chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his arm was sore; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE (age at vaccination 64-year-old) for COVID-19 IMMUNISATION. The patient medical history included covid-19 from 2020 to 2020 (mentioned that he tested positive for COVID last year, it was mild and resolved after 2-3 weeks), pneumonia from he has a history of pneumonia. The patient's concomitant medications were not reported. The patient previously took flu and pneumonia shot and hasn't been getting sick every year. It was reported that patient had experienced sore arm after receiving the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2020 Caller mentioned that he tested positive for COVID last year, it was mild and resolved after 2-3 weeks. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A spontaneous-unsolicited report has been received from a pharmacist concerning a 29 year old, female patient. The patient's medical history and concomitant medications were not reported. Since 12-Sep-2014, the patient had been receiving FLUMIST QUADRIVALENT (intranasal). The pharmacist reported that full dose of FLUMIST QUADRIVALENT was administered into one nostril which started on 12-Sep-2014. The outcome of the event of full dose of FLUMIST QUADRIVALENT was administered into one nostril was unknown. The reporter assessed the report to be non-serious.
I was not aware pt. was pregnant until after I administered her #3 GARDASIL.
This spontaneous report as received from a medical assistant refers to a 9 weeks old patient. On 14-MAY-2015 the patient was vaccinated once with first dose oral, ROTATEQ (lot # K00791 with expiration date: 29-MAR-2016; dose: 2 ml, orally) which was incorrectly stored. No adverse effects were reported. {Additional information has been requested./Additional information is not expected.}
On 04/04/21, I lost all hearing in my right ear and can only hear a ringing (tinitus).  This might not be COVID Vaccine related, but I have not taken any other medications and overall feel healthy. Went to the emergency room on 04/04/21, CT scans performed with no issues found.  They gave steroids and antibiotics to take. I Saw ENT on 04/06/21 and a hearing test was performed and it was determined that I had Sudden Sensory Deafness in my right ear.  Taking 60mg Prednisone each morning and 500mg  Valacyclovir twice daily.  The symptoms have not changed (improved or worsened) as of today.
Pt reports lip swelling, red/raw and burning.  It occurred after the first dose. Pt was evaluated by her dermatologist and given steroid taper. Symptoms improved and pt was told she could do second dose.  Pt had same reaction after her second dose of Moderna.
Fever up to 102, myalgia, headache, fatigue, nausea, diarrhea, vomiting. These systemic symptoms lasted 2-3 days. Red spot on arm where vaccine was given - still present today on Day 4 after vaccine.
heart palpitations, cold sweats at night, 5 days after the vaccine, on February 27, 2021. On the 10th day after the vaccine, I was playing golf around noon, and I started having heart palpitations and felt dizzy again and I stopped playing golf. I went to see my cardiologist. Diagnosed me that I basically had an occasional additional heart beat. It was occurring less than 3 percent of the time. They ruled out Atrial fibrillation.  I still have some episodes were I feel heart palpitations, they are not as frequent, they are totally random. It occurs maybe once a week now.  It doesn't stop me from exercising.
This spontaneous report as received from a registered nurse refers to a child of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 05-APR-2018, the patient was vaccinated with RECOMBIVAX HB (5/0.5 mcrg/ml) 5 Microgram, once by intramuscular route from lot L048236 that expired on 31-MAR-2018 for prophylaxis. Product did not have a temperature excursion. No adverse effects reported. No product quality complaint was involved.
(L) arm redness, pain, increased warmth and swelling. Tx = cephalexin 500mg 1 tab 4 times a day, warm compress, elevate arm.
Patient received her Pfizer COVID vaccine at approximately 11:40 a.m.. She stated immediately after she received her shot she had headache and felt shaky  She waited afterwards felt ok and so drove back to work (about 45 min drive).  Approximately 1 hour after shot she developed generalized itching especially around the head neck and arms.  She developed a red fine rash of her bilateral upper arms and blotchy rash on her chest and neck, similar to her prior reaction to Sulfa drugs in past.      She called employee health and was directed to be seen in clinic.  Pt walked down and notified me and she was immediately placed in room and was evaluated.  She did take PO Benadryl 50mg about 145pm.  Patient feels a little nauseous.  A little jittery.  No fever no chills no chest pain or shortness of breath no lip swelling or tongue swelling no difficulty breathing.  She had some loose stool yesterday.  Headache is improved no vision changes.  No prior history of anaphylaxis. No other new exposures (lotions, foods, pets, meds etc) other than COVID 19 vaccine today.  She appeared uncomfortable.  Solumedrol 125mg IM was given in office. patient was observed > 1 hour.  no change in symptoms.  vitals stable. discharged home with prednisone taper.
Complained of legs hurting and hurting to walk for about two days and was "not himself" as far as behavior, and then realized after getting the flu vaccine on 11/10/2017 noticed the behavior issues again.
Chills started at 0200 on 12/30/21. Left arm pain, headache, and vomiting at 0800 on 12/30/21.
Child was noted to be pale & less responsive. Lasted approximately 1-2 hours then child returned to baseline.
Left arm stiffness & soreness, fever, exhaustion Thursday evening (10/27) to Sunday 10/30. Thursday night 10/27 aching and left arm tingling from left upper central arm to fingertips x 4 days, decreased to localized tingling in center of upper left arm on 11/1/16; cold symptoms 10/30-present.
On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion. The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Vaccine administered 4/22/21 at 11am.  Upon awakening on 4/23/21, subject felt pain in left hip and left knew, noted swelling in left knee.  Subject did not know of pain origin, but assumed he may have strained muscles and did not seek treatment.  However at 2am on 4/24/21, subject awakened with itching/hot feeling to left knee and hip, and noted a "splotchy rash that looked like poison oak at first".  Stated that he "googled shingles and it looked exactly like those picture".  He phoned a friend on the morning of 4/24/21 who had recently had shingles, and obtained the friend's medication for shingles and began taking around 6pm on 4/24/21 (Valcyclovir 500mg po QD x 15 days).  He also applied calamine lotion to the rash.  He did continue to work as per scheduled and did not have issues with disability, but at night complains that rash is itchy and burning.  Completed valcyclovir dosage on 5/9/21.  With the use of valcyclovir and calamine, the rash had "dried up" within two weeks, but noted a new rash on right forearm beginning on 5/11/21 and also noted new rash (same as before) starting around the scabs of the old rash on left knew and left hip.  Currently, complaint of itching and burning at rash sites "at bedtime, but doesn't bother me when my mind is active".  Has not yet sought professional medical evaluation or treatment, but plans to go to emergency department or urgent care center once he has completed a home improvement project.
12/30/14 site was red and swollen in a 6 inch diameter, hot to touch, itchy, felt sick all week.
Patient complained of itching & hives on right arm & chest.  Benadryl 25 mg po given after consultation with Dr.  Monitored for 1 hr.  Discharged wtih instructions to take Benadryl 25 mg po q 6 hr for today & follow up with PCP.
IPOL was administered to a patient which was exposed to temperature excursion, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA293402 and 2019SA293404 (same reporter).  This case involves 4 month old female patient who received a dose of vaccine IPV (VERO) [IPOL] which was exposed to a temperature excursion.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and HIB VACCINE (HIB VACCINE) for Immunisation.   On 18-Oct-2019, the patient received second dose of suspect IPV (VERO) (lot P1F491M, Expiry date: 30-Nov-2020) via subcutaneous route in the right thigh.  It was a case of actual medication error due to improper storage of product in use.  It was reported that ActHIB, IPOL opened, Daptacel, Adacel, Fluzone Quadrivalent prefilled syringes 0.25 ml and 0.5 ml and multi dose vial (MDV), for temperature of 33.4 degrees F for 6 hours 48 minutes due to unknown reason. ActHIB (UJ076AA, expiry date: 21-Feb-2020), Daptacel (G5BE3, expiry date: 25-May-2021, Lot: J947T, expiry date: 30MAY2021), Adacel (lot: U6273AA, 24-Apr-2021, Lot: U6321AA, 07-Jun-2021), Fluzone Quadrivalent MDV (UJ223AB, 30-Jun-2020), Fluzone Quadrivalent 0.5 ml prefilled syringes (lot: UJ231AB, 30-Jun-2020) and Fluzone Quadrivalent 0.25 ml prefilled syringes (lot: UT6647JA, expiry date: 30-Jun-2020).  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
One leg has little red spots on it, like a rash; Rash is all over her body, arms and ankles, face,rash and it's still ongoing,rash that runs together; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (One leg has little red spots on it, like a rash) and RASH (Rash is all over her body, arms and ankles, face,rash and it's still ongoing,rash that runs together) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH MACULAR (One leg has little red spots on it, like a rash) and RASH (Rash is all over her body, arms and ankles, face,rash and it's still ongoing,rash that runs together). At the time of the report, RASH MACULAR (One leg has little red spots on it, like a rash) and RASH (Rash is all over her body, arms and ankles, face,rash and it's still ongoing,rash that runs together) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to safety for Follow-up.
Patient reported theses side effects in her following visit in 6/28/18. She stated that shortly after she had the shot, her left arm swollen, red. It was swollen for few days before swelling started to subside. Also patient reported bad headache lasted for one day and resolved with over the counter NSAID.   Patient about 6 weeks earlier received 1st dose MenB (TRUMENBA) and Flu vaccine.
Information has been received from a 26 year old female pharmacist with no pertinent medical history who in approximately January 1996, "14 years ago" was vaccinated with a dose VARIVAX (Merck) (0.5 ml, SC). There was no concomitant medication. On 07-MAY-2010 varicella antibody titers was performed and the result was negative. Unspecified medical attention was sought. Additional information is not expected.
Heart is racing a little, not much, 105 bpm; cold chills; cold chills; Fever of 100.8 ° F; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F). At the time of the report, HEART RATE INCREASED (Heart is racing a little, not much, 105 bpm), NASOPHARYNGITIS (cold chills), CHILLS (cold chills) and PYREXIA (Fever of 100.8 ° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 100.8 (High) fever of 100.8 ° F. On 30-Sep-2021, Heart rate: 105 (High) 105 bpm, not much.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was not having a history of COVID infection and myo/pericarditis.  No concomitant medication information was provided.  No treatment medication information was provided.
Menieres disease; Boil in mouth; Stomach ache; Head felt very heavy, spacey; Low grade fever 24 hours post injection.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 23Sep2021 at the age of 44-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Aug2021 at the age of 44-year-old as dose 1, single for covid-19 immunisation. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 24Sep2021, patient experienced boil in mouth, stomach ache, head felt "very heavy, spacey"; caused meniere's disease to act up.  low grade fever 24 hours post injection. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a female pt (age not provided) who on approx 8/22/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). The nurse reported that a day and half after receiving the vaccine, on approx 8/23/06 the pt developed what appeared to be hives. Unspecified medical attention was sought. Subsequently, the p0t recovered from the hives. Additional information has been requested.
the caller doesn't know the name of the medicine they have given her when she went in for them to look at her heart (after getting the first dose of Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that:  A female patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history and concomitant was not reported. On an unspecified date, The patient experienced the caller doesn't know the name of the medicine they have given her when she went in for them to look at her heart (after getting the first dose of covid-19 vaccine with outcome of unknown.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
About 27 hours later, I had a large welt at injection site, began to feel a lot of body pain and then nausea. For the next 12 hours, my pain and nausea worsened, and I developed a fever. I couldn't keep any water in my stomach, I am sure I was dehydrated as a result.. The skin reaction and slight pain continued the next day at a smaller scale
On July 10, 2009 patient received only one vaccine:  Chickenpox. On July 22, 2009 he was rushed to the hospital with high fever and Seizure. At the hospital he was dignosed with Pneumonia. He was hosplitized for five days. Test results conclued bacteria infection was not the cause.  10/5/09 Medical records received for dates of service 7/23/09 to 7/28/09.  DX: Respiratory distress secondary to pneumonia.  Presenting symptoms: Pt became ill 2 days prior to admission. Developed fever, nasal congestion, febrile seizure. Taken to ER, tx and released. Two days later increase in difficulty breathing and admitted to hospital. Assessment:  moderate respiratory distress, bi-lateral intercostal retraction, tachypnea, tachycardic, some rales and rhonchi. Tx with triple abx therapy.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).     Concomitant product use was not provided by the reporter. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.
Severe chills; muscle aches; fatigue; nausea; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to avocado (fruit allergy). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), ethinylestradiol/norgestimate (TRI LO ESTARYLLA) and loratidine (CLARITIN); all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 02:00 the patient experienced severe chills, muscle aches, fatigue, nausea, fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Severe chills, muscle aches, fatigue, nausea, fever were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine given to child under 16 years of age.   No treatment required.  No signs or symptoms or adverse reaction.  Mother of child informed and PCP notified.  Mother knows to contact clinic with any concerns.
Itchiness at vaccination site (left arm) spread rapidly across to chest and throat. Throat constriction followed, accompanied by coughing.  Treated with Benadryl and Albuterol. Following day (04/12/2013) itchiness at vaccination site reoccurred accompanied by redness and swelling and hives on left shoulder, throat & chest tightness and coughing.
Arm swollen. She was not too concerned about it. I called to check up on her and she said she was fine. Her main complaint was bruising due to COUMADIN.
The client had an unwitnessed fall to the floor as exiting the building. An employee saw the pt on the floor with feet raised, body shaking all over with tremors and his head hitting the floor repetitively. The body shaking lasted approx. 3-4 minutes. He was placed in a chair. When the nurse/MD were on the scene, the pt was placed supine. After ice pack to small raised area on crown, skin intact, color pale, lethargic, slow to answer questions and stated his age was 19. He did not know the day of week. Within 10 minutes, he had less lethargy and questions were answered less sluggishly. His pulse (radial) 68 and regular; respirations even and regular; no SOB/respiratory distress. No rash, pruritus or edema. He was treated and released from the ER. Per ER physician, dx: vasovagal syncope. Referred to pediatric neurology