chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 27 August 2012 from an investigator. A male subject was found to have an elevated Troponin level (Rapid Troponin I level reported as within normal limits (Negative) and an elevated central laboratory (lab) Troponin I level result of 0.21 ng/ml) on 15 November 2010 (with reported date of 17 November 2010) after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route and site not reported) on an unspecified date. During the event, the patient was reported as asymptomatic, according to the Investigator. The subject also had an electrocardiogram (ECG) reported as abnormal: "NCS", first degree atrioventricular (AV) Block on 18 November 2010. On same date, 18 November 2010, central lab Troponin result was reported as less than < 0.21 ng/mL. Treatment reported as "treatment (other than medication)". The subject had a past medical history of elevated cholesterol and currently of high blood pressure at screening visit on 08 November 2010 (elevated cholesterol and high blood pressure were reported as "no" on follow-up visit on 15 November 2010). The subject had a surgical history of umbilical hernia repair and one (right) rib removed reported at screening visit on 08 November 2010 (also reported as surgical history "no"), (both surgeries were reported as "no" on follow-up visit on 15 November 2010). The subject denied usage of topical steroids, and denied drug allergies. The rest of the subject's past medical history was negative (reported as "never" or "no"). Screening visit on 08 November 2010, reported concomitant medication as Amlodipine and EXFORGE taken since 04 March 2008 for hypertension (concomitant medications reported as "no" on follow-up visit 15 November 2010). The subject admitted to consuming alcohol two to four times a month and had a history of tobacco use, specifically cigarettes, amount of use not specified. The stop date of adverse event elevated Troponin was 18 November 2010. The subject recovered (also reported as "no residual effects") on date not specified. According to the investigator the event of elevated Troponin was possibly related to the trial product or the trial procedures. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: medical records.
Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 02 Apr 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022. Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion. No treatment information was reported.
Extremely heavy menstrual flow subsequent to the shot. Bleeding to the point it inhibits my daily activities. I have no prior history of menstrual or reproductive health issues. Also, irregular periods since the vaccine while I was very regular before.
improperly stored vaccine administered; This spontaneous report was received from other health professional (nurse) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies, concurrent conditions and concomitant medications were not reported. On 19-NOV-2019, the patient was vaccinated with improperly stored dose of  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dosage,  route, indication were not reported, lot # R021372 has been verified to be a valid lot number for (hepatitis b vaccine (recombinant)), expiration date reported as 25-MAY-2021) for prophylaxis (product storage error).   No product quality complaint was reported. The vaccine underwent temperature excursion and time frame 25 fahrenheit (F) for 6 hours 28 minutes and 55 fahrenheit for 7 hours. There was no previous temperature excursion. There was involvement of data logger. The outcome of product storage error was unknown.
Coughing; Sharp pains in the right side of the head; Blood pressure high; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSION (Blood pressure high), COUGH (Coughing) and HEADACHE (Sharp pains in the right side of the head) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic bronchitis.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced HYPERTENSION (Blood pressure high). On an unknown date, the patient experienced COUGH (Coughing) and HEADACHE (Sharp pains in the right side of the head). At the time of the report, HYPERTENSION (Blood pressure high), COUGH (Coughing) and HEADACHE (Sharp pains in the right side of the head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Blood pressure measurement: then it went down (Low) Low and 280/90 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient did not take any treatment medications for the symptoms. The patient experienced sharp pain which was like a stab. The patient went to emergency room (ER) on 12 Jun 2021, and studies were conducted. The patient's blood samples were collected and everything showed normal. The patient mentioned that the cough was more now and more frequent, specially at night.
Painful to touch which persisted for 7 days after the shot. During the next 3 weeks, the patient did not notice any pain and thought it had disappeared. She reports a "similar" pain that came about on the date reported. She cannot locate the exact spot of the pain but states its in the same area as the shot. She does not recall doing any activity which cause pain.
Per nurse involved (RN) "While vaccinating patient, needle came detached from syringe while needle was inserted in patient. He got a very small dose, but majority spilled out onto his arm. Provider was called. Decided with her since he got a small amount, we would readminister .4 ml in a second dose (normal dose from Johnson and Johnson is .5 ml). Explained what had happened to patient. He was understanding. All of his questions answered."
Approximately 4 months post vax, this pt experienced chills, aches, and swollen joints. Pt was seen in the ER and indicated that she had experienced those symptoms for "some time."
HEARING IS BETTER/MENTAL FOCUS/VISION IS GETTING/BETTER THOUGH PROCESS; POSITIVE CHANGES; FEELING AWAKENED; TREMORS; SHOULDER AND ARM PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included shingles, car accident, nerve damage on the entire body, and tremor in the right side of his body. The patient was previously treated with polio vaccine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced tremors. On 05-JUN-2021, the subject experienced shoulder and arm pain. On 07-JUN-2021, the subject experienced hearing is better/mental focus/vision is getting/better though process. On 07-JUN-2021, the subject experienced positive changes. On 07-JUN-2021, the subject experienced feeling awakened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shoulder and arm pain, and tremors, and the outcome of hearing is better/mental focus/vision is getting/better though process, positive changes and feeling awakened was not reported. This report was non-serious.
Chills, fever, body aches, back pain, headache, swollen left axillary lymph node
Had covid before in march. On first shot had fever and chills for 2 days.   Still feel lousy and weak. Feels like a strong immunogenic response. Not sure I want to take second dose since colleagues that didn't have covid before had these symptoms after the second dose not the first. I had covid before and I have these symptoms now.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness/Tingling in hands and face the day after
Morning after woke up extremely dizzy with buzzing in ears. Cleared up about 2 pm.  But 2 days later got dizzy spells again with buzzing in ears.
Tachycardia, HR 120-155 lasting from 7pm until 6am the following morning. Palpitations, diaphoresis, fever, chills, body aches, chest pressure, headache.
Information has been received from a registered nurse concerning a 10 weeks patient who on 04-MAR-2010 was vaccinated with the first dose of ROTATEQ and on 26-MAR-2010 was vaccinated with the second dose of ROTATEQ. No adverse effect was reported. It was not specified if the patient sought medical attention. Additional information has been requested.
2 days of fever, up to 101.8, 4 days of fatigue, loss of appetite, migraine x 6 days.  On Feb. 22, 2023 when I woke up I had a viscous migraine left side of head.  My left cheek was numb and remained so all day.  I took 100mg Sumatriptan that afternoon.  By 5-6 pm the migraine and numbness started subsiding.   Only other medication I took was acetaminophen and ibuprofen.
Symptoms mild: pain & swelling on (L) deltoid, feels warm to the touch; x 3 days.
C/O fever within 4 hours of receiving shot - c/o aching, headache, fever - temp 101-103.  Denies stiff neck, numbness, tingling - advised to see physician today.  3:40 pm 8/7/08 - PC to mom - states called physician and he said continue Tylenol - mom concerned fever not decreased 102 - advised go to minor need clinic if physician will not see patient.
Ct to receive PPD 0.1cc ID on 8/16/04, instead Ct. received Adult Td 05.cc ID to left forearm. Area became red and sore per mother-injection site management-cool compresses, Benadryl/Tylenol.
Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with ROTATEQ orally (dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Non traumatic subarachnoid hemorrhage requiring IR coiling and embolization, no HTN history
I had extreme tinnitus in the left ear, fatigue for 4 days, 101.9 fever for 12 hours, pressure in hands and feet, body aches.
Woke up at 2 am with fever, chills, extreme body aches, and diarrhea. Took Tylenol which brought the fever down but had to be repeated at 8am, 12pm, 8pm due to fever of 101.5 and chills. Also had quick bouts of moderate pain around my left temple intermittently throughout the day. Heart rate usually staying around 100-125 even at rest.
Redness, swollen at injection sight, redness traveled along neck, trouble breathing, itchy throat
Rash Narrative: Employee expereinced light rash on her left deltoid and her face, 8 days after the shot.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD22-012205.  A male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose number: 01, Lot number: 041B21A), administration date: 24Apr2021, for Covid-19 immunization; Moderna covid-19 vaccine (Dose number: 02, Lot number: 021C21A), administration date: 21Jun2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: The patient having a reaction to the Moderna Covid-19 booster. On 04Apr2022: 2nd booster dose of Moderna Covid-19 vaccine. Sore arm at injection site, 06Apr2022: The patient right hand was swollen and right arm could not bend. He went to the Emergency Room that night, they did blood work, & everything was good, 07Apr2022: Both hands were swollen, like mini boxing gloves. he had pain in both and could not use them. patient took ibuprofen, 08Apr2022: left knee started popping when he tried to straighten it, like on the left side of the kneecap, tried to make a teledoc appointment, but they could not talk and had a bad crook on neck the left side, 09Apr2022: consumer had a teledoc appointment with the nurse practitioner. told them he was better, because of Ibuprofen had taken. They said to call back if he had any more problems, 11Apr2022: The patient had bouts around his body & was losing weight. he lost 14 pounds. 21Apr2022 Today hand is so swollen you cannot see the knuckle, cannot lift arm. It feels like shoulder is out of the socket. Devoted is arranging for a Nurse Practitioner to call today at 3.30p. Dose Number was 2nd booster, Manufacturer: Moderna, Lot number: 033H21A, Dose: booster, Date administered: 04Apr2022  No follow-up attempts are possible. No further information is expected.
Employee did not divulge she had received a Pfizer Covid vaccination in January through  Pharmacy . Clinic staff thought they were vaccinating with first dose and used available dose of Moderna. When entering in database the error was discovered.
Numbness/ tingling in lips and left side of head/face.  I returned to Clinic area, had elevated B/P and took claritin.
Patient felt as though she was going to "pass out"  approximately 20 minutes after receiving the vaccine.  Patient felt hot.  Heart rate became elevated and blood pressure became elevated.  Patient also felt as though there was something at the back of her throat.  This was examined by the physician in which he stated the throat was normal without any swelling.  Patient did receive Benadryl 20mg PO.  Patient stated that this feeling felt similar to a reaction in the past when she had a severe reaction to Cipro.
Information has been received from a pharmacist concerning a patient who was vaccinated with ZOSTAVAX vaccine (Merck). The pharmacist reported that the patient developed "a knot" at the injection site. The pharmacist was the one who administered the vaccine. The patient sought unspecified medical attention. Additional information. has been requested
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #  M009378 with expiry date of 23-APR-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 31 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. Additional information is not expected as there was no consent to contact physician.
Tachycardia , bradycardia , chest pain , fatigue  Currently wearing holter monitor and scheduled for echocardiogram
Insomnia on 6/11/18, nausea including 1 episode of vomiting 6/12/18.
Had intense radiating nerve pain under the left armpit that extended half way down the upper part of the arm & had significant lymph node swelling in the left arm that started exactly one week after getting the vaccine. Lymph node swelling and nerve pain have persisted for at least 5 days now but is starting to decrease.
Patient was to be given a Moderna BiValent vaccine but was mistakenly given a Covid booster.  No adverse reaction or harm done.
Reports lightheadedness, tingling to left arm, warm during 15 min observation period following the vaccination.  Follow up reveals that she had short term lightheadedness that resolved with no further incident.
Pain at injection site; Hot to touch; Armpit lymph node swollen; Arthritis pain was worse; Lower back left side very painful; Headaches; General unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Jan2021 (Lot number: EL1284) at the age of 61 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), administered in arm left, administration date 06Jan2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Known allergies: Grass" (unspecified if ongoing); "Known allergies: other food allergies - not specific" (unspecified if ongoing); "Known allergies: Tomatoes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; VIT D [COLECALCIFEROL]; FISH OIL; ARTHROTEC; CALCIUM. Past drug history included: Known allergies: nicine, reaction(s): "Known allergies: Nicine"; Known allergies: statins, reaction(s): "Known allergies: statins"; Known allergies: cholesterol drugs, reaction(s): "Known allergies: Cholesterol Drugs". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Pain at injection site"; FEELING HOT (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Hot to touch"; LYMPHADENOPATHY (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Armpit lymph node swollen"; ARTHRITIS (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Arthritis pain was worse"; BACK PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Lower back left side very painful"; HEADACHE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Headaches"; MALAISE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "General unwell". The events "pain at injection site", "hot to touch", "armpit lymph node swollen", "arthritis pain was worse", "lower back left side very painful", "headaches" and "general unwell" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, feeling hot, lymphadenopathy, arthritis, back pain, headache, malaise.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
One finger is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (One finger is really sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (One finger is really sore). At the time of the report, PAIN IN EXTREMITY (One finger is really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Started afternoon of March 20. Drooping mouth first, then difficulty closing left eye. Treated in emergency room.
C/O 25 maculopapular lesions appeared on trunk (abd) and arms on May 19, 2007. No treatment provided as of May 24, 2007. No fever.
pt recv vax 920AM on 2OCT97 @ 210Pm pt began crying & was inconsolable;APAP & myoflex administered p/vax; no fever;mom reports never cried like this before;no sz by report infant wouldn't eat;
The area near my collar bone was swollen and hurt to touch and move. The area would also hurt when I moved my neck.
Patient stated after receiving his second covid vaccine on 06/15 he started having visual changes, which was confirmed a stroke on 06/25 by MRI.   Patient stated he noticed his stroke symptoms after receiving his second vaccine.