chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received Pfizer vaccines for Covid on 3/29 and 4/19/2021.  Symptoms started 9/30: chills, fever, fatigue.  Tested PCR + for Covid on 10/3.  Reported as breakthrough Covid case in a fully vaccinated person
Cancer; This is a spontaneous report received from a contactable reporter (Consumer (patient's husband)) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: The reporter mentioned that he was scheduled to receive the bivalent vaccine next Tuesday. Caller states he and his wife were taking Keytruda for cancer. His doctor said because they had received booster doses of the Pfizer COVID-19 Vaccine before and done well this one should not cause a problem as it is similar and a combination of mRNA from the original vaccine. The reporter was asking if he can get this vaccine at the same time as his flu vaccine, and if it is true that this vaccine is a combination of the old vaccine and something new for Omicron.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201169977 same vaccine and event, different patient;
arm heavy feeling & red swollen 2-3 inch diameter @ inj site for 3 days p/vax given;site hot to touch;knot in inj;location still prevalent 3 days p/vax;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot# K005402, expiration date: 07-NOV-2015, dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Onset of severe joint paint in both feet and right knee in September 2022 as well as unexplained weight loss, saw primary care doctor in late October 2022 and have been referred to rheumatologist for evaluation for possible rheumatoid arthritis (long wait to get in, scheduled for January 2023)
Patient explained that she has been vomiting since she received the flu shot.  Vomited a black liquid (said she drank Coca Cola) but also vomited green.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a physician via call. This case involves a patient who experienced high fever, while he/she received vaccine FLUZONE HIGH DOSE. The patients 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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a non-serious high fever (fever) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was high fever. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Patient received his first dose of COVID vaccine on 4/8 and developed GI symptoms ~ 4/16. Patient tested positive for COVID on 4/25 when he presented to the ED. However, he was sent home at that time since he was stable to go home and was not hypoxic. Pt presented to the ED again on 5/4 due to dyspnea on exertion and pain in the back of his knee. Patient was found to be positive for DVT and PE and was started on therapeutic Lovenox. Patient doesn't have a history of VTE, but he does have a family history of VTE. Since patient wasn't found to be hypoxic, COVID treatment wasn't started in the hospital.
Encephalitis syndrome beginning with focal one sided myoclonic jerking with progression to more generalized seizure activity - Relative (cousin) with close contact had subsequent H1N1 - confirmed illness with seizures.  11/23/09 Medical records and discharge summary received for DOS 10/25-11/05. Final DX: Presumed viral encephalitis, seizure disorder.  HA, R facial twitching, feeling limp, febrile, 3 R focal seizures. Secondary generalized seizures. Slurred speech, confusion. PICU. All cultures neg. MRI brain and EEG abnormal. bilateral hypoxic ischemic encephalopathy.  Bilious vomiting. Small bowel dilation, illeus or incomplete obstruction. Lungs scattered crackles. D/C to home.
This spontaneous report was received from a physician and refers to a 50-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 08-MAY-2017, the patient was inadvertently vaccinated with PROQUAD (lot number M037011 with an expiration date of 21-FEB-2018; dose regimen details were not provided) in the left arm for prophylaxis, instead of the intended dose of VARIVAX and M-M-R II. The physician reported that the mistake was due to human error. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Arm immobile due to pain, redness, chills, fever, nausea, vomiting.
11:00am Post vaccination reports dizziness, light headed w/nausea, and feeling anxious; medical monitoring, BP 138/85 P77.  11:20am Reports symptoms have resolved w/no additional symptoms reported; released from facility to self.
Swelled really bad; There's heat, like fever coming out from it; Left arm, hand and fingers are stiff; Left hand, arm and fingers are numb; Left arm, hand and fingers are sting; Like burning sensation; Like tingling sensation; Her pain level could be as high as 10, pain in her hand; It's difficult for her to key on the keyboard; Couldnt close her hand, could hardly hold ink pen; A red area; It's swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelled really bad), VACCINATION SITE WARMTH (There's heat, like fever coming out from it), MUSCULOSKELETAL STIFFNESS (Left arm, hand and fingers are stiff), HYPOAESTHESIA (Left hand, arm and fingers are numb) and PAIN (Left arm, hand and fingers are sting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelled really bad), VACCINATION SITE WARMTH (There's heat, like fever coming out from it), MUSCULOSKELETAL STIFFNESS (Left arm, hand and fingers are stiff), HYPOAESTHESIA (Left hand, arm and fingers are numb), PAIN (Left arm, hand and fingers are sting), BURNING SENSATION (Like burning sensation), PARAESTHESIA (Like tingling sensation), PAIN IN EXTREMITY (Her pain level could be as high as 10, pain in her hand), IMPAIRED WORK ABILITY (It's difficult for her to key on the keyboard), HYPOKINESIA (Couldnt close her hand, could hardly hold ink pen), VACCINATION SITE ERYTHEMA (A red area) and VACCINATION SITE SWELLING (It's swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (Swelled really bad), VACCINATION SITE WARMTH (There's heat, like fever coming out from it), MUSCULOSKELETAL STIFFNESS (Left arm, hand and fingers are stiff), HYPOAESTHESIA (Left hand, arm and fingers are numb), PAIN (Left arm, hand and fingers are sting), BURNING SENSATION (Like burning sensation), PARAESTHESIA (Like tingling sensation), PAIN IN EXTREMITY (Her pain level could be as high as 10, pain in her hand), IMPAIRED WORK ABILITY (It's difficult for her to key on the keyboard), HYPOKINESIA (Couldnt close her hand, could hardly hold ink pen), VACCINATION SITE ERYTHEMA (A red area) and VACCINATION SITE SWELLING (It's swollen) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information included heat and ice on hand.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 77.76.  On 17-Feb-2021, Excursion time was 09 AM, temperature was 22, total doses given for the day was unknown, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Arm began to swell same day of shot, progressed to whole upper arm redness x swelling. Had similar reaction to Prevnar in leg 14 months ago.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cauda equina syndrome" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2023) Positive, notes: Tested positive for Covid on Saturday 07Jan with two tests; (07Jan2023) Positive, notes: Tested positive for Covid on Saturday 07Jan with two tests; (10Jan2023) Positive, notes: Tested positive again today, 10Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient received BNT162B2 OMI BA.4-5 on an unknown date in Sep2022 at 11:00. Patient received paxlovid on 29Dec2022 as treatment for Covid-19. On Friday night, 06Jan, patient began experiencing symptoms of a bad cold, cough, massive congestion. Tested positive for Covid on Saturday 07Jan with two tests. No fever. Tested positive again today, 10Jan, symptoms (cough, congestion) continue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On February 1 at about 6 AM, I spoke to my husband about his doctor's appointment at 9:00 am each day, then at 7:40 AM, after showering, I asked my husband who was fully dressed, "Where are you going?"  He responded, " Did you forget?"  There was momentary brain fog and I didn't remember that he had this 9:00 am appointment-- more questions and difficulty with a quick recall for the answers; I and my husband became more and more concerned.   As the day progressed and I revisited the episode, I consider that it was an aberrant event that I should report.  I am journaling each day in case this or something else occurs.
This  86 year old  black female received the Covid shot on 1/20/21    and went to the ED on 2/20/21     and was admitted  on  2/2/21   with  the diagnoses listed below.  D69.6 - Thrombocytopenia, unspecified J12.82 - Pneumonia due to Coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified
pt recvd vax;had fever for 2 days;area around inject site was red,hard & hot; on 2nd day,devel a pox like rash w/in 2" from injection;rash dec in size on day 3;
Contracted Covid on 4/18/22. On 5/19/22 blood tests confirmed rheumatoid &/or Soriatic arthritis.
The next day I woke up noticed a spot on my back, I had a sore arm and it was swollen and I expected that. I went to urgent care and they diagnosed me with shingles and put me on medication.
Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vaccination.  pt complained of left leg swelling.
Patient presented to Emergency Department complaining of scratchy throat  with cough that began less than 30 minutes following first COVID-19 vaccination.  She has a history of anaphylaxis and states that this feels similar as she always has slow progression.  Patient took 2 Benadryl at home prior to presentation.  Patient has normal exam with clear lungs and no evidence of stridor or angioedema.  Patient received Solu-Medrol 125mg IV, Pepcid 20mg IV, and albuterol neb.
chest heavy, felt like inhaling water through the nose, dry cough, throat ache, weakness, dizzy (sometimes), very fast heart rate, tired, shortness of breathe for one week and still
Kinrix given to a 3mos 28 day old male, no s/s following IZ
Initial report received from health authority (116453) on 11 May 2010: This polymedicated patient with underlying condition of bronchopneumonia was vaccinated with S-OIV FOCETRIA (batch number 0902201) on 09 Nov 2009. The patient also received seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. The patient presented with an increase of respiratory infection on 03 Jan 2010. As corrective measures, the patient was given treatment with CIPROXIN, 500 mg oral from 03 Jan 2010 for 12 days and GLAZIDIM from 06 Apr 2010 for 6 days. Final outcome of the events was reported as not yet recovered.
This initial spontaneous case was received on 05-Jun-2017, from other non-health professional and concerns a female patient of unspecified age. On an unspecified date in 2012, the patient was administered with FLUVIRIN (dosage: 0.5 ml, lot number: 1204201, expiry date, anatomical location: not reported, route of administration: intramuscular). On an unspecified date in 2012, after administration of influenza vaccine, the patient experienced flu symptoms associated with fever and lingering cough for one and half weeks. The patient was treated with TYLENOL for fever. At the time of this report, outcome of the event influenza like illness was recovered. The reporter did not provide the causality between event and in influenza vaccine. The reporter did not provide the causality between event and influenza vaccine. The report was not serious.
2 days post-injection of FLUZONE High Dose vaccine, I developed severe weakness, muscle and joint pain, headache, high fever, chills, complete loss of appetite, dark urine, sleepiness, and lethargy. Although some of the symptoms have alleviated spontaneously, after nearly a week they still persist in a lesser form. None of these symptoms developed with previous flu vaccinations in recent years.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.48.  Concomitant products were not provided.  On 03-Apr-2021, excursion time was 9 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Vaccine was administered 1 hour past expiration time. (Vial had been out of fridge/punctured for 7 hours).
Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoids (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and HBV. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systemic analysis of the VICP's anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. An adult female patient (age not reported) with a medical history of kidney stones, endometriosis, asthma, gastritis, migraines, urinary tract infections (UTI's), and allergies to cephazolin, sulfa drugs and allopurinol, received an injection (route and site not reported) of DIPHTHERIA AND TETANUS TOXOIDS, lot number and manufacturer not reported, on an unknown date. On an unknown date within seconds after receiving the vaccine, the patient developed anaphylaxis with symptoms of dizziness, nausea, erythematous rash over arms/chest, diaphoresis, wheezing, diffuse erythema, and respiratory distress. The patient was treated with epinephrine, diphenhydramine, and methylprednisolone. The outcome was reported chronic anxiety, arthritis, and dizziness (not recovered). The reporter in this case is the same as cases: 2011-03324, 2011-03327, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
about 1 minute after receiving vaccine patient fainted for about 30 seconds. I touched her hand and she came to. Her husband came in to be with her and we gave bottled water. She sat in chair about 15 minutes and went home with her husband
This spontaneous report was received from a physician via company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with ROTATEQ (lot number and expiry date unknown) oral suspension (dosing regimen and frequency unknown). No concomitant therapy was reported. On an unknown date, 3 to 5 days after vaccination, the patient was taken to the emergency department for unspecified symptoms (adverse event). On an unknown date the patient tested positive for rotavirus while in emergency department (Rotavirus infection). It was unknown whether or not the patient was admitted to the hospital or if the patient was treated and released from the emergency department. The patient had sought medical attention (details unspecified). The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. The reporter did not provide the causality between the events and the therapy with ROTATEQ. There was no product quality issue reported. Additional information has been requested.