chrisvoncsefalvay/vaers-outcomes huggingface dataset:
within the first 15 minutes that my heart rate spead up dramatically; chest pain; Headache; blood pressure measurement 140/96; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 40-years-old female(non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EW0196), an unspecified route of administration, administered in Arm Left on 12Jul2021 14:00 (at the age of 40-year-old) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included migraine, pituitary adenoma, PCOS (polycystic ovaries), endometriosis, BPPV (vertigo positional), asthma, allergies and sulfa medications allergies from an unknown date and unknown if ongoing. Concomitant medications included galcanezumab (EMGALITY  [GALCANEZUMAB]) taken for migraine, phentermine (PHENTERMINE) and spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date for all the concomitant medicines were not reported. The patient not had COVID prior to vaccination and not tested COVID post vaccination. The patient did not taken other vaccine in 4 weeks. On 12Jul2021 at 14:00  the patient experienced within the first 15 minutes that her heart rate speed up dramatically (heart rate increased) ,chest pain. The patient had a blood pressure 140/96. She did not experience hives, swelling, or shortness of breath, but it has been 5 hours and her resting heart rate is 98-101bpm. The patient underwent lab tests and procedures which included blood pressure measurement: 140/96  and increased heart rate: 98-101 on 12Jul2021 .The only other medication taken was an Emgality injection. It is her 3rd and do not have reactions at all to it. It is a migraine medicine, yet isn't helping the headache which she also got after the vaccine. Not yet anyway. Again, she is continuing to monitor the situation. The treatment received for the event unknown .The outcome of the event was not recovered. The outcome of event blood pressure measurement 140/96 was unknown. Upon Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
32-year-old female with no significant past medical history presents to ED today (10/08/2021) for evaluation of palpitations.  Patient states that she got her second Covid vaccine earlier this morning, states that at the 12-minute mark during the observation period she started noticing that she was having palpitations.  Had vital signs taken, her systolic blood pressure was in the 170s and her heart rate was at 127.  States that she was sent here to the ED as protocol.  States that it resolved on its own after about 10 minutes.  States that she feels back to baseline at this time but does have some nausea.  States that after her first Covid vaccine, she did have some swelling around her C-section site.  Did not have palpitations after her first vaccination.  Endorses mild headache at this time but also worked overnight and then order Covid vaccine.  Denies dizziness, lightheadedness, chest pain, shortness of breath, vomiting or diarrhea.  A/P  Clinically well-appearing patient with stable vital signs presenting for evaluation of palpitations after receiving her second Covid vaccine.  No associated chest pain, shortness of breath.  States around 12 minutes during the observation period after she got the vaccinations, started having palpitations, elevated blood pressure and heart rate in the 120s.  Normalized on its own by the time patient arrived to ED.  Vital signs stable at this time.  Palpitations at past, no active symptoms other than mild headache.  Benign physical examination, EKG unremarkable.  Likely COVID-19 vaccination side effect.  Strict return precautions discussed.  Patient agreeable discharge plan.
Arm swollen, red, and itchy around injection site and a couple inches down arm and around area. After 4 days symptoms still present but improved.
About 10 days after receiving the 1st injection of the COVID-19 Pfizer-Biontech injection, I noticed a significant lump on my left collarbone that was palpable - had not been there in the weeks prior. It was somewhat tender to the touch and would move. My PCP examined the lump and ordered a neck ultrasound for the supraclavicular mass which found "mildly prominent lymph nodes in the supraclavicular region without frank lymphadenopathy and one small lymph node that measures approximately 4mm in short axis diameter that is not clearly demonstrating a fatty hilum but is smoothly marginated with a hypoechoic cortex." PCP then ordered Lactate Dehydrogenase test on 02/12/2021 which was slightly elevated at 629 IU/L (WNL considered as 313- 618 IU/L). Additional labs ordered and collected on 02/13/2021 for LD Isoenzymes, Ferritin and Iron/Transferrin - all within normal limits.  I received my 2nd injection on 02/05/2021. Then the following week the lump was even larger and more prominent and somewhat painful. Reported to my PCP who referred me to a ENT Head/Neck specialist and examined it without concern. Had follow-up appointment 2 weeks later and specialist still not concerned due to the lymphnode becoming smaller in size.  I can still palpate the lymphnode (as of 03/06/2021) but it is much smaller. Plan to wait until 6 weeks after 2nd vaccine injection and then will pursue further follow-up if still palpable.
Two satellite like lesions noted though dx with contact dermatitis by provider.  Coban and Telfa applied.  Instruction on proper care provided to patient-verbal instruction and written instruction. Verbalized understanding.
administered Pentacel instead of ordered combination of Daptacel and ActHib; was given a dose Daptacel and a dose of Pentacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was vaccinated with 0.5 ml doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5254AAand Exp. Date 18-Sep-2019) in the left Vastus Lateralis and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ066AD and Exp. Date 16-Oct-2020) in the right Vastus Lateralis instead of Daptacel and HIB (PRP/T) VACCINE [ACT-HIB] on 29-Apr-2019.  The patient had receive 3 doses of Pentacel and no concomitant medication given.  It was an actual medication error case due extra dose administered and wrong vaccine administered.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report was received from a physician via a company representative, and refers to a 12 year old male patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 15-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9, intramuscular, for prevention of human papillomavirus, (dose, frequency, lot number and expiration date were not provided). On 26-FEB-2018, the patient returned back to the office complaining about pain (arm pain) and weakness in the extremity. Nevertheless, it was also reported that no treatment was prescribed for the events and that no product quality complaint (PQC) was involved. Finally, it was also reported that the patient would not receive the other GARDASIL 9 doses. At the time of reporting, the outcome of pain in extremity and muscular weakness was unknown. The causal relationship between GARDASIL 9 and the reported events was not provided.
Cellulitis at middle arm and not on deltoid; Redness which is 3in in size; Itching; Hives; A spontaneous report was received from a nurse concerning a  27-year old, female patient who received Moderna's COVID-19 vaccine and experienced cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient experienced redness which is 3in in size, itching, and what the patient described as hives. The patient went to urgent care where she was diagnosed with cellulitis at middle arm and not on deltoid. Treatment for the events included antibiotic and loratadine.   Action taken with mRNA-1273 in response to the events was unknown.  The events cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 27 year old, female patient, who experienced a serious unexpected event of cellulitis; non-serious unexpected event of pruritus and urticaria and a non-serious expected event of erythema. The event of cellulitis, erythema, pruritus, and urticaria occurred 11 days after first dose mRNA-1273 (Lot# 025J20-2A) administration. The treatment medications included Claritin and antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ? 9/17/2021  Is this your first or second dose- 2nd Date of symptom onset - ? 9/19/2021 Symptoms - ? Severe migraine, fatigue, and puffiness around eyes (that she did not seek treatment for) Last day of work and shift - ? NA Home remedies- NA Any improvement- Employee stated all symptoms have resolved except for the migraine but it has improved Recommendation- Advised employee to take Tylenol per package instructions as needed for headache. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
hot; eyes were glassy; voice was like she was under water; cardiovascular system (CVS) reaction, atrial fibrillation; Initial information received on 16-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves a 58 years old female patient who experienced cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), while she received INFLUENZA VACCINE.  Medical history included two times before the patient had strange reaction to the flu vaccine that was nothing terrible but felt strange that sent her to Emergency Room (ER).  Medical treatments, vaccinations, 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 (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious hot (feeling hot), eyes were glassy (glassy eyes) and voice was like and was under water (dysphonia), 4 hours following the administration of INFLUENZA VACCINE, and her doctor told her to go to the ER.  On an unknown date, the patient developed a serious cardiovascular system (CVS) reaction, atrial fibrillation (atrial fibrillation), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient states that in the ambulance they gave her something, she doesn't know what it was, that put her into atrial fibrillation.  Relevant laboratory test results included: On an unknown date, EKG (Electrocardiogram)-:  [not reported].  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a 58 years old female patient who had atrial fibrillation, was feeling hot, had glassy eyes and dysphonia, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown for atrial fibrillation and compatible for others. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "splenic marginal zone lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2023, outcome "unknown" and all described as "got covid".  Clinical course: Caller stated she had splenic marginal zone lymphoma, she got covid 21Aug, "2923" (as reported) and want to know when it was best for her to get the new Pfizer covid 19 vaccine. She knew the guidelines it said 3 months. Caller stated she might have to get treatment in November with rituximab and bendamustine which was not 100% but for sure rituximab. Caller stated she was one of the first to get Pfizer's covid 19 vaccine she was working in the ER when Covid came out and she was happy to get it.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 NOS can not be fully excluded.
Extreme fatigue since first shot.  Continued after second shot.  Always exhausted and have no energy and can sleep for ten hours and still be tired.  This occured after the vaccine.  I have never been as tired like I am now.  I hoped it would go away but its still there.
3 DAYS AFTER ADMINISTRATION PATIENT PRESENTED WITH A HALF-DOLLAR SIZED RED/WARM/ACHY AREA APPEARED AT INJECTION SITE. RECOMMENDED MD VISIT TO CHECK.
Acute Myopericarditis - started having a tight chest and numb arm after second vaccine dose. Then had a stabbing sharp pain to my heart and couldn?t breathe. Had to rush to hospital and be put in emergency room for 2 days with medication to treat pain and the myopericarditis
PENTACEL and Hep B ordered, staff gave PENTACEL and hib. Staff not aware that PENTACEL contained Hib and not Hep B. Pt returned for Hep B.
This spontaneous report was received from a registered nurse, who referred to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient received two pediatric doses of VAQTA 25U/0.5 ml, 1ml (lot # M039202 and expiration date: 11-MAR-2018; indication defaulted to prophylaxis; route of administration not reported) to equal one adult dose. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Initial report was received on 22. Jul.2008 from a physician.  This 9-year old patient took first dose of VIVOTIF (Batch no.: unknown) on 21.JUL.2008.  The patient developed pruritic, papular erythematous rash on extensor surface of arms and on back.  According to the mother the symptoms were to come and go.  Otherwise the child had no systemic complaints, no fever, no chills, no shortness of breath and no cold or flu.  The patient was healthy when he took VIVOTIF.  This case was forwarded by Crucell / Berna Products.  Follow-up information was requested on 23.Jul.2008, 22.Aug.2008, 19.Sep.2008.
bruised area @ site approx 12-14mm circular large area of swelling approx fist size;
Tinnitus I have experienced ringing of the ears since about a week after my vaccine was administered.
I had a high dose Flu vaccine, then 6 days later got the COVID-19 vaccine. Within a few hours I started itching on the same arm that I got the shot. Arm was swollen and itching was very bad. Swelling went down in a few days, but itching moved and became a rash across body. Urgent care doctor gave me a shot of dexamethasone and proscribed prednisone.   Primary care doctor believed this to be an allergic reaction and referred to Dermatologist. Dermatologist biopsied rash. Thought It was Bullous Pemphigoid, but biopsy was negative. Rheumatologist proscribed a prednisone taper around Christmas time. Ordered CT scan of lungs.
This spontaneous report was received from a nurse and refers to a  female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2009, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 03-MAR-02017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). No adverse effect were reported. No additional information was provided. Additional information has been requested.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.
8 hours later I had severe chills, aches, severe headache, cough and complete exhaustion.  Could not hardly get out of the bed.  Thursday late morning stomach started cramping and I started throwing up.  I went to the doctors.   Could not report to work until 03/22/2021 The second shot I started feeling dizzy, hot then cold and feeling like I was going to pass out within 15 minutes of the shot.  I later find out that I spoke to people that I do not remember.
02/04/19 - 4 month well child check and vaccines. 2/5/19 - Woke with red spot in diaper - tested positive for blood per urinalysis. Pt had looser, mucus stools, more fussy. Follow-up bag urine was negative for blood.
Information has been received from a physician concerning an approximately 11 year old male who, about 4 years ago, in approx 2001 was vaccinated with a single 1ml IM dose of hep B virus vaccine rHBsAg (yeast). It was reported that within several hours he developed a fever of 104F, general malaise and hallucinations. Subsequently the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of blistery rash in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 9 days after receiving SHINGRIX, the patient experienced blistery rash and pain. The patient was treated with antivirals for systemic use (Antiviral) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the blistery rash and pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. One week after getting SHINGRIX had pain and 2-3 days later developed a 2 area blister rash on midline. The patient went to urgent care, they prescribed antiviral and told the patient to follow up with provider. On 12th October 2018, Friday, the patient went to the physician. The pain was present till the reporting time but rash was almost healed. The physician prescribed pain medication. The patient thought this all was a reaction to SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
Case number PHEH2014US017291 is an initial spontaneous report received from a medical assistant on 26 Aug 2014. This report refers to a 4 years old male patient. His medical history and concomitant medications were not reported. he was vaccinated with 0.25 ml dose of FLUVIRIN (batch number: 1412201) intramuscularly from a multidose vial on 18 Aug 2014. No adverse events were reported following the maladministration.
Urticarial rash started on abdomen 3-4 days after DTaP and HIB, extended to arms and face with slight angioedema. Responds to BENADRYL. Had similar reaction after 12 month vaccines (MMR, VARIVAX, PCV).
Patient was very cold, couldn't get warm.  Around midnight felt like she had a very high fever.  Blood pressure went to around 198/108 with HR of 100.  Patient cycled through hot and cold.  Next day the upper part of her arm was red.  Two days later the redness has subsided but remains itchy. Contacted medical doctor who said that was a normal reaction and that she would be fine.
pt recvd vax & 4FEB94 & 5 hrs p/shot pt turned gray, was cold all over, eyes half open didn't lift head, no fever; mom felt pt going into shock; called MD;
Patient had tingling and numbness to tongue and roof of mouth that lasted 5- 10 minutes.  Was given PO Benadryl and observed for 30 minutes.  Asymptomatic prior to discharge.  Patient had similar sx's after 1 st dose apparently also but they occurred 1-2 days after injection.
Within a minute of receiving vaccines, pt had a brief syncopal episode.  Appeared pale and diaphoretic.  Allowed pt to lie down, and gave her a sugared beverage.  Pt's color returned within a few minutes, and pt left office independently ambulatory within 15 minutes.
Dx. with chicken pox after vaccinated. Presents with approx 50 lesions some crusted some pustule like. Rash has been x 3 days. Denies fever.