chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subject had a TIA; memory loss; confusion/trouble telling time; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 84 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "aneurysm" (unspecified if ongoing). Patient had no known allergies and didn't have COVID-19 prior to vaccination. Concomitant medication(s) included: INFLUENZA VACCINE (Seqirus), on 19Oct2021 as unk, single. Patient was on BP meds. Vaccination history included: BNT162b2 (Dose 2, lot number: EN6205, administrator route: Intramuscular), administration date: 16Mar2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, lot number: EL9267, administrator route: Intramuscular), administration date: 21Feb2021, when the patient was 83-year-old, for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 24Oct2021, outcome "recovered with sequelae", described as "Subject had a TIA"; CONFUSIONAL STATE (hospitalization) with onset 24Oct2021, outcome "recovered with sequelae", described as "confusion/trouble telling time"; AMNESIA (hospitalization) with onset 24Oct2021, outcome "recovered with sequelae", described as "memory loss". The patient was hospitalized for transient ischaemic attack, amnesia, confusional state (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Negative, notes: Blood Test, covid test name post vaccination PCR; Cardiac function test: (unspecified date) unremarkable. Therapeutic measures were taken as a result of transient ischaemic attack, amnesia, confusional state, which included Diagnostic workup (as reported). Clinical course: patient had a TIA and was hospitalized. History includes brain aneurysm noted on Diagnostics but patient was asymptomatic requiring no treatment. Patient had memory Loss, confusion trouble telling time. No motor Weakness. Cardiac workup was unremarkable.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Transient ischaemic attack, Amnesia, Confusion cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Narrative: Per law enforcement report, patient's death appears to be natural causes. Wife found 91 yo patient on the floor having seizures. Patient was treated for seizure disorder and had recent Primary Care visit with updated labs. Seizure medication lab monitoring was monitored with no concerns.
The night of January 9th around 2330 I noticed that the left side of my face was acting a little funny.  As the night progressed into the morning I noticed that it was starting to get worse and my face was drooping. By the evening of January 10th the left side of my face was really droopy. I had heard that a small percentage of the new COVID-19 vaccines had caused Bell's Palsy in a small percentage of the clinical trial patients. I did some research on Bell's Palsy and found what to do in the event of an onset. I took Advil 2 to 3 times a day  for about a week and kept a close eye on it to make sure that it wasn't getting any worse. After about 2.5 to 3 weeks the symptoms of the Bell's Palsy went away on its own. I did not see any physicians for treatment.
Information has been received from a physician concerning a female patient with a history of urinary tract infection who in the last couple of weeks was vaccinated with GARDASIL. Fairly recently, the patient presented with high fever and some gastrointestinal issues after receiving GARDASIL. A blood work was performed with unknown results. The patient's outcome was not reported. Additional information has been requested.
Headache, malaise and nausea followed by vomiting. Patient felt better until the next afternoon about the same time when nausea and vomiting returned. Patient was fatigued and fell asleep at 6:30 pm and slept through the night. Following day, patient felt nauseous off and on until evening when strong nausea and fatigue set in. Patient had no appetite and ate very little for two days.
Patient was crying while vaccinations were given. Immediately after vaccinations were finished she explained that she felt dizzy. I laid patient on exam table BP 99/76. She laid there for 5 minutes and she felt good enough to sit up BP 107/63 while sitting up. Patient then stood up and stated she felt fine BP 102/68. I explained to patient and mother if she were to feel that way again to lay down and if condition does not improve, she shall go to emergency room. I walked patient to vehicle.
SEVERE HEADACHES; This spontaneous report received from a parent concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headaches was not reported. This report was non-serious.
Pt recvd 3 doses of Engerix-B & did not respond; pt did not want any more doses;
Immediately upon administering the vaccine, the patient loss consciousness. I was able to catch him. He was unresponsive for approximately 5 minutes. His eyes rolled back in his head and he made seizure like motions. By the time EMS arrived he was responsive.
Patient with history of myasthenia gravis with multiple prior myasthenic crises requiring IVIG and one requiring intubation experienced myasthenia gravis exacerbation with no apparent trigger that began two weeks after receiving J&J vaccine. Daughters noticed he was having progressive difficulty swallowing, slurred speech, and generalized weakness. O2 sats were also noted to be lower than normal with pulse oximeter at home (92% compared to baseline of 95%). On day of admission patient had a mechanical fall while carrying a tray with his walker.  Hypoxic to 88% on arrival. Labs notable for leukocytosis (13.68), hyponatremia to 127 and negative infectious workup. CTH with chronic microvascular changes and global atrophy but negative for acute process. He was admitted and continued on prednisone 5mg daily (outpatient regimen). Patient was started on a three day course of IVIG on 5/3/21 due to concern for myasthenia exacerbation with subsequent improvement.
Information has been received from a physician referring to currently 25 years old ale patient. The patient had no concomitant medication, pertinent medical history and drug reactions/allergies. Concurrent condition was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot# N025429 with expiration date 21-JUL-2020, dose and route unknown) for prophylaxis. On an unknown date, after receiving the first dose the patient developed hematuria in his urine for 1 day and had blood dripping from his penis. The patient did not seek any medical treatment. The hematuria resolved within 24 hours. The outcome of blood dripping from his penis was reported as recovered on an unknown date. No lab diagnostics/studies were performed. No product quality complaint (PQC) was reported. The causality between the events and GARDASIL 9 was not reported. Upon internal review, penile haemorrhage was considered to be medically significant.
Reports adverse reaction to Pneumonia vaccine he received 5-22-14. Day 1, redness, sore upper arm. Day 2, entire upper arm red, sore and hot. Muscle aches developed. Starting to feel better today, symptoms improving, stated, I just wanted to report the adverse reaction. Took the day off work today. Myalgia and rash.
Swollen, red area at injection site.  Painful and hot to the touch.  Worsening each day over past 2 days
Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of receiving the vaccine from the left elbow area (where the vaccine was administered) and gradually spread to other body parts over the next couple of hours. Has not resolved with over the counter oral anti-histamine and topical over the counter steroid cream as of 1/13/21.
Date 04/30/2021 Onset  of symptom at approximately 1:30pm: developed slurred speech. Lost of strength started to left lower extremity and weakness and followed up to left upper extremity with lost of strength and weakness. Symptoms lasted approximately 3 minutes, and was taken to Hospital with an admitting diagnosis of Transit Ischemic Attack.
Developed classic presentation of shingles at a young age not having had natural chicken pox or exposure to chicken pox. Only having had the varicella vaccine. Pain improved with Valacyclovir. Rash resolved spontaneously following the natural course of shingles. Symptoms started 11/28/18 with sharp dermatomal pain, but no rash. She was then seen in the office 11/30 with classic vesicular dermatomal rash of shingles. Follow up 12/10/18 showed lesions almost fully resolved.
Patient went to get in her car after completing time of wait after vaccination, felt cloudy, compared it to how she feels after having a glass of wine, denied vision changes but states perception of environment felt foggy. EMT assessed patient, HR normal at 71, O2 100%, Bp elevated at 182/100, patient did report anxiety, monitored for another 15-20min until patient felt better, cloudiness improved, Bp improved. Advised to consult with PCP re: Bp.
Heart palpitations; Chest pain; Lump underarm size of softball (left); This is a spontaneous report from a contactable nurse. This 46-year-old female nurse (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0168, and Expiration date: Unknown), intramuscular, administered in left arm on 14Jun2021 08:00 (at the age of 46-year-old) as dose 2, single for COVID-19 immunization, received at hospital. The patient medical history and concomitant medications. No additional vaccines were administered on same date of the Pfizer suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. No vaccination was given within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0169, and Expiration date: Unknown), administered in left arm on 24May2021, as single dose for COVID-19 immunization. The patient sated that she received the second dose of the Pfizer vaccine on 14Jun2021 and on 15Jun2021 at 15:00 experienced heart palpitations and chest pain that subsided after a couple of hours. On the same day at same time, she had a "lump underarm size of softball". Stated that she took pictures and sent them to her provider. No treatment was given for the events. The events did not require emergency room visit or physician office visit. No relevant testes were performed. No investigation assessment was done. The patient stated that she made an appointment to see her doctor. The outcome of events heart palpitations and chest pain was reported as resolved on 15Jun2021. He outcome of the event "lump underarm size of softball" was reported as not resolved.
Expected arm soreness in the 2 days following vaccination subsided. The 10 days following vaccination employee experienced intermittent tenderness and difficulty with horizontal elevation of arm which has not resolved.
On April 22, 2021, four days after receiving my second Covid -19 vaccine, I started to experience mild heart palpitations that slowly progressed over the next two days and on Friday, April 23rd, I wen to the ER for they would not stop and was constant for more than 5 hours.
They both had reactions to the flu shot.  both within 30 seconds after their shots.  Patient's muscles tensed up, she fell off her chair, and she was out for a few seconds.  Then, she also started to feel faint.  911 was called.  Both girls were sweaty and needed to remove their masks.  Patient stayed on the floor with her dada holding her while she remained in the seat.  Patient was up and talking within a few seconds, but quickly began to become sleepy and started slurring her words.  Paramedics arrived on the scene and took both girls to the hospital.
RASH AND REDNESS , ITCHINESS AT INJECTION SITE. 2 WEEKS POST INJECTION THE RASH IS SPREADING. HOT TO THE TOUCH.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 03-AUG-2016, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Pt developed rash - c/o itching after infection approximately 10 minutes - no other signs of hives or difficulty breathing. Pt was observed for 1 hr redness and itching continues to other arm - some redness on back - given BENADRYL 25 mgn sc.
swollen hands; red hands; itching on the inside of the hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hands), ERYTHEMA (red hands) and PRURITUS (itching on the inside of the hands) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen hands), ERYTHEMA (red hands) and PRURITUS (itching on the inside of the hands). At the time of the report, PERIPHERAL SWELLING (swollen hands), ERYTHEMA (red hands) and PRURITUS (itching on the inside of the hands) had resolved.            Concomitant medications included Vaseline Intensive Care Lotion.  The patient reported that the symptoms started on the left hand and then spread to the right hand.  No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: TCR form received on 12-JUL-2021 contains event outcome was updated.
Pt was found to have ITP-low platelets of 1000 during routine lab work done on 2/2/2021. Pt is asymptomatic--unknown if this is due to recent COVID infection in late Dec/early Jan or due to vaccine. He has responded to steroids and counts are improving.
Rotateq, Pediarix, HIB, and Prevnar given as ordered, no distress noted after baby discharged from Clinic to home mother called clinic within 1-2 hrs states "baby won't stop crying" instructed to give Tylenol as directed and comfort baby. Mother called clinic again between 2-3 pm 7/19/07-Instructed to return to clinic. 7/19/07 3:30 Children's Motrin 1/2 tsp po given @ clinic and examined baby/Dr. (Mother stated on phone today baby fussy and edema in leg-not noticed at office. Within 20-30 min after Motrin baby less fussy, also order for Benadryl 1/2 tsp po every 6 hr. Called mother at home 9/20/07-Baby calm.
Pt got lightheaded and almost fainted  after given vaccine. EMS  called to store to assist pt.  Pt eventually left on their own .
A lump developed on the top of my left hand between wrist bone and pinkie finger. Noticed it about an hour after injection. No pain. Today is three days later and the lump is still there. Mild sore-type pain and occasionally feels like someone sticking pins around base of the lump. Have not seeked any medical advice.
Began menstrual cycle 4 days after first vaccine dose. I have had horrible unusual cramps , bleeding, stomach pain for two weeks and counting.  I wish the cdc was more open about this side effect instead of not putting it out there with all others maids effects.
Case number PHEH2016US029867, is an initial spontaneous report received from a physician on 10 Nov 2016. This report refers to a 36 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly, on 16 Sep 2016. On an unspecified date 10 days after vaccination, the patient experienced dusky erythema,  edema and itchy, painful area a few inches below the injection site. The patient was treated with steroids (unspecified) and BACTRIM however symptoms did not changed with drug therapy. Upon follow up, the physician reported that, the patient was hospitalized after the initial adverse events and did not know if initial adverse event caused hospitalization. The outcome of the event dusky erythema was unknown. The final outcome of the events was condition unchanged. The causality of events were not reported. Follow up report received from a physician on 16 Nov 2016: Updated physicians seriousness comment.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017) (dose and unit unknown) for prophylaxis. The vaccine was exposed to 47.8F for 1.5 hours. No previous temperature excursion. Data logger was involved.  No adverse effects reported. As of 22-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1611USA001000: Mfr number.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 12Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027), in left arm, all intramuscular for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28Nov2022, outcome "not recovered", COVID-19 (medically significant) with onset 28Nov2022, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Additional information: No other vaccine in Four week. Tested positive for COVID-19 on 28Nov2022. Sore throat, sneezing, runny nose, congestion, mild cough. In addition, he had been experiencing pain in his left knee and ankle suddenly disappeared. He reported the same thing when he received the first two doses of Cominarty. Now joint pain disappeared at the same time he tested positive for COVID-19. No covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337269 same patient/drug, different dose/event;US-PFIZER INC-202201337387 same patient/drug, different dose/event;US-PFIZER INC-202201337388 same patient/drug, different dose/event;
Diarrhea after ROTARIX with mild dehydration. Diarrhea x 6 days so far. CULTURELLE was prescribed. Mom was advised to come back to office if not resolved by 4/26/13.
Patients received an expired dose; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported .  On 08-Nov-2021, the vial was initially stored in the refrigerator. It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions.
Temperature 101 degrees F (highest temp reached). Dizziness, chills, unable to stand up, nausea. Symptoms started on 6-27-11; PM; symptoms resolved 6-29-11; no specific treatment.
4 days after getting flu shot LD and hand had a sharp and sore aching pain. Started upper LD - radiated to hand. Pain continues and is worse lft. hand. Went to Dr. in one location 11-18-15 and in another location 12-15-15. Can't use hand to pick up heavy object. Started meloxicam today 12-15-15.
69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.  There was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped to APD.  The original was kept -15 to -25 and then shipped and kept refrigerate.  This lot was shipped 6-Dec-2021 . The error was caught on 11-Jan-2022 when a new shipment was received.
Swollen lymph node right groin started about 6-8 hrs after vaccination. Over next 48 hours below that lymph node down to the right knee increasingly red, swollen rash, pain. ER visit diagnosis Lymphangitis. Treated with IV antibiotics then released 7am 12 March. Treatment with clindamycin(450mg) 3x daily for next 7 days. Rest and elevate leg. 12 hours after treatment began, feeling better not well yet. Swollen lymph node appears to be mostly gone and painful swollen rash has been reduced.