chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a rapid heart rate, numbness of her lip and side of her nose, elevated blood pressure approximately 30 minutes after receiving her first Moderna COVID-19 vaccine. 3 days following the vaccine, she was still having symptoms and was seen at a local Urgent Care facility and then referred to be seen at the local Emergency Department, which she did.
Blood clots/3 blood in the left leg; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included partial knee replacement in Dec2020 and developed 1 blood clot. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The reporter reported that her husband (patient) developed 3 blood clots on an unspecified date in 2021 after his second Pfizer vaccine in May2021. Now he did have a partial knee replacement last Dec2020 and developed 1 blood clot, but was cleared of any blood clots 07May2021 after having a dobler sonagram was done, the following week he had his second shot and on 07Jul2021 he was hospitalized with 3 blood in the left leg, odd how this happened 2 1/2 months after his second shot. The patient underwent lab tests and procedures which included dobler sonogram: cleared of any blood clots on 07May2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Left lateral thigh with surrounding erythema. Pink,irregular,blanches. Nodule beneath the skin
On 1/24/19 mother noticed red cheeks that over the next two days progressed to fever, swollen face and lips and hives over entire body. On 1/26/19 they took him to the emergency room and they gave him a dose of liquid BENADRYL and did a Rapid Strep screen that was postitive. He was treated with Liquid Amoxicillin every 12 hours for 10 days.
Shingles; pain in left heel and thumb; rash on left waist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 4 months after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the patient experienced rash. On 1st January 2020, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in July or August of 2019 in an unknown arm. In October 2019, the patient experienced pain in her left heel and left thumb. The patient's health care practitioner thought it might be related to shingles. The patient experienced possible mild case of shingles. The pain in her left thumb and heel resolved in January 2020.  In January or February 2020, patient had a rash on the left side of her waist that was not itchy. The patient's health care practitioner gave her shingles medication and it cleared up in approximately 3 weeks. The patient did not remember name of medication. The reporter did not consent to follow up
Nausea, vertigo, fever, chills, muscle pain, bone pain, joint pain, knuckles popping, stomach issues
Developed a severe rash along the neckline.  Itching, redness and some swelling.  Treatment is twice daily cleansing with surgical scrub and neosporin.   Rash is still processing but not spreading.
Patient states that on day of vaccine, after receiving vaccine he felt tired, didn't feel well. Around 8pm that evening, he began having chills and didn't sleep well. On 19MAR, patient states he felt tired and vision got blurry while driving. Last thing he remembers is EMS personnel in ambulance stating that BP was very low. Patient states that while trying to brake prior to accident, he felt like he couldn't move his foot and stayed on the accelerator because he couldn't move his foot.   MVA 19 Mar 2021. States following his COVID vaccination on 18 Mar, he had fevers, chills, and body aches that night and into the next day. While driving to work on 19 Mar at 0900, he struck another vehicle from behind while traveling 40mph. States his vision went blurry and he was unable to move his leg off the accelerator. He was wearing his seatbelt and the airbags deployed. Denies any LOC. He was taken via ambulance to. Imaging performed, as above, unremarkable. SM denies any issues today and feels well, besides neck pain.   Unremarkable neurologic exam in clinic, no focal neuro deficits. MACE completed and showed a 2 point improvement from yesterday. Discussed importance of physical and mental rest, limit caffeinated products. Light indoor duty and no PT for next 3 days.  Will f/u on Friday, 26 Mar 21.
Pain at the injection site.; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient's daughter), reporting for a patient (Mother). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On an unknown date in Feb2021 the patient experienced pain at the injection site. The clinical outcome of the pain at the injection site was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient came to get Pfizer 5-11 pediatric Bivalent booster, but received Pfizer 5-11 pediatric Monovalent booster
She got the undiluted vaccine; She got the undiluted vaccine; Swelling at the arm site; This is a spontaneous report from a contactable consumer behalf of the patient. A 20-year-old female patient received bnt162b2 (manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown), via an unspecified route of administration in the arm on 09Jun2021 at 9:00 AM as unknown dose of 2ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Jun2021, who reported behalf of the patient reported that about an hour ago from the vaccine clinic that she got the shot from. And they told her that she got 2 milliliters of the vaccine. They did not dilute it as they were supposed to dilute it, so she got the undiluted vaccine and they wanted to tell her that. And so the patient was asking is there anything special that we need to be looking out for or there's anything they need to be doing differently. Obviously, she told them you can't, now you can't take that vaccine back obviously, but she don't think that there's anything particularly special that we be looking out for, unless obviously if she had like sort of anaphylactic response which she had not, she said that she was having swelling at the arm site in Jun2021 but they don't think that's totally abnormal, but I did not know if you guys had a, I figure that this had happened before, she did not know if she had any other comments that she could pass along to this patient. The outcome of the events was unknown.  Information about lot/batch number has been requested.
p/vax pt devel flushed face & an inj site react; mild redness & warmth; self-medicated w/benadryl
Very tired; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had fruit allergy to kiwi. 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 vaccination. On 11Mar2021 at 17:00 the patient experienced very tired and lethargic after first dose. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 outcomes of the events very tired and lethargic after first dose were recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Alopecia areata (Hair loss spots)on front and back of head, 2 spots. 5 white spots have also appeared on my arm. Both conditions have lasted over a year now and only one of the hair loss spots have gone away.
Had anaphylactic reaction after 12 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery. Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) outcome was unknown. Not Provided          Reporter mentioned that patient has been given steroids for seven days.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-051952 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-051952:Dose 1
Arm Swelled enormous (we have pictures) rash at site of injection, mottled purple, fever, lethargy, sleeping all day, rash.
Swelling on her knuckles; This spontaneous case was reported by a non-health professional and describes the occurrence of JOINT SWELLING (Swelling on her knuckles) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling on her knuckles). At the time of the report, JOINT SWELLING (Swelling on her knuckles) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Fevers Chills Polyarthralgia Malaise Headache Dizziness Diarrhea
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight.  Excursion duration was 1 month.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
After vax was given patient experienced VasoVagal syncope. Pt was monitored, given fluid & crackers observed for 30min before released.
Patient given vaccine at around 1120 and came back about 9 hours later with a 101 fever, chills, body aches, fatigue, loss of appetite and nausea.
Patient developed shingles like symptoms on left arm from site of vaccine administration down to wrist and a small area on left chest with rash and burning. Symptoms were verified by family physician.
Headache; She received her booster dose; She received her booster dose; She tossed and turned all night last night; This is a spontaneous report from a contactable consumer(patient). An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) as dose 1, single via an unspecified route of administration on an unspecified date for covid-19 immunisation. She had no issues with the first two doses. The patient reported she tossed and turned all night last night and received her booster dose on 28Sep2021 and experienced headache on 29Sep2021. Therapeutic measures were taken as a result of headache. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Medication error- 11 month old received TDap vaccine in ER. The patient had an abrasion over the left eye that the ER physician felt needed tetanus. The product is labeled for age 7 and up.
This spontaneous report was received from a registered nurse who reported that 3 patients received GARDASIL exposed to minus 1 degree C for 3.5 days (84 hours), an excursion that was unsupported by in-house stability data. No adverse symptoms reported. Nurse stated these patients received the product in question between 03-MAR-2014 and 04-MAR-2014. This is one of two report from the same reporter source (linked case MARRS# 1403USA004558). Additional information has been requested.
classic exaggerated cellulitis; painful arm; really swollen arm; Initial information was received on 12-Nov-2021 regarding an unsolicited valid serious case from an Other Health Professional via Agency (under reference 00855939).  This case is linked to cases 2021SA380564 and 2021SA386973 (Same reporter).  This case involves three patients (unknown age and gender) who had classic exaggerated cellulitis (Cellulitis) with symptoms, swollen (Peripheral swelling) and painful arm (Pain in extremity), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was unknown if the patients had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided   On an unknown date in between 8-nov-2021 to 11-Nov-2021, the patients received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Total, lot C5882AA and expiration date: not provided] via intramuscular route in the arm for prophylactic vaccination.  On an unknown date in Nov-2021, the patients developed serious exaggerated cellulitis (cellulitis) with symptoms, swollen (peripheral swelling) and painful arm (pain in extremity), 24 hours following the administration of vaccine.   These events were assessed as medically significant.  It was unknown if the patients experienced any additional symptoms/ events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received any corrective treatment.    At time of reporting, the outcome was unknown for the reported event.  Based on information previously received, the classification and initial justification were removed and narrative has been updated.; Sender's Comments: This case involves three patients (unknown age and gender) who had Cellulitis, Peripheral swelling and Pain in extremity after vaccination with ADACEL. The time to onset is compatible. Further information regarding medical history, concomitant medications, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
fever 1/5/21 102F chills same evening 1/6/21 chills and fever about 4am. Elevated heart rate all day headache, joint pain, muscle soreness, fever all day approximately 11pm felt much better. heart rate returned to normal, temperature 100f  1/7/21 local pain in injection site. no more fever. normal heart rate.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA008820: US-009507513-1708USA011856: US-009507513-1708USA011857.
He contracted covid and died.; Hurt his head; Had fallen; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He contracted covid and died.), HEAD INJURY (Hurt his head) and FALL (Had fallen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer (prostate cancer that was on remission).    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 COVID-19 (He contracted covid and died) (seriousness criteria death and hospitalization), HEAD INJURY (Hurt his head) (seriousness criterion hospitalization) and FALL (Had fallen) (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was covid-19. It is unknown if an autopsy was performed. At the time of death, HEAD INJURY (Hurt his head) and FALL (Had fallen) outcome was unknown.            No concomitant medication was given.  No treatment medication was given. It was reported that the patient received the first dose of Moderna Covid19 vaccine had certain medical conditions and had fallen and hurt his head. He was in the hospital because of hurting his head and there he contracted covid and died. He was 72 years old. He had prostate cancer that was on remission, but when contracted Covid, the cancer was activated and speed up the prostate cancer after having covid. This was directly related to getting Covid in the hospital.  Company comment This case concerns a 72-year-old, male patient, with medical history of Prostate cancer, who experienced the serious, unexpected, event of Covid-19, and other serious unexpected events Head injury and fall. The events occurred  on unknown date after first dose of Moderna vaccine. The reporter mentioned that patient had other medical conditions, was hospitalized and there he contracted Covid-19. The patient died on an unknown date. It is unknown if an autopsy was done. Patient's age, comorbidities and incomplete vaccine dose may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old, male patient, with medical history of Prostate cancer, who experienced the serious, unexpected, event of Covid-19, and other serious unexpected events Head injury and fall. The events occurred  on unknown date after first dose of Moderna vaccine. The reporter mentioned that patient had other medical conditions, was hospitalized and there he contracted Covid-19. The patient died on an unknown date. It is unknown if an autopsy was done. Patient's age, comorbidities and incomplete vaccine dose may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: COVID-19
Pt had a warm, red lump at site of injection. Pt saw doctor who advised ice packs and ibuprofen.
Left upper arm swelling, redness, warm to the touch, fever, chills that started about 6 hours after injection.