chrisvoncsefalvay/vaers-outcomes huggingface dataset:
runny nose on the side of the vaccine; the injection site irritated; watery eye on the side of the vaccine; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INJECTION SITE IRRITATION (the injection site irritated), LACRIMATION INCREASED (watery eye on the side of the vaccine) and RHINORRHOEA (runny nose on the side of the vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN and SIMVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 17-Feb-2021, the patient experienced PAIN (body ache). On 18-Feb-2021, the patient experienced INJECTION SITE IRRITATION (the injection site irritated) and LACRIMATION INCREASED (watery eye on the side of the vaccine).   On an unknown date, the patient experienced RHINORRHOEA (runny nose on the side of the vaccine). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   On 18-Feb-2021, PAIN (body ache) and INJECTION SITE IRRITATION (the injection site irritated) had resolved.   At the time of the report, LACRIMATION INCREASED (watery eye on the side of the vaccine) and RHINORRHOEA (runny nose on the side of the vaccine) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a medical assistant concerns an unspecified amount of patients (age and gender unknown). The patients' medical histories, concurrent conditions and concomitant medication use were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# M047660, expiration date 02-DEC-2018 or lot# M041513, expiration date 11-OCT-2018) for prophylaxis that were reconstituted with the properly stored sterile diluent. No adverse effects were reported. The vaccines were stored in the temperature of -14 degrees Celsius to -10 degrees Celsius for 5 hours 38 minutes. The vaccines also underwent an unspecified previous temperature excursion. The medical assistant also stated that she was unaware if any improperly stored doses were administered to any patients. She stated the storage unit has had multiple temperature excursions recently. She related these events to mechanical failure. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA002933:
Pain in the lower left leg 4 days after the 2nd dose and diagnose as Deep vein thrombosis (Blood Clot)
60 year old female given COVID 19 vaccine at OM on 1/16/21 who developed progressive L arm muscle weakness.   Began with pain at injection site on 1/30/21.  Following this over 1 week developed progressively worsening weakness in the L arm distally in the fingers extending proximally to the shoulder, and pain in the neck as well. Slight tingling in the hand.
quick onset with severe back pain, high fever that would not go down with ibruprofen, sore throat, fever that would not stay away without tylenol for 48 hours, migraines over left eye, night sweats, body pain so severe that it limited mobility
Pain in left knee. I cannot put my weight on it.; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Lot Number: En620A) as SINGLE DOSE for covid-19 immunisation, at 69 years old at Pharmacy or Drug Store. Medical history included allergies: food from an unknown date. Patient is not pregnant. No COVID prior vaccination.  No other vaccines in four weeks. No other medications in two weeks. Patient received the first dose of BNT162B2, (Lot number: En198) on 23Feb2021 15:00 at right arm for Covid-19 immunization, at 69 years old. The patient's concomitant medications were not reported. The patient experienced pain in left knee. She cannot put my weight on it on 16Mar2021 16:00. Treatment was received for the event (reported as ultra sound and X ray). Lab tests included ultra sound and x ray with unknown results on Mar2021. Event required emergency room and physician office visit. Patient was not tested for COVID post vaccination. Outcome of the event was not recovered. Seriousness criteria was reported as disability.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant mediation was not provided. On unknown dates the patients were vaccinated with a dose of oral ROTATEQ (lot# L006184, expiration date 13-DEC-2016, oral, dose and dose# unknown) which were improperly stored. Temperature and time frame was 11 degree for 35.5 hours as well as 0 degree for 241 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
red mark under injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (red mark under injection site) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (red mark under injection site). At the time of the report, INJECTION SITE ERYTHEMA (red mark under injection site) outcome was unknown.   Prior to receiving mRNA-1273, on 27-Dec-2020, the patient felt red marks under the injection site     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded
Three days after my first Pfizer dose I broke out in hives. I went to dermatologist who told me to take Benadryl for a few nights and prescribed me  desonide cream. I am getting my second dose tomorrow.
12/2/21 patient (who works at the healthcare facility) reported to ED with chest pain and SOB Patient received 3rd dose of COVID vaccine (booster) on 11/29/21 Patient experienced chills, myalgias and did not feel well starting on  11/30 Patient had cramping on right chest and PTE was detected. Patient admitted to hospital on 12/2 and started on Xarelto for PTE treatment. Patient discharged on 12/3 and Xarelto continued
w/in 1 hr of receiving vax began to vomit, & devel fever 103 & was irritable, one leg was swollen to 3x size; given APAP which reduced fever temporarily; taken to ER adm for 3 days; bladder infect dx;
Pt reports that after receiving a flu shot in her left deltoid in the afternoon 10/13/10, by evening she said her arm was "sore". This progressed in the next couple days to pain radiating from her neck to her fingers. She called the Medical Clinic NP, she rx'd Ibuprofen 800mg TID. Pain is better but still slightly sore.
resident was administered 0.5ml of vaccine above recommended dose but experienced no side effects or symptoms . Has been closely monitored with no reaction.
8/8/21: Patient arrived at the ER due to fevers and headaches. Patient tested positive for COVID on 8/8/21. Diagnosed with COVID-19 pneumonia, sepsis. 8/11/21: Patient on 3L of nasal cannula with significant cough  8/16/21: passed walk test, on room air; worsening renal function  8/23/21: worsening renal allograft function w/negative donor specific antibody 8/27/21: patient still admitted at the time of this form submission. NOTE: Patient received Moderna vaccine, first dose given on 2/2/2021 Lot # 031L20A  and second dose given on 3/2/2021 Lot # 011A21A. Patient received Moderna vaccine, first dose given on 2/2/2021 Lot # 031L20A  and second dose given on 3/2/2021 Lot # 011A21A.
- tingling from hand to face, legs, feet. - chills, achey bones, - headache, congestion, nausea, - tightness in chest
Severe upper extremity swelling; Erythema; Warm hard painful swelling; Induration; Warm hard painful swelling; Joint pain; Deltoid tenderness; Couldn't raise her arm well; A spontaneous report was received from a health care professional via telephone on 06MAR2019. The health care professional reported that the patient received her BioThrax (anthrax vaccine adsorbed) initial series with boosters then worked for awhile, and then changed jobs and restarted the series. She then received yearly boosters. On 18AUG2009 she received her annual booster and the following day, on 19AUG2009 she experienced severe upper extremity swelling, erythema, warm hard painful swelling, induration, joint pain in the knuckles of her fingers, deltoid tenderness, and she couldn't raise her arm well. She was treated with motrin, zytrec, and ibuprofen. Her next evaluation was on 24AUG2009 and it was reported that she had no joint involvement, and she still had induration but it had decreased, and the site was non-tender. The patient was told in the future to receive boosters every other year at a half dose, and she started with half doses yearly in AUG2010, and two weeks later got another half dose, and she has had some variation of half doses since then. On 28JUL2010, the patient was reported to be in good health.  Previous vaccination dates from the patient record: 29-JAN-2002 12-FEB-2002 26-FEB-2002 30-JUL-2002 30-JAN-2003 30-JUL-2003 29-JUL-2004 01-AUG-2005 09-AUG-2006 10-AUG-2007 15-AUG-2008 18-AUG-2009  Allergies reported as "penicillin mold" and codeine  No further information is expected.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 13-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 13-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unspecified age and gender. The healthcare worker reported that, on an unknown date, GARDASIL (dose, frequency, route, anatomical location, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. Follow-up information has been received from the medical assistant who provided the patients details. It was reported that the neonate patient of unknown gender, on 13-JUN-2014 (the day of birth) was vaccinated with a dose of GARDASIL lot number H020901, expiration date verified as 05-JUL-2015 (dose, frequency, route, anatomical location not reported) that from 09-JUN-2014 was exposed to temperatures between 29 degrees F and 30 degrees F. This is one of several reports from the same source. Additional information is not expected.
PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 LEUKOCYTOSIS  ACUTE RESPIRATORY FAILURE 7/26/2022 LEUKOCYTOSIS  HYPOXIA 7/26/2022 LEUKOCYTOSIS  PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 7/26/2022 ASTHMA, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 7/26/2022 ASTHMA, UNSPECIFIED  HYPOXIA 7/26/2022 ASTHMA, UNSPECIFIED
Fever and fussiness to start, followed by weakness starting in the legs, trunk and upper extremities. Ultimately diagnosed with Guillain Barre syndrome. IVIG over 5 days followed by another course of IVIG given over 5 days five weeks later.
got the shot, 2 years later got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that,got the vacine shot and 2 years later got the shingles This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Very bad migraine headaches since receiving the vaccine that have not stopped in the 6 months proceeding. No history of headaches previously.
On 4/9/2021 (approximately two weeks after my first dose of the Moderna COVID-19 vaccine) I felt a large lump in my left breast near the nipple on the side opposite my armpit (closest to the center of my body). My gynecologist completed an exam and confirmed a ~ 2cm lump. I was then referred for a mammogram and a sonogram. The lump began to decrease in size leading up to the exams, but the exams were still able to detect a small cyst at the location described above. The tests confirmed the lump was neither cancer nor a swollen lymph node. Shortly after my second dose of the Moderna vaccination on 4/22/2021, the cyst began to increase in size again. By mid-May I could no longer feel the cyst and it has not been large enough for me to notice ever since. I had never experienced a breast cyst in my life until receiving my first COVID vaccine on 3/25/2021. In addition to the cyst, I experienced heavier than normal vaginal bleeding with my seasonal birth control sugar pills beginning around 5/7/2021 and lasting for several days. This was the first time I had experienced vaginal bleeding on the sugar pills for approximately 1.5 years. Because I have been taking seasonal birth control for so many years, I no longer experience bleeding even while on the sugar pills. I will not know if this phenomenon will recur because I have not yet taken additional sugar pills since 5/7.
Patient initially called on 10/20/2017 and reported a large red swollen painful area at injection site. On 10/25/17 she reported the injection site to be itchy.
Left eye swelling above the right eyebrow area.; Left eye pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain) 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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain). At the time of the report, EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot# L002041 with expiration date of 27-JUL-2016 and lot# L013188 with expiration date of 02-NOV-2016; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Typhim Vi (Typhoid injection) 0.5 ml was mistakenly given in the back of the left arm SQ instead of IPOL (polio).  Tyhim Vi vaccine was in the state stock bin with other vaccines in mini fridge.  Manufacturer and child's pediatrician were contacted and informed.
Blood inside the eye; Burning sensation on the eye; Hot R arm of injection; Itchiness R arm of injection; Redness R arm of injection; Swelling R arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection) and VACCINATION SITE ERYTHEMA (Redness R arm of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood inside the eye) and EYE IRRITATION (Burning sensation on the eye). At the time of the report, OCULAR HYPERAEMIA (Blood inside the eye), EYE IRRITATION (Burning sensation on the eye), VACCINATION SITE WARMTH (Hot R arm of injection), VACCINATION SITE PRURITUS (Itchiness R arm of injection), VACCINATION SITE ERYTHEMA (Redness R arm of injection) and VACCINATION SITE SWELLING (Swelling R arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not receive any treatment.
1/12/2021 patient developed chills, cough, headache, nasal congestion.  Tested positive for COVID.
Headache abdominal pain  Narrative:  Per nursing report: " 2nd dose of Moderna this morning [2/2]. At 2pm c/o abdominal pain at level 8. Employee doubled-over in office with abdominal pain. Also c/o headache at level 6."
Fever of 103.3 (rectally) began on 05/02/2010 and continued fevers between 101-103 until 05/05/2010.  The fever did not react to Tylenol or other fever-reducing attempts.  On 05/06/2010, developed a rash on trunk, arms, legs, face, and neck varying from pinpoint red dots to welts.
sore blister on lip which appeared on 03/21/2021 but had other symptoms such as fever, chill, headache
Sister called 3-20-07 stating pt broke out rash 12/ hr after receiving 2nd Hep A and Varicella shot.
she experienced pain in her arm that she cant hardly move; she experienced pain in her arm that she cant hardly move; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route administered in right arm on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's second dose of the vaccine was due that day (at the reporting time) asking whether it was safe for her to get the second dose as she experienced pain in her arm that she can't move hardly on an unspecified date in 2021. She also wanted to know if she could get her second dose of the vaccine at a different arm. The outcome of events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Around 15 minutes after receiving vaccine, she complained of left sided chest pain and pressure. HR 50's, B/P 179/72. pulse ox 99% on RA. Paramedics arrived and performed EKG and advised her to follow up in the ER.
This spontaneous report as received from a pharmacist refers herself, a 61 or 62 year old female patient. The patient's current conditions included high blood pressure. The patient's medical history included cancer of the left breast (diagnosed 16 years prior to the adverse event) requiring a lumpectomy. On an unspecified date in 2011, the patient completed her three doses regimen for RECOMBIVAX HB. No dosage information or lot number was reported. Concomitant therapies included verapamil. It was reported that in February 2012, the patient was diagnosed with cancer of the left breast (considered as medically significant upon internal review). The patient sought medical attention and received chemotherapy treatment and a mastectomy for which she was hospitalized overnight. It was added that lab diagnostics studies were performed but this was not further specified. It was reported that the patient was still considered to be in remission. No further information was provided. Additional information has been requested.