chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the Merck pregnancy registry via a physician concerning a 16 year old female with attention deficit/hyperactivity disorder with a history of 0 pregnancies and 0 live births who on 17-AUG-2006 was vaccinated with a first dose of Gardasil (lot # 653937/0637F). On 26-OCT-2006, the patient was vaccination with a second dose of Gardasil (lot #653938/0954F). Concomitant therapy included CONCERTA. Subsequently, she became pregnant. Last menstrual period was 24-AUG-2006 and estimated date of delivery was 29-MAY-2007. On 09-NOV-2006 and ultrasound reported that the patient was 11 weeks and 3 days. On approximately 07-MAY-2007 the patient developed pre-term labor and chorioamnionitis. On 07-MAY-2007, the patient gave birth to a normal male. Other medications used during this pregnancy included KEFLEX. On 18-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot #657736/0389U). No further information is available.
expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccination (Dose Number: 1) on 20-Jan-2021 and COVID-19 Vaccination (Dose Number: 2) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccination and COVID-19 Vaccination. Concurrent medical conditions included Penicillin allergy (Allergic to Penicillin), Illness (Acute illness) and Illness (Chronic illness).    On 06-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Patient didn't have COVID-19 positive test.  No treatment medication was provided by reporter.
Diarrhea, Rash, 8cm x 10cm area of redness at injection site. Treatment Ice 2x daily, BENADRYL 25mg 3xdaily; TYLENOL 500mg 3x daily, ibuprofen 200 3x daily.
I first had a dry cough that was fairly constant and wouldn't go away.  I waited two days for the cough to stop. I decided to take a at home test it was positive.  That night I woke up coughing with shortness of breath, it was three in the morning. I slept the night in a chair. I woke up in the morning I was okay. I had about 6 bad hours of COVID-19.  The cough lingered for weeks. Two or three days I was very tired I couldn't do anything. I called the clinic and got a prescription for Paxlovid. I didn't notice any immediate change.
Fatigue; Headache; Muscle pain; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were reported. No treatment information was provided.
ARM SWELLING, PAIN, REDNESS & WARMTH WITHIN 48 HOURS OF ADMINISTRATION; PT GIVEN CLINDAMYCIN & METHYLPREDNISOLONE FOR TREATMENT
itchy arm; redness; feeling of warmth; Inflammation; Sleep difficult; had low blood pressure for a week, 84/48, 94/52; arm is swollen; pain in arm; rash on the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (itchy arm), ERYTHEMA (redness), FEELING HOT (feeling of warmth), INFLAMMATION (Inflammation) and INSOMNIA (Sleep difficult) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm), ERYTHEMA (redness), FEELING HOT (feeling of warmth), INFLAMMATION (Inflammation), INSOMNIA (Sleep difficult), HYPOTENSION (had low blood pressure for a week, 84/48, 94/52), PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE RASH (rash on the injection site). At the time of the report, PRURITUS (itchy arm), ERYTHEMA (redness), FEELING HOT (feeling of warmth), INFLAMMATION (Inflammation), INSOMNIA (Sleep difficult), HYPOTENSION (had low blood pressure for a week, 84/48, 94/52), PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE RASH (rash on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 84/48 (Low) 84/48 and 94/52 (normal) 94/52.     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.   No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received contains no new information On 13-Jul-2021: Follow up received contains no new inform,ation
Arm was sore; It was warm; Baseball size red spot on the arm; Arm swollen; A spontaneous report was received from a Consumer concerning a 54-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events baseball size spot on the arm, swollen, warm, red, sore.  The patient's medical history was not provided. Concomitant medications reported were Cholesterol med, Lipitor, probably Anastrozole (patient did not know how to spell it) for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the events baseball size spot on the arm. swollen, warm, red. On an unknown date, the patient experienced the events sore.  Treatment details included Benadryl and Tylenol told by doctor.  Action taken with mRNA-1273 in response to the events was not reported.   On 28 Jan 2021 the outcome of events baseball size spot on the arm was resolved.  On 28 Jan 2021 the outcome of events swollen was resolved.  On 28 Jan 2021 the outcome of events warm was resolved.  On 28 Jan 2021 the outcome of events red was resolved.  On an unknown date the outcome of events, sore was not reported.; Reporter's Comments: This case concerns a 54-year-old female who had NS expected vaccination site erythema, vaccination site pain, vaccination site swelling and NS unexpected vaccination site warmth.  Event onset occurred 11 days after the first dose of mRNA-1273. Treated with Benadryl and Tylenol. Most events resolved, with pain outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt got vaccine, then in the evening went to a party and had a couple of drinks. Said it was very hot at the party. After being back at home after the party; started getting itchy and broke out in a rash and blotches all over (even under breast and on scalp and feet). Today, 10/26, she took a shower and it made her more itchy. I told her to take Benadryl and if unbearable to contact the MD on call and maybe they would prescribe something for her. She said that she didn't want to do that. She asked if she could put something on it and I told her that she could try some hydrocortisone on the really itchy spots (kind of hard since it is all over). She could also use an Aveeno bath (she can't get in tub). And I told her to keep in mind possibly calling the on call MD if it worsened. I will also check back with her. She said that she never had any reaction before. 6:06 pm I called her back - said still itchy - took Benadryl earlier and just took 2 more. I suggested that she contact the MD on call.
Presented w/ chest congestion, cough & SOB; COVID-19+ w/pna; tx w/ abx, steroids, VitD3, O2; dc'd home w/HHC & O2.
NECK  PAIN; BACK PAIN; CHILLS; PAIN LEGS AND ARM; FEVER; HEADACHE; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced neck pain, back pain, chills, pain legs and arm, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, back pain, and pain legs and arm, and the outcome of fever, chills and headache was not reported. This report was non-serious.
Patient with 2 Moderna COVID vaccinations, last dose 05/14/21, who admitted with complications of COVID.  Provider discharge note below:  "Vaccinated patient presented with cough and dyspnea and on ER evaluation found to have hypoxemia and bilateral ground glass infiltrates suggestive of COVID.  COVID PCR was positive.  Patient admitted and treated with supportive care, decadron, oxygen.  She improved and tolerated room air.  Her course was complicated by difficult to control DM2.  She is transitioned home to have home care follow up.  She is expected to make a full recovery."
Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Followup received: Patient details received
blood clot in left leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENOUS THROMBOSIS LIMB (blood clot in left leg) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VENOUS THROMBOSIS LIMB (blood clot in left leg) (seriousness criterion medically significant). At the time of the report, VENOUS THROMBOSIS LIMB (blood clot in left leg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Fibrin D dimer: positive (Positive) positive. On 26-Feb-2021, Ultrasound Doppler: abnormal (abnormal) showed a clot in left leg..         Treatment was with Eliquis prescribed by her doctor. However the patient only took an aspirin daily.  The blood clot resolved.  The patient reported she was very healthy, runs daily, does not smoke, is not pregnant and is not on birth control pill (all of which are risk factors for DVT/blood clots).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081281 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081281:1st dose event
24 hrs after shot - extremely dizzy, couldn't stand without help. Spouse gave lg glass water, 1/2 banana, few pretzels. Was a little dizzy till bedtime, was ok next morning & ever since. Was not sick at all before & no vaccines prior to shot. Blood pressure was fine.
After initial vaccine I experienced intermittent headaches. After second vaccine I have experienced low grade migraines. The migraines are daily now. I am on Tylenol 3 times daily as of 2 weeks ago.
sick to stomach; sick; headaches; chills; coughing; sputum; breathing difficult; feeling of tooth pain; heart rate was very high; she is denture wearer no means of dental pain; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA VACCINE, the patient experienced stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort. The patient was treated with azithromycin and prednisone. On an unknown date, the outcome of the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort were unknown.   It was unknown if the reporter considered the stomach discomfort, sickness, headache, chills, cough, sputum, difficulty breathing, toothache, heart rate high and oral discomfort to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and pneumonia 26 vaccine on the same day. After receiving the two vaccines, the patient experienced a lot worse. The patient was sick to her stomach and had chills. She also felt like her mouth was full of teeth that needed to be pulled, but she wears dentures and does not actually have teeth. The patient experienced coughing up a lot of sputum, and also experienced short of breathe when doing any activity like going to the mailbox. The patient received Azithromycin and prednisone and while taking those medications her heart rate was very high, running around 111-112. The patient stopped prednisone 2 days before her taper was supposed to end and at the time of reporting she finished her course of azithromycin.      Lab Comments: on an unknown date heart rate was measured
Information has been received from an internet article which was posted by a consumer, for GARDASIL, a Pregnancy Registry product, concerning her/his 16 year old daughter who on unknown date was vaccinated with two doses of GARDASIL (lot# 660555/0279X and 661841/0653X). Concomitant therapy included MENACTRA. Almost immediately after getting the first 2 vaccines, the patient started having a whole list of problems. The patient's symptoms included back pain, numbness in both legs and left arm, headaches, pressure behind eyes, neck pain, racing heart, chest pains, stomach pains, difficulty breathing, weakness, dizziness, tingling in left arm and both legs, jerking movements in legs and arms. The patient was taken to several doctors including the emergency room. The hospital ran all sorts of tests including a CT scan, everything would come back normal. The patient continued to have problems. The once happy and healthy 16 year old patient had become a very sick girl. She was an A/B student but was failing her 10th grade year and having to re-take the 10th grade. She still had a list of problems. She threw her birth control in the trash because she didn't want anything in her system. She was so sick. Two weeks later, she found out she was pregnant. No further information is available.
Information has been received from a registered nurse concerning a 25 year old female employee who on 03-MAR-2008, was vaccinated with a dose of MUMPSVAX subcutaneously in the right arm (lot number 659616/1982U, Exp: 07-DEC-2009) in error. The nurse stated that the employee should have received the rubeola vaccine. No adverse event reported. The patient did not seek medical attention. Additional information has been requested.
Mother noticed rash 10/31/2001, 3 spots on face and trunk and diaper area. 11/01/2001 one spot on ear and arm associated with cough for 2 days and HA at presentation.
17 minutes after vaccination, had itching all over body, inside mouth; noted itching palate and tongue, hot flashes and given famotidine and diphenhydramine and sent to ED for evaluation. in ED: given diphenhydramine 25mg PO one time felt abdominal discomfort and radiating up to the chest and given GI cocktail with temporary improvement. also mild nausea given ondansetron x2; also NS IVF given for 2L  Discharged with ondansetron and prednisone 40mg PO daily for 5 days.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-APR-2018 and 18-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Patient admitted for SOB and orthopnea possible due to acute heart failure and NSTEMI from melena (upper gastrointestinal bleed) and/or acute coronary syndrome
Shortness of breath that worsened throughout each day. Difficulty breathing at night. Heavy weight on chest at all times with some relief in the mornings. Feeling inflammated in chest region. Difficulty focusing on tasks as a result of the chest pains. Sometimes would come in sharper pangs. Lasting about 2 months and continuing in a much milder form now.  Other milder symptoms accompanied including headaches/migraines and  coughing.
Started feeling soreness in my arm and by the 3rd day I started feeling sick. By late afternoon I had a fever, and I was aching all over. I felt very fatigued. By the evening I had fever, vomiting and diarrhea.
Bloody nose for 2-3 hours  Could not lay down with the bloody nose Arm and back pain stated after a couple hours and are still hurting. Cannot nove arm up
Injection site began itching, growing red, and warming approximately 6 days after receiving injection, progressing to a hard, hot induration with aching around the injection site and shoulder joint/neck. The hard red area has increased in size to about 2? diameter over 2 days.  Called PCP approximately 8 days after injection to see if symptoms warranted a visit - PCP advised that it was a common adverse reaction to the vaccine and recommended a hot compress if needed. Improvement seen approximately 9 days after, with almost complete resolution 14 days after receiving the vaccine.
Redness 2inches around the area, painful to touch, sore, fullness, hard, lump
The following Tuesday i started with a low grade fever. As the week went on the fever started to rise. I contacted my doctor and he put me on prednisone. I was tested for COVID-19 and the results came back that positive. The following week my temp continued rise to over 105 and I realized things were getting out of hand and call the emergency response. i  bled out, had hematoma, I had heart failure, and lost my ability to walk. Was admitted to for 12 days.  I was then transferred to Select Speciality for recovery.
On May 9th I had pericardial effusion and cardiac tamponade. they perform pericardialcentesis removing one liter of liquid. This was perfumed at a MedicalCenter
COVID vaccine breakthrough case. Moderna 7/22/21 040C21A, 8/18/21 002F21A, and boosted 2/9/22 084J21A
Injection site redness n swollen n hot, After 5 days, waves of occasional nausea.  severe headache, body n joint ache, weak,  lasting full 5 days. Brain fog  , feel weak
terrible pain in abdomen, kidneys, hurt to eat, go to the bathroom, breathe, pain to stand up straight
PATIENT RECEIVED A "BOOSTER" DOSE OF THE PFIZER VACCINE BUT HER ORIGINAL SERIES WAS COMPLETED WITH 2 MODERNA DOSES.
Rash after MMR-face, neck, trunk and extremities. Benadryl given.
Tightness in throat and muscle ache in arm and across shoulders, followed by runny nose, violent vomiting, diarrhea and headache lasting until morning, with spells of fever.
approximately 10 minutes after receiving the vaccine the patient started experiencing intense itching all over her body.  It also appeared that she was turning red, unsure if that was part of the reaction or due to the patient scratching.  Following up with the patient, she states that the reaction subsided after taking benadryl and has fully recovered.