chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.   On 12-Sep-2022, 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. On 03-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Red and indurated area on left deltoid at site of Administration approx 4 X 4 inches.  Associated pruritis
Right thigh area noted with redness 7x11mm lesion, no nodules as per NP assessment.
Hep A vaccine given in error instead of Hep B. Provider examined child. No adverse reactions. No signs & symptoms of distress. Hep B was given to opposite site.
very sore, raised bullseye around site, sore right side of body, fever no known treatment
Chills, body aches, headache, pain in my left arm where I can barely lift my arm, fatigue, upset stomach, fever. My whole body hurts. It started the morning after.
Headache, Myalgia, NauseaVomiting, numbness of left arm Narrative:
Saturday afternoon, I felt a sudden throbbing and pressure at the injection site. I ignored it. Later in the day, my arm felt sore, like someone had punched me. As the evening continued, I felt burning and itching around the injection site. I showed my arm to my family, who were shocked. There was an almost oval-shaped welt around the injection site, and surrounding that was an area of swelling. I applied an ice pack off and on for a while. Sunday morning, I took some ibuprofen and applied some lavender burn spray, and applied an ice pack to my arm again. By Sunday evening, the swelling had decreased some, and the redness of the welt was also decreasing. The burning, itching, and soreness/tenderness remain.
received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer(patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 24Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer covid vaccine on 24Jul2021 but tested positive after the first dose on unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was positive on 2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
A report was received from a health care professional who was also the consumer on 24 October 2003 concerning a female vaccinee of an unspecified age who experienced fever and injection site soreness 3 hours and 15 minutes after receiving Fluvirin on 24 October 2003. At 12.15 on 24 October 2003, the vaccinee experienced fever of approximately 99.9 degrees Fahrenheit and soreness in her upper extremity at the injection site. The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Approx. 20 min after shot pt. noticed itchy + tingly tongue. She also complained of a funky taste. She took 25 mg of BENADRYL and is doing fine.
arm was sore for a day; fatigue; chills; slight headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache). At the time of the report, MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache) outcome was unknown.            No concomitant and treatment information provided   Med Info Agent:  Moderna customer care warm transfer case # 169956.  Caller received her first dose of the Moderna COVID-19 vaccine on 28Apr2021 (lot # 036B21A).  She got her second dose on 26May2021 (lot # 039B21A).  After both shots, her arm got sore for a day or so.  This morning she reports that she felt fatigue, chills, and a slight headache.  Ok for the safety team to contact the patient later if needed       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains non-significant information. - Contact Info Updated
got the vaccine back in Jan2021 and had COVID-19 shortly afterwards; second dose is past day 36; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36) 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.    In January 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 COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36). At the time of the report, COVID-19 (got the vaccine back in Jan2021 and had COVID-19 shortly afterwards) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past day 36) outcome was unknown. Not Provided      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 information provided.  no treatment information provided
within 14 days i had 3 afib events around the same time 1am-3am. on different days documented on a doctor prescribed heart monitor i was wearing at the time. on day 14 i was admitted to the hospital diagnosed with splenic infarction. i lost a large part of my spleen, but did not require surgery
Site: Swelling at Injection Site-Medium, Additional Details: PT RECEIVED 3RD COVID-19 MODERNA VACCINE.CALLED PHARMACY THE NEXT DAY THAT HER ARM WAS SWOLLEN AFTER SHE WENT TO VISIT HER PROVIDER.
Flashing light left eye, black floaters.  Emergency Room Trip evening of 7/30 - 8/1/21. Diagnosis of PVD. (Posterior Vitreous Detachment)
Severe cough lasting over a month, fatigue, headaches, muscle pain, congestion, sore throat, dizziness.
Hives developed approx 5 hours after administration of Hepatitis A, first dose. The hives were located on abdomen, top of thighs, & back.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 03-APR-2021 for prophylactic vaccination. On 07-DEC-2021, the patient received non-company suspect vaccine MRNA 1273 (dose number in series: 2) ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced headache, congestion, fatigue, and mild fever. On 05-JAN-2022, the patient visited a clinic and had tested positive in covid-19 PCR (polymerase chain reaction) test which indicated confirmed covid-19 infection, and confirmed clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 07-JAN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000216639.; Sender's Comments: V0: 20220220752 -Covid-19 vaccine ad26.cov2.s-Confirmed clinical Vaccination  failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
July 12 - Painful abdominal cramps and profuse sweating all over my body. 10 mins after cramps and sweating started, I started my period. Sweating lasted about an hour, while the cramps lasted a couple of hours.  There was very little blood, but a lot of ?water? in my maxi pad. My periods are usually three days long, with only one heavy day. I am on my sixth day and have had a heavy flow each day. There still is very little blood but a lot of ?water.?
5-6 wks p/vax pt eyes were fluttering, body was limp & pt was trance-like; EEG revealed abnormality secondary to the presence of focal spots; overall impression was focal epilepsy w/underlying structural abnormality; tx w/ Depakote
Approximately 7 days post receiving the vaccine, I developed a tender, red, inflamed, itchy and warm-to-touch spot at the site of injection.  This was after having a sore arm approximately 24 hours after injection on 01/15/2021 that subsided on 01/18/2021.  As of 01/26/2021, this new spot and new symptoms have not resolved with OTC recommendations from my PCP.
Information has been received from a consumer and follow up information from someone at the physician's office concerning a 4 year old male pt who on 01-JUL-2004 at 11 AM was vaccinated in the left leg with a dose of MMR II (lot # 642700/0528M) that had expired on 07-JUN-2004. Concomitant therapy included vaccination in the right leg on 01-JUL-2004 at 11:00 AM with a dose of DTaP (lot# C1698AA) and vaccination in the right leg on 01-JUL-2004  at 11 AM with a dose of IPV (lot # X0706). The mother reported that later in the day, the pt experienced a low grade fever, a headache and pain in his legs. Medical attention was not sought. Follow up information reported that a phone call was made to the pt's mother (date not specified) to notify her of expired vaccine and when asked, the mother stated the pt had no reaction at that time. No further information is available.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (intramuscularly, dose, injection site, lot# and expiration date were not reported), after the vaccine had experienced a temperature excursion. No adverse effects were noted. Product quality complaint (PQC) was not involved. Additional information has been requested.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 T9-T10 VERTEBRAL STABLE BURST FX, INIT I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 T9-T10 VERTEBRAL STABLE BURST FX, INIT I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 HX OF ISCHEMIC STROKE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 HX OF ISCHEMIC STROKE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 LATE EFFECT OF STROKE I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 LATE EFFECT OF STROKE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/23/2022 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/8/2022 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
24 hours after receiving the second dose of the vaccine, I suffered extreme pain in my joints.  I ached all over, even my knuckles.  I had a headache and I was cold.  I took one extra-strength Tylenol and one Advil every 4-6 hours.  I didn't move for six hours, I was so fatigued and sore.  At 9:30 pm, I went to bed.  I took another dose of Advil and a dose of NyQuil.  I slept till morning.  I was still sore when I woke up, but it wasn't as extreme.  By noon, I could move around easily and by 5:00 pm, I was feeling almost back to normal.  After another good night's sleep, I woke up feeling fine on Sunday, 5/16/2021.
VZV and Hep A given at 11:30 10/7/06, redness on right arm noted 2 hours after with itching, swelling, hardness and pain noted 20 hours later.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 16:15 (Lot number: EW0176) at the age of 53 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; KLONOPIN; VITAMIN D NOS. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0176, lot unknown=False, administration date=14Jul2021, administration time=04:45 PM, dose number=1, vaccine location=Left arm), administration date: 14Jul2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: ANXIETY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "have anxiety but this has gone to extreme anxiety all day"; NERVOUSNESS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "feel shaky all day"; HEART RATE INCREASED (non-serious) with onset 05Aug2021, outcome "not recovered", described as "heart rate elevates up to 118 at resting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anxiety, nervousness, heart rate increased. Additional information: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Zoloft and Klonopin. Vitamin D and multi vitamin. She had anxiety but this had gone to extreme anxiety all day. Noticed it after my second shot. She had to Increase her anxiety medication to more than she normally take. She had never had anxiety during the day she only had it in the mornings only in the morning but now she feel shaky all day and my heart rate elevates up to 118 at resting. Nothing helps the shaky feeling inside and this is not normal. The patient had no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had Covid test post vaccination: [Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=PCR, Covid test date=29Jul2021, Covid test result=Negative]. The patient had Known allergies to PCN. Follow-up attempts are completed. No further information is expected.
At around 6:20pm patient began to lose consciousness. We moved him on the ground and laid him flat. He then woke up upon blacking out for 15 seconds. patient complained that he did not have any water since the morning. He was sweating profusely. EMS was called and arrived to the scene within 10 minutes. Patient said he was fine and refused to be taken to the emergency room. Patient returned to normal within a few minutes after the incident.
Rash, had black and blue spot develop under one of the itch bumps, took Benadryl around 12:00pm, rash seem to subside. Began to itch again in the evening, my feet itch the most, they burned and were red that evening. Took more Benadryl.  Today 4/17 woke up with blood pumping rapidly from left arm on and off for about 20 min. My left toe hurts and is dark.
4 hrs p/vax pt was crying hard; gave pt bath turned white & limp; this lasted 1 1/2-2mins then recovered & slept; had soreness for a few days & knot @ inject site still visible 2 wks later;
26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster).    No relevant concomitant medications were reported.   On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any adverse events after the vaccines were given.   No treatment medication was reported.  This case contains information about 19th patient out of the 26 patients.
vomited about 8PM p/vax then vomited @ school today 15APR97 subsided p/that morning 15APR97;consulted MD will receive hep B 3 as scheduled;
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. On 30-OCT-2013 the patient was vaccinated with MMR II lot # H020255 (expiry date: 08-NOV-2014), 0.5 ml, subcutaneous. Dose number, anatomical location and indication were not reported. It was reported that the administered dose of MMR II was incorrectly administered. On 29-OCT-2013, there was exposure at a temperature of 14 degrees C for 1.5 hours and 9.4 degrees C for 1.5 hours. On 30-OCT-2013, the dose was exposed to a temperature of 10 degrees for 3 hours. No adverse event or treatment information was reported. Additional information has requested.
Heart pain and stomach cramping. Stomach cramping started first a day after the 2nd shot. Then immediately followed by chest pain and heart abnormally strong beating.
approx 1mo p/vax pt exp a rash at inject site. no further info avail
This infant father called on 03/17/01, to report it was approximately 30 ,minutes after receiving vaccines. The infant became pale, and passed out with his eyes open. His breathing did not change, he stared straight ahead, he leaned his head over to one side and would not look at his father. He did not cry, he then "woke up" and started looking around. It lasted about 10 minutes. Called on 03/20/2001 no other incidents.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2023, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Aug2023 and still ongoing.  Clinical course: Patient tested positive for Covid for the first time ever. He had all the vaccines but not this year, his last one was last year. He had all the Pfizer vaccines (Unspecified Vaccines). He tested positive for Covid on Sunday and he was having all the symptoms pretty bad and he started Paxlovid on Monday and so far he was not noticing any improvement, that almost immediately with Paxlovid he had so much stomach ache, intestinal cramping and diarrhea with Paxlovid. He also stated that he was a very healthy 79 years old retired Pharmacist and Ihe had a very strong stomach and nothing  the he ate or drink before that bothered him but the Paxlovid or the Covid had been very harsh on his system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.