chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 15 April 2013. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received a post-partum dose of Tdap vaccine (unknown manufacturer) (batch number, dose number and anatomical site of administration were not reported) intramuscularly on 09 April 2013. It was reported that, the patient experienced 3 cm by 3 cm induration, raised, erythema, area at injection site. The corrective treatments and laboratory investigations were not reported. At the time of this report received, the patient was not recovered from the event. Follow up information received from a healthcare professional on 04 June 2013. The patient had received ADACEL vaccine (lot number U4567AA, expiry date 19-June-2015) subcutaneously and not intramuscular in right upper arm not in deltoid as reported previously. Case of misuse as patient received wrong route of vaccination. The patient's concomitant medications included prenatal vitamins. The patient instructed to take BENADRYL and prescribed clindamycin and had to return to clinic in 24-48 hours if no improvement was observed. The patient did not return with further concerns. On an unspecified date, the patient had recovered from the events. Follow up information received from a healthcare professional on 11 July 2013: The patient was post-partum at the time of vaccination. Documents held by sender: none.
Constant severe ringing in ears. Have not been treated yet, have an appt May 6
Covid monitoring documentation. PT admitted 1/5/22 documented to have positive covid. PT received Moderna 03/25/21 Lot 017B21A for dose 1. Dose 2 was Moderna given on 4/22/21 Lot 048B21A.
5/20-day after vaccine was extremely fatigued, a strong headache (took Tylenol for it), a bit nauseous, diarrhea once, and arm very sore. 5/21-felt almost 100% but noticed rash developing on arm where vaccine was given. Red and blotchy. 5/22-arm soreness gone with just a tiny bit of tightness. Rash still present. 5/24: rash fading. 5/25-rash back and worse than ever. About 4 inches across, red, and warm to the touch. No itchiness or pain.
No adverse effects were reported; 3 patients were administered the vaccine on March 3, 2023 at the beginning of the excursion, 9 others were administered the vaccine after the full excursion; This spontaneous report was received from a health care professional (HCP) referring to a 78-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No adverse effects were reported.   This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002750: US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002675: US-009507513-2304USA002694: US-009507513-2304USA002696: US-009507513-2304USA002759: US-009507513-2304USA002776: US-009507513-2304USA002840: US-009507513-2304USA002932: US-009507513-2304USA002992:
Information was received on 31-OCT-2016 from a registered nurse. The nurse reported that one unspecified patient (age and gender unknown) received an improperly stored dose of PROQUAD (Lot # M014301, exp. 22-SEP-2017) subcutaneously on 27-OCT-2016. No adverse effects were reported. No further information was provided. The temperature was -7C for 2 hours, 35 minutes recorded on a data logger. Additional information has been requested.
Medical assistant administered new, undiluted 10-dose vial of Pfizer Bivalent 6m-4y vaccine as a single dose to patient in error. Parent was contacted the following day (6/22/23) when error was discovered.  Parent reported patient to have experienced fever of 102F on the evening following vaccination, rash from belly to left thigh, and redness and swelling at both injection sites. Follow up by phone on 6/23/23, parent reported fever waxed and waned over 6/22/23, but at present no longer experiencing fever, belly/thigh rash no longer present, continued clinically expected redness at both injection sites. Parent noted increased fussiness as well.
Patient received the Pfizer - Orange cap for the primary series.  He received the incorrect product for his age., as the orange cap is for children 5-11 years old.  No adverse reactions were communicated to the clinic.
Pregnant; Sore arm; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), MYALGIA (Sore arm) and FATIGUE (Tiredness) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 18-Aug-2018 and Miscarriage in May 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Feb-2021 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 01-Jun-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), MYALGIA (Sore arm) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 10-Feb-2021, MYALGIA (Sore arm) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive (Positive) Positive. On 28-Sep-2020, Ultrasound scan:. On 14-Jan-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Since, an unknown date in 2003, Factor V laiden was also reported as maternal concurrent condition. No treatment information provided. Estimated date of conception was on 11-SEP-2020 The patient did not have any complications or acute illnesses during this pregnancy to date DIAGNOSTIC RESULTS  On 30OCT-2020: Prenatal panel screen: Normal On 31-DEC-2020: (ACOG) Prenatal genetic screen for 2nd trimester: Normal
Dizziness, chills, breathing difficulty cough, throat swelling, sinus swelling - lasted about 12-14 hrs after time of administration. No treatment required.
Very sore arm, pain has continued at injection site.  No swelling or redness, just pain with use of my arm which is very specific to the injection site.
DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.
Information has been received from a health professional concerning a male who was vaccinated with the fourth dose of MMR II. Subsequently, the pt experienced negative titers for mumps, lab result 0.66. The pt sought unspecified medical attention. Additional info has been requested.
Positive COVID test; Positive COVID test; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the 2nd of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was an Odontist and received COVID vaccine on Monday. He was scheduled to have a cath done on Thursday, but that was not happening now. The patient has positive COVID test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013678 same reporter/drug, similar event, different patient
Unsure if Vaccine related but 2 weeks after Patient received his booster a rash developed.  He had no other reactions from prior vaccines received. It would get better with OTC hydrocortisone cream but then within days would come back in various part of his body.  Review of his meds were completed and the current meds he is on are those he has been on since admission.  Facility had not changed cleaning products or laundry products.  Family had not changed any body washes or colognes or changed any of his food preferences.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Erythromycin, sulfa, keflex' and code to common LLT/PT of 'Drug hypersensitivity" (unspecified if ongoing), notes: Known allergies: Erythromycin, sulfa, keflex; "svt" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "mgus" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "pre diabetic" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD; "PTSD" (unspecified if ongoing), notes: Other medical history: SVT, mgus, pre diabetic, PTSD. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-2021366756 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300249268 same reporter/patient, different product/AE;
Very loud continuous ringing in ear (tinnitus) starting one day after receiving Pfizer booster.
Information has been received from a pharmacist concerning an 81 year old female who on 05-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664628/1018Y, exp 16-JAN-2010), 18 days after vaccination, on 23-MAY-2010 the patient experienced a chickenpox like rash on her upper arms. There were pink fluid filled blisters. The patient would see her physician and then considered the VZV program. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient received MENACTRA vaccine after approximately 2 years of receiving Meningococcal vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00798730) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 44-year-old male patient who was received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] after approximately 2 years of receiving MENINGOCOCCAL VACCINE (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.   On 05-Oct-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  It was reported "Patient received MENACTRA on 05Oct2021, but after leaving he realized he had received a Meningococcal vaccine approximately 2 years ago. Caller states according to regulatory authority, boosters for MENACTRA should only be administered every 4 years and is wanting to find more information in regards to this. He is asking for any problems associated with this"  No other 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 holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
Left arm 10x15cm flat area of erythema with visible sightly raised and scabbed over at the site of injection.
Bulls eye red mark with hard knob in center about the size of golf ball. Very painfully, can't lay on that side of my arm.
pt fainted & was in a starring stupor for about a min; pt was pale & ran a sl fever for 2 days-arm sore;
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of VAQTA, intramuscularly (lot# was not reported) which were each greater than the prescribed 0.5 ml. The nurse reported this occurred due to the fact that healthcare providers at her facility withdrew administered the entire contents of single-dose vials of all vaccines, and due to expected slight overfill of VAQTA single-dose vials. The doses that were ultimately administered to the patients could therefore range anywhere from 0.55 ml to 0.6 ml. No adverse effects were reported. No product quality complaint was identified since slight overfill of single-dose vials was expected. This is one of several cases from the same reporter. Additional information has been requested.
Flu; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA300020.  This case involves a female patient age not reported who experienced flu (influenza), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) one week following the administration of INFLUENZA VACCINE.  It was reported that she lived 83 years without getting the flu, but got a flu shot got the flu a week and only reason she got one then because she was in nursing home.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Initial information received from another company (no case reference number provided) on 21 September 2012. A patient (no individual patient identifiers reported) received FLUZONE HIGH-DOSE on an unspecified date. The lot number, route, and site of administration were not provided. An unspecified amount of time later, the patient experienced an anaphylactic reaction (bronchospasm). It was not reported if the patient was hospitalized or what treatment was required. No information was provided on the patient's recovery status. Documents held by sender: none.
Fever/Fever of 103; Chills; Weak; Dizzy; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer reported for granddaughter.   A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) as dose 2, single (at an unknown age) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received BNT162B2 as first dose at an unknown age for COVID-19 Immunization and she didn't really have a reaction with first.  The patient was having fever of 103 after the second shot. She had her second shot yesterday (27Jun2021). She was okay yesterday, there was no reaction. She just had her fever today (28Jun2021). She had been pushing fluids and giving tylenol.  The patient also experienced chills, weak, dizzy, tiredness, headache, muscle pain in Jun2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
1/20/2020, Was seen in clinic 1/17/2020 and Dxd with Shingles had broke out in the rash that day 11 days before he had gotten his Shingrix #2 shot rash feels irritated,not itching, no pain. has some pain in the shoulder joint may have some swelling in the lymph nodes no fevers started on Valtrex her for recheck, has questions at to transmission to family and time off work wife states pt has been under a lot of stress and should take time off to rest thinks it triggered the shingles. 1/17/2020, Patient is a very pleasant 58-year-old male who complains of some flulike symptoms over the last couple of days with a T-max of 101 degrees with some myalgias, cough and congestion. He took the day off work yesterday but felt better today so returned to work. While he was at work today he noticed a rash on his left chest. Patient notes that he got the shingles immunization 1 days ago. He does recall having had chickenpox in his youth. Patient had type 2 diabetes.
Both became positive with covid between doses.; Both became positive with covid between doses.; This is a spontaneous report received from a contactable Consumer.   This 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection, LOT NUMBER: UNKNWON) via an unspecified route of administration on an unknown date as a SINGLE dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On last Wednesday (24Mar2021), the patient tested positive of COVID-19 virus. The patient became positive with COVID between doses of the Pfizer vaccine. The second dose of BNT162B2 is scheduled for 07Apr2021; hence, the patient wanted to know whether the second dose of BNT162B2 could be rescheduled.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361947 same reporter/drug/event, different patient
I had an ischemic stroke on the right side of my brain on  March 26, 2021 (approximately 1 month after the 2nd dose of the COVID vaccine).  Symptoms were loss of sensation on the left side of my body.  I received TPA in the emergency room.
Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2022, the patient received the 2nd dose of Shingrix. On 27th October 2022, unknown after receiving Shingrix, 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: 28-OCT-2022 Reporter's Comments: The nurse report via web chat that she administered a dose of Shingrix to a patient and then discovered she had not reconstituted the dose, so the patient only received the adjuvant portion of Shingrix.   This was the patient's second dose in the series.   At the time of reporting, the second dose had not been re-administered.   The nurse ended the chat session before any further details could be obtained. The reporter consent to follow up. Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient experienced LLR less than 24 hours after injection. Patient presented with significant discomfort, decreased mobility, and hardening of the area surrounding the injection site.