chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No advers effects reported; 2 improperly stored doses of PROQUAD administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R080798, expiration date reported as 22-APR-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from -9 degree celsius to 8 degree celsius (2.62C), during 4 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.  Lot number R080798 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.; Sender's Comments:  US-009507513-1907USA012694:
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment history was reported. Reporter did not allow further contact; Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow up received: Updated reporter name and email address. Added dose number and new event.
Nausea/vomiting, Severe muscle pains all over the body, fever/chills  (Started 2 days after vaccine was given), Patient followed up with primary care physician after having these symptoms Sunday-Wednesday.  MD prescribed prednisone on Wednesday and patient reported feeling better today (Thursday) following that.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox in January, 1999. No further information is available.
Memory loss for 5 hours, weakness in legs, unable to walk, fatigue lasted 3 days.
Large red swollen splotch (hot and itchy) by injection 2 days later; Large red swollen splotch (hot and itchy) by injection 2 days later; Large red swollen splotch (hot and itchy) by injection 2 days later; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 at 13:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hypercortisolism. 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was allergic to grass and shrimp. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 14Mar2021 at 10:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 12:00, two days after the vaccination, the patient experienced large red swollen splotch (hot and itchy) by injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events large red swollen splotch (hot and itchy) was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
admit 29SEP93 muscle weakness, trouble walking, nausea, no hx of prior neurolgic problems, DX GBS. (CSF 191mg/% protein). Pt had to be intubated and ventilated;
I was asymptomatic (other than an enlarged lymph node in my neck, though we thought that it was just a reactive lymph node at the time ? December 2021) but I have been diagnosed with stage 2A mixed cellularity classical Hodgkin?s lymphoma at the end of January, beginning of February, 2022. It was caught through incidental finding. I had a chest x-ray as a part of a procedure and they found markedly enlarged lymph nodes in my mediastinum.
Case number PHEH2016US031075, is an initial spontaneous report received from a pharmacist on 28 Nov 2016. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 16 Nov 2016. On 18 Nov 2016, the patient experienced numbness, tingling and shoulder pain. Patient cannot lay or lean on it. Patient believes that it is getting worse. The patient is still experiencing reaction. The outcome of the events was reported as condition deteriorated. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Transient acute ITP based on routine yearly blood work on 12/19/22. plt 62,000. On 12/29/22 plts were 46,000.  On 2/24/2023 plts recovered to 206,000.
Pt started getting dizzy and pale looking about 5 minutes after receiving the vaccine. She was talkative but she complained of dizziness, mom asked for 911 to check her and went to the hospital for further review of symptoms
Received ER report from hospital. Child presented with c/o (L) arm red/warm - localized reaction (+) swelling u/s from ER T93.4 -  P.97 - R16 - BP 112/71 - SpO2 9.9  Rm air. C/o pain chest and (L) arm - Tx DECADRON 4 mg IM.
Information has been received from a health professional concerning a female with no pertinent medical history and no drug reactions/allergies who on 21-JUN-2007 was vaccinated PO with the first 2mL dose of Rotateq (Lot # 656393/0240U). Concomitant therapy that day included a dose of PEDIARIX, a dose of ACTHIB, and a dose of PREVNAR. There were no other concomitant medications. Between 05-JUL-2007 and 09-JUL-2007, two to two and a half weeks post vaccination, the patient was fussy and experienced diarrhea and abdominal pain with legs curling to abdomen. She was seen in the office on 11-JUL-2007 with odoriferous, lime green, loose stool which was positive for occult blood. The abdomen was negative for pain. The outcome was not recovered. The baby was noted to be breastfeeding. In addition, the baby's family was sick with colds for the past few weeks. No additional information was available at the time of the report. There was no product quality complaint. Upon internal review, loose stool which was positive for occult blood was considered to be other important medical events. Additional information has been requested.
my hair started to fall out; This is a spontaneous report from a contactable consumer. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history was not reported. No concomitant medication was reported. On an unspecified date, it was reported that she got the vaccine and a few days later her hair started to fall out. She would brush her hair in the morning and she would have a brush full of hair can you please tell me why I don't see anywhere that is one of the side effects. I have had to cut my hair short and was not happy about it so please help me. The outcome of Event was unknown.  Information on the lot/batch number has been requested
On 5/12/00, the pt received his 1st injection with Lymerix. Sometime thereafter, he experienced pain at the injection site. The information received on 5/23/2000, did not provide an outcome.
medical assistant administered expired IPOL to patient with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Media information (under the reference 00830572).  This case involves a 4 years old female patient (date of birth: 02-Mar-2017) who received an expired vaccine IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] for and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] for prophylactic vaccination.  On 26-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (solution for injection, once, lot number: R1F972M and expiry date: 03-OCT-2021) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  It was reported "Practice manager reports that a medical assistant administered expired IPOL to a patient. Practice manager asks what they should do next."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  The reporter assessed the causal relationship for event with the IPOL as not reported.  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.  There will be no information on batch number for DTAP and PROQUAD.
This spontaneous report as received from a male consumer of unknown age refers to himself. In 2012, the patient was vaccinated with the first dose of GARDASIL (lot # and dose not reported), injection and had not received the second or third dose. No side effects were reported. Additional information is not expected.
Prior to vaccines, client was very apprehensive, pulling away from nurse. While discussing vaccine info. with mother following administration, client fainted and fell to floor. Vital signs stable (BP 110/70, HR 84) EMS called. When EMS arrived, client was sitting up, eating and drinking, color improved. EMS did not transport. Mother states client has HX of fainting with needles. No injuries noted.
On 3/11/16 at 330 pm pt reported/nurse viewed red raised, sore to touch area of injection site for Hep-B and Tdap. Varicella site c/o itching. Tdap 7cm induration, Hep B 5cm induration, Varicella 5cm induration. Ice, TYLENOL.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of (Oka-Merck) PROQUAD subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
No adverse event; HCP vaccinated with a 3 day expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Severe fatigue and headache lasting at least 2 weeks after vaccine. Symptoms still continuing. Had immediate chills, fever, sweats, etc consistent with vaccine response. However has severe ongoing fatigue, mild dyspnea on exertion, brain fog, etc causing inability to work.
The area ached, red, hot to the touch, swollen and a bump around the injection site that was about 2 1/2 inches long.
Information has been received from a physician concerning his 18 month old son who on 3/15/02 was vaccinated with a dose of MMRII. Eleven days later, on 3/26/02, the pt experienced a rash on his face and trunk. Unspecified medical attention was sought. Additional information has been requested.
No adverse effects noted following vaccination. Individual requested and received a different COVID-19 vaccine. The individual received 1st COVID vax dose on 4/23/21 (Pfizer, Lot Number ER8734). The individual requested and received a 2nd dose of Moderna (Lot Number 027C21A) on 7/2/21 at 0812.  No reactions noted or reported and the report filed per protocol.
expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Adult and unknown gender patient to whom expired vaccine administered with no reported adverse event for vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received an expired dose of suspect influenza quadrival A-B vaccine, suspension for injection, (strength: not reported) (lot UT7325MA; Expiry date: 30-Jun-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: on same day).  Action taken : not applicable.  Outcome: Unknown.   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.
Developed chest wall pain along with stabbing pain LLLobe that lasted a week before I saw MD.   Had positive Ddimer.  CT chest showed moderate peri-cardial effusion.  Confirmed on echocardiogram.  After seeing cardiologist and rheumatologist there is no answer as to why this occured.  Thats why I thought it should be reported since I am otherwise a very healthy person.
Patient had a Pfizer bivalent injection on 1/19/22. She called the pharmacy the morning of 1/21/22 complaining of a rash that started to develop on the morning of 1/20/22  but was worse on 1/21/22. She had redness and bumpy patches all over her upper right arm near the injection site that extended down to her elbow. She previously had 2 doses of Janssen vaccine in 2021. She had taken Amoxicillin 500mg but had taken amoxicillin in the past with no adverse reactions. She visited the pharmacy around 11:00 am on 1/21/22 to show us her arm, it was still showing signs of redness and blotchy patches, but she stated starting to look better.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Vomiting for multiple days- fine for a week and then vomiting again several times. Sore arm and sweating and chills with vomiting.
I had severe pain and limited mobility in my left arm for at least a week.  When I returned home following the vaccine, I felt extremely ill. I had the chills, sweats, was shaking, and was extremely tired and needed to sleep for most of the day while I was experiencing these symptoms.
Immediately after receiving her vaccination client developed blurry vision and R arm pain. Denied cp/syncope/dizziness. She reported that she had not had breakfast in the AM. She was offered water and her symptoms resolved within 15 minutes of being observed.
This spontaneous report as received from a pharmacist referred to a 65 year old male patient. On 27-FEB-2013 the patient was vaccinated with ZOSTAVAX (dose reported as "just a small amount", Lot#, route and duration were unspecified) in the left arm. Pharmacist stated while administering the vaccine to patient today(27-FEB-2013), the needle came apart and most of the vaccine ran down the patient's arm and some squirted onto the pharmacist too. No adverse effects reported. It was unspecified whether patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information is not expected.
flu like symptom; brain fog; abnormal increase in body temp (felt feverish); worsened chronic fatigue; Right ear hearing strange; sore arm; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), FEELING ABNORMAL (brain fog), HYPOACUSIS (Right ear hearing strange), BODY TEMPERATURE ABNORMAL (abnormal increase in body temp (felt feverish)) and VACCINATION SITE PAIN (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications reported.  The patient's past medical history included Epstein-Barr virus infection (diagnosed with Epstein-Barr virus and never fully recovered (in their words).) in 2002, Postural orthostatic tachycardia syndrome ((hyper adrenergic type)), Ehlers-Danlos syndrome, Sjogren's syndrome (sjogren's syndrome diagnosis), Lupus anticoagulant (Lupis anticoagulant syndrome disorder), Whiplash injury (whiplash following an auto accident) in 2013 and Weight loss (whiplash caused them to experience weight loss.) in 2013.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and PYREXIA (mild fever). On 21-Mar-2021, the patient experienced HYPOACUSIS (Right ear hearing strange). On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom), FEELING ABNORMAL (brain fog), BODY TEMPERATURE ABNORMAL (abnormal increase in body temp (felt feverish)) and FATIGUE (worsened chronic fatigue). On 16-May-2021, VACCINATION SITE PAIN (sore arm) and PYREXIA (mild fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), FEELING ABNORMAL (brain fog), HYPOACUSIS (Right ear hearing strange), BODY TEMPERATURE ABNORMAL (abnormal increase in body temp (felt feverish)) and FATIGUE (worsened chronic fatigue) outcome was unknown.            No concomitant medication provided. No treatment medication provided. after the second dose, the patient experienced a sore arm and a low fever. On 25Mar2021, the patient began to experience worsened chronic fatigue, flu-like symptoms, abnormal increase in body temp (felt feverish), and brain fog. The right ear also was 'hearing strange' on 21May2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up: Lot no and expiration date added On 25-May-2021: FU
pt recv vax 14AUG95&24FEB96 pt devel pink papules which devel into vesicles;lesions were on the inner&outer aspect of the pt's rt arm w/ 1 of rt fingers very swollen;zang test positive for herpes zoster