chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 06-OCT-2016. This case involves a 55-year-old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 04-OCT-2016, one day following the vaccination, the patient developed a general rash. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I95.9 HYPOTENSION 2/24/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 2/15/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I95.9 HYPOTENSION 2/24/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXIA 2/15/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I95.9 HYPOTENSION 2/24/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 2/15/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 RECURRENT PULMONARY EMBOLISM I95.9 HYPOTENSION 2/24/2022 RECURRENT PULMONARY EMBOLISM R09.02 HYPOXIA 2/15/2022 RECURRENT PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I95.9 HYPOTENSION 2/24/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 2/15/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I95.9 HYPOTENSION 2/24/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 2/15/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I95.9 HYPOTENSION 2/24/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 2/15/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART I26.99 ACUTE PULMONARY EMBOLISM 3/14/2022 UTI (URINARY TRACT INFECTION) I95.9 HYPOTENSION 2/24/2022 UTI (URINARY TRACT INFECTION) R09.02 HYPOXIA 2/15/2022 UTI (URINARY TRACT INFECTION)
CANNOT RISE UP THE LEFT ARM; LEFT ARM HURTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s on right arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cannot rise up the left arm. On 19-MAR-2021, the subject experienced left arm hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot rise up the left arm, and left arm hurts. This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative. Reporter details (address, city, zip code) and due diligence.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious
heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition".  Additional information: She said that she had a daughter-in-law who had a heart condition and she had a covid shot. (She also mentioned that they both had 2 covid shots and 2 boosters).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300197739 same AE./drug,different patients;US-PFIZER INC-202300197463 same AE./drug,different patients;
This spontaneous report as received from a pharmacist refers to a child of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The pharmacist stated that an on either 06-MAY-2017 or 07-MAY-2017 a child in the same family as the patient was vaccinated with M-M-R II, for prophylaxis (route, lot# and expiration date unknown). The following day (approximately 07-MAY-2017), the patient developed a rash (NOS). It was unknown if the patient sought medical attention. The outcome of the rash was unknown. No additional information was available. Additional information has been requested.
This is a spontaneous report from a contactable consumer reporting for herself. This 65 year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration on 02Aug2017 for vaccination for Streptococcus pneumoniae. The patient medical history and concomitant medications were not reported. The patient started getting sore throat on 02Aug2017 soon after the shot, watery eyes in the afternoon of 02Aug2017, runny nose, nausea feeling, wasn't sleeping well and headache on 03Aug2017, on an unspecified date in Aug2017 (02Aug2017 or 03Aug2017) she felt like it was swollen in her throat, temperature was not normal anymore (99.7 degrees Fahrenheit) on 04Aug2017. She called the doctor who mentioned it could be an allergic reaction to the vaccine. The doctor asked her if she has trouble swallowing. She explained she could still swallow, but felt like it was swollen in throat. She was not wheezing. She took TYLENOL to treat headache and BENADRYL 1/4 tablet twice a day as instructed by doctor for other events. The doctor also told her to drink a lot of fluids, and if it would get worse advised her to go to urgent care. The patient was not recovered from sore throat (slightly worsened), watery eyes, runny nose, nausea feeling, felt like it was swollen in her throat, headache and abnormal temperature, she was recovering from not sleeping well.
patient presented for booster vaccine and visit noted for Pfizer booster. After administration it was noted in vaccine history and vaccine card that the initial dose was Moderna.
felt itchy in the face and legs. Benadryl 25mg po at 1135 with good effect
Patient complained of neck stiffness/soreness the day after his flu vaccine, that progressively got worse. He was taken to emergency department on 09/24/22 where he was diagnosed with Torticollis. Emergency department advised this could be due to the flu vaccine, but  origin is unknown. Patient was treated with opioid and muscle relaxer, and to follow up with primary doctor if unresolved in 72 hours. Patient has significant history of leukemia.
Blacked out at store the day after the vaccines administered.  Resulting in Bruise on front of Brain, and fracture of skull on back side of head
When I woke up in the morning, I was extremely nauseous but never through up. My entire body was very achey, injection site very sore but not red or swollen. I had a fever and chills on/off all day. I had a pneumonia vaccine and a flu shot, but I don't have specifics on names, manufacturer, etc. I don't know if the names/manufacturer I listed are correct but it's not giving me the option to say unknown.
This case was reported by a physician via call center representative and described the occurrence of calcium increased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 15th August 2018, the patient received SHINGRIX. On 22nd August 2018, 7 days after receiving SHINGRIX, the patient experienced calcium increased (serious criteria hospitalization), potassium decreased (serious criteria hospitalization) and creatinine high (serious criteria hospitalization). On an unknown date, the outcome of the calcium increased, potassium decreased and creatinine high were recovered/resolved. It was unknown if the reporter considered the calcium increased, potassium decreased and creatinine high to be related to SHINGRIX. Additional details were provided as follows: No batch number or expiration date of Shingrix was provided. The patient was hospitalized with calcium as high as 16.1, potassium as low as 2.9 and creatinine as high as 3.0. Extensive workup with multiple specialists was done but showed no definitive cause. The patient had since recovered. Lab Comments: On an unknown date, extensive workup with multiple specialists was done but showed no definitive cause.
Milf confusion, escalating to severe cold symptoms. Severe fatigue and sleepiness. Fever of 101, taken under arm
completed the dosing over a year ago and most recent flare up was undergoing at the day of call; shingles episodes/flare up; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 26th October 2020, the outcome of the shingles was not recovered/not resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient had completed the dosing for Shingirx but still had shingles episodes.  The patient completed the dosing over a year ago and most recent flare up was undergoing at the time of reporting (on 26th October 2020). The case was considered as suspected vaccination failure since the details regarding laboratory confirmation were not provided. The reporter consented to follow up.
My left arm and shoulder, where the second dose was given, continued to hurt very much after the vaccination. Also, my joints hurt and my legs became weak (both still are). Because of this, my foot steps are unstable.
Information has been received from a licensed practical nurse (L.P.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning herself, a 24 year old female patient with no pertinent medical history and no drugs reactions or allergies who on 14-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # unknown). There was no concomitant medication. The nurse reported that on 20-SEP-2010 when she was her doctor, she had a positive urine test for pregnancy. Last menstrual period (LMP): 20-AUG-2010. Her estimated date of delivery (EDD) was 27-MAY-2011. At the time of this report, the patient's outcome was unknown. Follow up information has been received from another nurse reported that the patient's pregnancy ended in miscarriage; with dilation and curettage (D&C) performed on 25-OCT-2010, she verified that the patient's LMP was 20-AUG-2010 and EDD was 27-MAY-2011. This was the patient's first pregnancy. The following course of events leading up to the patient's miscarriage: The patient was seen by general practitioner doctor when her pregnancy was first determined in September 2010. When the discovery of vaccine exposure during pregnancy was determined, she was referred to Doctor for gestational counseling and prenatal care. Patient's first appointment with doctor was on 28-SEP-2010. It was determined in early October 2010 under doctor's care that the patient's HCG lab values were slowly decreasing, the urine beta-human chorionic gonadotropin test (HCG) values were not readily available. The patient had an ultrasound on 19-OCT-2010 which reported the following: Diagnosis of missed abortion, 7 week old fetus not viable. There was no fetal cardiac activity and yolk sac was small for gestation. The patient was scheduled for and underwent a dilation and curettage (D & C) on 25-OCT-2010. The contents of conception were examined for pathology and the results are as follows: The uterine contents showed immature placental villus tissue with mild hydropic features with a possible hydatidform mole. When asked if any cancer was seen, the reporter stated there was no mention of cancer in the pathology report. The reporter stated the patient was currently 8 weeks' pregnant (estimated LMP 27-JUL-2012) and doing well so far. Missed abortion, miscarriage and possible hydatidform mole were was considered to be an other important medical event. No further information is available.
fever of 38.6; cold fingers all day; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 16Dec2020 at 18:15 at 48-years-old at a single dose for COVID-19 immunization; administered in a hospital.  Medical history included Vertigo, chronic pruritus from Apr2020 to Jul2020 (Vertigo, chronic pruritus (treated and recovered with gabapentin).  Concomitant medications included ergocalciferol (VIT D), krill oil (MANUFACTURER UNKNOWN), niacin (MANUFACTURER UNKNOWN), guaifenesin (MUCINEX), loratadine (CLARITIN); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination).  The patient previously took ketoconazole and experienced Known allergies, gabapentin for pruritus and vertigo; all from an unspecified date to an unspecified date. On 16Dec2020, the patient experienced: very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm. On 17Dec2020, the patient experienced: cold fingers all day (non-serious). On 17Dec2020 at 17:50, the patient experienced: fever of 38.6 (non-serious). Prior to the vaccination, the patient was diagnosed with COVID-19; and since the vaccination, the patient had been tested for COVID. The patient underwent lab tests and procedures which included body temperature: 38.6 on 17Dec2020, Oral Throat Swab PCR (polymerase chain reaction): positive on 22Nov2020, Oral Throat Swab PCR: negative on 10Dec2020.  Therapeutic measures were taken as a result of cold fingers all day, fever of 38.6, very sore deltoid area from the night of 12/16 thru 12/17, cant raise my right arm. The clinical outcome of the events: cold fingers all day, fever of 38.6, was recovered on an unspecified date. The clinical outcome of the event, very sore deltoid area from the night of 12/16 thru 12/17 was recovered on 17Dec2020. The clinical outcome of the event, cant raise my right arm, was unknown.
My intestines flared up and were very painful.  I took some Tylenol and the pain dissipated.  The following 2 days, every lymph node itched very badly.   This dissipated after 2 days.  7 days later, there was blood test showing elevated amount of A cells and Platelets.  Follow up tests are yet to be performed.  Pacemaker logs show many irregularities as well, so doctor proscribed blood thinners.
swelling, red, hot to touch, 6 days p/vax;MD gave ATB to prevent infect;
GBS 2 wks p/vax on respirator 6 mos; pneumonia; vibration either markedly diminished or absent below the knees & wrists; strength dec; back discomfort, ascending paralysis, resp paralysis & multiple pulmonary complications & infections;
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 18 years old male patient who was vaccinated with 0.5 ml first dose of MENACTRA (batch number: U4288AA and expiry date: 07-Oct-2013) via intramuscular route in the left deltoid on 02-Aug-2012. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was vaccinated with a first dose of TDAP on an unspecified date. It was a case of actual medication error due to missed dose because a booster dose prior to 16 years old acne be given which was missed. It was reported that the patient was getting ready to receive second dose shortly at age 18. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Delayed injection site reaction; Redness; Injection site pain; Swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), ERYTHEMA (Redness), SWELLING (Swelling) and INJECTION SITE REACTION (Delayed injection site reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache) and SWELLING (Swelling). On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) and ERYTHEMA (Redness). On 24-Apr-2021, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), ERYTHEMA (Redness), SWELLING (Swelling) and INJECTION SITE REACTION (Delayed injection site reaction) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given
Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  Expiry date of vaccine was  12 Oct 2021. The reporter thinks it was the second dose but was not sure.   This case was linked to MOD-2021-354381, MOD-2021-354454, MOD-2021-354535, MOD-2021-355209 (Patient Link).
Mom reports that this young man had nausea and fever beginning the night of 8/21/01 and then vomiting and diarrhea beginning 8/22/01. As of 8/23/01, the symptoms continues. Mom reports that child had similar symptoms, lasting 1 week, after vaccinations on 7/11/01.
Patient noticed left bicep turned red and tender, also had fever 12/28/16 and 12/29/16, pt took acetaminophen for 2 days.
On 1/29/02, woke up with a sore arm. A few days later, maybe on 2/1/02, was swollen under arm. Left arm from injection site up to left side of neck painful with some types of movement, especially in back. Swelling under arm is gone at this time. But pain from injection site to neck is still there. Referred to physician.
pt woke up 11PM w/stomach cramps-hives-severe h/a;nose stopped up;took med;relief in 45min-1hr;
Pt recvd 3 doses of Engerix-B 6AUG90, 2SEp90, & FEB91; 4AUG91 pt exp elevated liver enzymes; Pt was hospitalized & is being monitored;
Patient vaccinated at a clinic on 8/9/23 and seen by me at a different clinic on 9/5/23.  Pain at injection site for approximately 5 days.  Symptom resolved and patient has been experiencing pain without paresthesia or decreased motor function at the injection site over the past couple weeks.   Patient with pain upon palpation and with movement of arm. No scar tissue.  Pain is starting to subside.
Information has been received from a Healthcare Worker concerning a 23 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 30-DEC-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 665547/1318Y). On 24-FEB-2010, the patient was vaccinated with the second dose of GARDASIL. Concomitant therapy included unspecified oral contraceptives. It was reported that on 25-FEB-2010, after receiving the second dose of GARDASIL, the patient developed itching and a small lump on her left arm at the injection site. At the time of the report, the patient had not recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from the Healthcare Worker who reported that the patient with no pre-existing allergies, birth defects or medical conditions, on 24-FEB-2010 was vaccinated with the second dose of GARDASIL. It was stated that the patient called on 01-MAR-2010 with complaints of soreness at the injection site, "small bump" (7-8 mm of diameter). The patient was advised to go into the office to be seen right away. On 03-MAR-2010, the patient went to the office when the dime sized indurated tender bump felt at the injection site. It was reported that the patient stated that it was slightly larger before. No other problems or findings were reported. No laboratory diagnostic studies were performed. No further information is available.
Onset of numbness 7 hrs post injection from site of injection from right deltoin to wrist. Non-itching rash also present both arms. Also c/o nausea  To ER given injections of benadryl and toradol injections.  Symptoms resolved by morning of 2/2/22.
This patients just went around the county get vaccinated so she could get gift cards.  She did not provided her correct information so we could not find her in the database.  She got 3 pfizer on 8/14; 8/17; 9/14, and got a J & J on 10/08.  I can't get a hold of her because she is homeless.