chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at site of injection; Fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an intramuscular route of administration in the left arm on 09Jan2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an intramuscular route of administration in the left arm on 18Dec2020 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On 10Jan2021, the patient experienced soreness at site of injection and fatigue, which were most noticeable 12 hours after the second vaccine. 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, soreness at site of injection and fatigue was resolved on an unknown date in 2021. The patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an intramuscular route of administration in the left arm on 08Oct2021 (at the age of 21-year-old), as a single dose for COVID-19 immunisation.
heart palpitations: started 5/3/21 around 7am, early beat every ~10 beats. Later in morning 9am, skipped beat every ~10 beats. symptoms stopped around 12pm.
pt recvd vax 20OT93 & exp painful joints & stiffness in the morning; No further details were provided;
Headache, Myalgia, Arthralgia, NauseaVomiting, sore arm Narrative:
only received one moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Reaction 3 hrs after injection vomiting, nausea, jaw locked fever spiked to 102 degrees shaking, shivering hot/cold. Shot rec 2:45 reaction 6:30-6:50.
Two minutes after receiving his vaccination, he reported feeling lightheadedness. He was taken to a private section of the arena and monitored. He had resolution of symptoms within 15 minutes of monitoring.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age an gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored GARDASIL (unknown dose and route) lot # K008931 and expiry date of 04-MAR-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient had a flare up of spinal nerve pain after receiving 2 dose of SHINGRIX series. He has had a history of this type of pain, but was stable for a long period of time previous to this vaccination. He was not sure if it is related, but wanted to put the report in for data in case there is a correlation
doses beyond the use-by date was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses beyond the use-by date was administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses beyond the use-by date was administered). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses beyond the use-by date was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ten patients got those doses between 01Oct2021 and 03Oct2021. The date in which the vial initially stored the in the refrigerator was 30Aug2021.  No concomitant medications was provided by the reporter. No treatments medications was provided by the reporter.
Have only been sick with flu when I got a flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Agency through social media  on 28-Nov-2020.  This case involves a 76 years old female patient who experienced have only been sick with flu when got a flu shot (influenza) , while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient  ha only been sick with flu when i got a flu shot (influenza)    Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Noticed swelling around and beneath injection site approximately seven hours after receiving the vaccination. Attempted icing the area. Woke up the following morning with redness and warmth with continued swelling of left bicep extending down to elbow. Associated symptoms include mild discomfort at injection site and nausea.
Developed painful and pruritic swelling in left arm at injection site that extended from Deltoid down to lateral elbow between 12-24 hours after her immunization. Developed paresthesias in median and radial nerve distribution. No motor deficits. At time of evaluation 72 hours after shot patient had redness, pruritis at injection site and persistence of paresthesias in radial n. distribution of left hand
body aches; headache; chills; Came down with this fever; fever is on 100.7 right now.; feeling weak; Nausea; eye pressure; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's mother). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced eye pressure. On 22Jul2021, experienced body aches, headache, chills, came down with this fever; fever is on 100.7 right now, feeling weak and nausea. Reporter reported that the patient received his first dose of the Pfizer BioNtech covid 19 vaccine on Monday on 19Jul2021 and he did not have no side effects on Tuesday, Wednesday, so yesterday on thursday he began to experienced side effects such as fever, body aches, headache, and feeling weak on 22Jul2021. So on thursday he came down with this fever, chills, headache and same today. His fever is 100.7 right now and he had headache and eye pressure and body ache. Reporter wondering if it is normal to have these side effects four days after the vaccine. Reporter also reported that she experienced side effects within the first two days of receiving her covid vaccine. The patient underwent lab tests and procedures which included body temperature: 100.7 on 23Jul2021. The clinical outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Bells Plasy , i am not able to blink my left eye and also not able to close the mouth on left side. When speaking my mouth is going towards right
1 1/2 cm area of redness at injection site. Small pinpoint pustule.
Information has been received from a consumer, for the Pregnancy Registry for VARIVAX (Merck), concerning a male baby. On 19-JUN-2009 the baby's 39 year old with penicillin allergy, hyperthyroid and 3 previous pregnancies, 1 full-term delivery with no birth defects in any previous pregnancy and miscarriage in previous pregnancy mother was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 662460/1535X). Concomitant therapy included levothyroxine Na. The baby's mother stated that she was 6 weeks pregnant after getting the first dose of VARIVAX (Merck) following the baby's mother's request for lacked immunity. It was reported that the baby's mother tested negative for varicella antibodies before vaccination with VARIVAX (Merck) during previous pregnancy. No adverse effects involved. Unspecified medical attention was sought. Home pregnancy test was performed. The baby's mother's LMP was 25-MAY-2009, and her EDD is 01-MAR-2010. The baby's mother reported that her son was born on 23-FEB-2010, full-term, "healthy and well, but he was born with DUANE Syndrome which was a neurological disorder that affects the eyes." The baby's mother added "that is the only problem he has." DUANE Syndrome was considered to be a congenital anomaly. The mother's experience has been captured in NWAES # 0907USA02020. Additional information has been requested.
Left arm localized redness + swelling, hot to touch, no pain or tenderness.  Complaints of itchiness.  No fever, patient took Benadryl for allergic reaction (itchiness)  to continue Benadryl.
had DTP/OPV/HIB 9NOV082 & no fever but was irritable, agitated for 24 hrs p/vax screamed all day;
Awake on floor, then mom noticed eye rolling and head twitching such as seizure. Called pediatrician right away.
Weakness; Chills; Fever; Dilated Pupils; This spontaneous case was reported by a consumer and describes the occurrence of MYDRIASIS (Dilated Pupils), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Relevant Medical history was not provided.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYDRIASIS (Dilated Pupils), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weakness). At the time of the report, MYDRIASIS (Dilated Pupils), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not  provided.   Reporter did not allow further contact
Sore arm, red raised skin about 2x3 inches, headache, fever, chills for 1 and a half days.
Temporary soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Temporary soreness around the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Temporary soreness around the injection site). At the time of the report, VACCINATION SITE PAIN (Temporary soreness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants are included. No Treatment included.
Breakthrough case admission after 3rd vaccine  1st Dose 2/5/21 - EL3248 Pfizer 2nd Dose 2/26/2021 - EN6200 Pfizer 3rd Dose 10/6/2021 - FC3181 Pfizer
Breakthrough case admission after 2 vaccines  Pfizer 4/29/21 lot# Ew0172; Pfizer 5/20/21 lot# Ew0179
Itchiness is very intense; 2.5x2.5 inches rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness is very intense) and VACCINATION SITE RASH (2.5x2.5 inches rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the events included Benadryl, Caladryl and cortisone cream
Mild stroke; Bell's Palsey; losing weight; cellulitis in left arm; Fever; Rash; extreme weakness; swollen left arm; pain in shoulder; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 69-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 1st August 2020, the patient received Boostrix (intramuscular) .5 ml. On 3rd August 2020, 2 days after receiving Boostrix, the patient experienced cellulitis of arm (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), rash (serious criteria hospitalization), weakness (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and shoulder pain (serious criteria hospitalization). On 9th August 2020, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant) and weight loss (serious criteria hospitalization). On 10th August 2020, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm and shoulder pain were not recovered/not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm, shoulder pain and weight loss to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix in left arm. After Receiving Boostrix, the patient experienced fever, rash, swollen left arm, pain in shoulder and cellulitis in left arm.   He went to the Emergency room and was hospitalized for 4 days and put on antibiotic therapy for the cellulitis.   The patient went home and 2 days later, he suffered a mild stroke and Bell's Palsey.   He ended up going back in the hospital.   The patient reported that the issues were not completely resolved.   He also reported losing weight and extreme weakness.   The patient stated his doctors have said he had a reaction to a contaminated needle and did not think these symptoms were from the Boostrix shot. The reporter did not consent to follow-up. No healthcare professional information was provided.
Woke up on day 4 with swollen eye lids. Woke up on day 5 with swollen eye lids and lips Both with sore tingling
POSSIBLE UNEXPECTED BENEFIT (DID NOT WAKE UP IN THE MIDDLE OF THE NIGHT WITH HEAVY SWEATING. PREVIOUSLY PATIENT WAS WAKING UP 2 TO 3 TIMES WITH SAME AND IT WAS REALLY BAD); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included history of woke up in the middle of the night with heavy sweating. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced possible unexpected benefit (did not wake up in the middle of the night with heavy sweating. previously subject was waking up 2 to 3 times with same and it was really bad). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible unexpected benefit (did not wake up in the middle of the night with heavy sweating. previously patient was waking up 2 to 3 times with same and it was really bad) was not reported. This report was non-serious.
Patient was vaccinated on 2/4/2021 at 1:02pm. She was monitored  for a 1/2 hour due  to history of anaphylaxis. No concerned noted upon release. It was Reported by a nurse, that patient reached out to her with a reaction from the vaccine and that she took Benadryl at 2pm. She started to have some coughing, then her throat is sore and tight. Nurse called patient at 2:40pm. Patient stated that symptoms have improved. Patient was instructed to take epi pen for worsening  symptoms and go to the ED. Patient agreed. PCP notified; supervisor notified  Patient reported that after her first dose she did have mild hives, slight cough about hour after, then diminished. -This was reported by patient during phone call with nurse.
Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Gender dysphoria, Cystic acne, Endocrine disorder and Drug allergy. Concomitant products included ISOTRETINOIN (ACCUTANE) for an unknown indication.    On 21-Dec-2021 at 9:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021 at 9:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times). On 21-Dec-2021 at 9:50 AM, EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Reported that Six patients being administered doses from a vial left out overnight from 20-DEC-2021 to 21-DEC-2021 roughly. 18 hours from open to the last patient it was used for on Tuesday morning.   This case was linked to MOD-2021-422292 (Patient Link).
My left eye began twitching  the day after and it has been non stop since then. Then my lip also began twitching. I have no existing medical issue and have never had this issue before.
pt had a positive COVID test on 5/20/22; at Rehab Center; pt declined since diagnosed with COVID; lethargic, sluggish, in pain due to previous fractures; poor oral intake; pt passed away
Patient is describing a rash that began in the lower extremities and has spread/also appeared from the neck around the shoulders to the arms.
Remained asymptomatic after receiving moderna booster.  I was only sore around injection site. Approximately 10 days after receiving the  booster skin reactions and irritation occurred throughout my whole body. My skin felt uncontrollably itchy and after scratching that certain area my skin would flare up in raised red marks.  The red marks/patches would vary in size. Some were more localized and other times they would flare up and cover a larger portion of my body.  Sometimes the itchiness subsides quick but other times the itchiness is incontrollable and painful. There are no signs of a rash or bumps. I have been dealing with this skin reaction for a week now with no improvement. I have been taking Zyrtec daily and using topical hydrocortisone to stop the itching.
Patient complained of feeling very anxious and jittery within minutes of receiving vaccine. Patient also complained of itchy, heavy eyes. He stated he felt like there was a delayed response time to his actions, for example, he would move his head or read something but it took a few seconds for this eyesight to catch up. Patient was asked to remain seated beyond the recommended 15 minutes. Patient denied having problems breathing, problems swallowing, tightness in chest. Patient was offered to contact emergency medical services but declined. Patient was also offered diphenhydramine but declined. Patient left pharmacy on his own terms and stated he was feeling better.
Approx 7 hrs post vax pt stopped breathing; prior to incidence pt very lethargic; Could not arouse; Initiated mouth to mouth; taken to ER; Hospitalized for 3 days; now on apnea monitor;