chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017), the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, on 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, on 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005086: US-009507513-1802USA005085: US-009507513-1802USA005087: US-009507513-1802USA005089: US-009507513-1802USA005090.
10/12/04 Hard knot and discomfort niticed; unable to slee due to discomfort. Knot on arm went down at injection site but developed rash on arms about 1 week later. 10/22/04 No swelling but red rash, warm to touch from shoulder to elbow noted. To PMD today.
I have tympanic temperature  btw 100.3-100.6 F while at work. I was having body achy, headache and feeling chilli. I took Tylenol 750 mg.
I was told that Patient lived in area and worked in area.  She died only days after her 2nd vaccine given on April 16th, 2021.  Word is spreading that that is how she died.  I don't know if this was previously reported but I am trying to make sure that it was reported by reporting this myself even though I do not have all of the information
patient is symptomatic for 1 week with a positive covid test today 4/14/2021
Patient reports sudden onset blurry vision in distance with a headache in back of head.  Describes  dizziness upon standing.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of VAQTA (lot L013380, expiration date 04-NOV-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse effects; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of an unknown gender and age.  No information regarding drug reactions, allergies or medical history was reported.   On 16-JUL-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #R023500, expiration date: 13-FEB-2020, therapy type: rha) (dose and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion of -12.7 degrees Celsius; time frame was 58 minutes. There was no previous temperature excursion. Concomitant therapies included sterile diluent. The sterile diluent was properly stored. There was no adverse effect reported. The call was made because of a digital data logger.  This is 1 of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000927:
that night I kept waking up because of intense muscle/joint pain in my legs. I also felt hot and cold, almost feverish. I did not take my temperature. That next morning I woke up and took a hot bath, which helped with the pain. I continued to have pain throughout the day, as well as fatigue. The second day after the shot the pain was gone, but I noticed I had a rash around the injection site, about 2 inches wide by 3 inches long.
First Pfizer vaccine administered 8/25/21, Developed substernal chest pressure 8/26/21-8/27/21, presented to Hospital on 8/28/21 AM
About an hour after the vaccine I started getting a headache.  Appr. 3 hours later, had a constant tickle in my throat causing me to cough excessively, so that I was hoarse within an hour.  Woke up during the night from a fever. (I did not get up and take my temp) Woke up in the morning with a HUGE headache, eyes watering, a slight fever. Had a headache throughout the day on Oct. 9th. On Oct. 10, felt better, very slight headache remained, and small sore throat.
Went to sleep normally, woke with right side pain, tingling, weakness Pain on back and have been developing cysts/boils on back and shoulder  Tests have diagnosed rt side heterogeneous mass
On January 21, 2021, approximately 9 days after I received first vaccine I began seeing eye floaters. I went to eye doctor the same day and the doc thought retina looked good. The eye doc sent me home. On February 25 the I received second Moderna vaccine shot. Two days later, February 27th, I began having difficulty with my vision. On that same day I went to the eye doctor who indicated I had a spontaneous detached retina. Emergency eye surgery was performed on the following Monday, March 1st. Doctors do not know what caused my detached retina (right eye).
Sudden onset of OCD and anxiety symptoms. Onset occurred within 3 days of vaccine and included excessive worry, checking and obsessive thoughts.  Child went from no anxiety at all, to sudden persistent anxiety and OCD symptoms daily
This patient received the Pfizer COVID-19 vaccine on 05/20/21,  On 05/28/21 pt brought her child in for catch-up vaccines and reported this "adverse reaction".  She stated that upon waking on the morning after she received the vaccine, 05/21/21, the fingers on her right hand, excluding her little finger and thumb, were swollen and "stuck in place".  Pt described what sounds like "trigger finger".  She took Ibuprofen and Tylenol during the day and was back to normal the next morning.  Subsequently, patient stated that on the morning of her child's vaccines, 05/28/21, she experienced this issue again on only one finger.  I observed no edema and the patient appeared to move all digits on both hands without difficulty.
Headache for the day of the vaccine; This is a spontaneous report from a Pfizer sponsored Immediate via a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced headache for the day of the vaccine with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports he started experiencing ringing in his ears within 4-5 hours after his first dose of the Moderna COVID19 vaccine. He was seen by Medical Center for evaluation but no significant findings were reported. Patient did experience mild tinnitus prior to receiving his first dose of the COVID19 vaccine.
Chills; Body aches; temperature of up to 102.5; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age 78-year-old via an unspecified route of administration in the right arm on 05Feb2021 03:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient did not have covid prior to vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN); simvastatin; amlodipine; carvedilol and colecalciferol (Vit D); all indication, start and stop date were not reported. The patient did not receive other vaccine in the past four weeks. On Feb2021, the patient experienced chills, body aches and temperature of up to 102.5. The patient reported that she has experienced after receiving the vaccine. She mentioned that she did not have a reaction to the first vaccine until 2 weeks later (Feb2021) she developed a temperature of up to 102.5 and had the chills and body aches. This lasted about 36 hours and she did have a Rapid Covid19 test which came back negative. The patient has not been COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient presented to emergency room on 9/4/2021 with generalized body aches and loss of consciousness. He was found to be COVID-19 positive on 9/3/2021. Patient's symptom were mild at that time and was discharged home with instructions for further management. Patient presented to emergency room again on 9/7/2021 with chest pain and shortness of breath. He was immediately placed on high-flow nasal cannula and admitted for further management. He was treated with dexamethasone and baricitinib and was transferred to the ICU on 9/8/2021. Patient's condition continued to deteriorate and he was intubated on 9/24/2021. Patient's condition was further complicated with bacterial infection, septic shock, acute renal failure requiring CRRT, acute toxic metabolic encephalopathy, and GI bleeding. Patient went into PEA arrest on 10/18/2021 and was unable to be resuscitated. Patient expired on 10/18/2021.
On 24Oct2018, a report was received from a Study. Patient is a 52 year old male with history of allergy to penicillin and pork who was vaccinated with ACAM2000 (LotVV03-013-C) on 06OCT2018 at 16:35 hr. No concomitant medications were reported. On 24OCT2018, the subject presented to the clinic with an secondary scab (autoinoculation) near his original vaccination site, and was similar in size. The secondary scab started on 17OCT2018 and on 24OCT2018 both sites were in a scabbing stage. The subject stated that the bandage had caused tearing to his skin. It was noted that the subject had two scabs present and was counseled on vaccination site care by the health care provider at the clinic, in addition to being supplied a site care kit. The Principal Investigator considers this as a case of autoinoculation. The case was reported as amild and not serious adverse event that was related to the administration of ACAM2000. Company Medical Assessment: The Company agrees with the Investigator's assessment. For reporting purposes seriousness has been upgraded to serious (medically significant) due to commitment to the FDA.
Headache and increased heart rate 2 hrs after vaccination.  Next morning fever, chills, nausea, full body joint pain, headache and extreme fatigue.   Took 8 hour arthritis tylenol in the afternoon to break fever/chills.  Then had night sweats all night.
Shingles on right side, mid back to front and upper right leg; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included double vessel bypass graft (double by-pass 4 years ago) in 2017 and peanut allergy. 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 vaccination. Two days after getting first Pfizer shot, on 01Apr2021, the patient developed shingles on right side, mid back to front and upper right leg. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event with antiviral medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles on right side, mid back to front and upper right leg was resolving at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
received vaccine and site tender and at 3pm worsened and radiated to leg in the evening. remained sore and became difficult to walk the next day in the afternoon and continues.
Pt recvd HIBTITER/TINE & devel hives the next day, tx DPH;
Soreness and pain at the site of administration that was eventually reported to the pharmacy on 6/19 as a burning rash on/around the site of administration on left arm. Diagnosed as cellulitis by the patient's PCP and prescribed KEFLEX 500 qid for 7 days.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. This case is linked to case 1404USA014115 (sibling). On 21-JAN-1999, the patient was vaccinated with their first dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). On 24-FEB-1999, the patients were vaccinated with their second dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided) in another facility. The registered nurse had no access to those lot numbers. No co-suspect or concomitant therapies were reported. The nurse reported that, on an unknown date in 2005, the patient had negative (not immune) hepatitis B titers, and on 10-MAY-2013, the patient received their third dose of RECOMBIVAX HB 5 MCG/0.5ML, lot # H017304, expiration date 11-JUL-2015 (route not provided). At the time of the report, the outcome and relatedness for the event "had negative (not immune) hepatitis B titers" were unknown. The registered nurse stated that the patient and his sibling were coming in for a well visit (date unavailable). Additional information has been requested.
Ever since patient has had shot they have been experiencing chronic headache, blurred vision, and dizziness
Patient's wife states that hours after receiving Comirnaty, that her husband began to experience sporadic hand tremors. Now, a week later, the states that his hand shakes all the time. Patient has an appointment today to see his doctor.
Within minutes, post vax, child developed 5 spots that became larger while mom and nurse observed on pt's calf area. Child rushed to MD's office within 5 minutes. Benadryl was given.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 336, 168, 1172, 80, 24, and 416 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chest pressure, shortness of breath for 3  days, no treatment, doctor is monitoring, continued intermittent pangs in chest
Chronic and debilitating head ache for 3 days (still continuing). Taking ibprofin (400 mg) every 4 hours.
That evening I had a red rash on my left arm below the injection site.  My left underarm lymph node became swollen. The following day I had brain fog.  Had a hard time concentrating on work and a headache.  The rash on my arm faded after several days and then returned on day 9.  The rash took another week to fade away.   My lymph node under my left arm is still visibly swollen and it has been 3.5 weeks since the injection.  I went to see my primary care doctor who examined me and suggested I get the second vaccine in the right arm since the lymph node is still swollen.   I went to the dentist 7 days after the vaccine and the hygienist advised that my left neck glad was also swollen.   I am concern about getting the second vaccine with the lymph node still being swollen.
patient received GARDASIL 9 vaccine in 2015 and never received dose 2 or 3; genital warts; recently diagnosed with HPV; This spontaneous report as received from a physician refers to an approximately 31-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. In 2015 the patient was vaccinated with a first  dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis for prophylaxis (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient never received the second or third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Approximately in June 2021, reported as recently,  the patient was diagnosed with human papilloma virus infection and genital warts. The outcome of anogenital warts, and papilloma viral infection was unknown.The causality assessment for human papilloma virus infection and genital warts was not reported.
3 days after shot, experienced lightheadedness, vertigo, nausea x 5 hours. Slowly got better over next 3 hours.
He reports symptoms of Other: Nausea, dizziness, diaphoretic, clammy and cold. Pt placed on cot, initial vital signs include:  HR - 86, RR 22, SBP 118/76, Spo2 98%.  Pt able to answer questions appropriately, Confirms he is a Type 2 diabetic, takes insulin daily. Has a implanted device that he checks his blood sugar with his phone. BS at this time is 171.  Color continues to improve as lying on the cot. Less diaphoretic. Nausea subsiding. Close monitoring done.  Vitals signs rechecked after 10 minutes include:  HR 90, RR 20, SBP 110/76, Spo2 98%.  Patient feels much better, all symptoms resolved. Sat up to edge of cot, denies light headedness, dizziness or nausea.  Breathing easy.  Provided with water, taken without difficulty. Pt stayed 30 minutes in observation area. Agrees he is fine to leave. Cleared by RN. Advised to seek medical attention should anything change.  Verbalized understanding.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in October 2016, also reported as, on or about October 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On or about 08-OCT-2016, the patient experienced shingles and was treated by a physician assistant at a medical associate. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
At approximately noon, patient described blurry vision in right visiual field. On examination, patient's right eye did not respond to light stimulus and remained dilated at approxim 4 to 5 mm. No redness, discharge, itchiness or other symptoms noted. After 10 minutes, patient noted increased blurry vision in right visual field and consequently returned for evaluation. Pulse rate was normal.  Patient self-administer cetirizine 10mg PO x1. After sitting quietly for another 15 minutes, pulse increased and patient reported anxiety attack. Patient was referred to emergency department for examination of eye and evaluation of anxiety.
Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, 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 (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Imaging procedure: Unknown results; Magnetic resonance imaging: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.