chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in hives; Itchy hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included low thyroid, glaucoma and hypertension. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), losartan (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and ergocalciferol (VIT D) and unspecified daily multiple; all from unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 07:00, the patient broke out in hives, itchy hands and feet. The event resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with PREDNISONE, famotidine (PEPCID), cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL); all from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events broke out in hives, itchy hands and feet were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I have been having diarrhea every day since 05/29/2021. Went to the clinic & so far nothing in terms of results of what is wrong.  Second dose was 06/19/2021 & symptoms are constant, if not slightly worse.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician mentioned other patients who had other side effects and she did not see skin outbreak. The reporter gave authorization to contact physician. This case linked with US2020075690 and US2020075700, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020075690:same reporter US-GLAXOSMITHKLINE-US2020075700:same reporter
Was given Fluarix vaccine IM 10/19/06 at workplace by RN on site. Has reported today pain in arm since and peels as if worsening. Didn't note any swelling/hot/redness or hardening of skin muscle. Hurts when using arm to dress, move, etc.
The patient was coming into the clinic for a Well Child Check. Immunization was drawn up and verified by provider and administered to patient. When inputting vaccine to system is when I realized that Immunization was incorrect. Provider was aware of immunization error.
Shortness of breath, chest discomfort, patient states feeling throat swelling, no visible swelling. Blood pressure elevated and tachycardia.
a severe pain in the right part of jaw; Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (a severe pain in the right part of jaw), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (a severe pain in the right part of jaw), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN JAW (a severe pain in the right part of jaw) had not resolved and PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medication was provided.  No Treatment medication was provided.  Patient reports that pain in jaw reduced by drinking water and walking.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Translation Received on 21-July-2021 and contains dose information and added events
facial numbness; This is a spontaneous report received from a contactable Pharmacist via other health care professional. A patient of unknown demographics received pfizer-biontech covid-19 vaccine (BNT162B2) dose 1, via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, patient had developed facial numbness 30 mins after the Pfizer covid vaccine first dose. He wanted to know if there is any information about the second dose for this patient. The patient still has the unilateral facial numbness. The outcome of the event facial numbness was not recovered. Additionally it was reported that Caller stated they had 8 patients (gender and age is unknown) who received the Pfizer covid vaccine that they think, not sure, if the vial was over diluted or if the doses were drawn not full 0.3ml. caller wanted to know if the vaccine losses its effectiveness if they are over diluted..  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Peanut sized cyst (L) upper thigh remains after 2 mos.
PATIENT STATED HE DID NOT RECEIVE ANY VACCINATION THE LAST FOUR WEEKS. AFTER WE GAVE THE SHOT, HE ASKED FOR RECORDS AND I SAW HE GOT MMR 3 WEEKS AGO. HE RECEIVE VARIVAX ONE WEEK EARLIER THAN RECOMMENDED.
Patient received two Flu vaccines- 9/13/2022 and 1/19/2023.
Tues, woke up next day red, swollen size of egg, itchy at site of injection. Weds - size of tennis ball; yesterday size of baseball. Red, warm, swollen, painful, itchy, aches.
Slurred speech; left arm clumsy; drooping in face; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. This consumer reported the same events under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced drooping in face, slurred speech and left arm clumsy, all on an unspecified date with outcome of unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606116 Same reporter, drug and events; different patient;US-PFIZER INC-2021606004 Same reporter, drug and events; different patient
mom stated pt started crying @ 3PM w/high pitch cry that lasted for 3 hrs; redness @ site of both injects; no swelling; temp unk;
HEART RATE HIGH; STUTTERING; EXTREME COLD/CHILLING; SUPER HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. 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 an unspecified date, the subject experienced heart rate high, stuttering, extreme cold/chilling, and super high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from super high fever, heart rate high, stuttering, and extreme cold/chilling. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Under eye redness; dry skin; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 17:15 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Feb2021 17:00 for COVID-19 immunisation. On 03May2021, the patient experienced under eye redness and dry skin. No treatment was received for the events. Vaccination facility type was pharmacy/drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st pregnancy, 32 weeks and 1 day, due July 1, 2021  adverse reaction: hives (small, itchy, red bumps) on inside of both arms from just pass the wrists to the middle of biceps
acute pulmonary emboli--difficulty breathing far beyond COPD; PFT indicates no change in COPD status atrial fibrillation
seizures, first seizure was five days after immunizations. She was asleep than woke up and it started, her eyes were rolled to the side and her whole body was shaking it lasted at least two minutes. Eight days later she had another seizure once again she was asleep than woke up and it started. It did'nt last as long but like the first her eyes rolled to the side and her body was shaking, it lasted 45 seconds to one minute. Six days later she started having staring seizures. She had several a day, I was not sure they were seizures for a few days, but then they started get more frequent. She would be staring for about 30-45 seconds and then fall right to sleep,this continued for 2 days then I took her to the emergency room where she had another full seizure eyes rolled to the side and her whole body shaking. They did more test and found ct scan normal, blood work normal, chest x-ray normal. I had taken her to urgent care after the first seizure. Then I made an appointment with her doctor, it just so happened that the next seizure came the day before. He ordered a eeg and blood work which all came back normal. Now pt is taking Phenabarbotol to control the seizures. She has seen a neurologist he says he sees no developmental delays she is actually above average. The medicine is working well so far. His diagnosis is epilepsy.
Patient experienced extreme headache, chills, and aches within 30 minutes of receiving vaccine.  Nurse advised her to take pain reliever and rest.  Patient reported feeling improved 20-30 minutes later.  Symptoms did not return as of 2 days later.
Severe headache and nausea about 2 hours after first dose, lasted about 24 hours. Improved with Tylenol.
severe headache that is not responding to Tylenol; nausea; This is a spontaneous report from a contactable consumer. This 49-year-old female consumer (patient) reported that the patient (non-pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot: unknown) through an unspecified route in Left arm as UNKNOWN, SINGLE on 27Jan2021 for Covid-19 immunization. The patient had not tested positive for covid prior the vaccination or after the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included that the patient was allergic to aspirin and the patient also had asthma. Concomitant medications included unithroid. On 27Jan2021 11:30, The patient had severe headache that is not responding to Tylenol and some nausea. The patient had not received treatment for adverse event. The outcome of the event was reported as recovering.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Infant started having seizures 6-7 hours after given first dose of vaccine. Body was seizing with eyes rolling into back of head. Rash and inflammation of the face, eyes, arms, torso and top of head was red and swollen. Eyes swollen and would not open. Infant refused to feed and has to be given formula orally by syringe. Transported by air to NICU level 3 unit. Diagnoses with seizures and put on pheonobarbital.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient received vaccine in deltoid.   This case was linked to MOD-2021-361706 (Patient Link).
Other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine; This is a spontaneous report from a contactable consumer or other healthcare professional. A female patient of an unspecified age received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisaion. The patient's medical history and concomitant medications were not reported. It was reported that, the report was cross referenced to report ID: withheld. The caller was a Pfizer colleague called in regards to the Pfizer Covid-19 vaccine. The caller reported that, she was diagnosed with shingles and the health care provider asked whether the caller had gotten the Covid-19 vaccine. The caller reported that, the health care provider said that, she's had other people, including her mother, the patient, who had gotten the Covid-19 vaccine and wound up with shingles. The caller reported that, she asked the provider whether the patients had received the Moderna or Pfizer Covid-19 vaccines and the provider informed her that it was a mix of the two. The provider stated that, her mother or some other relative and 2 other patients in the last day or so, were diagnosed with shingles after receiving the Covid-19 vaccine. Caller reported that, the provider didn't specify whether the patients had received one or the other vaccine. The caller declined to complete safety report as she was unable to provide further details for the patient or the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine. The caller stated that, she just knew that she was obligated to report the adverse event as the Pfizer Covid-19 vaccine had been mentioned. Report was filed with minimal information provided by caller. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856879 Same reporter/drug/AE, different patient
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Light red circle appeared a  few days after the injection with some itching.   My arm was sore for a few days but nothing too bad.  The soreness went away after about three days.  I noticed the redness is still there and actually looks redder.  The itching came back so I took an Allegra and that stopped it.  The redness is still there today which is ten days after I received the vaccine.   I believe a similar thing happened when I got the Shingles vaccine last year.  It eventually went away.
Seizure; had normal EEG, CBC, & 02 level in ER; Seen by family MD for check-up on 15JUL91; No problems found;
Syncope - Pt fainted when attempting to stand ~10 minutes after vaccination.  Pt regained consciousness w/i ~1 min and was oriented to person, place, and time.  Pt stated that he was fine afterwards and refused EMS transport.
Information has been received from a physician concerning a 14 year old male who on 26-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 656922/0450U). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was noted a TB skin test was performed. In approximately July 2007, the patient experienced a nodule, local injection site pain and local injection site swelling. He sought unspecified medical attention. Subsequently, the patient recovered from a nodule, local injection site pain and local injection site swelling. Additional information has been requested.
pt recv vax 15JUL98 & same day pt exp dyspnea, urticaria & pruritus especially in ears;pt did not sleep much;16JUL98 pt to hlth professional;18JUL98 pt sx got worse w/inc chest pressure;pt referred to ER tx w/med;
pt stated that she noticed pink rash on her back in between shoulders and down both arms to the elbow.
Patient passed out in sitting position 5 minutes after receiving vaccine, opened ammonia salts at 1:40pm, but patient became unresponsive by 1:48, administered EpiPen in right thigh.  EMS contacted - HR of 54, BP too low to calculate.  MD/hospital referral.
Got the Flu Vax and Died shortly thereafter; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult female patient who got the flu vax and died shortly thereafter while receiving vaccine 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 lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event got the flu vax and died shortly thereafter (death) (unknown latency) following the administration of Influenza Vaccine.   It was reported that My mom got the Flu Vax and died shortly thereafter.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event got the flu vax and died shortly thereafter. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) got the flu vax and died shortly thereafter.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves Adult female patient who got the flu vax and died shortly thereafter while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: died
Returned for 2nd varicella. First given 10/23/2001. "I had to go to MD a few days later my arm got big. I ashed all over my back and legs hurt a lot. He gave me Benadryl."
Sore throat; Tested positive on PCR test; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive on PCR test) and OROPHARYNGEAL PAIN (Sore throat) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Tested positive on PCR test). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, COVID-19 (Tested positive on PCR test) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Polymerase chain reaction: positive (Positive) Positive. On 10-Jan-2021, Laboratory test: positive (Positive) Positive.     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.   Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.