chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vacciation failure; All symptoms of whooping cough; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   The reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had an issue with TDAP vaccine, specifically the pertussis or whooping cough portion. The patient experienced all the symptoms of whooping cough. This case was considered as suspected vaccination failure case since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whooping cough were not reported. The patient further stated that he/she would get the TD vaccine only next time. The researched it afterwards and the vaccine was the new version with more side effects than previous. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249175:same reporter
12/28/06 Td given in left deltoid, influenza given in right deltoid. Email from patient (coworker)to county nurse on 2/15/07 stating, "Right after I got the tetanus shot, the arm I got it in got really sore which I expected.  Unfortunately, the pain hasn't gone away and I'm having problems straightening my arm out.  I know I didn't injure the elbow or strain it but I just can't get rid of the pain in the elbow and now the wrist is starting to bug me." We referred the individual to her primary care physician. pc to patient on 3/5/07 found that patient did not seek medical attention. She states now she occasionally needs to pick her left arm up with her right one to move it.
Information has been received from a medical assistant referring to multiple patients of unknown ages and genders.  The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076, expiration date 25-MAY-2017) orally. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Upper Lip very swollen with second dose. (Lower lip was slightly swollen with first dose and PCP advised to take Benadryl day before second dose and some days after second dose). Took  Benadryl by mouth 25mg (2tabs) on 8/13/21 by 8:20am and also Bluebonnet NAC 500mg  (2 capsules) by mouth on 8/13/21 by 7:15pm. In the morning of 8/14/21, the swelling was gone.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Pt woke up on Saturday 8/30/14 feeling a sore arm. Noticed it was hot to touch, and felt chilled/malaise all day. Better with Ibuprofen. Arm sore, red, hot at injection site all wknd. Better today.
fever, chills, fatigue and body aches.  Also a hypersensitivity reaction just below the injection site.  The first symptoms went away within 3 days.  The hypersensitivity reaction (extreme redness, heat and pain) lasted almost a full week but eventually went away.
Localized topical injection site reaction including redness, swelling, and soreness. Circular shape.  Contained to above the elbow. Treatment of cold compress, diphenhydramine and acetaminophen.
Covid symptoms with 1st shot.  Extreem fatigue and chest pain, shortness of breath with 2nd shot.  After two trips to the Emergency room I was admitted to the hospital and diagnosed with Pericarditis and a Pericardial effusion.  Traeted with steroids, Colchicine and high dose NSAIDS
This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to a 104 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration dates not reported). On unknown dates, the patients experienced a cervical cancer. The outcome of cervical cancer was unknown. The relatedness between the cervical cancer and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Upon internal review the event of cervical cancer was considered to be medically significant. Additional information is not expected as no contact details were provided.
Entire week of not being able to work for being sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Entire week of not being able to work for being sick) in a male patient of an unknown age 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 ILLNESS (Entire week of not being able to work for being sick). At the time of the report, ILLNESS (Entire week of not being able to work for being sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  The patient got the first round of the Moderna COVID vaccine a week ago.
7/22/2019 - DISCOLORED URINE, FATIGUE: 7/23/2019 DR VISIT DIAGNOSED WITH DEHYDRATION: 7/25/2019 EXTREME FATIGUE, SLURRED WORDS, NO APPETITE: 7/26/2019 WENT TO EMERGENCY ROOM - DIAGNOSED WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA - TWO BLOOD TRANSFUSIONS AND 80MG PREDNISONE INITIALLY, WEEKLY INFUSION OF RITUXIN FOR 4 WEEKS AND CONTINUED PREDNISONE - CURRENTLY 15 MG/DAILY
Received 3rd vaccine (booster) on 12/16/21. On 12/31/21, broke out in hives/welts all over my body.
Side effects of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    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 ADVERSE EVENT (Side effects of the vaccine). At the time of the report, ADVERSE EVENT (Side effects of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
About three hours after I got the vaccine, I started feeling just "not well", headache, very cold and my hands were freezing, and just plain tired. My left arm was very sore for two days.
found blood in his stool; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 6205), via an unspecified route of administration in the right arm on 02Mar2021 at 06:30 PM at single dose for COVID-19 immunization. Medical history included allergy to beef (was informed may have an allergy to beef but not be fully tested due to covid restrictions). Concomitant medications were none. The patient had no other vaccine in four weeks, no other medications in two weeks. The following day the patient found blood in his stool on 03Mar2021 at 09:30 AM. It was unsure if this was related to the vaccine but never had an issue prior to the vaccination. No treatment was received for the event. Outcome of the event was not recovered. The patient had no covid prior vaccination, no covid tested post vaccination.
Redness, itching, tingling and burning on neck, upper chest and shoulders. Doctor prescribed antihistamines.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program and medical information team. A contactable consumer (patient herself) reported that a 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient received the first dose of the vaccine on 19Jan2021 and the second one was scheduled for 09Feb2021, but she tested positive for COVID on 07Feb2021. Enquired about how long does she have to wait until she could get her second dose or how does she proceed. It was reported that, patient had question regarding the second vaccine. Patient don't know the guidance when she was supposed to get the 2nd vaccine. Enquired should she be getting the vaccine or not. The outcome of the events was unknown.  Information about lot/batch number has been requested.
complaints of fever and arm pain/ the patient complained of "increased swelling and redness over the entire arm/ was diagnosed with cellulitis; Upon withdrawing the syringe from the patients arm the "luer lock" component on the syringe "fell off". The needle remained on the syringe after the syringe was removed from the arm; This spontaneous report was received from a pharmacist referring to a 53-year-old male patient. The patient did not have any pertinent medical history, drug reactions, and allergies. His concomitant medications included a flu shot in the arm.   On 15-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route in the left arm (lot # S029542 with an expiration date on 10-JUN-2021) for prophylaxis (strength was not reported).        On 15-FEB-2020, upon withdrawing the syringe from the patient's arm the "luer lock" component on the syringe "fell off'. The needle remained on the syringe after the syringe was removed from the arm.  On 17-FEB-2020, the patient called the pharmacy with complaints of fever and arm pain. The pharmacist instructed the patient to take ibuprofen (ADVIL) as treatment. Later on, the pharmacist additionally reported that the patient complained of increased swelling and redness over the entire arm.   The patient was told to go to urgent care. Subsequently, on 18-FEB-2020, the patient went to an unspecified urgent care and was diagnosed with cellulitis and given a prescription for oral cephalexin antibiotic to be taken for 10 days. It was unknown by the reporter if laboratory diagnostics and studies were performed.  The outcome of the cellulitis was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.     Upon internal review, cellulitis was considered a medically significant event.
COVID symptomatic 8/3/2022.  Positive antigen test - symptoms:  diarrhea, head congestion & sinus drainage causing cough, lethargic however had trouble sleeping, loss of appetite
Numbness in the entire arm, tingling, pins and needles in fingers, stiffness in arm/hand/fingers Lasted 3 hours Called a nurse hotline - was told if symptoms persisted to go to an emergency room
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAR-2017, the patient was vaccinated with PROQUAD)(dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after getting the vaccine. There was initial soreness that I expected but its more than 2 weeks past now and now I do not want to receive my 2nd dose on 1-26
Mother reports fever of 102, 101, and 99.1 for past 2 days (today is 4/23/10). Advised that physical exam on 4/22 was normal. Mother also reports lump on left thigh that developed after vaccination area of induration about 25-30 mm induration and redness.
Widespread vesicles, DX chickenpox 03/02/2006, post vaccination 11/29/1999, TX Acyclovir.
pt tested positive for COVID on 1/20/22 in nursing home; per death certificate, pt died at the nursing home with causes of death being metastatic prostate CA, CAD, COVID 19
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (quarter size welt, hard, hot and itchy) and URTICARIA (it spread a little sideways and it was a little hard and hot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced URTICARIA (quarter size welt, hard, hot and itchy). On 20-Mar-2021, the patient experienced URTICARIA (it spread a little sideways and it was a little hard and hot). At the time of the report, URTICARIA (quarter size welt, hard, hot and itchy) and URTICARIA (it spread a little sideways and it was a little hard and hot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.
Dose received: 3; sore arm; temp 101; body aches; chills; night sweats; hot flashes; my period is always on time and started 5 days late; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 05:00 (Lot number: FE3594) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: shell fish" (unspecified if ongoing), notes: known allergies: shell fish; "known allergies:cow dairy milk" (unspecified if ongoing), notes: known allergies: cow dairy milk; "known allergies: gluten" (unspecified if ongoing), notes: known allergies: gluten. Concomitant medication(s) included: SYNTHROID; LIOTHYRONIN; CALCIUM. Vaccination history included: Bnt162b2 (dose number=1,, lot number=EW0158,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 12Apr2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (dose number=2,, lot number=EW0173,, vaccine location=Left arm, Shots 1 & 2 only gave me sore arm), administration date: 01May2021, when the patient was 44 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 05:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "sore arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "temp 101"; PAIN (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "body aches"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "chills"; MENSTRUATION DELAYED (non-serious) with onset Dec2021, outcome "unknown", described as "my period is always on time and started 5 days late"; NIGHT SWEATS (non-serious) with onset 18Dec2021, outcome "unknown", described as "night sweats"; HOT FLUSH (non-serious) with onset 18Dec2021, outcome "unknown", described as "hot flashes". The events "sore arm", "temp 101", "body aches", "chills", "my period is always on time and started 5 days late", "night sweats" and "hot flashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, body temperature increased, pain, chills, menstruation delayed, night sweats, hot flush.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
9-week-old patient that received a dose of Fluzone Quadrivalent; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 weeks old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that 9-week-old patient that received a dose of Fluzone Quadrivalent (product administered to patient of inappropriate age).  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); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL).  On 13-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ209AA and expiry date: 30-Jun-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown 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 holder's compliance with the requirements set out in 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.  List of documents held by sender: none.
Severe pain at injection site - 4 days. Swelling, itching - 4 days. Bedridden x 3 days, pain in extremities.
Client reported they were 12 years olf when they were only 11. Adult dose of Pfizer was given incorrectly.
COVID infection following COVID vaccine series 04/12, Pfizer, dose #1 05/03, Pfizer, dose #2 09/21 COVID-19 ANTIGEN BINAX result: not detected 09/21 COVID-19 MONT result: not detected 11/17 pt cc: cough, fever exposure: unknown 11/17 CXR impression : No acute disease is seen. Of note, plain radiography is insensitive for the detection of subtle groundglass as can be seen in viral infection. 11/17 COVID swab, result: detected 11/17 SARS-COV-2 Variant Sequencing result: pending 11/26 COVID swab, result: detected
This non serious case was received on 30 April 2009 from a health care professional.  A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender:  none.