chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brown/green discharge from breasts; Feeling of nausea; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCHARGE (Brown/green discharge from breasts) and NAUSEA (Feeling of nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025-B21A and 048-A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis, Postmenopausal symptoms, Hysterectomy and Fusion of vertebra. Concurrent medical conditions included Blood pressure fluctuation, Acid reflux (esophageal) and Thyroid disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LISINOPRIL and CARVEDILOL for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, PARACETAMOL (TYLENOL), GUAIFENESIN (MUCINEX), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (Feeling of nausea). On 30-Apr-2021, the patient experienced BREAST DISCHARGE (Brown/green discharge from breasts). On 10-Apr-2021, NAUSEA (Feeling of nausea) had resolved. On 30-Apr-2021, BREAST DISCHARGE (Brown/green discharge from breasts) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-101727 (Patient Link).
Patient had swelling & redness at injection site starting 8/30/12 then she developed a rash on her body 9/4/12.
Extreme swelling, extreme pain, and redness. called 08/25/2010 and they had me come to the office. Dr. saw it and felt it was an allergic reaction or possibly a hematoma. Told me to put ice on it and watch for other symptoms. I called again the next day because there was no change. She said if it went down even a little I did not have to come back in. Swelling and pain and redness continued throughout weekend and the swollen hard solid lump began to decrease slightly today 08/30/2010. Have been taking ibuprofen for pain. Could not drive the day after the vaccination because of dizziness, my daughter had to miss a college class to take me. I know this is no one's fault it's that I have yet to resume my tasks as a homemaker.
temperature excursion occured, temp. low of 1.85C for 30 min due to human error with no reported adverse event; opened ipol was administered to the patient with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old male patient who experienced temperature excursion occured, temp. low of 1.85c for 30 min due to human error and opened IPV (VERO) [IPOL] was administered to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date the temperature excursion occurred for IPV (VERO), temp. low of 1.85c for 30 min due to human error with no reported adverse event (product storage error) (unknown latency).  On 11-May-2023, the patient received a dose of 0.5 ml (frequency: once) of standard strength suspect IPV (VERO) suspension for injection (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for immunization was administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
pt recvd vax 17OCT95 & 315PM pt @ meeting & rt side of lip became numb, then got dizzy, dropped a coke from hand; then went down on the floor; never lost consciousness;nauseated; BP elevated; mini stroke; chest problems
I95.9 HYPOTENSION 3/6/2022 DIASTOLIC HEART FAILURE, ACUTE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 DIASTOLIC HEART FAILURE, ACUTE I95.9 HYPOTENSION 3/6/2022 CHRONIC DVT OF RIGHT LEG, UNSPECIFIED VEIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 CHRONIC DVT OF RIGHT LEG, UNSPECIFIED VEIN
Information has been received from a pharmacist referring to 4 newborns (numbered 152, 153, 154 and 155). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30/2F. On 31-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Pt had pictures of rash under both breasts,stomach,  between thighs,swelling to face,  and white thrush in mouth. Symptoms started on or before 4/3/21. Went to ER 1st and was given antibiotic cream for rash. Symptoms got worse so went to private doctor and was prescribed po antibiotics, Diflucan x 2 pills for the thrush in mouth.
Patient presented with a hx of fainting with vaccination to get her Covid vaccine. After receiving the vaccine, she started filling light headed. We had her lie on her back and put her feet up. We also gave her a cold compress to place on her neck. She started feeling better within  minutes and sat up waited 30 minutes in our post vaccination area. After 30 minutes of monitoring her, she said she felt fine and left the pharmacy.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medial histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Soreness at site on (R) deltoid & on axilla. Vaccine 5/24/12. Office visit 5/29/12.
Grandmother comes in clinic without child. States child has rash all over and red blotches on his face. Grandmother was counseled on potential side effects from vaccinations. Vaccine information statements were reviewed and provided. She denies other medications or changes. Advised grandmother to see physician for evaluation. She stated she understood and left to get child and take him to see physician.
Info has been received from a physician concerning a 10-week-old "healthy" female, breast-fed, with a history of jaundice and diaper rash, who on 04/10/2001 and 06/11/2001 (also reported as 06/19/2001) was vaccinated with the 1st (lot #638792/1825K, administered in the left side) and 2nd doses of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy, on those same dates, included the 1st and 2nd doses of poliovirus vaccine inactivated (IPOL) (lot #T0757, 1st dose, administered in the right side), Streptococcus pneumoniae vaccine (Prevnar) (lot #474-729, 1st dose, administered in the right side) and alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) (Lot #995A2), 1st dose administered in the left side), respectively. The pt had congestion and rhinorrhea at the time of both vaccination episodes. On 04/23/2001, the child was seen for a sick visit and was afebrile. It was documented that on 04/21/2001 the pt experienced a temperature of 99. The physician documented the presence of minimal thrush on the pt's tongue and problems with bowel movements. The pt's last bowel movement was on 04/22/2001, but she had not had one, prior to that on 04/18/2001. The bowel movement was described as soft, large, and watery. The had been given apple juice 1 oz. x 1 day. On 05/26/2001, the pt was seen for an upper respiratory infection (incidental finding). She had a "deep" cough and was coughing so hard that she expelled emesis that morning. She had been fussy and irritable for 4 days. At that time, she was afebrile and having loose stools daily. She had "yellow" rhinorrhea for 1 week. It was noted that she was taking ibuprofen (Motrin) and that her sibling had RSV at the time. On 07/11/2001, she was seen for a well-child visit and received her immunizations as reported above. On 07/30/2001, she was again seen by the physician. It was noted that the upper respiratory infection symptoms were resolving. At that time the pt had a red macular rash on her trunk, palms, and soles. She had a fever for 3 days, up to 100.7, was fussy and sleep decreased. The physician's impression was a viral syndrome. She had been taking acetaminophen (Tylenol) and ibuprofen (Motrin). On 08/14/2001, she was seen for a well-child visit, at which time she was afebrile (97.4) and noted to be teething (incidental finding). Upper respiratory infection and teething were considered to be incidental findings. This info was received in follow-up to a case reported through the Pregnancy Registry. The pt's mother was vaccinated with varicella virus vaccine live, while pregnant with this child (WAES #00062591). Additional info is not expected.
Pt received vaccine and as patient began to schedule second appointment, they experienced a syncopal episode. Pt relaxed back into chair and became unresponsive. Pt was assessed immediately and EMS was called. Heartbeat was palpated and patient was breathing. Within thirty seconds of syncopal episode, pt roused and began to answer questions. Pt was moved to side of the room where they were assisted to a supine position with their legs propped up on a chair. BP 107/80 HR 70 O2 Sat 99%. EMS arrived at 1435. Pt denied feeling dizzy or faint and refused EMS services. Pt remained supine until 1445 at which time pt denied having any symptoms at all and was escorted out of the building.
Information has been received from a licensed practical nurse concerning a 64 year old white female with adult onset diabetes, hypertension, arthritis, depression and allergy to aspirin. On an unspecified date, the patient was previously vaccinated with pneumococcal 23v polysaccharide vaccine (the number of previous doses was unknown). On 15-JAN-2008, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 659150/1384U) 0.5 mL IM in the right arm at 3 PM. Concomitant therapy included simvastatin (MSD), EFFEXOR, COREG and metformin. On 15-JAN-2008, the night of the injection, the patient developed pain, and redness and swelling from the injection site to the elbow. The patient was having trouble moving her arm due to the pain. The patient sought medical attention (office visit). No diagnostic tests were performed. At the time of reporting, the patient had not recovered. Follow-up information was received from the licensed practical nurse. The patient was seen by the physician on 16-JAN-2008 for these complaints and medication refills. She was treated with MEDROL dose pack and analgesics. The outcome of the events was not reported. No additional information is expected.
Vaccine was mixed with Sterile Diluent instead of Sodium Chloride 0.9%. No symptoms reported in patient.
Information has been received from a physician concerning a pt who in 1990 was vaccinated with a dose of varicella virus vaccine live and six months later developed "full blown varicella".  On approximately 03/18/03 (this past week) the pt developed "full blown varicella again".  It was unknown if medical attention was sought.  The physician also reported on another pt with a similar experience (WAES # 0303USA02378).  Additional information has been requested.
Information has been received from a pharmacist concerning a 72 year old female patient who on 09-SEP-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) in her right upper deltoid. Secondary suspect vaccinations received at the same time included AFLURIA (manufacturer unspecified). On an unreported date, the patient experienced warmth at the injection site. It was reported that the patient was recently diagnosed with breast cancer and had not started any form of treatment at the time of this report. Upon internal review, breast cancer was determined to be an other important medical event. The patient's outcome was not reported. Additional information has been requested.
August 15: sinus headache August 16: sinus headache, dizziness August 17: sinus headache, dizziness August 18: sinus headache, sore throat, swollen lymph nodes, wave of exhaustion around noon August 19: pain level 6 sinus headache, achy body, sore throat needing cough drops constantly to provide any relief, running nose, sneezing, exhaustion, dizziness, loss of appetite August 20: sinus pressure, throat phlegm, coughing August 21: body felt like I was trying to move inside of molasses, headache, coughing, achy body specifically in my back August 22: headache like my head was in a vice, extremely swollen lymph nodes, coughing attacks August 23: runny nose, sore throat, exhaustion August 24: runny nose, sore throat, exhaustion August 25: runny nose, sore throat, exhaustion August 26: runny nose, sore throat, exhaustion
Narrative: Patient reported mild headache following administration of Pfizer covid vaccine. Patient required no intervention and was able to be released.
Dizziness / Lightheadedness; Passed out for 10 minutes.; This case was reported by a consumer via other manufacturer and described the occurrence of passed out in a 56-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the passed out was recovered/resolved and the outcome of the dizziness was unknown.   It was unknown if the reporter considered the passed out and dizziness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:   The age at vaccination was not reported. The patient had a bad reaction to his flu shot including dizziness, lightheadedness, and he passed out for 10 minutes.
2 days after 2nd COVID vaccine (Pfizer), started to notice random onset heart palpitations and tachycardia, as well as random minor chest pains, and occasionally moderate chest pains. chest pains could be described as a sharp pain or tightness that only lasts a second or two then typically goes away. It is now 6 months later and I am still experiencing heart issues: palpitations, elevated heart rate, fatigue, feeling "winded" when climbing stairs. Elevated heart rate is sometimes as high as 160bpm, even when sitting on the couch relaxing. Marijuana use will occasionally raise heart rate, but not consistently enough to be the cause of tachycardia. When heart rate is elevated, I will sometimes experience anxiety, which can lead to slight "difficulties" breathing (this seems to be caused by the anxiety, and when I notice my heart rate is high, I get nervous and think too much about it and probably focus too much on breathing normally)  These symptoms and issues were not present prior to receiving my 2 COVID vaccines
Big red patch at site of injection, swelling, itching, redness and pain at the site of injection.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 19-SEP-2013 the patient was inadvertently administered RECOMBIVAX HB (dose, indication unknown) instead of VAQTA as prescribed. Other suspect therapies included VAQTA. No adverse effects was reported. Additional information has been requested.
66-year-old male patient came in for seasonal flu vaccine and covid-19 vaccine appointment on 10/19/2023 at 10:00am. Patient received both doses, covid (left deltoid) at 10:01am and flulaval (right deltoid) at 10:04am and returned to his car where he decided to wait 30 mins before leaving. At 10:30am patient returned to the flu clinic to report rashes on both arms and tingling in his mouth/tongue. Patient was assessed by RN, RN, and myself RN Rashes were visible on both arms, two distinct areas of hives on his left elbow and hand. He also had one area of hives on his right wrist. Due to the ?tingling on tongue? as reported by the patient, we collectively decided to administer 0.3 mg of epinephrine injection per policy for administering epinephrine for anaphylaxis; given by RN at 10:40am in patients right thigh, patient remained stable. RN called urgent care and spoke to charge nurse, who informed me to ?call 911 per protocol.?  Per the RN?s in the flu clinic it was recommended to the patient that we call 911 due to protocol. Patient agreed, 911 was called by RN and the ambulance arrived around 11:00am to the flu clinic. Patient report and snapshot of his chart was given to the paramedics by RN. Patient was assessed by paramedics where vitals were taken as well as two EKG?s.  One paramedic called their base to inform their Dr. of situation. Dr. requested to speak with patient over the phone. Paramedic spoke with the Dr. to double check that patient needs to be transported to the hospital because he was given epinephrine. Paramedic informed patient that he will need to go to the emergency room for further monitoring. Patient declined ambulance transportation and opted to have his wife pick him up and bring him to nearest emergency room. Paramedics had patient sign a liability waiver that he was declining transportation via ambulance. RN signed waiver as a witness.  Patient was brought via wheelchair to main entrance of the clinic by RN and was safely transferred to his wife?s car.
Soreness in the left arm/shoulder that required pain medication to tolerate.  Back ache, muscle aches in legs, chills.  I was scheduled to work the day after the second shot and worked the full shift with all the symptoms; we are a small facility and had no fill in coverage available, the fill in /prn staff quit working due to the pandemic due to over age 65 for one and another due to having an autoimmune disorder and not preferring to work.
Fever; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 05-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Tylenol BID
Myalgia, Tachypnea, Diarrhea & NauseaVomiting Narrative:
A report has been received from a Health Professional concerning a 16 year old male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 24-Jan-2014. It was reported that nurse had administered expired FLUMIST QUADRIVALENT. (Preferred Term: Expired drug administered) to student which started on 24-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
pain on right leg, pain on right arm.; Right Ankle swollen; rash through body; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 10Feb2021 (at the age of 55-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history was not reported. Known allergies were reported as no. Concomitant medication included methimazole (METHIMAZOLE). Patient previously received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9809) via an unspecified route of administration on an unspecified date (at the age of 55-years-old) in right arm as dose 1, single for COVID-19 immunization and no reaction reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination. On 14Feb2021 at 13:00, the patient experienced pain on right leg, pain on right arm, right ankle swollen, rash through body. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 08Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Injection site is red rash; red rash orange in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O4M20A) for COVID-19 vaccination.     no medical information provided.  Concomitant products included FENOFIBRATE, HYDROCHLOROTHIAZIDE (DICHLOTRIDE [HYDROCHLOROTHIAZIDE]) and CALCIUM LEVOMEFOLATE (METHYL FOLATE) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size). At the time of the report, VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
Patient awoke from a nap and felt like she had lost strength in her right hand. The Prevnar 13 vaccine had been administered in her right deltoid muscle earlier in the day, so she correlated the hand weakness with the shot. Patient claims she had difficulty lifting heavy objects with that hand (such as a gallon of milk) and felt a nerve in her hand tingling at times. Patient said she was going to see her doctor Monday to have this issue evaluated.