chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Nurse Practitioner via company representative, referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients received a dose of ROTATEQ, orally, for prophylaxis (dose, lot number and expiration date were not provided). The Nurse Practitioner reported that the patients would had choked after receiving the dose of ROTATEQ. It was not reported if the patients sought medical attention, if treatment was given for the event or if lab diagnostics or studies were performed. The outcome of the event choking and the causal relationship between the event and vaccination with ROTATEQ were not reported. Upon internal review, choking was considered to be medically significant. Follow up information was received on 29-MAR-2018 from Nurse Practitioner and refers to a female patient. At the time of vaccination the patient was almost 6 months old and had nasal discharge and otitis media in right ear. The patient had no preexisting (physician-diagnosed) allergies, birth defects or medical conditions. On 14-DEC-2017, the patient was vaccinated with third dose of ROTATEQ orally (lot # N005078). Other suspect therapies included third doses of PENTACEL (intramuscular into right arm) and PREVNAR 13 (intramuscular into left arm). After ROTATEQ was given, patient started couching, there was no color change, lungs were clear. The event resolved immediately. The experience required prescription drug treatment. The outcome of choking was reported as recovered/resolved. The causal relationship between the event and vaccination with ROTATEQ was not reported.
vision changes; This case was reported by a consumer via interactive digital media and described the occurrence of visual disturbance in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown.   It was unknown if the reporter considered the visual disturbance to be related to Shingrix.  Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know how common vision changes were after receiving Shingrix. Additional Supportive Information: The follow up would not possible as no contact details were available.
tingling and numbness in right arm; tingling and numbness in right arm; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (09Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose number unknown (booster), 0.3 ml single (Lot number: GH9694) at the age of 42 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUTICASONE nasal. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: PARAESTHESIA (medically significant), HYPOAESTHESIA (medically significant) all with onset 09Sep2022, outcome "unknown" and all described as "tingling and numbness in right arm".  Clinical course: Pharmacist calling about Pfizer Biontech Covid 19 vaccine, bivalent booster, she wanted to file a report for an adverse event. She did not have further questions. She confirmed contact details upon transfer. Patient received Pfizer covid19 bivalent booster today and about 5 minutes later he started experiencing tingling and numbness in right arm where he had the injection. The paramedics were called and evaluated him and stated that it did not seem like a normal reaction so they recommended to go to urgent care. He opted to drive himself instead of taking an ambulance and paramedics said he was ok to do so. Time vaccination was given: around 12:30pm. He was experiencing the numbness and tingling when he was leaving to the urgent care but has not followed up with patient since he left. Treatment: declines any , She has to go and declined to complete the rest of the report.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events PARAESTHESIA and HYPOAESTHESIA  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
sz x 1 episode; temp recorded per mom @ time of visit to ER-103.? R; mom reports pt given alcohol bath to dec temp
vertigo very bad and continues; Menstrual period lasting longer; low blood platelet count; This is a spontaneous report from a contactable reporter via COVAES. A 40-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 10:00 as (At the age of 40-year) dose 2, single for covid-19 immunisation. Medical history included migraine, autoimmune arthritis, (I believe autoimmune deficiency arthritis of some aurtis) and covid-19 from an unknown date. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was Unknown if patient been tested for COVID-19 Since the vaccination. Patient was not pregnant at the time of vaccination. The patient previously took bnt162b2, dose 1, administered in Right arm on 05Apr2021 10:00 as dose 1, single for covid-19 immunisation. It was reported that adverse event Began after the 2nd shot vertigo very bad and continues. Menstrual period lasting longer. Testing shows low blood platelet count on May2021. Patient was visited Doctor or other healthcare professional office/clinic for events ae treatment Vertigo Meds- Lab work showing low blood platelets retested 28May2021 and awaiting results. The patient underwent lab tests and procedures which included platelet count decreased: unknown on 28May2021, platelet count decreased: low blood platelets in 2021, sars-cov-2 antibody test: positive on unknown date. The outcome of events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
tingling in jaw after the vaccine; This is a spontaneous report . A non-Contactable Consumer reported information for himself and his wife. This is the first of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient reported that he and his wife both had tingling in jaw after the vaccine. The outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076002 Same reporter, same product, same event, different patient
This spontaneous report was received from a medical assistant and an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 26-MAY-2017 to 09-JUN-2017,  the patients were vaccinated with improperly stored doses of ROTATEQ (lot number M025569 with expiration date of 18-JAN-2018 and lot number M031807 with expiration date of 02-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour at a temperature of 51.4 degrees Fahrenheit on unspecified dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005075: US-009507513-1706USA010930:
Injection site became red and swollen.  The swelling and redness became larger.  The redness kept going down  my arm  to the elbow,  I was worried it was going down pass my elbow, but it stopped there.  the site is starting to lessen insize and color but is still itchy.
Immediately after receiving 1st Gardasil vaccine, student had "seizure-like"  movements for approximately 15-20 seconds then passed out. Per student, no history of seizures no activity even no ppeng with other vaccines. Does "feel faint" when has blood drawn.
Patient received vaccine, was told to wait 15 minutes for observation. After about 10 minutes she said she felt dizzy. I had her sit and elevate her feet. She said she felt a bit better, then a minute later felt nauseous. She vomited a small amount and said she felt a little better. I took her blood pressure and it was 118/79 mmHg and 91 for pulse. She said she was feeling better but she'd wait around some more. She left about 10-15 minutes after she said that.
Red itchy spot on arm at the injection site; Red itchy spot on arm at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site) outcome was unknown. Not Provided          Treatment information included cortisone cream.  Action taken with mRNA-1273 in response to the event was not applicable.
blood clotted; had persistent synovitis in all knuckles; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ew0186 and Expiration date: unknown), via an unspecified route of administration, in arm left on 26May2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amitriptyline hydrochloride (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 10 mg and frequency for unknown indication; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took flu shot on an unspecified date in 2017 and experienced synovitis. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 28May2021, since his first Pfizer shot have had persistent synovitis in all knuckles. On an unspecified date in Jun2021, 12 days after first Pfizer shot donated blood and blood clotted in tubes before completion. He had donated about 40 times and that was the first time his blood has clotted. The case was assessed as non-serious. No treatment was received for events. The clinical outcome of had persistent synovitis in all knuckles, blood clotted were not recovered.
This case was reported by a other health professional via call center representative and described the occurrence of bloody diarrhea in a 3-month-old male patient who received ROTARIX (Batch number A41CB548A, expiry date 12th February 2017). The patient's past medical history included premature birth. In 2015, the patient received ROTARIX (oral) 1 ml. On 2nd December 2015, 2 days after receiving ROTARIX, the patient experienced bloody diarrhea (serious criteria GSK medically significant). On an unknown date, the outcome of the bloody diarrhea was unknown. It was unknown if the reporter considered the bloody diarrhea to be related to ROTARIX. Additional details were provided as follows: The health care professional reported that the premature patient experienced bloody diarrhea two days after receiving the ROTARIX vaccine as the first dose in series. The patient returned to the physician's office on 2nd December 2015 for a follow-up visit and test result for hemoccult was positive. No other follow-up treatments were provided. The health care professional called for clinical data regarding bloody stools following administration of ROTARIX vaccine as well as further guidance in the administration of the 2nd dose in series for this patient. No further information was reported regarding the event. The batch number was reported as A4FB548A, which does not exist. However according to the sales data the batch number was changed to A41CB548A.
HA and muscle pain at injection site within  1 hour, joint  pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all  treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30  minutes at 14 hours post dose - no treatment, self-resolved
Swelling and burning at the site of injection. Over 24 hrs. erythematic area worsened - ER visit
Pt rec'd flu vaccines (2011-2012) x 2. Rec'd 1st vaccine 10/13/11 & 2nd vaccine 11/30/11. Pt. did not remember getting 1st vacc & req'd another. No known injury.
Onset of pain, swelling and redness about 24 hours after immunization. Has erythema, urticarial lesion right exterior thigh about 5cm in diameter.
severe side effect unable to walk and can't hold up his own weight since getting the vaccine; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient grandmother).  This case involves a 25-years-old male patient who experienced severe side effect was unable to walk and cannot hold up his own weight (gait inability), while he received RABIES VACCINE.  The patient's medical history included bitten by a pit bull (animal bite) on 10-AUG-2020. The patient's concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received two doses of suspect RABIES VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route in the lower leg and also in the buttocks for post exposure immunization (animal bite).  Vaccine was administered in emergency room.  On an unknown date, the patient experienced a non-serious severe side effect unable to walk and cannot hold up his own weight (gait inability) (Unknown latency) following the administration of RABIES VACCINE.   Laboratory details were not reported.  On the first visit to the hospital, the patient was prescribed Augmentin and Naprosyn upon discharge. The patient was taken back to the emergency room and was then prescribed Ibuprofen 200 mg (tablet) and Robaxin (methocarbamol) 500 mg (tablet) on the second visit to hospital.  The outcome of event gait inability was not reported (unknown).  There will be no information available on lot number for this case.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a currently 9 months and 17 days old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On an unknown date, at the age of 9 months and 17 days, the patient was vaccinated with a dose of PROQUAD (dose and route of administration were not reported) (lot # L032761 and expiration date 04-FEB-2017). It was stated that the patient has not experienced any adverse effects. No product quality complaint was involved. Additional information has been requested.
infection; a tunneling wound the size of a quarter; Initial information received on 17-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional(non-Hcp).  This case involves a 44 years old female patient who experienced infection and a tunneling wound the size of a quarter while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV] and Antibiotic unspecified.  The patient's past medical history included Pneumonia and patient was hospitalized for the event on an unknown date. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (dose and strength; unknown) (lot UJ027AA and expiry date:30-Jun-2019) via intramuscular route in the left deltoid and received a second dose of vaccine (lot UT5899MA and expiry date 30-Jun-2018) via intramuscular route in an unknown administration site (AL) for immunization.  On an unknown date, 3years ago, the patient started taking Antibiotics unspecified (formulation, dose, strength, route, expiry date and lot number: unknown) for unknown indication.  On an unknown date the patient developed a non-serious infection and a tunneling wound the size of a quarter(wound complication),(unknown latency)following the administration of  Influenza Quadrival A-B Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events infection, wound complication.  At time of reporting, the outcome was Unknown for the event infection and wound complication.
suspected vaccination failure/got my 2nd dose and boom have shingles; shingles/got my 2nd dose and boom have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient now have had shingles from the vaccine, got his/her 2nd dose and boom had shingles. Additional supportive information:This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported narrative, the patient now had the shingles therefore partial onset date was captured.
Myalgia, Fatigue, Chills, swollen glands, sore throat & congestion Narrative:
Child developed bilateral eye redness soon after shots were given.  Overnight s/s were sudden onset:  Malaise, difficulty sleeping, dizziness, papular rash on trunk & extremities (non - urticarial), difficulty breathing, vomiting & muscle aches, fever of 102, facial swelling.
Received PREVNAR 13 on 12/8/15. Tuesday evening, ran fever increased to 101.0 F, body aches, small amount of redness at injection site. 12/11/15 morning redness/swelling from shoulder to elbow. Warm, itchy.
sore-throat; runny-nose; ear-ache; loss of apatite; headache; possibly fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore-throat), RHINORRHOEA (runny-nose), EAR PAIN (ear-ache), DECREASED APPETITE (loss of apatite) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore-throat), RHINORRHOEA (runny-nose), EAR PAIN (ear-ache), DECREASED APPETITE (loss of apatite), HEADACHE (headache) and PYREXIA (possibly fever). At the time of the report, OROPHARYNGEAL PAIN (sore-throat), RHINORRHOEA (runny-nose), EAR PAIN (ear-ache), DECREASED APPETITE (loss of apatite), HEADACHE (headache) and PYREXIA (possibly fever) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Patient received COVID-19 vaccine at 330pm. Approximately 15-20 minutes later the patient felt well, was released. At around 4:00pm patient then developed "tongue fullness" and felt flushed. She returned to vaccine clinic. No reported rash, voice changes, wheezing, shortness of breath at the time she presented back to the vaccine clinic. 153-173 sbp, HR 60; Doctor on call advised to give Benadryl 50mg IM and send to the ER for evaluation and monitoring for 4 hours. Benadryl was given to patient at around 4:15pm. Patient was taken to ED around 4:30pm.  Patient requested early discharge from ED as  she stated she " Feels normal now. Requesting DC as she is a nurse and feels better and wants to be with her family."  Per ED note: patient discharged with antihistamines and epipen.