chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INTERNAL BLEEDING; THROAT CLOSING UP/CANNOT BREATHE; BLURRY VISION; MOUTH FULL OF BLOOD; BLACK VOMIT; BLACK STOOL; BACK PAIN/KIDNEY PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney stones, diverticulitis, brain injury (2011), and covid-19, and concurrent conditions included: non alcohol user, and non smoker. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: 11-DEC-2021) dose was not reported, 1 total administered on left arm on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, two hours after the vaccination, as the patient was driving home, he felt his long distance vision went, was not able to read the street signs even with his reading glasses and everything was blurry. The patient also had issues with his short distance vision. The patient stated that his vision was 20/10 or 20/15 and he used glasses only for reading. The patient could not read his car speedometer with his glasses off since vaccination. On the same day, in the night, the patient's throat closed up and was not able to breathe. Treatment medications included: diphenhydramine hydrochloride (Benadryl) and it helped in opening up his throat. A week later, the patient's throat closed up again and had taken Benadryl. The patient woke up the same night to find out his mouth was full of blood and half an hour later, the patient vomited which looked like black corn flakes followed by black stools that looked like black corn flakes. The patient also experienced severe pain in wrist, elbow and shoulder (join pain). The pain felt like someone was punching him in the kidneys and back. The patient had gone to see the chiropractor, who told him that he was having a reaction to the vaccine.  The patient had then visited his doctor on 26-OCT-2021, who told him that the patient had already developed antibodies when he had got covid, so when he received the vaccine, this antibodies started attacking his old scar tissue from passing the kidney stones and diverticulitis and the patient had an internal bleeding. The patient reported that all symptoms were better now except his vision and joint pain. The patient has an appointment with his eye doctor on 29-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from internal bleeding, throat closing up/cannot breathe, mouth full of blood, black vomit, black stool, and back pain/kidney pain, and had not recovered from blurry vision, and joint pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211125045-Covid-19 vaccine ad26.cov2.s-Internal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt administered Pneumococcal vax p/it had expired; @ time of report, there were no adverse exp;
5/02 Pediarix and 6/01 Proquad Vaccinations. Oct 17th at 04:08 am pt. was found seizing on the floor for about 30 seconds then was unresponsive for about 15 minutes with eye scanning and moaning.
Information has been received from a 70 year old physician (pediatrician) with Cholesterol high and high blood pressure, allergy to ZESTRIL and a history of an operation on his maxillary sinus because of pneumococcal maxillary sinusitis (date unknown) who starting in 1990 and every five years until 2000 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) and on 01-OCT-2009 at approximately 12:00 was vaccinated with a dose of PNEUMOVAX 23 in the left deltoid (route and lot # not reported). Concomitant therapy included AVALIDE and ezetimibe (+) simvastatin (MSD). He reported that almost every time he received the vaccine in the past he experienced a site injection reaction, further described as redness and tenderness. On 01-OCT-2009, around 21:00, he experienced heat and pain at the injection site and he was not able to sleep on his left side that night. On 02-OCT-2009, he felt ill, further described as he felt like he was having a low grade fever and his legs were hurting him. On 02-OCT-2009, he noticed erythema on his left biceps and toward his left axilla. On the same day, he was able to sleep on his left side. It was unknown if there were any relevant laboratory data. It was reported that he was feeling better in general; it was unknown if his legs still hurt or if he continued to have low grade fever; the injection site was less tender and was not red. He continued to experienced erythema on his left arm. It was not specified if the patient sought medical attention. Additional information has been requested.
pt recvd vax 22OCT95 & 24OCT95 became congested, had chills, h/a, 3" red strip on arm from flu shot, sore;25OCT went to clinic they took blood, had very high allergy count;pt given allergy shot & Keflex;also aching all over
Patient waited for 15min after the vaccine in the pharmacy waiting area. After 15 min patient left pharmacy and returned back from outside stating "she has thigh throat, shortness of breath. and hive. We administered Epi Pen  right thigh.  After Epi she has jitteriness and racing heart. We called 911 and monitor patient until paramedics arrive. Patient decline emergency care. Left pharmacy in a stable state. I make a follow up phone call on 08/26/21 and left a message.
Caller has appointment for second vaccination.but needs a wheelchair; This is a spontaneous report from Pfizer-sponsored program. A Non-contactable female consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she has appointment for second vaccination. But needs a wheelchair, didn't know how to contact site for information. The patient didn't need a wheelchair for the first appointment. The outcome of event was unknown.   No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Within 1 degrees of administration of vaccine pt's Mom states dime sized hives appeared on abdomen for approx 1-2 degrees - Mon states no SOB, no itching, "didn't seem to bother her." No other reactions noted as parent states.
Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.
Typical menstruation cycle is 25 days, I have had no period in 31 days
Spots formed on her torso approximately 2 weeks after immunization later the same day lesions to the entire torso, not itchy, just red and swollen.
After administration, 15 minutes, my arm felt very cold. After about 30 minutes, my arm hurt down to my elbow. 24 hours later, I experienced elevated heart rate to 80 bpm (I usually am at about 60 bpm), chills/fever, fatigue, lymph node swelling/pain in left armpit. The following day, I got a headache and took ibuprofen. Headache lasting about 24 hours. Chills, fever, fatigue subsided after 48 hours. Lymph node subsided 72 hours after injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydromorphone, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "unknown", COVID-19 (medically significant) with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 28Jan2023 to 03Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report was received from a medical assistant concerning a 20-year-old patient of unknown gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On 14-MAR-2016 and on 11-MAY-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018 and lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided) respectively. The vaccines underwent temperature excursion of either +1 or -1 Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
This spontaneous report as received from a Medical Assistant refers to a 46 year old female patient. Concurrent conditions and medical history were not specified. On 11-JUN-2015, the patient was vaccinated with 0.5 ml of PNEUMOVAX 23 (intramuscular injection) lot#K007826. Later that same day, the patient developed cellulitis just below the injection site. Concomitant therapies included LIPITOR, PRINIVIL and metformin. The patient was seen in the physician's office on 12-JUN-2015 and was prescribed an unspecified antibiotic to treat the cellulitis. There was no intervention to prevent serious criteria and no labs were performed. The event was considered to be not cancer, overdose or life threatening. There was no significant disability, incapacity, hospitalization or prolongation. PQC was not involved. The outcome of the and the relatedness with PNEUMOVAX 23 were not reported. This case is one of two cases from the same reporter (MARRS#506USA009646). Additional information has been requested.
Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date; Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  The nurses gave vaccines after the beyond use date.It was reported that the vial was brought to clinic and placed in refrigerator on 05 Jan 2022.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up information included no new information.
fever; Cough; headache; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN 5318), via an unspecified route of administration, administered in Arm Right on 26Jan2021 13:15 as single dose at Workplace clinic for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 13:30, the patient experienced fever, cough and Headache. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was Recovering.
Red rash at injection site, raised, and hot to touch. Patient took Benadryl and rash disappeared in 3 days.
Information has been received from a registered nurse concerning a 20 month old white male 23 lbs., 32 inches, who on 04-DEC-2006 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #654528/1044F). Concomitant therapy included influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated)) and measles-mumps-rubella vaccine (M-M-R II). On 24-APR-2007 the patient experienced maculo-papular lesions on the abdomen and groin. Subsequently, the patient recovered from maculo-papular lesions on the abdomen and groin. The patient was seen by a physician and treated with Calamine and Benadryl. The patient was 6 lbs. 12 oz. at birth and has no siblings. No further information is available.
Fevers Weakness  Extreme Fatigue Throwing up Extreme weight loss Cognitive processes/behavior problems Anemia B12, Iron, folic acid Dystonia Had to have testing to rule out seizures  Heart murmur POTS disease Heart regurgitation
Reports 48 hours after Td booster, soreness, swelling and itching at site. 4 days after Td booster eval. in ER DX-Adverse Reaction to Td and Cellulitis.
No Adverse Event; Nurse reported AE for improperly stored administered GARDASIL 9. Declined full patient demographics. No additional AE/PQC.   GARDASIL 9 w013388 exp 12/16/24 previous excursion  ----administered lot  6/2/23; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JUN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #w013388, expiration date: 16-DEC-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion (product storage error). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA003034:MSD
pt recvd 1 dose of Engerix-B & on 21JUN92 exp an asthma attack which resolved;
A pediatric dose of VAQTA on 3/5/2020 in error.; This spontaneous report as received from a license practical nurse, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not provided.  On 05-MAR-2020, in error, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot number reported as "S023449" with expiration date on 24-AUG-2020 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  Lot number S023449 is an invalid lot number for hepatitis a vaccine, inactivated.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a 25 month old male with no history of chickenpox and no known allergies who on 06/24/03 was vaccinated with a dose of varicella virus vaccine live (Lot # unknown). The pt has had a recurring vesicular rash determined to be varicella positive. A specimen has been obtained on 10/30/03 for PCR analysis from a scab. The physician indicated that the child has had three rash outbreaks, with the last rash (patches on back, left arm and chest) occurring on approximately 10/17/03, "2 weeks ago". Unspecified medical attention was sought. There was no product quality complaint. Additional information indicated that the pt developed 3 episodes of a rash, determined to be herpes zoster. The first episode occurred on 07/16/03 as 2 discrete vesicular papular lesions on his left cheek and right lower back. The second episode occurred on 08/09/03 as 2 discrete lesions on left cheek (same spot as before) and right arm. The third episode occurred on 10/17/03 as 2 areas of erythema, 3cm in diameter. One was on the upper back and the other was on the back of the right arm. Both areas had multiple little vesicles. There were also 3 discrete papulo-vesicular lesions on his chest. The rashes did not occur at the site of injection post-vaccination. The outcome was reported as recovered. Additional follow up information received on 11/07/03 indicated that the PCR results revealed that the specimen contained the manufacturer vaccine strain virus. The specimen was obtained on 10/30/03 and sent to the lab on 10/30/03.  The source was the scab of a vesicle. VZV DNA was amplified. The VZV strain identification showed vaccine-type. B-globin was amplified. The interpretation was adequate specimen with vaccine strain.  Additional follow up information received on 22-Mar-2004 indicated that the patient was diagnosed with acute lymphocytic lekuemia (ALL) 10 days after varicella vaccine was given. Chemotherapy medication was initiated prior to 31-Oct-2003. The reporter indicated that the child was treated with acyclovir for his rashes and "is now better as far as she know." It was noted that the reporter "is going to check further to make sure the child does not have any chronic rash, but she does not think so." Information was recevied which pertained to events which occurred 10 days after vaccination with varicella virus vaccine live. This information contained the following adverse experience: ALL (acute  lymphocytic leukemia) (04-Jul-2006). Additional information has been requested.
It was identified that the patient has received 7 doses of Pfizer and 1 dose of J&J.  Patient continuities to seek additional COVID vaccines doses even though his series is complete.  The patient has been turned away several times at Pharmacy for attempting to get additional doses.   It is possible  the patient is seeking additional doses outside of Pharmacy.
Raised, red, really hot  reaction below immunization site, rash all over body (chest, arms, legs), fever, chills, headache for 2 days after.
site of administration very sore; 16NOV94-arm is still very sore & now experiencing SOB, over all muscle soreness;
PT started throwing up and Had fever of 102.7. Given ibuprophen to keep fever down.
but tested positive for covid; fever of 101 Fahrenheit/100 Fahrenheit fever; flu symptoms; nasal congestion; chest congestion; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her Pfizer Covid Shot on 28Feb2021 and after 24 hours of no problem she had 2 days (01Mar2021) of 101 Fahrenheit fever and other flu symptoms. After that a few days (Mar2021) of 100 Fahrenheit fever with nasal and chest congestion, and fatigue, the patient has no fever now for about a week but tested positive for covid on 9Mar2021. She was hoping her chest congestion will dissipate in a few more days. She inquired if she should go for her scheduled 2nd Covid shot on 21Mar2021. The outcome of the event fever was recovered on Mar2021 while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/5/21 (EN6206) Pfizer Dose 2 3/25/21 (ER8732) Pfizer Dose 3 12/10/21 (33030BD) COVID Positive 12/10/21  12/10/21: Patient was sent to the emergency department after getting his COVID-19 booster shot.  Patient is a poor historian.  Patient told the clinic at the booster shot initially that he has been feeling well.  After shot checked on him and he reported that he felt short of breath.  He he then let them know that he felt short of breath for a few days and has been coughing.  They checked his pulse oximetry and found it to be 84% on room air and sent him here for further evaluation.  Patient arrived to the emergency department with a pulse oximetry of 84% on room air.  12/14/21: Patient was admitted for acute hypoxemic respiratory failure secondary to COVID-19 and COVID pneumonia.  Patient was treated primarily with dexamethasone and remdesivir with supplemental oxygen and nebulizer treatments.  Patient has progressed well. Patient was provided antibiotic regimen to prevent secondary bacterial infection.  Patient progressed well in the hospital and completed his course of remdesivir.  He is afebrile and breathing easy.  His oxygen saturations are 94-95% on room air.  Patient feels well for home disposition.  Patient will be discharged home on dexamethasone and continued antibiotics and nebulizer treatments.