chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse and a 55 year old male physician who on 02-JAN-2009 was vaccinated with a dose of PNEUMOVAX (Lot# 1163X), IM in right deltoid.  There was no concomitant medication.  On 03-JAN-2009 the patient experienced soreness in his right arm, warmth and pain. The reaction went from 1 inch from the elbow to up to the shoulder and to the back.  It was really tender all around the arm.  There was no change.  The patient never received PNEUMOVAX in the past.  At the time of the reporting, the patient had not recovered.  This is one of several reports received from the same sources.  Additional information has been requested.
I have a fever and headache.  The lymph nodes in my neck are swollen and painful.
Decreased eating on oz per feeding. Increased fussiness. Increased spitting up/vomiting. Fever.
Throat swelled causing difficulty breathing, chills, fever, nausea, stomach cramps, headache, diarrhea.
Fevers, muscle, joint aches, fatigue, "crawling skin"extreme thirst X6 days as of this form
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child male patient who experienced dose of DAPTACEL was given to a patient one day past the expiration date, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose dose of suspect DAPTACEL lot C5014AA, expiry date- 29-Jul-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab data.) Final diagnosis was dose of DAPTACEL was given to a patient one day past the expiration date. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for dose of DAPTACEL was given to a patient one day past the expiration date. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
No adverse events. Vaccine given 8/21/14 by mistake. Expiration date 8/10/14. Patient had no adverse reaction.
Pt. recieved vaccine past 12 hour expiration. No adverse event. MD contacted pt. Declines revaccination.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 10-OCT-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Exacerbation of lupus symptoms following vaccines (hair loss, fatigue, joint pains, skin changes). Fatigue, Malaise 60 days, lesions, macule on scalp and face c/w lupus; on back, c/w tinea versicolor, alopecia (hair loss), joint pain, multiple joints, muscle pain.
Rt thigh redness and swelling developed within 2 days of vaccine (3x5 cm in diameter). Went away and 10 days later recurred with vesicles suggestive of chicken pox in center of redness.
This spontaneous report was received from a registered nurse concerning to a 23 year old female patient. Nurse mentioned that on an unknown date, the patient was received MMR II or monovalent vaccine as rubella, mumps and measles as a child and then in 1988 the patient had a child and received a rubella vaccine post-partum. No other co-suspects were reported. No concomitant medications were reported. The nurse stated one vaccination record had a date next to MMR and another vaccination record had a date next to rubella, mumps, and measles therefore nurse did not know if the patient received the MMR II or monovalent vaccines, rubella, mumps and measles. No treatment information was reported. The patient had another child in 2005 and had a rubella titer that was positive in March 2005. The outcome of the event was unknown. Additional information has been requested.
The doctor informed her that his son had modified measles after an MMR 2 shot; This spontaneous report was received from consumer referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant therapies,  previous drug reactions, or allergies was not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis  On an unknown date, during the reporter's daughter's doctor visit, the physician informed to the reporter,  that his son had modified measles after the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (measles post vaccine) It was unknown by the reporter if treatment was given, or if lab diagnostics were performed due to event, and the outcome of the event.    The consumer's causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II ) and measles post vaccine was not reported.  Upon internal review, the event measles post vaccine was considered to be medically significant.
Dose 1  I immediately experienced numbness and tightness and a metallic taste and mouth was numb and went away quickly. Dose 2 - extensive bruising that showed up on my legs. Urgent care said there was nothing to worry about. The bruising stayed for a week. It went away gradually and faded out. For a while it looked like it was getting bigger. It is difficult for any doctor here to acknowledge anything related to the covid related vaccine. I still had joint pains within a week and severe migraines within the month and tingling in fingertips and numbness within the same week after the 2nd dose. Severe migraine in Dec2021 and had vision changes, the next day it felt like my head had a hammer and it hurt. I went to the emergency room.
Episcleritis, inflammation in the eye, diagnosed by the eye physician and noted as unusual for a child so young, but suggested as a possible adverse reaction to the Covid vaccine
I felt numbness in my right leg, the numbness went up to my right arm and then I started slurring. This happened within a few minutes. I laid down and called a  nurse adviser. I was recommended to go to ER, so my wife took me to ER. They did CT scan of my head, then CT scan of my head and neck with contrast, then MRI of my head, then MRI of my head and neck with contrast. It was confirmed that I had an ACUTE ISCHEMIC STROKE. It was decided to perform carotid endarterectomy surgery to remove a clot in the neck carotid artery. The clot was removed.
pt recvd vax;in ofc w/ redness/swelling & bruising;advised cold packs; go to er if crying persist;4jan95 seen in ofc crying > 3 hrs;severe local rxn; pc to mom, did not take pt to er for crying;
pt recvd vax 24JAN94 & 2 month later in MAR MD observed dimple @ inject site; By 2MAY area SC atrophy & hypopigmentation of the skin (2 x 3 cm) had devel @ inject site; orthopedist consulted; no neurovascular involvement
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, the patients were vaccinated with a improperly stored dose of VARIVAX (Merck) lot # K016128, expiration date 23-SEP-2016 (dose and route were not reported). No adverse effects reported. The dates of the temperatures outside of the recommended range were 11-APR-2015 to 09-JUN-2015. This is one of two reports from the same source. Additional information has been requested.
Patient began to faint almost immediately after receiving vaccine. She sat down on the bench near the pharmacy with her mother's assistance. Pt regained conciousness but still appeared pale, she began coughing and proceeded to vomit in the trash can near the pharmacy several times. She went into the restroom with her mother to wipe her face and said she felt fine when she came out. Mother stated she has fainted and had this reaction before when having blood drawn.
Hospitalization: 2/15/2023 - 2/18/2023 (3 days) Presentation to the ED: presyncopal episode  COVID + date: 2/15/2023 Treatment: none noted.  Discharge to: home.   EL8982 2/23/2021 EN6204 3/16/2021
FACE, HAND AND ARM NUMBNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 56.8 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tadalafil, and treprostinil sodium.  The patient reported that on an unspecified date she experienced possible adverse event from vaccine which caused face, hand and arm numbness. The patient was hospitalized on 13-APR-2021. No further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face, hand and arm numbness. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked.; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-FACE, HAND AND ARM NUMBNESS. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Employee reported to ER for care on 6/5/19 reporting left sided arm redness and swelling  after receiving the tetanus vaccine.  Employee reported per ER report  "4 hours after receiving the vaccine that she had swelling, bumps on her hands spreading up her arm toward her neck and throat area.   She  describes some mild feeling of tingling in her throat and some discomfort going up the back of her head.  She denies any difficulty breathing, difficulty swallowing or any chest pain or discomfort.  She denies any other rashes or other recent illnesses".
numbness on the left side of the body; Balance issues; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MQ0A and 001A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN + HIDROCLOROTIAZIDA SANDOZ) and METOPROLOL for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues). At the time of the report, HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
Information has been received from a nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored GARDASIL. The patients were not experiencing any known symptoms. Attempts are being made to obtain additional identifying information to distinguish the individuals patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
4 pt describe severe achiness & malaise beginning 2-3 days p/vax;sx lasting 2 wk;no other sx;
SEVERE VAGINAL ULCERS; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid positive, and concurrent conditions included vaginal ulcers not related to sexually transmitted infections, and not sexually active, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 15-MAR-2021, the subject experienced severe headache. On 15-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced severe vaginal ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, and had not recovered from severe vaginal ulcers, and fatigue. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Rash and itching on back, sides and hands and armpits. This is my 3rd (booster)dose and did not have this reaction before
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.). On 15-Apr-2021, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
This case was reported by a physician via a GSK representative, and described the occurrence of bloody diarrhea in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). The subject's medical history included cow milk protein allergy. On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). At an unspecified time after vaccination with ROTARIX, the subject experienced bloody diarrhea. The subject also experienced decreased bicarbonate (11-12, unspecified units) and acidosis after a least one dose of ROTARIX. It was unclear whether the subject experienced decreased bicarbonate and acidosis after the 1st dose, 2nd dose or both doses. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. After the next vaccination with ROTARIX the events recurred (see case A0784664B for more details). There was no further information at the time of reporting.
Fever for about 36 hours and as high as 101 degrees, chills, aches, headache, red rash at injection site of about 3" x 4", extreme swelling at the injection site and it was hot to the touch. After 9 days, I still have redness and itching at the site.
chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none.  Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 14-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
extreme headache, body stiffness, fever, chills, bad digestion, body ache, sore all over
6 days after receiving vaccine, experienced  sudden onset of vertigo, vomiting. ENT determined unknown nerve damage of left ear, hearing loss probably due to interruption of blood flow. No apparent injury.
On 03/29/2021 I started feeling sick I then went to the doctor on 04/05/2021 and I was diagnosed with shingles.
maybe a little bit of arm pain; nausea; about to die; worst body aches of her life; worst headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (about to die), PAIN IN EXTREMITY (maybe a little bit of arm pain), PAIN (worst body aches of her life), HEADACHE (worst headache) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (about to die), PAIN (worst body aches of her life), HEADACHE (worst headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (maybe a little bit of arm pain) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (about to die), PAIN IN EXTREMITY (maybe a little bit of arm pain), PAIN (worst body aches of her life), HEADACHE (worst headache), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Positive test for COVID-19 1/18/2022 at a pharmacy clinic. Pharmacy assistant advised of test results and to stay home 10 days. Coughing, stuffiness and body aches lasted about a week. Fatigue lasted about 6 weeks.
Brusing, swelling and rash on ankles.  Trouble walking. Fever 101 po times 2 days. Started on 11/20/04.  Rash also on lower body. Diag- HS Purpura.  CBC, ESR and ASO titre drawn. UA ordered.  Patient also has hx of Idiopathic Hypercalcemia and Hematuria.   ESR-21  ASO-<14  UA had occult blood CBC- WBC7.2 RBC4.09 Hgb11.4 Hct34.0 Platelets367 MPV6.3 Neutrophils59 Lymphocytes 38 Monocytes3 Scheduled for recheck appointment in office.
Pt vaccinated w/DTP/OPV developed cellulitis/infection @ the injection site.
Patient had reaction after receiving 5 vaccines at his workplace at 5:10pm. Patient started not feeling well around 7pm  and fainted at work at 8:40pm. He left his workplace to go home and couldn't finish his shift.  He is experiencing  overall body pain and weakness. He is also has pain at the base of his head and pain down his spine. Patient was not showing any signs of an allergic reaction (no hives, no trouble breathing). Patient has not received medical attention for his condition but I advised him to do so if need be.
Information was received from a registered nurse concerning a patient (demographics not provided), who on 09-OCT-2013, was vaccinated with an expired dose of ROTATEQ lot # 0278AE, expiration date 21-SEP-2013. This was the first dose in the ROTATEQ series. No adverse effects were reported. Additional information has been requested.
left arm severe pain; hard stool; gas pockets; liquid stool; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia in January 1992. Concurrent medical conditions included Myositis since 2002 and Drug allergy (Sporanox, Codeine, Morphine.). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA) and CELECOXIB (CELEBREX) for Pain, ALLOPURINOL (ELAVIL [ALLOPURINOL]) for Sleep apnea, TRAZODONE, VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, VITAMIN D NOS and AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets). At the time of the report, PAIN IN EXTREMITY (left arm severe pain), DIARRHOEA (liquid stool), FAECES HARD (hard stool) and FLATULENCE (gas pockets) outcome was unknown.            treatment details not reported.   This case was linked to MOD-2021-008723 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: NNI followup received on 24-May-21.
Side Effects included: headache, body aches (back pain), low-grade fever, chills, soreness in arm after injection and throughout the next 24-48 hours, overall fatigue/tired.   Most went away after the 24 hour mark. After the 24 hour mark -- soreness in arm continued and same with the headache.