chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare professional concerning a 31 year old female with no past medical history and no known allergies who on 06Mar04, also reported as 19Mar04, at 9:30AM was vaccinated in the deltoid with a first dose of varicella virus vaccine live (lot 645288/0689). On 29Mar04, ten days later, the pt experienced an area on her upper arm that was a half dollar size with a blister. The area was sore and itchy, and the pt was afebrile. The pt was treated with diphenhydramine hydrochloride (Benadryl) and cool compresses. No further information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt experienced erythema and tenderness at the site. The outcome was reported as unk. Additional information has been requested.
Horrendous backache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Horrendous backache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced BACK PAIN (Horrendous backache). At the time of the report, BACK PAIN (Horrendous backache) outcome was unknown.            Concomitant products included Blood pressure pill for an unknown indication.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  The patient had Horrendous backache one week after administration. She felt better now.   This case was linked to MOD-2021-060751 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information was received on 12-May-2021 does not contains any new information.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "rosacea" (unspecified if ongoing). The patient's concomitant medications were not reported.  If vaccine received: Yes. Other medication in 2 weeks: Unknown.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
07/02/2022 presents to EC ED for RUQ abdominal pain. Choledocholithiasis S/P laparoscopic cholecystectomy. PMHx of recovering opiate addiction on methadone.
Mole of skin; This spontaneous case was reported by a consumer and describes the occurrence of MELANOCYTIC NAEVUS (Mole of skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MELANOCYTIC NAEVUS (Mole of skin). At the time of the report, MELANOCYTIC NAEVUS (Mole of skin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reports pain at the site of administration starting the night after receiving  the vaccine. The pain has progressively gotten worse to the point where it is limiting range of motion and so the patient is now seeking treatment. The patient is going to receive a cortisone shot and physical therapy.
Patient had COVID Disease 6 months after the 2nd Monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2022, the patient experienced COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster). At the time of the report, COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2022, SARS-CoV-2 test: Positive.         Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Reporter did not allow further contact
Information has been received from a medical assistant referring to a 5 month old male patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a dose of MMR II (dose, route and lot number not provided). The nurse practitioner reported that the patient developed herpes simplex of the mouth after the vaccination on an unspecified date. It was not specified if the patient sought medical attention. No further information is available.
SOMETHING GOING ON WITH LIVER AND LIVER NUMBERS ARE REALLY HIGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No personal or family history of liver issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced something going on with liver and liver numbers are really high. Laboratory data (dates unspecified) included: Lab test (NR: not provided) liver numbers are high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of something going on with liver and liver numbers are really high was not reported. This report was non-serious.
The pt developed a rash (papular pustules), initially tender then itchy, only on 1 dermatome. Symptoms are only compatible with dx of shingles (Herpes Zoster) after varivax.
Left side of throat, left soft palette, left side of mouth, left side of tongue, left side of jaw, left side of nose all felt numb, lymph node by left ear was swollen, left eye pressure, drooling Treated in Emergency Room, no monitor, no IV fluids, discharged with information on paresthesia, stomatitis
My father had a massive stroke 3 days after taking his shot. He is now currently paralyzed on his right side and not speaking
Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 04/05/21. Hospitalized from 07/28/21-07/31/21. Below is copied from discharge summary:   Patient is a 55 y.o. female patient who is being discharged today.   Hospital Course:    Sepsis with acute organ dysfunction/Acute hypoxic respiratory failure due to COVID-19  - Meeting sepsis criteria based on tacycardia, tachypnea and source of infection - requiring oxygen 2 lpm , oxygen for home ordered - continuous cardiac and SpO2 monitoring - cont dexamethasone daily until 8/6 - Remdesivir 7/28 - 7/30, in  View of improvement, ok to stop therapy - therapeutic anticoagulation with Lovenox while inpatient - albuterol PRN   Hypercoagulable state/Elevated d dimer -d dimer> 4K with inconclusive CTA chest -Full dose AC while inpatient   Chest pain/LBBB - likely 2/2 COVID and not ACS - LBBB  Present on prior EKG - cont daily aspirin, statin and BB   COPD -Stable - Breo Elipita  - cont montelukast - DuoNebs p.r.n.    Hypertension  - cont losartan, metoprolol, minoxidil  - hold chlorthalidone    Hyperlipidemia  - cont atorvastatin    Type 2 diabetes mellitus  -Controlled - cont Jardiance    Hypothyroidism  - cont levothyroxine  - TSH 1.4   Anxiety/Depressive disorder - cont citalopram, amitriptyline    RLS - cont Requip    Migraines - cont Topiramate    Fibromyalgia/ Chronic pain syndrome: -Resume amytriptiline -Oxycodone prn   Morbid Obesity, BMI of> 40: - lifestyles modifications regarding low fat diet, weight loss and daily excercise -F/U OPD with PCP   Patient is discharged in stable condition with stable vital signs
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions medical history and concomitant medication was not provided. On unknown dates the patient were vaccinated with doses of improperly stored M-M-R II (lot # L010488, expiration date 26-MAR-2017, dose, dose# and roué unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
on arriving for 4 mo old visit while arranging to vax w/shot mom reported that pt cried for 6 hrs straight p/1st DTP inject;
1 DAY /p 1ST VAX, EXP DIARRHEA, FEVER, NAUSEA, & POSS. POTENTIAL CLINICAL HEPATITIS. Unclear if actually had acute Hept B or false positive, off work until retesting done, symptoms resolved /wout Heptatitis 27Feb90.
Pt recv vax on 3/13/98; on 3/15/98 pt exp a rash in the creases of his elbows, under chin, and across belly & upper back.  Pt had cough & not sleeping well. Pt was seen by the LMD 3/27/98.
Flu like symptoms day after dose. Fever 102.00, chills. Fever subsided after 1 day. Severe swollen lymph node in armpit on same arm I had the vaccine, swollen like a golf ball even after 2 days.
pt recv vax 1JAN97 & 9JUL97 pt exp ataxia;
Constant runny nose in beginning, dizzy, stomach ache, achey joints muscles, irritability, feeling water swooshing ears, feelings of cold sensation on inner thigh, some headache
Moderna Covid-19 Vaccine EUA Chills, joint pain, headache, palpitations (ekg from Watch showed PVC's- I am Cardiology nurse) that lasted approx 12 hours
Child started coughing and face and eyes started turning red, wheezing. Slight redness at site. Orapred, Benadryl, Epinephrine given.
He had two vaccines that I am aware of:   J and J at Health dept 5-7-21  and Pfizer on 11-26-21 at this locatioin   pharmacy  Nursing Home resident  sent to ER  2-2-2023 with what they thought was chest pain (he is unable to give history)  , did not have MI, had dehydration, covid and renal issues and found to have E coli UTI and was rehydrated.  Also had high sodium.   On 2-7-23 he tested + for covid and had to be kept for five days and then ended up being transferred to med center to consider Peg tube.   His course was complicated and he was sent to hospice for further care.
Received a dose of Pfizer Covid vaccine 02/07/2021. She received a dose of Moderna vaccine on 9/14/2021
only received one dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter was the patient's friend who reported that her friend only received one dose of Shingrix. The reporter did not wish to provide any demographic information for herself or for her friend. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
12-14-2011 - Headache reported. 1st seizure. High fever at 104 degrees and vomiting. 12-15-2011 - Vomiting, 2nd seizure, ER and hosp. admission 1 day. 12-17-2011 - Seizure, ER and hosp admission 2 days. 12-25-2011 - Seizure, ER and hosp. admission 5 days. ADEM diagnosis.
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 29-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 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-009507513-1810USA001959.
case had symptoms. home tested for covid. was positive and went to hospital where upon she was admitted on 1/26 and is still there now
violent shivering for 6 hours; muscle aches for 24 hours; headache
patient reported redness in arm. I believe patient reported to rph on duty on Saturday 6/13. pt claims she was going to urgent care. rph called patient on sunday 6/14 to follow up but patient did not seek medical care yet.
he records his blood pressure every day, it had been 160-170 /90 since Friday (12Mar2021); This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and autoimmune disease. The patient reported that he records his blood pressure every day, and it had been 160-170 /90 since Friday (12Mar2021). Therapeutic measures were taken as a result of the event. The patient stated that he had been increasing his blood pressure medication from 25 mg to 40 mg, and that his HCP instructed him to call if his blood pressure goes up to 180 in 2 days in a row. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Nauseous, disoriented, my tremors in my hands got worse with more frequency and more amplitude later on in the evening and the next day it was even worse. Also had "freezing" where i sit and cant move around. Out of balance.
stomach cramps, intestinal cramps, burning sensation in the entire abdomen for over 12 hours
Large red raised area (like a single hive) about 4" in diameter around injection site. Starting itching 2/21/2018, but did not look at site. Work up 2/22/2018 and it was very tender, red and swollen along with itchy.
still having breathing issues; fever till last night; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (still having breathing issues) and PYREXIA (fever till last night) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced DYSPNOEA (still having breathing issues) and PYREXIA (fever till last night). On 01-Jun-2021, PYREXIA (fever till last night) had resolved. At the time of the report, DYSPNOEA (still having breathing issues) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
This spontaneous report as received from a registered nurse refers to her 61 year old husband with no pertinent medical history and no drug reactions or allergies. On 18-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J008434, expiration date 11-OCT-2014) (dose and route not reported). Concomitant therapies included LEVOXYL. The nurse reported that on 21-NOV-2013, 3 days after vaccination, the patient had severe pain on the scalp area and redness on right ear. He was taken to the ER and diagnosed with shingles. The "next day" on 22-NOV-2013, the patient had lesions typical of shingles. The patient continued to experience tingling on the side of his face. The patient was treated with FAMVIR. There were no Lab diagnosis or studies performed. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Woke up the morning and was so weak I couldn't walk. No fever. Stayed in bed all day. Next day I was 90%. The following day I was fine. After the second vaccination I found what I thought was a blood clot between the second and third finger of my left hand. Went away after six months.
Patient was seen and examined on 12/24/2021.  The electronic chart / pertinent notes reviewed.   Patient is a 66y.o. with a past medical history of COPD on 3.5L nc at baseline, HTN, DM2, CAD s/p CABG, CHF with preserved EF, pulmonary hypertension, CKD IV, OSA, and anemia who who presented to facility with a complaint of shortness of breath. Patient currently on bipap and still lethargic so is poor historian, much of the history is obtained from the chart. She was found to be satting 36% by EMS at home. Placed on NRB which was then weaned to 6L nasal cannula. Patient still lethargic and she is a difficult ABG stick, so she was placed empirically on bipap for presumed CO2 retention.    Upon my evaluation, patient on bipap with fio2 32%. She is slow to answer but spontaneously alert with eyes open following commands. Per bedside RN, this is an improvement in her mentation from prior. Patient states she is comfortable with bipap and is feeling better. Emotionally distressed at learning she has COVID. Complaining of pain in her back and sacrum. She was vaccinated x2 with moderna. She had a CXR which is being read as multifocal pneumonia. Of note, patient recently discharged on 12/15 from our facility for AKI on CKD. She was COVID negative during that admission.
pt vax 2nd hepta B. pt ex rapid heartbeat, lightheadedness, pallor, & tiredness.  sx resolved w/i few hrs.
After I had acute left side abdominal small intestinal - bloating and gas. There was acute pain. It felt like it was CEBO - but it hit fast and hard. All on the left side and with the unusual pain that came with it. Cramping that was unusual. The next day it did the next thing where it was painful to be standing and walking because of the pain. Left side bloating - very left side. Really not feeling great; burping and gas. CEBO isn't just one side so that was not seeming it. I called this GI doctor last Thursday and he ordered a CT scan which I am going to have next Friday - he ordered a Fecal test (and I dropped that sample off already) - CT scan for next week. He put me on Xyfaxan - (My Internist had put me on that) and Doctor got me in and my GI doctor continued it. At first it was getting better with the first five days of Xyfaxin  but then it wasn't working after those five day.   Dicyclomine - I am not currently on it but the GI doctor gave it to me to use as necessary. So we're mid-diagnosis at this time.  My Gastroenterologist is seeing this kind of thing being triggered by the vaccine. GI system is largest part of the immune system and my previous reactions  to dose 1 and dose 2 of the COVID vaccines were auto-immune responses (with arthritis symptoms that were happening in my joints - that didn't happen with this vaccine). My blood sugar went completely bananas - he said that was a side affect of a side affect (Tangentially caused by the vaccine). There are some CEBO symptoms but there are more than CEBO symptoms.
Expired vaccine is stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 18-Oct-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment medications were reported.