chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12MAY woke up 6AM w/severe nausea, stomach cramping, dizzy, weak & chills (no fever noted), body aches these sx seemed to inc & dec in intensity throughout the day 12MAY; feeling better by late PM did not see MD as was advised;
A 17 month old patient was administered Quadracel/no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00636504) and transmitted to Sanofi on 10-Jun-2021.  This case involves a 17 months old female patient who received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA, expiry date: 26-Aug-2022, (fourth dose DTAP, fourth Ipol)) via intramuscular route in the left thigh for prophylactic vaccination on 09-Jun-2021 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  Medical assistance (MA) reported a 17 month old who was behind on vaccine schedule and was administered Quadracel. She asked for an appropriate follow-up.  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 by the regulatory authority. 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.
Post vaccination felt weak and fatigued, slept all day on 8/30 then developed palpitations, came to emergency room in evening and ER MD admitted as observation patient to hospital just after midnight, patient had stress test done 8/31 and cardiac event ruled out, patient was sent home. ER MD notes and admitting physician notes did not think event was cardiac related rather viral syndrome vs vaccine reaction
Information was received from a consumer regarding concerning his 27 year-old wife, who on 13-JUN-2013 was vaccinated with GARDASIL (dosage, route and site of administration not provided). The patient received the vaccine while pregnant. Initial exposure to GARDASIL was at 29 weeks (calculated LMP of 22-NOV-2012 and EDD of 29-AUG-2013 based on gestational age provided of 29 weeks). The patient's husband reported that the 27 year-old female was accidentally administered GARDASIL, but did not mention what vaccine the patient was supposed to receive. The pregnancy outcome is pending. Additional information has been requested.
devel ITP on 31OCT95;had viral synd mid-late september (gastorenteritis)
Patient had a slight cold - just a runny nose at the time of the vaccines. His pediatrician said it would be ok to give some vaccines since he didn't have a fever at the time and just a minor cold. About 7 hours after the vaccines, he had a slight fever of 100. I gave him the weight appropriate amount of ibuprofen. He had no appetite. Later that night, around 12 AM, he became very restless in his sleep, almost as if he couldn't control his body like it was spasming. Moving his legs and pushing and moving and pushing. He was whining quite a bit and asked to go to the bathroom. He couldn't stand on his own and his whole body was shaking. Sitting him on the toilet, his entire body still uncontrollably shaking. He began crying and was inconsolable. He said he was really scared and began saying things that made no sense.... "the babysitter is coming! the monster is in the cage! you are going to leave!!" He couldn't stop shaking. He said he wanted to go to the hospital. We decided to take him to the ER. In the car, still uncontrollable shaking/spasming and crying. He started to calm down on the way to the hospital - at this point it had probably been about an hour of the shaking and crying. In the waiting room, he stopped shaking and crying. The ER doctor saw him and monitored him. His fever was higher at 101.8 now. He was given some more ibuprofen in the hospital. Fever came down. He was coherent again. We went home and he slept for 5 more hours soundly.
Face and neck swelling going down into her shoulder; Face and neck swelling going down into her shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Caller states after first injection she had lymph node swelling under the arm she received the injection), for COVID-19 Immunization, reaction(s): "lymph node swelling". The following information was reported: SWELLING FACE (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "Face and neck swelling going down into her shoulder".  Additional information: The patient stated these symptoms have lasted for 3 months.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT PASSED OUT, AND WOULD NOT COME TO WHEN NAME WAS CALLED OR WHEN HE WAS SHAKEN.  CALLED 911, ADMINISTERED EPIPEN, AND PREPARED TO PERFORM CPR (DID NOT NEED TO AS THE PATIENT CAME TO WITH THE EPIPEN)
pt brought to hosp by EMS after pt fell at home and was unresponsive; family initiated CPR; EMS found pt in PEA arrest; treated and ROSC obtained; intubated; to ED; positive for COVID; given steroids; positive for cocaine; metabolic acidosis; suspected NSTEMI versus alternative arrhythmia; CT brain scan showed possible encephalomalacia; stroke work up; pt experienced multiple cardiac arrests with PEA; ACLS; reintubated; ROSC achieved; pt had another PEA arrest and passed away in the hospital
Headache, Myalgia & Fever Narrative:  Employee stated after receiving vaccine develop, headache, chills, fever, night sweats, lymph node swollen under right arm.
I had sore throat, coughing, difficulty breath, fever, body ache, fatigue, and loss of taste. These lasted for about a week and a half. On Feb 4th, I tested positive for COVID-19.
Patient received Pfizer COVID-19 vaccination on 4/16/2021 and the 2nd dose on 5/14/2021. He had his 1st gout attack 06/15/2021.
Patient developed a large red welt that was warm to the touch and caused swelling at the site of injection. It is over 2 weeks later and the swelling has gone down but there is a unraised red rash that still remains.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who developed some difficulty with his immune response and lymphadenopathy, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, 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 lot number not reported via intramuscular route. On an unknown date, the patient developed a non-serious the patient develops some difficulty with his immune response following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious lymphadenopathy following the administration of INFLUENZA QUADRIVAL A-B VACCINE. In the past the patient has taken the FLUZONE INTRADERMAL as the alternative to the Quadrivalent IM, but it not available this year. No lab data reported. Final diagnosis was lymphadenopathy and the patient develops some difficulty with his immune response. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the patient develops some difficulty with his immune response and as Unknown for lymphadenopathy.
Arm pain; This is a spontaneous report from a contactable pharmacist through a Pfizer-sponsored Program.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on 20Oct2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm pain on an unspecified date. The patient was still complaining of arm pain. The outcome of not recovered.  No follow-up attempts are needed. Information about batch/Lot number cannot be obtained. No further information is expected
ACCIDENT; HIGH FEVER 104; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced accident, and high fever 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from accident, and high fever 104. This report was non-serious.; Sender's Comments: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that Department of Health recommends being revaccinated at their earliest convenience.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4410179-00. A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, (booster) single (Batch/Lot number: unknown) at the age of 60 years intramuscular, as dose 2, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BENIGN NEOPLASM OF THYROID GLAND (medically significant), outcome "recovered", described as "had 50 percent of thyroid removed it was benign"; FATIGUE (medically significant), outcome "recovered"; PAIN (medically significant), outcome "recovered", described as "body soreness". The action taken for adalimumab was unknown. Clinical Information: It was unknown if patient was enrolled in a Covid-19 vaccine trial. Causality assessment for the events fatigue and body soreness by vaccine BNT162B2 was reported to be possible. Regulatory Authority opinion is the event of THYROID BENIGN is not assessable. Regulatory Authority's opinion is that there is no reasonable possibility that the events of VACCINE CAUSED FATIGUE and VACCINE CAUSED BODY SORENESS are related to HUMIRA (ADALIMUMAB). The reporter's assessment of the causal relationship of "had 50 percent of thyroid removed it was benign", "fatigue" and "body soreness" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events Benign neoplasm of thyroid gland, Fatigue, General body pain and the suspect drug BNT162B2 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.
On 12/26/2022, patient presented to the emergency department with chest pain and back pain. Patient had an EKG done and it showed an acute anterior wall myocardial infarction; She was also found to be COVID positive via NAA test. Patient had an urgent CT angiography which ruled out dissection of the thoracic or ascending aorta; She had emergent coronary angiography performed. Patient was diagnosed with myocardial infarction, hypertension, dyslipidemia, diabetes mellitus, remote stroke with contracture of upper left extremity, peripheral vascular disease, renal insufficiency, and acute COVID pneumonitis. She was admitted to the hospital for further treatment. Patient died on 12/31/2022 while an inpatient at the hospital.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Right arm became very sore in area of shot and there is a red band around the arm.  Soreness area grew to encompass entire upper arm.  Left arm became very sore in area of shot.    I became very lethargic the day of the shots and throughout the following day.  I did not sleep very well the first night after receiving the shots.  I may have had a low grade fever.  Left arm soreness is somewhat going away but the righ arm soreness is still a problem; area grew and the red band developed.
Had influenza vaccine between 3pm & 4pm. By 8pm had throat swelling & difficulty swallowing, tongue itching, raspy voice and chest tightness. Seen in ED, epinephrine given SC, SOLUMEDROL & PEPCID given IV. Sent home with Rx BENADRYL, PEPCID & MEDROL DOSE PAK. 10/28/09:  Emergency Department Records received for Date of Service 9/30/09. Dx:  Allergic reaction-drug, Hypokalemia.   Assessment:  Presented a few hours after getting a flu shot with itchy, scratchy tongue and throat with difficulty swallowing as well as tightness around the chest and abdomen "like a band," moderate in intensity.  Experienced change in voice, denied swelling of the tongue or mouth.  Increased anxiety noted.  Medicated with benadryl, Pepcid, Medrol Dose Pak and Micro K 20 mEq.    ICD Codes:  995.3, 995.27, 276.8, E949.6, E849.9, 905.1.
FEVER 100.7 LOCAL REACTION AND SCREAMING EPISODE LASTING MORE THAN 4 HRS AFTER RECEIVING IMMUNIZATION.
administering the patient to use a prefilled 0.9% saline syringe instead of 0.4% saline; 54 year old patient recive ActHIB; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 year old male patient who received Booster dose of HIB (PRP/T) VACCINE Box lot Lot # Box Act HIB UI914AAA exp 11/14/2019 (Vial- Lot # UI914AA exp 11/28/2019) 0.9% prefilled syringe via intramuscular route in the left deltoid on 16-Aug-2019.  The patient's medical history included allergic to latex,   Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was a case of actual medication error due to inappropriate reconstitution technique and Inappropriate age at vaccine administration. (It was reported that nurse administering the patient to use a prefilled 0.9% saline syringe instead of the diluent provided. After the patient got the dose she realized that it should have been 0.4% saline)  It was unknown whether any adverse event occurred.  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.  Documents held by sender: none.
Patient received SP vac in conjunction with activation.  Within one month of receiving the vac he suffered an Acute Myocardial Infarction.  He was also undergoing some strenuous training that month.
Patient reported that hours after the injection, she began to experience muscle and joint pain near her deltoid, injection site redness and swelling with an accompanied reduction in range of motion (about 25%). I advised the patient to take TYLENOL to help with pain, and apply a cold compress for 15 minutes several times throughout the day. After calling patient later this evening, patient has already reported improvement. Additionally, I offered to contact her primary care physician (closed the day of this report) Monday 3/11/2019 to discuss the reaction. I advised the patient that her reactions were common side effects listed by the drug manufacturer, but to continue to observe her adverse reactions and report any changes to myself and her doctor. I will follow up with the patient frequently until resolution of symptoms.
On the 23rd of September I experienced 2 non-consecutive head spinning bouts that lasted for about 10 minutes or so. Shortly after, a ringing sound started to develop in my right ear and has persisted since the 23rd of September to the current day.  The symptoms appear to be parallel to what is experienced with tinnitus - phantom sounds vary from a whooshing, to a high pitched ringing. There has been no break since the onset of the ringing on the 23rd of September.
had shot about 2PM; had APAP prior to shot ; started constant crying episode about 6PM & lasted until 11PM; fell asleep & slept all noc; during that time wouldn't nurse & was unconsoleable;
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling.   Within 5-10 minutes she developed a rash on hands, face, neck and chest.   She notified the staff, who provided ice packs for the swelling and placed her in front of a fan.   She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems.   She began developing a mild headache.   She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses.   She took Tylenol for headache.   The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
Patient states she expieranced stomach pain and headache the morning after she recieved her flu shot.
severe local rxn, tender, warm, red, indurated, then turned black & blue 10cm area;
Only symptoms are fatigue for that last 2 days; patient got Covid-19 test- it showed positive; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive) and FATIGUE (Only symptoms are fatigue for that last 2 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELATONIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive). On an unknown date, the patient experienced FATIGUE (Only symptoms are fatigue for that last 2 days). At the time of the report, SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive) had not resolved and FATIGUE (Only symptoms are fatigue for that last 2 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: (Positive) On 22Jan2021patient got Covid-19 test- it showed positive on 24Jan2021. On 25-Jan-2021, SARS-CoV-2 test: (Negative) On Monday 25JAN2021 she was re tested and it came back negative on the 26JAN2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
Patient received vaccine on 10/17/2022 and mother observed that his arm turned red, swelled up, and was itchy.  Patient's mother was informed that this is a normal reaction to flu vaccine and that it will go away in a few days.  She was also consulted to ice the site as well as give some acetaminophen and ibuprofen to help with swelling and pain and to seek medical attention if the redness spread.
Pt experienced throat tightness, site swelling up to baseball size; red inflamed tenderness. Swelling today, 05/12/16 8 cm wide X 5 cm high.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old male patient, who had a rash while on previous therapy with amoxicillin and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with a third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported) on 23-JAN-2014 at 3:40 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents notified to re-vaccinate and declined to re-vaccinate. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Patient was given only one component of the vaccine which was diluted with a sterile diluent.  Patient did not experience any adverse effects.
Pt received flu and pneumonia on 10/26/05. Four hours later that night clients arm was very sore/painful- was pink and swollen 1/2 way down to elbow - difficult to left arm, chills next day symptoms slowly resolving - pain continued in arm especially with lifting arm.
few hrs p/shot pt started to cry louder higher pitched-very irritable all noc-very excitiable-no fever; cried as in pain-no normal cry- called MD told to watch;