chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2:30 am I awoke with my teeth chattering and my body shaking with cold. For about 2 hours I had to stay really warm or the shaking would start. That part subsided and I transitioned into feeling like I had the flu. Body aches and sore skin, very very tired. I slept a lot. That lasted until late afternoon. Then I had a bad headache for the rest of the evening. I took over the counter pain reliever for the headache (probably Advil). I did not seek medical attention. The next day I felt great!!
A spontaneous report was received from a other healthcare professional concerning a patient of unknown age, male who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: an administration error were (where) a few drops of the vaccine came out of the syringe as the hub was not in all the way. The patient's relevant medical history was not provided. Concomitant treatments not provided. On unknown date the patient received the first of two planned doses of mRNA-1273 (Batch Number unknown) via unknown route for prophylaxis of COVID-19 infection. On 26 Feb 2021, a voicemail was received from a pharmacy student regarding a vaccine administration error while administering the vaccine to a patient. The patient was not identified. The pharmacy student was administering a dose of Moderna's COVID-19 Vaccine (mRNA-1273, lot number: unknown) to a patient. It was reported that a few drops of the vaccine came out of the syringe as the hub was not in all the way. Further information regarding the administration of the vaccine and further action were not provided by the reporter. A call-back attempt to gather more information was attempted. The caller at that time who was not identified stated they, "already had the answer to the clinical issue and did not provide any patient identifiers." Follow up: On 25 Mar 2021 Outgoing call was placed to verify the identity of the patient reported on case. Original reporter was not present at the time and I was referred to a another Pharmacist  whom the Other Healthcare Professional had instructed to be her proxy in follow-ups regarding this case. The Pharmacist confirmed the reported event and stated that the reported case involved a Male patient. She could not provide anymore information regarding the case. Treatment  was not provided. Action taken with mRNA-1272 in response to the events was Unknown. The outcome of events, administration error were a few drops of the vaccine came out of the syringe as the hub was not in all the way was Recovered / Resolved; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # unknown with no associated AEs
with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother reported that the patient had only mild GI symptoms as a reaction. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot and batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433434 same reporter/drug/event, different patient.
L arm pain and muscle spasms form injection site to elbow and into upper trapezius and sterno cleido mastoideus, exacerbation of fibromyalgia symptoms.
Started with body weakness, pain, joint pain, headache, and feeling feverish the same night of the vaccination. This continued until about noon on 1/24/21.
Patient states continued muscle soreness/stiffness in left shoulder area; > 1mo. since vaccination.
Patient is an 8 year old male with PMH of VUR s/p bilateral ureteral implantation and Stage 1 CKD who presented to the EC with fevers and vomiting. In the EC he tested positive for COVID, which mom states that he tested positive 7/20 and has been overall asymptomatic. His UA came back positive for 1+ Leukocyte esterase, 1+ bacteria, and and 6-10 WBC. He had an elevated WBC to 18.5, was hyponatremic at 132 bil/L, and had elevated creatine to .62 from his baseline of .44. He was started on D5NS and Rocephin 1g qDay. He also had Tylenonal Q6 H PRN for pain control. His abdominal x-ray and KUB were WNL. Vital signs have been stable and he has remained afebrile. His fluids were stopped this morning as he was tolerating PO intake. Urology was consulted who felt that UTI was less likely diagnosis. They recommended stopping antibiotics prior to discharge and following the urine culture--planning to restart if urine culture turned positive after discharge.   His nephrologist, was also consulted and recommended a follow up renal funtion panel, a repeat urinalysis, and a urine protein/creatine. UA improved, without bacteria, and trace leukocyte esterase. RFP showed improving creatinine to 0.59 and sodium to 136. Patient was discharged in stable condition. Pediatric team will follow up urine culture results and treat if indicated. He will follow up with urology and nephrology outpatient in approximately 1 month. He will also follow up with PCP in 2-3 days.
I received my 1st shot and 2 and a half weeks now,  I have numb finger tips on several fingers. I am making a Dr. appointment.
PROLONGED, MODERATELY SEVERE ARM PAIN IN RIGHT DELTOID WITH NO IMPROVEMENT 8 DAYS AFTER VACCINES - DURATION SEEMED ATYPICAL
I contracted COVID-19 on 05/29/2022 with symptoms of weird sense of taste, brain fog, light cough, and exhaustion. I was prescribed PAXLOVID on 06/01/2022. I was ill for 7 days before symptoms began to resolved. I had lingering symptoms of fatigue for another week after my other symptoms began to resolve. I am fully recovered with no lingering symptoms.
Pt had pain, swelling, and redness at site. Tylenol, Benadryl and ice.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
The doctor ordered Pneumovax-23 and the patient was, inadvertently,  given Tdap. Patient thought he may have been allergic to tetanus as he had a" flushing" reaction years ago-this was because he had been given 7 tetanus vaccines  0in a very short time. Patient was kept in the office and monitored for about 15 minutes, vital signs okay, no reaction at all. Patient left the office.
From telephone contact received on 10/14/02, it was reported that a 40 year old female pharmacist (DOB 2/1/1962) was administered Fluzone on 10/14/02 at 10:30AM. A short time later, she reported feeling hypoglycemic and had orange juice. Additionally, she complained of lower extremity fatigue, weakness and tingling. She also felt nauseated and went home to bed. It is not reported whether the patient recovered from these adverse events.
Patient was given vaccine and felt dizzy, disoriented, eyes rolled, and she was pale. We encouraged her to lay down and we monitored vitals and patient status for 30 minutes. Patients vitals were WNL and patient received follow up phone call from dr that evening and patients mother reported patient is doing well.
Patient's arm swelled significantly enough to be of concern and go to the hospital er for treatment. According to patient, she was given steroids and antihistamines to control reaction.
vaccination site cyst; Slept long time; Was feeling cold; Felt very sick; Felt tired; Had chills; Had fever; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick) and FATIGUE (Felt tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills), PYREXIA (Had fever) and MYALGIA (Soreness on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-May-2021, SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills) and PYREXIA (Had fever) had resolved. At the time of the report, VACCINATION SITE CYST (vaccination site cyst) outcome was unknown and MYALGIA (Soreness on arm) had resolved.            Concomitant medication was not provided.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  dose 1-day1-3pain/redness at inj site; day4-21-pain at inj site dose 2-day1-3-pain/redness at inj site;day 4-5-pain at inj site; day 1- 3-joint pain;fever;bodyache;fatigue;n/v  Other Relevant History:
Localize reaction. Injection site, swelling, red and hot Fever treated with Motrin and Benadryl.
weak; dizzy/light headed; felt like her husband had a Covid again; nauseated; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated) and PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UBIDECARENONE (Q10) for Heart failure.    The patient's past medical history included COVID-19 rapid POC test positive on 05-Feb-2021. Concurrent medical conditions included Drug allergy (Librium), Drug allergy (stern) and Drug allergy (losartan). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), INSULIN, HYDROCHLOROTHIAZIDE, INSULIN ASPART (NOVOLOG), SOTALOL HYDROCHLORIDE (SOTALOL AF [SOTALOL HYDROCHLORIDE]), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), CLOPIDOGREL BISULFATE (PLAVIX) and UBIDECARENONE (COENZYME) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UBIDECARENONE (Q10) (unknown route) 200 mg once a day. On 23-Apr-2021, the patient experienced ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 tablets. At the time of the report, ASTHENIA (weak), DIZZINESS (dizzy/light headed), COVID-19 (felt like her husband had a Covid again), NAUSEA (nauseated), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.5 (Inconclusive) 101.5 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Interstitial Lung Disease(ILD)" (unspecified if ongoing). Concomitant medication(s) included: OFEV; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; LIPITOR; BYSTOLIC. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive. Therapeutic measures were taken as a result of sars-cov-2 test positive.  Addition information: Reported Event: After taking Paxlovid and feeling fine, a re-test today was positive and symptoms were chills and fatigue and runnning nose The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness, swelling, itching, redness extending up and down arm, chest, and left arm
4-14-16 - Pain LUE (specifics not known to me). 4-19-16 Trip to ED for pain (I have no access to details). 4-26-16 To ED with increasing and severe pain L. neck going down L. shoulder and arm. Dx: muscle and spasm neck and Cervical Radiculopathy. Work Comp case opened- at that time pt. thought pain due to non-ergonomic chair. 4-27 to 5-13-16 - Tx'd by MD or P.A. and physical therapy. 5-13-16 to ED - Increased weakness, numbness LUE and LUE weakness. Dx: Weakness LUE abnormal MRI of head.
Extreme chills, muscle and joint aches, headache, weakness, shortness of breath, and extreme tiredness.
I started to have headaches, fatigue and feeling ill. I already had chronic headache and fatigue, but I haven't had headaches for a while and I barely use my medication for it. My arm was sore on vaccination site. On the 4th -7th I took several medications for headache because it wouldn't go away. I also used and ice pack for my migraines which works better than the medications. I drove to the urgent care on the 8th for my headache, which was better that day. My doctor ran some test, and I had an acute non-intractable headache. On 10th-14th I started having migraines again and I was taking medication for it. On the 16th-17th I had more headaches. I am waiting on my doctor to see if she wants me to get an MRI.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "generalized depression and anxiety" (unspecified if ongoing); "generalized depression and anxiety" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with Paxlovid from 05Jun2023 to 09Jun2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222670 same patient, different drugs and events;
Sore arm; Bad cold; Sick; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Bad cold) and ILLNESS (Sick) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7647B and 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in April 2022. Concurrent medical conditions included Thyroid disorder and Heart disorder.   On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jul-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Bad cold) and ILLNESS (Sick). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Bad cold) and ILLNESS (Sick) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 05-Jan-2021, the patient received first dose of moderna covid-19 vaccine (batch/lot number: 011J20A), Second dose was on 04-Feb-2021 (batch/lot number: 0787721), third dose was on 09-Nov-2021 (batch/lot number: 011F21A) and fourth dose on 01-Aug-2022 (batch/lot number: 006M21A) for covid-19 prophylaxis.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19  vaccine.  Patient has received 6 doses of  the Moderna COVID-19 vaccine so far and has only had a sore arm each time he has received  the shot. Patient's wife reported that does not know which arm received the vaccine in and how long the sore arm  lasted for. Patient was also sick in DEC-2022 with the same symptoms and had (bad cold). However, patient never  tested on own for COVID so it was is unsure if had COVID again at that time.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-733910 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733910:Monovalent
Injection given 2/18/15-mom brings child to office 2/23/15 for lightheaded, arm pain at injection site, body aches since injection on 2/18/15.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient woke up Wednesday morning and experienced nausea, vomited once, weakness, stuffy nose, clammy hands. Called us Sunday 9/26/2010 and relayed message to us, she was still experiencing stuffy nose and clammy hands but her other symptoms were gone.
RASH GOT WORSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced rash got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash got worse. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious
discomfort at the injection site; arm very sore / sore arm; numbness in my left hand / hand is slightly numb; Swelling; Fatigue; feel a sensation to my elbow; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 2nd dose of Shingrix. On 5th November 2019, 5 days after receiving Shingrix, the patient experienced injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow. On an unknown date, the outcome of the injection site discomfort was recovering/resolving and the outcome of the pain in arm, numbness in hand, swelling, fatigue and pain in elbow were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient arm was very sore and on day of reporting the soreness if much better, however, patient had numbness in left hand. The patient asked whether it was a normal reaction. The patient had the sore arm, swelling, fatigue. The patient still felt a slight discomfort at the injection site, but mostly gone. Every now and then patient felt a sensation to elbow and his/her hand was slightly numb. The reporter requesting consent to follow up.