chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt reportedly devel cellulitis, a hugh white welt in the lower two-thirds of arm 5 days p/vax;pt had not recovered as of the reporting date;
high pitched crying, encephalopathy/encephalitis (brain inflammation), high temp., very sleepy, & sz all occurring w/in 72hr of vax;
Lightheadedness, throbbing headaches, musuclar achiness, tightness in feet, numbing and tingling in left arm where injection was received. Symptoms lasting 3 weeks after vaccine.
Muscle weakness, and nerve issues.  Lost all use of muscles holding in joints. Joints started to pop. Depression started.
Patient took first oral Typhoid on an empty stomach the evening of 3/20/16. Patient states she woke up on 3/22 with nausea, fever of 100.0 F, and diarrhea which she had "2-3" episodes that day, pt reports decreased appetite and occasional diarrhea the rest of the week along with some  "loose stools". Fever only 0n 3/22. No vomiting. Denies rash. Denies other allergic sx's. Patient is currently tolerating food/fluids.
Information has been received from a 23 year old female with pertinent medical history and drug reactions/allergies not reported who on 12-MAR-2007 was vaccinated with Gardasil, 0.5 ml, once. Concomitant medication was not reported. Subsequently, on an unspecified date, the patient experienced a feeling of her throat closing 5 minutes after receiving Gardasil. One hour after the vaccination, the patient "felt like she was having an asthmatic attack with a metallic taste in her mouth" . The patient called the physician's office and was advised to go to the local emergency room. The outcome and causality of the event  was not reported. Additional information has been requested.
02/23/22 presents to Cardiovascular Surgery for "Left Atrial Myxoma Removal". PMHx of "dyslipidemia, carotid artery stenosis and left atrial mass noted on echocardiogram (10/2021)"
p/vax pt exp numbness on rt side of body; p/numbness subsided; rt arm went numb from elbow to shoulder; h/a; hot & w/d flashes, 4-5 days flu symptoms, extreme fatigue, lt arm went numb; tingling remained;
FEVER, CHILLS, BAD HEADACHE-FEVER AND CHILLS LASTED MOST OF THE NIGHT. HEADACHE PERSISTED FOR 2 1/2 DAYS.
This non-valid spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot # N023961; expiry date 01-SEP-2019 (dose, frequency, route of administration were not provided). The Oka/Merck VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in -14 Celsius degrees for 4 minutes. The previous excursion was n -14 1 C for 7 minutes and 55 seconds. Data logger was involved.
Incapacitated; Felt like she had the flu; Thought she was going to die; This frightened her; Unable to walk; Even trying to move around hurt so much that she cried; Even trying to move around hurt so much that she cried; Unable to eat a lot during this time; Feels very weak; Very nauseated; Headache; Very sick; This spontaneous case was received on 16-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-03816) and concerned an 80-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient received a flu vaccine, but never experienced side effects.   On 13-Oct-2020, in the morning, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular; anatomical location: left deltoid) as protection against seasonal influenza. The batch number was not reported. It was confirmed that it was 2020-2021 formulation.  On the same day, after receiving Fluad Quadrivalent, around 3 pm, the patient developed a headache that continued to get worse and worse as the day progressed. By the end of the day the patient was very sick and 'thought she was going to die'. The patient lived alone and that frightened her. She stated it got to the point where she felt like she had the flu, was unable to walk and that even trying to move around hurt so much that she cried and was incapacitated. The patient was very nauseated, unable to eat a lot during this time and also felt very weak. No corrective treatment was applied for events.  At the time of initial reporting on 16-Oct-2020, the patient was recovering from events, as until that date the patient did not see some of these issues started to lessen and she still felt very weak and was still nauseated, but it was not as bad as it was from 13-Oct 2020 to 15-Oct-2020.  The reporter did not provide a causality assessment.  The event of 'disability' and 'flu' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.; Sender's Comments: Disability, influenza, fear of death, fear, gait inability, pain, crying, feeding disorder, asthenia, nausea, headache and malaise were associated with the use of the suspect product - Fluad Quadrivalent. Chronology seems very suggestive and possibly related for influenza, gait inability, pain, feeding disorder, asthenia, nausea, headache and malaise and unrelated for fear of death, fear and crying.
Pt developed fever to 104 approx. 12 hours after vaccines, no other symptom of infection. Had febrile seizure, about 3 minutes duration. Seen at ER, exam normal, CBC and urinalysis normal.
He was not due for this shot - he should have waited till he was 65 to get this shot to start his pneumonia series - no adverse effects. Reported by patient
Patient presented to ED on 10/13/21 from a long term care facility with covid positive status. Patient is fully vaccinated, on hospice care.  Due to failure to thrive, family transitioned the patient to private facility and patient passed on 10/24/21.
Hives/Hives was reported as worsened.; Hives itched; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, Lot/NDC/Expiry: Unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives/Hives was reported as worsened."; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives itched". The event "hives/hives was reported as worsened." was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information:This Nurse reported that they had a patient come in 20Dec2021 who had gotten the second dose of Pfizer Covid-19 Vaccine on 20Nov2021 and 1 week later developed hives which have continued through today. Date of onset of hives: Onset date approximately 1 week after 20Nov2021; he reported hives for 3 weeks as of today and that prior to the last week the hives were intermittent; but event got worse over the last 1 week. The hives were heavy and still present. The onset of the symptoms may vary. Caller indicated hives itched. Caller reported it sounded like the patient had seen his doctor back in withheld a couple of times for this event as well. Second dose completed his prescribe therapy. Caller had no known allergies per his record. Caller reported that the only information she was aware of regarding and treatment or medical interventions performed relative to this event were that he had been given some steroids; hydroxyzine, probably for the itch; and over the counter standard treatment of oatmeal baths and aloe. The patient did not visit the Emergency Room. It was unknown that any prior vaccinations (within 4 weeks) of the suspect vaccine. Patient was not hospitalized for events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12JUL95 & 22APR96 pt exp chickenpox w/300 or more lesions & a fever;pt sister was also given vax & devel chickenpox;
No adverse effects reported; patient received second dose of MMR II series on 5/29/2019 after receiving first dose on 5/10/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 10-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. On 29-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 2, therapy type rHA, lot # R031681 and expiration date: 01-NOV-2020 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). Other suspect therapies included sterile diluent(STERILE DILUENT) lot # N029829 and expiration date 01-MAY-2020 (dose, frequency and route were not provided). No adverse effects reported.
VACCINE MESSED UP/SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine messed up/side effect. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine messed up/side effect was not reported. This report was non-serious.
Itching on the initial day, it was itchy on and off until the day the site was red. 2 days later I had small red bumps but I didn't think anything of it. The next day the bumps spread all over but I thought it was mosquito bites so I didn't do anything. The implantation site started turning purple and then raised. I felt like I couldn't breathe so I went to the ER. I got a neb treatment and BENADRYL. The next night I had trouble breathing so I had to call an ambulance to get me to the hospital. Less than 24 hours later I was back in the hospital having trouble breathing and the area where I got the implantation was worse so they did a CXR.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history was not reported. On 12-MAY-2014 the patient was orally vaccinated with a dose of ROTATEQ (dose, lot#, expiration date not reported). Concomitant medications were not reported. It was reported that the patient spit ROTATEQ up and did not vomit the dose but spit some of it out. The reporting nurse stated that when the patient spit some of the dose out, some of the dose got into the patient's mother's eye. There was no treatment given for the event and none laboratory tests were performed. The outcome of the event was reported as recovering/resolving. This is one of several reports from the same source. Additional information is not expected.
Patient got light headed and fell. Patient stated that she did not eat or drink anything before the vaccine and this is why she got light headed and fell. I had the patient stay in the pharmacy for another 20min to monitor for more symptoms. Patient requested some water to drink, she was informed to just sip on it, she also was given some glucose tablets to help raise her blood sugar. After 20 minutes patient stated she was fine and left. She was told that if she had other serious reactions that she should go to the emergency room immediately.
Did not give Bivalent as the 3rd dose gave regular under5. -No reactions
Patient was given FluAD instead of Fluarix for their age by staff. Patient had no adverse events and patient is also aware of the incident and comprehended well. RPh has reach out to the doctor as well.
Sever Headache, swollen glands, fever, chills, exhaustion, nausea.
gave her cousin cancer and disconnected.; This is a spontaneous report received from a non-contactable Consumer for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "gave her cousin cancer and disconnected". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day post vax, the pt appeared sick. Her eyes were puffy, she was irritable, she didn't want to eat. She became very unsteady. She awoke at 1 am crying and screaming which lasted until 6 am. Definite change of eating, sleeping, and bowel habits. Slight fever of 101.4.
I got COVID-19 from my son.  I felt chills and my eyes felt like they were burning and my forehead was warm.  I took a COVID-19 test and I test positive.  I felt hot and cold at the same time.  I immediately called the doctors office and they called me back within the hour and my doctor prescribed Paxlovid.  She also gave me a lot of information on what to do and what to expect. I began taking the Paxlovid the same day. Still having post-nasal drip.
pt started w/a cough 4MAR99 & began labored breathing;went to peds office & was dx w/croup & given med;T101;sent home overnoc, returned next AM still cough & recv IM med & nebulized saline & 02;pt sent to med ctr, intubated 6MAR99 w/IV atb.
About 24 h after shot, pt notice a low-grade fever (99 degrees) and then a 3in diameter red patch (slightly beneath injection site on the left arm). She reported otherwise feeling fine.
Swelling, redness, pain, blisters. Patient reports most severe symptoms day after injection, pain to the point of not being able to move arm. Gradual improvement over 4 days, but still not completely recovered.
Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3246), via an unspecified route of administration (at the age of 42-years-old) on 21Jan2021 10:00 at a single dose in right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included rosuvastatin calcium (CRESTOR), spironolactone, tacrolimus, and macrogol 3350 (MIRALAX). The patient experienced lip tingling/fizzing on 28Jan2021 19:00 with outcome of recovering. No treatment received for the adverse event. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was considered as non-serious.
Soreness in right arm.    Swollen lymph nodes 5 days later.  Pain in collar bone. Pain down entire right arm. Dizziness.    Chest hurts and making me cough.
Local Reaction/Immunization (left thigh) area 5x5 warm, red, non tender. No pain noted.
Noted that employee had red rash to chest, neck, face, right upper back. Employee describes it as itching. Employee used Benadryl to help with symptoms.
Developed itching around 2-3 p.m. then rash appeared and covered entire body.  5 p.m. having problems with nausea.  Had tried to call family Dr. after closed.  T/C to health department advised of need to go to ER.  6 p.m. chills/fever took ASA and Crotison plus 10 applied to rash.  Awake during the night with itching and feeling bad.  Denied breathing problem.
Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with no urticaria, no respiratory involvement, no intraoral swelling or voice changes, no GI symptoms.  He is warm and well-perfused although is slightly tachycardic but appears anxious.  His reported inability to move her arms and legs does not seem consistent with a neurologic etiology of this complaint and more likely consistent with anxiety/conversion reaction in the setting of a vasovagal episode.  Will give zyrtec at mother and patient's request, PO challenge and reassess.
This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a dose of ROTATEQ injection, route of administration not reported, defaulted to oral (dose, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The doses were administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Moderna COVID?19 Vaccine EUA - redness, firmness and soreness around injection site.
Delayed injection site reaction beginning about 10 days after receiving the vaccine.  A round, red circle  about an inch or so across appeared that's firm and warm to the touch.  So far has persisted for 4 days.
Headache, Myalgia, Fever, Diarrhea,  NauseaVomiting, Chills, sore throat, runny nose, insomnia, pain at injection site Narrative:
she should have started her menstrual cycle on 7/21/2023 and as of today is four days late; varicella titer to be low; This spontaneous report was received from a consumer concerning herself, a 43-year-old female patient, who is no pregnant. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date in 1998, the patient received at least one and maybe two varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (dose, strength, lot #, and expiry date, route were not provided) as prophylaxis.   The patient's health care professional (HCP) performed blood work on an unknown date in June 2023 and found her varicella titer to be low (antibody test negative) and recommended she receive an additional varicella virus vaccine live (Oka/Merck) (VARIVAX). On 20-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered intramuscularly for prophylaxis (dose, strength, lot #, and expiry date were not provided). The patient asked if the vaccine could affect her menstrual cycle. The patient stated she should have started her menstrual cycle on 21-JUL-2023 and as of today (25-JUL-2023) was four days late (menstruation delayed). On an unknown date, the patient received unspecified COVID vaccine. The patient mentioned the COVID vaccine affected her menstrual cycle but did not elaborate on those details. No treatment was given for menstruation delayed. The patient also reported her HCP instructed her to avoid pregnancy for one month (not the 3 months as suggested in PI). At the time of reporting, the patient had not recovered from the event of menstruation delayed, the outcome of the event antibody test negative was unknown. The action taken with varicella virus vaccine live (Oka/Merck) (VARIVAX) regarding events not applicable.   The causal relationship between menstruation delayed, antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Severe Migraine- taken to the ER. Performed CT scan, blood work etc. Given meds to help. Migraine.
her heart was beating fast; she started to feel weak; Back pain; Pain Ankle; Knees Pain; Shoulder Pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she started to feel weak), BACK PAIN (Back pain), HEART RATE INCREASED (her heart was beating fast), ARTHRALGIA (Pain Ankle) and ARTHRALGIA (Knees Pain) in a 75-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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced BACK PAIN (Back pain), ARTHRALGIA (Pain Ankle), ARTHRALGIA (Knees Pain) and ARTHRALGIA (Shoulder Pain). On 27-Mar-2021, the patient experienced ASTHENIA (she started to feel weak) and HEART RATE INCREASED (her heart was beating fast). At the time of the report, ASTHENIA (she started to feel weak), BACK PAIN (Back pain), ARTHRALGIA (Pain Ankle), ARTHRALGIA (Knees Pain) and ARTHRALGIA (Shoulder Pain) outcome was unknown and HEART RATE INCREASED (her heart was beating fast) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Heart rate: high (High) her heart was beating fast which was normal after 10 minutes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.