age of 62-years-old) (Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history included ongoing blood pressure high, ongoing asthma and anaphylaxis from an unknown date and unknown if ongoing, anaphylaxis to drugs and insects and shell fish from unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) 50 mg two times a day taken for high blood pressure, start and stop date were not reported; amlodipine (AMLODIPINE) 5 mg one time a day taken for high blood pressure. 0n 20Mar2021, patient had the first dose of the Pfizer vaccine and ell fish so we did the extra 30 minutes of observation and during that time the only thing that she noticed was soreness in arm and just weird petroleum jelly kind of taste on lips. Patient goes for lunch and goes out the last evening for a half an hour so and at 11PM, her nose stuffed up and bottom lip swelling up and she took two Benadryl (Treatment) dissolvable 12.5 to equal a total of 25mg so they chewable to children but she could not make it them dissolve faster and stopping allergic reaction quicker. She woke up this morning and half of the lips was normal and other half was still slightly swollen hence worried that, it was not good with the second dose like if she get second dose it might an anaphylactic reaction. Patient was stuffiness like in her nose and then in bottom lip started swelling and it was about 12 hours almost exactly 12 hours later but yes that was where she was with the anaphylaxis. Usually, she get bumps on inside of the bottom lip then on tongue, throat and on nose will start to swell and thats as an urgent situation and shen had an EpiPen and Benadryl so she tried Benadryl first and not had using EpiPen till the time of reporting. Patient got very strange reaction and at 12 hours later, on 21Mar2021 in morning half of her lips was still swollen and she look kind of weird. The patient received treatment of Benadryl for event nasal congestion and lip swelling. The outcome of the events was unknown  No follow-up attempts are possible. No further information is expected.
developed pain; numbness; tingling from her hips all the way to her feet; Sciatica; she is feeling is muscle pain up on her knee.; she had trouble walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 2, single (Lot number: EW0179) at the age of 83 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0179, Expiry: Unknown, Site: Left arm), administration date: 08Jul2021, when the patient was 83-year-old, for COVID-19 immunization, reaction(s): "No problem". The following information was reported: SCIATICA (non-serious) with onset 08Aug2021, outcome "recovering"; PAIN (non-serious) with onset 08Aug2021, outcome "recovering", described as "developed pain"; HYPOAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "numbness"; GAIT DISTURBANCE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "she had trouble walking"; MYALGIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "she is feeling is muscle pain up on her knee."; PARAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "tingling from her hips all the way to her feet". Therapeutic measures were taken as a result of pain, hypoaesthesia, paraesthesia. Additional information: The patient received her 2nd dose of the Pfizer covid vaccine back on 03Aug2021, on 08Aug2021 (also reported as 5 days after) she developed pain, numbness, and tingling from her hips all the way to her feet. The patient says it was first diagnosed as sciatica. The patient was asking if there is any way we can help her for the situation. She also says later on that what she was feeling was muscle pain up on her knee. She said that the 'sciatica' did not work and she went to 4 doctors and found out what it was. She heard it was a reaction to the second shot. She said that she went back and looked and she said that 5 days after receiving the shot, she had trouble walking. She takes no other medications just some Vitamins.
Had chills and shakes and threw up. Went to ER approximately 2 hr after shot. Gave fluids and recovered.
Patient reported symptom onset on 4/2 with severe chills where his whole body shook. The symptoms came on all of a sudden. Patient's wife called the EMTs about two hours later and patient had a fever of 102.5. The fever did not last long. Patient reported shortness of breath and congestion but says that he always has those symptoms and that he had them long before COVID. He also vomited on the gurney. They were told that he aspirated and that was how he developed pneumonia. Patient reported having a CT scan but was unsure if they did a chest x-ray. Patient was on oxygen but not a ventilator. Patient was not admitted to the ICU but was on the COVID wing at the hospital.
This is being reported since the Moderna COVID-19 vaccine dose #1 was given in error for a 17 year old. Only the Pfizer vaccine is approved for 16-17 year old individuals. There are no adverse events associated with this incident.
Nausea. Client had blood drawn prior to coming to get vaccine.  Evaluated by EMS-Refusal to transport.
FLU SHOT CAUSED ME TO LOSE HEARING IN MY RIGHT EAR AND CAUSED SEVERE TINNITUS IN MY RIGHT EAR.  I DO NOT KNOW THE EXACT VACCINE OR MANUFACTURER.  IT WAS THE OVER 65 YEARS OLD DOSE OF FLU SHOT.
Immediately after administrated Immunization,pt check out dizziness, noticed very pale. Ammonia inhaler place nostrils, elevated legs,epic nephrite, 3 cc administered Pulse was weak, chest pain.
rash noted very faint pinkish, not well demarcated & or raised;no urticarial rash;diarrhea;
Pediatric patients were administered a dose of Fluzone HD with no reported adverse event; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Regulatory Authority number: 00900069.  This case is linked to case US-SA-2021SA422744(CLUSTER).  This case involves a two years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 15-Dec-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ709AB and expiry date: 30-JUN-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event was reported.   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.
About 2 minutes after vaccine he became very pale and diaphoretic and he lost consciousness for several seconds and had bilateral body muscle spasms. Lifted his legs and put him on a gurney, applied ice to neck. Gave ammonia whiffs. Stat team was called and he was taken to a treatment area for further care.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of crying in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 01 October 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 1 October 2013; rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on 1 October 2013. On 1 October 2013 the subject received a dose of PEDIARIX (unknown details). On 2 October 2013, 1 day after vaccination with PEDIARIX, the subject experienced crying, irritability and fever. The nurse reported that the subject was "crying and irritable with a 104 degree fever." Relevant test results included body temperature taken on 2 October 2013 with results of 104 degree fever. At the time of reporting the outcome of the events were unspecified. The nurse documented 2 other cases with PEDIARIX. See cases A1044387A and A1044385A for details on the other cases.
The day after the vaccine was administered, patient starting having high fevers, hives and seizures (or what they thought were true neurological seizures). We rotated TYLENOL and MOTRIN that was recommended by doctor. He had high fevers, hives and seizures for a month. Once the high fevers and hives finally went away, patient still had the seizure episodes and started to have behavioral problems, delays, speech problems and was beyond in his milestones. He was diagnosed with a Sensory Processing Disorder at 2.5 years old and still has what doctors are calling mimicking seizures now caused by migraines but they have not been able to pinpoint exactly what the episodes are or what is causing them.
Systemic: Allergic: Rash Generalized-Mild, Systemic: localized rash on right arm (opposite of injection); stated itchy, duration >14 days. Recommended hydrocortisone cream and to check with MD if rash worsens or persists.-Mild