chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 62 year old,  male. The patient's height, and weight were not reported. The patient's past medical history included diagnosed with prostate. Other pre-existing medical conditions included No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, frequency one total, administered on 05-MAY-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. Patient got the JNJ Covid 19 vaccine on 05-MAY-2021. He had a blood work done with an antibody test on 15-AUG-2021 result was negative (coded to confirmed immunological vaccine failure). He did not mentioned the name of the antibody test. He also stated that he did not had the confidence in the JNJ booster shot since the first shot did not worked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000191134.; Sender's Comments: V0:20210854788-Covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
sore arm for 6 months; fatigue; got coronavirus after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got coronavirus after vaccination), DRUG INEFFECTIVE (Lack of drug effect), PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (Patient reported she has a bad immune system because of this.). Concomitant products included ZINC, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), VIT D [VITAMIN D NOS], ETANERCEPT (ENBREL), ASCORBIC ACID (VITAMIN C ACID), MULTIVITAMIN [VITAMINS NOS], FLUOXETINE HYDROCHLORIDE (PROZAC) and PREDNISONE for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (got coronavirus after vaccination) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue). At the time of the report, COVID-19 (got coronavirus after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 128 (High) Patient reported she has very high antibodies,especially considering she does not have a good immune system..         Treatment information was not provided.   This case was linked to MOD-2021-406306 (Patient Link).; Sender's Comments: This is a spontaneous, lack of efficacy case concerning a 64-year-old, female patient with current medical history of Rheumatoid arthritis, who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately 5 months after the second dose. Immunosuppression due to current medical history of Rheumatoid arthritis, is a confounder for the event  lack of efficacy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Covid monitoring documentation. PT admitted 12/10/21 documented to have positive covid. PT received Pfizer 12/30/20 Lot EP1685 for dose 1. Dose 2 was Pfizer given on 01/20/21 Lot EJ1685.
Patient fainted about 1 minute after vaccination;  he lost strength in his legs and fainted for about 5 seconds. Patient became awake after and coherent of what was going on around him. He still felt weak afterwards and reported light headiness. The paramedics arrive and vitals were reported to be normal. Patient elected to go to the hospital.
Pt was prescribed Mupirocin and Cephalexin to treat cellulitis after receiving her booster dose of Moderna. The vaccinating pharmacy technician that administered the shot did so too low on her arm. Pt had a fever that peaked at 104 degrees F. The fever has down more each day, but she still complains of coughing, raspy voice and general feeling of malaise. Injection site was still red today (12/23/21).
Patient stated that she caught a cold from the vaccine. I tried to explain to her that this vaccine is inactive and could not cause the cold/flu and recommended a cough medication for her. The following day she called back asking if she should go to the emergency room because she felt so bad from coughing so much. She stated that she did not have a fever but that she was coughing up clear flim. I recommended that she go to a walk in clinic.
Patient received Moderna COVID vaccine on 2/28/21 (lot # 024M20A), 3/8/21 (lot # 001B21A), and Pfizer COVID vaccine on 11/4/21 (lot # FE3590). On 9/14/22, patient admitted to our inpatient facility med/surg unit with acute hypoxic respiratory failure likely due to community-acquired pneumonia as well as COVID infection and essential hypertension. Patient discharged on 9/19/22.
Information has been received from a male physician of unknown age via field representative referring to himself. Information about medical history and concurrent condition was unspecified. On an unknown date, the patient was vaccinated with his first dose of PNEUMOVAX 23 (lot number, dose and route were unknown), and did not report any adverse effects from his first PNEUMOVAX 23 dose. On an unknown date (reported as "at least 5-10 years ago"), the patient was vaccinated with his second dose of PNEUMOVAX 23 (lot number, dose and route were unknown), and he experienced local inflammation around injection site with re-vaccination. The patient sought medical attention via physician visit, and recovered from the event on an unknown date. The causality between PNEUMOVAX 23 and the event was unspecified. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with an improperly stored vaccine of GARDASIL 9, via intramuscular, lot # R016127, expiration date 22-MAR-2020 for prophylaxis (dose was not reported). The administered dose of the vaccine experienced a temperature excursion of 56.3 degrees Fahrenheit (°F) for 3 hours and 20 minutes, as recorded by a data logger. The administered dose of the vaccine experienced a previous temperature excursion of 35.6 degrees Fahrenheit (°F) for 12 minutes. There was no adverse effect reported. The outcome of the event product storage error was not reported.
Information has been received from a registered nurse concerning an unspecified number of female patients who on unspecified dates were vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patients experienced pain after vaccination. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this reports. Additional information will be provided if available.
This case was considered medically important. Information regarding PREVNAR was received from a physician regarding an 18-month-old male patient who experienced severe consolidated pneumonia with pleural effusion, and Pneumococcal hemolytic uremic syndrome. The patient received the second dose on an unspecified date, at 4 months of age. The patient experienced severe consolidated pneumonia with pleural effusion at 18 months of age. Several days later, the patient developed Pneumococcal hemolytic uremic syndrome - drug ineffective. The outcome of all events was unknown. No additional information was available at the time of this report.
Pfizer COVID-19 Vaccine EUA:  found to have pulmonary embolism with significant right heart strain, right atrial thrombus, and acute kidney injury in the setting of COVID-19 infection for two weeks. Admitted to the hospital, received anticoagulation, oxygen, and IV fluids. Thrombectomy performed. Discharged home medically stable.
Breathing problems, severe pain, blood pressure 137, was unable to walk, heart rate dropped, was put on oxygen by healthcare provider.
Inappropriate schedule of vaccine administered; This spontaneous report was received from other health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 13-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-MAY-2010 and 20-JUL-2012 (inappropriate schedule of vaccine administered), the patient was vaccinated with the first and second dose, respectively, of hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strengths, lot numbers, expiration dates, routes of administration and anatomical location were not provided).  This is one of 4 cases of the same patient.; Sender's Comments:  US-009507513-2303USA008560: US-009507513-2303USA008558: US-009507513-2110USA001194:
High sugar; Just felt light headed; Just felt sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High sugar), DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.  No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (High sugar), DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder). At the time of the report, BLOOD GLUCOSE INCREASED (High sugar) outcome was unknown and DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder) had resolved.     No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623259, MOD-2022-623266.
Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakness. Treated with  high dose steroids
T 101 Ax, local rxn, rash, adenopathy, allergic event, wheezing
Adverse events occurred 10 -12 hours after the shot.  - 101-degree fever - Chills - Body Aches - Swollen Lymph node in the left armpit - Headache - Nausea  Symptoms lasted about 15 hours, the fever broke and the rest of the symptoms began to diminish.  I took Tylenol to help with the symptoms.   The lymph node in my left armpit is still swollen and certain areas of my body ache almost 48 hours later.
This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL (0.5 ml, lot # K006960 (expiration dates, route and site of administrations were not reported)) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. The health care professional explained that the shipment was received on 29-APR-2015, therefore went under only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information has been requested.
Early January began having palpitations. Cardiologist went up on metoprolol from 25 twice daily to 37.5 twice daily and down on lisinopril 15 to 10 daily. This had no effect. Had EKG which showed PAC's.  Tried ibuprofen 600 twice daily which stopped the palpitations for a month but every time weaning was tried the palpitations would start up again. Now on Mag Sulfate daily which has helped minimally and continues to have palpitations.  Next will be appointment with electrophysiologist and/or adding verapamil.
slipped and hurt her ankle; fever (T100.9F); chills; sweaty; right arm really hurt; body aches (felt like a truck had run her over); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and PYREXIA (fever (T100.9F)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)) and CHILLS (chills). 02-Apr-2021, the patient experienced PYREXIA (fever (T100.9F)). On 03-Apr-2021, the patient experienced ARTHRALGIA (slipped and hurt her ankle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Apr-2021, HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and CHILLS (chills) had resolved. On 04-Apr-2021, PYREXIA (fever (T100.9F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 f (abnormal) 100.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
2nd vaccine received 3 inches lower on arm than 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine). On 14-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable Patient took Acetaminophen before and after vaccination   This case was linked to MOD-2021-044692 (Patient Link).
Right after my first Pfizer shot I felt my left ear clog up and within 10 minutes the left side of my face from my cheek bone to my chin began to tingle and have a pins & needle feeling. It is 6 hours later and I still have this tingling on the left side of my face. It is not as intense as it was earlier but it is definitely still there. I called my Dr.?s office  and they told me they had no reports of this and told me to report it here. In the past with food allergies I have had tingling in my arms but never like this. I was completely fine this morning and this was like within 5 minutes of my first dose I began to experience this. My Dr?s office said you may contact me which is fine. Hopefully this quits soon. Also what do I do for my next vaccine in 3 weeks?
Approximately 4 hours after the shot, my vace and head broke out in with what look like "in grown hairs".  The next morning, 4/23, my lymph nodes on the side of my neck, and under the tip of my chin swelled up  significantly. Still there... Then the headache started (4/23), and is still ongoing. This is accompanied with major body aches, a very low grade fever, and occasional chills. Today, 4/27 at approximately 6:30pm, I started puking.  I'd rather roll the dice with Covid then get a second shot!!!!!!
Strong Itch and rash and still on going . Dr. ordered  Allegra for itch and said not to get the second vaccine. I would like to know what the CDC recommends following an adverse reaction.
Patient woke up next morning on 11/27/2013 after receiving vaccines complaining of a migraine. Migraine per mother led to blurry vision and nausea.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 43rd of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient received her # 1 moderna on 12/30/2020.  Eight days later on 01/07/21 she woke up and felt a "bee sting sensation".  She looked at her arm and noticed below the injection site was a reddened area approx 2.5 inches long by 2.0 inches wide.  The "bee sting sensation" has gone away shortly after noticing the reddened are and now is just tender to the touch.  Encouraged patient to put Ice on the reddened area and or Tylenol or Ibuprofen if needed for pain or swelling. Patient will report back to me tomorrow.  The health department will monitor this situation over the next couple of days. Encouraged patient to follow up with her primary care physician for worsening symptoms.
Information has been received from a Nurse Practitioner concerning a female who was vaccinated with a first dose of GARDASIL (lot # not reported). The nurse reported that the patient "developed swollen lips a few days after receiving her first dose of GARDASIL". It was also reported that the patient had also "just started an unspecified birth control medication". The patient sought unspecified medical attention during a phone call to the office. Patient outcome was not reported. Additional has been requested.
Approximately 5 minutes after the injection, patient experienced lip tingling, nausea, and fullness in his head and right ear. He expressed feeling tightness in his chest. VSS were taken and patient with BP 142/82, Pulse 80. Sats 99-100%. He sat for approximately 30 minutes and most symptoms resolved. Vital sign stable. Still had residual fullness in his right ear and top of head. He was assisted via wheel chair to the ED for further evaluation.