chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had whole body erythema,severe burning sensation,no frank urticaria. Also,intense ocular burning sensation. Reaction resolved w/benedryl. Had severe headache, resolved after 1 to 2 hrs.
Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned.  I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg.  I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot.  By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.
Administered Moderna monvalent covid booster on 9/1/2022 after the monovalent had been discontinued
Followng 1st dose of vax developed h/a, low grade fever & migratory arthralgia; Same sx recurred two wks p/2nd dose;
Information has been received from health professionals via the published abstract as titled above concerning a 4 year old male with chromosomal deletion of 11q23.1, and clinical features of Jacobsen syndrome including dysmorphic craniofacial features, developmental delay, and short stature with a low insulin-like growth factor-1 (IGF-1). Previous history was significant for asthma, allergic rhinitis, atopic dermatitis, and severe food allergies. The patient also had recurrent otitis media and persistent sinopulmonary infections, requiring frequent and prolonged courses of antibiotics. On an unspecified date, the child was vaccinated with Pneumovax 23 (lot # not reported). Concomitant therapy was not specified. On an unspecified date, the child experienced severe pneumonia requiring intubation for acute respiratory distress. During this hospitalization, he developed anemia and thrombocytopenia. Immune evaluation revealed low total IgG, with deficiencies in IgG1, IgG2, and IgG4 subclasses. IgA, IgM levels, and B cell numbers were low for age, and pneumococcal antibody titers were non-responsive despite previous vaccination. Treatment with intravenous immunoglobulin (IVIG) during and post hospitalization, led to normalization of immunoglobulin levels and clinical improvement. The authors concluded: "Although recurrent otitis media and sinusitis is common in Jacobsen syndrome, there have been no reports to our knowledge of combined variable immunodeficiency (CVID) or life threatening infection associated with this disorder. Immune evaluation should be considered for patients with Jacobsen syndrome who present with severe or recurrent infections." No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
9JUL05 pt recv vax & was limp, flushed, & warm; eyes in and out of focus; sent to clinic; 7JUL95 450PM immed care pt went into sz-could not be controlled;
An hour after receiving the shot, my arm felt like I had been punched in it. Later that evening,  the injection site begin to swell and. turned red. By the next morning, it begins itching  It is lumpy, red, swollen and itchy still today (4/10/21). A full week later.  My  entire left arm feels achy like I slept on it wrong but I didn"t.  The skin  at the injection site  has darkened and the itching is maddening.
Case number PHEH2012US009206 is an initial spontaneous report received from a nurse on 27 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 27 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: M10126A) intramuscularly on to unspecified site an did not receive the MenCYW-135 liquid conjugate. No adverse reaction was reported following the maladministration.
pt was given vax approx 1-2min p/vax had a syncopal episode & became rigid, legs were twitching;pt stared straight ahead w/eyes fixed;total episode lasted 30seconds;then became conscious, alert & oriented & diaphoretic BP 108/60, R24, P60
Patient was mistakenly given a 0.25ml dose instead of the 0.5ml dose indicated.
Lingering Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Lingering Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Lingering Headache). At the time of the report, HEADACHE (Lingering Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 25-Apr-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information include Painkillers with a sleep aid for treatment of sore arm.  No concomitant medication reported
Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which started 3 days after receive Johnson and Johnson COVID vaccine.  She denies swelling or any other associated symptoms.  I ordered Venous Duplex which was done today and revealed b/l femoral DVT.  Patient immediately started on Eliquis .
redness, noticeable swelling, itching, warm, no pain  - started within 24 hrs, still occurring.  Recommended benedryl
Headache, Myalgia, Fever,  fatigue, chills Narrative:  Fever up to 101F, headache, chills, body aches, almost felt  delusional. Side effects are resolving, but still having head fogginess. Took  OTC pain reliever and used ice for her head, was able to sleep afterwards.
Administration / with a diluent other than the GSK supplied; Administration / with a diluent other than the GSK supplied; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA440A, expiry date 31st March 2022) for prophylaxis.   On 9th August 2021, the patient received Menveo. On 9th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: Registered nurse reported that the patient was administered with a diluent other than the GlaxoSmithKline supplied diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Reporter consented to follow-up.
This spontaneous report as received from the patient's mother, concerning her child of unknown age and gender. On an unknown date the patient ws vaccinated with a dose of M-M-R II (lot #, dose, and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serious side effects after receiving M-M-R II. The patient had severe hives and shortness of breath. The outcome of severe hives and shortness of breath was unknown. This is one of several reports received from the same reporter: MARRS 1407USA000508 and MARRS 1407USA000434. Additional information is not expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided         This case included information of patient 88th out of 100 patients.  No concomitant medication was provided by reporter.   No treatment medication was provided by reporter.
Patient 's family member called for help reported feels nauseated. A bucket was provided, patient puked on it about 100ml of fluid and undigested food. Pt reports severe nausea, has pale appearance. She is moved to a private area. BP 154/105, pulse 78, pulse ox is 98. Patient reports not having taken BP medication. Family member collects medications, after 40min arrives and delivers 40mg of lisinopril. Patient has had water and reports feeling much better before departure.
A medical technician reported that a 62 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 11/13/00. On 11/15/00, the pt developed an injection site reaction characterized by redness and swelling.
Prior administration of the vaccine; patient had mentioned that he was afraid of needle injection. 5 minutes after administration of vaccine, patient went to sit down at the waiting bench for observation. He stated he felt light headed; tingling sensation on the injected left arm; he dropped his cell phone on the floor, and then passed out flat on his tummy on the floor for about 5 second.  Nearby stander fire fighter responded right away. Pharmacist activated emergency respond with patient's stepmom approval. Patient was well alerted, oriented, and ventilating well after the event. Patient stated that he may have bitten his lips. However, no injuries noted at the time of the incident. Patient father cancelled the emergency respond. Patient's father (who is an endodontist)  stated that his son would be okay, and he would not want to seek for Emergency Medical help. Pharmacist asked to observe patient for additional 30 minutes; however, stepmom said they were okay and left the pharmacy area at 2:25PM.
Dizziness c/o feeling warm and flushed. Felt dizzy while getting into recliner. monitor 15 min. Resolved. Narrative:  2nd dose given. C/o feeling warm and flushed. 183/73, 63, O2sat 100%. Felt "dizzy" when transferring to the recliner. no loc. VS monitored: 159/71, 60; After 15 min: 138/64, 60 and asymptomatic and no c/o
pain under her ribs in L side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain under her ribs in L side) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain under her ribs in L side). At the time of the report, PAIN (pain under her ribs in L side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
NO ADVERSE EVENTS REPORTED. MODERNA BOOSTER DOSE 0.25ML GIVEN INSTEAD OF 0.5ML DOSE.
This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been adminsitered to patients. The first set of vaccines were RECOMBIVAX HB, Meningococcal Protein Conjugate and COMVAX, GARDASIL, ROTATEQ which were exposed to 30F to 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were Meningococcal Protein Conjugate and COMVAX and GARDASIL which were exposed to 30F for 221 hours adn 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007004, 1406USA007005, 1406USA007006). Additional information has been requested.
Patient is fully vaccinated. Admission:  COVID and transient ischemic attack. 55-year-old female presents with right arm weakness in the context of a COVID infection the week prior to presentation. CT head was negative, vascular Doppler showed no significant stenosis, EKG did not reveal any atrial fibrillation.BP 141/63  | Pulse 61  | Temp 97 °F (36.1 °C) (Axillary)  | Resp 16  | Ht 172.7 cm (5' 8")  | Wt 93 kg (205 lb)  | SpO2 99%  | BMI 31.17 kg/m²  Patient was started on aspirin and high intensity statin. Patient was seen by neurology. Patient was stable from a neurological standpoint. Discharged
Within 10 minutes of receiving vaccine, patient reported dizziness, headache, SOB, & "hard to swallow," light-headed, was diaphoretic. Was seen in ED, given oral Benadryl, Epinephrine, Zofran.  Monitored in the ED for 5/12 hours, then discharged to home.
Over 3 weeks, patient/mother noted dimpling over (Lt) thigh injection site measures 3 cm in diameter. No pain referred to plastic surgeon for consult. We will also refer to peds/derm. (Mother defers additional referrals)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 06Jan2020; LITHIUM, start date: 09Nov2020; OMEPRAZOLE, start date: 04Apr2022; TYLENOL, start date: 02May2022 were other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (12May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Symptomatic Rebound positive antigen test after 5 days after concluding Paxlovid and 6 days after first negative antigen test.  Follow-up attempts are completed. No further information is expected.
Skin rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin rash). At the time of the report, RASH (Skin rash) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 27-MAY-2021 contains non-significant information.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient received an improperly stored dose of M-M-R II (lot # N002337, expiry date: 20-JAN-2019) for prophylaxis which was reconstituted with a properly stored sterile diluent (STERILE DILUENT) (lot # N013282, expiry date: 23-AUG-2019). The temperature excursion ranged between 32 degrees Fahrenheit (°F) to 35°F (35.4F) on an unknown date for a time frame of 2 minutes. There was a previous temperature excursion which ranged 32°F to 35°F (35.2 F) for 11 minutes and 47°F to 77°F (51.9F) for 17 minutes. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1803USA004145: US-009507513-1803USA002996:
Information has been received from a literature article concerning an unidentified previously healthy male patient who was vaccinated with a dose of varicella virus vaccine live. "Five months after receipt of varicella vaccine the patient's 3 year old brother (WAES # 00080565) who was otherwise normal was noted to have thoracic zoster." Fourteen days after his brother developed thoracic zoster, the patient who had been immunized the same time as his brother was, developed a mild case of varicella. On the second day of his illness, he was observed to have 50 vesicular lesions in a generalized distribution on the trunk and scalp. He was playful and did not seem to be very ill. It was indicated that the patient's "mother had not had varicella during pregnancy" and the patient had "no known exposure to varicella except for contact three days before their immunization with a child who had the onset of rash three days later." Virus isolated from the patient was analyzed via polymerase  chain reaction and identified as "vaccine type." Subsequently the patient's experience was reported in a published literature article. It was reported that the patient developed a mild varicella-like rash from which vaccine strain varicella virus was isolated. This is an amended report. The event of secondary transmission was removed as the patient was vaccinated with VARIVAX and therefore the report does not meet the definition of "secondary transmission". No further information is expected.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Pt. had Hgb checked in room-then was administered MCV4 and HPV vaccines. Shortly after rcving vaccines was talking-then fainted fell off exam table and fell onto floor hitting her head. LOC-20 sec. 911 called. Sent to ER-DC'ed after CAT scan.
Patient is former 31 week premie with chronic lung disease and still on O2. Had 2 month DTaP, IPV, Comvax and Prevnar. Developed ALTE (acute life threatening event) shortly after vaccines and several time subsequent. Work up showed silent tracheal aspiration.  Nurse follow up on 07/30/04 states: "constipation; apnea."
My right and left arms had a blistering rash developing.  During the day, more blisters arose on my fingers, hands, my neck, back and face.
3 1/2 x 4" swollen, warm to touch red area rt arm itches now - woke up during middle of night due to pain in area.
The patient received Yellow Fever vaccine on 6/25/2018. Varicella vaccine administered today. As of right now, no known adverse reaction.
sharp pain in my right upper arm; coated tongue; bad taste; coated mouth; coated throat; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient stated that 'I had the 1st Pfizer vaccine. After the Pfizer vaccine I felt ok. Later in the day I experienced sharp pain in my right upper arm. Saturday morning I woke up with a coated tongue and coated mouth and coated throat and this bad taste and sharp pain in my right arm Sunday morning and Monday I woke up with a coated tongue and coated mouth and coated throat and this bad taste with sharp pain my upper right arm.'' This outcome of events was unknown.  Information on the lot/batch number has been requested.
After three years of menopause, the month after the vaccine I experience several PMS symptoms, including very swollen and tender breasts, body aches, and fatigue. 5 weeks after the shot, I am bleeding as if menstrating.
Patient was nauseous and vomited immediately after vaccination. Has a history of anxiety related to vaccines.
AUGMENTIN (600/S) 8ml PO BID for ten days area of erythema 4"x3".
Headache, Arthralgia,  FATIGUE Narrative:  Other Relevant History: