chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Quadracel to 19-month-old patient with no adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old female patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 25-Jul-2022, the 19-month-old patient was administered 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection, strength; unknown (lot C5862BA; and expiry date 01-Apr-2023)  via intramuscular route in the left thigh for prophylactic vaccination with no adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event administered quadracel to 19-month-old patient with no adverse event.   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.
swollen; itchy; arm was red; experienced a welt that formed; inadvertently administered the Shingrix Diluent component only without lyophilized component; inadvertently administered the Shingrix Diluent component only without lyophilized component; This non-serious case was reported by a nurse via call center representative and described the occurrence of swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BX77, expiry date 02-JUL-2024) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (right arm). On 19-MAY-2023, immediately after receiving Shingrix, the patient experienced swelling (Verbatim: swollen), pruritus (Verbatim: itchy), erythema of extremities (Verbatim: arm was red), welts (Verbatim: experienced a welt that formed), inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Diluent component only without lyophilized component). The outcome of the swelling, pruritus, erythema of extremities, welts, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.     It was unknown if the company considered the swelling, pruritus, erythema of extremities and welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The registered nurse reported that on the day of reporting, the patient inadvertently received a dose of Shingrix diluent component only without lyophilized component and stated that immediately after administration in right arm, the patient experienced a welt that formed and arm was red, itchy and swollen.  The reporter mentioned that this was an attempt at the second dose of Shingrix for the patient. The reporter called to inquire how to proceed and asked could they use a different kind of diluent for the patient. The reporter did not consent to follow up. The patient inadvertently received a dose of Shingrix diluent component only without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 29-MAY-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of Oka-Merck PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447:
Secondary Transmission Nonvaccinee Limited information available. (Information obtained from lab that ran PCR and culture.) Vaccinee believed to be stationed overseas and contact was his wife. Lesion developed on her right elbow. No information on date of vaccination, when lesion appeared, or how transmission occurred.
Patient complained of nausea, vomiting, fever (100.1), swelling and redness at sit of injection (left deltoid) IM. Adacel.
Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on the left arm on 26Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thyroid disease, HBP (high blood pressure), mild depression, ADD (attention deficit hyperactivity disorder), and migraines. Patient was not pregnant. There no other vaccine in four weeks. Other medication were taken in two weeks. The patient previously took sumatriptan (IMITREX) and zolmitriptan (ZOMIG) and experienced allergy. The patient experienced shortness of breath, itching/hives, face swollen on 27Mar2021 14:00 that resulted in clinic/ emergency room visit. Patient was given IV steroid, Benadry, Prilosec at hospital. Patient was not diagnosed with covid prior to vaccination and had been tested (nasal swab) post vaccination on 28Mar2021 with negative result. Outcome of the events was recovered with sequel.
Covid-19; Covid-19; Upper abdominal pain; issues with lungs/growth appearing on lungs; psoriasis symptoms came back; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 22K-163-4468308-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for COVID-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Upper abdominal pain"; PULMONARY MASS (non-serious), outcome "unknown", described as "issues with lungs/growth appearing on lungs"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis symptoms came back". Clinical course: report by a consumer of an adult female with events of non-serious (as reported) COVID-19 and pain in right upper abdomen side with upadacitinib. There was no reported medical history. On unknown dates, the patient experienced issues with lungs/growth appearing on lungs, no antibodies reported for COVID after receiving the two doses and psoriasis symptoms came back. It was reported that the Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent the following laboratory tests and procedures: Antibody test: no antibodies reported for COVID after receiving the two doses; SARS-CoV-2 test: Unknown results. The action taken for upadacitinib was unknown.  Causality for upadacitinib: The reporter's causality for the events of COVID-19 and pain in right upper abdomen side with upadacitinib was a reasonable possibility (also reported as probable).  The reporter considered "COVID-19" and "upper abdominal pain" related (reported as probable) to BNT162b2. The reporter's assessment of the causal relationship of "issues with lungs/growth appearing on lungs" and "psoriasis symptoms came back" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Leaked from patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Leaked from patient's arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (Leaked from patient's arm). At the time of the report, VACCINATION SITE DISCHARGE (Leaked from patient's arm) outcome was unknown.        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.   Concomitant medications were not reported  No treatment was specified
I felt really tired and sore, but the swelling in my neck and elbow stayed after the second dose and hasn't gone away yet.
Itchiness around the COVID-19 vaccination site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown, Expiration Date: May2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness around the COVID-19 vaccination site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is in follow-up to report(s) previously submitted on 7/8/2008. Information has been received from a medical assistant concerning a 17 year old, 60 inch, 94 pound, female with no known pre-existing drug allergies, birth defects, no pertinent medical history and no illness at the time of vaccination who on 03-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 ml, IM. There were no concomitant medications. Subsequently, on the night of 03-JUN-2008 the patient developed swollen lips. She sought medical attention in the office and the swelling resolved on 04-JUN-2008 without any treatment the following night. No other details were provided. Additional information has been requested. No additional information is available.
Intractable nausea and vomiting with excruciating stomach pain for 4 hours - only relieved by Zofran.
The next day on 4/9/2021, I went through a range of achy symptoms. I realized several weeks later, my upper body was in pain. Mostly on my right side. My right hand shoulder and arm. Sometimes my upper back and neck as well. I was taking Advil on a regular basis for it. I received my third dose on 12/4/2021 - Lot# FH8027. After my third dose I put it together that is was the vaccine causing the pain. My hand is now 10 times worse. My doctor has now put me on prescription medicine and I have to see a rheumatologist. I can barely move my right hand because of the pain. It is now very hard for me to work.
Patient had a reaction on arm. Patient"s arm was red warm, raised and sore , symptom ongoing.
Sxs onset within 10 minute of vaccination, developed dyspnea, feeling of flushing.  Resolved after Benadryl with stable vitals.
Child received DTaP, MMR, and IPV on 3-28-06.  Mother presents with child today complaining of swollen arm.  Child's right arm swollen, warm, and tender to touch.  Encouraged mother to see MD if desires.  Child to be seen by doctor today (3/30)
Pt received vaccine on a Monday and by Tuesday she had a very large hive/welt. She said it did itch. She said Wednesday that it was getting better and that she was taking BENADRYL at night. No breathing problems though.
Burning skin; Itchy skin; Crawly feelings like bugs crawling all over; Sometimes pins and needles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 05Apr2021 at 11:45(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's antibodies (no medications) and blood pressure. Concomitant medications included methrochlorize (MANUFACTURER UNKNOWN) started on an unknown date for blood pressure. The patient was known allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient had burning skin, itchy skin, crawly feelings like bugs crawling all over, sometimes pins and needles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of burning skin, itchy skin, crawly feelings like bugs crawling all over, sometimes pins and needles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received both PNEUMOVAX and FLUZONE HD same day. Had redness and swelling in arm that received both vaccines (upper arm to elbow). Also complained of chills and fever the day after receiving vaccines. Gave BENADRYL on 10/16/2014.
Symptoms  included clustered pimply white bumps around the injection area (both upper legs), and spread to both arms and then lower back legs. HepA was injected by the nurse "accidentally" without parental consent/signature even though parent specifically stated that she would like to opt out from the HepA and just have her daughter get the 3 required vaccines (MMR, Chickenpox, and pneumococcal).
A report has been received from a health professional. The report concerns a 5 year old patient of unknown gender. The patient's concurrent diseases included allergies and asthma. Concomitant medications included Allergy Medications, Salbutamol Sulfate, Fluticasone Propionate and Mometasone Furoate. On 29-Aug-2012, patient received nasal FLUMIST. The patient tested positive for influenza A on 07-Jan-2013. The patient recovered from the event of tested positive for Influenza a on an unspecified date. The reporter was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 24-Jan-2013 from health professional: Outcome of event was updated from unknown to recovered. Concomitant drug and concomitant diseases were added. Corrected report 29-Jan-2013: Manufacturer of suspected drug added. Reporter's type med rep was added. Corrected report on 01-Mar-2013: event coding changed, narrative updated.
It started as a mild rash. However, other symptoms transpired eg itching, crying and screaming for hours and hours, loss of appetite, upset, not drinking from the breast as usual, biting the breast before latched, rash turned more pronounced and pronounced bumps all over his body. Scratching and itching out of control, not sleeping, throwing himself on the ground in fits.
each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (Dose 2, Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single), for COVID-19 immunisation, reaction(s): "each of them feeling sick"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single), for COVID-19 Immunization, reaction(s): "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional Information: Caller reports receiving 6 Pfizer COVID--19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312955 Same patient/vaccine/event, different dose (Dose 6);
sore in the arm; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for 19-Year-old patient (reporter's son). A 19-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 (at the age of 19-year-old) at dose 1, single for covid-19 immunisation. Medical history included autism, lyme disease and allergic to gluten and silica related compound. Concomitant medications were not reported. On an unspecified date the patient experienced sore in the arm. Verbatim and Event Description: The reporter reported who has autism and lyme disease and is about to get his first dose of the covid-19 vaccine today, 22Jun2021but wanted to ask and clarify about the ingredients of the vaccine if containing any gluten and silica related compound which she suspected withheld to be allergic to. While getting information regarding withheld mentioned about her other son named withheld who she stated, got his first dose of the Pfizer covid-19 vaccine last Thursday, 17June2021 who had a sore in the arm. Created and submitted a manual AE form: due to concern mentioned related to the Caller's other son, who had an adverse event after getting the first dose of the vaccine but was not the main reason for the call. Outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number been requested.  Follow up (20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A purplish spot developed at the corner of my lower lop. Looks like a purpura (?)  About 8mm in length. NOT raised, NO soreness
Erythema of skin, without infection ---left deltoid. Angioedema of left deltoid/tricep area. From shoulder to just above elbow. Onset less than 24 hours, consistent with localized marked reaction, most likely to KINRIX.
- Approximately 3/1/21 my hands began to hurt. - On 3/23/21 my left forearm swelled up nearly as large as my thigh.  I have a picture. - On 4/7/21 my left leg got a rash and spread from my hip to the bottom on my foot.
Patient experienced a rash eruption on around entire abdomen and upper right back that was pruritic. She developed a secondary rash on night of 3/29/2020 that was painful and limited to a small area above the right shoulder blade - this appeared more vesicular in nature and limited to this area (different from the trunk rash). She was prescribed prednisone and valtrex on 3/30/2020