chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 4 minutes of vaccine administration- (post well care) pt's grandmother was yelling for help from the exam room. Grandma reports patient complained he was dizzy and thought he might pass out but thought it was due to fear of needles. Within a couple seconds of saying  that he started having body shakes and eyes rolled back in his head for about 1-2 seconds. He then snapped out of it according to grandma and started vomiting. Patient's vitals were then checked- within normal for his age and NP performed exam. Diaphoresis noted and some fatigue but was responsive and alert. Ice pack placed to chest, vitals and physical exam completed x2 after that at 15 minute intervals and within normal findings. Patient's mom was at the clinic by then and was able to be sent home with strict instructions regarding ER protocols. Printed information about myocardititis and MIS-C. Instructed patient he may not participate in tennis or any strenuous activity.
PT DEVELOPED PETECHIAE FROM THROMBOCYTOPENIA DIAGNOSED WITH IDIOPATHIC THROMBOCYTOPENIA AFTER ADMISSION TO HOSPITAL
12/4/20201 Contracted Covid 19 - sore throat, headache, cough, sinus pain and congestion, body aches, fatigue
LT arm inject site @ deltoid shows 3/4 size discoloration( deep brown with clearly defined oval edge). Denies numbness, tingling, itching, soreness, fever, or drainage. Has not changed shape or color since 1/5/17.
4 hours after receiving vaccine pt c/o H/A dizziness and nausea that lasted 5 hours.
tingling sensation on the left side of my body from face to feet, then it traveled toward my right side.; numbing sensation on the left side of my body from face to feet, then it traveled toward my right side.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included tourette syndrome from unknown duration. The patient had a known allergy to chamomile and penicillin. Concomitant medications included MENOPUR, GONAL F and CLOMID taking as fertility medication and were received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Mar2021, at 17:45, the patient experienced tingling and slight numbing sensation starting 10 hours after the first dose, on the left side of her body from face to feet, then it traveled toward the right side of her body. The patient did not receive any treatment for the events. The clinical outcome of the events tingling sensation and numbing sensation was not recovered.  No follow-up attempts are needed. No further information is expected.
<24 hours right arm red swollen 14 x 11cm. Tender to touch. Tylenol, cold compresses.
Fever of 101.0 F that lasted until the next morning. Fever of 101.0  F for 2 hours the next night. Fatigue for 2 days, Chills with the fevers, night sweats for 6 days.
About 3 hours after receiving the vaccine pain both right and left arm, weakness in both right and left arm still happening, weakness right and left leg still happening. Overall feeling of coldness over my extremities (feet, hands, ect.) still happening The first night after vaccination both right and left arm had tingling and numbness, it felt like when you arm falls asleep last about one day.  I have been feeling fatigued which has been improving.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUL-2015 the patient was vaccinated with an improperly stored dose of VAQTA (25U/0.5 ml; lot # K007791, expiration date: 22-AUG-2016; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 6 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 1172, -3, -3 and R; 80, 30, -1.111111111 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 336, 59, 15 and R; 168, 49, 9.444444444 and R; 24, 48, 8.888888889 and R; 416, 47, 8.333333333 and R. This is one of several reports received from the same source. Additional information has been requested.
temperature excursion involving  unopened adacel, tenivac and menquadfi and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event; ADACEL being administered post excursion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA052418(CLUSTER).  This case involves a 48 years old male patient to whom Diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] being administered post excursion with no reported adverse event and temperature excursion involving  unopened Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi], diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult and meningococcal a-c-y-w135 (t conj) vaccine (formulation, strength, lot number and expiry date were not reported) temperature excursion occured and the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event  (product storage error)    On 07-Feb-2023, the patient received a suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 ml (strength not reported) ( lot U7648AA and expiry date- 15-Feb-2025) via intramuscular route in the left deltoid for immunization post excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
when pt was breast feeding on 7/24 pt started trembling, then arms & legs began jerking & had blank stare; episode lasted seconds up to 3 min; pt taken to ER
Patient reports vomitting that began the day of her 2nd dose of Pfizer injection and has lasted 3 weeks at this point. The vomitting was significant the first 3 days after the injections and now still persistant nausea and vomitting multiple times per week. New onset joint pains.
chills, fever, neausa, fatigue, 48 hours, I thought I was going to die
Large swelling at site - approx. 3-4 inches in diameter. First few days it was hard & hot, then got softer and less red. Reaction was evident for 6 days.
Redness, swelling, hardness (R) posterior arm - noted approx 18 hrs after injection; redness spreading, no fever, no pain noted. Dx cellulitis, tx: BACTRIM, compresses.
TINNITUS; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious. This case, from the same reporter is linked to 20221135750.
Employee was given  the Pfizer-BioNTech COVID-19 Vaccine EUA at  Hospital on 1/8/21.  Our facility recorded this as his first dose as the employee reported that he had missed his first dose appointment with us.    When the registration staff entered the 1/8/21 dose in the  system the next day,  it was noted that patient had received the MODERNA vaccine on 1/2/21 at another Hospital.  Patient did not make our facility unaware that he had received a Moderna COVID vaccine on 1/2/21 - he mistakenly thought that he was just receiving his second dose at our facility.    He received the following:  1/2/21 ? Moderna 1st Dose  @ Hospital                  1/8/21 ? Pfizer 1st Dose  @ Hospital  Patient denies any adverse reactions to either vaccine. He denies any localized or systemic symptoms and reports that he felt well after each vaccine.  There was no adverse reaction reported.  He was scheduled for his second Pfizer COVID dose at an appropriate interval and he was advised not to proceed with the second Moderna dose.  Hospital was notified as well.
Patient was dizzy after vaccination . she said she is nervous for vaccine. she did not want pharmacy call 911. Pharmacy watched patient for 30 min and once she felt better she left.
Right arm (site of Prevnar vaccination) red, sore,  and swollen around injection site  prior to urgent care center visit. Next day prior to prescription medication treatment, symptoms have lessened somewhat.
Pt developed R calf and knee pain about 24 hours after his first dose of the Moderna Covid vaccine. We saw him first on 5/4/21 and he had a R LE doppler which showed a deep vein thrombosis in his Right posterior tibial vein.
High fever of 101 2-4 hrs after patient had 400 mg IBU and red raised rash on right arm site of shot.
This spontaneous report was received from a physician via company representative, and refers to a 16 year old female patient with no medical history, current conditions or historical drugs reported. The physician stated that the patient had not eaten anything prior to the office visit on 04-NOV-2017, where the patient was vaccinated with an unspecified dose of GARDASIL 9, intramuscular for prevention of Human Papilloma Virus (HPV) (lot# and expiration date were unknown); BEXSERO, for prophylaxis (route of administration, lot# and expiration date were unknown); and influenza virus vaccine (manufacturer unknown) for prophylaxis (route of administration, lot# and expiration date were unknown). It was also mentioned that during the patient's visit a tuberculine test was performed, test results unknown. Shortly after vaccinations on the same date, she began to feel lightheaded and dizzy, fainted, and then fell off of the exam table and hit their head on the blood pressure machine, the patient was unconscious for 5-10 minutes. The physician also documented the events as sudden and moderate. The patient had a follow up visit to the physician's office on 06-NOV-2017, and everything was OK. The patient did not receive any treatment and no laboratory diagnostic studies were performed. The patient recovered from syncope, loss of consciousness and dizziness on the same date of vaccination, and recovered from head injury in November 2016. Upon internal review the event Loss of consciousness was considered as medically significant.
Strep throat like symptoms began 3 days after my 2nd covid vaccine (Friday January 29, 2021). Sore, red, and swollen throat, white patches on tonsils, low grade fever (max temp 100.5), chills, body aches beginning Friday, January 29, 2021.  I initially went to urgent on Sunday, January 31, 2021 for a strep test. The test was negative and the nurse practitioner told me to return if my symptoms didn?t improve in a few days.  On Tuesday February 2,2021, after my symptoms worsened, I went to Urgent Care for a second opinion/strep test as this is generally the hospital I use for treatment as opposed to the urgent care that I mentioned previously. The nurse practitioner did not swab me for strep, but rather observed my red, swollen, white patch filled throat and ordered me a round of steroids and antibiotics. I started both the antibiotics and steroids today, February 2,2021.
I gave the patient the second dose of Moderna today on 4/21/2021 because she has to complete the series even though she is under 18 years old. Patient is 17 and 11 months old today
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
A report was  received from a health care professional on 05/Dec/2006 concerning a 64 year old female vaccinee. No details of the vaccinee's past medical history or concomitant medications were provided. The vaccinee received Fluvirin by intramuscular injection on 12/OCT/2006. On 05/Nov/2006 she began complaining of low back pain, which spread up to her mid back over 1.5 weeks. The pain was severe, and on 11/Nov/2006, the vaccinee developed tingling in her hands when reaching out. the vaccinee was seen by a neurosurgeon, but no cause was found for the pain. the vaccinee had no pain control with Lorcet, Lortab , Demerol and Pnenergan. She was then admitted to hospital and commenced on a Morphine pump which provided some pain relief. By this time the vaccinee had had 10 MRI and CT scans with no results. A CT of her chest revealed ataletasis secondary to not breathing deeply due to the pain. On 27/Nov/2006, the neurologist performed nerve conduction studies, which revealed inflammation of the nerve roots, the vaccinee's physician considered this to be caused by either a virus or immunisation. Further information is requested.
Pt was admitted for frequent falls.  He was found to have a subdural hemorrhage as well as being COVID positive.
Patient developed a bump that lasted approximately 7 days. Continued to have tenderness in arm and joint area limiting range of motion. Ibuprofen and ice help with symptoms.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial).    Patient age was between 6 months to 5-years. Concomitant medication was not reported.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake.   Treatment medication was not reported.  This case contains information for the 24th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Patient passed out, had brief generalize seizure like activities, lasted for a few second. Then patient was awake, vital sign stable. No fever, no vomiting, no incontinence. Patient was able to walk home.
"pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient had no adverse reaction. Patient was given a Moderna vaccine instead of Pfizer. Patient was monitored, no signs or symptoms of having any reaction or side effects to vaccine.
Edematous at injection site, warm to touch, large amount of swelling in upper arm and under axilla, pain
chills, temp 102+ 3 days APAP extra strength, liquids, rest & cold compresses to forehead;
Patient had insomnia for 24 hours could not sleep, she admits to having a bad headache and vertigo that have not resolved.
Information has been received regarding a case in litigation concerning a 49 year old female who on 19-Nov-2007 was vaccinated with first dose of hepatitis A virus vaccine inactivated and experienced pain, irregular bleeding and menstrual irregularities. The patient went to see a gynecologist on 28-Jan-2008 and reported having these symptoms the past four weeks (approximately 29-Dec-2008). The patient was diagnosed with dysfunctional uterine bleeding. The patient also experienced unspecified gastrointestinal symptoms (onset date unknown). At the time of report the patient had not recovered from the events. Additional information has been requested.
Patient developed fever and vomiting. Redness and induration at injection site. Site tender to touch. Patient 25 mg tab of Benadryl.
On 12/17/2020, patient called pharmacy reporting pain and swelling that occurred shortly after receiving flu immunization and lasting currently. Patient discussed with oncologist who speculated that she may have nerve damage.
LETHARGY AND NAUSEA AFTER RECEIVING VACCINE, WANTED TO EAT SNACK AND LIE DOWN BEFORE DRIVING, DID NOT EAT PRIOR TO COMING. VSS. SYMPTOMS RESOLVED AND PATIENT ESCORTED TO EXIT WITH NO ISSUES AT 1300. 1240P BP 146/86 HR 61 RR 18 SATS 97% RA
Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009867: US-009507513-1707USA009868: US-009507513-1707USA009869: US-009507513-1707USA005581.
This spontaneous report as received from a nurse concerning a 49 year old other healthcare worker with no history of drug reactions or allergies. The reporter stated, that on 22-MAY-2014, an unspecified patient received a complete dose of ROTATEQ (lot #, exp date: not provided) and a short time later he/she blew bubbles/spit on the face of staff member (healthcare worker), who on about 23-MAY-2014 developed chills, diarrhea, and headache. She did not seek medical attention. No lab diagnostic studies were performed. The outcome of developed chills, vomiting, diarrhea, and headache was reported as recovered/resolved. Relatedness between adverse events and ROTATEQ was not reported. This report is linked with MARRS # 1406USA004410 (Same Reporter Link). Additional information has been requested.
I was sickest I've ever been after taking a Flu shot; Initial information received on 13-Nov-2020 and live follow up received on 20-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a patient of an unknown age and gender for whom it was reported was sickest have ever been after taking a flu shot (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient had got a flu shot years ago and was very sick from it for 2 weeksp (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not recovered.  There will be no information available on the batch number for this case.
COVID arm - bullseye rash around injection site, it's sore & warm too, 14 days after injection; seems pretty mild  The lot # may be 007M20A or it may be 067M20A - it's hard to read
Fever of 101.2F and chills, severe night sweats, dry cough, body aches, fatigue, headache and diarrhea. Headache and diarrhea lasted for 1 week. Chills, fever, cough and body aches lasted 2 weeks. Night sweats and fatigue still persist 5 weeks later.