chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 25-MAY-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Due to prior reaction (itchiness, rash) to another formulation of Hep B vaccine, client went to HCP after HEPLISAV was given and took a medication (unknown) to try to prevent reaction. Client stated that at 11:00 am on 6/6/18 (25h after vaccine admin), she started experiencing flushing, hotness, sweatiness, itchiness, and mild airway constriction. Antihistamines decreased these symptoms and she has only been experiencing a "needles and pins" feeling (through 6/7/18 - ongoing). Injection site remains warm and red (about a 40mm circle) today (53 hours after vaccine admin). Client will visit HCP today for exam and recommendations, as our Health Clinic cannot provide this intervention.
2 weeks later had severe left buttock pain (over left ischium/left sacrum), sometimes with associated inability to walk. Continues to bother her to this day. 10/10 pain in the evening, 5/10 pain during the day. Of note, mother had the same reaction 2 days after her 2nd covid shot (given on the same day as this patient)
stomach ache; legs got tight; both my back of my legs got tight; I can't stretch anymore; I do walk, it's hurts to walk and it's feel like my legs are heavy at work; it's like I drag my feet and back of my leg is swollen; knee got swollen both; my left knee, behind my left knee was swollen; back of my leg is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "legs got tight; both my back of my legs got tight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I can't stretch anymore; I do walk, it's hurts to walk and it's feel like my legs are heavy at work; it's like I drag my feet and back of my leg is swollen"; JOINT SWELLING (non-serious), outcome "unknown", described as "knee got swollen both; my left knee, behind my left knee was swollen"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "back of my leg is swollen".  Additional information: The caller mentioned that he took the two vaccine shot and "two booster" shot back in Jul so after he took the vaccine he mentioned that the next day, he got a stomach ache and his knee got swollen both and his legs got tight." When paraphrased the concern: Consumer stated, "Yes. I just talked to my pharmacist and he recommended me calling, he didn't even know I am calling you but he told me to call you on that to talk if have you heard anything like this before." Consumer stated, "I want just you to help me out at the problem like this. Let me tell you that what happen when I took the booster shot back in Jun or Jul. They are part of no records however I had them. They do not give my card, The next morning I woke up my left knee, behind my left knee was swollen and both my back of my legs got tight and It's been like since, I can't stretch anymore, you I try to do exercise I am 35 years old (Further not clarified) and I do walk, it's hurts to walk and it's feel like my legs are heavy at work, it's like I drag my feet and back of my leg is swollen and I am calling you to have you heard this before, it's a coincidence, I don't know the day after I had the booster nothing, when I had first two shot had effected, I had the first two shots and nothing affected me it was the booster shot ,It's kind of co-incidence the next morning, I woke up with this issue. Is this have it anybody else"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12JUN96 & 13JUN96 pt devel red mark around inj site;16JUN96 pt devel few spots;by 19JUN96 pt had devel a rash of 140 papules which were not fluid-filled & which distributed over the entire body;no itching & fever;
Hair loss/Patchy bald spots developed 4/12/2021 went to see my PCP they did labs Went to see dermatologist- they are seeing an increase of patients with hair loss with vaccinated people they told me to use OTC Miniixidill for 6 months and if needed to have PRP done   Positive mammogram - followed up with 2 mammogram and will have to follow up in 6 months
Throwing up 6 am the morning after, nauseous all day, and 101.4 fever at 7pm (fevers are rare for me)
A repot was received from a health care professional on 3OCT2003 concerning a 44 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 3OCT2003. On 3OCT2003, the vaccine inadvertently received 2002 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 2January 2004: Further information was received from a health care professional on 2JAN2004 indicating the vaccinee experienced no adverse reaction. No follow up pending, all information received. Cross reference PJP200300761.
fever to 102.5 w/in 24hr of vax also had coincident OM;
pt recvd vax & devel flu like illness; pain at inject site; local rxn dx; bad HA; fever to 104; to er; admit to hosp; neg meningitis & sepsis; pt had migraine also;
Patient vaccinated with Modera X2 last dose on 5/26/2021, who admitted to the hospital after a positive COVID test.   Provider summary below: "Patient has Chronic respiratory failure with hypoxia (Home oxygen @ 2 L/m) due to COPD (chronic obstructive pulmonary disease) but developed Acute on chronic respiratory failure with hypoxemia with Pneumonia due to COVID-19 virus.  He has now completed a course of steroids (>10 days) and has returned to his respiratory baseline but has Generalized weakness and work with therapies and he was recommended for subacute rehab but there were a number of barriers to placement so as the patient became stronger, he opted to be discharged home.  On admission also had Acute kidney injury superimposed on  Chronic kidney disease (CKD), stage III (moderate) now resolved and have been holding SPIRONOLACTONE, angiotensin receptor blocker, TORSEMIDE, TERAZOSIN as his blood pressure has been lower though has a history of HYPERTENSION, BENIGN ESSENTIAL. At discharge restated the angiotensin receptor blocker but discontinued the other diuretics and the TERAZOSIN.   "
Adverse event: patient inadvertently received Moderna vaccine instead of Pfizer. No adverse reaction/response reported by mother of child.
In adverted administration on 6/16/2021 of a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number K2CJ4, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 16th June 2021, the patient received the 3rd dose of Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The patient inadvertedly received third dose of Shingrix, which led to extra dose administered. The reporter mentioned that, patient forgot that he had already received second dose of Shingrix and failed to tell the Health care professional. No further events were reported. The reporter consented to follow up.
Follow up Report: acute hypoxic respiratory failure / flash pulmonary edema Admission Date: 5/1/2023 Discharge Date: 5/12/2023 Patient enrolled in the Janssen study. Subject received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 Patient presented to study site via hospital transfer with a chief complaint of Shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that subject woke from their sleep and complained of severe shortness of breath on 4/30/2023, It was at that time the patient called EMS and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient was admitted to ICU for shock and he was transiently on pressors.  Both the pressors and ventilator have been weaned off and the patient transferred to the PCU. Given his echocardiogram was concerning for a vegetation, infectious disease was consulted for management of endocarditis. Patient was started on ceftriaxone and Vancomycin and will continue to take IV abx at home for 6 weeks.  On 5/3/2023 TEE confirmed a large highly mobile echodensity attached to the non coronary cusp of the aortic valve.  Additional findings support moderate to severe aortic valve stenosis.  Blood cultures have been negative to date.  Inflammatory markers are elevated including CRP and procalcitonin. 5/5/20203: Cardiology was consulted and patient received interventional cardiology aspiration procedure and a CT head angiogram to rule out bleeding prior to the cardiac procedure. Patient was also found to have bilateral pleural effusion with partial collapse of the right lower on CT abdomen which correlates to his increase oxygen demand 5/4. US thoracentesis drained 1.7L from the left lung. Patient respiratory status improved and no longer require oxygen after the left thoracentesis.  The patient will be sent home with ceftriaxone daily and vancomycin Tuesday Thursday and Saturday after dialysis. Patient will follow up with the Infectious Disease team and their office upon discharge. Patient will be set up with outpatient home health for education on home infusions for his antibiotics. I updated the patient's daughter and patient's wife at the bedside prior to discharge. All medications were reconciled prior to discharge patient is in agreement with the current plan.  Outpatient referral for Urology for his renal lesions that were found incidentally on CT scan. This was communicated to the renal transplant team as well. Patient was assessed as severely malnourished during this hospitalization based upon the ASPEN criteria. Outpatient follow-up: Discharged 5/12/2023 to home health care service. Staff has given causality / relationship assessment as not study related
RTC on 08/07/2001. Redness swelling and heat on RD area. Recommended cool compress and pain reliever. RTC if worsen.
Client states that after first dose, she began having a hight pitched noise in her ears that pulsed along with her heartbeat. States she postponed 2nd dose d/t sx. Received 2nd dose on 7-30-21 and states symptoms worsened and have remained present since then.
itching like a bug bite around the injection site; mild red ring about 2cm x 3cm around injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Small Pulmonary Embolism; blood clots in upper arm, arm pit, neck, across right side of chest; Opposite arm blew up like a baloon; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Small Pulmonary Embolism) and THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PULMONARY EMBOLISM (Small Pulmonary Embolism) (seriousness criteria medically significant and life threatening), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) (seriousness criteria medically significant and life threatening) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon). At the time of the report, PULMONARY EMBOLISM (Small Pulmonary Embolism), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  Treatment medications for the events included Xarelto (rivaroxaban).  Reporter states patient went to Urgent Care on 22-Apr-2021 due to the events and was then told to go to the Emergency Room.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen lymph in right neck throat; painful and difficult to swallow.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6205), via unspecified route of administration in the right arm, on 05Mar2021 at 09:00 AM, as a single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications included Ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol and vitamin B not otherwise specified (MULTIPLE VITAMINS), Saw Palmetto 320,NSK-SD 100 mg. The patient was allergic to Shell fish. On 06Mar2021 at 10:00 AM, the patient experienced Swollen lymph in right neck throat making it painful and difficult to swallow. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
reported to PCP office 2/5/2021 c/o bodyaches, cough, fever, congestion, flu test negative, COVID IgG positive 2-5-2021, pt recieved Bamlanivimab 700mg IV infusion on 2-5-2021 at the Hospital for symptom control. has home oxygen 4lpm nc but admits to not wearing it as she should, sob on exertion on presentation to MH
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow up information has been received from the nurse on 10-NOV-2014. The nurse reported that an additional excursion has affected the same doses of GARDASIL (lot#J006850, exp 31-MAR-2016) and of ROTATEQ (capture in MARRS # 1411USA003388), and multiple patients have been administered red both products. No adverse effects reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Left arm, back and chest pain, swollen lymph nodes the next morning following vaccine. Progressive pain, arm and hand , fingers numbness. Continued for 7 months
Level 4: A level 3 reaction & increase LOS. Increased LOS til the evening of the same day vaccine was administered. Dermatologic (swelling).
Resident has received 2 pfizer covid vaccines (3/20/21 and 4/6/21) and a booster (10/26/21).  Then during the Moderna Booster clinic, on 12/2/21, resident also received a Moderna booster dose.  She had no adverse reactions.
sore throat, malaise, light fever, fatigue Sleep longer and deeper overnight, and fell into a 1.5 hour nap at lunch today (24h after vaccine)
Pt did not devel "protective titers" p/3 injects of Engerix-B; "plan to revaccinate" pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if person contracts Hepatitis";
This spontaneous report as received from a consumer mother refers to a 15 year old female patient with no pertinent history or drug reactions/allergies who about a month and a half ago (approximately in November 2012) was vaccinated with GARDASIL (product circular: 9883616). No other co-suspects were reported. No concomitant medications were reported. Within the month (approximately in December 2012), the patient started drastically losing her hair. The patient's mother consulted the physician and subsequently scheduled appointments with a specialist (unspecified) to determine a diagnosis. At the time of reporting, the patient's condition has not improved. The relatedness for the event was unknown for GARDASIL. Additional information has been requested
Participant has MS, feels that her MS has worsened and thyroids. 102.6 fever after 2nd dose-February 2021. Sick for 36 hours after 2nd vaccine, extreme sickness.
Varicella vaccine (R) upper arm now with redness, swelling, itching, blistering at site of injection.
ADMINISTRATION ERROR:  Sister went to visit him and found out that they had given him the vaccine which actually was his 3rd dose, which the facility did not find.  She brought it to their attention, they then checked his records and then determined that he had already had 2 vaccines, and the system showed the dates and information regarding the other two vaccines.   She informed the girl from the unit last night, who called somebody else a gentleman who said that they asked patient and he said that he wanted the vaccine.    As far as she could tell he was not having any reaction and seemed okay, and acted normally.  He had told her that he got  a shot and then she followed up and found out what he had gotten.  She called the head nurse who said she didn't know anything about it and that she would call her back.     1st dose:  1/25/21, 2nd dose:  2/22/21  Mental Health Facility, 3rd dose:  4/20/21.
Patient was administered 1.3ml IM of Pfizer Covid vaccine on 10/16/21 around 1000.  Error was discovered at 1100, in which the family was notified of the error. Follow up was conducted on 10/17/21 in which family reported high fever and "not feeling well and had a rough night".  No further information was given by family to provider.
Approx. 12 hours after shot....pain, redness, swelling  at injection site. Lasted 3 days. Developed redness with warm to touch on skin about two inches below  injection site two days after shot-lasted about three days.  12 hours after shot, chills lasting about three hours with fever (101). Temp up and down with ibuprofen for about 12 hours. Continued to have higher than normal temp-not fever- for four days.  Extreme fatigue from 12  hours after shot lasting about three days.  One week after shot, all side effects have stopped except slight fatigue. Did not seek medical attention-nothing was severe enough for that.