chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
pt recvd vax & surrounding area of inject site red, radiating redness to both legs, then fine red rash covering most of abdo & chest; pt crying not high pitched w/o wheezing & difficulty breathing;
Offender was called back to the clinic and vital signs were taken and were WNL. Offender showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Offender was release back to security.
shoulder was tender after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder was tender after first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced ARTHRALGIA (shoulder was tender after first dose). At the time of the report, ARTHRALGIA (shoulder was tender after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified seizure medication.  No treatment information was provided for first dose.   This case was linked to MOD-2021-356019 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 08-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
High blood pressure lasting 2 days self monitored beginning before I got home from the facility. Starting day 2 vertigo that lasted for 8 days (severe for the first 5). Treated  at home with rest and limited movement, no medication.
Extreme swelling and redness of the arm and soreness at the site.  Induration measures 3 inches by 2 inches.  Pt also has flu like symptoms but no fever.  No nausea or vomiting.
This spontaneous report was received from a male patient of unknown age. The pertinent medical history, drug allergies and reactions were none. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was unknown) 3 times a week for one whole year when he was a child. Concomitant medications were none. On an unknown date, the patient developed blisters on face and in the eye as a result of receiving VARIVAX (Merck) numerous times. The lab tests were none. The patient was recovering from the events. The patient sought medical attention. Additional information has been requested.
Patient with a long standing history of complex partial seizure disorder. Patient was taken to the ER with a concern for seizure onset as witnessed by the nurse observer post vaccination
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
Patient fully vaccinated (Moderna), but not boosted, admitted on 1/23/22 with COVID-19 and associated hypoxia. Patient was discharged on 1/24/22.
Evening of innocculation developed chills, localized pain, nausea, and limited movement of left arm.  Dr. notified.  No further treatment given.
After my daughter received the three shots of GARDASIL vaccine she was left with permanent blurred vision. Before the shot she had just passed an athletic physical with 20/15 vision. After the shots she kept complaining of blurred vision. I called her doctor and the nurse called me back and the only response I received from her was that blurred vision was not a side effect of the vaccine. Now my daughter has to wear contacts and glasses.
reports feeling sick just days after 2nd shot. Right foot and leg kept swelling, SOB on and off. Seeking medical when symptoms were so severe
Twenty hours after second vaccine shot my pulse rate increased 50% increase.  Even while sleeping almost completely the next 36 hours my pulse remained very elevated. Also my blood pressure has been elevated by 15 to 25 points ever since the vaccine.  Which has now been four weeks.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: Patient has Hx of "wooziness/feeling faint" post injections/blood draws. Wife was with patient and me for entire event. Order of events: 1 - Discussed COVID-19 vax history w patient 2 - admin vax in patient's left arm while he was seated 3 - approximately 45 seconds post admin patient became: "green", sweating, overheated, vomiting, syncope. 911 responded. I spoke w/wife approx 45 min later; reports patient fine
Pt given DTAP x 4 up to 18 mos no reaction. Given KINRIX on 9/16/14 left arm deltoid area immediately got warm and red. BENADRYL and compress applied with ice and continued. Pt returned 9/18/14. Still pruritic, erythematous, swollen, not indurated and told to continue present regimen.
Received FLUZONE 0.5 ml dose L deltoid at 2:30 pm on 10/1/08. Began to experience severe body aches with muscle spasms of trunk and back 5 hours post injection. Discomfort was so severe it caused pt to cry. Positive chills, no temperature, positive chest tightness. L deltoid site had positive soreness, no swelling, no redness. Advil - tablet 9 pm. Feeling better in am. Symptoms improved. Advised to notify PCP of event.
Autoimmune disease; Allergic to everything; Sick all of the time/Went from healthy to severely ill; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Extreme fatigue unable to function and work.; Feel like I'm dying; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 2, single (Lot number: Fr2583) for covid-19 immunisation. The patient had no relevant medical history. No covid prior vaccination. Known allergies: Was never allergic to anything until the patient got these vaccinations now the patient allergic to everything. Other medical history: Nothing. Healthy adult until the patient was forced to get these vaccinations. There were no concomitant medications. No other vaccine in four weeks. Other medications in two weeks: No! Nothing. Healthy individual. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Fp7137), for COVID-19 IMMUNIZATION, reaction(s): "Was never allergic to anything until I got these vaccinations now I'm allergic to Everything". The following information was reported: AUTOIMMUNE DISORDER (disability, life threatening), outcome "not recovered", described as "Autoimmune disease"; HYPERSENSITIVITY (disability, life threatening), outcome "not recovered", described as "Allergic to everything"; ILLNESS (disability, life threatening), outcome "not recovered", described as "Sick all of the time/Went from healthy to severely ill"; FATIGUE (disability, life threatening), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability, life threatening), JOB DISSATISFACTION (disability, life threatening), outcome "not recovered" and all described as "Extreme fatigue unable to function and work."; NEAR DEATH EXPERIENCE (disability, medically significant, life threatening), outcome "not recovered", described as "Feel like I'm dying". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid test post vaccination Nasal Swab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (AUTOIMMUNE DISORDER, HYPERSENSITIVITY, ILLNESS, FATIGUE,LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES,JOB DISSATISFACTION,NEAR DEATH EXPERIENCE) and BNT162B2. 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. ,Linked Report(s) : US-PFIZER INC-202300218909 same reporter/patient/drug, different dose/event;
pt recvd vax & hrs post vax exp tingling in lt arm which comes & goes,nausea,dizziness;pt sent to ER for eval;sx are cont;MD states pt is lost to f/u no further info available
This spontaneous report was received from a registered nurse, via field representative and refers to a female patient of unknown age. Medical history of the patient was not reported. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medications were not reported. After receiving the first dosed of GARDASIL, the patient experienced sycophancy (adverse event following immunization) and "seizure like activity" while still in the physician's office. No treatment was given for the events. No laboratory studies were performed. The outcome of the events was reported as recovered. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Nausea, dazed, eyesight weird, tired, stomach ache, stiff,
Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administration of the vaccine.  He stated like he was feeling like he might pass out.  He removed mask, stated he was getting warm, hat removed.  He asked to be lowered to the floor.  Never lost consciousness.  Color pale.  Skin diaphoretic.  BP 137/84 pulse 80, SpO2 96%.  Cold washcloth applied. Rapid response team called.  Vital signs monitored.  Patient assisted to chair for observation.  10:02 am patient recovered and left the facility in stable condition.
TZ developed a low grade fever up to 100.5 Degrees evening of the shot.  Temp. went up to 103 Degrees in 24 hours on 01/20/2005 (48 hours later), at about 5PM he had a brief convulsion.  Then was confirmed by the ER - He was being treated for sinobronchitis w/Amoxil (01/11/2005 - 01/25/2005) - No further treatment.
flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States.  This case involves female patient of an unknown age who experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination concomitant medication 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: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that got her flu shot. She got the flu. Medication details and reason for taking the medicine: not provided.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.  There will be no information available on the batch number for this case.
pt recvd vax & exp abdo pain, weakness, dyspnea & f to 102.7;pt was hypotensive; pt tx w/ apap & epinephrine;taken to hosp due to worsening hepatic renal, & pulmonary func; X ray revealed bilateral pulmonary infiltrates "characteristic ARDS
Pt reports developing a red rash on both of her cheeks 2 days after receiving her first dose of Moderna COVID-19 vaccine. Pt reports taking Benadryl for 3 days absent any results. The rash still persisted. Pt did not see a provider or take any other medications. Pt presented today for her second dose, 28 days later, with some noticeable redness on her cheeks. Pt requested 2nd dose, which I administered after discussing risks and benefits. Advised pt to take some Benadryl and see a PCP in regards. Pt did not report having any swelling of her lips, face, tongue or throat or developing hives.  Pt verbalized understanding.
Body aches; Dose number:3; This is a spontaneous report from a contactable reporter (Consumer or other nonHCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 03Dec2021 at 11:45 (Lot number: EN5318) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FF2589, Route of administration: Unspecified), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN5318, Route of administration: Unspecified), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 11:45, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 05Dec2021 at 01:00, outcome "unknown", described as "Body aches".  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 single dose via intramuscular route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient developed cellulitis due to poor injection technique; dose was administered too low in the bicep on an unspecified date with outcome of unknown. The reporter did not think the adverse event of vaccination site cellulitis was related to PREVNAR 13.
Terrible pain and swelling in armpit of infection site. Progressively worse on second day than first.  Presume it?s lymph node swelling
This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included anxiety, depression and menstrual bleeding that occurred two days prior to this report. Concurrent medications included Prenatal vitamins. On 17 January 2013 at 16:20 the subject received 1st dose of FLULAVAL (.5 ml, unknown, right arm). Her last menstrual period (LMP) was on 07 December 2012 and estimated date of delivery (calculated based on LMP) was on 14 September 2012. The subject was exposed to FLULAVAL during the first trimester. On 17 January 2013 at the time of vaccination with FLULAVAL, the subject experienced vaccine exposure during pregnancy. The pregnancy was ongoing. Follow up received on 8 February 2013 from physician. The physician documented that the conception was normal with no in-vitro fertilization. On 14 January 2013, the subject was evaluated by her OB/GYN due to spotting and cramping and "was being monitored for threatened abortion." The subject reported to the OB/GYN that one day prior to vaccination (16 January 2013), the vaginal bleeding had increased. Per the physician, the gestation at the time of the intramuscular vaccination on 17 January 2013 was 5 weeks and 6 days. On 23 January 2013, an "ultrasound and lab test revealed that she had spontaneously aborted." The gestational age at the time of the event was calculated to be 6 weeks and 6 days. The physician did not consider this case as serious. GSK has determined this case is serious.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
tunnel vision; Shortness of breath; headache; couldn't move arms/legs; This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date, at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tunnel vision, shortness of breath, headache and couldn't move arms/legs all on an unspecified date with outcome of unknown.  The information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tunnel vision, shortness of breath, headache and couldn't move arms/legs due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including eye examination at baseline and during subject drug therapy, Head CT/MRI, chemistry panel and chest x-ray , counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.
Initial information received from a non-healthcare professional on 04 November 2013. A female patient (whose demographics and medical history was not reported) had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date, the patient developed one swollen lymph node. Lab investigation and treatment medications were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none.
Tachycardia (rapid heart rate) - ER Visit and admitted to hospital for observation and testing
Received FLUARIX Quadrivalent. Stated her throat felt a little "itchy" after. Stated she took 2 BENADRYL gel caps and symptoms resolved in 3-5 min.
Extreme fatigue and brain fog beginning around 10:45am On and off high fevers reaching 105.5 beginning around 3pm Inability to stay awake beginning around 4pm Severe migraine beginning around 6pm.  Symptoms still ongoing, although there are longer periods of time between Symptoms.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 29-OCT-2021 contains No New Information.
Patient had shot, left office and started to experience illness (like my body was tearing it apart from the inside) and called this office - she was advised to go to ER - no difficulty breathing. Hospice nurse arrived at her home and advised calling ambulance c/o SOB. Treated with Epi, SOLU-MEDROL and BENADRYL en route to ER.