chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cardiac arrhythmias; Initial information received on 27-Jan-2022 regarding an unsolicited valid serious case from was received from a consumer/non-healthcare professional.  This case involves a 27 years old patient of unknown gender who experienced cardiac arrhythmias, while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no medical history, concurrent disease or risk factor.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed severe cardiac arrhythmias (arrhythmia) (unknown latency) following the administration of influenza vaccine. Reportedly, it went on and on, and on; it's happening everywhere and was not normal.  This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  Corrective treatment: the patient had to undergo an operation because of severe cardiac arrhythmias.  At time of reporting, the outcome was Unknown for the event of cardiac arrhythmias.; Sender's Comments: Sanofi Company Comment dated 07-Feb-2022: This case involves a 27 years old patient of unknown gender who experienced cardiac arrhythmias, while receiving influenza vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, 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.
Information has been received from a nurse aid concerning a 17 year old female who on 12-AUG-2009 was vaccinated with a dose of GARDASIL (route and lot number not reported). On 14-AUG-2009 the patient experienced dizziness, nausea and fainting. It was unknown if she had any laboratory testing performed. As 22-FEB-2010, it was unknown if the patient would received any more GARDASIL and the dizziness, nausea and fainting had resolved on an unspecified date. It was unspecified if the patient sought medical attention. Additional information has been requested.
11 days p/ vax pt exp mild fluid-filled rash w/approx 25-30 pox over parts of body
Mom reported to this nurse over the phone on the following day that child had spiked a fever of 102.3 degrees Fahrenheit from midnight to 3am.
2 Shingles shot was no help, didn't prevent me from getting virus/suspected vaccination failure; Still got virus; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: 2 Shingles shot was no help, didn't prevent me from getting virus/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got virus).The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that two shingles shot was not helpful. The reporter further stated that if you were a target to get the virus, you would get the shingles regardless. The reporter stated that it was so true but shingles was a virus and two shingles shots did not prevent him/her from not getting the virus (shingles). The reporter had the prevent shingles shots and still got the virus. The patient was way over 50 and herbal natural herbs helped him/her tremendously. The patient was Indigenous native and healing remedies were his/her biggest weapon against the virus. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Numbness in both feet for three days starting the night of my shot (March 4th).   I had severe back pain  for three days, which started on Friday, the 5th. Left foot is still completely numb 8 days later.
redness at the injection site 1 1/2 weeks later with mild itching. No other symptoms.
RED, HOT, PAINFUL, 6CM X 5CM IRREGULAR BORDERED AREA TO UPPER L ARM AT INJECTION SITE.
This spontaneous report was received from a other health professional (dentist) refers to a female patient of unknown age. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, therapy route, lot # and expiry date not reported). Concomitant medications were not reported. In 2014 (reported as unspecified date earlier in the year) the patient experienced seizure like symptoms on an unspecified date, after receiving GARDASIL. No product quality complaint (PQC) was reported. Outcome of the event was not reported. Causality assessment was not provided. This is one of the several reports received from the same source (MARRS #1412USA001509). Additional information has been requested.
At 1345, EMT found patient on ground. Patient's mother stated patient fainted and fell face first onto ground from chair. Patient was alert and oriented to person, place, time and situation. Patient stated she felt dizzy before she fainted. Patient reported no history of fainting, eating breakfast, and no chronic conditions. At 1350, patient vitals were blood pressure 124/80 mmHg, pulse 65 beats/minute, and SpO2 95%. At 1349, 911 activated . At 1353, paramedics arrived and assumed care. Patient's mother signed an Against Medical Advice form. Paramedics left scene at 1407. Lead RN educated patient and patient's mother on following up with primary care provider, signing up on v-safe, and signs/symptoms of when to seek emergency care. Patient left observation area with mother at 1409.
Both hands cramping, body ache, fever. Advised to take TYLENOL for fever.
2nd COVID-19 vaccination on 02-11-2021.  NO symptoms with 1st vaccination.  I woke up to a fever of 99.8 on 02-12-2021, which gradually escalated to 102 within 2 hours.  It remained at 102 for most of day. Finally came down to 101.1 by around 6:00PM.  My normal body temperature is low- around 97.6.  I also had an odd sensation at the back of my throat- cannot really describe it- sometimes hurt to swallow- but not consistently.  Only felt that symptom the day of 02-12-2021.  The next morning, my temperature was 99.2.  Eventually returning to normal around 3:00 PM that afternoon. I did not take any OTC medications during the course of recovery.
"mom states p/vax lt arm became red, hot & swollen @ site w/in 24hr of vax & taken to MD p/3rd day 24JAN97;say MD ATB in case infected;improved p/ATB;"
Patient c/o chills, body ache, generalized weakness after vaccination. On 01/12/21, patient's symptom improved, only soreness at the injection site.
Starting 12/04/2022, she woke up with a fever and malaise. She had some sinus congestion and we took her to urgent care and she was tested for flu. We tested her at home earlier for COVID-19 and it was negative so we assumed she had the flu. They didn't tell us the strain of flu, but she did test positive. They told us to increase her fluid intake and told us to manage her fever at home. We used TYLENOL and MOTRIN over the next few days to manage the fever but otherwise her symptoms were mild. She had received the flu vaccine in October. Tuesday afternoon into Wednesday she did not have a fever so we assumed she was getting better and planned to send her back to school on Thursday 12/08/2022. 12/07/2022, in the evening, she became altered (couldn't answer questions appropriately or follow directions). She also was talking gibberish and would not make sense when she spoke. We took her to the nearest emergency room because we were concerned she was having a stroke. They did a lot of tests including tests to check for pneumonia (chest x-ray), blood work and a CT scan of her head. All of the tests were negative. They sent us to the local hospital where they did a lumbar puncture and that was negative. So, the diagnosis was flu induced encephalitis. She was admitted for observation and was discharged on 12/08/2022. She progressively got better that day and only received TYLENOL for a mild headache as she got better. We went home and she stayed home from school the next day. We limited her activity and refrained from screen time until she could fully recover. As of today, she appears to have made a full recovery.
Profound fatigue, interfering with work and daily life (working as a nurse, driving, etc)
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 07-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513 1610USA004339: US-009507513-1609USA014830.
Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90,  chest tightness,  itching  throat,  and headache,
Patient felt fine after vaccine until seated in observation area. Became very dizzy, vision became blurry, and patient started sweating.   Laid patient on floor and elevated legs and feet. After about 10 minutes patient stated symptoms had resolved.
Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: PATIENT WAS HAVING TROUBLE BREATHING. GAVE PATIENT 20 ML BENADRYL.  PATIENT BREATHING IMPROVED QUICKLY. PARAMEDICS WERE CALLED. REPORTED PATIENT VITALS NORMAL. PATIENT DID NOT GO TO HOSPITAL.
Bell''s palsy; This is a spontaneous report from a contactable consumer or other non health professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection),via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown single for COVID-19 immunization.The patient medical history was not reported. concomitant medications:None.The patient experienced bell''s palsy on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101453228 Same reporter/durg, different patients.
myelitis transversal (thoracic level); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 28May2021 as dose 1, single (Batch/Lot number: unknown) and on 21Jun2021 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: MYELITIS TRANSVERSE (disability, medically significant) with onset Jun2021, outcome "unknown", described as "myelitis transversal (thoracic level)". Clinical course: Patient was struggling with a disease that came about approximately 2 years ago, myelitis Transversal. He since had a disability on his right foot. He was in crisis. He had to go to the hospital where he was given morphine because he was hurting and hurting. It calmed for a while, but then it started again. He had been in and out of the hospital. He was now in a wheel chair. He needed to be going to the hospital. He was now limited on things he can do. He needs to go to the hospital because he needs treatment for his myelitis transversal. The injections made him be in a wheelchair. He was looking for assistance because the doctor at the emergency room at the nearest hospital is not capable of helping him with his condition that is in the thoracic level.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pregnant resident requested H1N1 on 11-12-09 states at 2P 11-12-09 developed 104 temp, dizziness HR change & body aches accompanied by nasal D/C + sore throat.  She consulted with her OB DR 11-13-09 at noon. Dental resident took TYLENOL & fluids.  12/8/09 Medical records received. Prenatal records from 9/22/09 to 12/8/09. IUP 21wks. No other info provided.
Patient received her 2nd COVID vaccine on 4/26/2021 at  Pharmacy.  Since her 2nd dose she has had terrible diarrhea.  Stool cultures are negative.
Shot on 1/8/21, Arm Sx started 1/16/21, pt seen 1/19 and arm still has large pink area. No fluctuance. Arm slightly warm, no pain with motion. Pt does not have systemic signs.
joint pain all over my entire body; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Mar2021 11:00 (at the age of 50-years-old), as second dose, single dose for COVID-19 immunisation. Medical history included HIV and Diabetes Type II. Concomitant medications included emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY); pioglitazone; and testosterone (ANDROGEL) all taken for an unspecified indication, all start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date not reported), via an unspecified route of administration, administered in the left arm on 16Feb2021 11:00 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced joint pain all over my entire body on 13Mar2021, four days after the 2nd dose. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
feeling strange; tightness in back of his throat; stuffy nose; soreness in his lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034211A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-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 FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes). At the time of the report, FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Not specified
contracted COVID -19 Tested on 8/10 received POSITIVE test on 8/13 Cough, Loss of smell and taste, lethargic. (cough lingers) symptoms started 8/9. No Treatment NO hospitalization.
This spontaneous report as received from a pharmacist refers to two or three patients of unknown age. On an unknown date the patients was vaccinated with a dose of ZOSTAVAX, administered by the pharmacist On an unknown date the patients developed "wheel reaction" at the injection site after receiving the dose of ZOSTAVAX. This "wheel reaction" was defined as redness and swelling. No rash was involved. The pharmacist stated that he believed that the "wheel reaction" for these patients may have been attributed to the manner in which he was administering ZOSTAVAX (administration method not specified). These patients recovered from the "wheel reaction" after an unspecified amount of time. It was unspecified if the patient sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
This patient received PNEUMOVAX on 10/9/2009 and 6/2004. No details of the reaction are available for review. Complained of arm swelling after vaccination.
ill all night last night; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 15Mar2021, outcome "unknown", described as "ill all night last night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
father reports excessive somnolence, unresponsive x 15-20 mins then crying cont x 2 days; fever also-(temp not taken);
Patient received ZOSTAVAX on 8-19-15. On 11-9-15 patient reported to pharmacy that her left upper arm still hurt and she could not lift it above her shoulder level. RPh reported symptoms to PCP.
HERPES SIMPLEX 2 BREAK  OUT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: herpes simplex type ii. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced herpes simplex 2 break out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from herpes simplex 2 break out on 26-AUG-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Mild stroke on Right side of body affecting the left side of body one week after second covid vaccination shot
face was becoming stiff; arm bothered a bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (arm bothered a bit) and MUSCULOSKELETAL STIFFNESS (face was becoming stiff) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTRIN (BENEFIBER [DEXTRIN]) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced LIMB DISCOMFORT (arm bothered a bit). On 28-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (face was becoming stiff). At the time of the report, LIMB DISCOMFORT (arm bothered a bit) and MUSCULOSKELETAL STIFFNESS (face was becoming stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient was visibly nervous prior to receiving the vaccine. About 5 minutes after administration (during the 15 minute watch period), patient appeared to be slumped over in the chair. He had eyes closed and seemed to be shaking slightly. Pharmacist and tech grabbed the emergency kit and laid patient on the floor. After a few more seconds the patient woke up and was able to respond to questions. He was very pale, sweaty, reported feeling clammy and dizzy. Patient claimed he had not eaten since the morning. We gave him some water and a pb&j sandwich. Patient stated he felt better and he just gets very nervous around needles. The patient sat with us for another 30 minutes until his grandmother and cousin were able to come pick him up from the pharmacy.
Pt received his two vaccinations and penicillin injection on 1/7/16. On 1/8/16 he presented with complaints of headaches, chills, and some lightheadedness. He was given acetaminophen for this.
Mild ischaemic brainstem stroke. Symptoms: weakness in right leg and right arm, slurred speech, profuse sweating and vomiting without nausea, left eyelid drooping, visual field rotated 90 degrees clockwise. Ambuance to Regional Hospital admitted for 4 days.   Speech, Physical, and Occupational Therapy.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 16-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2302USA000403: US-009507513-2302USA000417: US-009507513-2301USA009943: US-009507513-2302USA000455:
pt recv vax 23MAR95 & 9APR95 pt exp numbness & tingling in the lt arm,particularly in the lt hand;