chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered a dose of yellow fever at a travel clinic and part of the liquid came out so the provider administered another complete dose/ no adverse event; Based on information previously received on 04-Feb-2020, the following information product coding changed to yellow fever vaccine (UNK MFR) from YF-VAX and Stamaril has been amended.  Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 23 months old female patient who received a dose of YELLOW FEVER VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date and it was reported that liquid came out so they administered another dose of the vaccine (incorrect dose administered).  Medical history, medical treatment, vaccination and family history were not provided.   It was actual medication error due to incorrect dose administered. It was reported that when a person took the granddaughter to a travel clinic to get the yellow fever vaccine and the provider stated some of the liquid came out so they administered another dose of the vaccine. Physician is concerned that the toddler has more than the recommended vaccine in her system and wants to know what to watch for. She would like a call back with recommendations. Caller doesn't know if it is YF-VAX or Stamaril.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Based on information previously received on 04-Feb-2020, the following information product coding changed to yellow fever vaccine (UNK MFR) from YF-VAX and Stamaril has been amended.
I developed a sore throat, fever, a blocked nose. I completed a COVID-19 home test on Sunday, and it was positive. My symptoms had worsened by this point. I contacted the doctor did not prescribe anything because I am breast feeding. On Monday my throat was much worse. I was not able to sleep so I called back and asked what medication I could take. My symptoms improved on Wednesday and by Friday. By Saturday I felt I completely recovered. I still have a cough, but I am able to do my normal daily activity. The sore throat was my worse symptom.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 14-MAY-2018, the patient was vaccinated with improperly storage doses of ROTATEQ, lot # M046008, expiry date: 29-JUN-2019, orally, for prophylaxis (strength, dose, route and dosage schedule were not provided) and PEDVAXHIB injection, lot #N01893, expiry date 30-APR-2020 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided). No adverse effects were reported. The temperature excursion and time frame for both vaccines was between 47°F to 77°F for 30 minutes. No previous temperature excursion was reported. Data logger was reported.
Immunizations given 7/8/04. Child developed red area to left thigh with large and sever smaller clear blisters surrounding injection site.
shortly after shot area turned red, about a half dollar size, hot and painful time I got home it was the size of a small pancake really red hot , small lump and painful. on Saturday I had chills, very tired and loopy still red, hot lump painful but felt somewhat better, Monday arm is still red and shape of a small pancake, hot,  painfulful and starting to itch.
Patient's husband returned 10/11/2017 stating that patient returned home "not looking well", she was sweating and weak. Then she had a seizure. He did not seek medical attention or call the pharmacy. He states she is okay now but very weak.
Woke up 10/13/23 feeling light headed and weak on entire left side from shoulder to foot. Left hand was swollen. Had difficulty walking, fell twice. Dropped coffee because no strength in left hand. Soaked in hot water and swelling in hand went down. All side effects completely resolved by 10/14/23
EXTREME pain at area of injection. Symptoms - It hurt like hell and still hurts bad 20 hours later.
Pt awakened approx 4 hrs p/DTP vax was given; mom noted unusual behaviors, appeared unresponsive, had irregular resp, face & lips sl blue, some froth @ mouth & difficulty exchanging air & tonic clonic movement; eyes deviated; sz
I developed a small, bumpy, red rash on my upper left arm where I received the shot. The rash only showed up 6 days after I received the vaccine.
The patient was at our pharmacy on 10/17/23 to receive the newest COVID vaccine by Pfizer, Comirnaty.  A few hours after he received a dose, he felt a sudden pain on his stomach.  He said it was very painful.  He took over-the-counter pain medications he had at home and the medications did help.  The next day he felt better.
I experienced extreme headache, nausea, vomiting, low grade fever, shaking chills, and weakness. This continues for 48 straight hours. I went to my doctor and was told to wait to see if this would pass. I was getting daily headaches. My headaches feels like it is all over my head to my eyes. I contacted my doctor again about the headaches and had blood work done.  I do not know the results as of yet. I have now noticed moderate hair loss as well. I have also had visual disturbances and eye pain. I am making an appoint to an eye doctor to see if this is related to the headaches.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Mar-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received included no new significant information.
A mother reported that her 18-month-old daughter received an initial dose of Hib-Titer (haemophilus B conjugate vaccine) vaccine "14 months ago", at the age of 4 months. Post-immunization, the child developed hives. The mother stated that the incident was reported, possibly to the CDC. No further information was available at the date of this report.
11-22-08, 11-23-08, 11-24-08, seen for f/u on localized cellutitis to (R) arm inj. site. PNEUMOVAX given, IV + po antibiotics given. (TDaP + Flu)
temperature excursion / the vaccines were administered after the excursion; No additional AE/PQC reported.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. Concomitant medication included a sterile diluent. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 mL ,lot # U017140, expiration date 28-NOV- 2022 (formulation, dose number, site and route of administration were not reported) for prophylaxis (product storage error). Since 02-NOV-2021, the administered dose of vaccine experienced the temperature excursions of 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 4 hours and of 14 degrees Fahrenheit up to 46 degrees Fahrenheit for 4 hours and 45 minutes. No additional information provided (no adverse event). There were no previous temperature excursions.  This is one of several reports received from the same reporter.
pt recvd vax; inject site rxn consisting of swelling,erythema,tenderness & warm to touch;event occurred w/in 24 hrs of vax;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date unknown) for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. In March 2019, the patient experienced pruritus and injection site pain. In March 2019, the outcome of the injection site pain was recovered/resolved. On 18th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the erythema of extremities and pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, pruritus and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that she received her 1st dose of SHINGRIX into the left deltoid in the evening of 14th March 2019 and her arm was red and sore which she read was normal and it seemed to fade away and on 20th March 2019, it seemed redder than it had been. The patient further clarified that she had a big red circle and it was sore, which started the day after. The soreness went away after about three days. The patient stated it was a little itchy too, then clarified just every once in a while. The patient did not feel like she really had to scratch it. The patient also experienced pain at the injection site which lasted for a day or two. The patient did not have any other information to provide regarding location of vaccine, expiry date was unknown to her. The batch number of SHINGRIX was reported as E3272, which was corrected to E3Z7E as per sales data sheet.
13 TH OCT 0500 SORENESS IN LEFT ARM. 14TH OCT 0500 DIMINISHED RANGE OF MOTION IN LEFT ARM, UNABLE TO INTERNALLY OR EXTERNALLY ROTATE SHOULDER, NECK PAIN, TENDERNESS TO PALPATION, PAIN SCALE 7 OUT 0F 10 DURING RANGE OF MOTION, BACK ACHES, MALAISE.
Provider summary "the patient presented with dyspnea found to be COVID positive and have multifocal pulmonary embolism without right heart strain. Required oxygen, weaned during stay to room air without issue. Treated with lovenox while hospitalized -- > eliquis on discharge. Provoked so needs 3-6 months therapy, with consideration for life long given his having cancer.   Stay complicated by AMS  due to decadron, which was stopped and not provided for covid hypoxia. CT actually showed minimal parenchymal injury to lungs so hypoxia really just was from pulmonary embolism"
Patient diagnosed with chicken pox 4/2/06 after known exposure. Reportedly received vaccine 5/21/97.
Sharp pain in the chest behind sternum upon inhalation started approximately one week after the vaccine accompanied by chest tightness and an occasional non productive cough. The pain and occasional cough lasted for approximately 3 weeks and spontaneously resolved. No other illness symptoms were present at this time.
hearing loss in the right, pain and pressure in the right ear Narrative:  patient has had multiple medications and Tympanostomy to treat the condition
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No just down feathers" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Dec2018; LEVOTHYROXINE SODIUM; DICLOFENAC SODIUM, start date: Dec2018; ASPIRIN 81, start date: Jun2016; FISH OIL, start date: May2013; HYDROXYZINE HCL, start date: Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received other medication (Multivitamin) in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented to emergency department on 1/5/2022 with nausea, vomiting, and elevated blood pressure. He was diagnosed with COVID-19 approximately 9 days prior to presentation. Patient was admitted to hospital for management of ureterolithiasis. Patient was asymptomatic for COVID during admission and required no supportive care. He was discharged home on 1/10/22.
Warmness; I am not feeling that great; I'll sweat; I feel kind of cruddy; I feel little feverish/fever will break through in the night; little achy; I am sick for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2019 (unspecified if ongoing); "Covid", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "I feel little feverish/fever will break through in the night"; PAIN (non-serious), outcome "unknown", described as "little achy"; ILLNESS (non-serious), outcome "recovered", described as "I am sick for 2 days"; FEELING HOT (non-serious), outcome "recovered", described as "Warmness"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling that great"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "I'll sweat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel kind of cruddy".  Additional information: Patient took the original 2 Pfizer shot when it first came out, then she took two of the boosters back about a year and a half ago. She didn't take one last year but she took another booster this year (Pfizer Covid-19 booster shot) So, the total she have had 5 shots. she wanted to know if it was common or uncommon, that meant, she got almost like 12 to 14 hours after the shot, she felt little feverish, little achy, if all those little things were normal. Reporter stated, If anyone knew if it was normal or anybody else were reported anything like that because she had the same reactions for like two days and then the warmness or fever will break through in the night and she was sweat and then she was normal again. She wanted to know if that was a reaction to the shot or it was just if it worked with some people. She felt kind of cruddy but she was not feeling that great but she guessed so." Just board it out the last time and within 48 hours, it finally like she broke fever in it but she was back to normal. So, she guesses it was giving her a hint, if she take any four of them.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357098 same patient, different dose/AE;US-PFIZER INC-202300356952 same reporter, different patient/AE;
Received shingles vaccine & a flu shot on 10-13-2011. 10-15-2011 felt first shingle pain...10-19-2011 shingles confirmed before her dr prescribed valacyclovir tablets, triamcinolone cream, acetaminophen w/codeine #3 tablets.
RASH ALL OVER BODY, LARGE WHITE PATCHES, ITCHING, RED.
After taking my 2nd dosage of Shingrix on 10/12/2021, my skin became itchy. On Sunday 10/17/2021, I noticed that I had a rash covering my stomach. Today, it is even more visible on my breasts. I have been taking Benadryl and applying Triamcinolone Acetonide cream 0.1 % to no avail. I am miserable.
Dizziness, Headache, Myalgia, NauseaVomiting, Red eyes Narrative:
Insane sweating of only my head face and neck.  A lot of canker sores.  Mild Sore throat. Joint pain. Tiredness. Terrible neck pain at sight of previous surgery.  Mild Tenderness of old scars. Shoulder, elbow, hip,ankle wrist joints painful.
Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient rolled over the morning after receiving vaccine, the patient's arm was sore. This case is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252429:Same reporter, different patient US-GLAXOSMITHKLINE-US2020AMR252428:same reporter, different patient US-GLAXOSMITHKLINE-US2020AMR252425:same reporter, different patient
Nausea,dry heaves,dizzy,fever 102.7,fast heart rate  Extreme fatigue. Started 623 pm 2.4.21. Continued thru 2/5/21 330am. The
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates in 2016 (reported as between 17-FEB-2016 and 07-MAR-2016), the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # L035124, expiration date 14-SEP-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 17.42C for 24 hours. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt fully vaccinated for COVID. Hospitalized for renal injury and dehydration. Tested positive for COVID upon admission
Information has been received from a RN concerning a 4 yr old white male, with no pre-existing allergies, birth defects, medical conditions, and no illnesses at the time of the vaccination, who on 02Feb02 was vaccinated, by another healthcare provider, with a first dose of varicella virus vaccine live (route and lot number unk). There was no concomitant medication. On 04Apr05, at 19:00, the pt experienced blistery like rash on neck, anterior, chest, red raised rash and was itchy (it was previously reported that the pt experienced mild varicella like rash with 10 lesions on 04Apr05 and no other symptoms were noted). The report also indicated that no precipating factors or unusual exposures were noted. On 04Apr05 the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No relevant diagnostic tests and lab studies were performed. There were no adverse events following prior vaccination of pt or siblings. Additional information is not expected.
Friday night was bit by a dog and received tetanus booster at the ER as a precaution. Mild red rash started on back over the weekend and developed to a bigger area on the back and right forearm by Monday. Wednesday woke up with intense spasm in the jaw muscles that caused a lot of pain and tension in the head and face. Flushed/hot face and mild nausea present. Pain in the facial muscles and severe tension made it uncomfortable to eat even soft foods. Difficult to concentrate at work. Called M. D. to describe symptoms and she said to skip urgent care and go to the ER. They didn't do any treatment and said to come back if high fever or throwing up. Severe muscle spasm and discomfort in the face and jaw muscles continued all day Thursday as well, but lessened in intensity by evening.
3/8/18 HA and visual anomalies at 6:00 p.m. I took acetaminophen 500 mg caps x 2. 3/9/18 0155 = severe chills and shaking x approx. 45 minutes. 10A=repeated acetaminophen dose for HA.
isolated sinus tachycardia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency WEB. Regulatory number: DE-RA-202200062676 (RA).  A 45 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Dec2021 (Lot number: SDEW9) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single, lot number 1G040A, route of administration Intramuscular), for covid-19 immunisation. The following information was reported: SINUS TACHYCARDIA (hospitalization) with onset 22Dec2021, outcome "recovered" (29Dec2021), described as "isolated sinus tachycardia". Therapeutic measures were taken as a result of sinus tachycardia. Only conditional recovery occurred with therapy.   No follow-up attempts are possible. No further information is expected.
Patient jumped a bit on administration, bruise noted immediately, arm swelled more. Left arm at meningococcal vaccine.
Client complained of pruritis and redness to  RA and and L leg. Client evaluated by MD and Benadryl 50 mg given. Client observed for additional 15 minutes. Symptoms improved and client returned to baseline. Patient husband drove client home.
Client went to facility for treatment and eventually went to another facility for follow-up on 2/10/2010. On this date the following was noted upon assessment: pinpoint papular rash to forehead and small pinpoint diffuse rash to chest with small scabs of papular empty wheals. The physician prescribed hydocortisone cream 1% twice a day to affected area, one Claritin 10 mg tablet orally, prednisone 10 mg orally once daily for 3 days. Rash resolved by the follow-up visit on 2/15/2010.