chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to pharmacy with large red welt in area of subcutaneous administration. She did not state any other adverse effects. Advised OTC diphenhydramine, ICE to area and for her to call MD to report situation as well as to report any worsening of welt or spreading.
pt recv vax & exp a lack of antibody response;prior vax w/MMR occurred when pt was 12mo old;
3-24-21 7:25PM PT 'ITCHING TO BOTH ARMS, BACK AND LT LEG'. SLIGHT REDNESS NOTED.  NO SOB/DYSPNEA, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP WITH EASE.NO ACUTE DISTRESS NOTED. BENADRYL 50MG PO GIVEN. 7:31PM PT STATES SHE IS 'FEELING BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISL AND STEADY.
Started with sinus drainage,  which became constant and intermingled with blood.  Arm was sore,  joint and muscular aches.  Then progressed to persistent productive cough.  No fever during  this time.  These symptoms lasted until 2/15/2021.
patient received an expired ACT-HIB (wtih no reported adverse event); Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who received an expired Haemophilus Type B (Hib) Vaccine (Act-Hib) wtih no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine inact (vaqta) for prophylactic vaccination; and pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination.  On 10-Nov-2023, the patient received 0.5 ml of suspect Haemophilus Type B (Hib) Vaccine (Act-Hib) Powder and solvent for solution for injection (lot number: UJ756AA, Expiry date: 12-Aug-2023) (Diluent, Lot number: unknown, expiry date: 07-Oct-2023) (Strength: Standard) (Frequency: once) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation).   On 10-Nov-2023, the patient received an expired Haemophilus Type B (Hib) Vaccine (wtih no reported adverse event) (expired product administered) (latency: same day).  It was reported, A medical assistant transferred from Customer Service stated that a patient received an expired ACT-HIB. Caller is asking if they should revaccinate.   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 and Regulatory Authority 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.
CLEAR FLUID FILLED RASHES NOTED ON LEFT BACK, SIDE AND ABDOMEN. PATIENT COMPLAIN OF ITCHING AT TIMES.
Immunization given on 4-3-10, turned red, warm on that evening, 4th was the same 5th was given BENADRYL, TYLENOL, 6th and 7th was some better, worse on 8th RAd cephalexin, seen on 9th and very much improved.
nausea; My 8yr has vomited 3 times with only the second dose; these two kids have been sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 10:00 (Lot number: FL8094) at the age of 9 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=FL0007, prev dose administration time=10:00 AM, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 03Jan2022, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "My 8yr has vomited 3 times with only the second dose"; ILLNESS (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "these two kids have been sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, illness.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.Reporter stated both my children (6yr and 8yr) received their Covid-19 vaccines on the same day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200286921 same reporter drug AE different pt
Admitted to hospital on 6/25/2021, positive test 6/26/2021. Fully vaccinated with Moderna COVID vaccine on 3/3/2021 & 2/3/2021
Pt develpoed fever of 103.0 per mom now, 2/04/2011 has developed diffuse rash,
I developed a rash that is very itchy.  along the hairline of my entire face and on my shoulders and upper chest (not on my breasts)
Vomited blood.  At the Emergency room tested for  Covid-19 and pneumonia.  Two blood transfusions and transferred to convalescent care for three weeks.
Pt developed red rash to face about 20 minutes after receiving COVID vaccine. No other anaphylaxis symptoms. MOC said similar to rash she developed last Wednesday. Given Benadryl chewable 12.5 mg x 1 and observed for 10 minutes with HR and pulse ox normal. While re-checking vitals, pt said she felt some slight difficulty breathing and said that it felt like what she "usually has with asthma." Pt is a poor historian. Denied throat swelling, abdominal pain, vomiting, wheezing. Normal pulmonary exam. Rash had resolved at this point. Observed patient for 15 more minutes. On recheck, pt said she felt better without any breathing issues. Rash had completely resolved. Repeat vitals (T, HR, BP, and Sp02) were normal. Pt was cleared for discharge but gave strict ED/return precautions to mother and extensively reviewed anaphylaxis symptoms (increased work of breathing, wheezing, throat swelling, high fevers, persistent vomiting/diarrhea/abdominal pain).
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 25-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) Lot number: J0013315 expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several received from the same reporter. Additional information has been requested.
Mom called 8/30/13 to report thumb print size red spot at site of varicella vaccine on 8/19/13. Did experience fever 1 week ago, but other family member also ill. Also had PCV 13 that day. Spots at injection site resolved on Sunday.
Within a short time my arm was very sore and swollen. By day two I was incontinent, unable to walk without assistance, my head was extremely foggy, eye sight was blurry, needed excessive sleep.
felt like i was going to die; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like i was going to die) in a 62-year-old patient of an unknown 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 FEELING ABNORMAL (felt like i was going to die). At the time of the report, FEELING ABNORMAL (felt like i was going to die) outcome was unknown.            No concomitant medications provided. No treatment details were reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 02-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication ws not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, FATIGUE Narrative:
Dizziness, Headache, pain to injection site, headache, dizziness Narrative: pain to injection site day 1-6; headache and dizziness Day 1; headache Day 2;
swollen right arm, "rock hard", "hot to the touch", from shoulder down to elbow, erythematous, painful to touch. Patient called his PCP on 09/20/21 who told him he had "COVID arm" and advised antihistamine and ibuprofen. He took "generic" antihistamine and ibuprofen, significantly improved within 1.5 days. Still "hot to the touch".
Within a day or two, the inside of my mouth, my tongue, and my lips have become partially numb.; centered on the injection site - some pain,; hives; muscle spasms; This is a spontaneous report received from a Pfizer A contactable consumer (female Patient) reported for herself that a female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient received her 2nd Covid 19 vaccine in mid-February (Feb2021). Within a day or two, the inside of her mouth, her tongue, and her lips had become partially numb. The condition continued. It was reported "Has this be reported as a side effect. Does it resolve." The other effects were all centered on the injection site - some pain, but also hives and muscle spasms. The outcome of the events was unknown.  Information regarding lot/batch number has been requested.
This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA004296, 1411USA009915, 1411USA009918) with the same reporter link. Additional information has been requested.
Initial misuse report received from a healthcare professional on 16 October 2013. The cases were received on 21 March 2014. A patient (no other information was provided regarding the patient) had received FLUZONE on unspecified date. It was reported that patient received 2 doses 10 days apart. No date on administration 2 doses to adults in the same season. No adverse event was reported. List of documents held by sender: none.
nasal congestion, , sinus congestion, head congestion, headache, cough. starting 12/27/21
This spontaneous case reported by a consumer, describes the occurrence of pruritus (feeling itchy) and nasal congestion (feels her nose and throat clogging) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 12, 2021, patient experienced pruritus (feeling itchy) and nasal congestion (feels her nose and throat clogging). At the time of the report, pruritus  (feeling itchy) and nasal congestion (feels her nose and throat clogging) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Client had pain in arm in the evening after shot given.  Took 2 Tylenols before going to bed.  Awoke to fine arm reddened, warm and a little sore.
Pt had a large red knot to come up the day after vaccination. Complaints of itching and hurting. Cold compresses and TYLENOL given.
'tested positive for HPV; This spontaneous report was received from a register pharmacist referring to a 23-year-old female patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  In approximately 2010 (at around 11 years of age on unknown), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administered as routine vaccinations for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknow date in August 2022 (a few weeks ago), the patient was tested positive for human papillomavirus (HPV) confirmed by PAP smear. The patient was 'hysterical'. The present status was not recovered (considered the outcome was not recovered). The causality was not reported.
received COVID vaccination, Pfizer, LOT EL9264 and within 5 minutes of receiving the second dose patient reported lump in throat. Denies pain and no swelling of posterior pharynx upon assessment. BP126/74 HR 103 98% saturation on room air. 25 mg Benadryl administered. patient observed for 30 minutes post vaccination with resolve of all symptoms. Left area with family.
Site: Pain at Injection Site-Mild, Systemic: Headache-Mild
pt recv vax & on 10MAY93 & 11JUN93 transaminase values were elevated (SGPT, alkaline phosphatase, SGPT); No further details were provided;
This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored VAQTA (Lot number, dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
w/in 48 hrs, pt exp an inject site react which included swelling & pain of the entire arm; unk if pt has recovered or if treatment was initiated;
muscle pain; Joint pain; fatigue; fever; Swollen arm; Vaccination site warmth; swollen lymph nodes at my shoulder/neck and armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE WARMTH (Vaccination site warmth), LYMPHADENOPATHY (swollen lymph nodes at my shoulder/neck and armpit), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 80777-0273-15) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information  was reported.  Concurrent medical conditions included Drug allergy (Minocyclin) and Drug allergy (Prozac).    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE WARMTH (Vaccination site warmth), LYMPHADENOPATHY (swollen lymph nodes at my shoulder/neck and armpit) and PYREXIA (fever). On 25-Aug-2021, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). 25-Aug-2021, the patient experienced FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. On 26-Aug-2021, PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE WARMTH (Vaccination site warmth), LYMPHADENOPATHY (swollen lymph nodes at my shoulder/neck and armpit), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), FATIGUE (fatigue) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Relevant concomitant medications were not reported.
I broke out in hives, loss of motor functions. Fell down 10 step stairway. Split head open, back of head and bridge of nose. Later had fever of 106 degrees, then flight to hosp. in ICU for 3-4 days then released on 20th Aug. 14.
By 9:00 AM the day after the vaccine was administered (Friday, 10/18/2013) by my primary care physician, my right arm began to be swell and was painful.  By Tuesday, 10/22/2013, the swelling and pain became very severe.  I called my physician to advise him of these adverse events and he instructed me to immediately go to the ER room of my local hospital.  The ER doctors took my vital signs, performed a CT scan of my right arm, and then performed an aspiration of the fluid in my right arm, guided by a second CT scan. The purpose of aspiration was to culture the fluid and to send it to a lab to determine organism/bacteria type.  The results of the culture would not be known until Thursday, 10/24/2013. In the interim, I was admitted as a patient on Tuesday night (10/22/2013) at approximately 9:00 PM and began a regimen of Azactam, an antibiotic, intravenously at the rate of 1 gram every 8 hours through Thursday, 10/24/2013, by the infectious disease doctor on call at the hospital. On Thursday morning, 10/24/2013, the results of the culture mentioned above were received by the hospital and the diagnosis was cellulitis. I was discharged by the infectious disease doctor on Thursday, 10/24/13 at 1:00 PM and was prescribed an oral antibiotic (Avelox  400 mg) by him to be taken at the rate of one tablet per day for 5 days. The discharge orders indicated that I was to follow-up with my primary physician, within one week of Thursday, 10/24/13.
Approximately 3 weeks after flu vaccine I noticed significant and persistent frothy urine (proteinuria). In the span of several weeks of proteinuria, this led to fluid retention and fluid overload, causing shortness of breath and hospitalization. I was diagnosed with nephrotic syndrome and renal biopsy showed minimal change disease. I was started on high dose steroids six months. I relapsed six months after steroid taper and had to be put on high dose steroid therapy again. There are several case reports showing development of minimal change disease after administration of vaccines, including influenza vaccination.
Pain at injection site and radiating down to fingers Shaking, chills, temperature of 101.1 Body aches( hips, knees, eyes and teeth) Headache Nausea -lasted about 24 hours Enlarged under arm lymph nodes seen in breast MRI
heart rate went up over 100; blood pressure went up to 130/80; palpitation; mild headache; fluid in chest/lungs; injection site was hard; swollen; itchy; red; has gotten really thirsty; running eyes; when she rinses it out, it gets crusty; when she finished eating she gets tired; itching in the ear; sharp muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate went up over 100), BLOOD PRESSURE INCREASED (blood pressure went up to 130/80), PALPITATIONS (palpitation), HEADACHE (mild headache) and CHEST DISCOMFORT (fluid in chest/lungs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included LEVOTHYROXINE, VITAMINS NOS, DIAZEPAM, MAGNESIUM, CALCIUM and AZITHROMYCIN for an unknown indication.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEART RATE INCREASED (heart rate went up over 100), BLOOD PRESSURE INCREASED (blood pressure went up to 130/80), PALPITATIONS (palpitation), HEADACHE (mild headache), CHEST DISCOMFORT (fluid in chest/lungs), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), THIRST (has gotten really thirsty), LACRIMATION INCREASED (running eyes), EYELID MARGIN CRUSTING (when she rinses it out, it gets crusty), FATIGUE (when she finished eating she gets tired), PRURITUS (itching in the ear) and MYALGIA (sharp muscle pain). The patient was treated with SALBUTAMOL SULFATE (PROVENTIL [SALBUTAMOL SULFATE]) for Chest tightness, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (heart rate went up over 100), BLOOD PRESSURE INCREASED (blood pressure went up to 130/80), PALPITATIONS (palpitation), HEADACHE (mild headache), CHEST DISCOMFORT (fluid in chest/lungs), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), THIRST (has gotten really thirsty), LACRIMATION INCREASED (running eyes), EYELID MARGIN CRUSTING (when she rinses it out, it gets crusty), FATIGUE (when she finished eating she gets tired), PRURITUS (itching in the ear) and MYALGIA (sharp muscle pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
mom states that child started w/inc fever & had episode of sz 3hr post vax;paramedics were called;child was stabilized;mom was advised to take child to MD;
Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 22-AUG-2014, the patient was vaccinated with expired PNEUMAVAX23 (dose and lot number were not provided, expiration date 10-AUG-2014). Pharmacist stated the PNEUMOVAX23 did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.