chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seen 5/18/10 for itchy lesions on back. Approximately 30 lesions. Supportive treatment for symptoms advised.
A Vaxelis vaccination was given to a child (age 10), but is only approved for children under 5. The child needed all the components of the vaccination and was the correct time interval.
Approximately 1 minute after vaccine patient began turning white and sweating. He briefly was unresponsive to verbal command or stimuli along leg or arm but was breathing.  We put an ice pack on the back of neck and got him a soda once he opened his eyes back up. His mother and him remained in our IMZ booth for another 30-40 minutes until he was steady enough to stand.  I called to check on him an hour after they left and the mother reported that he was in bed with a bad headache.
Patient experienced numbness in the vaccinated arm after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious), outcome "unknown", described as "Patient experienced numbness in the vaccinated arm after receiving the vaccine".  Additional information: It was also reported that event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ringing in her ear; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain). At the time of the report, TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sz onset following Hep B inject p/leaving the building; pt was taken to ER via ambulance following sx; pt states sz was due to medication since it happened minutes p/given;
A medical assistant reported that a 24 month old child received an injection of Acel-Immune and developed an injection site reaction. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Illness; inflammation; joint aches; swollen lymph nodes; muscle aches; chills; fever; head aches; Booster; (flu)  vaccine taken together; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral since 01Sep2021 (ongoing) (Batch/Lot number: unknown) at 5 mg 2x/day; influenza vaccine (INFLUENZA VACCINE), administration date Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Nov2021, outcome "unknown", described as "(flu)  vaccine taken together"; ILLNESS (non-serious) with onset 16Nov2021, outcome "recovering", described as "Illness"; INFLAMMATION (non-serious) with onset Nov2021, outcome "recovering", described as "inflammation"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovering", described as "swollen lymph nodes"; MYALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "muscle aches"; CHILLS (non-serious) with onset Nov2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "head aches". The action taken for tofacitinib citrate was temporarily withdrawn. The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial information received on 01-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to 2018SA248519 (Same reporter). This case involves a 15 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUBLOK QIV (batch number QFAA1801, expiration date and route of administration not reported) in the left deltoid on 01-Sep-2018 instead of FLUZONE QUADRIVALENT (batch number and expiry date not reported). The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong drug administered and drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Blurry vision; Pain in the eyes; Pain in the left breast; Fatigue; A spontaneous report was received from a healthcare professional concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blurry vision, eye pain, fatigue and breast pain.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 02 Jan 2021, the patient reported having blurry vision, pain in the eyes, fatigue and pain in the left breast. Patient had not taken any treatment for the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events, blurry vision, eye pain, fatigue and breast pain was not recovered/not resolved.; 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, causal relationship cannot be excluded.
08/24/2005 right arm with redness, mild swelling, non-tender.  Review of systems: No fever, Active, feeling well.
Merck representative reporting an AE. Caller stated the customer indicated GARDASIL 9 was given to a 46 year old. Caller had no further information. Customer was not on call. No additional AE. No PQC.; No additional AE; This spontaneous report was received from a consumer via company representative and refers to a 46-year-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, at the age of 46, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). There was no additional adverse event reported.
Arm soreness; couldn´t lift his arm much; got very tired; slept for 24 hours; leg was partially numb; balance was bad; hard to walk; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 2 days after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that he received the 1st dose of shingrix on 26th August,2020 and on the second day patient experienced arm soreness, more than normal  on the The third day the patient couldn´t lift his arm much and got very tired in the evening, went to sleep and slept for 24 hours until his wife woke him up and His left leg was partially numb, and balance was bad. On day four patient was still numb and was hard to walk. It was reported that On day 4 and 6 the events gradually resolved and patient is no longer experiencing symptoms. The reporter consented to follow up.
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 66-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID-19 Treatment, brand=Paxlovid, treatment start date=17May2022, treatment stop date=21May2022, indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Came into office with rash on her back stings & burns.  The rash is at the level of the lumbar dermatome.  FAMVIR 500 mg ordered.
10 minutes after the shot I had a hot flush in my chest with a rapid heart beat. This happened as I was having a conversation with my daughter who took the shot, also.   It was difficult for me to concentrate and respond to the conversation.  My daughter got up from her chair and walked away.   ( we were asked to sit in chairs for 15 minutes after our shot) I sat and had a visual that I was standing in a park surrounded by trees and I asked what is going to happen now.  Suddenly the symptoms stopped.  I stayed in my seat.  I didn't tell anyone.  I did my yoga breathing and stayed calm.  My daughter returned to let me know she had scheduled and 2nd shot and that the 15 minute waiting period was up.  I never told my daughter what happened.  I did tell her I wanted to sit for another 5 minutes.  We did and then we left.   No other symptoms other than a bruise at the injection site that stayed bruised and tender for 4 weeks.
Approximately 45 minutes to one hour after receiving second Covid-19 vaccine, patient noticed side of face was beginning to swell and he was having difficulty swallowing and breathing Went to emergency room and received treatment.
This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on an unspecified dates, the patients were administered an unspecified number of improperly stored doses of ROTATEQ oral liquid (lot # K020181 with expiration date 24-JUN-2016 and lot# K024700 with expiration date 30-JUL-2016; dose was not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
suspected vaccination failure; Had the vaccination. One shot and 2 shot. Srill got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received one shot and 2 shot but still got shingles vaccine. The reporter asked if the vaccinations still work. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. No further information would be available.
Pt received first dose of Pfizer vaccine at 1058. Pt states she felt dizzy and lightheaded after vaccine but did not mention it to nurse. She sat down on chair for her 15 min observation and reports everything went black while sitting. Pt was observed falling back from chair onto floor hitting back of head. Pt did have LOC but was able to regain consciousness within a few seconds. RN went to assist patient immediately, ammonia was used, ice pack applied to back on neck/head, ice water brought to patient, VS TAKEN, RN STAT called immediately. Upon observation, pt was pale, diaphoretic, alert, able to answer all questions asked. Pt was slowly helped from floor up to gurney and VS were taken while laying on gurney: 124/75, HR 108, SpO2 97% at 1104. RN from treatment room responses to RN STAT call, report was given to RN and pt was transported to Treatment Room. Upon arrival to treatment room, pt stated she was feeling slightly better. VS at 1116 were the following 116/ 64 (84) HR 93, SpO2 100 on RA.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown when the vial was stored in the refrigerator. The Number of doses/vials administered on 10-Nov and 11-Nov-2021 was 168 doses. Vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contains non-significant information.
This spontaneous report was received from the patient's mother referring to her daughter, a female patient of less than 12 months-old. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported), prior to being 12 months-old; however, no adverse events were experienced.
Pt. c/o lightheadedness 20 min after administration VS stable BP 108/72 HR 82. Pt instructed to drink H2O and eat food. No s/sx of anaphylaxis.
skin rash: erythematous macular over trunk & limbs 30min p/vax;pt went to ER & dx viral rash; no hives;now w/viral rash;
Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo. On 16th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 4 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168203:same reporter US-GSK-US2022168204:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168199:same reporter
Projectile vomiting approximately 8-9 hours after vaccines given - administered @ ~1500 on 06/03/09 Started vomiting ~ 0100 - 0200 06-/04 /09
SEVERE ABDOMINAL PAIN, NECK AND BACK PAIN, SWOLLEN LYMPH NODES, MENSTRUAL PERIOD FOR 3 months now, Anemia, headaches, swollen and achy joints, heat intolerance, fatigue, weight gain.
This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a female patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not provided. The reporting nurse stated that the patient's mother said that the patient experienced fever last time she had vaccination with PREVNAR 13 and other unspecified vaccines. Event outcome was unknown. The patient's mother decided not to vaccinate the patient with more than one vaccine at the time.
Large, hot swelling at injection site which failed to go away through at least today (11/11/10). Shooting pains through shoulders and back and down left arm.  On 11/8/2010, Dr. said it should be gone in 2 days or less and should be improving.  Told him it was getting worse.  He said that it was definitely an abnormal reaction, but since it was localized in the arm it was fine.  He said the other pains weren't related.  Pains continued, meds didn't help, pain spread to shooting down right arm as well.  Going back today.
REDNESS, WARMTH, SWELLING @ INJECTION SITE TO L DELTOID WHICH HAS IMPROVED WITHIN ;AST 24 HOURS WITH USE OF TYLENOL. ALSO REPORTS HEADACHE DAILY SINCE Td injection.
This spontaneous report as received from a medical assistant refers to patients of unknown age. On unknown dates unknown number of patients were vaccinated with MMR (manufacturer unknown) (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
mom reports pt recv vax 23JAN98 & pt became lethargic, vomited 10-12 times less than 12hr p/vax;pt fine now;
No additional AE; HCP reported that RECOMBIV AX HB that had expired yesterday (11/2/2021) was administered to a patient today (11/3/2021).; Information has been received from a medical assistant, referring to a 9 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2021, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # S030794, expiration date on 02-NOV-2021 (anatomical location and administration route were not reported) for prophylaxis. No additional adverse effects were reported.
Received vaccine #2 07/09/2021; 07/22/2021 had sharp abdominal pains in a.m.. These worsened til evening when he presented to Hospital ER and was found by CTAngiogram to have thrombus in Celiac, Splenic and Hepatic arteries. Transferred to another Hospital
pt recv vax 1OCT96 & 24DEC97 pt devel probably under 20 lesions, almost like a bug bite, w/a little vesicular patch in the center;
On 10/29 I had the flu shot in my left arm, and the PNEUMOVAX 23 in my right arm. Some soreness at injection sites the next day. But about 24 hours later, 2pm 10/30 I started having moderate pain in my right armpit a few inches from the injection site. By 8pm that night, 10/30 I could not even lift my right arm without a good amount of pain. I also started having chills that night, that persisted thru about 11am Wed 10/31. The pain in my armpit lessened 10/31, and is still a bit there 11/1. As of Nov 1 there is still some residual pain in my right armpit, but no chills. I also did not have any fever at all during this time. I took 2 TYLENOL (325mg) and 2 ADVIL (200 mg each) Tuesday night 10/30 for the pain. I called both my pharmacist at pharmacy and my primary health care provider at Family Pracitice (spoke to a nurse), and both said they have had no reports of side effects from this vaccine. I was told by my Primary care physician to come in the next day, but the pain was very much less, so I did not go to the doctor.
Fever of 103.3.  Head aches, body ache, fatigue.  Lasted 24 hours.