chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided.
Injection was given I.M. in left deltoid muscle. Patient is having a rash on left arm between elbow and shoulder (several inches below injection site). Patient states skin feels itchy and hot. Skin is red with several small blisters present. Injection was given 4/11/2018, reaction did not occur until 4/19/2018.
Tips of feet upto ankle burning very intensly after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported by reporter.  Concomitant products included ATORVASTATIN for Cholesterol, OXYCODONE for Pain, AMLODIPINE for Tachycardia.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot). At the time of the report, BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications include unspecified Prostate medication and unspecified Androgens. Treatment information was not provided.   This case was linked to MOD-2021-318478 (Patient Link).
Minor soreness at injection site for 48 hours after injection.  Redness, itchiness and swelling at the injection site first began  8 days after injection.
second vaccine causes arm pain more than one month later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later). At the time of the report, PAIN IN EXTREMITY (second vaccine causes arm pain more than one month later) outcome was unknown.            No concomitant medications reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Reporter did not allow further contact
4 years after adult dose given by mistake (instead of starting varicella vaccine series) patient experienced acute onset of shingles, left thoracic T2 T3 dermatomes (culture pending). Pt has never had varicella primary infection.
Facial Dermatitis; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to strawberries and mangoes. Concomitant medications included estrogens conjugated (PREMARIN), metoprolol (MANUFACTURER UNKNOWN) and amlodipine besilate (MANUFACTURER UNKNOWN); all on unknown date for unspecified indication. Patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 15Mar2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced facial dermatitis. Therapeutic measures were taken as a result of reported event and included treatment with prednisone, mupirocin and triamcinolone. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event facial dermatitis was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on 10/13/98; on same day pt exp hot feeling, nausea, vomiting, shakes &weakness.
Fever, convulsive shivering (3 episodes, 30 minutes each over 12 hour period), aches.
10/22/2023 new onset severe sinus bradycardia with PVCs and hypotension not related to MI, CAD or new heart block or conduction delay. History of RBBB only, mild HTN and HLD. Patient received Fluzone HD 23-24 PFS Sano, Lot U8984AB on 10/21/2023
Headache Numbness and loss of muscle control at mouth,  drool, similar to prior history of Belles Palsy years ago.
after administration of vaccine, up and about to another chair, next to his friend, to help interpret medical questions.  he fainted while sitting on a chair, his friend helped him go down to the next empty chair. pass out about 1 minute, elevated his feet with other chair and applied cool compress on his forehead.  awake and alert, gave some water and juice. up and sitting on a chair in the waiting room, friends bought his lunch and was eating. no vomiting and alert and talking.
Information has been received concerning a 31 year old female with no pertinent medical history and no known allergies who on 06-MAR-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 655503/0012U, expired date 13-JUN-2009).  On 30-JUN-2007 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 658094/0524U, expired date 28-FEB-2010).  On 05-MAY-2008 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 659964/1978U, expired date 29-AUG-2010).  Concomitant therapy included "nasal spray" (unspecified), occasional antimicrobial (unspecified) as needed and NUVARING.  On 20-MAY-2010 the patient had a Papanicolaou test (PAP) that indicated "HPV high risk detected".  The patient had previous PAP test in which HPV was not detected.  The dates of the PAP tests were:  27-SEP-2007, 05-MAY-2008, 03-JAN-2009 and 23-JUL-2009.  Medical attention was sought via office visit.  The outcome of the patient was not reported.  Additional information has been requested.
Patient was not a candidate for this vaccine due to age (17 at time of injection).  Moderna is currently only approved for individuals aged 18 and up.  Follow up was conducted and patient tolerated both doses well, despite the fact that she should not have received either innoculation.
pt sent to local Medical Center on 1/14/22 for possible CVA; dx with UTI and hyperglycemia; dc'd to nursing home, found to be positive for COVID on 1/17/22 in nursing home; comfort measures; pt more confused, hallucinating, poor oral intake, increasing SOB, malaise, non-productive cough, O2 sats worsening; O2 supplementation on pt; pt continued to decline and passed away in the nursing home; medical records and death certificate sent to VAERS.
severe painful headache, very bad fever, pain in left leg (was limping on it if forced to walk), nausea, unable to eat, dry mouth. i felt light headed almost immediately after given the shot..but did not feel the other symptoms until the day progressed (id say an onset of 5:00 of when they began). My brother is experiencing the same symptoms (who is 20 years and 5 months).
1st dose received on 12/27/20 and first spot bruise/inflammation onset on 1/16/21. Normal labs 1/19/21 (CBC,cmp,crp). Normal Doppler of right leg 1/21/21. Second dose of vaccine 1/23/21 and another large bluish bruise on right leg behind knee.
patient collapsed 15 to 20 minutes after receiving MCV4 and Gardasil vaccines. 06/20/07-records received from facility for DOS 3/29-3/30/07-DC DX: Syncope. Head Trauma. After injection positive loss of consciousness for about 2-3 minutes. No nausea, vomiting fever or chills but headache for about 2 days. No visual changes.
patients have received FLUZONE QIV NP vaccines that expired; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via AGency (under the reference 00814533).  This case was linked to cases 2021SA344107, 2021SA345249, 2021SA345624, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345617, 2021SA345823, 2021SA345419 and 2021SA344343 (same reporter).  This case involves a 13 years old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that expired (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 14-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, once, lot UT7108MA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  No adverse event was reported.  At time of reporting, the outcome was Unknown for the event.  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.
Information has been received from a physician concerning a 14 year old female with no allergies/drug reactions and no pertinent medical history, who on 12-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658282/0929U) 0.5 mL, IM. On 15-APR-2008, the patient was vaccinated with the second dose of GARDSIL vaccine (yeast) (lot # 659964/1978U) 0.5 mL, IM. Concomitant therapy included MENACTRA. The patient experienced hives and itching after receiving the first and second dose of GARDASIL vaccine (yeast).  The patient sought medical attention: phone call. At time of reporting. the patient was recovered.  Additional information has been requested.
Within less than 4 minutes, started having trouble breathing - throat need base of neck started closing up, skin got read and was sent to ER for treatment.  Was give benadryl, and other treatments and  finally Sodimedrol.  Afterwards had painful swelling around ribcage area, legs, feet, ankles and left abdominal area.  Have been sent to allergist for further testing, sent to cardiologist who stated the continued swelling has caused the veins in my legs not to work properly and is hoping once swelling goes down will work correctly.  Have followup with both.  OB/GYN is doing further testing - noticed that uterus is swollen, CT showed possible fibroids or cysts since this medication and swelling in skin tissue (still - ribs, legs, abdomen, ankles and feet).  Was on water pills but caused increase pain.  Vision has been effected at times - have followup with eye doctor next year.
Dizziness and pain in arm started immediately after vaccine administration. Took Tylenol last night before sleep.. Dizziness continues second day and it doesn't stop. Don't know of this is a serious side effect effect and need to be treated.
Night of injection, pt had discomfort in left shoulder down (never had fever, site not hot to touch). The next day, it was swollen and same discomfort. On the 2nd day, had increased swelling and decreased discomfort but redness at the injection site to wrist. No mobility restrictions.
Redness, swelling to upper right arm and making more red splotches (3) on arm at other spots, warm to touch, tired, lazy feeling, 3rd day starting to slow down.
Right after the first dose, I experienced hot flashes, headache, and nausea. The next day I was extremely fatigued and my left arm hurt quite a bit. After the second dose, I didn't experience anything until that night when sleeping was difficult due to the pain in my arm. The following day, I had chills and body aches, stomach ache, and a head ache.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 22-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (Lot# J009827, expiration date 10-AUG-2014). No adverse effects were reported. Additional information is not expected. The reporter did not want to be contacted.
Reaction in all my joints with flu-like symptoms, settling predominantly in my left knee resulting in 80 cc's of fluid being drained in an 18 hr period.
INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE FROM A BATCH TO BE DISCARDED; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. Age at time of vaccination 32 years old. No concomitant medications were reported. On 03-MAY-2022, the patient experienced administered vaccine from a batch to be discarded. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine from a batch to be discarded and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220761815, 20220759113 and 20220759219.
fever like symptoms where I was very hot and then very cold; rash at the site of injetion
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. This patient's current conditions and medical history were not reported. Since unspecified dates in October 2014, the patients were vaccinated with doses of improperly stored ROTATEQ (unknown strength and route defaulted to oral) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as one year ago), the pharmacist gave the patient a second booster shot for PNEUMOVAX 23 (dosing details, lot# and expiry date were not reported) for prophylaxis; instead of the first booster and on 22-DEC-2016 (reported as today), the patient came in for second booster and the pharmacist gave him PREVNAR 13 (dosing details, lot# and expiry date were not reported) which was supposed to be the first booster. The pharmacist mentioned that he didn't know what were the ramifications of this situation. Additional information has been requested.
92m x 75 redness (sl) feels warm to touch-no complaints unless area touched-played-no loss of appetite, did appear tired & took a nap yesterday-otherwise no problems noted by mom;
Heart palpitations started soon after (a couple weeks).  Had halter monitor testing, EKGs, etc. but palpitations are very random so nothing showed up.
Local redness at site left arm, warm to the touch - size - palm of his hand, itchiness and soreness.
14 YEAR OLD PATIENT GIVEN FLUBLOK VACCINE INDICATED FOR 18 AND OVER. NO ADVERSE EFFECTS
Periorbital swelling/erythema and erythematous rash (patches) of neck and torso
Narrative: COVID infection following COVID vaccine series 03/17, Pfizer, dose #1 04/07, Pfizer, dose #2 07/15 COVID swab, result: not detected 09/15 COVID swab, result: detected 09/15 BinaxNOW COVID-19 Ag result: not detected\ 09/15 SARS-COV-2 Variant Sequencing result: pending 09/15 PROCALCITONI: <0.05 09/15 pt admit to ED cc: cough, st, body aches, fever x 4 days dx: COVID 19 infection /Mild to moderate illness/No pneumonia/Normal oxygenation Asthma exacerbation/reactive airways LOS: 1 day 09/11 pt cc: exposure: unknown
Small aches; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 09-MAR-2021, the subject experienced small aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small aches. This report was non-serious.
Information has been received from a physician concerning a 24 year old female with no relevant medical history or drug allergy who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # not reported) " a week ago", on approximately 12-MAR-2009. After the vaccination the patient became light headed however did not faint. The patient sought an unspecified medical attention. It was reported that she continued to "not feel well" for 2-3 days. The patient admitted she did not eat before coming to the office. The patient recovered about 2-3 days after administration. Additional information has been requested.
Fever  102,5 F and higher; Chilles; Headache; Nausa; This is a spontaneous report from a contactable consumer reported for himself that: A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9262 and expiry date were not reported, Solution for injection) via an unspecified route of administration, administered in arm left on 22Jan2021 at 08:45 AM (at the age of 71-year-old) as single dose for COVID-19 immunization. The medical history included a type 2 diabetes, sleep apnea, hypertension, Coronary artery bypass graft, Post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received another vaccine NA (sodium) on the same day of vaccination for unknown indication on 22Jan2021. Patient had no known allergies. The concomitant medications were not reported. On 22Jan2021 at 01:00 PM (same day of vaccination), the patient experienced a fever 102.5 f and higher, chills, nausea, headache. The reporter assessed all the events as non-serious. No treatment was received for events. The outcome of events is recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Narrative: 71 yo male with PMHx of metastatic prostate cancer (liver, bones), hyponatremia, HLD, who presented to the ED on 7/12/21 d/t fever and R sided abdominal pain for the last week. Wife states temps up to 103. Patient also with cough. Wife states that he has increased cough after eating and drinking. Patient was also with c/o bone pain, fatigue and anorexia.On 7/15/21 pt transfered to home hospice. Pt died on 7/17/21 at home hospice. Pt had received covid vaccinnes outside facility on 2/1/21 & 3/9/21. Appears death is not related to covid vaccinations.
Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after shot and lasting for 6 to 8 hours
Within 1 hour of injection I had numbing in my right face cheek. I liken the feeling to that of when  your Dentist gives you a shot of Nava Caine and it begins to numb.  After and hour or so it moved to my left forehead and eventually to my right forehead and was across the entire forehead. Later that night approximately 3 hours later it moved to the top of my head. I would say it lasted for approx 6 hours.
Presented to clinic with rash (bullock lesions on trunk, legs, CBC done, started on anti-histimine on 7-16-04. Rash resolved on 7/20: Father phoned today 7/22. Started rash appearing and very itchy . CBC normal limits.
Became very light headed; cold chills with shaking for 45-60 minutes; cold chills with shaking for 45-60 minutes; Sweating for next 12 hours; Date of start of drug: 08Jan2021, Dose number: 2; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 08Jan2021 08:30, at single dose, for COVID-19 immunization, in the doctor's office/urgent care. Medical history included depression, anxiety and COVID-19, all on unspecified dates. The patient has no known allergies. Concomitant medication included vilazodone hydrochloride (VIIBRYD 40 mg) and folic acid 1 mg. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 19Dec2020 12:30, at single dose, for COVID-19 immunization. On 08Jan2021 at 21:00 (reported as 12 hours after the shot), the patient became very light headed. He experienced cold chills with shaking for 45-60 minutes and was sweating for next 12 hours. The patient had no fever. All events subsided by 10:00 next day, 09Jan2020. The patient received no treatment for the events. 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. The outcome of the events was recovered on 09Jan2020 at 10:00.
Patient reported that her hand started feeling tingling after her vaccine. She denied any s/s of respiratory symptoms. She has full ROM to her hand. She denied treatment to the ER. Advised her to go to the ER if the tingling continued in her hand and did not resolve or became worse. She verbalized understanding.