chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZY; THROAT TIGHTNESS; SWOLLEN UPPER LIP; DIFFICULTY BREATHING; NAUSEA; VOMITING; This is a Spontaneous report from a Contactable Nurse. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 07Jul2021 at 10:30 (at the age of 38-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, and schizophreniform disorder from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations four weeks prior to the vaccination. The patient previously took Gemifloxacin (MANUFACTURER UNKNOWN), nabumetone (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) and experienced drug hypersensitivity; and experienced latex allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 12Jun2021 (Batch/Lot Number EW0179) for COVD-19 immunisation. The patient experienced dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting all on 07Jul2021 at 10:45. The patient was taken to ER via ambulance by EMS. Therapeutic measures were taken as a result of dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting which included epinephrine 0.15 dose x1 in right thigh, and IV Benadryl and solumedrol in the ER. The clinical outcome of the dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting was recovered on an unknown date. It was unknown if the patient was tested for COVID post vaccination.    Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the events dizzy, throat tightness, swollen upper lip, difficulty breathing, nausea and vomiting cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Information has been received from a physician concerning a 15 years old female patient, who on an unknown date was vaccinated with the second dose of GARDASIL 0.5 ml (route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date while on GARDASIL, the product affected the color of her (the patient's) menstruation. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. Therapy with GARDASIL was reported as discontinued as not reintroduced. The patient did not seek medical attention. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SICKNESS; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information received on 21-DEC-2022. The patient's weight, height, and medical history were not reported. The patient was previously administered with two doses of covid-19 vaccine (Unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following 2 doses of covid-19 vaccine (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis which was associated with Revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in DEC-2022, the patient experienced sickness. On the day of reporting, the patient still had sickness since 11 days after the booster (Dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test results not reported, tested covid-19 multiple times. It was reported that, "I took two and a booster have been sick sense 11days after the booster and have had tested coved mulwt times". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263936. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
230 pm - Mother called and reported hives, rash to body, no problems breathing. Treatment - Benadryl 2/22/07.
Severe diarrhea for 48 hours; fever; muscle aches; chills; Is_pregnant: Yes; This is a spontaneous report from a non-contactable consumer (patient). This is a (maternal or fetus/baby) report.   A 29-year-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0180), via an unspecified route of administration, administered in arm left on 22Jun2021 at 12:15 (29-year-old at the time of vaccination) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0186), via an unspecified route of administration, administered in arm left on 01Jun2021 (29-year-old at the time of vaccination) as single dose for COVID-19 immunisation and resulted maternal exposure during pregnancy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021 patient was pregnant and on the same day at 01:00, she experienced severe diarrhea for 48 hours, fever, muscle aches and chills. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. She was 19 weeks pregnant at the onset of the event. Her LMP was on 08Feb2021. The mother was due to deliver on 15Nov2021. Patient did not receive any treatment for the events. Outcome of the event maternal exposure during pregnancy was unknown and was resolving for all other events.  No follow-up attempts are possible. No further information is expected.
fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9
He started vomiting at midnight 2/24/07, then had mucus and blood in a diarrhea stool was admitted to the hospital and had surgery for intusussecption. Could not be reduced by an enema.  3/15/07 Received medical records from hospital which reveal patient experienced a 2 day history of bloody diarrhea.  Had been seen at outlying ER & transferred for higher level of care.  Taken to OR for exp lap for bowel obstruction.  Intussusception reduced & appendectomy was performed.  Held overnight for observation.  Did well & d/c to home. FINAL DX: Intussusception, surgically reduced.
expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 13-month-old female, to whom an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 06-Mar-2023, the patient received a Booster dose at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, Strength: standard (lot number: UJ646AA, expiry date: 05-Mar-2023) via intramuscular route in Left Quad for Immunization and on the same day expired dose of acthib was administered to a patient with no reported adverse event (expired product administered).  It was reported, requesting validity information.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  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.
My right hand began tingling and became cold within 30 minutes of receiving the J & J booster. It still tingles some and is cold but now has also moved to my left hand. I had only achy bones for one day when I received the first J & J shot.    It seems that the booster was the culprit.
They were all fully vaccinated, however it was the second time they all had it; they all had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "They were all fully vaccinated, however it was the second time they all had it"; COVID-19 (medically significant), outcome "unknown", described as "they all had COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 2 inches around vaccine injection site skin is warm to touch, very itchy and skin feels tough/inflamed
The next day my arm hurt very badly and started to get red. Today the site is very hot, red 4" diameter and hurts and raised.
Severe diarrhea started about one month after second Covid shot. At same time severe dry eyes with pain and inflammation causing me to wake several times at night. Saw family doc for diarrhea and eye doc for dry eyes.  Family doctor took stool samples and treated with several prescriptions to rule out bacterial cause; when that didn't help, he sent me to my gastroenterologist,  who performed a colonoscopy. Showed severe inflammation, colitis, unspecified.  Treated me with Colestipol and then when that didn't work, a steriod for two weeks. At follow up visit he and I both agreed it was brought on my the Covid vax, causing inflammation of colon.  He advised I should not get boostser
Flu-like symptoms.  Severe chills, nausea, fever, headache, body aches, fatigue throughout the night and into next day. Felt a little nauseous immediately after shot. Flu symptoms came on around 10pm and lasted until about 5pm on 3/21/2021. Worst period of symptoms was overnight (about 12 hours.) Took 2 Tylenol 2-3 times while I was experiencing side effects which helped some with symptoms.  Had pain with injection and sore arm for about 48 hours after. It was a much more severe, deeper muscle pain than with other vaccines.
Pt was given shots at 10:30am. Mom called back about 3:53pm stating child had an episode of staring off in one direction and head jerking a little. Thighs were red and swollen and baby has a rash on her face. Mom was instructed to come back in with child. Dr saw pt et gave infant TYLENOL et infant BENADRYL per mom. Pt. was fine by the next day.
6SEP89 pt recvd vax & 7SEP89 pt seen large local accompanied by fever & crying several hrs;
Left arm, deltoid area, red, swollen and painful over about 50mmX60mm area.  Mom reports more swelling yesterday, but decreasing in size today.
Immediate burning at injection site. Baseball sized swelling developed itchy rash area was painful but did not bruise. BENADRYL/Hydrocortisone provided some relief. Swelling is decreasing.
Mother observed child to have muscle weakness morning after immunizations (DTaP #3, PCV #3) given. Eval. in ER approx 6 hours later - child had normal exam.
Moderate to severe joint and widespread muscle pain and weakness beginning day after vaccine and still occurring as of 11/12/2022. Keratitis diagnosed on 11/11/2022.No problems prior to vaccine.
Information has been received from a nurse referring to a patient of unknown age and gender. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L008057, expiration date 01-DEC-2016, dose and route were unknown). The vaccine was stored under 0.4 degree centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Loss of consciousness 10 minutes after administration while leaving pharmacy.. No syncope before episode or awareness of feeling unwell. Woke up on the floor and couldn?t stand without syncope and nausea for 2 hours. Required emergency department visit and sent home once medically cleared.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of  PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929 , Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. ; Sender's Comments:  1805USA009899:Original Case : 1805USA006787 1805USA009900:Original Case : 1805USA006787 1805USA009901:Original Case : 1805USA006787 1805USA009902:Original Case : 1805USA006787 1805USA009903:Original Case : 1805USA006787 1805USA009904:Original Case : 1805USA006787 1805USA009905:Original Case : 1805USA006787 1805USA009906:Original Case : 1805USA006787 1805USA009907:Original Case : 1805USA006787 1805USA009908:Original Case : 1805USA006787 1805USA009909:Original Case : 1805USA006787 1805USA009910:Original Case : 1805USA006787 1805USA006787:Original Case : 1805USA006787 1805USA009912:Original Case : 1805USA006787 1805USA009913:Original Case : 1805USA006787 1805USA009914:Original Case : 1805USA006787 1805USA009915:Original Case : 1805USA006787 1805USA009916:Original Case : 1805USA006787 1805USA009917:Original Case : 1805USA006787 1805USA009918:Original Case : 1805USA006787 1805USA009919:Original Case : 1805USA006787 1805USA009920:Original Case : 1805USA006787 1805USA009921:Original Case : 1805USA006787 1805USA009922:Original Case : 1805USA006787 1805USA009923:Original Case : 1805USA006787 1805USA009924:Original Case : 1805USA006787 1805USA009925:Original Case : 1805USA006787 1805USA009926:Original Case : 1805USA006787 1805USA009927:Original Case : 1805USA006787 1805USA009928:Original Case : 1805USA006787 1805USA009929:Original Case : 1805USA006787 1805USA009930:Original Case : 1805USA006787 1805USA009931:Original Case : 1805USA006787 1805USA009932:Original Case : 1805USA006787 1805USA009933:Original Case : 1805USA006787 1805USA009934:Original Case : 1805USA006787 1805USA009935:Original Case : 1805USA006787 1805USA009898:Original Case : 1805USA006787
Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "not recovered" and all described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: Tested positive on the morning of 04Jun; (10Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (11Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (12Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (17Jun2022) positive, notes: positive again on 17Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Flu Shot given at workplace at 9:30 am on 10/16/2008.  Fever beginning at 5:00 pm lasting until 10/19/08.  Hives beginning at 8:00 pm 10/16/08.  After calling Dr. on 10/17 patient began taking Benadryl and Zantac.  Worsening hives requires patient to go to the After Hours clinic on 10/20/08.  Shot of steroids was given and a prescription given for Prednisone 30 mg per day tapering dosage over next seven days. In addition take Zyrtec 1X day and Zantac 150 MG 2X day.  As of today's date condition is mildly improved.  History of sensitivity to sulfites, wonders if the vaccine contained sulfites used as a preservative.  Was hospitalized in 1993 for severe allergic reaction from flu vaccine but have taken numerous flu shots in following years with no problem.
Nose bleed; my 5 year old was given the injection and she had may be 4 hours afterward and then again may be 2 hour after that she had a nose bleed.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Nose bleed"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "my 5 year old was given the injection and she had may be 4 hours afterward and then again may be 2 hour after that she had a nose bleed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ADW2586, EW0180, 3005690 and 34396TB) for COVID-19 vaccination.     Concomitant products included CITRALEX for an unknown indication.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Company Comment: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, SARS-CoV-2 Test Positive (reported as Covid-19 virus test positive) which occurred approximately 1 month after receiving a dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, SARS-CoV-2 Test Positive (reported as Covid-19 virus test positive) which occurred approximately 1 month after receiving a dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.