chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from a pharmacist on 17-Oct-2018, concerns a 24-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medication included birth control pill. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252229 and expiry date: 31-May-2019). This was the first time the patient received the flu shot. On the same day, after vaccination, the patient experienced myalgia, running nose, spots on face, itchiness on her back and sore throat. The patient displayed an extreme migraine. Eight hours after vaccination, the patient got sick. The patient experienced nausea, extreme headache which displayed flu symptoms. On an unspecified date in 2018, the patient experienced rash on her back. The husband of the patient thought that she was going to get Guillain Barre syndrome. On an unspecified date in 2018, the patient was feeling numb and very weak and reported that she might have to sleep during the day. The patient had not taken any treatment measures for the events. At the time of this report, the patient was recovering from the events (reported as patient was ok). The reporter assessed this case as non-serious. Follow-up received from other health professional on 02-Nov-2018: Events migraine, flu symptoms, sickness, nausea, headache, rash, numbness, daytime sleepiness and weakness were added in the event tab. It was also confirmed that, the patient's concomitant medication included birth control pill. The narrative was amended accordingly.
Patient states she has lower back pain that started after she got her booster of Moderna, while she was still sitting in the chair outside the pharmacy waiting for 15 minutes after her vaccine. It has continued into the next day despite her taking tylenol and meloxicam.
Patient was inadvertently administered an expired dose of PNEUMOVAX 23; This initial spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.   On 11-OCT-2020, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), one shot, lot # S025133 (expiration date of 15-SEP-2020), for prophylaxis. No additional details or product quality complaints were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; 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
Red, warm circle (about 1.5 inches in diameter) around the injection site. Arm is a little sore.
Information regarding Prevnar was received from an investigator regarding a 3month old male participant in a study who experienced SIDS. The participant received the first dose on 4/12/02. The participant also received the first dose of Infanrix, the first dose of Engerix B, the first dose of Act-HIB, and the first dose of IPOL on 4/12/02. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/12/02. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, Act-HIB, and IPOL. On 5/15/02, the patient expired as a result of SIDS per the county coroner's office. The investigator and medical monitor considered sudden infant death syndrome to be not related to the study product. The report of a serious labeled event is being submitted in an expedited time frame as requested by the FDA.
The patient received the shingles shot and about 2 hours later started experiencing arm pain where she was vaccinated. The arm pain continued to get worse and 2 days later the patient saw her PCP because she could barely move her arm. Her PCP referred her to an orthopedic doctor who diagnosed her with "frozen shoulder" and prescribed a short course of weekly physical therapy for the patient. The patient is expected to fully recover and says her arm is almost back to full range of motion and normal as it was before the vaccine.
She states that following that, she had swelling of the left arm.  She also developed an axillary lymphadenopathy on the left side, pain, and redness.  She also had flu-like symptoms.  About 3 days later, she started to have cramps in the legs.  Initially they were mild, but around Wednesday or Thursday of this week, the leg pain became significant.  She had stiffness of the calves and she had had difficulty walking.  She still came to work on Thursday, but because of worsening symptoms, she went to the emergency department.  She was evaluated and was found to have an elevated CPK of 14,000.  She was admitted for further evaluation and management.
within 15 minutes of injection , patient felt tingling and numb on face and body and tongue felt "odd" . never had a reaction to a vaccine before. administered  12.5 mg of Benadryl liquid at 11:37 am and another 12.5 mg of Benadryl at 11:59 AM and felt 75 % better at 12:08 and left for work . spoke with the patient next day and did not need any more Benadryl and worked until 9 pm that evening
This spontaneous report was received from a pharmacist referring to 9 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 27-SEP-2016 and 10-OCT-2016, the patients were inadvertently administered with improperly stored ZOSTAVAX (8 doses of lot # L046896, expiration date 23-FEB-2017; 1 dose of M032139, expiration date 02-OCT-2016; dose and route were unknown) for prophylaxis. The vaccines were stored under the temperature 6 Celsius degree for 432hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. Product quality complaint (PQC) was not involved. A call was placed to the pharmacist on 07-DEC-2016, that requested patient identifiers and date of vaccination.  All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected since no further information was available. Narrative updated.; Sender's Comments: , MERCK 1610USA005098:Mfr number.
Chills; Body ache in both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body ache in both legs) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Body ache in both legs). On 22-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Body ache in both legs) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided No treatment medications provided
Immediately after shot patient said she didn?t feel well... said she felt very warm and she was extremely anxious .. said something about not being able to see asked for a energy water she carries ... apparently did not eat all day and had exercised yoga before shot .. her relative told me she has had problems with vaccines.. called 911 they checked her and she was released to go home ... the ambulance people implied it was an anxiety attack mixed with perhaps dehydration
Dr.  ordered Pfizer Covid bivalent vaccine for 6months-5 years. MA drew up the vaccine and administered. Later in morning, it was discovered that the covid vial was not labeled and only a small amount remained in vial. No other Covid vaccine was given in morning. MA confirmed that he forgot to dilute the vial prior to giving injection.   Dr.  was notified. Parent was called and notified. Dr.  will send msg with further information to parent.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2022) Negative, notes: negative tests in the morning and evening of Friday 09Sep (09Sep2022) Negative, notes: negative tests in the morning and evening of Friday  09Sep; (Sep2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received anti viral. treatment start date: 03Sep2022, treatment stop date: 07Sep2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site, swollen, fingers numb, arm feels heavy, tingling feeling going up and down, was told by dr that she has COVID arm.
No additional ae reported; Concomitant administration of VARIVAX and PROQUAD was administered to a patient instead of MMR II and VARIVAX; Concomitant administration of VARIVAX and PROQUAD was administered to a patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.    On 28-JAN-2022, the patient was vaccinated concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) instead of Measles, Mumps, and Rubella Virus Vaccine Live (MMR II) and (Varicella Virus Vaccine Live (VARIVAX) (overdose and wrong product administered).   The nurse was requesting medical information regarding the side effects so she can inform the patient's parents.  No additional adverse events were reported.
Shots administered in upper shoulder on bone. Cannot lift my arm without extreme pain.  It has been 4 days now. Had other reactions, but they subsided.  Went to walk in clinic today.  Doctor said this may last week or or months.        now.nowHaotherredactions
This  patient was admitted to Hospital on 1/29/22 for COVID related symptoms. This is considered a breakthrough case
Hight heart rate (tachycardia), flushed face and feeling of impending doom for about 2 -3 minutes. Resolved within 3 minutes. reported to the RN who administered the vaccine
lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3 hours after vaccine, patient developed facial swelling and erythema, localized to periorbital area and facial cheeks bilaterally. No airway compromise, trouble breathing, chest pain or shortness of breath. No headache, dizziness, lightheadedness.
Acute pulmonary embolism, first symptomatic on the evening of 4/15/21.  Received first vaccine on 3/5/21, second vaccine on 4/2/21.  Only other risk factors for PE are age and a long car trip around 3/14/21.
erythematous site reaction about 3 inches by 2 inches. Recommended treatment included icepack
This spontaneous report as received from a health professional refers to a 12 years old male patient with ADHD, unspecified episodic mood disorder, neurofibromatosis type 1 and post-traumatic stress disorder. The patient was vaccinated with lot # (670048/0963AA) dose 2 GARDASIL, IM, right deltoid on 29-DEC-2011 at 16:15. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received immunization that was stored at a temp out of range <32 degrees F. No adverse reactions occurred. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a RN concerning a 32 month old female who on 04Nov04 was vaccinated with a dose of varicella virus vaccine (lot 0341N). On 05Feb06 the pt developed breakthrough varicella characterized by a generalized rash with less than 50 lesions and a fever of 1 day. Unspecified medical attention was sought. At the time of the report the pt had not yet recovered. There was no product quality complain involved. Additional information has been requested.
First Vaccine was 3/26 and second dose was 4/9. Tinnitus started post first vaccine around 3/27.  As of 5/26, it hasn't completely diminished and occurs intermittently racing heart after first vaccine and as of 5/26 hasn't diminished paresthesia, tingling in left hand and left arm numbness started 5/8
Developed facial warmth, then another person noticed blotches on her face and arms.  Then she felt itching.
I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation.  Medical history included was none. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks after receiving COVID vaccine. The patient had no history of COVID prior to vaccination and did not test post vaccination. The patient also stated that on 15Feb2021 at 10:00 PM, he had severe chills, fever and muscle cramps overnight. He was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours (on 16Feb2021), the fever broke and returned to 97F. The patient stated that on 15Feb2021 at 10:15 AM, about 30-45 minutes after vaccination, he experienced elevated heart rate. His Apple Watch alerted him asking if he was working out, and upon checking his heart rate, it was oscillating between 85 - 110 BPM. After about an hour, his heart rate dropped back down. The patient did not receive any treatment for the events. The outcome of the events chills, fever and muscle cramps was recovered on unspecified date in 2021. The outcome of the event heart rate increased was recovering.
vomiting fever 102.6 body pain all over lost voice arm that Covid vaccine was adminitered in became immobile due to extreme pain
Facial rash 02/24/21 a.m., increased severity x2 days; notified allergist 02/26/21; as per MD - Benadryl and Allegra PO BID; No improvement; MD office visit 03/02/2021 -  Prednisone 60 mg PO day 1, 40 mg PO daily x4 days, 20 mg PO x2 days; rash cleared 03/04/21.
Information has been received from a physician concerning a 21 year old female patient who on 02-MAY-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included AMITRIPTYLIN (manufacturer unspecified, start date unspecified, but prior to vaccination with Gardasil). Post vaccination client had a Home pregnancy test and it was found out that the client was pregnant. Patient also had an x-ray of the lumbar spine on or about 07-MAY-2007. No other information reported. The outcome was unknown. Additional information has been requested.
5 days after vaccine administration presented to the ER with decreased swallowing, increased drooling. Progressed while admitted to respiratory failure secondary to suspected paralysis from botulinum toxin. Confirmatory studies pending.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
SEVERE HEADACHE, LIGHT SENSITIVITY, HARD LUMP AT INJECTION SITE, RED SKIN REACTION, FELT HOT AROUND INJECTION SITE.  ONSET WAS WITHIN 12 HOURS OF SHOT AND TOOK 5 PLUS DAYS TO RESOLVE.  PATIENT DID NOT SEEK MEDICAL ATTENTION.
Flu shot given on 10/21/2004 approx. 1000am Pt. states headache right away and hives by 1400 on 10/21/2004 still with rash and itching started today(10/25). Denies any breathing difficulties, did not see a doctor or call one. PHN strongly encouraged her to call her PCP. Called ODH; said to do a VAERS.
Severe fatigue, fever, whole body aches, cold sweats, injection site hot to the touch, itchy, stings, red and swollen
Information has been received from a nurse practitioner, for the Pregnancy Registry for VARIVAX (Merck), concerning a 17 year old female with no pertinent medical history and no reported drug allergies, who on 19-FEB-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (Lot number 661856/1222X). There was no concomitant medication. The patient was 16 weeks pregnant at the time of vaccination; the date of last menstrual period was 26-OCT-2008. The patient sought medical attention in office. Laboratory tests performed included urine pregnancy test. Follow up Information has been received from a registered nurse concerning a 17 year old female with a history of 1 pregnancy and 1 live birth and no reported allergies who on 19-FEB-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (lot number 661856/1222X). Concomitant therapy included DTaP (unspecified manufacturer). The registered nurse reported that the patient did not experience local reaction of vaccination site neither herpes zoster symptoms after vaccination. The patient was schedule for an ultrasound prenatal testing on 10-MAR-2009. Information has been received from the registered nurse through the Pregnancy Registry for VARIVAX (Merck), concerning the patient who on 17-JUL-2009 (38 weeks) delivered a normal and healthy male baby weighing 6 pounds and 10.9 ounces. No congenital anomalies. There were non concomitant medications during pregnancy. There were complications or abnormalities, the patient delivered per elective c-section (not further specified). There were no complications during the pregnancy and labor/delivery, and no concurrent medical conditions. On 12-DEC-2008, during the pregnancy, the patient experienced Chlamydia infection which was treated on the same day. There were no other medications used during this pregnancy. Upon internal review elective C-Section was considered to be an other important medical event. Additional information has been requested.
As soon as I walk 5 steps from the vaccination station everything became black and I got very dizzy. I sat immediately because I felt I was about to faint. I waited 20 min for the dizziness to diminish and was able to walk by myself. My vision was blurry and felt my eyes were moving rapidly side to side. My husband drove me home because I still fell too dizzy to drive back home. The dizziness continued the day of the 2nd dose administration and got less bothersome if I stayed in bed. The following day the dizziness was much less but I still stayed in bed. Monday March 15 I also experienced dizziness and stayed in bed. Since the first dose on Feb 09, 21 I have felt tired and not always being able to complete my physical therapy routine. The tiredness is not every day. It comes and goes.
Fever, chills, nausea, Severe muscle aches, headache, dizziness off and on for 48 hours. I was not told I would be getting the High dose shot. I have taken flu shots for many years and never have had a reaction like this. I am a 4 year cancer survivor and felt as bad from this as I did during my chemotherapy. I feel this is very dangerous to older people who's health is already compromised.