chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021; nocturnal severe itching of palms, hands, and soles of the feet; elbow and joint pain; severe burning and itching at the palms of her hand, soles of her feet that lasted for months; have affected her activities of daily living; allergic reaction; especially in her elbows keep her from sleeping; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Jan2021 (unspecified if ongoing), notes: her joints were so sore, especially her elbows. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, around middle of Sep2021, Route, Anatomical Location: arm), administration date: Sep2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset Sep2021, outcome "unknown", described as "Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021"; PRURITUS (medically significant) with onset 2021, outcome "recovering", described as "nocturnal severe itching of palms, hands, and soles of the feet"; ARTHRALGIA (medically significant) with onset 2021, outcome "recovering", described as "elbow and joint pain"; BURNING SENSATION (medically significant) with onset 2021, outcome "recovering", described as "severe burning and itching at the palms of her hand, soles of her feet that lasted for months"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 2021, outcome "recovering", described as "have affected her activities of daily living"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "especially in her elbows keep her from sleeping". Therapeutic measures were taken as a result of pruritus, arthralgia, burning sensation, loss of personal independence in daily activities, hypersensitivity, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Vagal response to vaccine - she fainted right after receiving vaccine - EMS stated prob vagal response
Pt has a history of fainting with blood draws. Small fainting spell. Did not fall out of chair or injure herself. Woke back up within seconds. Mother and daughter left shortly thereafter.
Information has been received from a pharmacist concerning a patient who on 31-AUG-2009 was vaccinated IM with a "standard dose" of PNEUMOVAX 23. The patient developed a dime size hematoma after PNEUMOVAX 23 was given. The nurse who administered the vaccine thought that she might had punctured a blood vessel. At the time of reporting, the patient had not recovered. Additional information has been requested.
COVID rapid antigen test was positive; COVID rapid antigen test was positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID rapid antigen test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Negative; (Nov2022) Positive.  Additional information: She developed a sore throat yesterday 10Nov2022 with negative rapid antigen COVID test at that time. Continued to have sore throat and throat congestion today, with possible low grade fever. Took another COVID rapid antigen test which was positive. She has been evaluated by her primary care physician and is following his recommendations. This is being reported as a breakthrough infection following the Comirnaty bivalent booster vaccine.  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-PV202200102394 Same patient/vaccine, different dose/event;
This spontaneous report was received from a registered nurse referring to some patients pf unknown age and gender, that were vaccinated, on an unknown date, with a dose of ROTATEQ, (dose, route of administration and lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the ROTATEQ was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
Information has been received from a registered nurse (RN) concerning a 6-month-old female who on 22-MAR-2007 was vaccinated with the first dose of Rotateq. Unspecified medical attention was sought. No problems were reported. No further information is available.
Approximately 6 hours after my vaccination I had a very high fever of 106 for 3 days but then after estimated 2 months after I had an unusual gastro symptoms such indigestion, increased gas which was very unusual for me and it has been happening towards the end of 2021 - and I had a colonoscopy in December and ever since then I felt so much better. I was prescribed with Nexium and up to this day January 28, 2022 I am still taking it.
Right after i recieved the vaccination i did not feel well and slept all afternoon i recieved the shot in the morning. I was vomitting, almost fainted, sweating uncontrollably. Then my whole body was shaking and would not stop. This happened the morning after i recieved the vaccination. I was very dizzy and had to go to the emergency room that afternoon to recieve medicine to stop shaking, vomitting. I stayed in bed for two days straight sleeping. I was very dizzy. Now I still have stomach issues and my body and health does not feel the same.  6/29/09 Received ER medical records for 6/19/2009. FINAL DX: Vaccine reaction Records reveal patient experienced dizziness, chills, shakiness, vomiting x 1, near syncope x 1 day.  No previous reactions to immunizations.  Tx w/IVF & meds.  Improved & d/c tohome w/anti vertigo meds.    8/10/09 Received PCP medical records for 6/18-19/09 Records reveal patient on antidepressant & requesting BCP.  Meds adjusted & vax provided.  6/19/09 reported lightheadedness & shaking jerky movements of UEs.  Sent to ER.
Feeling better, but weak; Arm has a slightly reddened area and is warm to the touch; Foggy brain; warm to touch; Unable to concentrate; Chills; Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit; Received 2nd dose 36 days after first dose; Right arm was sore\aches and pains; Poor Sleep; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain) and FEELING HOT (warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore\aches and pains), POOR QUALITY SLEEP (Poor Sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose). On 18-Oct-2021, the patient experienced ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate), CHILLS (Chills) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose) had resolved. On 18-Oct-2021, POOR QUALITY SLEEP (Poor Sleep) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to -MODERNATX, INC.-MOD-2021-357651 (E2B Linked Report). This case was linked to MOD21-144365 (Patient Link).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-357651:daughter case
Widespread patchy skin eruption and pruritus. No respiratory distress. HR 104/min, RR 22/min.
had covid injections in March of Moderna doses at Health Center, stated had second shot 4 days prior to operation that ?went sour,? had hernia repair that was supposed to be ?in and out,? BP 65 systolic after procedure and received 5 units of blood, he is not sure of the cause of hemorrhaging, client did not provide dates of Moderna dosing but stated all in March and that hernia surgery was also in March 4 days after the 2nd Moderna dose.
Dissected aorta,  emergency surgery to repair it upon arrival at the ER. Ongoing bleeding, burst hematoma's
After receiving shot on 5-31-12 my shoulder has been hurting. I have gone to doctors 2x the last month for the pain. They said its a rotator cuff injury. I asked for xray the doctor said no. He gave me info. on stretches to do and ibuprofen.
I felt pain with injection. 2 hours later I was unable to move my arm. Knife like pain in upper arm from elbow to shoulder with limited range of motion. Injection site was unusually high on my shoulder. I emailed my doctor who prescribed cold packs and Tylenol. Tried all of that. 5 days later slight improvement and finally some range of motion. We are now 10 days post injection and stabbing pain continues with certain movements. Difficulty with getting dressed, pulling clothes over head. Restricted use of arm without pain. I feel like it's not the shot itself but the administration site that is causing the problems.
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
20 days following vax pt began w/high fever (any where from 103-105),rash,edema,meningitis,dehydration,diarrhea,vasculitis,vomiting,arthritis,anemia,pericardial effusion among numerous others-these cont for wk
Started as soreness at the injection site immediately after injection followed by itchiness and redness surrounding the injection site within 24 hours from the time of vaccination.  The redness increased in size after 24 hours from time of injection hence sought consultation at the Student Health Center.
Pt admitted for acute respiratory failure with hypoxia and currently on high flow nasal cannula, aspiration pneumonia, and sigmoid colon obstruction status post colostomy.  Pt has an initial COVID test that was negative, and then was positive on a respiratory panel.  A PCR was done and the CT value was 32.4.
Feels fatigue and like she's about to have a panic attack before fainting....has happened twice and had convulsions once.
Bilateral eye puffiness within 5 hrs after receiving 4 y.o booster vaccines (MMR, KINRIX, VARIVAX).
sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's father. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), intramuscular at left arm on 20Jan2021 14:30 at single dose for COVID-19 immunization at a Nursing Home. The patient's medical history included hypertension and increased blood cholesterol. For concomitant medications, there was no other vaccine in four weeks. The father experienced sore arm and headache on 20Jan2021 after his first dose vaccination. He was scheduled for 2nd dose on 10Feb2021. Overall, the father was fine with the vaccine. Treatment was received for the events included Tylenol. The outcome of the events was recovered (in Jan2021). The father had no COVID-19 prior to the vaccination. The father had tested post vaccination, included COVID-19 virus test (Nasal Swab) on an unspecified date: Negative.  Information on the lot/batch number has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 04-AUG-2015, the patient was vaccinated with the first dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). On 12-OCT-2015, the patient was vaccinated with the second dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). On 08-DEC-2015, the patient was vaccinated with the third dose in the three-dose series of GARDASIL intramuscularly (strength, dose, lot # and expiration date were not provided). This schedule was outside the labeled recommendations in the GARDASIL prescribing information. No adverse effect was reported. Additional information has been requested.
No adverse effects reported; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report has been received from a vaccine coordinator concerning a patient of unknown age and gender.      The patient's pertinent concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On 23-MAR-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, vaccination scheme, route of administration, and anatomical location, were not reported) with lot number (lot # S020159 (verified to be a valid lot number) expiration date reported and stablished as 30-JUN-2021) for prophylaxis. The vaccine temperature was -13.3 Celsius. The time frame was 5 hours and 5 minutes. The vaccine had a previous temperature excursion with a temperature excursion of -13.6 Celsius for 24 minutes. The call was due to a datalogger.  No additional adverse effects were reported.
Feet and lower leg swollen up and weeping a clear fluid. enough each day to wet socks. I NEVER EVER had this problem in my whole life . Antibiotics and rash ointment. Outcome still have it now
Information has been received from a physician concerning an approximately 5 month old male who on 05-APR-2007 was vaccinated orally with a 2 ml dose of Rotateq (lot# 656192/0022U). Subsequently, the patient experienced intussusception, was hospitalized and released after surgery. On an unspecified ate, the patient recovered. No product quality complaint was involved. A lot check was requested. Intussusception was considered to be immediately life-threatening and an other important medical event. Additional information has been requested.  9/11/07 Reviewed pcp medical records & vax records which corrected vax lot #.  VAERS database updated w/same.  Records reveal patient experienced good health w/sneezing, pinpoint facial rash & colic.  Hospitalized 6/1-6/6 for intestinal polyp surgery.  Received 2nd dose RO on 6/21.  3rd dose held. 9/25/07 Reviewed hospital medical records which reveal patient experienced bilious emesis on day of admit 6/2-6/6/2007 followed by coffee grounds emesis & bloody stool.  Seen at outside ER & transferred for higher level of care.  Upon admit was lethargic, abdomen soft & nondistended & no mass palpable.  To OR for exp laparotomy & reduction of ileocolonic IS.  Did well post op & d/c to home when tolerating oral feeds & having stool. FINAL DX: Ileocolonic Intussusception, surgically reduced. 9/25/07 pcp medical records & vax record faxed to CDC.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2019) for prophylaxis. On 13th March 2019, the patient received SHINGRIX .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain and shivering. On 15th March 2019, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site induration were recovering/resolving and the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received Shingrix in the left arm. Two days after receiving vaccination, the day of reporting the injection site area was red, warm and felt a little hard. The lot number was from the vial. The reporter had discarded the box. The reporter gave consent to follow up.
Pt received varicella vaccine 6/19/07 and developed chicken pox 7/10/07
huge swelling hard and red, and hot; arm blew up; 2 and a half for 3 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) Abnormal.         No concomitant was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received and test  added (Highest level of antibodies)
Myalgia, Arthralgia, NauseaVomiting, fatigue, arm pain, runny nose Narrative:
The vaccine was administered to the patient, but it was expired the night before. The patient did not have any symptoms or side effects to the vaccine.
Developed pain then rash on R scalp, neck in dermatomal pattern, seen ER and PCP, tx ACV, Lortab, Neurontin, then Valtrex
Screaming, Arching of back, Inconsolable crying, Developed strabismus's, Extreme temper, Delayed speech, Learning disabilities.
wife called on 7/26 stating her husband quickly felt arm pain and fatigue on 7/24.  At 9pm pt was unable to speak and taken to the hospital. CT scan was performed and while that was happening patient lost feeling in arms and legs.  Ct scan ruled out acute stroke.  Pt must have been well enough to be discharged b/c  wife then mentioned she was still concerned and brought him to hospital. He was admitted and as of this morning was waiting  for the MRI results.
On 04/14/2021 pt. presented to EC:   "Patient is a 63 year old female with HTN, HLD, DM2, arthritis, nueropathy, marijuana use, recent covid-19 infection, PE on xarelto presented to ec from home via ems for confusion. Reports hx of living independently. Son reported that he noticed patient is not making sense while taking on phone, son called ems, apparently patient answered the door for EMS naked."   Discharged Home with Skilled Home Care on 04/21/2021.