chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; Fever, chills, congestion, fatigue, muscle aches, headache. Notably: today, I have experienced gradually increasing "bone ache" deep in top of my RIGHT humerus that shoots down my arm, into my ribs, a; The is a spontaneous report received from contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 08Apr2021 13:30 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included seizures, migraines, depression, all from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications included levetiracetam (KEPPRA), ascorbic acid (VIT C), ergocalciferol (VIT D), vitamin b complex (VIT B COMPLEX), Fish Oil and Mg received within 2 weeks of vaccination. The patient previously took the second first of BNT162B2 administered in left arm on 18Mar2021 13:30 (Batch/Lot Number: EP7534) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. No COVID tested post vaccination. On 08Apr2021 18:30, the patient experienced fever, chills, congestion, fatigue, muscle aches, headache. notably: today, he has experienced gradually increasing "bone ache" deep in top of his right humerus that shoots down his arm, into his ribs and behind his shoulder. 8/10 severity of pain. Currently recovered from all symptoms ASIDE from the "bone ache" which has just started today. No treatment received for the adverse event. Outcome of the events was unknown. The events were assessed as non-serious.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient received on 9/24/2018. Presented to clinic 9/26/18 stating "I went to Clinic and a NP told me to come here for you to fill out a VAERS report for my arm." Patient states she did not have formal exam at clinic. Left deltoid local reaction not warm to the touch, no fever. RN recommended that patient use warm compresses and or ice on and off for comfort. Patient reports slight itching. Hydrocortisone or BENADRYL recommended. RN provided s/sx to report to PCP. Patient reports that she feels run down and tired since receiving the SHINGRIX vaccine. Patient notified that sx should resolve within 2-3 days. Patient states that she is "feeling better."
This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 lot # L036301 (expiry date: 20-DEC-2016), lot # L043213 (expiry date: 28-AUG-2018) and lot # M007764 (expiry date: 30-JAN-2018). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a certified medical assistant, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant reported that on an unknown date, the patients were vaccinated with improperly stored doses of included COMVAX, lot#: J013884, expiration date: 19-AUG-2016. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 4 year old Asian male who on 25-MAY-2007 was vaccinated with the second SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 655270/1409F) at 10:00 in the deltoid. Later that same night, the patient developed hives and a rash on and off. Unspecified medical attention was sought. The patient was treated with diphenhydramine (HCL) (BENADRYL) and was noted to be getting better. Subsequently on 06-JUN-2007, the patient recovered. Additional information has been requested.
Patient experienced a large (2-3 inch diameter) localized reaction approximately 24-36 hours after receiving vaccine. I advised ice (15 minutes a few times per day), and ibuprofen. I instructed patient to seek further medical care if they developed a fever or reaction site became hot and/or larger.
sore throat; severe rash/rash on stomach and back/rash on rear end; rash on legs and arms; rash on neck; rash itching like crazy; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6199, Expiry date was not reported) via an unspecified route of administration, administered in the left arm on 09Mar2021 12:30 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included from Lung cancer, fibromyalgia, legs are full of cellulitis, cancer, her voice has gone astray, chemotherapy, unknown date and unknown if ongoing and blood transfusion from 05Mar2021 to an unknown date. The patient had not received any other vaccine within 4 weeks. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 10Mar2021, the patient experienced severe rash/rash on stomach and back/rash on rear end, rash on legs and arms, rash on neck, rash itching like crazy and sore throat. The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient were told to take Benadryl and that doesn't work. The patient underwent lab tests and procedures which included blood test: unknown result on unspecified date, body height 4' 8" on unspecified date. The outcome for the event's severe rash/rash on stomach and back/rash on rear end, rash on legs and arms, rash on neck was not recovered and for the event sore throat was unknown.  No follow up attempts are possible. No further information is expected.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the Vial was placed in refrigerator : 18-OCT-2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
Patient reports "tongue was a little numb and felt a tingle on his lips" shortly after vaccination and during wait period. States he tasted "a metallic taste" with injection that resolved immediately.  Did not alert staff while waiting 30 min post vaccine. Reports s/s resolved "about 10 minutes after leaving. Denies SOB, rash, tongue/face/throat swelling.
Fever - of 104, p/3 doses of APAP pt contacted FMD;
I experienced strange chest pains and never had such chest pains before. I felt strange symptoms like pins and needles pain and sensation quite often in my heart,  frequent palpitations, shortness of breath and weakness in legs and felt weak in my body and no energy at times to function well. I am was active person and was in good health with good appetite however lost appetite after vaccination. On 30th I was rushed to emergency with severe chest pain and couldn't even take one step as my whole body got too weak and no feeling in legs and no strength even to take one step. I had all tests done and was put a stent. I was in hospital for 3 days. I still weak and no energy like I used to have before vaccine.
Chills, nausea and headache, also a terrible taste in my mouth and food tastes bad to me/no sense of smell
devel inc temp to 102, very reddened thigh, w/palpable lump persisting for 3wk, persistent crying;
sore throat; spots on the back of her throat; This is a spontaneous report from a contactable consumer (patient's husband) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first shot last 25Feb2021 her second dose will be on 18Mar2021. The reporting consumer asked if the patient can take the vaccine (2nd dose) even after having a sore throat or white spots on the back of her throat yesterday, 09Mar2021. It was queried if it can become an infected throat or if she's sick. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
no adverse event. short dated batch accidentally given to patient on their second dose, batch expired on 4-28-21
This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (Lot # L038018; expiration date: 13-SEP-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F for 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Papular skin rash with fever after immunized with MMR, Varivax, Hib for 1 year of age.
FATIGUE; LEFT HAND CLENCHED INTO FIST FOR THE PAST TWO MONTHS AND A HALF; PREVIOUS RIGHT SIDED NUMBNESS WAS MORE INTENSE; DECREASED ENERGY; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, numbness of the right side, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced left hand clenched into fist for the past two months and a half. On 26-MAR-2021, the subject experienced previous right sided numbness was more intense. On 26-MAR-2021, the subject experienced decreased energy. On 26-MAR-2021, the subject experienced feeling unwell. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand clenched into fist for the past two months and a half on 15-MAY-2021, had not recovered from decreased energy, feeling unwell, and previous right sided numbness was more intense, and the outcome of fatigue was not reported. This report was non-serious.
Swelling at site of injection within seconds of receiving vaccine in office; ice pack applied to area, observed for 30 minutes; no oral edema, wheezing, or respiratory distress, no other c/o sx by pt; Pt contacted office approximately 5 hrs later and came in for follow up same day. Injection site edema decreased; no respiratory distress noted; pt c/o chills and fatigue approximately 2-3 hrs after receiving vaccine while at work. Pt felt light headed and left work early. Pt examined at 3:30pm-vitals 99.8 ax temp, normal BP, 02 sats, and HR. Given acetaminophen 650mg in office. Reviewed common side effects again with patient. Follow up prn.
Patient received the Moderna vaccine on February 14, 2021 via Pharmacy; Pharmacy scheduled patient to receive her 2nd dose at the Covid Pod.  Patient then received the Pfizer vaccination at the  COVID Pod on March 10, 2021.  No adverse reactions were witnessed after 30 minutes of observation.
Patient received both doses before her 18th birthday, 01032021 and 02052021
Pt received Moderna 0.25ml IM booster in his left deltoid at12:35pm on 11/18/21. Within minutes (2-3) he complained of a headache followed my very sore arm then dizziness and nausea.  He was escorted to a stretcher and given water and a cool pack and then laid down. Vitals at 12:45pm: 140/90, 76 , 94%. Vitals at 1pm: 130/9, 76, 95%. Pt fell asleep and was monitored continuously by writer.  Pt continued to have a headache but refused to be sent to the ED. His wife, a nurse,  was contacted by writer and she came to pick up her husband at approximately 2pm. Pt was escorted to the car by writer. Pt did report to work on the morning og 11/19/21 ans stated that he felt better.
2DEC started w/itching & rash bilateral hands & arms; hives spread all over body; took DPH; 3DEC hives worse & throat felt like closing; taken to ER & given DPH; 6DEC ER again w/tachycardia & SOB & anxiety;
On 12/2/02, patient was administered right thigh DTaP IM, IPV left thigh IM. Patient presented to our office on 12/3/02 with right thigh where DTaP given, redness, swollen, warm to touch, itchy last night 12/2/02.
Covid-19 vaccine associated myocarditis; This is a literature report for the following literature source(s): "Cardiac magnetic resonance imaging midterm follow up of Covid-19 vaccine associated myocarditis. A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis".; Sender's Comments: Based on the available information in the case, the causal association between the event MYOCARDITIS and the suspect drug BNT162B2 cannot be excluded.  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.
tremendous dryness in mouth; thickness in throat; arm hurting; tingling in lips; Frightened; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anxiety (frightened), dry mouth (tremendous dryness in mouth),  increased upper airway secretion (thickness in throat), pain in extremity (arm hurting) and paresthesia oral ( tingling in lips).  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced tingling in lips, thickness in throat and arm hurting that went away in about 45min to 1 hour. On an unknown date, the patient experienced the tremendous dryness in mouth and was frightened.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, tingling lips and thickness in the throat was resolved on 4 Mar 2021. The outcome of the other events was unknown.
migraine headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraine headache".  Additional information: Pursuant to the guidelines for post-marketing Reporting of Adverse Drug reactions, effective Mar1992, she was submitting initial information received an adverse event report associated with COVID-19 vaccine, unknown dose. Contact Information, address and phone Number was unknown.  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) : AE-2021-4325
Vaccine administered at 1:30pm.  Frequent cough started at approximately 4:30pm accompanied by throat irritation and tightness in chest. Symptoms were partially relieved with Benadryl.
Patient began experiencing shingles symptoms on 9/19/07. Saw her physician and received Valtrex.
Pt. awoke at 2 am with c/o (L) deltoid pain, redness, swelling, feels like knot in arm. Can't lift arm and muscle ache. (no fever) sl. warm to touch.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 21:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asplenic/spleen was removed" (unspecified if ongoing), notes: at 4; due to trauma; "Trauma" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "eczema" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL ER; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA; CETIRIZINE HCL; METFORMIN; MONTELUKAST; NALTREXONE HCL; OMEPRAZOLE; VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Negative; (26Nov2022) Negative; (28Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Vaccine scheduled for 6:30 pm on 12/28/20. only new loss of taste and smell the next morning approx. 5:15 am of 12/29/20.
2/6/07 abdominal pressure, vomited, some diarrhea, chills, lasted 28 hr still R flank achy.
Too many Hep A vaccines (4 or 5)/HCP thought she needed to get additional doses everytime; Kept missing recommended dose intervals; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a female patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced extra dose administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   Linked case(s) involving the same patient:  US2022AMR148351, US2022AMR148935   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's comments: The nurse stated that she had Havrix and Engerix-B prefilled syringes that she placed needles on, but the patient had changed her mind. Reporter had asked that for how long they were stable. The reporter had probed and stated that the patient had changed her mind because she had too many Hepatitis A vaccines (4 or 5) because she kept missing the recommended intervals for the doses and her Healthcare Professional (HCP) thought that she needed to get additional doses every time.  Healthcare professional (HCP) had mentioned that the patient was from out of the country and could not provide any information on if the vaccines were Havrix or another Hepatitis A series.  The reporter did not consent to follow-up and stated that the doses were not administered at their facility. Additional supportive information: The patient had too many Hepatitis A vaccines (4 or 5) because she kept missing the recommended intervals for the doses, which had led to extra dose administered and inappropriate schedule of vaccine administered. For tolerance of Havrix and Engerix B vaccines refer case US2022AMR148351 and US2022AMR148935, reported by same reporter. As the number of doses received was not clear hence only single suspect and event were captured.; Sender's Comments:  US-GSK-US2022AMR148351:Same reporter US-GSK-US2022AMR148935:Same reporter