chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 4 month old female pt received IPOL and ActHIB, and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HEPATITIS B VACCINE and administration info not provided, two years ago. An unspecified amount of time later (reported as two years ago) the pt deveoped supraventricular tachycardia which lasted for four days. The pt reported that the supraventricular tachycardia is controlled today by medicine (unspecified). It was reported that the pt did not recover from these events. From additional information received on 20/Jan/2004 from Merck (WAES0401USA01072), it was reported that the event was reported by a health care professional and that the event of supraventricular tachycardia occurred in approximately December 2001. The supraventricular tachycardia was considered to be disabling. The patient has not recovered. No other information was reported. Follow up on 06/25/04 states: "From additional information received on 06/21/04 from the responsible physician, it was reported that the pt was not their health center pt. She was seen in another clinic by a different physician. The reporter that has been provided has no address or phone number available. No other information was provided. No further information is anticipated, this case is considered closed." Supraventricular tachycardia was considered to be disabling.
Father states that upon waking up the morning following immunization child had red, puffy eyes that were matted shut and had a fever of 103.  Child has continued to have cough & fever and has not been eating very well.  Parent states they have not taken child to physician, however states child will be seeing a physician today.
Right arm was throbbing; whole right arm went numb; swollenness in her arm; tingling in her arm; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollenness in her arm), PARAESTHESIA (tingling in her arm), PAIN (Right arm was throbbing) and HYPOAESTHESIA (whole right arm went numb) in a 66-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01L20A and 01LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollenness in her arm) and PARAESTHESIA (tingling in her arm). On 21-Feb-2021, the patient experienced HYPOAESTHESIA (whole right arm went numb). On 21-Feb-2021 at 6:30 PM, the patient experienced PAIN (Right arm was throbbing). The patient was treated with GABAPENTIN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Manual therapy (Therapeutic touch treatment) for Paraesthesia. On 28-Apr-2021, PAIN (Right arm was throbbing) and HYPOAESTHESIA (whole right arm went numb) had resolved. At the time of the report, PERIPHERAL SWELLING (swollenness in her arm) and PARAESTHESIA (tingling in her arm) outcome was unknown.            Treatment included Heating Pad.  No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 4-May-2021, reporter details, medical history, vaccination details(anatomical location), events and treatment details were added
Cellulitis with Lymphangitis to the LT axilla 2-3 days after vaccination. No systemic sxs.
After receiving the vaccine the patient reported feeling light headed. I (the pharmacy manager) was called over. I witnessed the patient have a near fainting episode (diagnosis). The patient shook, and was guided from the chair to the ground. she did not hit her head. someone remained with patient the entire time. Patient was given water while waiting for EMT to arrive. EMT evaluated patient, diagnosed with near-fainting episode related to anxiety. EMTs do not believe response was vaccine related. BP, sugars, and all other tests within normal limits. Mom arrived and patient left pharmacy once she calmed down.
pt recvd vax 8SEP93 in lt thigh seen @ office on 8DEC93 w/redness & fluctuence @ site; referred to surgeon MD; had multiple incision & drainage in the office w/twice dialy visiting nurse visits for dressing changes;required surgery
Got the shot at 6pm on 9/12 then at 10am on 9/13 I started to get chills and felt very cold.  Every muscle in my body got stiff i felt like i needed to stretch the a lot.  I got very sleepy.  I tried to keep myself awake all day at work but couldnt move much.  When i got home i went directly to sleep and slept for 12 hours.  I have never been so tired in my life.  My arm is red, raised up, and warm.  Ice and  heat did not help.  Still red and score as of 9/15
Immunization was administered and then approximately 7-10 minutes post immunization became light headed and fell to the ground.  She came to immediately and said she was fine.  Iced head and continued to monitor for 15 minutes post adverse event. Mother is in healthcare and felt comfortable going home with patient.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Concurrent condition, medical history and concomitant medication were unknown. On 05-SEP-2017, reported as "3 days ago" the patient was vaccinated with a dose M-M-R II indicated to prevention of measles, mumps and rubella (strength, dosage schedule, route of administration, expiration date and lot number were not provided). On an unknown date on September 2017, the patient had had an unspecified oral surgery, and after the procedure she was prescribed an unknown dose of MEDROL. It was unknown if laboratory diagnostics studies were performed. The outcome to oral surgery was unknown and the causal relationship between the M-M-R II and the adverse event was not provided.
She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second day, she vomited in school. She also had a headache and troubles breathing. She had belly pain, as well. On Wednesday, around lunch break she called me to pick her up, she had troubles breathing and headache and feeling blah. Also on the first evening,  Her arm was hurting and her left body side was hurting. (Wednesday this got a little bitter but she still had pain on her front left side -- especially her left leg.)  I took her to primary care and he prescribed Prednisone.  Prednisone started then. On Thursday, she still had troubles breathing and she stayed home from school. On Friday, it was okay for her to go to school.
A male pt (date of birth not reported) had received a left deltoid dose of Menactra, lot number Y204578A (this is not a valid lot number), on 8/8/06. The trade name and route of administration were not reported. The expiration date of the Menactra used was 10/13/2007. Six hours post immunization, the pt developed numbness, and tingling in his legs lasting two weeks. The numbness and tingling had started on the right leg and then went to the left leg and groin area. The pt was subsequently evaluated by a physician. The neurologic examination revealed paresthesia, numbness and slight weakness of the lower extremities. No diagnostic tests lab date were performed. The physician reported that the symptoms were related to the Menactra vaccination received on 8/8/06. Reportedly, the pt fully recovered two weeks after onset of symptoms. A new version was created for the sole purpose of correction the pts initials. No new medical information was received.
sore arm; Patient has not taken second dose till day 40 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Follow up received on 23-MAR-2021. Patient's age and batch number has been  updated.
Patient just wanted us to know that she passed out in the AM and woke up around 1PM on 11/24/2020, but her vaccinations was on 09/30/2020.  She said she was ok when she woke up and that she did not need any medical attention.
Soreness in the injection site that started about 6 hours after the injection and continued overnight; mild achiness in my body; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EL3247) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ankle joint where I had a previous injury" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL3247, Administration time: 03:00 PM, Vaccine location: Left arm), administration date: 01Mar2021, when the patient was 42 years old, for Covid-19 immunisation, reaction(s): "Pain and soreness in my arm around the  injection site", "body aches", "tiredness", "pain and stiffness in ankle joint where I had a previous injury", "pain and stiffness in ankle joint where I had a previous injury". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "Soreness in the injection site that started about 6 hours after the injection and continued overnight"; PAIN (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "mild achiness in my body"; FATIGUE (non-serious) with onset 22Mar2021 21:00, outcome "recovered" (24Mar2021), described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pain, fatigue.  Additional Information: The vaccine was given at a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mouth
This study case was received from the investigator in a trial on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 (lot number, route, site and date not reported). The subject was diagnosed with other, chest pain on 03 October 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Urticaria. Benadryl PO, Methylprednisone IM.
Diarrhea for over 48 hours; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (age at vaccination 48-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, heart disease, sleep apnea. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included lisinopril; hydrochlorothiazide; metoprolol, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 01Feb2021 13:00 (age at vaccination 48-year-old) as single dose for COVID-19 immunization. The patient experienced diarrhoea for over 48 hours since 22Feb2021 16:00. The patient did not receive any treatment for the adverse event. The reporter assessed the event as non-serious. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Covid test post vaccination (Nasal Swab): negative on 23Feb2021. Outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Intermittent at first: bloodshot left eye, then right eye, sometimes both eyes over the course of a few weeks, Intermittent throbbing pain alternating between eyes started, sometimes both eyes throbbing pain. Became more persistent, left eye became very bloodshot and double vision in right eye. Went to primary care physician thinking I might have had stroke. Ordered MRI. Referred me to ophthalmologist, neurologist. Ophthalmologist found possible blood flow problem in right eye. Blacked out eye for a few days until vision corrected. No further treatment.  Neurologist  referred me to another Dr. for bilateral temporal artery biopsy. Negative test results. No further treatment. Conditions: bloodshot eyes, throbbing pain, persist intermittently. Ibuprofen for pain.
77-year-old female to the emergency department on 8/9/22 for evaluation of right-sided chest pain, shortness of breath, upper abdominal pain.  States this has been worsening over the course of the day.  Has a history of COPD and metastasized lung cancer.  Does not use oxygen at home but was found to be saturating in the low 90s and was started on 4 L by EMS. Tested positive for COVID on 8/12/22
Delayed reaction of 8 days at the injection site. Symptoms were tightness, redness, bumps, warm skin and swelling.
This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Information on their concurrent condition, medical history and drug allergies were not reported. On 12-APr-2016, 18-APR-2016 and 21-APR-2016 unspecified patients were vaccinated with improperly stored 1 dose of PEDVAXHIB, on 13-APR-2016 with 3 doses, on 19-APR-2016 with 2 doses and on 20-APR-2016 with 4 doses of PEDVAXHIB lot # L035878, expiry date 11-AUG-2018, (dose number, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse events reported. There was no product Quality Complaint (PQC) involved. The vaccine administered was maintained at a temperature of 58 degree Fahrenheit for a time frame of 1.5 hours. This case is also linked to MARRS#1604USA015519 (same reporter link). Additional information has been requested.
FELT SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case US2018107212). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, muscle pain and feeling bad. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain, headache, muscle pain and feeling bad were unknown. It was unknown if the reporter considered the fever, pain, headache, muscle pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The reporter stated that had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated and that her limbs were heavy. She was ambulated with assistance x2 to the exam table by the CNPs. She was laid in the supine position, feet elevated and given a cool cloth for her head. VS 150/96, HR 82 and regular, pulse ox 93% on room air. She was monitored for approximately 10-15 minutes, and the patient then stated that she was having involuntary twitching and her limb heaviness was worse. Strength 3/5 to BUE and BLE at that time. She stated a medical history of anxiety/depression and tardive dyskinesia, NKA, no previous history of vaccine reactions. She states she had eaten breakfast that day but did not have lunch. Her blood glucose was 111. 911 was called to escort the patient to the ER for further evaluation. Vitals remained stable during the observation period, repeat BP 138/76, HR 80 and regular, pulse ox ranged from 89-93% on room air, she did state some heaviness with breathing. Respirations appeared even and non-labored. She remained oriented x4 but was drowsy. She was not able to sit up or move herself to the medic cart upon arrival. Her husband was notified and she was transported to the hospital.
The symptoms started the evening of 2/25/2023. I had fever, runny nose, coughing fits, etc. On 2/26/2023, I took a COVID-19 test, and it was positive. I called the nurse's hotline, and they recommended that I go to urgent care because of my age, which I did. At urgent care, they gave me an exam and prescribed PAXLOVID and benzonatate for my cough. I then followed the isolation protocol recommended by the CDC. The symptoms were pretty strong for three days and then tapered off. Then the runny nose, coughing and fever subsided. On 3/8/2023, I had a runny nose and coughing fits again, but no fever. I took another test on 3/9/2023 and got a positive result. At the time of this writing, my coughing and runny nose are a little bit better, but I still have them. I also feel fatigued, which I did the first time around, also.
Patient presented to the ED and was subsequently hospitalized for elevated LFTs and alcoholic hepatitis with ascites within 6 weeks of receiving COVID vaccination.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 17-JUN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomtiant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger. This is one of the many reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA011226: US-009507513-1612USA011227:US-009507513-1612USA005074.
I was diagnosed with fibromyalgia early in 2022. I don?t think the fibromyalgia syndrome is directly connected to the Covid-19 vaccines.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/1/2022 GI HEMORRHAGE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/1/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/1/2022 GI HEMORRHAGE
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored ROTATEQ orally, dose, lot numbers and expiration dates were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Mild fever, sore arm, aches, fatigue, upset stomach.  Covid shot received at same time and in same arm as flu shot.  Symptoms lasted several hours.
2 leg ulcers appeared on patient's lower leg approximately 2 weeks following first injection. Leg ulcers eventually became infected and victim was admitted to hospital with sepsis on May 24, 2021. It was discovered that patient also had 2 blood clots, one being a deep vein thrombosis in his upper leg, which are believed to have caused the leg ulcers. At the same time, patient was also diagnosed with Chronic Lymphocytic Leukemia (CLL) on May 25, 2021. Patient was also complaining of extreme fatigue and dizziness. Patient also had chronic low platelets for which multiple transfusions were required over the next 4 months. Patient appeared to have inflammation throughout his body and was diagnosed with arthritis in the back of his neck, which was making swallowing difficult and eventually impossible. He also ended up with internal bleeding in September 2021, the root cause of which was never discovered. Patient died on October 16, 2021 - 8 months following his first injection.
Itching and burning at shot site. Next day it got enlarged and hard feeling. Also itching terribly. I think they call it COVID arm.
1.  Severe hair loss, big bold spot about 2" since beginning of 2021 after vaccination(s) - bold spot still exists, growing hair only parts of the bold spot, still receiving treatments   2. Lab test results came out concerning on various tests after the booster shot - Dr. ordered additional follow up tests
Received Moderna Covid Vaccine #1 on 12/26/20 in left arm.  Had arm pain first few days.  On 12/28/20 he began having right calf pain that worsened over the next few days.  Was evaluated in Urgent Care  and diagnosed with an extensive DVT.  No history of previous DVT or venous issues.  Pt was on Plavix and ASA at the time for dx of CAD.