chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose and frequency not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
% minutes after receiving the vaccine the patient stood up and toppled over chairs landing face down on the ground.  He was pale white and shaking.  He had no recollection as to what happened.  The pharmacist ran over to assist.  Kept him laying down, brought him cold water and asked him a series of question in which he was able to respond.  An ambulance was called.  EMTs checked his vitals and the patient was ok.  He opted out of going to the hospital  His wife came and gave him a ride home.
Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling in hand and coldness in extremities. Patient has history of fibromyalgia and does not believe it to have contributed to latest onset of symptoms. Still currently having side effects as of 8/29/21, is contacting MD 8/30/21 for follow up.
Initial report was received from a health care professional on 13 February 2012. A 44-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd lot number C3990 (sanofi pasteur Inc. lot number U4137BA) on 05 February 2012 and an unspecified amount of time later experienced left arm cellulitis, left arm numbness, fever and chills. At the time of the report, the symptoms were improving but still persisting. Illness at time of vaccination was reported as none. The patient had no known allergies and no reported medical conditions. The patient had no other vaccinations within four weeks of ADACEL. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
pt presented on 3/31/21 with facial numbness and headache. patient had follow up with OB and blood clot was found behind the placenta and there were no fetal heart tones on 4/23/21.
On 12/12/2022, he started having a snotty nose. He slept fine that night, but we kept him home from school because the color of his snot. Then, he began to run a fever on 12/14/22. We gave him Motrin that night and he ran a fever for about 24 hours. His fever got up to 103. That night his stomach was hurting and had a headache. We took him to the doctor, and he tested negative for Flu, COVID-19, and RSV. He is feeling better, but he still has a little cough and some dry sinuses.
Redness of face, feeling "flush", elevated BP 160/90 that lowered to 138/84 after several minutes, feeling shaky, patient treated with Benadryl 50mg at 1200pm.
Rash left thigh documented 10/21/14. Rash started about week ago with 2 blisters and now radiating lt buttock cheek, groin and back.
Severe hepatitis second Moderna vaccine 2/11/21 and felt feverish that night and the next several days.  He took ibuprofen for a few days. His had subjective fevers after that that worsened in early March. His temperature was normal during these times.  His urine got dark.  His saw his PCP and labs showed increased LFTs. He was admitted.  Liver biopsy 3/15/2021: Portal and lobular hepatitis with cholestatic features, negative for steatosis or fibrosis. Subsequent hepatology diagnosis was "All his symptoms started after COVID vaccine #2 but unable to identify any other DILI source."
Bell's Palsy - symptoms started 8 hours after first vaccine. Treated with prednisone and Valtrex on DOS 12/16/21.
PATIENT WITH HISTORY OF SYNCOPAL EPISODES  HAD A SYNCOPAL EPISODE MINUTES AFTER VACCINE WAS ADMINISTERED. HE WAS IMMEDIATELY PLACED ONTO A BED IN A RECOVERY POSITION. EKG WAS NORMAL. VITALS STABLE. HE HAD ANOTHER SYNCOPAL EPISODE, STARTED POSTURING. REGAINED CONSCIOUSNESS ON HIS OWN. PT STATED THAT HE HAD NOT EATEN YET. HE WAS GIVEN SOME CRACKERS AND WATER. MONITERED FOR 30 MINS. MADE A FULL RECOVERY AND WAS RELEASED.
WITHIN 24 HOURS, PATIENT BROKE OUT WITH AN ERYTHMOUS, RAISED, ITCHY AND PAINFUL RASH ON ARM, NECK AND BACK.
Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.
COVID DIAGNOSIS 8/18/2021; HOSPITALIZED 8/24/2021 WITH COVID PNEUMONIA; ACUTE RESPIRATORY FAILURE.
15 minutes after receiving the FLUBLOK vaccine the patient reported feeling short of breath with difficulty breathing and throat tightness.
Patient first dose received was Moderna vaccine, 2nd dose administered was Pfizer. Patient reports he feels fine.
soreness at and around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. In December 2019, 1 week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of Shingrix vaccine and about a week later he started experiencing soreness at the injection site. The soreness was still the same and it was present in 5 inches by 5 inches of area at and around injection site on left arm. The patient consented to follow up.
PULMONARY EMBOLISM; CHEST PAIN; This spontaneous report received from a patient via a company representative via the local news, concerned a 60 year old male. 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) at an unspecified dose on 06-MAR-2021 for prophylactic vaccination. The anatomical vaccination site was not reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 01-APR-2021, 26 days after vaccination, the patient went to hospital due to chest pain. On 08-APR-2021, 33 days after vaccination, the patient was diagnosed with pulmonary embolism, and was hospitalized. The patient reported he suffered a blood clot after receiving the vaccine and was diagnosed with a pulmonary emboli. On 11-APR-2021, the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: A 60-year-old man experienced chest pain 26 days after vaccine and was hospitalized with pulmonary emboli 33 days after vaccine. Medical history and concomitant medications were not reported. The latency of greater than 3 weeks makes this unlikely related to vaccine. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including contacting the news station that reported the event.
severe hypoglycemic event (POC=38)/hypoglycemia; chest pain; He was found driving the wrong way down the highway; no memory of the event; This is a spontaneous report from a non-contactable pharmacist. A 70-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9265) intramuscular, on 01Feb2021 at 08:00 (at the age of 70 years old), for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021, after vaccination, the patient experienced severe hypoglycemic event (POC=38)/hypoglycemia and chest pain. He was found driving the wrong way down the highway with no memory of the event, once stopped by authorities. He was admitted to the hospital with hypoglycemia and chest pain. His home diabetes coverage was an insulin pump and there was denial of decreased PO intake. The insulin pump was stopped once the patient was admitted. His glucose improved and insulin regular SSI was initiated. He was brought for cardiac cath on 02Feb2021 with no new issues seen. The patient was stabilized, was set for follow-up with PCP and endocrinologist and discharged on 04Feb2021. The events resolved on an unspecified date in Feb2021.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available.   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.
uncontrollable shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 08:30 (Lot number: EL3247) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAZODONE; GLUCOSAMINE; IBUPROFEN. Past drug history included: Vicodin, reaction(s): "drug allergy", notes: Known allergy: Vicodin. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Arm Right, lot number: EL3247, Time: 09:00 AM), administration date: 11Feb2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Mar2021 22:30, outcome "recovered" (Mar2021), described as "uncontrollable shivering". Therapeutic measures were not taken as a result of chills.  Additional information: Event Description: Approximately 14 hours after receiving second dose patient experienced chills and uncontrollable shivering. The symptoms lasted approximately 4 hour to 6 hours. The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included trazodone, glucosamine, multi vitamin, ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient described pain and redness to injection site. No other information obtained as medical documents not obtained up to this reporting date. Patient discharged and has recovered.
PATIENT HAD A SHINGLE LIKE RASH ON THE LEFT SIDE OF HIS CHEST BY NIPPLE AND ARMPIT AREA.  ON THE 20TH IT WAS JUST RED, BY MARCH 31ST THERE WERE RED BUMPS AND SCARRING.  HE ALSO HAS 7 CIRCULAR SHAPED DARK RASH MARKS ON HIS BACK (THESE DEVELOPED MORE RECENTLY, EXACT DATE UKNOWN).  PATIENT STATED ON MARCH 20TH THAT HE HAD NO PAIN, THE RASH WAS ITCHY AND SENSITIVE ONLY.
Information has been received from an 89 year old male with no pertinent medical history or drug allergies who on approximately 19-OCT-2007 "6 weeks ago," was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) (no lot# provided) by the physician while he had shingles. There was no concomitant medication. The shingles went away but after 4 days on approximately 23-OCT-2007 the shingles "came back." The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information from a physician indicated that the 89 year old retired male who on 02-NOV-2007 at 11:00 was vaccinated SC with a 0.5 ml dose of Zostavax (Oka/Merck) (lot# 658395/0966U) in the right arm. The patient stated that he had shingles on the "down deep inside of his body at the time of vaccination." Follow-up with the physician never had an actual diagnosis of shingles at any time. A screening form also indicated that there was no illness at the time of vaccination or contraindications to therapy. Additional follow-up information from a physician indicated that the patient did not receive Zostavax (Oka/Merck) (lot# 658395/0966U) during a shingles episode and that the patient never had shingles. The physician does not have any additional information. No further information is available. This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information received from the consumer stating that the physician prescribed him codeine for his pain-which had not helped. No further information is available.
had vertigo, ran into a wall; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (had vertigo, ran into a wall) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 VERTIGO (had vertigo, ran into a wall). At the time of the report, VERTIGO (had vertigo, ran into a wall) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication not provided. Treatment medication not provided.  Reporter did not allow further contact
07/19/2021 DURING WORK HOURS I STARTED SNEEZING THEN MY NOSE STARTED RUNNING CO WORKERS SAID "YOU HAVE ALLERGIES,"  BUT I DONT HAVE ALLERGIES 07/20/2021 I HAD FACIAL CONGESTION AND MY EARS WAS HURT ING I WENT TO THE DOCTOR AT 9 AM . I WAS TOLD I HAVE A SINUS INFECTION  AND I WAS GIVEN ANTIOBIOTICS AND STERIODS.  I HAD A COVID TEST DONE AS WELL.   I LOST SMELL AND TASTE ON 07/21/2021 07/21/2021 MY COVID TEST RESULTS CAME BACK POSITIVE.  07/22/2021  I HAD A DETACHED RECTUM 07/23/2021 I HAD SURGERY FOR THE DETACHED RECTUM.  I WAS GIVEN A  REGENERON COCKTAIL INFUSION THROUGH IV I HAD TO STAY IN THE HOSPITAL FOR 1 DAY BECAUSE i WAS POSITIVE FOR COVID AND COULDN'T GO FOR A FOLLOW UP   ON 07/24/2021 I WAS DISCHARGED 07/25/2021 WAS MY LAST DATE OF QUARANTINE 07/26/2021  I RETURNED TO MY NORMAL DAILY ROUTINE I WOULD LIKE TO KNOW WHAT VARIANT I  HAD? IF POSSIBLE! FYI: I FEEL LIKE I WAS EXPOSED TO COVID AT WORK  (WEEK PRIOR TO MY SYMTOMS, I WORK AT A  SMALL LAW OFFICE TWO ATTORNEYS 07/13 AND 07/14 ONE OF ATTORNEY S WHO WAS NOT VACINNATED KEPT COUGHING MORE LIKE POST NASAL DRIP MONDAY, TUESDAY AND WEDNESDAY HE WAS  COUGHING THURSDAY AND FRIDAY HE WAS SNEEZING. HE ENDING UP FINDING OUT ON THE 21ST OF JULY THAT HE WAS POSITIVE FOR COVID . HIS WIFE AND GROWN SON WAS POSITIVE AS WELL. HE WAS  PLACED IN ICU AND HE DIED THE FOLLOWING TUESDAY. )   I WOULD LIKE TO KNOW IF COVID IMPACTED MY STAMINA
dizziness; body aches; Nausea; chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 09:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis and hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN) and levothyroxine sodium (SYNTHROID) both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0158) via an unspecified route of administration in left arm on 08Apr2021 at 09:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 21:00 the patient experienced nausea, dizziness, fever, chills and body aches which were lasting 15 hours or so. 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 outcome of nausea, dizziness, fever, chills and body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected. .
After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness. When nurse arrived to assist patient, patient took a deep, snoring breath and regained consciousness. After being placed on monitor, patient noted to be bradycardic with HR as low as 36. Pulse palpable. O2 sats remained stable. BP noted to be 80 palp. Blood glucose level noted to be 91. Patient coloring noted to be very dusky originally and patient noted to be clammy. Patient oriented when regaining consciousness. O2 applied via nasal canula and HR returned to low 70's. Patient given Gatorade and monitored by EMS. Patient declined transport to hospital and left ambulatory without any lasting symptoms.
Patient was fine after vaccine. Mom is aware that does not have 6-11 yr moderna vaccine. Advised to schedule at another location that has the vaccine... Mom declined
1st shot was fine, after 2nd shot had body aches, fever of 102, chills; 1st shot was fine, after 2nd shot had body aches, fever of 102, chills; 1st shot was fine, after 2nd shot had body aches, fever of 102, chills; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 17:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included escitalopram (MANUFACTURER UNKNOWN) and norethisterone (NORETHINDRONE); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation and was fine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First shot, the patient was fine, after second shot, the patient had body aches, fever of 102 (units unspecified), chills on 22Apr2021. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events after second shot had body aches, fever of 102 (units unspecified), chills was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26.  She had hives on her neck, arms chest, headache arm pain and mild dizziness.  Symptoms resolved with Benadryl   She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER.  She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80)  given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen   With ongoing asthma, dizziness, light headed , nausea  and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil  --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
I was taken to the ER because I started with numbness in my face and itching; I was taken to the ER because I started with numbness in my face and itching; Terrible headache; Sore throat; Chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included blood pressure high and thyroid problems. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid problems, spironolactone. The patient just had side effects from the Covid Vaccine (clarified as Pfizer BioNTech Covid Vaccine). Actually when the patient had the shot she was taken to the ER because she started with numbness in face and itching on unknown date but now since that was on Tuesday 19th, so today the patient had a terrible headache, she had sore throat and today she started with chills on unknown date. Before the patient had blood drawn latest before she got shot. The patient was in the hospital, she was given Benadryl, Pepcid and steroid through the IV. The patient had been treating in home with either Tylenol, Ibuprofen, Excedrin Migraine, Aleve, she mean, trying to relief the headache and it's not helping. The outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.