chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.
"I had shingles vac. ten years ago; do I need one again? And if you already had shingles, can you get it again?"; This spontaneous report has been received from a consumer, regarding to itself, a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On an unspecified date in 2012 (reported as ten years ago), the patient was vaccinated with a dose of Zoster Vaccine Live (ZOZTAVAX) subcutaneous injections (reported as shingles vaccine) as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  On an unspecified date, the patient experienced shingles (Herpes zoster). The patient was inquiring if another dose was needed. The outcome of herpes zoster was not reported.  The causal relationship between herpes zoster and Zoster Vaccine Live (ZOZTAVAX) was not provided.
Large (3x4 in) red area lt deltoid; seen by ER MD placed on oral ATB;
According to registry, patient received Moderna dose 1 at "pharmacy" on 3/3/2021.  Patient arrived in ED on 3/4/21 at approx 9AM via ambulance.  ED physician note:  "56-year-old male brought in by EMS intubated with CPR in progress.  It was reported that he arrived to work and then passed out.  CPR was initiated almost immediately.  BLS determined that he was  pulseless and AED was applied.  He was defibrillated twice.  He was then intubated by ALS and administered epinephrine twice with return of spontaneous circulation.  He maintained a pulse for approximately 20 minutes when he again developed cardiac arrest.  ACLS guidelines were again initiated and there was no return of pulse for approximately 20-25 minutes until he arrived in the emergency department.  Emergency department CPR was continued and he was administered an additional epinephrine with return of a pulse.  Is reported that he had no complaints prior to the event."  Patient was intubated and ventilated, started on norepinephrine drip in ED.  Twelve-lead EKG demonstrated right bundle branch block with left posterior fascicular block and diffuse QRS widening and diffuse repolarization abnormalities.  Family consented to Cath Lab.    Per Interventional Cardiologist note:  "1.  Angiography demonstrated proximal to mid LAD hazy 90-95% lesion likely culprit for cardiac arrest.  1 stent placed.  2.  Diffuse distal right coronary disease that is likely nonculprit for cardiac arrest.  3.  Left ventriculography demonstrated severe anterior wall hypokinesis with overall left ventricular ejection fraction of 40%.  4.  Patient electrically and hemodynamically stable.  Levophed has been stopped.  Amiodarone bolus given in the Cath Lab for frequent ventricular ectopy.  No drip was continued due to resolution of ectopy.  5.  Dyslipidemia he will be on high-dose statin therapy.  6.  Diabetic management as per primary team.  7.  Quad-Lumen placed by me.  Hypothermia protocol to be initiated in the ICU given GCS score less than 8 with no purposeful movements.  Head CT scan completed before cardiac catheterization that demonstrated diffuse cerebral edema.  8.  Prognosis guarded and likely poor.  The next 24 to 40 hours will be critical.  Family was updated in detail."  Patient transferred to ICU post Cath Lab.  Remains intubated, ventilated in ICU.
client became dizzy shortly after receiving vaccine. Patient was placed supine and felt better shortly afterwards. Patient was offered snacks and drink , client accepted snacks and after drinking and eating was able to sit in chair on her own. Client was assessed Vitals obtained at 2:55pm HR 113 O2Sat 98% at 3:13pm HR 75 O2Sat 94%..
rash; did not complete the 4 doses of the oral typhoid vaccine; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced rash and did not complete the 4 doses of the oral TYPHOID 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 total dose of suspect TYPHOID VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date: not reported) (Drug Treatment Duration: Not Applicable) via oral route in unknown administration site for Immunization.  On 06-Jan-2023, patient did not complete the 4 doses of the oral typhoid vaccine (incomplete course of vaccination) due to a rash (unknown latency), that may/may not have been caused by the oral typhoid and reporter wanted to know if the vaccine schedule could be completed with TYPHIM VI.  It was reported, caller was requesting information about TYPHIM VI and the safety of using it after an oral typhoid vaccine. Caller also requests product composition of TYPHIM VI. Caller encouraged to reach out to the manufacturer of said oral typhoid vaccine if she could get that information from the patient.  Action taken with TYPHOID VACCINE (TYPHOID VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (rash).  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Day after receiving TD on 8/4/14, her entire (L) upper arm became red, swollen and itchy. She used ice packs and BENADRYL. Problem resolved in a few days. She is a Post Bone Marrow Transplant patient and the dose of TD given 8/4/14 was her 3rd dose post transplant.
Pt had syncopal episode 5 minutes  after vaccine admin while sitting in chair. Pt reports being nervous prior to vaccine administration. Bp monitored. 911 called per protocol. Pt declined EMS transport. Walking and talking when leaving clinic after being observed by nurses and EMS staff onsite.
Within a brief period, less than one hour, the pt experienced weakness, pallor, dizziness, nausea and had flushing of the face. The pts pulse was 76. Additional information has been requested.
sore arm at injection site the next day and two days following with red welt - felt hot.  Got Shingles Vaccine on Thursday evening 9/6. My arm was bad on Friday, Saturday and Sunday. I felt sick and had flu like symptoms including dizziness on Friday evening, Saturday and Sunday. I feel fine now.  Injection site still has redness,  but has shrunk in size.
Persisting local swelling, induration, pruritis, and pain. Pain radiates into neck/head, chest, and lower arm.  Arm tender to touch. With associated nausea, blurred vision, and intermittent sharp chest pain.
After  receiving the 1st vaccine I experienced pain in my arm, chills and swelling of both hands and both knees After receiving the 2nd dose I experienced the same symptoms except the pain in my arms and the chills. I'm still experiencing swollen hands and knees. Not able to make a fist and lot's of pain in both knees and both hands especially the mornings. Joint pains and swelling in my hands are affecting my ability to hold things firmly without dropping  everything.
17-year-old male with past medical history of vitiligo presenting with chest pain in the setting of acute myocarditis.  Patient refers history of pressure-like chest pain which started suddenly on the morning of presentation, retrosternal, nonradiating, 4/10, with no exacerbating factors, relieved with a p.o. dose of metamizole, which prompted a visit to  Hospital.  He developed a dry cough in route to the hospital. At the hospital, CBC, BMP, and CRP were done and unremarkable.  U tox, SARS-CoV-2 PCR, and rapid strep were done and unremarkable.  Total CK (317), CPK-MB (13), troponin I (3.34), and myoglobin (168) were done and elevated.  Repeat troponin I 2 hours later was higher at 4.85.  EKG revealed sinus bradycardia and sinus arrhythmia.  Chest x-ray was done and unremarkable.
After patient received the immunizations (Kinrix, MMR, Varicella, Hep A) he left the building with his mom and sister. After they got in the car, his sister said his eyes rolled back and he was shaking for approx. 20 seconds. Mom brought him immediately back to the office. He was noted to be alert but extremely pale and clammy. His vital signs were normal but he was given oxygen via mask until he became less pale and he was given some apple juice to drink. The patient was alert and could converse easily. He did not appear to be post ictal. He kept saying "I feel fine." He was observed in the office for approximately 15 minutes and his vital signs remained normal (pulse:90 B/P:90/60)and his color returned. He was then released with his mom. Two days after the event mom states that he had remained asymptomatic other than low grade fever and slightly more tired the rest of the day.
Initial unsolicited report received from a consumer on 06 November 2015. This case involves a [age and gender unknown] patient who was vaccinated with a [dose in series were not reported] intramuscular first dose of INFLUENZA VACCINE (INTRAMUSCULAR FLU SHOT) ([batch number, expiry date and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, few years following the vaccination, patient developed six months of fasciculation and tingling. Lab data and corrective treatment were not reported. The outcome of event was recovered. List of documents held by sender: none.
Patient reports feeling feverish the night after receiving his vaccine, however never checked his temperature. The patient reports feeling muscle pain in his legs and lower back starting the day after receiving the vaccine. The patient was still able to perform his daily activities by going to work despite these symptoms.
Area of Observation, Patient feels suffocation and skin looks reddish on face. Patient reports not having any medication left for hypertension. 1st intervention VS 170/90, 2nd VS 160/80 P: 111, sat 98%.
SWELLING, HIVES, SHORTNESS OF BREATH OVER A 1.5 HRS TIME SPAN.
wife said approximately 6-17-21 they were camping and he started having chest pain. the following monday they went to the ER. He got a complete check up and nothing was found to be wrong with his heart or health
rash at the site of injection; fever (102); chills; overall body ache; headache for 24 hours; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Shingrix. On 22nd December 2021, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain and headache. On 3rd January 2022, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, fever, chills and general body pain were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, chills, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient got vaccine and same the day the patient came down with a fever (102 degree F) chills , overall body ache, headache for 24 hours. The patient had all the side effects and 12 days later the patient had a rash at the site of injection. The patient asked if it was normal.
couldn't sleep for 2 days; Pain started with one side of hip then both; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Experiencing some pain in arm too; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep for 2 days), ARTHRALGIA (Pain started with one side of hip then both), PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and PAIN IN EXTREMITY (Experiencing some pain in arm too) in a 46-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced INSOMNIA (couldn't sleep for 2 days), ARTHRALGIA (Pain started with one side of hip then both), PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and PAIN IN EXTREMITY (Experiencing some pain in arm too). At the time of the report, INSOMNIA (couldn't sleep for 2 days), ARTHRALGIA (Pain started with one side of hip then both), PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and PAIN IN EXTREMITY (Experiencing some pain in arm too) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-049289, US-MODERNATX, INC.-MOD-2021-114700 ; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049289:Same reporter US-MODERNATX, INC.-MOD-2021-114700:Same reporter
I had the vaccine on 3/12/21.  On Monday, 3/22/21, I broke out with severe hives all over my body. I also experienced severe itching. The next day, Tuesday 3/23/21, I went to see my primary care doctor who put me on Singular 10mg 1 tab in the evening, Hydroxyzine 25mg 1 as needed and Prednisone 50mg  1 tab everyday for 5 days. On Thursday, 3/25/21, I started to have pain a pleuritic  pain when breathing. I went to the Regional ER  They drew blood tests, did an EKG a chest CT. I was given Benadryl and Methylprednisolone by IV. Tests were fine and I was sent home. I still have hives.
Pt exp red rash over entire body, some temp elevation-none over 103-104; Seen by MD;
He got a cyst formed on the inside ankle of his right leg. I noticed it a few days after the 1st shot. We were not sure if it was related to the COVID vaccination. He had the second shot on 08/15/2021 at the same clinic. The lot # for the second shot is EW0191. I noticed the cyst became bigger a few days after the second shot. It got smaller at the time of submitting this report.
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2019SA059189 (same reporter). This case involves a 4 months old male patient who experienced received vaccine PENTACEL outside of the shipping standard. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 26-Feb-2019, the patient received a 0.5 ml second dose injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ065AAA (expiry date: 16-Oct-2020) via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. The PENTACEL shipment was received 25-FEB-2019 and shipped on 20-FEB-2019. It was reported that no adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
possible seizure activity on morning of 11/16/2020. Pt received vaccines on 11/12/2020.
Information has been received from a consumer concerning her 18 year old daughter, with a history of family history of cancer, who in June 2007, was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not specified). There was no concomitant medication. In January 2008, seven months after the vaccination, her daughter had a Papanicolaou test (PAP) and tested positive for human papilloma virus. At the time of this report, her daughter had not recovered. Her daughter visited a physician for unspecified medical attention. The patient's sister also experienced an event similar to the above, when vaccinated with Gardasil (WAES #0802USA03516). Additional information has been requested.
Became congested @ 4PM temp elevated to 101F cont to run fever until 6PM to ER w/temp over 105F; Dx rxn fr DTP (has rash @ this time & was given Benadryl); DX pneumonia;
That day patient prescribed Cipro for urinary tract infection; doctor said vaccine was ok to receive as long as there was no fever.   Tetanus received at ER in hospital maybe within last month.    Patient took antibiotics around 5pm and arm felt funny.  Patient started to get chills and shaking and could not control it.  Patient fell down when tried to move to get blanket and scraped arm on table on the way down. Patient wet herself, sat down for a while.  Finally got up and went to bed; not sure at what time this was.   On Sunday, did not feel the best went got up, spent afternoon with kids. On Monday felt like got tired easily.  Today feels chills and aches but feels better now.  Patient called pharmacist today, VAERS number given, and encouraged to follow-up with doctor; will not go to the doctor since doesn't feel as bad now.   Patient at 80% recovery.
Rash on upper left arm (where injected).  Lasted 3 days.  Took Benadryl tablet twice a day to treat it.
Same day of vaccination, pt developed a fever of 105.5, no convulsions, no other symptoms. Pt didn't go to ER.  Treated with tylenol.
facial swelling; low grade fever; with in hour lips went numb from right to left; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), HYPOAESTHESIA ORAL (with in hour lips went numb from right to left) and PYREXIA (low grade fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (with in hour lips went numb from right to left). On 01-Mar-2021, the patient experienced SWELLING FACE (facial swelling) and PYREXIA (low grade fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (facial swelling), HYPOAESTHESIA ORAL (with in hour lips went numb from right to left) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
cough; I was in outer space; I was out of it; disoriented; When trying to get out of bed, legs collapsed; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), COUGH (cough) and DAYDREAMING (I was in outer space) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 13-Mar-2021, the patient experienced DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it). On an unknown date, the patient experienced COUGH (cough). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 15-Mar-2021, DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it) had resolved. At the time of the report, COUGH (cough) had resolved.            No concomitant medications were reported
Had severe panic attack, I thought I am having a heart attack; My shoulder within the right arm, it was sore for 3 weeks; Joints still hurt; had severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Aug2021 (Lot Number: EE2588) at the age of 54 years as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Patient wanted to report an adverse event that patient had from getting the vaccine. The first shot that she received, her shoulder within the right arm, it was sore for 3 weeks and the joints still hurt. Patient had had severe panic attack, she thought she was having a heart attack (Further clarification was unknown) and patient got passed that, so she got her second shot. Outcome of joints still hurt was not recovered and the other events were unknown.  Follow-up attempts are completed. No further information is expected.
About ten minutes after vaccine administration, patient noticed small erythema on lower left arm . Area also had minimal pruritis and erythema on left shoulder. No difficulty breathing, tightness in chest, dizziness or other symptoms. Given 25mg of bendaryl PO at 1435. Patient waited additional 30 minutes and all symptoms resolved before leaving.
In February 1998, the pt began experiencing symptoms of eosinophilic gastroenteritis. He sought medical attention and was dx on 12/15/1998.
Swelling and redness on left deltoid. 2 1/2 in wide x 4 in wide. Stated achy and low grade fever.  Suggested Benadryl
PT PRESENTED FOR 2ND DOSE. STATED THAT APPOX 3 WEEKS POST 1ST DOSE SHE EXPERIENCED HEAVER THEN NORMAL MENSTRAL BLEEDING WITH SEVERAL LARGE CLOTS. THIS WAS NOT THE NORM FOR HER.  WAS IMPROVED AFTER 2 DAYS. AFTER CONSULTATION AND FACT REVIEW I REFFERED HER TO GYNECOLOGIST FOR ASSISTANCE PRIOR TO 2ND DOSE. MEDICAL REFERENCE IS LACKING IN THIS AREA SO REFFERAL WAS DECIDED. PT APPEARS TO BE FINE NOW AND NO FURTHER PROBLEMS NOTED