chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with Headache at 10pm (Right between eyes)  Pain started spreading through entire body.  1020pm  Hands itchy and swelling, chest tight 1020pm  Took 2 Tylenol and two benadryl 1030pm  Itchy hands and tight cheat subsided by 1130pm  Headache and severe body aches throughout entire body continued through and did not get better until 04/08/21.  Bed ridden for duration.  No fever.
Taken COVID 19 Treatment; Taken COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3, booster ,single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fibrilator" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing); "Melanoma" (unspecified if ongoing), notes: Cured 15 years ago; "Hypogonadism" (unspecified if ongoing); "BMI" (unspecified if ongoing), notes: BMI33. Concomitant medication(s) included: TESTOSTERONE CYPIONATE; ANASTROZOLE.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Taken COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Heart rate increased: 170; SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Information has been received from a pharmacist concerning a 28 month old daughter who at 12 months of age was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included MIRALAX. On 14-JUN-2010 at 2.5 years of age, the patient had chickenpox. The patient had no itching and no fever. She stated that the lesions were not getting better. The patient had 2 office visit and not recovered at time of reporting. Follow up information received from a pharmacist indicating her daughter was hospitalized and chickenpox was ruled out. Her daughter has an infectious disease. The outcome was not reported. Additional information has been requested.
Case initially assessed as non-serious listed. Initial report received on 15 November 2011 from a health care professional. A 37-year-old female patient, with no relevant medical history, experienced swelling and pruritus at the vaccination site 1 day after receiving an intramuscular deltoid injection of FLUZONE (lot number UH463A) on 13 September 2011. It was unknown if the patient had recovered at the time of reporting. Follow-up information was received on 20 January 2012. According to the reporter, the patient had recovered from vaccination site swelling and pruritus. The case was upgraded to serious, due to the following event. It was reported that the patient was prescribed MEDROL dose pack on 15 September 2011. Documents held by sender: none.
Polymyalgia rheumatica presenting as total body pain, fatigue, malaise, low grade fever, nigh sweats. After infectious disease workup, treated successfully with prednisone but relapsed in 2023.
Swollen sore arm where injected, headache and fever.  Swollen painful knee. One week after shot, still have trouble walking.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with VARIVAX, lot # M024683 with expiry date on 18-MAY-2018, lot # M023380 with expiry date on 11-MAY-2018 and lot # L021215 with expiry date on 10-JUN-2017 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced an excursion of unknown temperature for 48 hours. The previous temperature excursion of 10 degrees Fahrenheit for 19 hours was also reported (it was unknown if the vaccines which experienced previous excursion were administered to the patients). Data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000401: US-009507513-1706USA003359.
headache, nausea, lightheadedness, near syncope, bilateral upper arm numbness.
Tested positive for Covid-19 on November 30, 2022. Fever, body aches, headache, extreme fatigue, cough. Symptoms started as very strong and lasted for two weeks. Fatigue lasted for almost a month
No adverse events were experienced 5 patients were vaccinated with Monovalent Pfizer Vaccine as a booster between 9/3 thru 9/13, after the approval of the Bivalent vaccine, when the monovalent vaccine was no longer authorized to be used as a booster.
Has redness extending from edges of smallpox site across chest about 9 inches, warm, red.
patient already had problems with interaction; he noticed his sugar level went way down after he had the vaccine; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable consumer (patient's friend) reported that a 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. Co-suspect drug included insulin pen from an unspecified date for Diabetes. The patient's medical history included he had a stroke a year and a half prior to the report and had trouble talking; had Diabetes and used an insulin pen. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Reporter would like to know if there were any problems with diabetes medicine and covid vaccine. Clarified that the patient already had problems with interaction. Reporter was calling in regards to her friend, she is the healthcare power of attorney for. She stated patient had a stroke a year and a half prior to the report and had trouble talking so she called for him. He had Diabetes and uses an insulin pen. He had received both doses of the vaccine. He did not bring anything up until after the second shot but he noticed his sugar level went way down after he had the vaccine. However, he had also improved his diet and through more fruits and vegetables. She stated he had been using an insulin pen for awhile and now all of the sudden he was having lower blood sugar levels. He still had to take some insulin but not as much. She stated he was thankful to get the vaccine so this was minor to him. She asked if there was an interaction between the vaccine and insulin. Action taken for insulin was dose reduced. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling/lump, redness, itching, and bruising in area still today. Thought I should report to note as a symptom for people with blood thinners as it?s been three weeks since my second dose, the bruise is still there, it?s light, but there. Bruising is a side effect of eliquis so could be enhanced by the vaccine
This is more of a side effect but that occurred after the v-safe check in dates of 5 days and is in regards to a new vaccine, so wanted to report it, as I am the second person at my work reporting this. Warm, red, itchy, tender area near injection site that popped up on 1/13, over a week after the vaccine given. There was some injection site tenderness and arm pain for 1-2 days after vaccine that cleared up and then this new new spot popped up about 9 days post vaccine. It is still present today 1/14 but smaller area seems to be red. Provider at my work reports a similar issue for her at one week post vaccine. If it gets worse, I will be seen for it.
10 minutes post vaccination patient reported that he was having some difficulty swallowing and some itching, no other issues.  Called 911 and monitored patient until EMS arrived. By the time they arrived he was feeling better and all vitals checked out ok. Patient refused further treatment.  Offered Benadryl to patient but he refused.  Advised him to take one when he gets home.  Followed up with the patient 2 times and he has fully recovered.
On 04/08/2003, pt started having irritability, low grade fever, then rash began on upper thighs and quickly spread (apprx. 6 hours) over rest of body. At time of presentation, macular-papular rash without  vesicules or pustules.
He received the jab at 4:30 pm, by 7pm or 8 he started coughing, the next morning he had a runny nose with a cough and it has continued up to this day. Sunday I called the Dr to tell her about it and she said it was not the vaccine. Sunday, Monday and Tuesday along with the mucus and cough he felt hot to the touch but th en thermometers keep reading a normal temperature of 77 or 78. By Wednesday afternoon he developed a rash on the back of his neck, and today Thursday that is the 7th day after the vaccine the rash seems to be spreading to the chest.
Gangrene - Below-knee amputation of left lower extremity. The patient tolerated the surgical procedure without complications and was hospitalized for a total of 3 nights following the surgical procedure. The hospitalization was necessary for pain control, therapy, medical care and discharge placement. Hospital admission within 6 weeks of receiving the COVID vaccine.
No adverse affects reported; a expired dose of VAQTA was administered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 13-AUG-2019, the patient was administered an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 50 (units not reported), lot # R022983 and expiration date on 09-AUG-2019, for prophylaxis (route of administration and anatomical location were not reported). No adverse effects were reported.
15-20 very small scabbed papules.  Diagnosis-Varicella Transcription-symptomatic
Dizziness, shaking. BP 209/117 (pulse 105), 122/108 (pulse 120). Sent to the ED.
He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking, and he had fever of 105, they gave him Tylenol suppositories and he passed away 2 hours later.  They should not have given him should not have given him the vaccine that is on hospice, it was not the right decision. I am worried about the elderly and those very sick.
This spontaneous report was received from a 74 year old, female consumer reporting on herself, with history of having the shingles 20 years ago (approximately in 1993), and who is allergic to sulfa and penicillin. ON 28-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies were reported. Concomitant medications included Prednisone (manufacturer unknown) and "aspa cream". On 30-JUN-2013 the patient experienced a burning sensation that rotates from place to place, started happening in the hip and the thigh. Started feeling a burning sensation on the left side wrapping to the front. Also felt the burning sensation on her vagina. The outcome of the above mentioned events was unknown at the time of the report.  The patient reported that unspecified treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. Additional information is not expected.
hematoma; This spontaneous report was received from a physician and referred to a 4-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were unknown by reporter.   On 05-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered subcutaneously for prophylaxis (strength and dose were not provided); and received therapy with sterile diluent solution for injection/infusion, lot #U034538, expiration date: 14-MAY-2024 (strength, dose, frequency, route of administration, and indication were not provided).  On 05-APR-2023, the patient experienced hematoma after the subcutaneous administration. It was unknown whether the patient sought medical attention, or any treatment was given. Information about lab diagnostics/studies was unknown by the reporter. At the time of reporting, the outcome of the event hematoma was not known. The causal relationship between hematoma and both suspect products was not provided.
He had 3 jerky movements of upper extremities and suddenly woke up and said what happened. The incident lasted for less than 5 seconds then he felt dizzy for another 10 minutes. No sweating, pallor or cyanosis. No apnea, facial twitching's, frothing or sphincter incontinence.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient received a dose of Shingrix and had a sore arm. The reporter did not want to provide additional details regarding this event.
At 12:30 am awoke and felt thirsty and achy in my right arm.   I had been feeling chills off and on for a couple of hours.   I got out of bed and went to the kitchen, drank a small amount of water and located the bottle of Tylenol.   While I was attempting to open the safety seal on the Tylenol I suddenly felt very dizzy and immediately passed out.   I awoke on the floor moments later and passed out a second time.  After awaking the second time,  I remained still and waited a few minutes for the dizziness to go away.    I then carefully  crawled back to bed without standing.     I continued to fill chills throughout the night and the next day (3/10/2021) , as well as fatigue.  The following day (3/11/2021)  the symptoms all seemed to disappear, except for bumps and bruises I sustained in the fall.
pt states rash devel evening of 21OCT93 vaxed afternoon of 2OCT94 rash described as being on both cheeks & sides of nose & down rt side of neck; erasor to pea size when itching & raised w/edges, then fade to a measle like rash;
This spontaneous report was received from a registered nurse refers to 4 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 02-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063 and 806USA004064).
Fatigue and buckling of knees/fall: 6 hours post shot thru next 5 days. Rash on chest, neck, face: 48 hours post shot thru 11/17-still mildly present. Swelling of face: noticed about 48 hrs post shot thru 11/12. Tightness in chest and shortness of breath: 6 to 48 hours post: Did not report until 11/17 but saw doctor who confirmed reaction to flu shot and advised reporting as soon as possible. Put on prednisone 10 days.
Information has been received from a pharmacist concerning ten approximately 75 year old patients who on unspecified dates were vaccinated with Pneumovax 23 vaccine (lot 657526/0555U). The pharmacist reported that the patients developed "serious adverse events" post vaccination. Subsequently the patients experienced pain and swelling at injection site moving downward on the arm. The patients sought unspecified medical attention. Some of the patients had to go to the hospital, but it was unknown if any of the patients were admitted to the hospital. At the time of this report, outcome was unknown.  The pharmacist requested a lot check on Pneumovax 23 (lot# 657526/0555U). Pain and  swelling at injection site moving downward on the arm was considered to be disabling. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
left forearm, left middle finger and abdomen rash; This is a spontaneous report from a contactable consumer. This 52-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 26Jun2021 at dose 1, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Consumer asking should I get the second dose of the Pfizer Covid-19 Vaccine after experiencing left forearm, left middle finger and abdomen rash after receiving the first dose on 26Jun2021. : Possible duplicate AE information e-transmitted. The outcome of event was unknown.
Swollen eyes, spots on body, every lethargic. Body was very tired. Has not spoken since. Has signs of an autistic child.
p/administering the HIB vax, pt lt leg swelled up; nursing staff had the PA from rural hlth clinic look @ leg; advised pt to put warm compresses on it & use APAP for pain;
Fever, chills, body aches, site tenderness, swelling, warmth x 3 weeks
Day of injection: Left shoulder pain & swelling, headache,  Day 2: fever, chills, & body aches, day 1 symptoms persisted
Case number PHEH2014US025160, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 54 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
On 11SEP2022 I woke up at six AM my right eye was swollen and had drainage I had a temperature of ninety nine point two and went to Urgent care to be seen and was treated with antibiotic eye drops I was given Polymyxin B Sulfate Trimethoprim on the same day the left eye was draining and both eyes were treated with the drops on 21SEP2022 I was treated at Urgent care for both eyes and was given oral Augmentin was referred to a doctor, and was Azelastine eye drops. My eyes cleared up and then I had surgery 04NOV2022.
Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR.  Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable.  He was pronounced deceased at the hospital due to a heart attack.  He had no previous heart disease diagnosis.
flu-like symptoms; feet swelled up; hot flashes; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PERIPHERAL SWELLING (feet swelled up) and HOT FLUSH (hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
About 5 minutes after injection, stated thirsty. Walked away & swayed a little. Assisted to floor. Pale and able to respond verblly. Bp 92/56 thready pulse given water, cool cloth to forehead & neck. Bp after 10 min 104/78 P 84 stated felt better. Assisted to sitting BP 104/80 P 88 Color improved returned to work after apporx. 15-20 min.
Patient had syncope event 12 minutes after COVID-19 Vaccine. Patient recovered after event. Vitals remained stable. Provider cleared to leave with parent without having to go to hospital.
Patient immediately started feeling unwell after being given the Moderna Covid Vaccination. He passed out briefly within about 5-10 minutes after the vaccination. He stated that he was not having difficulty breathing but felt light headed and dizzy and needed to lie down. He was placed on the floor and 911 was called. He was not given an Epi injection as he was not having difficulty breathing. Paramedics arrived and  stated he was in bradycardia and needed to be transported to the hospital. The man refused to ride with the paramedics in the ambulance, but stated that his wife would drive him to the ER.
pt recvd flu vax & exp redness & burning @ inject site; pt also devel rt ax lymphadenopathy w/in 24 hrs of the inject;
Breakthrough COVID-19 infection. Patient hospitalized with positive COVID-19 result on 1/22/22.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Additional Details: Blood pressure taken at around 200/110 initially right after vaccine after pt reported dizziness.
ACHY JOINTS; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic leukemia. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced achy joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy joints on APR-2021. This report was non-serious.
Hives on face, neck, chest and injection sites, 10-15 minutes, post vax, were given. Diphenhydramine was given IM. No respiratory distress was observed. Hives resolved in 5 to 10 minutes, after antihistamine was given. Appt. and seen in urgent care pediatrics and was discharged home by MD with Atarax. Follow-up done.
Patient presented with redness and swelling on vaccinated arm below injection site. There were distinct margins for the redness and swelling in arm. Patient said that this reaction began 2 days post vaccination (on 10/11/2019) and had lasted that whole day.  It is unknown if she the reaction has gotten better or worsened.
Body aches, chills, hot flash & fever. Lasted about 4 hours. No treatment, I just let it run it's course.