chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy on arm where shot was recvd x 1 day; sore arm-red presently; malaise x 1 day; pain in neck & arm;
parent reports that patient started having symptoms on 1/27/20 of severe anxiety, auditory and visual hallucinations. Self harm. multiple episodes requiring in patient psychiatric care for 1 week. These symptoms having been occurring over the last 6 weeks.
This spontaneous report was received from a pharmacist regarding a 66 year old female patient, with no pertinent medical history reported. On 09-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not specified)(0.65ml subcutaneous, anatomical location not reported) for routine vaccination. It was reported that on 11-APR-2013 (reported as "today"), the patient contacted the pharmacist to report that she had a red, swollen and itchy area at the injection site that was 2-inches in size. The patient's present status was reported as not recovered. The pharmacist reported that she called a nurse of the patient's doctor, a treatment of TYLENOL and BENADRYL and not to rub was given for the event. It was reported that the patient sought medical attention by contacting the pharmacist. The pharmacist did not assess the causality between ZOSTAVAX and the red, swollen and itchy area at the injection site. Additional information is not pharmacist.
This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Missing menstrual cycle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Missing menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (Missing menstrual cycle) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED. NO CLEAR DOSE TEXT WAS GIVEN.
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04621A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 28-Apr-2021, CHILLS (chills) and PYREXIA (fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
no adverse event; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse and refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-MAR-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021827, expiration date 25-JUN-2022 (strength, dose, route and frequency were not reported); along with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S031482, expiration date 07-OCT-2021 (strength, dose, route and frequency were not reported) for prophylaxis. The nurse reported no adverse reactions.
Vaccine is placed in refrigerator on 03Nov2021 and administered on 10Nov2021; 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 (Vaccine is placed in refrigerator on 03Nov2021 and administered on 10Nov2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 03Nov2021 and administered on 10Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 03Nov2021 and administered on 10Nov2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned No Treatment information was reported.
HEADACHE; LEG SWELLING; LOSS OF APPETITE; SHIVERS; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced leg swelling. On 12-MAR-2021, the subject experienced loss of appetite. On 12-MAR-2021, the subject experienced shivers. On 12-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, leg swelling, loss of appetite, shivers, and weakness. This report was non-serious.
About 1 hour after vaccine was injected a lump started forming just below the puncture, it grew to size of an egg and became very painful and hot. I called Dr he said I should go to the E.R. because he was too busy to me. Instead I took ibuprofen for 5-6 days as recommended by my pharmacist until the lump dropped down to my elbow and disappeared.
It occurred about 4 days after the booster. I got up dizzy, and I was extremely dizzy for at least 2 days. I took meclizine which I had on hand from the previous episode after the 2nd vaccine. I had some weakness and being tired and so on for a few days after that. I did also test positive for COVID in February 2022 after booster. The doctor gave me a prescription for dexamethasone to treat COVID which did help. Symptoms for that was the worst sore throat. Could hardly eat or talk, but I did not have to go to the hospital. Just went to the drive through to be tested. A lot of tiredness for a while after having COVID. Contacted doctor - no in person visit.
I started feeling pain at the injection site the afternoon ofn1/172021.  The pain would not allow me to do any of my normal activities on that day.  I went to bed around 9:00 PM that night; however, by 11:00 PM on that date the pain at the injection site was so excruciating that I woke up and  called the Clinic nurse on demand as my pain level was 8.   The nurse told me to take some Advil and to ice my arm.  I took the Advil and ice my arm.
Information has been received from a physician concerning a patient with a birth twin who was vaccianted subcutaneously on an unspecified date with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot unknown). Subsequently, the patient developed an elevated white blood cell count of 19. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The physician reported that the patients sibling experienced an adverse reaction following vaccination WAES0606USA01411. Additional information has been requested.
Upper back hurts; Chest hurts; Huge red lump on arm from the injection; Huge red lump on arm from the injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection). At the time of the report, BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ oral (dose, lot number and expiry date were not reported). No adverse effects reported or product quality complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
11:41 C/O feeling flushed BP 155/100, HR 95, resp 18, sats 98%. Reports recent Dx of hypertension. 12:08 symptoms improved left ambulating for home verbalized understanding to F/U with primary Doctor. First vaccine.
Patient is a 50 y.o. female with a history of Crohns disease who presents with abdominal pain.  Her pain started suddenly at 6:45 this evening and has been is constant and diffuse since.  Her last bowel movement was at 4:00 p.m. and she has been passing a minimal amount of gas.  She has had significant nausea and vomiting since the onset of the pain.  No blood in her emesis or bowel movements.  Nothing has improved the pain. She denies SOB or chest pain.   Her husband notes she has been very weak the past few months and has not been able to gain much weight back though she has been able to eat adequately.   She has a history of Crohn's status post ileocecectomy 25 years ago.  She was hospitalized. Admitted on 11/16  to Surgical And Digestive from PACU with LAPAROSCOPY DIAGNOSTIC, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS .
16 yr old was given Moderna vaccine as a booster instead of Pfizer; 16 yr old was given Moderna vaccine as a booster instead of Pfizer; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer).    No concomitant products were reported.  It was reported that the patient was not immunocompromised.  No treatment drugs were reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose and route of administration were not provided; lot # M033214, expiration date: 17-JUL-2018) reconstituted in sterile diluent (manufacturer unknown). No adverse event was reported. The medical assistant stated, that a duration of the minimum/maximum temperature excursions were documented as the worst possible times due to the fact that they did not use a data logger thermometer and therefore from around 5:00 pm to 9:00 am each day they had no way to know how long the temperature excursion lasted. Generally, the excursions took place since 10-NOV-2016 to 05-APR-2017. The doses of vaccine experienced temperature excursions in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit and 15 degrees Fahrenheit to 46 degrees Fahrenheit. Additional information has been requested.
immediately started menstrual cycle on 9/8 which was 13 days early. Got the same reaction after first shot. on 9/10 I developed a rash that looks like hives- itchy red rash on under arms and torso. Still have the rash after 10 days
Child was given vaccine from an undiluted vial. No adverse affects at this time. Parents notified to monitor for any sign or symptoms of reaction and call clinic immediately.
My daughter began having a headache a few hours after being vaccinated - that was on Sunday 6/6/21 and we didn't think much of it. The headache (and fatigue) continued Monday and Tuesday as well. But by that Tuesday afternoon 6/8, she was complaining that her vision was impaired.  She couldn't see things out of the right corner of her right eye. Example, when she looked at my face she could only see the left half, not the right half. When she looked down at her phone, some numbers on the right side of the screen seemed to be missing from her field of view. Additionally, she said she was having a hard time spelling easy words (ex. "because") and was processing information really slowly when reading -- she noticed she was going much slower than normal.
Information has been received from a consumer concerning her now 6 year old son with "family genetic history (predisposition) of motor skill problems" who in August 2003, was vaccinated with MMR II (HSA) (total daily dose, route and site not reported). Together the patient was vaccinated with VARIVAX (total daily dose, route and site not reported). "Within a day or 2" of receiving the vaccines, the patient began to stare into space for 2 days and his limited language skills (mom-mom and pop-pop) stopped. Also his face began to swell and he developed a rash. He was diagnosed with apraxia shortly after receiving the vaccines. He was undergoing therapy 5 days a week for the past 4 years and had "physical issues with his gut/gastrointestinal problems". The patient was not recovered from above events. The patient sought medical attention. No further information is available.
Vaccinated at Medical Center 1/22/21 - Sunday, 1/25/21 developed rash from elbow to shoulder. Initially treated with topical meds. The pain was so severe, he saw Doctor 1/28/21 and was diagnosed with shingles. The rash remained localized to his right arm only. Treated with anti-inflammatories and pain medication. He called Medical Center to inform us he could not return 2/11 for his second vaccination due to the shingles - another person had also called with same complaint (VAERS form submitted) so a decision was made to enter both of these variances.
Around 12 PM start to feel a little chilly  and neck aches a bit (it was a little colder today so didn?t think too much of it and thought neck aches were from shrugging when a little chilly).  By 1:30-2 PM, was pretty chilly and wrapped up in sweatshirt and fleece jacket. By 3:30 PM used heating  pad and blanket but still cold.  From 4-6 PM  added another heating pad and 3 blankets totally covered from head to toe. Got up at 6 PM and took temperature and it was 102.1. (Don?t know if accurate since bundled up to much) neck aches more pronounced and giving me headache. Only lightly covered with blanket now so warming up finally  7:45 PM temp is 101.2. Whole body just achy now but especially low back.
Fever; Body ache, really severe body ache; Headache; Swelling on the injection site; Vomiting; There was too much sweating overnight, way too much that he has to shower his face; He was shivering like cold; Blood pressure gone down, it was like over 108/62; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. On Apr2021, the patient experienced Fever, Body ache, really severe body ache, Headache, Swelling on the injection site, Vomiting, There was too much sweating overnight, way too much that he has to shower his face, He was shivering like cold, Blood pressure gone down, it was like over 108/62. Reporter stated, "My son he is 23-year-old, he got his second vaccination for Covid the last Saturday at around 10:00 am and then the same day around 6:00 pm or 7:00 pm, he was kind of feeling like fever and body ache, really severe body ache and headache, so I gave him a Tylenol (treatment). Also, he has got swelling on the injection site and vomiting. So, this is Saturday night and I keep giving him Tylenol (treatment), I gave Tylenol at night time around 4:00 am. There was too much sweating overnight, way too much that he has to shower his face and also, he was shivering like cold. So, I called my consultant and as due to this Covid, he is not in the clinic. So, I still want to know as he has little bit fever but it controlled by Tylenol again. Also, this morning, his blood pressure gone down, it was like over 108/62. My son, he has no underlying condition, he is healthy, he is an athletic. So, I was wondering, is there any kind of side effect to the Pfizer dose like I described to you now." The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
itching at left arm only after 4.5 hrs receiving the vaccine; Benadryl 25mg IM inj given. Symptom resolved a few min after getting the Benadryl
She got her vaccine and after she received it she was okay, after 10 minutes she had a heated sensation to her neck, and chest and radiated down her right arm to her finger.  Her legs from the knees down went numb.  She had waves of this that would come and go.  Then her upper lip got numb decided to leave as feeling it may have been anxiety.  On her way home in the car she had these reactions again and called her husband and told him that something was not right and that she felt weird.  She talked herself out of going to the ER, and went home.  She still was feeling really weird to be ok that came and went.  She called her friend who is a nurse who told her to take Ibuprofen and to go to bed.  She felt better after about 2 hours, and seemed to be doing okay periodically until the day before yesterday when she started feeling numbness in her legs, arms and then her upper lip which was pretty severe.   The heat from the arm is burning and burns to her upper chest and neck.  Yesterday morning she could hardly feel her feet saw a report of somebody getting Guillain Barre from it.  She took an Aleeve PM to go to sleep.  She woke up yesterday morning and the muscle pain was go but the numbness was still there.   She called the CDC who told her to contact us and to get in touch with her PCP and she was seen by her yesterday who ruled out Guillain Barre.  She examined her and said that her that the glands are swollen and relays the reaction to the injection and that may be causing the neurological numbness in her arms and legs.  She put her on a 5 day steroid to see if that helps to alleviate her symptoms.   She does feel better today but still having some numbness in the arms and legs, and swelling in her glands.
11Sep90 pt vax w/ hepta B after needlestick.  12Sep90 pt devel fever 102F, chills, h/a, nausea.
pt recvd vax & w/in 30mins p/vax exp arthralgia & myalgia on the rt side of body;
expired dose of Daptacel was inadvertently administered to a patient/no AE; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 36 months old female patient who was inadvertently vaccinated with an expired second dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5206AA, expiry date: 17-May-2019) via intramuscular route in the right thigh on 18-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.  It was a case of actual medication error case due to expired vaccine used.  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 holder's 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.  List of documents held by sender: none.