chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A, 018C22A, AS1412B, 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was provided by reporter.  HCP stated an unknown number of patients were vaccinated in a mobile unit after a serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022. Age group was from infant to adults. No AEs were reported.  No treatment medication was provided by reporter.
Arm turned red and hot swollen, hot and painful.  Started as a small lump but over the next couple of days grew substantially.
Patient call the pharmacy on 3/3/21 and reported that a couple days after being vaccinated on 2/19/21 she experienced nausea, vomiting, diarrhea, and fainted. The paramedics were called by the patients husband when she fainted. The took her to the hospital for observation. The GI events lasted for a few days and resolved.
Localized redness and swelling to right arm at injection site. Redness to left arm and leg, which improved after bandaid removal. 1 tsp of BENADRYL given PO per MD order. Recheck reaction at 10:46 AM symptoms improving patient smiling and laughing, patient went home.
Information has been received from a physician for VARIVAX, a Pregnancy Registry product, refers to a 29 year old female patient. On an unknown date the patient was vaccinated with VARIVAX (Merck). The patient was 13 weeks gestation. The patient became pregnant with LMP of 20-MAY-2013 and EDD of 24-FEB-2014. Physician reported that patient received a varicella vaccination, which may have been VARIVAX (Merck) in the "early stages of pregnancy". The patient sought medical attention for pregnancy. No adverse effect reported. The pregnancy outcome was outcome pending. Additional information has been requested.
devel chickenpox p/vax;rash started saturday still breaking out w/new pox on day 3;tx of sx calamine lotion topically;antihistamine orally;aveeno bath;
Information has been received from a consumer concerning her daughter who years ago on an unspecified date was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston) (Lot number not provided). Subsequently the patient experienced a slight case of ATTENUVAX a few days later. The patient sought unspecified medical attention. On an unknown date, the patient recovered from a slight case of measles. The consumer "was sure that her daughter was already infected with measles before she was vaccinated and that the outbreak had nothing to do with the vaccination". No further information is available.
Large area (shoulder to elbow) red, edematous with vesicles at injection site (VARIVAX-SQ). Treatment: BENADRYL 25mg po q day, ice, Acyclovir ointment.
p/vax pt was seen by MD who noted 50 crusted papules on face, chest & a few on arms, ears & legs;no fever noted;it was reported that rash lasted for 5 days & vaccine failure was suspected;
Reporting a vaccine error - Patient was administered a total of three Janssen vaccinations during off-site clinics. Dates of vaccinations - 05/25/2021, 06/22/2021, and 08/05/2021.  (Lot numbers 201A21A, 201A21A, 204A21A).  Error found upon entry of vaccine #3.
Left deltoid redness, warmth, tenderness around injection site: no itching, difficulty breathing or swallowing or in ROM. Tx Zithromax 250mg 2po qd (d1-5) Celebrex 200mg po BID Warm compress 3-5 x day`
Site: Pain at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: pt states magnet sticks to injection site-Severe
Noticed a couple lumps in my right breast at the beginning of July. They could have appeared sooner than that and I didn't notice. They were not painful. I saw my primary care provider, then she referred me to the breast clinic. I went there in mid-July and the did mammograms, ultrasounds, and a physical exam by a nurse practitioner. The lumps were diagnosed as cysts and not malignant.
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX (batch number FS575, expiry date 30th June 2014. On 23rd October 2014, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
Viral illness on Friday, Sunday and Monday with new lesions extending at various areas from chest back and face and extremities.
Generalized skin rash legs, arms, trunk with dried pustules and fine rash on trunk.
pt recv vax 26AUG98 & devel mild case varicella 13SEP98;
Initial information received on 28-Aug-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 61 years old female patient who experienced one episode of loss of consciousness, lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves and looser than normal stool, worsening headache, tingling and nausea while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly. On 15-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U5898AA and Expiration Date 31-May-2020) in the left deltoid. On 25-Aug-2018, the patient developed a serious one episode of loss of consciousness, 10 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious lymph nodes in her neck are 'pulsing", burning sensation to her entire body, numbness in her ankles and toes, chest heaviness and pressure, difficulty breathing, sweating, drop in blood glucose, pressure in her head, confusion, feeling "foggy", painful joints, loss of appetite, four pound weight loss, feels pressure in her neck on the right side from mid-throat to collar bone, "jabs of pain" in her feet and hands and calves, looser than normal stool, worsening headache, tingling and nausea following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was one episode of loss of consciousness, looser than normal stool, "jabs of pain" in her feet and hands and calves, feels pressure in her neck on the right side from mid-throat to collar bone, four pound weight loss, loss of appetite, nausea, painful joints, feeling "foggy", confusion, pressure in her head, drop in blood glucose, sweating, difficulty breathing, chest heaviness and pressure, numbness in her ankles and toes, burning sensation to her entire body, tingling, worsening headache and lymph nodes in her neck are 'pulsing". It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: None. Sender's Comments: This case involves a 61 years old female patient who presented with loss of consciousness post vaccination with ADACEL. Time to onset is compatible. However, patient's medical history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
I was very dizzy. The room was spinning very fast and I became nauseated with a bad headache.  The symptoms were worse the first day and lasted for a week. I took Dramamine for the dizziness and Tylenol for the headache.
felt very mild flu like symptoms; unfocused; injection site was a little hard to touch but it did not hurt; tired; little sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore). At the time of the report, INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Covid monitoring documentation. PT is 78 yom admitted 10/3/21 for sob, known covid infection. IPT tested positive 9/20/21, symptoms begin 9/24/21, received monoclonal antibodies on 9/29/21. PT reports fevers (resolved), coughing, sob, fatigue, malaise, chills, nausea, diarrhea, poor appetite. Inpatient was vaccinated with Janssen 3/11/21, Lot 1802068. SARS-COVID-19 resulted positive 10/3/21. This was reported to VAERS 10/6/21.
Information has been received from a mother concerning her 2 year old daughter who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On approximately 15-NOV-2007 or 19-NOV-2007, the patient developed a mild case of chicken pox. Subsequently, the patient recovered on an unspecified date. It was reported that the patient sought unspecified medical attention by the physician. No further information is available.
patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263393 and 2019SA263367.  This case involves a female patient (age unknown) received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the left deltoid on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report 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.  List of documents held by sender: none.
Diabetes, pain in joints while standing and sitting, numbness in hands, cramps, chills, fever, back pain, erectile dysfunction, arthritis.
Anaphylaxis 1 hour later (hives tightness in throat) given Benadryl at home. Symptoms subsided 15 minutes later. Severe  leg cramps for 5 days post vaxxed. Severe head pain behind right eye starting one day after vaccine and subsiding 3 days later.
3 episodes of staring, hypotonia and unresponsive X 15 seconds each episode. Startled and normal acting after episodes.
28 minutes after receiving the vaccination, the patient began to experience throat itching. The patient was brought back to the monitoring area and vital signs @0759 BP 138/85, HR 85, SpO2 98% on room air. She denied shortness of breath and chest pain. She was administered diphenhydramine 25mg PO at (reduced dose at patient request) at 0802. Patient was monitored closely, breath sounds clear, no stridor or wheezing, strong pulse on exam. She reported tongue swelling and was administered Epi Pen at 0810. Rapid response was called. Vital signs @ 0815 129/82, HR 94, SpO2 98% on room air. Patient was transported to the ED via Rapid Response team. Patient states that she had COVID-19 infection of November 2020 and was hospitalized for approximately 5 to 6 days. She reports that she did not require high flow nasal cannula, intubation, or mechanical ventilation. That she has had what she terms "long haul syndrome "whereby she has continued to be followed for persistent symptoms of tachycardia and lightheadedness. She states that she awoke in her usual state of health this morning and presented for the vaccination. She did receive it in the left upper extremity deltoid region. She notes about 15 minutes after that she felt the onset of some "scratchiness "in her posterior pharynx. Given that she received both epinephrine and Benadryl a rapid response was called and the patient was transported uneventfully to the emergency department. The patient reports feeling improved but not returned to baseline. As noted in the review of systems she does not report any throat closing sensation, hoarseness, shortness of breath, chest pain, palpitations, lightheadedness, near syncope, nausea, vomiting, or pruritus of the skin. She denies urticaria.
See description previously mentioned Saw practitioner May 24, treated for sinusitis w prednisone and antibiotic for 5 days. Cough returned on June 1.  Saw practitioner again on June 7, treated with zpack and a prednisone for 5 days. Cough returned June 15 and I have not been back to the dr; waiting to be seen by PCP
24 hours after the vaccine vomited continuously could not eat. Received 2 IV bags of fluid along with Zofran and Tornadol.  Had right ear Pain and neck pain. Also have vertigo with nystagmus and dizziness that is still present 1 week later. Not able to walk well without feeling off balance. Symptoms are improving slowly. Have a hard time driving.
Significant sneezing and rhinorrhea (allergy-type symptoms) that lasted approximately 12 hours. Did not respond to Sudafed.
Shortness of breath, gradually progressed over two weeks time to become more pronounced.  Doctor visit on 6-5-21 and lab tests showed elevated D-Dimer results, indicating presence of a blood clot, where CT scan showed presence of "extensive" clotting, primarily in lower lobes.  Was prescribed blood thinner medication (Xarelto).  Remained in E.D. overnight under observation.  Results over the past four days are that breathing is getting better.
Post vaccine administration, about 2-3 minutes later, patient reported numbness at injection site and increased warmth radiating to near chest/axillary region. Pt was able to speak clearly, no anaphylaxis. Pt was able to move fingers/arm but numb to injection site.  Contacted paramedics who took BP and advised pt to go to hospital - pt declined paramedic escort and volunteered to be driven to hospital by self/guardian
Hospitalization; Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalization) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) and INCOMPLETE COURSE OF VACCINATION (Miisses his second dose due to hodpitalization / unable to get second dose due to hospitalization) 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.   No relevant concomitant medications were reported.  No treatment information was reported.  This is a case of an Incomplete course of vaccination  with mRNA 1273  with limited information available. Further information has been requested.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Initial additional; Sender's Comments: This is a case of an Incomplete course of vaccination  with mRNA 1273  with limited information available. Further information has been requested.
Pt recvd 1 dose of Engerix-B & devel Epstein-Barr;
Experienced break through case of covid even after being fully vaccinated with 2 primary doses; Experienced break through case of covid even after being fully vaccinated with 2 primary doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Experienced break through case of covid even after being fully vaccinated with 2 primary doses". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event Experienced break through case of covid even after being fully vaccinated cannot be excluded based on temporal association and available information.
I noticed my heart rate going down. I went to the clinic, and they did labs, and everything was normal. On Monday morning I started having chest pains. I went to the ER for monitoring. The EKG and monitoring showed I had 30% premature atrial contractions. I started of metoprolol. They told me to stop taking metoprolol and put me on a different medication.
Can't eat; Abdominal pain; Diarrhea; Dizziness; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no allergies, did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine and had no chronic illnesses prior vaccination.  The patient's past medical history included COVID-19 in November 2021.    On 05-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Apr-2022 at 9:00 PM, the patient experienced FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Can't eat), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Patient stated that he does not take any concomitant medication. Patient also stated that he took Tylenol as a treatment for the symptoms but did not felt better.
received one dose of a Shingles vaccine / developed a case of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. A Pharmacist reported that a patient received one dose of a Shingles vaccine and then developed a case of Shingles. The reporter was unsure which shingles vaccine was received by the patient. The reporter did not consent to follow up. The pharmacist declined to supply AE report details when requested.
Approximately 18 hours after receiving the Moderna 2nd booster, I started feeling lightheaded and it was difficult to stand.  About 21 hours after the booster, I started to faint. The EMT's were called and my blood pressure was 80/60. I was taken by ambulance to the ER where multiple blood tests were done. I was discharged approximately 6 hours later when I became stable.