chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe pains in my heart/squeezing pains in my heart; more heart flutters and palpitations; more heart flutters and palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 23-years-old) as dose 2, single for Covid-19 immunization in other facility. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Since the vaccination, the patient has not been tested for Covid-19. Medical history included depression, anxiety, ptsd (Post-traumatic stress disorder), lactose intolerance, temporal lobe seizures, migraines, known allergies: lithium, Covid-19 (prior to vaccination). Concomitant medication(s) included fluoxetine hydrochloride (PROZAC); vitamin B6; cannabidiol (CBD OIL). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for Covid-19 immunisation in other facility and experienced trouble focusing and developed a big headache, her eyes had trouble focusing, she was experiencing severe depersonalization, her legs lost function and she could hardly walk, the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing), she struggled to think or talk, it felt like her body was forgetting how to work, she have been having seizures. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has been tested for Covid-19. On 20May2021, the patient experienced severe pains in her heart/squeezing pains in her heart, more heart flutters and palpitations, shortness of breath. It was reported that, four days after her second shot, she experienced severe pains in her heart and shortness of breath, which brought her back to an ER. Since then, she still has squeezing pains in her heart, but not as frequent nor with shortness of breath as much. Yet she does have more heart flutters and palpitations. The heart pains were very regular and intense for about two weeks after the second dose, where she almost went to the ER several times. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart monitor: results unknown and MRI: results unknown on an unspecified date in 2021, nasal Swab: negative on 06Jul2021. Therapeutic measures were taken as a result of the events with IV fluids, benadryl, Reglan. The outcome of the events was not resolved.
Vaccinating nurse did not dilute vaccine. Patient received 0.3ml dose from undiluted vial.
Pfizer COVID-19 Vaccine. Patient presents today 3/30/21 for medical observation of near syncope s/p COVID - 19 vaccine # 1. Past medical history is significant for SVT. Had not eaten anything prior to vaccination. Denies feeling of chest tightness, swelling of the face/lips/tongue and pruritus.  Reports nausea. Patients vital signs were initially 117/70, 76, remained stable. Bilateral breath sounds CTAB, no swelling of the face/lips/tongue or rash.  Alert and Oriented X 4, no gross neurological deficits. Patient was given ondansetron 4 mg ODT, juice, and crackers. Patient reports resolution of symptoms prior to being discharged.
Vertigo -- intermittent, associated with head movement. Suddenly turning or changing the orientation of my head results in vertigo for several seconds. I experienced nausea for a few minutes after getting out of bed this morning.  I developed the same symptoms (but much milder) 8 days after receiving the first dose of the Pfizer covid vaccine on Dec. 23 (the morning of Dec. 31). Those symptoms mostly occurred when I went from supine or prone to any other position (eg, rolling over). They resolved after about 1 week. I did not report those symptoms because I didn't associate them with the vaccine. That vaccine was Lot # EH9899.
I just tested positive yesterday; I just tested positive yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I just tested positive yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: I took a home test and it came out positive; (10Aug2022) Positive, notes: I just tested positive yesterday.  Clinical course: Inquiry: The caller questioned if Paxlovid can be taken with Amiodarone and if there is a potential drug drug interaction. Per caller; healthcare provider is aware of the medications that I am taking it was my pharmacist who indicated the problem, pharmacist called the doctor and the doctor told him to quit taking amiodarone, for the 5 days of the treatment but one thing with amiodarone once it is in your system is there for weeks, if not months at the time, even if you quit it has residual effect, I can't risk having arrhythmia problem again with my heart, so I guess I will not be able to take a Paxlovid because I cannot risk having an arrhythmia problem again. I will call my cardiologist in the morning, to see if they had any experience with the interaction between those two, I see that it is contraindicated for quite a few medications. I just tested positive yesterday, I have been fully vaccinated fully boosted so I have a mild case, I thought it was a "head cold" initially till I took a home test and it came out positive, I had both Pfizer upon further clarification caller referring to initial vaccinations and boosters with Pfizer COVID 19 vaccine, I was hoping I was able to make it till October when you supposed to be releasing a modified vaccine that will cover Omicron BA.4 and BA.5 variant but I currently did not make it .   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
runny nose; fever; arm pain; sore throat; the second dose the symptoms got worse; This is a spontaneous report received from a contactable consumer (patient).  A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Reportedly, patient received the second dose of the Pfizer Covid 19 vaccine 14 days ago. The next day patient had a fever and arm pain that lasted 2 days, five days later patient had a sore throat that hasn't gone and 3 days ago patient started with a runny nose. Patient asked if it was normal and how long will it last? Patient went to the doctor and took antihistaminics, ibuprofen, Tylenol and does not feel any improvement. Patient had same symptoms after the first dose and went to the doctor, he suggested a throat culture and everything went well, but after the second dose the symptoms got worse. Outcome of the events were unknown.  No follow-up attempts are needed. No further information expected.
Chills, Fever, Achy, Tired, Nauseous, Diaharrea  Basically all flu like symptoms.  Lasted approximately 15 hours. Took 2 tylenol but not until 12 hours later after symptoms started.  All  symptoms gone the next morning.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038664, 20211039749, 20211038269, 20211002617, 20211034734, 20211038411, 20211038442, 20211038614 and 20211039732.
Pt is 19 yrs old. He received a pediatric dose of Hep A on 4/12/17instead of adult dose. Pt did not have any reaction.Pt notified and revaccinated with adult dose of Hep A on 4/22/17.
pt recv vax 18MAR99 4-530PM & the following day pt woke w/swelling et rash to fingers;seen by MD 19MAR99 by 10:30 had full body rash;PDH given, pred given;sx have disappeared;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with an allergy to CELEBREX, iodine and ibuprofen. No pertinent medical history was reported. On 12-AUG-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, Lot # J014812 to prevent shingles (dose and route of administration not reported). Concomitant therapies included atorvastatin, ABILIFY, SPIRIVA, oxycodone, fluticasone, fluticasone propionate, ADVAIR, gabapentin, famotidine (manufacturer unknown), DETROL LA, KLOR-CON, ropinirole, fluticasone, furosemide and tizanidine. In August 2014 the patient experienced injection site reaction after vaccination with ZOSTAVAX. The patient described injection site as itchy and red. The patient sought medical attention by contacting the pharmacist. No lab diagnostics studies were performed. No treatment was given to the patient to treat the events. The outcome of injection site reaction described as itchy and red was reported as not recovered. Relatedness between ZOSTAVAX and injection site reaction described as itchy and red was not provided. Additional information has been requested.
Morning of 1/27- 12 days post vaccination noticed redness and warmth around area of vaccine. Redness grew in size to 2-3 in in diameter and itching continued. Patient took hydroxyzine hcl 50mg to help with itching. Itching resolved. Redness and slight warmth remain.
pt recv vax 15SEP95 & 11DEC97 pt exp chickenpox;a visit to MD office was required;pt recovered from chickenpox;
Pt. is pregnant. LMP 2/5/2010. 3/12/2010 found out she is pregnant.
1st day: Achiness, sore arms, sore lymph nodes, tired, overall flu-like symptoms, bone pain in left arm, painful ribcage  2nd day: felt good, arms sore, but not as bad; 3rd Day: symptoms of first day back, plus low grade fever, tight throat  4 day Day: repeat of 3rd day.
Pt recv vax on 1/25/99; on 1/26/99 pt exp swollen, red rash at vax site w/ maculopapular rash/ itchy on neck downwards x 4 day
After receiving Td and Hep B vaccine, client walked to lab area and collapsed, hitting chin on scales and cutting an area approx 2.5cm. Client unconscious approx 2-3 minutes. B/P 160/90, P 80. No rash, difficulty breathing. PERLA, diaphoretic after 2 minutes B/P 120/70, P 80, PERLA, alert, oriented, 911 called. Taken to hospital for evaluation.
Both my Breasts started growing 2 or 3 weeks after i had recieved my shot. I'm a skinny guy and my doctor was a little surprized it was happening. i was sent for a Mammo Gram ( somewhat Painful ) on March 2, 2022 resuluts came back as: A-Fatty, Benign for cancer, and little Gynecomastia. They said there just growing and i can go home.  Now its June and my breasts are still growing, sometimes painful and at times they itch.
Face swollen around eyes, nose, cheeks & neck this AM. c/o not feeling well last PM; Rash on face-bright pink/red, a little raised, splotchy-irregular; keeps rubbing hand over face. must itch; rt delt very red & swollen rt arm; 3-3 recoverd
Patient states that approximately 2-3 days post-injection he began to have swelling in throat, neck, jaw, and ear on the left side of body.  He states that it was severe swelling and that he had difficulty swallowing.  States that he took OTC antihistamine in large doses.  Rates the severity of his condition on a scale as 10/10.  Approximately three days post onset, he states his condition is now 6-7/10.
Patient reports awakening on 9/8/16 with an area of hot redness at site of varicella vaccine. Treated with ice, Advil and Benadryl on the advice of her sister who is a nurse. States area of redness/heat doubled overnight and on the morning of 9/9/16 was also swollen. On 9/10/16, reports the effected area was less bright red and hot, but was a darker shade of red and her arm was achy from shoulder to hand. By the afternoon of 9/10/16 the condition was not improved and her sister advised her to go to Urgent Care. Urgent Care provider told her she had "a staph infection" and gave her Rx for antibiotics which she started on 9/12/16. When I spoke to her today, she says she feels fine, but a small area on her arm remains slightly red/warm. States she never felt swelling of throat or shortness of breath during the entire incident.
From exam on 8-23-07, T 98.2 ax, (R) upper arm swollen, erythematous, warm, no notable tenderness to palpation. No sharp demarcations. Good ROM of arm, normal sensation. Mom reports that 24 hours after vaccine she noted swelling of (R) UE. Took to clinic and started on Augmentin, r/o cellulitis. Mom tried ice and Ibuprofen. Mom reports to activity - subjective fever.
2 weeks following injection noted generalized itching for one hour followed by redness. Soreness to injection site - increased in soreness & redness over next 2 days. 3 cm firm induration erythema  & heat noted. Without adenopathy. T-98. Advised BENADRYL at bedtime & corticosteroid cream. Cellulitis vs delayed allergic reaction.
Few blotchy, raised, itchy lesions over extremeties and trunk.  Treating with Benadryl- up to 3 teaspoons every 8 hours as needed.
Episode of pallor associated with irregular breathing in afternoon following vaccine admin. in am. Fussy then fell asleep upon awakening had episode of pallor associated with brief apnea approximately 5 seconds followed by shallow breathing. Occurred 2-3 times. No cyanosis or apnea. No vomiting. Not related to feed. Self resolved. Transported to ED. Observed in ED for 2hrs. Well appearing.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient (age not reported) who experienced local reaction at injection site of itching and redness, while she received vaccine FLUZONE QUADRIVALENT. 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 Quadrival A-B Vaccine lot number not reported via transdermal route in unknown administration site. On an unknown date, the patient developed a non-serious local reaction at injection site of itching and redness (vaccination site erythema) (vaccination site pruritus) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. It was an actual medication error due to inappropriate route of vaccination. It was reported that the patient was vaccinated with FLUZONE QUADRIVALENT transdermally. (Other relevant tests included No lab data.) Final diagnosis was local reaction at injection site of itching and redness, local reaction at injection site of itching and redness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for local reaction at injection site of itching and redness. 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.
Local reaction around area where vaccine was administered-roughly 2-3" diameter, red, slightly raised and warm to the touch-started w/in 24 hours of vaccination.
615 pm c/o tingling of tongue and itching upper lip. Some slight itching in mouth - 620 pm Benadryl 25 mg po - 630 pm BENADRYL 25 mg po - 645 pm Improved - agreed to go to ER for evaluation and observation - 730 pm - At home - did not go to ER as advised - 1/20/2010 630 am Sx returned, tingling, itching on legs and "compression on legs' went to ER - Rx with BENADRYL at hospital given MEDROL DOSEPAK and discharged after 3 hrs observation.
Injection at 3pm on Saturday 4/24. Sore arm a few hours.  By 10pm, body aches, soreness, mild fever. Next morning (Sunday 4/25): Body aches, soreness in injection arm (left) and left hand, persistent headache, minor gastrointestinal urgency, fever over 100 degrees F.  Most symptoms gone (or very mild) by 10pm Sunday. However, Tuesday afternoon (today 4/27), I developed swelling, redness, hardness and itchiness around the injection site. I understand these are all common symptoms, but I am reporting to contribute to the data.
Arm is still sore after a few days and she is unable to lift her arm. She also noticed swelling around the injection site that is oval shaped and the size of about two quarters.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: After patient had vaccine sat down, then felt light headed and broke out into a sweat. Pulse very shallow = 60bpm.  Would get better than worse again.  Called emt's, came w/i 15 minutes.  Said had high bp, but on no meds. when emt's came he passed out and pulse down to 40bpm, emt's gave epinephrine. pulse back up to 60, put on stretcher, passed out again.  Took to local hospital/ER
Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 26-AUG-2016, the patient was inadvertently vaccinated with ZOSTAVAX (once, strength, lot# and expiration date were not reported) subcutaneously. Instead of VARVIAX. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "cold sores" (unspecified if ongoing); "herpes simplex mostly due to sun exposure" (unspecified if ongoing), notes: herpes simplex mostly due to sun exposure; "Interchange of vaccine products" (unspecified if ongoing), notes: had the two initial Pfizer vaccine shots, one Moderna booster and one Pfizer booster. There were no concomitant medications. Past drug history included: Poison ivy, notes: he got into poison ivy and got a shot, that was several years ago, 2-3 years ago. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Moderna (First Booster); Flu shot (Caller states he did get the flu shot this past fall, like 6 months ago around the same time he got the first 2 Pfizer shots). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "It makes sense that the vaccine is helping with the cold sores since they are caused by a virus". Additional information: Caller reported what he thinks is a good side effect or benefit of the COVID vaccine. Since he was a child, he has had cold sores, herpes simplex around his mouth and that he was a 61-year-old male. The caller added that after the vaccine shots he had not been presenting cold sores so he was wanting to report. He had not changed his lifestyle, no medications whatever, the only thing that changed was he was poked 4 times with the vaccine. He was theorizing that it was possible that it has had an effect on the herpes. He tried to look it up and if we have several people that have mentioned this maybe, since there was no cure. He was thrilled about this, he hated it and he had not changed anything. He noticed cold sores not presenting, caller states that typically in spring and fall he got the cold sores and he had not had any. Stated they were due mainly to sun exposure and he had been outside a lot. Stated the last few months he would usually have had 1-2 by this time. Caller stated he did get the flu shot this past fall, like 6 months ago around the same time he got the first 2 Pfizer shots. He did not even take vitamins. The last he was at the doctor was because he got into poison ivy and got a shot, that was several years ago, 2-3 years ago. Caller stated his 1st booster was Moderna COVID-19 vaccine and his 2nd booster was Pfizer COVID-19 vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none, Prior Vaccinations (within 4 weeks) None and Relevant Tests: None. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diagnosed with varicella 11/20/2003- was vaccinated 05/11/2000 vaccine failure.
Patient got the seasonal flu shot on 08/21/20 around 2:39 P.M . She called around 6:30 P.M and said she felt her arm was weakness,pain, and tingle sensation, and a little swollen comparing to other arm. Pharmacist recommended that she could take Ibuprofen and applied ice at the injection site. Pharmacist said will call patient back on Monday to check on her. Called patient today at 8:20 P.M. Patient said she is feeling much better and back almost to normal.
My son began having focal seizures after getting the dtap vaccine. He had major regression and stared into space and changed from my happy smiley boy to baby who had a blank stare and looked like the kight shut off in his eyes.
Had vaccine Monday, Woke up Wednesday with left side of my face swollen and a couple of bumps around my knee. Swelling was minimal by bedtime. Took two doses of Benadryl once in the AM once before bed. Woke up  Thursday with facial swelling predominately on the right side and it was about 4 times it?s usual size, lip was majorly swollen, had a rash all over the back of my legs around my knees shoulder, lower back onto butt. Went to urgent care Thursday morning at 8, rash had subsided on it?s on for the most part. She gave me a steroid, took the steroid 2 times Thursday. Woke up Friday morning with a little swelling still under my right eye and cheek. No rash
Arm hurt at injection site, upon lifting arm, felt a sensation in arm near injection site and had what appeared to be a seizure that lasted around 10-15 seconds. A few moments later another seizure occurred. Resulted in a hospital visit and a follow-up with a neurologist.