chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Injection site itching; Injection site pain; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness). In 2022, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of pain, red, itching at injection site for booster dose had worst reaction with Humira ( Adalinumab) was a reasonable possibility. The reporter's causality for the event of FLU LIKE SYMPTOMS was not provided.
Redness/swelling at the injection site w/ temp 101.8. No aching.
pt presented to clinic today w/redness, swelling & warm to touch in the lt upper arm;pt recv vax 20MAy96;no other complaints;mom says swelling has resolved somewhat
Patient had a syncopal episode within 10 minutes of the administration of the vaccine.  He fell off of the examining room table and hit his head causing lacerations that required suturing and possibly a concussion.
11:13 HPV injection given (L) deltoid. 11:14 c/o n/v, syncope episode, BP 88/50 HR 40. 11:15 Dr at bedside. Trendelenberg pos. BP 85/44 HR 50 SpO2 98% RA. 11:18 Epipen injection (R) thigh. 11:20 HR 102 BP 128/71. 11:25 Ambulance here, transported to medical center.
8-9 cm diameter read in to right deltoid Pt on Cefzil 250/5 100cc m Tsp BID, red, swollen at site.
About an hour after getting the shot I started not feeling to good. I ended up with a headache, shortness of breath, and swollen glands. I tried to wait it out but it continued to get worse so I went to the emergency room and was admitted.
This spontaneous report as received from a physician via company representative refers to 7 year old female patient. No relevant medical history was reported. Drug reactions or allergies were reported as none. On an unknown date when the patient was one year old, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, frequency and anatomical location: not reported, (lot #, exp date: unknown). The patient also received second dose of (Oka/Merck) VARIVAX (lot number not reported) on an unknown date for prevention of chicken pox. Concomitant medications were reported as none. It was reported that the patient woke on 08-JUL-2014 with chicken pox, diarrhea, fatigue and low grade fever after receiving (Oka/Merck) VARIVAX vaccine. No laboratory diagnostic studies were performed. The patients sought medical attention (office visit on unspecified dates). The outcome of fatigue, low grade fever, chicken pox and diarrhea was unknown. Causality of the events fatigue, low grade fever, chicken pox and diarrhea and (Oka/Merck) VARIVAX was not reported. Follow up information was received from medical assistant. The medical assistant had no information on recovery of the patient. The patient never called to office with any health difficulties following office visit on 08-JUL-2014. The treatment was just palliative, no prescription was given. The medical assistant had no information on severity or duration of breakouts. Additional information has been requested.
she was really cold/right calf is cold to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 08:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset Mar2021, outcome "not recovered", described as "she was really cold/right calf is cold to touch". Additional information: The patient had her vaccine at 8:30 on morning of day of reporting. The patient did not really have any reaction when she was there. When she got back to work, she was really cold. That went away except on her right calf. Her right calf was cold to touch. There was no rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "He said that his son got a blood disorder from Pfizer Covid 19 vaccine". Additional information: The reporter called on behalf of his son. He told that he wants to file a lawsuit against Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Admitted to hospital with shortess of breath, cough, diarrhea, nausea, vomiting. While admitted increase in oxygen demands
Information has been received from a physician and the office manager concerning a 58 day old female patient who on 24-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
headache; fatigue; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose unknown via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was unknown if covid prior vaccination and covid tested post vaccination. The patient experienced headache and fatigue on an unspecified date. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Localized area of erythema and swell induration at injection site (Lt) upper thigh. No blistering problem no lips swollen. Size = 2x3 cm.
I started to have trouble breathing at 16 minutes after vaccination and my throat tight and lips funny sensation. I was observed by nurse for another 20 minutes after given benadryl by mouth. I left van drove home and I increasing worse breathing. Later in early evening was very tired which unusual for me and was achy feeling and went to bed. Middle of night awoke in extreme pain all through arm's and leg's and by morning was not able to step down on my feet as bottom of feet were so much pain that any pressure to walk not possible. I then got a bad headache and neck pains. I felt like tons of trucks have run me over and over. I then got a bad burning fire pain in left elbow above wrist and at shoulder. I ran fever of 101.2 for a time and went down with Tylenol then back up. I was very sick not able to step down on feet and honestly not able to get up out of bed for close to a week. I then called my PCP and went to office one of 3 visits in about month and half.
Swelling at site of injection with a very hard knot under the skin.  Extremely tender to the touch and hot to touch.  Increased tiredness. Interfered with sleep - could not lay on that side.  Did not need medical attention.
Moderna vaccine given outside of recommended age range.  Child felt feverish the next day only per mom.
"5mins post vaccination, pt c/o left leg numbness.  Pt was at a hospital earlier that morning (8am) for anxiety, not overnight.  No medication given during visit.  Per pt, he was told that he was dehydrated.  Vitals: @10:15 BP 174/64, HR 79, RR 16 -- > @10:24 138/67, 71, 16, 100% RA. Pt stable and released from the vaccination site. PMH: Asthma and Anxiety Medications:  albuterol 2inh Q4hrs PRN wheezing Sertraline 100mp PO Daily"
2yo vaccinated with Rubella vax in approx DEC90; FEB91 was hospitalized & dx w/acute myelocytic leukemia.
Patient came into Pharmacy on 12-10-2018 and while here mentioned that she may have had a reaction to the high dose flu vaccine received on 11-20-2018 and just thought she would mention to us. She states that the day after the injection she had a hard lump at injection site and was red and sore. She states that the redness and lump resolved after about a week and was replaced with a sore that has not healed as of the reporting of this event today. She pulled up sleeve showing a scabbed over spot on her left upper arm and says that she is sure that this was the injection site.
Child received vaccine (Menactra and Boostrix) On 1/2/08-diagnosed with Guillain-Barre. On 1/18/08 at med ctr child is in PICU presently.  2/5/08 Reviewed hospital medical records which reveal patient experienced over prior 6 days back neck & leg pain, stiffness, nausea, intermittent abdominal pain, emesis, decreased appetite, decreased activity, fatigue, excess sleepiness, 5# wt loss.  Admitted1/18-1/26/2008.  Neuro, ICU, ID consult done.  Developed left facial paralysis.  LP done.  Transferred to PICU.  IVIG x 5 days.  Improved dramatically & facial paralysis resolved w/IVIG & PT.  D/C to home w/ outpatient PT & neuro f/u. FINAL DX: Guillain-Barre.
No adverse event; Oral Herpes improved for a period of 6 months after each Moderna shot.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084L21A, 004F21A, 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Oral herpes.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Oral Herpes improved for a period of 6 months after each Moderna shot.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information was reported.  It was reported that patient was trying to get Bivalent Moderna COVID-19 booster vaccine.  No treatment information was provided.
I don't have all the info you want, but my Mother In Law, who resides at this senior assisted living center,  had falls the day after her Moderna first and Moderna 2nd vaccine.  Each landed her in the ER, suspected fainting episode.  Lots of testing done, bruised eye and forhead each time.  It may be noteworthy to report that she contracted covid 19 dec 30, about 3 wks prior to the first dose of vaccine.
This spontaneous report was received from a 74 years old male patient who was a physician and reporting on himself. The patient's concurrent condition included hypertension. The patient's historical condition included stent placement. Any drug reactions or allergies were not reported. On 28-Sep-2017, approximately in September 2017, reported as "Unspecified date 6 days ago", at an unspecified pharmacy, the patient was vaccinated with ZOSTAVAX for prophylaxis, reported as "prevention of shingles" (dosage, route of administration, lot#, expiration date were unknown). Other suspect therapies included sterile diluent for unknown indication (dosage, route of administration, lot #, expiration date were unknown). Concomitant therapies included TAMIFLU, CRESTOR, sodium (unspecified) and PERCOCET. On 02-OCT-2017, the patient experienced feeling abnormal, blood pressure decreased, myalgia and lethargy. The patient received treatment due to the adverse events (also reported as received unspecified doses of TAMIFLU and PERCOCET on unspecified dates. No diagnostic tests were performed. The outcome of feeling abnormal, blood pressure decreased, myalgia and lethargy was reported as recovering/resolving, reported as "feeling much better today". Relatedness between the events and ZOSTAVAX and sterile diluent was not reported.
swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 26Jan2021 10:00 (Batch: EJ1685; Lot Number: EL3248; expiry: not reported) as single dose for covid-19 immunisation at hospital (at the age of 40 years). Medical history was none. The patient concomitant medications were not reported. No predisposing factor and no culture performed and no antipyretic use (around the date of Vaccination). On 26Jan2021 10:00, the patient experienced swelling of lip occurred after second dose. The patient also stated that the no action was taken for adverse event (no therapeutic measures were done) and reaction recurred on re-administration of product. The outcome of event was unknown.  Pfizer product had a causal effect to the adverse event (Causal Relationship): Yes
Within 24 hrs ;  raised  red  welt  , hot to touch, sore to touch@ injection site approximately 4 inch diameter , overall weakness,   Nausea, vomiting for next 8-24hours  Exacerbated ms symptoms , lost use of rt leg  could not transfer, was bedridden for 3 days.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with improperly stored GARDASIL (lot # K005083, expiration date: 04-NOV-2016), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS #1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004958 and 1501USA004960). Additional information has been requested.
rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of Shingrix and experienced rash on the leg that resolved about 10 to 20 hours later.
Evening of vaccination had nausea, headache, axillary lymphadenopathy/tenderness. Next day had spontaneous rash on lower arm of vaccinated arm, blotchy, not raised, not itchy, blanching.
CLIET SEATED FOR IMM. NO HX OF VACCINE REQ. FOR SCHOOL. AFTER BECAME PALE WITHOUT C/O. ADMITTED TO LIGHT HEADEDNESS WHEN ASKED. NO DIAPHORESIS, LOC, CHANGE IN EYE. HELPED TO EXAM TABLE. DECREASED AOB & INCREASED FOB. 144PM - 90/60. 1:50PM 100/70. P 80. NO FURTHER LIGHTHEADEDNESS OR COLOR CHANGE. TOLERATED SITTING THEN STANDING/WALKING WITHOUGH ANY S/S. DISCUSSED FUTURE IMM & POS. ETC.
The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, heart was beating harder and faster, stomach felt upset, she was burping a lot Feb 8th went to primary care doctor. BP was 175/90. She felt dizzy and lightheaded, ringing in ears was louder than usual She gave another BP med to take, but she didn't take it. Instead took an extra of hr own propranolol. Yesterday was the first day the sxs were better. Other than taking the extra propranolol on Feb 8th, she just rested 2/11/21  is the first day the tiredness has let up
pt recv vax 6OCT95 & LMP 11SEP95 & it was determined that pt was pregnant @ time of vax;an ultrasound was performed during pregnancy (results not reported);@ 31 wk pt exp pre-term labor tx terbutaline;pt delivered early child nl;
experienced pure pain in both of her arms, pain in hand; cannot exercise; she has been hurting, painful, experienced pain; Uncomfortable; cold; pain comes down in the muscle to across her back; soreness, muscle pain, soreness is never ending, soreness goes and comes back.; pain comes down in the muscle to across her shoulder; Patient received the second dose 22 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable) and NASOPHARYNGITIS (cold) in an 80-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.     Concurrent medical conditions included Eye disorder NOS. Concomitant products included LATANOPROST for Eye disorder NOS, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, 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 experienced PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.), ARTHRALGIA (pain comes down in the muscle to across her shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand) had not resolved, EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.) and ARTHRALGIA (pain comes down in the muscle to across her shoulder) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose) had resolved.            Treatment information was not provided for all the other events.   This case was linked to MOD-2021-296304 (Patient Link).
3 days after receiving Pfizer COVID-19 vaccine patient experienced a syncopal episode while at school.
65-year-old male who has a complicated past medical history of diverticular abscess with small bowel obstruction requiring diverting ileostomy who had been at a nursing home  rehabilitation center with multiple readmissions for various complaints. He was back at rehabilitation for  rehab and was diagnosed with COVlD 7 to 10 days prior to presentation to ED. He has reported he had  a decrease in appetite and overall generalized weakness. He was noted to have some hypoxia with  exertion. He was sent to the emergency room for further evaluation and care. BUN was 37. Creatinine  was 2.3. COVID PCR was felt positive. CT abdomen and pelvis revealed multifocal pneumonia, but  otherwise no acute findings. He was admitted to the hospitalist team, placed on supportive care for  his COVID-19 pneumonia. Wound Care was consulted for his chronic wound issues. Shortly after being  admitted, he was started on antibiotics as there was some concern he had superimposed bacterial  infection. He started refusing medications and treatment and started to rapidly decline. Case was  discussed with his POA. He was changed to DNR on the 01/23/2022. Patient had  progressively worsened.
Mother reported that the child got a single welt at administration site and few hours later it expanded as hives through the whole body.
This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 19-MAY-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, patient route of administration not reported) and PROQUAD (Merck) (lot#, expiration date, dose, patient route of administration not reported). No concomitant medications were reported. No adverse effects noted. Additional information has been requested.