chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer via a internal colleague. A 61-year-old male patient received a dose of PREVNAR13, intramuscularly on 13MAR2012 at 06:15 in the left arm. Relevant medical history included high blood pressure, high cholesterol and chronic back pain; all from unknown dates and ongoing. Concomitant medications included BENICAR HCT, lisinopril, verapamil, PROTONIX, ULORIC and ENBREL; all from unknown dates and ongoing. On 15MAR2012 at 23:00, the patient experienced nausea, diarrhea, vomiting, body ache and fatigue. The outcome of the events, nausea, diarrhea, vomiting, body ache and fatigue was recovering.  Follow-up (03APR2012): New information reported from a contactable physician via internal colleague includes: the case is not medically confirmed and no further information is available. Follow-up attempts completed. No further information expected. Follow-up (26APR2012): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a registered nurse refers to a female patient of approximately 24 years of age at the time of report. The patient's pertinent medical history included exercise induced asthma. The patient had no drug reactions or allergies. On an unknown date in July 1994 the patient was vaccinated with M-M-R II HSA. Another dose of M-M-R II was administered on an unknown date in April 1998. The concomitant medications were none. On an unknown date a lab test for the antibody titers were performed and was determined to have negative antibody titers to MMR. The patient sought medical attention by visiting the office. No treatment was provided. The outcome of negative antibody titers was not resolved. The causality was unknown. Additional information has been requested.
Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that patient had Booster dose. Also reported that on 04-Nov-2021, the vaccine was initially stored in the refrigerator. Date of administration of vaccine to the patients was on 05-Nov-2021 and 12-Nov-2021. And also stated that the vial did not undergo any temperature excursions and no adverse events as a result of this misadministration.  No treatment medications were reported.
Lump is still there until now.; Her left arm was swollen for a week or so.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump is still there until now.) and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced INJECTION SITE MASS (Lump is still there until now.) and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.). At the time of the report, INJECTION SITE MASS (Lump is still there until now.) had not resolved and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that 10days after she had a lump on her arm and her left arm was swollen for a week or so. Patient's 2nd dose of Moderna vaccine is scheduled but she said she will not probably get it. No concomitant medications were mentioned. No treatment details were reported.
Vaccine vial was not diluted in accordance with the emergency use authorization. Vaccine vial diluted with 1.8ml normal saline 2 hours and 47 minutes after removal from refrigeration. 1 vaccine dose of 0.3ml was administered from this erroneously reconstituted vial by LPN to patient. Patient waited 15 minutes in office after administration and denied any adverse effects.
the patient ''became sick"; persistent cough; This spontaneous report was received from a physician and refers to a male patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 31-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously for prophylaxis (lot number: R000550, expiration date was not reported but upon internal validation established as: 08-JAN-2020) (exact dose was not provided) used with sterile diluent (MERCK STERILE DILUENT) (formulation, dose, strength, frequency, indication, lot number, expiration date and route of administration was not provided).   On 02-SEP-2019, the patient became sick and developed a persistent cough which was currently unresolved. The patient sought medical attention and he saw the physician. On an unspecified date, unknown physician prescribed him prednisone (dose and frequency not provided), but the symptoms have persisted.   The outcome of malaise and cough was reported as not recovered. The causality assessment was not provided.
Two day post vaccine administration on the right thigh, the pt developed low-grade fevers, tender, warm, swelling lateral to injection site.
mom states pt was sleeping & was breathing very rapidly states body was shaking & that hands & feet were cold & blue;pt taken to clinic; pt appeared groggy closing eyes, sl dec in muscle tone & floppy;some cyanosis;feet cool to touch
Dizziness, Headache, HYPERtension, Tachycardia, Fatigue, sore arm Narrative:
12 hrs post vax pt woke up & had uncontrollable crying most of the noc; APAP helped but for 36 hrs had unconsolable crying; Pt happy @ this time 16MAY91;
Within 10 minutes of shot:  slight nauseousness  then throat instantly went completely dry.  Kept clearing throat.  Drank 5 glasses of water.  Took Benadryl that night to sleep.  Next day slept only 41 minutes in 36 hour period.  Followed that with a nap, woke up with migraine and vomited.  I haven't vomited in over 25 years.  Next two days had a slight headache.  Then back to normal.
Left thigh red, swollen and hot to touch.  Red/swollen area approximately 10-12 cm.  Tender to touch with walking.  Noticed Saturday 08/16/2003 at DTaP site.  Redness and swelling improved by 08/17/2003 PM.  Not so tender or warm.  Not seen by physician or Dr.
Early in the morning of February 26, 2023, I woke with pain in my left side, and it would not go away. I gave it about 45 minutes, but the pain continued. I went to the emergency department. They found blood in my urine. I got a CT scan, and they found a 3mm kidney stone. I was given some medication and sent me home to try and pass the stone at home. I had side effects from the medication and the pain made me nauseous. On March 3rd I consulted with a urologist that was helping monitor. After about a month I woke with severe pain again. I was able to control the pain with medication. I made it until Sunday, March 26, 2023, and had severe pain again and went back to the emergency. I was given morphine and sent me home again. I was given more pain medication to help before passing. I finally passed the kidney stone on March 30, 2023. I am much better as of today.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Arm got itchy/it is itchy), VACCINATION SITE PARAESTHESIA (she was also tingling), VACCINATION SITE DISCOMFORT (Felt like there was something under her arm), TENSION (Tense) and VACCINATION SITE PAIN (Whole arm was very sore/still painfull under the arm, ackey) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (About 20 years ago) and Autoimmune disorder.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (she was also tingling). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm got itchy/it is itchy), VACCINATION SITE DISCOMFORT (Felt like there was something under her arm), TENSION (Tense), VACCINATION SITE PAIN (Whole arm was very sore/still painfull under the arm, ackey) and VACCINATION SITE ERYTHEMA (Red mark the size of a nickel/big red mark). At the time of the report, VACCINATION SITE PRURITUS (Arm got itchy/it is itchy), VACCINATION SITE PARAESTHESIA (she was also tingling), VACCINATION SITE DISCOMFORT (Felt like there was something under her arm), TENSION (Tense) and VACCINATION SITE ERYTHEMA (Red mark the size of a nickel/big red mark) outcome was unknown and VACCINATION SITE PAIN (Whole arm was very sore/still painfull under the arm, ackey) had not resolved. Not Provided      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 provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Medical history and event information was updated.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dates, since 30-OCT-2014, those patients had been administered doses of ROTATEQ suspension, route of administration not reported, defaulted to oral (strength, dose, lot# and expiry date unspecified), that were exposed to a supported temperature excursion. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient notes she started feeling bad about a week ago, and tested positive on 1/11. She developed increasing shortness of breath, malaise, fever/chills, nausea/vomiting, dry cough and loss of taste/smell. She also notes increasing weakness and profound fatigue. She reports difficulty ambulating around her house. She eventually purchased a home pulse oximeter and noticed that she was 83-84% on room air and she decided to come to the ED for further evaluation. She is s/p COVID vaccination and booster.
Hive/Rash cluster on right hip, left forearm, right ear and left cheek below eye.; Hive/Rash cluster on right hip, left forearm, right ear and left cheek below eye.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 03Apr2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included TB when the patient was 17 and allergy to molds and pollen allergy. Concomitant medications included thioctic acid (ALPHA LIPOIC ACID) and multivitamin (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient previously received vicodin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient experienced hive/rash cluster on right hip, left forearm, right ear and left cheek below eye. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events hive/rash cluster on right hip, left forearm, right ear and left cheek below eyes was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient came in for 2nd covid vaccine. Had a reaction to the first vaccine and patient had an itchy throat. Patient was instructed after that visit that she was to consult her PCP for further instructions on receiving the 2nd vaccine. Patient came back to the off ice today for second vaccine. Patient was fine 15 minutes then started with the itchy throat. I did consult the provider, Vital signs were taken and was instructed to give 25 mg of Benadryl orally. Patient stated that she felt better 10 minutes after taking the Benadryl. After another 10 minutes the patient started to become sweaty and stated her chest was getting tight. I did go get a provider and he came out to asses patient. Vitals taken again and was given instructions to observe patient. After 10 minutes patient that she was feeling fine and back to normal. Patient observed for another 20 minutes then left to go home. Patient did have a driver to drive her home.
Patient became unresponsive in his chair at home. CPR was attempted by patients wife and paramedics without success. Patient is deceased.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX (strength and dose were not reported) (lot # M003440, expiration date: 20-JAN-2018) subcutaneously for prophylaxis. The administered dose of VARIVAX was reconstituted with sterile diluent (lot# and expiry date were not reported). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Redness, swelling, burning, itching, whelps at site, sore and hot to touch all at the site on left arm
The last time patient got the flu shot and pneumonia shot, patient was never so sick in patients life; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via social media.  This case involves a patient of unknown age who was never so sick in patients' life (influenza), while being received vaccine influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the last time patient got the flu shot and pneumonia shot, patient was never so sick in patients' life (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
I had a delayed reaction and have a rash that's on my back; This is a spontaneous report from a contactable consumer(patient). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 28Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2(BNT162b2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported) via unspecified route of administration as a single dose for COVID-19 immunization. The reported stated, 2 weeks after that, I had a delayed reaction and have a rash that's on my back. There was nothing else new that I changed, it was just really the vaccine on May2021. She reports concern and asks, I did see that delayed reactions can happen with the vaccine. I just wanted to confirm and how long and what I should do to treat it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
On Friday, January 8th, I started to feel pain/tenderness in my left armpit. It also felt firmer than my right armpit. I still feel pain/tenderness today, Saturday, January 9th. The pain is mild/moderate. I am still able to do my day-to-day activities.   (I did not think it was vaccine related, so I did not make note of this during my v-safe daily check in.)
Information has been received from a registered nurse concerning a 11 year old female who in August 2001, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently the patient experienced a reaction. It was unknown what type of reaction. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Follow-up information form the registered nurse indicated that this was a "possible" event cited by the patient's mother. The possible event took place several years earlier and the mother could not provided specific information regarding the event. The event took place at another clinic. Due to the circumstances the registered nurse was unable to provided any further information.
The patient is red, warm, swelling, itching, and has a 12 by 12cm area to the left deltoid.
Onset of lightheadedness/ dizziness within a hour of vaccine. Second day still experiencing lightheadedness combined with moderate headache and body aches. Taking Tylenol and Advil as needed for headache and muscle body aches.
Mother states was taking child to bathroom when she noticed right thigh swollen states child c/o pain in leg. Right thigh is edematous warm to touch and soft with redness. Refer to MD for evaluation T 99 mother states she gave child some Advil at 2:00PM 10/5/04 ER physician evaluation. Mother states swelling almost gone and a bruise is left.
Client had Pfizer vaccines for Covid on April 2 and April 30, 2021 at Hospital.  Developed Covid symptoms (fever, nasal congestion, loss of smell) on 8/20.  Tested rapid positive for Covid 8/22.  Reported as a breakthrough Covid case in fully vaccinated person.
Information has been received from business manager via a company representative referring to a 12 year old female patient with pre-existing irritable bowel syndrome. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date were unknown, one dose, once) intramuscularly. The patient has "exacerbated irritable bowel syndrome" after receiving the vaccine. The irritable bowel syndrome had worsened to the point that the patient was no longer able to go to school. The outcome of the event was reported as not recovered/not resolved. Upon internal review, the event of exacerbated irritable bowel syndrome was considered to be disabling. Additional information has been requested.
Patient got really sick starting 5/7 (the day of vaccine). On 5/9 she woke up with a large rash on her left arm but lower than where the shot was given. She was extremely tired. On 5/10 she came into the pharmacy and her arm was really warm and the rash had spread. Dr decided it was an allergic reaction later on 5/10 and prescribed famotidine because the patient is allergic to benadryl.
Pt had local reaction of erythema, edema, and pruritis at site of 1st Varicella, resolved with antihistamine. Symptoms began approx 1 wk after inoculation.
Arm Pain, nausea and vomiting , fatigue, headache, Diarrhea
Information has been received from a lawyer regarding a case in litigation. It is alleged that a female on 03OCT2012, was vaccinated with a dose of ZOSTAVAX (Merck) Lot #1160AA. After the pharmacist administered the medication, the patient began having side effects, swollen arm and redness, did not want to "seize" after patient called the pharmacist many times and instructions were given in what to do by pharmacist. On 14OCT2012, the patient was hospitalized since she could not "more" her arms and legs. In the hospital, the patient was diagnosed with Guillain-Barre Syndrome and had respiratory failure. As to date, the patient is taking physical therapy. Upon internal review, Guillain Barre was determined to be a medical significant event. Additional information has been requested.
Arm soreness, chills, sore throat, nausea, body aches, headache
pt experienced dizziness & neck pain following the vaccination.  pt. denies any other s/s.  resolved with comfort & calming measures.  BP: 152/75, HR: 81, RR: 18.  Medic paresent.
Received intramuscular injection at (L) deltoid 2nd MCV4 and FLUZONE 1/8/15 and then developed 8 cm x 10.5 cm area of redness, swelling and itching 1/9/15. Seen 1/12/15. Txd reaction: Diphenhydramine 25mg and triamcinolone 0.1% oint x 2 days.
sore left arm; increased menstrual cramps; increased menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: HF9275) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 1,SINGLE), for covid-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 19Sep2023, outcome "not recovered", described as "increased menstrual bleeding"; DYSMENORRHOEA (non-serious) with onset 19Sep2023, outcome "not recovered", described as "increased menstrual cramps"; PAIN IN EXTREMITY (non-serious) with onset 19Sep2023, outcome "not recovered", described as "sore left arm". Therapeutic measures were not taken as a result of pain in extremity, dysmenorrhoea, heavy menstrual bleeding.  Additional information: The patient had no known allergies. No covid tested post vaccination.