chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (patient's daughter) concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, therapy start date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's s kidney transplant team recommended getting another shot of the Janssen covid-19 vaccine because the result of his antibody test was negative (suspected immunological vaccine failure).The reporter also wanted to know where to get the Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191377.; Sender's Comments: V0 20210858460-covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Flu like symptoms: body aches, 101 fever, tired. I stayed in bed all day and felt better after about ten hours. My vaccine site was swollen, huge and red for about a week.
Severe fatigue, muscle pain, joint pain, headache, nausea, dizziness and loss of balance. Mild difficulty breathing. Slept for 22 hours straight. Fever, hot flashes, chills and shivering. Burning in nose.
Fingers are "going to sleep" often and my shoulder has dull pain which, is recurring and not something that I have experienced often
Redness, warmth and pain starting the following day, worsening so came into office on day 2.
This spontaneous report as received from a medical assistant referring to five patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II lot # M039913, expiration date 26-SEP-2018 for prophylaxis, reconstituted with sterile diluent (manufacturer unknown). On an unspecified date, the vaccines and sterile diluent (manufacturer unknown) were exposed to temperature ranges between 47° Fahrenheit (F) to 77° F during a time frame of 12 hours 30 minutes. There was not previous temperature excursion. The temperature excursion was not called by a data logger. Adverse effects were not reported. Follow up information has been received from a medical assistant on 29-AUG-2017. He reported that on 10-JUL-2017, the patient was administered with an improperly stored dose of M-M-R II. Sender's Comments: US-009507513-1707USA004550: US-009507513-1708USA013497.
lethargic, slept for 13 hours first night, 11 hours second night.  No appetite, diarrhea and nauseated.  low grade fever.  Needed 1 1/2 bags of IV.
Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The patient Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on  06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired.  Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered.  Follow up (15Feb2021): This follow up report contains no new medically significant safety information.  Follow up (17Feb2021): This follow up report contains no new medically significant safety information.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In December 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician assistant for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
started 14 hours after injection, very hot at site and spreading outward, pink to red to color, edema  with pain from injection site up to and including lateral neck surface , from injection site  down arm to finger tips , swelling underneath arm , axillary area, did not note lymph node edema
Patient presented to the Emergency Department for evaluation, and he was triaged to room. I reviewed the nursing notes, and he was evaluated by me. Patient presents to the ED with a mild fever followed by a rash after having his MMR vaccine 12 days ago. His exam is with a mild rash here in the ED but is otherwise reassuring.  He is non-toxic appearing and is quite active here in the ED. Interestingly, the timing of his rash and fever coincides perfectly with a reaction to the vaccine, particularly the measles component.  He has not had any contact with known infected persons nor has he been in any endemic areas.  I don't feel that he has a wild type infection at this time.  I feel that continued outpatient management is indicated however we did provide the parents with extensive return precautions.  We discussed these precautions and answered the questions that they had.  He will follow up with his PCP and will return to the ED for any persistent, worsening, or worrisome symptoms.  I wish him the best. Final Diagnosis: 1. Reaction to MMR vaccination; 2. Rash; 3. Fever
expired PENTACEL injection administered to 4 month old baby with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient of an unknown gender who was administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-May-2023 at 5:15 hours, the patient received an unknown dose once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for immunization. Information regarding batch number was requested.  On 15-May-2023, a 4 months old patient was administered expired pentacel injection with no reported adverse event (expired product administered) (latency: same day).  It was reported, "HCP wanted to know if that is considered viable or do they need to repeat the dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 27-SEP-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Client called and stated  left arm very red, swollen and warm to touch. Hurt to move arm. Upper part of her arm. Told client to take Tylenol/Advil every 4-6 hours for pain, cool compress. If worse, call her doctor. Client needed an MMR and told HD that she needed a Varicella instead. Client had Chickenpox as a child.
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 16-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 135 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
C/O "EGG SIZED" LUMP AT INJECTION SITE PER TELEPHONE AND INSTRUCTED TO COME INTO CLINIC FOR EXAM. AFTER EXAM NOTED INDURATED AREA ON UPPER LEFT ARM, WARM TO TOUCH, TENDER AREA PT WAS ADVISED TO GO TO ER, AS SHE HAS YET TO RECEIVE INSURANCE.
Loss in visual acuity, dry mouth with increased and constant phlegm in throat, dry eyes, increased pain in all previous surgery sites. To include : R-wrist, R-ball of foot, both knees, both hip sockets, C-spine, and L-spine, stool is thinner in diameter. On 22Dec21, extreme flu-like symptoms started, including 102.1F fever, chills, congestion, more body aches, coughing, and sneezing. On 25Dec21 tested positive for COVID.
I had a rash that took over my whole body starting with my arms and chest, then my asthma got worse.  I had to take prednisone 3 separate times, use a topical steroid (clobetesol) and take pepcid daily.  After lab work, it was determined that my eosiniphils and IgE levels were very escalated.  I was then put on Dupixent to help decrease the IgE and eosinphil levels.
PATIENT GOT FIRST DOSE PFIZER TODDLER AND SECOND DOSE OF MODERNA TODDLER. HE GOT MIX AND MATCH VACCINE
Patient developed nausea and low-volume emesis within 5 minutes.  Rapidly improved and returned to baseline following emesis.
NURSE WAS CALLED TO FACILITY.  PT WAS NOTED TO BE MORE CONFUSED THAN USUAL.  HE TOLD NURSE THAT THINGS WERE "FLYING THROUGH THE AIR".  HE DID HAVE 2+ PITTING EDEMA TO BLE(NEW TO HIM).  HE DID THINK THE DATE WAS MARCH 4, 2091.  LEFT EYE ALSO SLIGHTLY RED/SWOLLEN.  VSS AT THIS TIME.  MD NOTIFIED.  CG INSTRUCTED TO MONITOR FOR WORSENING EDEMA, INCREASED SOB, INCREASED CONFUSION/HALLUCINATIONS.
The site was little red with inflammation. Around the site is hard to the touch. Patient will take ibuprofen and apply hydrocortisone cream and will go see a doctor if symptoms get worse.
Patient tested positive for Covid-19 after receiving the full series of the Moderna Vaccine for Covid-19. The vaccine was administered by the Department.   Patient tested positive on 4/9/2021 Patient tested negative on 4/10/2021
This study report as received from a consumer, as part of a marketing research program, referring to herself a 72 years female. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date in 2006, the patient and her husband were vaccinated with ZOSTAVAX (dose, strength, total daily dose and therapy route were not reported). The patient reported that her doctor ordered another shingles shot even when the doctor knew that they had a shingles shot. They trusted that the doctor knew what he was doing and yet received another shot on 27-APR-2016 from a nurse, who informed them that shingles vaccine shot was given only once in lifetime. The patient and her husband were having very bad side effects, as of the time of the report and wanted to know regarding this issue. The action taken with ZOSTAVAX was not applicable. The outcome of the event, very bad side effects and overdose was unknown. The causality of the event, very bad side effects to ZOSTAVAX and study procedure was not reported. The reporter considered the event very bad side effects to be serious (details unknown, considered as medically significant). The case is linked to MARRS# 1605USA005707 via same reporter link.
sore arm; head feeling little funny; tasting medication in the tongue; soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included BIOTIN, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for Supplementation therapy, VITAMIN B COMPLEX and ASCORBIC ACID, SODIUM ASCORBATE (VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]) for Vitamin supplementation.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Apr-2021, FEELING ABNORMAL (head feeling little funny), DYSGEUSIA (tasting medication in the tongue) and VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (sore 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.   Patient stated that still have some symptoms, seen a cardiologist- since wondered if developed a myocarditis and have an appointment for a cardiac echocardiogram, stress test and halter monitor on 25-JUN-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-231450 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information received and patient updated that still have symptoms. On 13-Jul-2021: New event sore arm was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-231450:MOD21-114592 (Cross-linked)
Itching very frequent area get red and swollen almost every day since shot was administered. It?s been 3 weeks and same intense itch at injection  area
Hospitalized fatigue, progressive weakness, altered sense of taste, febrile, required O2 at 1-2 L. Treated with remdesivir and dexamethasone
Patient received vaccine, had no problems in store. Left to drive home, started to feel faint, pulled over on side of road and had fainting spell. Patient stated no other problems occurred. Followed up w/PCP w/in 24 hours.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 22-JAN-2016, the patient was inadvertently vaccinated with a dose of an expired PROQUAD (Merck), lot number reported as L010209, expiration date 17-JAN-2016 (dose, route anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Swollen rash on back side of right thigh; Swollen rash on back side of right thigh; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jun2021 at 10:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chiari malformation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL); both from unknown dates for unspecified indications. On 03Jul2021 at 19:00, the patient experienced swollen rash on back side of right thigh. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the  event and included treatment with steroid cream (MANUFACTURER UNKNOWN). The clinical outcome of the event swollen rash on back side of right thigh was resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In addition to reactions I was informed were possible, like headache, nausea, malaise, soreness, chills, body aches, I had several others I was not made aware would happen.   Five hours after the injection, my heart rate increased and I experienced palpitations. I checked to make sure it was not tachycardia, but it was close. My injection site started to become sore around this point, too.  Ten hours after the injection, I experienced extreme chills and body aches. General malaise and body aches followed.  Between 12 and 16 hours later, my heart rate returned to normal; I still had chills and body aches, but I developed a headache, nausea, and pain in my joints. I experienced shooting pains through my joints (shoulders and knees primarily). My anterior left shoulder experienced sustained pain (not shooting pain, sustained pain); this was not the arm I received the injection. Lastly, my body felt swollen even though I did not look swollen. These reactions lasted about 12 hours, after which the pain subsided. The nausea was the next to stop, but my headache dissipated slowly over the next 12 hours.  From injection to reactions subsiding, the duration lasted 48 hours. While I was warned about the headache, nausea, general malaise, soreness, chills and body aches, I was never told I may experience an issue with my heart rate or that amount of pain in my joints.
This spontaneous report as received from a 41 year old female patient (who was also the physician or the pharmacist) with hypertension. In 2004, the patient was vaccinated with 2 doses of VARIVAX, 1 DF for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown) and nifedipine (PROCARDIA). On AUG-2017, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The relatedness between the event and the vaccine was not provided.
Seen in office 8/27/07 for 12 month WCV received Varivax and Prevnar in right thigh, Hep A in left thigh. Seen again 9/6/07 for a few day history of blister and redness on right diagnosis with reaction to Varivax with mild cellulitis treated with Augmentin.
Resident stated her hands and right elbow felt like they were numb, tingly, and like her arthritis was "flaring up," approx 4 days after flu shot. Continued to get worse, and resident developed painful, red rash on 10/14/20, to her right arm. Was sent to the clinic, and received diagnosis of Shingles. Pain continued to get worse, rash spread, resident had falls, and ended up hospitalized from 10/16/20-10/18/20 for chest pain and fainting. Continues to have Shingles pain to right arm, chest, and back ever since.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M017346, expiration date 06-APR-2018 (formulation, strength, dose, frequency, route of administration, indication, were not reported) for prophylaxis. The outcome of expired product administered is unknown.