chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guest in post observation for allotted time after receiving 1St first dose of Pfizer.  Guest complained of being dizzy and slumped in chair and then to floor in supine position client did not hit his head.  While on the floor the guest had some posturing movements in upper extremities for what appeared to be a few seconds. Mom states, ?that this has not happened to him before with any shots.?  Once on the floor he cried out and he responded to his name being called by his mother.   At 11:53 R.N.s, responded and started emergency supportive care.  Guest was alert and answering the assessment questions and assessing vital signs was completed as well.  Guest was diaphoretic and pale expressing anxiety about finding himself on the floor. Supported into a sitting position and encouraged to remain on the floor until he was no longer dizzy.  Explained to guest that he was probably experiencing low blood sugar because he and his mother stated that he had not eaten today, and he was hungry when he entered the site.  Juice was offered and accepted- two containers.  Educated guest that the juice was to help elevate blood glucose levels, since he had not eaten this am.   Guest was supported to a sitting position on a chair by R.N.s  11:53 BP 198/88 guest is alert and talking yet pale and diaphoretic. States he is still feeling dizzy, lightheaded and that his stomach was still upset. Cold compress applied to back of the neck and forehead, client conversing and stating that his," stomach is upset."  11:55 BP 160/84 R.N. discussing with guest and mom that having an empty stomach and low blood sugar may cause this response when vaccinated. Mom requesting that 911 be called, and 911 was called Guests was no longer pale and diaphoretic, states,? he felt better,? Mom and guest stated, ?that they were going to go to the food court to get food.?   They were offered an accepted the use of the wheelchair to go to the food court.    Mom voiced concern regarding the usage of 911 and possible expense of this service.   Encouraged to stay and be assessed by EMS before living to go get food.  12:00 Informed that 911 was entering the site. 911 assessed and evaluated and released the guest.   Guest felt better and exited the clinic with use of wheelchair and accompanied with Mother and brother to the food court.
Patient is an exclusively breastfed newborn. He has had rhinovirus symptoms since 9/5 which consisted of minor congestion. That has been the only symptom and never got worse. When I woke him up on the morning of 9/12,  he was very tired and hardly ate. He slept through his next feeding. Around 3:00 he started getting fussy but still would not eat well. His congestion was not any worse than it had been. He remained irritable. I fed him around 7:30. He didn?t eat well again but I put him down to bed after. Around 11:00pm, his heart rate monitor went off because his heart rate spiked. When we got him out of bed, he felt so warm. He had rapid breathing and seemed to be struggling. His under the arm temperature was 100.8 on one arm and 100.9 on the other arm. I called the exchange and they said to bring him to the ER. When I brought him in, they swabbed him and sent blood and urine in. His rectal temperature was 100.8 at the hospital. The only thing that came back positive was for rhinovirus. As I was processing everything, I realized that the progression of symptoms were the exact progression of symptoms I had from the covid vaccine. I asked the ER doctor if that could have any relation and if it could be noted in the file since he had the same symptoms for a whole week and everything else came out of nowhere and so fast. The ER doctor said it absolutely could not have anything to do with that and quickly dismissed me. Prior to talking to the doctor, I mentioned it to the nurse and she said it could be but they don?t have enough research on the effect on a nursing newborn. They gave him Tylenol at 2:00 am. When he was discharged around 3:30 am, he went to bed as soon as we got home. At 10:00am when he woke up and I fed him, his underarm temperature was 98.6 with no other medicine given to him besides at the hospital at 2:00am. He was smiling and back to his normal self with just the minor congestion. He has remained this way ever since. I was disappointed the doctor dismissed it so quickly and did not want to consider it. My pediatrician?s office recommended me reporting it here.
Got shingles shot, a yr later had singles; Had singles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had singles and primary care physician told after ninety days that he or she needed to get shingles shot.  The patient did, a year later he or she had singles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient 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: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101190403 different patient, different event and same drug.
Patient had immediate itching at injection site, swelling of injection site (size of softball), tingling of left arm and hand. Was seen in Health Clinic, given 25mg of BENADRYL PO, cool compresses to injection site. Twenty four hours after injection, still had itching of site.
Patient received IMZ, no reaction at that time. 10 minutes later patient felt dizzy. She sat down in the IMZ booth. After a few moments she stated that she was having an allergic reaction. 25mg dose of BENADRYL was given to patient. About 10 minutes later she thought her throat was swelling. Another 25 mg dose of BENADRYL was given to patient. After another 10 minutes she thought that the reaction was dissipating. Five minutes later she stated that she felt that she was able to leave. She left. At 430pm, she was contacted and she stated that the allergy response was gone.
On the afternoon of 2/5/21 I developed dizziness, right hand numbness/weakness, difficulty speaking while at work. On 2/7/21 and 2/8/21 I noticed difficulty in writing so I called my PCP who ordered a brain/spine MRI for 2/12/21 which showed a right cerebellar subacute infarction, occupational therapy for right hand weakness/writing deficits, mostly resolved (~95% resolved)
Developed severe pain in joints/muscles (shoulders/elbows, hips/knees) Limited mobility with illness. Attending physician diagnosed with PRM Polymyalgia Rheumatica.  No relief with treatment so went to Rheumatologist started on Prednisone 10mg for 30 days with decreasing by 1 mg each month  and Cymbalta 60 mg daily with titration in 12 weeks.  Physical therapy for shoulder due to limited mobility.
Erythema, Hyperemia and edema at injection site R thigh and oral lesion measuring 10x7cm
Patient described pain in both shoulders and rash started (approximately 4 inches in length) at both sights the night of the vaccination. Presented today (6/28) with rash still present on both shoulders but appeared to be improving. Patient was using topical hydrocortisone to help with pain. This was patient first time experiencing reaction.
Clinic course: 13:50 patient given covid vaccine #2-Pfizer.   14:10 patient c/o sob and throat closing.  02 sat 94%.  Epipen 0.15 mg given IM to lt thigh.  02 at 4l/nc started.  14;15 EMS called to transport patient to UTMB ER.  Bp-150/88, p-75. O2 sAT 98% ON O2@4L/NC.  Patient  Has audible wheezing and unable to talk above slight whisper.   14:20 Patient feeling a little better.  Talking in a louder whisper now.  Denies sob.  States throat still feels like throat is opening a little.  02Sat 98% on 02 at 4l/nc. Patient was evaluated by NP-  Employee Health.   14: 25- patient feeling better.  I asked her if she has ever had a reaction needing epi pen before and she stated yes. For allergy shot.  I asked her if she told MA when asked and she stated no as I didn't think  I would be able to get covid vaccine if I said anything about it.  She states no reaction to 1st covid vaccine.  ED Course: is a 68 year old female with CAD s/p PCI, HLD, OSA, seizures, HTN, asthma who presents after anaphylaxis following 2nd dose of COVID-19 vaccine. Chest tightness and original EKG concerning for STEMI, but on review EKG was artifact and did not evolve. Normal sinus the following day with resolution of symptoms. Epipen also improved symptoms which would be inconsistent with ischemia. Patient respiratory status improved on prednisone and breathing treatments. Patient is now stable for discharge.
The following symptoms began approximately 5 hours after injection: fever, extreme fatigue, headache, sore throat, lack of appetite, pain at injection site. These symptoms lasted 48 to 60 hrs post injection. I was unable to work for 1.5 days.  It should be noted that I tested positive for Covid-19 in mid-Nov 2020 and displayed these exact symptoms for 9 days.
Patient stated she had nausea and vomiting after the immunization and also developed a rash on her right hand wrist.
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 13 year old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of of GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020), (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
RN reported that a child who was exposed to wildtype chicken pox devel shingles as a result of exposure to children that were recently vaccinated w/varicella;It wa noted that the MD was not convinced that the varicella vax was the cause
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in 2016, the patient was inadvertently vaccinated with expired M-M-R II, lot # M001200, expiry date 28-AUG-2016, 1 dose, subcutaneously. No adverse effects were reported. Therapy with M-M-R II was continued. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Commercial vaccine Menveo given with State vaccine MENVEO LOT: 3CB9L exp:11/30/2024 NDC :58160-827-03
This is a serious observational study case, initially received on 31-Oct-2018, concerning a 27-year-old, pregnant female, subject. This was the subject's second pregnancy. The subject had a previous pregnancy and no birth defect was reported. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 08-Feb-2018. The gestational age of the subject was 34 weeks. On 04-Apr-2018, 07-May-2018, 27-Aug-2018 and 24-Sep-2018, the subject underwent ultrasound test and no major congenital malformation was noted. On 07-May-2018, the subject underwent first trimester screening test and no major congenital malformation was noted. On 08-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported) (explicitly considered as exposure during pregnancy). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, which suggested large for gestational age, polycystic ovarian syndrome and herpes simplex virus. The subject's estimated date of delivery was reported as 15-Nov-2018. At the time of this report, the outcome of the events was not reported. This case was linked to the original case: 201805222.
ARM PAIN, REDNESS AND SWELLING. "FELT LIKE ARM WAS CUT OFF AND RE-ATTACHED" Narrative:  Other Relevant History:
expired Daptacel administered to patient / no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5307AA via (Expiry date 23-Oct-2019) intramuscular route in the left thigh.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); and HEPATITIS A VACCINE INACT (VAQTA).  It was an actual medication error case due to Expired vaccine used.  At a time of reporting No adverse reaction reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Swollen, red, cool left upper arm 6 x 15 cm, pale in center, itchy to pt. Given Benadryl 25 mg 6 prn #24.
First: I did not willing get the shingles vaccine. They stuck me with the lady that was going after me?s vaccine and then gave me the Covid booster.   Second: Woke up with a burst blood vessel in my eye and pressure behind and around my eye. I?ve never had issues with it before,  and was concerned it was something major.  Went to the doctors where they took my blood pressure and did an eye exam as well as test me for flu and Covid. Everything came back fine. That was Thursday. Today is Monday and I still have the same symptoms.
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
Patient was immunized with Moderna on 12/29. The next day she developed a sensation of tingling and numbness on the lower left side of her face  and left side of her tongue. Her father (a neurologist)  examined her, due to being concerned about the potential for Bells Palsy due to reports of that with the Pfizer vaccine.  No motor findings at all and normal CN exam by her father. She reports that today, 2 days after vaccine, the symptoms are improving.
High fever (104.5); uncontrollable chills; joints from head to toes severe pain( practically could not move); practically could not move; headache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 23Apr2021 at 14:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 02:00, the patient experienced high fever (104.5), uncontrollable chills, joints from head to toes severe pain, practically could not move and headache. On 24Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be high fever of 104.5 (unspecified units). The events did not result in doctor or other health care professional office or clinic visit and emergency room department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high fever (104.5), uncontrollable chills, joints from head to toes severe pain, practically could not move and headache were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
28dec89 pt vax hepta B.  29dec89 pt devel h/a, body aches, and chills.  01jan90 pt devel. pharyngitis, upper respiratory irritation and herpes-like lesions on scalp.  10jan90 pt scalp irritation was desc. as small bumps.   See worm...
Provider d/c note:  "31 YO female with cerebral palsy admitted with nausea and abdominal distention, CT suggesting gastric outlet obstruction.  Resolved with NGT and supportive care.  More indicative of gastroparesis and slow-transit constipation.  Bowels moving, diet advanced without difficulty.  Recent covid test with mild illness only, not requiring treatment at this point.   Problem list: Gastroparesis, slow transit constipation                -avoid further reglan with dystonia               -senna/lactulose - reassess with PCP. Did not respond to Linzess. Hypernatremia, resolved  COVID -Supportive care Cerebral palsy -Mother notes chronic dysphagia, though patient wanting to avoid PEG -home tizanidine -EGD scheduled in 2 weeks "
hot; rash on injection site; red; sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and O11M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore). At the time of the report, INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore) had not resolved.            Action taken with mRNA 1273 in response to event was consider to be non applicable.  No concomitant and no treatment medications were provided.
Narrative: 75yo male died during care at short term rehab facility on 1/16/2022. Pt with renal failure on dialysis. Pt with the following problem list: PROBLEM LAST MOD PROVIDER Renal impairment (ICD-10-CM 08/17/2021 N28.9) LAB REPORT Gout (ICD-10-CM M10.9) 12/14/2015 Raised prostate specific antigen 12/18/2013 (ICD-9-CM 790.93) (ICD-10-CM N18.3); Chronic kidney disease stage 12/14/2015 (ICD-9-CM 366.9); Cataract* (ICD-9-CM 10/13/2009 366.9/366.10) (ICD-10-CM I10.); Benign essential hypertension 12/08/2016 Peripheral Vascular Disease, Unspecified 11/21/2007 (ICD-9-CM 443.9) (ICD-10-CM E11.65); DM- Diabetes mellitus 12/14/2015 (ICD-9-CM 311.); Depression* ((ICD-9-CM 11/15/2006 311./300.4) (ICD-10-CM M16.9); History of osteoarthritis 12/08/2016 (ICD-9-CM 414.9); CAD* (ICD-9CM V45.82); Postsurgical Percutaneous 03/28/2005 Transluminal Coronary Angioplasty Status (ICD-9-CM V45 (ICD-10-CM Z72.0); Tobacco use (CT 08/24/2021); (ICD-9-CM 553.1); Umbilical hernia * (ICD-9-CM 03/28/2005 553.1) (ICD-10-CM E78.5); Hyperlipidemia (CT 08/24/21); Pt had received a covid vaccine on 03/17/2021 (J&J). This death is not related to covid vaccine.