chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the two days I noticed, first pain under left shoulder blade then went to arm muscle then elbow then called store then I spoke to employee, then another employee said use heating pad. Then on 11-5-18 it travelled middle lower back. Pain from flu shot the first time ever. I am not one for pain so you see it sucked. On 9-20-18 I received a back up call and talked to employee about a flu shot on 9-12-18. Today 9-24-18 10:31 AM I realized my pain could be from force of pain from a injection in the muscle. First pain under shoulder blade left side back, left arm first. Call store tomorrow talk to who gave me my shot on 9-12-18 and then Monday call other employee ask or have him let me know what's up with a shot in left arm muscle under and above arm.
No other AE reported; temperature excursion 11 C for 10 hrs, vaccine administered; This spontaneous report was received from a medical assistant and refers to a 11-year-old male Hispanic patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2021 (also reported as yesterday), the patient was vaccinated with improperly stored 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007035, expiration date 01-MAY-2022 (the route of administration was not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours. Data logger was involved. There were no previous excursions reported.  On 09-MAR-2021, an inbound phone call was received from a medical assistant (MA) who works with nurse practitioner (NP, correspondence contact). The MA was calling in response to the Merck correspondence received in the mail regarding the patient who had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations after the vaccine had undergone a temperature excursion on 16-FEB-2021 for 10 hours. The lot number and expiration date were previously reported. The adverse event follow-up process was reviewed with both the MA and the NP and they verbalized understanding. The MA stated that she was the health care professional (HCP) who administered the vaccines to the four patients listed below. The MA states that she was certified and trained to administer these vaccines. The MA provided patient's age, gender and ethnic group. The MA stated that she would hold onto each letter in case there was additional information to report. Minimal information was obtained on that day, due to the HCPs being "very busy". At the time of the phone call, the patient had not experienced cellulitis, erythema, or swelling at the site of the injection. The vaccine was not available for return.  Additional information is not expected.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001467: US-009507513-2103USA001532: US-009507513-2103USA001535:
developed a Metallic taste in the mouth; This is a spontaneous report from a contactable nurse (wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, the patient developed a metallic taste in the mouth a couple of hours after the vaccine which lasted from Thursday-Saturday. The outcome of the event was recovered on 24Jan2021.   Information about Batch/Lot number has been requested.
pt recv vax;24 hrs prior to ER visit,began to exp a papular rash on face,arms,back & abd;also exp fever prior to er visit;
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.  Unable to reach patient to inform of adverse event.
Dotted rash on arms, leg, and stomach; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 20th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in left deltoid and had dotted rash on arms, leg, and stomach.  The patient was treated with a steroid. The reaction has since resolved. The reporter did not agree to follow up.
Patient received second dose of Moderna too early. First dose was given 11/19/21 and had not been 28 days. The patient is scheduled to return to the clinic on 1/7/22 for repeat second dose.
Left facial paralysis Tx: Prednisone 20mg #29 ORX LACR-LUB OPTH OINT ORX HTDROXYPROPYL M. CELLULOSE SOLN ACYCLORVIR 400MG #30 ORX FERROUS SULFATE 325MG TAB #90
PATIENT CAME IN WITH REDNESS TENDERNESS AND SWOLLENNESS ON LEFT ARM PATIENT ALSO COMPLAINED OF HEADACHE.
Hive on left buttock 24 hour after administration. Resolving with topical HYDROCORTISONE
This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL (lot numbers not reported); dose 3 received on 28 March 2011, dose 2 received on 05 October 2010, and dose 1 received on 19 July 2010 (route not reported). The subject developed cold-like symptoms (onset not reported) and cough on 11 April 2011, approximately 14 days after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 02 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 03 May 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 02 May 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a 56 year old male consumer referring to himself. Information on patient's concurrent conditions, medical history and concomitant medication were not reported. On an unknown date, the patient started therapy with losartan potassium(COZAAR) (Lot# and expiration date unknown), 100/12.5mg once daily orally for hypertension. Other suspect therapies included metformin given 500mg once daily. On an unknown date, the patient experienced blood potassium decreased. On an unknown date in 2018 (also reported as in November 2018 or late October 2018), therapy with losartan potassium(COZAAR) was discontinued. The outcome of blood potassium decreased was unknown. Causality was not reported. Follow up information received on 19-APR-2019 from consumer via physician. The patient's historical vaccines included FLULAVAL (twice), AFLURIA, FLULAVAL, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDaP) and PREVNAR 13. On 19-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 milliliter (lot#/expiration date: R012497/08-JAN-2020) given at right deltoid for prophylaxis and on 25-MAR-2019, the patient was vaccinated with BOOSTRIX 0.5 milliliter (lot#/expiration date:MF9EA/ 12-JUN-2021) given at left deltoid for prophylaxis. On unknown date in September 2018, the patient got the vaccination shot and had high fever. It was reported that the patient was hospitalized on 25-SEP-2018 due to high fever.
Severe myalgia and arthralgia (back, ribs), tactile temps, chills, nasal congestion, dizziness.
This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter comments: The reporter stated that she heard no complaints from any of the 10 patients. She also confirmed that no patients were pregnant. For relevant test results see appropriate report section.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left deltoid area where shot was given there was a hard, raised, warm to touch area.   Area was the size of a softball.  Client did not run a temperature.  Area was not red. Improvment in 3-4 days.
I had diarrhea and very lethetic. I felt so ward out. I am really tired. I am out of breath more since I got the shot.
Pin prick sensations in hand and neck, tingling/irritaiton of tongue, throat soreness, feeling of heartburn, face became red.
3 days post vax, the pt developed screaming and refused to nurse, lasting 48 hours.
Some redness at injection site. Extreme dizziness about 12 hours after injection that lasted several hours.  Couldn't walk without help and had to crawl to the bathroom in the middle of the night.
This spontaneous report received from a medical assistant concerning a current 28 year old female patient with no known drug allergies. On an unknown date the patient was vaccinated with M-M-R II (dose, route and lot# not reported) as a child. On an unspecified date, the patient was diagnosed with Type I diabetes treated with insulin. It was reported that the patient had Measles, Mumps and Rubella titers drawn for employment. There was documented that patient received M-M-R II as a child, but the titers came back negative on an unspecified date. There was no treatment given for the event. At the time of reporting, the patient's outcome was unknown. The patient did not seek any medical attention. Additional information is not expected.
When Pt woke up today he was having a low grade fever. Said his arm was sore. Mother looked at the arms and noticed that the right arm was swollen. She measured them there is a 1/2 in difference between the left and right arm. Pt temp was 101.0 at that time. Mother is giving Tylenol and Motrin for the fever. She is to watch the area and use cool compress.
Loss of consciousness and possible seizure followed by vomiting and discombobulated behavior, exhaustion.
11/26/22 Sudden severe fatigue, sinus pain 11/27/22 Positive at-home COVID test, Fever 101.7 worse sinus pain/congestion, fatigue, chills and hard tremors 11/28/22 fever 100.9, started medication Paxlovid100 mg pack 5 days; continued flu and cold symptoms 11/29/22  fever broke, sweats, chest cold started 11/30-31 no fever, head and chest cold symptoms 12/2/22 positive COVID test; continuing cold symptoms 12/3/22  Dark red coagulated blood from nose, large pieces, dry cought 12/8/22 Positive COVID test, chills/sweats, continued cold symptoms, dry cough 12/13/22 Positive COVID test, mild head cold, dry cough
While on the bus with his father, the 8 y/o pt was given an adult dose of the Pfizer vaccine by EMT. Patient did not experience any adverse reactions, or signs / symptoms of any issues.
Started with a lot of arm pain that radiated down same arm (R). Started the same evening after receiving immunization. Pain gradually subsided and after 6 wks - resolved.
Onset 7 days after first dose Large hive at injection site measuring approximately 5 ? in diameter. Raised welt, hot and itchy. Treated with OTC histamine (H1 and H2) blockers (Benadryl and Pepcid).   Hive remained localized and began to diminish in size and severity after 48 - 72 hours.  Arm is still warm but there is no discoloration and minimal itchiness eight days after onset of symptoms (15 days post injection)
Burning sensations in nerves; his arm was twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensations in nerves"; MUSCLE TWITCHING (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "his arm was twitching".  Additional information: It was reported as, patient had pfizer vaccine 3 weeks ago. 20 minutes later his arm was twitching. Twitching for a week. Burning sensations in nerves.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 0 (injection) : soreness, pain, and heat at injection site. Swelling of lymph node under left armpit AND lymph nodes at throat and mouth. Headache, fever (99.8F), chills, very strong shivering, fatigue, strong aches and pains in muscles, unusual joint pain, loss of concentration or brain fog, disorientation, drowsiness. Increased tinnitus. Sore throat. Chest tightness. Increased appetite.  Day 1: soreness and pain at injection site. Lymph nodes at armpit and throat/mouth still a little swollen. Headache all day. Disorientation or brain fog. Major fatigue. Sore throat. Tinnitus. Lack of appetite.  Day 2-4: Insomnia (inability to fall asleep, easily awoken, unable to fall back to sleep, unable to sleep for more than 3 hours at a time). Minor psychedelic visual effects (auras around objects, long tracers following moving objects, brighter or more intense colors). Headache (minor, all day). Drowsiness. Loss of coordination (minor). Brain fog.   Day 4 specifically: Irregular menstrual cycle, my period immediately began 1.5 weeks early and very heavy. Flow is unusually fluid and more like the consistency of blood, not viscous like usual.
Diarrhea; Felt hot, but no temperature; Nausea; Vomiting; Appears the Botox did not work; Shaking from the Parkinson's is aggravated; He was not feeling well; A spontaneous report was received from a consumer concerning a 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work.   The patient's medical history, as provided by the reporter included parkinson's. Concomitant medications reported included botox injection.  On 08 Mar 2021 at 01:00 pm, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 003A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.   On the 09 Mar 2021, after receiving mRNA-1273, the patient experienced he was not feeling well, shaking from the parkinson's is aggravated and appears the botox did not work. On 10 Mar 2021, the patient experienced, diarrhea, nausea, vomiting, felt hot, but no temperature.   Lab details was not provided by the reporter.  Treatment for the events was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 69 years, in right arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Lot number: 00SM21A), in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (30Jul2022) Positive, notes: COVID rebound - positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Vaccine was past the bud of 10 weeks in the fridge when given.  Vaccine expired on 3/30/22.  Patient was called, not interested in re-vaccination at this time, may come in a couple months.
Skin on both arms and face got red like a bad sunburn, burning and raised welts and intense itching.  Treated with topical hydrocortisone on one arm and Benadryl cream on the other arm to see if one of them will provide relief.  Ongoing redness and welts.
Parkinson's Disease; fast asleep with drool coming out of his mouth shortly; sleepy; This is a spontaneous report from a contactable consumer (Wife). A 75-years-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Wife said her husband had Parkinson's Disease. The patient took his first COVID-19 Vaccine shot, and stayed a half hour after to be monitored. While she was driving her husband home from the COVID-19 Vaccine facility, she and her husband had only gone a couple blocks, and she saw her husband was fast asleep with drool coming out of his mouth. She said that was not normal for her husband, so she pulled their car over to wake her husband up. She was able to wake her husband. When her husband got home, he went to bed and slept the rest of the day. The patient was sleepy for a couple days after receiving his first COVID-19 Vaccine. The outcome was unknown.   Information on the lot/batch number has been requested.
Narrative:  Patient with PMH of Type 2 diabetes diagnosed, HTN, and history of HPV received 2nd dose of COVID vaccine series on 4/10/21 and reported symptoms of palpitations and "heart racing" shortly after administration. Vital signs and blood glucose measured during observation after receiving 2nd dose were within normal limits, and patient was given orange juice and water since she reported not eating breakfast or taking medications prior to receiving the vaccine. Patient requested to go to the ED given reported family history of heart disease. Bedside EKG monitoring in ED was normal and patient was asymptomatic at time of leaving ED.
ONCE THE NEEDLE WAS INSERTED INTO THE PATIENT'S LEFT DELTOID, AND THE PLUNGER WAS PUSHED, THE VACCINE SPILLED OUT. NO VACCINE WAS ADMINISTERED DURING THIS ATTEMPT. NEW VACCINE WAS THEN ADMINISTERED WITHOUT ANY FURTHER ISSUES/CONCERNS.
Doctor and EMT on site and provided care.  Vasovegal syncope. Symptoms presented within 5 minutes of vaccine given.  Tingling started in Left arm tingling own to fingers and  traveled to right arm and down through both legs. Rapid heart rate and disorientation prior to fainting.  Sternum rub given to revive. Patient vomited. Able to drive home after 30-45 minutes.  Continues to feel week and dizzy. Currently 24 hours after incident. Pain in arm preventing me from normal daily activities.
The next day I had a low grade fever. The highest was 100.9. I took Aleve for my period cramps and Tylenol around 2pm. Around midnight I took Motrin, 600mg. The next morning, my temp was normal. I then had back and arm pain. The arm pain was like a nerve pain. I called  my PCP on the 11th. Dr. said she thought it was idiopathic brachial plexopathy. She prescribed Prednisone at 50mg and tapered down over 4 weeks. I had an MRI of my brachial plexus and that showed inflammation. I rested my arm for 4 weeks and then I started physical therapy this week. I will be seeing another neurologist next week that specializes in neuromuscular disorders. He might order a nerve study.
pt recv vax; devel a varicella like rash described as breakthrough chicken pox; pt's brother who was not immunized devel wild type chicken pox;
PATIENT STATED ALLERGIES PRIOR TO ADMINISTRATION AND WAS CONCERNED IMMUNIZER ADVISED TO SEEK MD APPROVAL AT WHICH POINT PATIENT STATED SHE ALREADY HAD SPOKEN TO HER PRIMARY DOCTOR. IMMUNIZER AND MYSELF DECIDED TO CLOSELY MONITER HER IN OBSERVATION AFTER ADMINISTRATION. AFTER VACCINE WAS ADMINISTERED PATIENT STATED SHE FELT FLUSHED AT WHICH POINT SHE WAS OFFERED WATER SHE REFUSED,THEN PATIENT ASKED TO USE THE RESTROOM AT WHICH POINT I ACCOMPAINED HER TO THE RESTROOM, SHE EXITED RESTROOM COMPLAINING OF RASH THAT SHE SHOWED ME AND WENT TO SIT BACK DOWN IN OBSERVATION AT WHICH POINT ABOUT 15 MINUTES LATER SHE COMPLAINTED OF ITCHING AT SITE OF RASH AND WAS ESCORTED IMMEDIATLY TO THE ER BY IMMUNIZER WHEN SHE WAS TRIAGED AND TAKEN TO AN EXAMINATION ROOM IMMEDIATLY. APROX AN HOUR LATER IMMUNIZER FOLLED UP IN ER WITH PATIENT WHERE SHE STATED SHE WAS FEELING BETTER JUST GROGY FROM MEDICATION RECIEVED IN ER. ON 8/20/2021 PATIENT CALLED AND STATED SHE IS FEELING 100 PERCENT BETTER, WAS TREATED WITH MEDICATION IN ER AND THANKED US FOR HELPING HER.