chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in bones of feet and toes; sore arm/both legs in pain/pain in both feel; minor knee pain/mild knee painboth knees; swelling in the feet; Muscle pain in calves/Mild pain in calves muscles both legs/pain right thighmuscle; mild soreness at injection site; minor bruise near injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (minor bruise near injection site), PAIN IN EXTREMITY (sore arm/both legs in pain/pain in both feel), SWELLING (swelling in the feet), BONE PAIN (Pain in bones of feet and toes) and VACCINATION SITE PAIN (mild soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nephrectomy on 02-May-2002 and Splenectomy on 02-May-2002. Previously administered products included for an unreported indication: BOOSTRIX (Patient took  one dose of injection in arm.) on 08-Jan-2021. Concurrent medical conditions included COPD since 26-Jun-2018 and Allergic reaction to antibiotics (Amoxicillin). Concomitant products included LOSARTAN from 2018 to an unknown date and HYDROCHLOROTHIAZIDE from 2018 to an unknown date for Blood pressure high, IPRATROPIUM from 2018 to an unknown date for COPD.    On 03-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE BRUISING (minor bruise near injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at injection site). On 15-Feb-2021, the patient experienced MYALGIA (Muscle pain in calves/Mild pain in calves muscles both legs/pain right thighmuscle). On 16-Feb-2021, the patient experienced SWELLING (swelling in the feet). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm/both legs in pain/pain in both feel) and ARTHRALGIA (minor knee pain/mild knee painboth knees). On 19-Feb-2021, the patient experienced BONE PAIN (Pain in bones of feet and toes). The patient was treated with PARACETAMOL (TYLENOL) on 16-Feb-2021 for Pain, at an unspecified dose and frequency. On 18-Feb-2021, SWELLING (swelling in the feet) had resolved. At the time of the report, VACCINATION SITE BRUISING (minor bruise near injection site), PAIN IN EXTREMITY (sore arm/both legs in pain/pain in both feel), BONE PAIN (Pain in bones of feet and toes), VACCINATION SITE PAIN (mild soreness at injection site), MYALGIA (Muscle pain in calves/Mild pain in calves muscles both legs/pain right thighmuscle) and ARTHRALGIA (minor knee pain/mild knee painboth knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Medical history updated and concomitant drugs were provided. Prior vaccine details provided. Event outcome for selling in feet was changed from unknown to recovered with stop date.
Rash over body.; Rash is red; Rash is red and sometimes contain water and grew bigger.; 'I' felt itchy; Short fever; Several days of tiredness/felt again tired.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took ibuprofen (MOTRIN) for an unknown indication on an unknown date and experienced drug allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD157) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 16:15 the patient experienced rash over body. The rash was red and sometimes contained water and grew bigger and the patient felt itchy. Additionally short fever and a several days of tiredness, even after nearly two weeks after the 2nd dose the patient felt tired again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash over body, felt itchy, short fever and a several days of tiredness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
midnight he had vertigo once; Soreness at the injection site; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (midnight he had vertigo once), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 18-Oct-2021, the patient experienced VERTIGO (midnight he had vertigo once). In October 2021, VERTIGO (midnight he had vertigo once) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown.            Treatment medications included Antibiotic and steroids.   This case was linked to MOD-2021-358840 (Patient Link).
Had a heartbeat of 119 BPM. I have never had a heartbeat this high before, even under stress. Additionally, after I went to the ER I got an unusual bruise after having an IV put in me. I have gotten an IV before but I never bruised this badly.
deathly ill with the flu until it finally killed her; Initial information received on 07-Oct-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional via public post on the Sanofi flu shot campaign.   This case involves female patient (unknown age) who was deathly ill with the flu until it finally killed her (influenza), while she received INFLUENZA VACCINE.  The patient's past vaccinations included flu shots (INFLUENZA VACCINE) every year and every year she was deathly ill with the flu.  Concomitant medication(s), medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number and expiration date were not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was deathly ill with the flu and that it finally killed her (influenza) (serious) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome of the event Influenza was fatal as the patient died due to it on an unknown date.  It was not reported whether the autopsy was done or not and the cause of death was reported as Influenza.  Information on the batch number to be requested.; Sender's Comments: A case was reported which involves a female patient of unknown age who died due to influenza, after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. The patient used to have flu shots every year and had got ill every time in the past. Additional information regarding patient's relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results is needed for complete assessment of the case. Thus, a role of the vaccine could not be assessed.; Reported Cause(s) of Death: deathly ill with the flu until it finally killed her
Pt developed swelling, redness and warmth to injection site. Was given Kinrix.
I had Moderna COVID-19 vaccine EUA.   Somewhere between one and two weeks following my first injection, I experienced rapid heartbeat and increased blood pressure. I saw my doctor and he referred me to the hospital ER for further testing. All lab work was WNL.
This spontaneous report has been received from a physician referring to a 18 year old male patient. The patient did not have drug reactions or allergies. Information regarding the patient's concurrent conditions and concomitant medications was not reported. The patient presented symptoms of anemia in Spring 2017. On an unspecified date in April 2017, a colonoscopy was performed (results were not reported). On 15-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N000326, expiration date 14-OCT-2017 (strength, dose, route and anatomical location were not provided) for prophylaxis. On 22-AUG-2017, the patient received the second dose of GARDASIL 9 lot # N007931, expiration date November 2017 (strength, dose, route and anatomical location were not provided) for prophylaxis. On an unspecified date in 2017, the patient was diagnosed with Crohn's disease. The patient went to the physician's office for medical attention and he received an unspecified treatment. The outcome of Crohn's disease was reported as not resolved. The causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon internal review the event of Crohn's Disease was determined to be medically significant.
?Covid arm?. No symptoms immediately after vaccination. Red, sore, swollen area appeared on top of left shoulder more than a week after my second dose. It has been getting larger and more painful for the last 5 days. It?s circular, more than an inch in diameter, warm to the touch.
headache; Soreness in left arm; nausea; swollen face on left side; dizziness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 in the right arm on 15Jan2021 (Lot number: unknown) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. On 05Feb2021, the patient experienced soreness in left arm, nausea, dizziness, swollen face on left side and headache. No treatment received for AE. On 07Feb2021, the patient tested COVID post vaccination. The patient tested Nasal Swab and the result was negative. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Developed a rash on both arms and lower legs. Also on upper body. Flat red rash. Vaccination site is a bit sore. When the vaccine was administered on February 1 my upper arm was a little sore. On February 10 was when I first noticed the rash. It first  noticed it around the vaccination site o my upper left arm the it spread down both arms, upper body and legs. My left arm was swollen around the vaccination site. Did not have any fever or  inability to breathe. My next shot is due on March 1.
6 hrs- whole left arm heavy, sore deltoid, fatigue 18 hrs- Day 2 moderately severe headache, stiff neck, heavy appendages x 4 as if concrete, elbows, wrists and knees ache, but low back pain worse, shivers, cold/hot feeling off and on, sleepy Day 3- headache 50% better, neck quite stiff still, low  back pain but joints better.  Still fatigue, anorexia.
This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old  female patient received PREVNAR 13 (Lot# L99262, Exp Date Nov2016), intramuscular at 0.5 ml, single in the left upper arm, on 24Nov2015 for immunisation. Medical history included stage 2 kidney disease from 2014 and ongoing, back surgery in 2001 and in May2015. Concomitant medication included lisinopril since 2006 and ongoing, amlodipine since 2011 and ongoing. On 30Nov2015, the patient experienced slight dull headache, lower back pain, pain in the side around her waist area, joint pain in the knees, muscle aches, fatigue, general feeling of discomfort or illness, couldn't lie down to sleep, pain shooting in her legs, shooting to the back of her arms, 9 on a scale of 0 to 10, severe stiff neck towards her shoulder, general feeling of discomfort or illness, sometimes loses her voice and becomes hoarse, shakiness. In Nov 2016, the patient was hospitalized due to these events and was treated with Dilaudid with outcome of recovered. Also experienced feels weak on 30Nov2015 with outcome of unknown, pain gets much worse when lying down on an unspecified date with outcome of unknown.  Follow-up (03MAR2016): Follow-up attempts completed. No further information expected. Follow-up (31Oct2016):  New information obtained from a contactable consumer includes: Concomitant added, outcome, treatment received, and hospitalization.; Sender's Comments: Linked Report(s) : 2015423784 Legacy paper report number.
C/O flush to facial region,   observed, no treatment. Flushing  subsided, feels better..
Moderately severe headache, Dizziness, Sore arm (8/10), Rigors, Fever by touch, Nausea, malaise, muscle weakness. I couldn't have worked. Lasted 4 days. Worse on day 1 and 2. I did have similar symptoms with the first dose 2.5 months earlier but not nearly as severe. Would not get another immunization with SHINGRIX if it was recommended.
barely walk; severe side effects; Initial information received on 16-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient (age and gender: unknown) who experienced barely walk and severe side effects while receiving vaccine Influenza vaccine.  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 of suspect influenza vaccine produced by unknown manufacturer (strength, dose, route, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed  a non-serious events barely walk (gait inability) and severe side effects (vaccination complication) (latency: unknown) following the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (gait inability, vaccination complication).  At time of reporting, the outcome was unknown for the events gait inability, vaccination complication.
This  72 year old male received the Covid shot on 2/6/21 and went to the ED on  2/18/21 and was admitted  on  2/18/21 and again on 3/13/21  with  the diagnoses listed below.  COVID-19 Pneumonia due to Coronavirus disease 2019 Cerebral infarction, unspecified
Developed a few hives while sleeping. Treated with a little hydrocortisone cream. Hives were gone next morning. Didn't seek medical care.
HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis; This spontaneous case was reported by a pharmacist and describes the occurrence of DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis) in a 7-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. In November 2022, the patient experienced DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis). At the time of the report, DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. HCP confirmed that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis, diagnosed November 2022. HCP informed that treatment has not commenced, however, the patient's prior treatments included antihistamines topical and over the counter. HCP explained that the patient will require additional vaccines as well as other vaccines afterwards because this treatment can effect their immune system. HCP did not have previous vaccine product information.
worsen episode; heavy breathing; lightheadedness a day; passed out; the left arm was very weak then the whole body very weak; trouble breathing like a shortness breath; tingling feeling in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ASTHENIA (the left arm was very weak then the whole body very weak), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body). On 12-Jun-2021, the patient experienced RESPIRATORY RATE INCREASED (heavy breathing) and DIZZINESS (lightheadedness a day). On 15-Jun-2021, the patient experienced CONDITION AGGRAVATED (worsen episode). The patient was treated with LORAZEPAM (ATIVAN) on 15-Jun-2021 at an unspecified dose and frequency. On 11-Jun-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (trouble breathing like a shortness breath) and PARAESTHESIA (tingling feeling in the whole body) had resolved. At the time of the report, RESPIRATORY RATE INCREASED (heavy breathing), DIZZINESS (lightheadedness a day), CONDITION AGGRAVATED (worsen episode) and ASTHENIA (the left arm was very weak then the whole body very weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include birth control very low dose.  Based on the 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. Further information has been requested.; Sender's Comments: Based on the 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. Further information has been requested.
Patient is a Gravida 2, Para 1001, with a due date of 7/2021. She received the first dose of the vaccine when she was 29 0/7 weeks gestation. She experienced chest pain and shortness of breath and at 10:00 PM she was admitted to \HOSPITAL EMERGENCY ROOM. Her heart rate was 122, Temp 99.1 °F (37.3 °C) (Oral) | Resp 19 | SpO2 97%  She was given IV fluids and Acetaminophen Tab 1,000 mg.
Nausea; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headaches). On 13-Mar-2021, NAUSEA (Nausea), CHILLS (chills) and HEADACHE (headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On 17-Mar-2021, the patient again had nausea and headache which resolved on 18-Mar-2021.  The patient may took paracetamol and ibuprofen.
10-28-16 phone call from pt's husband stating pt's arm is red and swollen where she received the pneumonia yesterday. Encouraged to contact MD for evaluation. Phone call received from pt's husband stating pt is being admitted to hospital for IV antibiotics. 10-31-16 phone call to pt husband states was in the hospital for 3 day and was sent home with oral antibiotics. States MD told them she had an infection from a contaminated needle.
SORE ARM; both vaccines administered in left arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone (Inactivated Influenza Vaccine)) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix and Fluzone (Inactivated Influenza Vaccine) at an unknown dose and frequency. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and off label use. The action taken with Fluzone (Inactivated Influenza Vaccine) was unknown. On an unknown date, the outcome of the pain in arm and off label use were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received both Fluzone and Shingrix during same visit. Both  vaccines were administered in left arm. which led to off label use. No report of adverse events were reported other than sore arm.
This spontaneous report as received from a female consumer of unknown age refers to herself. On 18-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous, lot # not provided. On 19-JUL-2013, the patient experienced an enlarged redness with bumps at the injection site for ZOSTAVAX. Caller stated the area was like a hard-knot. The patient did not seek medical attention. There was no treatment given for the patient's events. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information is not expected.