chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high D-dimer test result (485); rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via unspecified route of administration on 11Feb2021 08:30 AM in left arm as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. Concomitant medication included (other medications in two weeks) lisinopril, simvastatin, fluticasone propionate, salmeterol xinafoate (ADVAIR), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any COVID prior vaccination. Since the vaccination the patient was not tested for COVID-19. The patient experienced rapid heart rate on 14Feb2021, high D-dimer test result (485) on 15Feb2021 at 7.00 PM. The patient did not receive any treatment for the events. The AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.
Tight chest, sleepy (slept for days), body sore, back especially, dizzy when standing, cold sweets, night sweats, wound looked infected as it was big, full of pus, large red mark around shoulder.
Pre-syncopal epsiode this morning. Felt flushed when he was standing at a breakfast spot waiting for his sandwich. Reports he sat down. Got up to get sandwich when his name was called. His legs felt rubbery, slow crumple to the ground. Reports did not lose consciousness. Pt reports he stood up without assistance quickly after "popping up". Felt okay afterwards, slighlty lightheaded. Staff at restaurant gave him a bottled water and called the EMS. Vitals: BP 98/70, Pulse 98, Fasting blood sugar: 169. No other suspected factors that contributed.
Elevated temperature by mom's report. Wheals to abdomen, legs and arms which was observed by this nurse.
Started getting bumps all over right after the shot, then the sight of the shot doubled in size and has little bumps all over it, and hard as a rock. Now it is growing in size.
I began having a itchy, painful bumps on my heel of my foot and my fingers. It spread to my whole body. I went to the doctor about this. They did blood work, which came back normal.
Information has been received from a pharmacist concerning a 60 year old male patient who on 19-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# 669589/1453Z. Exp date, 28-JAN-2012), may be by the intradermal route. Pharmacist reported that on 19-DEC-2010 the patient had developed a red, warm lump the size of a quarter at the injection site. It was also reported that the lump began shortly after vaccination. At the time of the report the patient had not recovered from these symptoms. The patient sought medical attention by calling pharmacy. Follow-up information has been received from the Registered Pharmacist, who reported that the male patient with no illness at the time of vaccination and no pre-existing allergies, birth defects, medical conditions, was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot# 669589/1453Z. Exp date. 28-JAN-2012), SQ, Right arm, at 16:00 on 19-DEC-2010. The pharmacist stated that on 19-DEC-2010 the patient experienced a red lump immediately formed post injection. The pharmacist also stated that the lump was red and warm to the touch and became itchy after 1 day on 20-DEC-2010. The pharmacist mentioned that the patient had seen a Doctor who stated that these events were a slight reaction and did not prescribe anything. At the time of the report the patient's outcome was unknown. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QUADRIVALENT had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Woke up morning of 7-11-07 obviously uncomfortable and throwing up small amounts of bile a few times every hour. Pediatrician referred us to the ER at 5:00; bloody diapers began around 6:30 PM. Ultrasound at 9:15 PM revealed intussusception. Drs attempted to reduce via enema 3 times unsuccessfully. Surgery at approx 1:00 AM on 7-12-07.  8/3/07 Received vax record which confirmed RO dose & lot # as reported. 8/14/07 Received hospital medical records which reveal patient experienced abdominal pain, bilious vomiting, decreased appetite & blood stools x 1 day.  Admitted 7/12-7/14/2007.  Exam revealed softly distended abdomen w/palpable mass at LLQ.  BE unsuccessful & surg consult obtained.  To OR for exp laparotomy & bowel resection FINAL DX: Intussusception, surgically reduced.
pt recvd vax & 2 min later both arms extended & jerking;  head hyper extended; eyes rolled upwards; pt responsive w/in 30 sec after inhalant admin;
Infant appeared to tolerate vaccines well.  At approximately 2100, Dad was reportedly carrying infant, infant had an episode of limpness, pallor, perioral cyanosis, improved with Dad positioning neck.  EMS was called and arrived, infant was pale.  Evaluated in ED, hospitalized for approximately 1.5 days for observation/testing, no clear cause found for event.
CONVULSIONS FOR 2 HOURS; This spontaneous report received from a patient via company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry date were not reported) dose was not reported, 1 total (first shot) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On the same day night of vaccination with covid-19 vaccine ad26.cov2.s (unspecified date), the patient experienced convulsions for 2 hours. It was reported that "After that first Covid shot, that night went into convulsions for 2 hours. Called the Pharmacy and asked about it and said it was normal. Is this correct". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from convulsions for 2 hours. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221241972-convulsions for 2 hours.. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
only time patient ever got the flu was the one time patient got the flu shot; Initial information received on 09-Dec-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who only time ever got the flu (influenza), was the one time patient got INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that only time the patient ever got the flu (influenza), (latency unknown) was the one time patient got the INFLUENZA VACCINE.   Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
During the first and second day, my upper left arm was slightly tender from the shot. When that pain subsided during the second day after the shot, I started to get some swelling and pain in my left armpit. Discomfort was such that it interfered with my ability to sleep through that night. The following day (Day 3 after injection) the discomfort mostly subsided but still has not completely gone away. Currently on Day 6 after injection. No treatments or medications have been applied to alleviate the issue.
Three months of arrhythmia; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Three months of arrhythmia) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Three months of arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Three months of arrhythmia) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. Latency is unknown but it is reported that after the administration of SPIKEVAX 2023-2024 vaccine the patient developed three months of arrhythmia. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Received vaccine 12/23/20; mild redness and swelling with moderate pain noted x2 days but resolved after days 5-6; day 7 redness returned to injection site with notable swelling and induration around injection site.  Area became hot, itchy, more swollen and red so this writer contacted staff health for a consultation. 7 days of oral antibiotics prescribed for presumed cellulitis of left upper arm. Area marked with skin marker to observe for worsening redness. No fever at time of consultation.
Muscle pain; fatigue; This is a spontaneous report from a contactable consumer who is reporting for herself.  A 26-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration left arm single dose on 21Jan2021 12:30 for covid-19 immunisation. No other vaccine was received in four weeks.  The patient medical history was not reported. There were no concomitant medications. The patient experienced muscle pain on Jan2021, fatigue on Jan2021. No treatment received. The outcome was not recovered
Administered monovalent dose as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster).    Concomitant product use was not provided by the reporter.  Reporter found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters.  Reporter called public health, who said there was no harm in it.   Reporter was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  Treatment information was not provided.
pt recv vax & exp a feeling of hard to swallow/swollen in throat;pt taken to a MD d/t exp;
The patient presented with acute chest pain approximately 4 weeks after Pfizer dose #2.  She was found to have an acute cardiomyopathy with EF 30-35%.  Cath showed non-occlusive CAD.  At the time, the diagnosis was "broken heart syndrome" related to passing of her brother.  But it occurred to me that this could have been a vaccine adverse event based on other information that has come out since then.
Left leg numbness left abdomen numbness. Hospitalization. Tests and MRI scans dx transverse myelitis.  5 days IV steroids.  Numbness continues on left full leg.
103.8 plus fever for 72 hours. Dizziness. Excessive sleepiness. Loss of appetite. Ear infection.
approx 3hrs p/vax began to cry uncontrollably, t103-104ax;according to mom became very lethargic & limp;could not sit up (was sitting fine prior to this) not focusing; not eating; 4 days later broke out in rash & had dry cough;
pt had a positive COVID test on 7/21/22 at the Health Department; pt passed away at home; no medical records in our records
Information has been received from a nurse concerning a male who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 665924/0930Z, expiration date 17-JUL-2011). Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is an amended report. Vaccinated at: unknown and vaccinated with: unknown were added in therapy screen.
blacked out 26 minutes after the vaccine while driving. Hit a fence. Was a few hundred feet from my driveway. Car hit a fence with me in it. The impact woke me
11/02/2021 A day after my booster shot it was very sore from the shot and very warm to the touch. It got difficult to move it around as well. As the days progressed it became increasingly hard to move it to the side and above my head. Since then I have been able to get some more mobility back and it started to create additional muscle pain down the arm and through the wrist. It feels as if my muscles twist when moving in certain directions. I cannot get my arm above my shoulders or pull up my pants or shrug into a jacket. I am going to go to an ortho specialist in about a week from 02/03/2022. I am currently going to physical therapy and decided that more investigation is needed.
Left side facial swelling Lip Swelling  Rash/hives all over the body  Presently using Benadryl
A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced INADVERTENT ADMINISTRATION OF FLUMIST TO A 12 MONTH OLD which started on 14-Sep-2012. The outcome of the event of INADVERTENT ADMINISTRATION OF FLUMIST TO A 12 MONTH OLD is unknown. The report was considered to be non-serious by the reporting health professional.
got the vaccine and still get shingles/ suspected vaccination failure; shingles; less pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and still get shingles with less pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Hospitalization for COVID symptoms on dates 7/9/22-7/18/22. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, and zinc 50 mg PO daily.
first dose of Shingrix 12/2019. does she need to restart and get both shots; This case was reported by a other health professional via Interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose, which led to incomplete course of vaccination. The reporter enquired if the patient had to restart and get both shots or if she could she could just get the second shot.
patient states she got the COVID vaccine and immediately started with itching and burning throughout body. She denies shortness of breath. .
Pt has flu like symptoms, vomiting, diarrhea, chills, loss of appetite.
got the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who still got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for influenza immunization.  On an unknown date, the patient still got the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Tingling on mouth and tongue; Red patches on the skin/red rash; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache). At the time of the report, PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment information is unknown(maybe Acetaminophen)   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Added patient demographics and event updated from erythema to red rash.