chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started feeling very unwell. My heart rate was high. These heart symptoms started to ramp up over a period of a week or two starting 11/25/21. My chest was tight and there was a strong discomfort in the breast bone area. I would wake up in the morning to my heart pounding. I was also having heart palpitations. headache. Fatigue. Metallic/sickly taste in my mouth. December 8 I went to the ER because I was feeling so unwell. When I got there my HR was high 100-120 when my heart rate is usually 60-70. My bp was also high.
This spontaneous report was received from a 23 year old female patient (also a pharmacy intern) concerning on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified dates, the patient was vaccinated with M-M-R II injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. The patient's concomitant medications included NUVARING. In May 2017, the pharmacy intern "failed a titer" for Measles, Mumps and Rubella (MMR). On 10-MAY-2017, the pharmacy intern received a dose of M-M-R II injection, lot # M045390, expiration date: 14-NOV-2018 (strength and dose were not reported) for prophylaxis. It was also reported that the patient had a "2 step TB test" performed. The first step was performed on "last Monday" and the second step was performed on 25-JUL-2017 ant it would be read on Friday on an unknown date. At the time of the report, the outcome of the event was unknown. The causality assessment between the event and the M-M-R II was not reported.
Redness, heat and mild swelling to left upper arm at injection site. Denies pain.
Injection site pain, fatigue, headache, chills, nausea, upset stomach, feeling unwell, inability to eat  Took 2 Tylenol
Initial information received on 21-Jan-2019 regarding an unsolicited valid serious case received from a Health Care Professional. This case involves a 55 years old female patient who experienced the patient tested positive for influenza A and there was a significant disruption of normal activity, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot LVJ005AF via intramuscular route in the left arm. On 11-Jan-2019, The patient developed a serious cough and sore throat 2 months 27 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On 12-Jan-2019, the patient developed a serious lethargy, fever of 103F, chills and rigor 2 months 28 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious anorexia, dehydration, laryngitis and nausea (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious the patient tested positive for influenza A (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On an unknown date, the patient developed a serious there was a significant disruption of normal activity (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. This was the case of lack of efficacy. The patient reported that she was bedridden for one week. Other relevant tests included the patient tested positive for influenza A on 14-Jan-2019. Final diagnosis was there was a significant disruption of normal activity and the patient tested positive for influenza A. The patient was treated with TAMIFLU for five days and was prescribed fluids. The patient was recovering at the time of report. List of document held: none. Sender's Comments: This case concerns an adult patient who presented with Influenza A infection after and despite vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, smoking history, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
14 minutes after receiving vaccine, patient was sitting in chair and had a syncopal episode.  Unresponsive for 10-15 seconds.  BP 92/50, pulse 66.  Transported to hospital.  Diagnosed with vasovagal reaction and sent home.
diagnosed with CAD and severe aortic insufficiency.  She was admitted and taken to the operating room on October 14, 2021 at which time she underwent CABG x1 with the LIMA to the LAD and AVR with a 19 mm bioprosthetic valve.  The intraoperative post procedure TEE demonstrated satisfactory bioprosthetic valve function. Hospital admission within 6 weeks of receiving the COVID vaccine.
The morning after dose 3, I woke up with a frontal headache and a very sore left arm at injection site.  Within a week, the headache had gotten worse and the arm was not better.  By the end of week 3, I went to a doctor. This past weekend, I had heart palpitations and went to the emergency room.
Congestion, fatigue, overall tiredness, feeling worse  five days after receiving the COVID 19 J&J vaccine.
Arm red, swollen, warm to touch, pain elbow to shoulder; had vax in the past; 1FEB93 no addtl event information recvd;
24 hours after second dose of VARIVAX vaccine (first dose on 1/27/97) developed swollen red arm at injection site, fevers, and severe myalgia. Also developed swollen lymph glands in neck. Symptoms abated after four days. Also had blurry vision in one eye, nl ophthalmology exam, resolved.
Chest tightness, sharp pain in back, headache, eye drainage, swollen throat.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 10:00 as dose 4 (booster), single (Lot number: gh9694), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2022) Positive; (05Dec2022) Negative; (06Dec2022) Negative; (08Dec2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient didn't received other medication in 2 weeks. Tested positive Covid on 29Nov, started paxlovid on 29Nov completed on 03Dec, tested neg on Mon/ Tues 05Dec, 06Dec. On 08Dec morning woke up with symptoms sore throat/ cough/ running nose, tested positive COVID since 08Dec - rebound covid. On 12dec2022 product quality group providing investigation results were reported.  Investigational details: This is a daily notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process. Refer to the below table for details.Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Fever, lethargy, shortness of breath, chest pain, neck pain, swollen lymph nodes
Pt had flu shot 24OCT91 @ 230PM & 6PM could not move-called ambulance & went to ER;
Weakness, heart pounding, loss of feeling in both arms, chills,  shaking, fatigue .
A few minutes after the injection patient developed left eye itching and throat scratchiness (approximately 0905). Vitals at 0913: 104/74 BP, 74 HR, 98.3 temp, 100 % oxygen saturation. Gave 50 mg oral Benadryl at 0916. Vitals at 0918: 100 % oxygen saturation, 111 HR, 133/71 BP, chest heaviness noted at this time. Vitals as of 0923: 114 HR, 100 % oxygen saturation, 122/83 BP. Patient transported to Emergency Room.
Numbness and tingling left shoulder, radiating to left shoulder blade, down left arm to fingertips, and to left side of face.  Is currently present and progressively getting worse.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Registered nurse reported that on unknown dates, unspecified patients had been administered RECOMBIVAX HB (strength, dose and lot numbers were not reported) outside of the prescribing recommendations. Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA005428 via same reporter link. Additional information has been requested.
Medication error occurred during COVID vaccination administration. Incident happened during shift change. Multiple distractions occurred during vaccine preparation including a patient emergency during shift change resulting in human error. Incorrect medication dose given to the patient (0.5mL instead of 0.3mL of Pfizer vaccine). Persons was monitored for 20 minutes post vaccine admin. and denied complaints. VSS. No apparent distress. FA aware. MD aware.
TOOK ONLY ONE DOSE/ DID NOT COMPLETE VIVOTIF COURSE ONE-WEEK PRIOR TRAVEL; This spontaneous case (PVX2019-884) was received from a pharmacist on 15-Apr-2019. It describes a 59-year-old adult male consumer who "took only one dose/ did not complete Vivotif course one-week prior travel". The consumer was receiving Vivotif for international travel.  Case report: The consumer took first dose of Vivotif on 11-Apr-2019 after that did not take any more doses. The consumer had a planned trip on 22-Apr-2019 to travel internationally to another country.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was unknown.  Company's Comment: The causality of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose/ did not complete Vivotif course one-week prior travel" was considered as not applicable.
Information has been received from a grandmother concerning her 11 year old granddaughter who in July 2008, was vaccinated with GARDASIL. Concomitant therapy included "other vaccines" (unspecified). In July 2008 the patient experienced injection site pain, redness at injection site and swelling at injection site. Subsequently, "2 weeks after the vaccine was received," the patient recovered from injection site pain, redness at injection site and swelling at injection site. Additional information has been requested.
A 17-year old minor came to receive his 2nd Moderna vaccine on 5/17/2021. While validating patient's information & demographics with the mom, we came to realize we were provided with the wrong DOB, by the father, when administering the 1st dose, making him 2 years older, & eventually eligible to receive MODERNA.
administered Tdap intradermally in the forearm and the patient was having a reaction; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves Elderly and unknown gender patient who was administered diphtheria, tetanus and acellular pertussis vaccine intradermally in the forearm and the patient was having a reaction.  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 diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (lot number, strength, expiry date, dosage, formulation- not reported) via intradermal route in the forearm NOS (not otherwise specified) for Prophylactic vaccination (Immunisation). Information on the batch number was requested  On an unknown date the patient was administered tdap intradermally in the forearm and the patient is having a reaction (immunisation reaction) (unknown latency) following the administration of diphtheria, tetanus and acellular pertussis vaccine  Reportedly, medical assistant administered Tdap to an elderly patient intradermally in the forearm and the patient is having a reaction. "Is there anything to be advised of?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event
Information has been received from a nurse concerning a patient with unknown history of shingles prior to receiving ZOSTAVAX (Merck) who was vaccinated with a dose of ZOSTAVAX (Merck) (lot# was not available). The patient developed shingles "2 weeks after receiving the vaccine". Follow up information was received from a Licensed Practical Nurse (L.P.N.) concerning the 75 year old female patient with histories of breast cancer and chickenpox when she was less than 7 year old of age as well as no drug allergies who on 02-APR-2009 (at 11:00 am) was vaccinated subcutaneously in the right arm with the first dose of ZOSTAVAX (Merck) (lot number 662998/1620X). Concomitant therapy included chondroitin sulfate sodium (+) glucosamine sulfate, calcium, multivitamins, ENAPRIL, calcium ascorbate, B12, atenolol, aspirin and alendronate sodium (MSD). The patient did not experience a rash post vaccination. The patient had gallbladder removed on 12-JAN-2009 and rehospitalized on 25-JAN-2009 with complications. The patient stated that she was still recovering at the time of injection. On 09-APR-2009 the patient noticed itchy vesicle at the base of right neck. The area was itchy all day. It works upon on 10-APR-2009 with 4 grouped vesicles and more pruritus. There was no pain or aching. The patient felt fatigue and pruritus. There was vesicles never blister. The patient was seen in physician's office on 11-APR-2009. Tzanck test was done on 11-APR-2009 and the result was positive for zoster. HZV culture was done on 11-APR-2009. Final report on 12-APR-2009 indicated that no varicella-zoster virus was detected. The patient was given VALTREX, 1 g, three times a day for 7 days. The patient didn't keep 10 day follow up appointment. She stated she felt fine. As of 04-MAY-2009, the patient stated that vesicles still visible but fading. It was reported that the patient was not recently exposed to chicken pox or shingles. No further information is available.
Pre-syncope - BP 94/59 recovered after 10 min of laying down.
I had sores they came across my throat; Rashes are becoming sore/ rashes moving up to the chin; Developed rashes; Patient developed a blister on the neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (I had sores they came across my throat), BLISTER (Patient developed a blister on the neck), RASH (Rashes are becoming sore/ rashes moving up to the chin) and RASH (Developed rashes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Patient developed a blister on the neck). On 15-Apr-2021, the patient experienced RASH (Developed rashes). On 22-Jun-2021, the patient experienced RASH (Rashes are becoming sore/ rashes moving up to the chin). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (I had sores they came across my throat). The patient was treated with CORTISONE for Rash, at a dose of 1 dosage form and HYDROCORTISONE for Rash, at a dose of 1 dosage form. On 15-Apr-2021, BLISTER (Patient developed a blister on the neck) had resolved. At the time of the report, OROPHARYNGEAL PAIN (I had sores they came across my throat), RASH (Rashes are becoming sore/ rashes moving up to the chin) and RASH (Developed rashes) outcome was unknown.            No information on concomitant medication was provided.  Treatment medication also included moisturizer and other lotions.  Action taken with mRNA-1273 in response to the event was not applicable.         Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Patient information added, events updated, event outcome updated, treatment medication added.
Patient received J&J vaccine and at the time was 16 years old.  Vaccine is approved for 18 and older.
Pt states that after receiving 3rd Anthrax shot, some where about mid April, 1999; he started having rotator pain and about the beginning of June, 1999, he started experiencing pain in the right big toe's joint. Pt states that sometime in December, 1999, he started experiencing back pain. Pt states that around the same time, he started noting joint pain in his right elbow and arm. Pt, also, states that he constantly feels fatigue. Pt states that currently, he is experiencing cramping in both hands, as well as, all previously stated signs and symptoms.
Hospitalized 11/19/21 - 12/2/21, signs and symptoms abd. pain severe nausea, and diarrhea
temp elevation 102 on 18OCT94 active & alert, anorexia mild coryza, no sz or emesis viral vs reac to DTP acel;
Muscle Pain (since day 2) Joint pain (since day 3 - particularly in wrist, hands and shoulders) Weakness in upper arms (since day 4) Moderate and sometimes severe nausea  (since day 2) Tight muscles all over (since day 4)
herpes zoster eye disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at Senior Center for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for herpes zoster eye disease. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review, the event of herpes zoster eye disease was considered to be medically significant.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1687292; expirationdate: 25-AUG-2022; 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-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Fever 101, muscle joint aches, chills, nausea lasted 5 days.
Patient complained of a red, itchy, warm lump at the site of injection after receiving Zostavax vaccine.  Patient described lump as hard and localized at site of injection.  Self-treated with hydrocortisone cream.  By the time patient re-presented at pharmacy a week after vaccine administration, the symptoms have mostly resolved.
Second dose Moderna covid vaccine 3/11/2021. had exposure to tested positive person and developed symptoms on 8/5/2021 of weakness, chills, fatigue, cough. Received monoclonal aby on 8/6/21
patient developed mild symptoms  on 7/14/21 and tested positive for covid on 7/15/21
Pt seen 2/5/13 by me, having been to ER previous night, dx with viral infx in ER. In office T 102.1, very uncomfortable with neck tilted to (L), multiple enlarged tender (L) post ax LN, sl enlg (R) post ax LN. Normal neck flexion, but child irritable. Diffuse somewhat lacy M-Prash sib had had a sore throat. Patient did not have red throat but (+) throat culture.
Papulomacular erythematous rash to back, chest and face. No blisters.
Flu vaccine administered on 10/10/07 about 5:00 PM. 1st noticed swelling on 10/12/07. Had pain beginning evening of vaccine. Has had facial flushing off and on since administration.