chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feverish; hot flashes; arm and leg pain; period started the next day (though it wasnt due for a week); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EC6818) via an unspecified route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 01Apr2021 at 12:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Apr2021 at 02:00, the patient felt feverish, hot flashes, arm and leg pain and period started the next day (though it wasn't due for a week). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feverish, hot flashes, arm and leg pain and period started the next day (though it wasn't due for a week) were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Small bubble formed 1 inch passed the injection site; Some of it may have been injected subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously) and VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006H20A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously). On an unknown date, the patient experienced VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site). On 12-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously) had resolved. At the time of the report, VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # 006H20A with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # 006H20A with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009326: US-009507513-2001USA009327: US-009507513-2001USA009325: US-009507513-2001USA009328: US-009507513-2001USA009324:
Some patients received the vaccines without the powder portion.; Some patients received the vaccines without the powder portion.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a n unknown number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMXA440A, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that some patients received Menveo vaccines without the powder portion. They believe that there were three patients that received a partial dose of Menveo but they were not sure. The reporter consented to follow up by email. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Soreness at injection site (4 on pain scale 1-10); body aches (3-4 on pain scale); sore throat (2 on pain scale); nausea (occasional); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site (4 on pain scale 1-10)"; PAIN (non-serious), outcome "unknown", described as "body aches (3-4 on pain scale)"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat (2 on pain scale)"; NAUSEA (non-serious), outcome "unknown", described as "nausea (occasional)". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in left upper arm.  Seen by Physician on 10/29/13.  Diagnosis - Left arm pain/contusion, left shoulder strain.  Continue Motrin, given Tramadol, given sling.
Diarrhea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue) in a 90-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. Concomitant products included METFORMIN, Glypicide, LISINOPRIL, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT), CALCIUM, DENOSUMAB (PROLIA) and WARFARIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt was hospitalized within 6 weeks of COVID vaccine.  ED visit 3/27/21; hospitalized 4/2/21
2 days after receiving my first dose my tongue began to feel tingly and swell, I could feel the tightness in the back and in my lymph nodes as well. I began to have sensitivity to spicy foods on Thursday. On Friday I woke up and my words were slurring as my tongue felt more swollen  and I started to notice some slight swelling in my throat, maybe 5%. I started gargling diphenhydramine on Friday night and that helped a lot, I also took loratadine and Fexofenadine. By Sunday my symptoms were masked by the allergy drugs and I stopped taking the diphenhydramine. 1 week later, 12 days post Moderna Vaccinne I stopped taking the fexofenadine and Loratadine. I continued to have tongue irritation and a sore on my tongue for 2.5 weeks. I then had an adverse event after the 2nd shot as well.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician).  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "mild protein S deficiency" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) positive; (16Dec2022) negative; (18Dec2022) negative; (19Dec2022) negative; (24Dec2022) positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Dec2022 to 19Dec2022. The patient experienced COVID rebound after Paxlovid. Tested positive on 13Dec2022 with minimal to no symptoms. Began Paxlovid on 14Dec2022, tested negative on 16Dec2022, 18Dec2022 and 19Dec2022 and had no symptoms. Began having fevers, chills, cough, tachycardia and diaphoresis on 24Dec2022. Tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Anti Hbs-negative test result 4DEC90; 1 1/2 yrs p/initial series employee not immune according to testing; Given 5 doses 14DEC88, 13JAN89, 16JUN89, 18DEC90, 22MAR91 fr lot#s 0302S, 1238S, other doses not recorded;
Around the 2nd I was coughing up green phlegm and had a severe cough. After getting antibiotic, the symptoms were not better after the dosage was over. I started getting more of a wet, heavy cough. Most of the phlegm I was coughing up was coming from my lungs. I was getting light headed and breathing was getting very struggled. On the evening of 6/10/2021, my mom advised that I go to the ER as my breathing was getting very taxed. During this visit I was diagnosed with RSV and tested COVID negative.
Burning pain in joints / knees; Visual issues (flashing / swirling in peripheral); Significant chills; Significant nausea; Vomiting; Rash/swelling around eyes; Swelling around eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 04May2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 13Apr2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 04May2021 at 18:00, the patient experienced burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I started developing swelling in my hands. Left hand swells more than the right. I have pain in my fingers. I have Trigger finger on all four fingers and 3 fingers on my right hand. My hands goes numb and tingly. This has been going on since April 2021. I went to doctor about this several times. They sent me for a EMG test and x-ray of both hands, normal results. There is no diagnosis. I am going to a new primary care and she is going to do blood work. I am now having pain going down my front bone in my right leg.
low grade fever, chills, body aches, headache and swollen lymph node by right clavicle
This spontaneous report was received from a pharmacist via a field representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, schedule, route, lot # and expiration date unknown) for prophylaxis. On an unknown date, the patient developed an unspecified reaction to the injection. The outcome of the event was reported as recovering. The causality assessment was not provided.
Patient came into the pharmacy to pickup prescriptions and spoke with me about side effects from her recent TwinRx and Shingrix vaccine from 5/26. Patient said since the vaccine she has had increased neuropathy pain in her legs and feet which she has had previously due to her diabetes. After 2 weeks it is still at an increased level. She is seeing her doctor on 6/13 for an unrelated reason and I encouraged her to speak with her doctor regarding this issue to keep him informed on her progress.
This spontaneous report as received from nurse refers to a 45 year old female patient. There was no medical history for the patient. The patient was not allergic to any drugs. On 14-OCT-2015 the patient was vaccinated with MMR II (albumin status of rHA) (dosing details were not reported) lot# L009545 with an expiry date of 19-MAR-2017. Concomitant medications included unspecified birth control. On 28-OCT-2015, 15 days after vaccination patient broke out in a body wide measles like rash. Patient did not receive treatment for the event. Patient sought medical attention by making a call to physician's office. The outcome of event was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Shortness of breath. Happening 2 days after the shot. Been occurring for over an hour now. Can't even speak a sentence without getting out of breath
Event: Nausea, chills, fever 102.3, body aches, headache, fatigue Treatment: Ibuprofen, Tylenol, Rest Outcome: Okay after 24 hours
Information has been received from a health professional concerning a 6 year old child who on 06-JUN-2006 was vaccinated with a dose of Varivax. On 08-FEB-2006 the patient developed chickenpox. The child had too many lesions to count, near 500. The lesions were papular, vesicular and macular. Unspecified medical attention was sought. The patient was treated with acyclovir. There was no product quality complaint involved.  The reporter considered the patient's chickenpox to be an other important medical event. Additional information has been requested.
Monday, December 20, 2004 patient received his flu shot.  On Wednesday, December 22, 2004 he began having symptoms of tingling and numbness in hands and feet, severe sensitivity to cold (tap water felt icy), tightness in leg muscles, tightness in chest, shortness of breath, unable to stand at times, unable to walk at times, headache, severe upper back pain.  He was admitted to hospital on December 25, 2004 through the ER.  He received MRIs, EMG, numerous blood tests.  On Tuesday, December 28, 2004 the back pain was tolerable and walking with assistance.  The doctors said it was a "clinical diagnosis" and discharged him to home without any medications.  The evening of December 28, 2004 the pain returned.  He was admitted to another hospital through the ER on Wednesday, December 29, 2004.  The severe pain persisted.  MRIs, flat plate of abdomen, spinal tap, blood tests were done.  Spinal tap showed high protein levels in the spinal fluid and a definite diagnosis of Guillain-Barre Syndrome was determined. Pain finally became managable and pt was discharged to home on Wednesday, January 12, 2005 with pain medication, Prednisone, Nexium and Duragesic patch and Physical Therapy.   2/7/05 Medical Records of 12/29/2004-1/11/2005 received.   FINAL DX: Guillain Barre syndrome Records state pt experienced HA & tingling in toes on 12/22/04 that progressed to back pain, stumbling and spincter control diminished.  Admitted to outlying hospital 12/27-12/27, Neuro & cardio consults done, MRI of brain & spine WNL, EMG mildly abnormal, but pt improved & d/c to home.  Then back pain acutely worsened, paresthesias of LEs continued & readmitted to higher level of care.  Neuro consult & LP done.  Reflexes decreased.  Improved & d/c to inpatient rehab.
Chills, fever, joint ache, fatigue, cough starting at approximately 12 hours after injection.  Took Tylenol and aleve.  Today , Sunday, I feel better.
In the early morning I had fatigue and achiness. Late morning body soreness, sore throat, no appetite, headache, blurry vision, extreme fatigue. By the afternoon fell asleep and awoke gasping for air/difficulty breathing and fast heart rate. All these symptoms persisted until the next day.
dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...
Mom noticed rash 2 days after 1 yr shots were given (MMR, VARIVAX, PCV 13 & Hib). Child was seen by FNP on 7/29/11 & diagnosed with VARIVAX reactions. Rash looked better by next day 7/30/11.
periorbital edema both eyes, throat swelling; initial treatment after swelling became evident I took benedryl 50 mg , once the throat swelling was noted I took prednisone 10 mg by mouth. No progression of symptoms was noted after the prednisone was taken. The time was approximately 1;20 PM. Over the next 2 hours the throat swelling subsided but the periorbital edema lasted for three days.
Pt received flu vax in 1995. Six weeks following IZ, the pt developed right brachial neuritis. The pt recovered within 6 months.
Moderna COVID-19 Vaccine EUA dose given 19 days after BUD for refrigeration
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 11/22/2022 DELIRIUM DUE TO MULTIPLE ETIOLOGIES  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/30/2022 DELIRIUM DUE TO MULTIPLE ETIOLOGIES  ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 11/22/2022 ANEMIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/30/2022 ANEMIA
Patient received Dtap, HIB, MMR, Hep A and Prevnar, as well as PPD on 11/13/2006. Today came in with large area hot, red, indurated cellulitis Left thigh and indurated only Right  thigh
Systemic: Diarrhea-Medium, Additional Details: Patient's wife reported patient has diarrhea that is darker than normal. She also told me he's on iron supplements.
65 year old man with HTN received second shot of Pfizer COVID 19 vaccine on 5/3/2021.  He was found unresponsive on 5/4/2021.  He was diagnosed with left intracranial hemorrhage with resulting right hemiparesis.  His admission platelets was 46.  His admission systolic blood pressure was 220.  He only responds to touch and pain.  He does not track movement.  He is currently comfort care and on hospice
Admitted 9/6/2021: Patient is a 4-year-old female with past medical history of Alzheimer's dementia, hypothyroidism, COPD currently on 2 liters nasal cannula, and IBS who presents today with chief complaint of weakness, fever, altered mental status.  Patient is accompanied by a daughter who provides history.  Patient started states that 2 weeks (8/22) ago patient developed some weakness, confusion, cough seen it, and fever.  Patient was seen and examined by a physician who discharge patient home.  Daughter tested her mother for COVID with a home  test on 8/24 and it was positive.  Daughter  took her mom to the hospital and patient was treated with monoclonal antibodies, Z-Pak, and steroids.   Daughter  took her mom to the hospital and patient was treated with monoclonal antibodies, Z-Pak, and steroids.  Daughter states that patient improved the following day after treatment.  Approximately 1 week ago daughter states that the patient developed increasing weakness, confusion,  difficulty standing, and shortness of breath.  Daughter states that this morning patient was unable to stand  which prompted her to bring patient into the ED today.      Pt discharged 9/14/2021.  Pt discharged to health facility and Rehab.
No adverse reaction noted. Pt given Moderna vaccine  and is currently only approved for pts 18 and older.
Case previously recorded as MA2009-5166. Initial case report received from a physician via agency, on 19 Nov 2009. A 3-year-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-008308.