chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medications were not reported.   Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP.  No treatment information was provided by the reporter.  This case for patient 87 out of 100 patients.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
Itching all over-difficulty breathing, shaking, tachycardia. Hospitalized for 7 days after influenza shot.
Information has been received from the below mentioned literature article regarding 4 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by the Review Board of School of Medicine. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 NAEPP expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, anatomical location and lot number was unknown). On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to the be related to PNEUNOVAX 23. A copy of published article was attached as further documentation of the patient's experience. This is one of the several reports received from the same literature article. Additional information has been requested.
Severe and continuing chest pain, tightness, and difficulty breathing.   Pain increases during physical activity.  Severe pain and discomfort lasted 6 months, but still have occassional discomfort once every 2 weeks.
Patient was admitted to Hospital on 01/18/2022 with acute on chronic abdominal pain and high output ileostomy causing dehydration with acute kidney injury.  CT showed mild enterocolitis.  Acute kidney injury initially resolved with IV fluids.  Nephrology was consulted d/t worsening.  She incidentally had Covid-19.  Patient continued to decline in spite of supportive treatment.  Patient and family agreed for hospice and transitioned to comfort measures only.  The patient expired on 01/31/2022.
Less than an hour later, arm started to swell. By night time, swollen, red, itching and red spots, down to the elbow. Lasted for nine days.
A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non health professional (office staff).   This case is linked to cases 2019SA224138, 2019SA196353, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224144, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot-C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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 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.  Documents held by sender: none.
High fever; Muscle aches; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks. On 30Mar2021, the patient experienced high fever, muscle aches, headache and nausea. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events of high fever, headache, nausea and myalgia was recovering at time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1, Lab data "Body temperature" removed since only High fever was provided in the source document. 2, Vaccination Facility Country added. 3, Final sentence updated.
Same day reaction, came into the clinic two days later with redness and swelling around the injection site on (R) deltoid where the Tdap was given. Pt saw a provider and was given antibiotic (Doxycycline 100mg BID x 7 days).
After 1st injection this patient's finger joints swelled and hurt, stiffness in his shoulders. It got worse after 2nd injection; and gradually got better aver 6 months. The patient refused  his last injection. Per annual follow-up, doc 215044; symptoms still persist but seem to be slowly improving with time.  Follow up:  Patient continues to have pain and swelling in hands especially after heavy use of his hands.  Slight sleepiness at middle fingers joints.  STiffness in knuckels essentially stated. Never stated any redness in any joint.  No treatment, no diagnosis, no medical records available.
High fever , extreme sweeting , throat closed up but not completely.  Still running low grade fever and have swelling and soreness still in throat. 4 days and counting.  Two days of almost closed throat and soreness still continues.
Information has been received from a Registered Nurse Practitioner (R.N.P.) concerning a 14 year old female student who on 12-JAN-2007 was vaccinated IM in her left deltoid with a first dose of Gardasil, lot# 655619/1427F. Concomitant therapy included ADDERALL TABLETS, STRATTERA, PROZAC, montelukast sodium, bupropion, "exofendadine", ranitidine and minocycline. Of note, the patient was switching from CONCERTA to ADDERALL. On 20-FEB-2007 the patient developed arthralgias in hips, ankles, and hands. Patient saw pediatrician. It was reported that the events persisted as of 09-MAR-2007. On 16-MAR-2007 the patient's mother reported, the events resolved. The outcome was unknown. Additional information has been requested.
Patient went to hospital with hypertensive crisis (said blood pressure was VERY high) on May 18, 2021. She said they did a heart catheterization, in which everything looked good except for the artery in the back of the heart was 70% blocked. She said she is now on a cholesterol medication, an additional blood pressure medication, they increased her current blood pressure medication, and also put her on a blood thinner.
congestive heart failure; immunocompromised; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) and IMMUNODEFICIENCY (immunocompromised) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion medically significant) and IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure) and IMMUNODEFICIENCY (immunocompromised) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with a history no reported medical history, who experienced the serious (due to medically significant) unexpected, events of Cardiac failure congestive and Immunodeficiency, which occurred related to the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The outcome of both events was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
RASH AND ITCHING ALL OVER ARMS AND SPREAD OVER CHEST; FEELING HOT AND NIGHT SWEATS; ARM SWELLING; ARM BRUISING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced rash and itching all over arms and spread over chest. On 12-APR-2021, the subject experienced feeling hot and night sweats. On 12-APR-2021, the subject experienced arm swelling. On 12-APR-2021, the subject experienced arm bruising. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, arm swelling, rash and itching all over arms and spread over chest, feeling hot and night sweats, and arm bruising. This report was non-serious.
Patient became lightheaded and had syncopal episode in chair, breathing irregular and snoring.  911 called, patient did come to in less than one minute, vital signs stable.
Headache, Sedation, Rash, UrticariaPruritus & NauseaVomiting Narrative:
Had a seizure was put in hospital for a few days. Bloodwork was done as well as a EKG and an EEG.
patient stated right sided leg and hip pain.  has bene taking Tylenol extra strength for it . says pain came on 5 hrs after injection given in evening time  pt advised to seek ER/UC TREATMENT within the next 24 hours , or sooner if leg pain returns given history of dm and blood clots in leg due to her history of lupus.
04/17/2021 Chronic cough, especially at night. I am a former smoker. I went to doctor and had x-rays. Was diagnosed with pneumonia.
Redness; temperature of 102.7 F/fever; loss of appetite/no appetite; Lethargic; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number, expiry date unknown), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, temperature of 102.7 F/fever, loss of appetite/no appetite and felt lethargic in Feb2021. It was reported that while the patient didn't have much redness, he has had a temperature of 102.7 F. They wanted to know if this is normal and how long should they anticipate him having a fever or is it something he should expect over the course of one or multiple days. He also had loss of appetite and felt lethargic. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
increased pain and swelling of joints started 3 days after vaccination, continued through period including second vaccine injection until 3/12/21 noting slight improvement. Also changed medication starting  2/26/21 to cosentyx.
Fever, Severe chills, headache, body aches, nausea, fatigue, beginning approx 11 hours after vaccine administration. Treated with ibuprofen 14 hours after symptom onset. Interferes with normal activities.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications information was reported.  It was unknown if the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non-significant information.
Headache, Sedation, Myalgia & Fever Narrative:  Other Relevant History:
received flu quad and started breaking out in very red rash on face and chest around 8pm. slightly itchy. Went to HCP 10/21 and they prescribed Zyrtec.  Had steroid shot in knee day before vaccine.
Missed expected period on 4/20/21, still have not started menstruating and I am on day 50 of my cycle. Negative pregnancy test on 5/1/2021
Swollen Tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Swollen Tongue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWOLLEN TONGUE (Swollen Tongue). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 16-Feb-2021, SWOLLEN TONGUE (Swollen Tongue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment includes diphenhydramine hydrochloride (Benadryl ) and it helped to get the swelling down.
patient looked at the arm and it had like a 6 inches rash; Injection started to get itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash) and VACCINATION SITE PRURITUS (Injection started to get itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2014) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection started to get itchy). On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash). The patient was treated with CETIRIZINE HCL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (patient looked at the arm and it had like a 6 inches rash) had resolved and VACCINATION SITE PRURITUS (Injection started to get itchy) outcome was unknown.            Treatment information includes hydrocortisone for itchy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: The patient reported rash with both doses; denied additional follow-up
Covid Arm- injection site pain, swelling about 2 inches by 3 inches, red light itchy rash, warm to touch, hard under skin injection site about 1 1/2 inch wide.  Lasting longer than 3 days
103.7 fever, Nauseous, Headache, Lethargy, shoulder to elbow redness, tenderness, hot to the touch.