chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via media concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 06-DEC-2021 and 08-DEC-2021. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The dose number in series was 1. 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 an unspecified date, the patient after vaccination, "got Covid (suspected clinical vaccination failure, and suspected covid-19 infection) and was pretty sick". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20211213065. This case, from the same reporter is linked to 20211212261 and 20211223580. This report was associated with a product quality complaints: 90000205503 and 90000205720 . The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0; 20211212673-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
I broke out with hives and itching and I was advised to get over the counter Benadryl and that did not work. The hives continued.
Information has been received from a registered nurse referring to a 25 year old female patient. The patient had no concurrent, historical condition and drug reaction or allergies. On 30-JUN-2016 the patient was vaccinated with VARIVAX (lot # M006156 with expiration date 05-FEB-2018, subcutaneous, once). There was no concomitant therapy. The patient called the office to state she was pregnant with last menstrual period (LMP) of 25-MAY-2016 and estimated due date (EDD) of 01-MAR-2017. The pregnancy outcome was pending. An unknown testing was performed to verify pregnancy. No adverse effects were reported. No treatment was given. The patient sought medical attention at doctor's office. Additional information has been requested.
On 11/16/21, morning. I had itching in my upper legs (both) and scratched. Within a few minutes, I saw hives (small bubble rash) all around that area. Then I felt itching on other parts of the body - behind the ears, back of the neck, back of the hands, inside wrist, etc. Those itchy areas became read and thick. I tool antihistamine (Cetrizine) and a couple of hours later the bubbles disappeared but redness and scratchy sensation continued. Applied Cartizone anti-itch cream on the local spots. Continued the above treatment for 2 days and today (11/19), I had an appointment with my primary doctor. He asked me to continue the same treatment and added Calamine lotion. I never had any allergy before (food or drugs) and in the past 4 days did not eat anything new and never exposed to garden stuff. One of my friend had a similar reaction after Covid shot and has been getting these episodes once in a while.
pt recv vax 31AUG98 & according to pt about 30min p/vax devel h/a for 4 days & few blister sores around mouth (blisters appeared 5 days p/shot);pt had a huge h/a;bump on lip;miserable;had a little bit of crust;
Pt. vomited 7/13/17 the evening she had the vaccine. She began to have small red rashes on lower back and back of legs and on foot. Injection site had same redness and swelling.
Constant severe nausea, severe abdominal burning and cramping, vomiting, loss of appetite, weight loss, severe lymph node pain in arm, neck, shoulder leading to nerve pain in arm.
SEVERE HEADACHE; 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  (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine  was not applicable. The outcome of severe headache was not reported. This report was non-serious.
Experienced a problem after first dose; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and incomplete course of vaccination. On an unknown date, the outcome of the adverse event and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had problem after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Approximately  48 - 72 hours after vaccine was administered, she was found deceased in am of 05/16/2021
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 69 year old female. Initial information was processed along with additional information on 19-AUG-2022. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 10-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 67 years old. No concomitant medications were reported. No adverse events reported following vaccination (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 30-Oct-2021 for covid-19 prophylaxis.  On 16-AUG-2022, the patient started symptoms two days ago with a sore throat (dose number in series 2). On 17-AUG-2022 (day before reporting), the patient got fever and a headache and tested first time negative in the afternoon (dose number in series 2). On 18-AUG-2022, more than 2 weeks following booster shot with Janssen covid-19 vaccine, the patient tested again late at night with home test and this one was positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.  The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as reported complaints were adverse events). this record is for the primary vaccination, however the patient tested positive for covid after the booster. this record therefore captures an adverse event in relation to the primary vaccine. record captures the lack of effect in relation to the booster shot. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220841198.; Sender's Comments: V0: 20220841147-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Head ache, fatigue, burning eyes, myalgia--- all very mild,- no fever.
Elevated monocytes; This non-serious case was reported by a consumer via call center representative and described the occurrence of monocyte count increased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown day patient received 1st dose).   On 26-JUN-2023, the patient received the 2nd dose of Shingrix. On 29-JUN-2023, 3 days after receiving Shingrix, the patient experienced monocyte count increased (Verbatim: Elevated monocytes). The outcome of the monocyte count increased was unknown.   It was unknown if the reporter considered the monocyte count increased to be related to Shingrix.     It was unknown if the company considered the monocyte count increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was the wife of the patient.  The reporter asked could Shingrix cause elevated monocyte levels. The patient had routine blood work in preparation for a physical on Thursday 29-Jun-2023.  The lab work showed elevated monocytes.  The reporter consented to follow up with her and healthcare professional (pharmacy). This case was linked with case US2023090629, reported by same reporter.; Sender's Comments:  US-GSK-US2023090629:Same Reporter
hot; slightly swollen; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included LETROZOLE for Breast cancer.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Patient presented to the ED with CC of weakness. N/V, fever and SOB requiring oxygen. Mild left shift of total WBC, SARS-Cov-2 swab positive, CXR noted mild pulmonary vascular congestion and small bilateral pleural effusions. elevated troponins with no chest pain. diuresis was given and patient had improvement of symptoms of SOB. Patient was discharged to maintain isolation.
Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour.  I am four days into symptoms.  I still have some chest heaviness and still having asthma issues which includes coughing.  I also had side effects of sore arm, chills, fatigue.  Did not seek treatment.  I had no idea how long this would last.  I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER.  I have suffered with this since Saturday.
MOTHER CALLED STATING CHILD WOKE UP THIS MORNING AT 4AM WITH A FEVER OF 101.3 AND VOMITED. STATES CHILD ALSO REPORTED FEELING "LIGHTHEADED, DIZZY, AND HAVING CHEST PAIN". MOM REPORTS MAX TEMP HAS BEEN 101.3 AND SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN. STATES FEVER RESPONDS TO MEDS,  BUT GOES BACK UP WHEN THEY WEAR OFF. ALSO REPORTS PATIENT HAS VOMITED 2X TODAY  AND IS UNABLE TO KEEP "ANYTHING DOWN". ENCOURAGED MOTHER TO TAKE PATIENT TO  URGENT CARE OR THE ER FOR EVALUATION SINCE HE "CAN'T KEEP ANYTHING DOWN" AND HAS  COMPLAINED OF BEING LIGHTHEADED, DIZZY, AND HAVING CHEST PAIN.
Received vaccine on left arm.  Days followed, had Pain in chest, back and right side of next. Progressing pain on right side of body as well as chest. Rash on the right arm and stiff neck as well as sharp and burning pain down the right arm.
Patient received first vaccine 4/8/2021 and second vaccine 5/6/2021. He is now COVID positive requiring high flow nasal cannula 100% FiO2 and 50Lpm. He is immunosuppressed for his prior liver transplant.
Persistent sharp pain at injection site 2 wks after vaccination on 11/9/11.
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 37  days.  Appropriate steps were taken to notify the state and are coordinating efforts to notify patients to repeat vaccination.
This is a spontaneous report from a contactable other HCP. This other HCP reported for a 74-year-old male patient that.  A 74-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183, Expiration date: 31Oct2021), via intramuscular, administered in deltoid left on 25Aug2021 (at the age of 74-year-old) as dose 3, 0.3ml, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: 30May2021), via intramuscular, administered on 14Jan2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: 31May2021), via intramuscular, on 04Feb2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Nausea, Ulcerative colitis, small bowel obstruction, Lymphocytic leukaemia, Thyroid cancer, Basal cell carcinoma all from an unspecified onset and unknown ongoing and concomitant medications were not reported. On 26Aug2021, after the vaccination, the patient experienced headaches and nausea for 5 days. reported that patients are moderately immunocompromised and has a history of leukaemia and received his 3rd dose of the vaccine at the request of the patient's haematologist. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (10Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected.
Extreme pain; Adverse symptoms following administration; arm turned color and it was a full month before the patient was over it; This spontaneous report as received from a other refers to a female patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On an unknown date the patient experienced pain, skin discolouration and adverse event following immunisation.    The outcome of pain, skin discolouration and adverse event following immunisation was reported as recovered/resolved.
Patient came in on 1/27/19 and I gave him a SHINGRIX at around 2:30pm. I recommended him to sit for 10 minutes before leaving. His wife told him to sit down while she shopped. I went to get some vinyl gloves and a shopping cart. When I came back, I noticed him very sleepy while sitting on the chair. I settled my shopping cart for trash, and my gloves and paper work. Then I noticed him at the window, and all of a sudden he fainted and was on the floor. I paged his wife, and we stayed with him. He responded to my question, his breathing normal. After 15 minutes lying on the floor, we helped him walk to the chair. His wife mentioned that he had the same problem with drawing blood. He would stress and faint. However, his flu shot in Oct 2018 was fine. We recommended his wife to take him to urgent care to have his head checked out.
0200 Eyes swollen, lips, tongue swollen. "Whole face puffy." Patient took albuterol, SINGULAIR, BENADRYL, & put PANTHENOL eye drops in both eyes." 0600 repeated above.
lump appeared the following day at injection site that was warm to the touch. The lump has reached the max size three days later (28th of March roughly), but is still there.  The lump is 3 inch x 3inch x 0.5-0.75 inches (L x W x H).
Shingrix shot to Lf Arm sore, Red, Hot to touch. Suggested Ice Pack/Cold Compress/Tylenol, and call to doctor.
significant redness @ site of shot;broncho spasms-mild wheezing;hives;
Accidental Double Dose of Hep B.  First dose on 23 Feb PM, and accidental 2nd dose by Hospital Admin on 24 Feb AM
55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.
Pt noted she felt "weakness, dizzy, woozy like an out of body experience" beginning 4:45 PM on the day of receiving vax. There were no anaphylactic symptoms. The weakness continued until 2:00 AM but the dizziness stopped at 9:30 PM.
Pt. reports pain down entire arm for several days, it got better, but  then returned again.
sore eye and his eye were tender to the touch; lacrimal of his eye is swollen like a little bead in there, hard and tender to touch; like there is a bead in it/lacrimal of his left eye is swollen like a little bead in there; was red/area of lacrimal of left eye red; black skin in his lacrimal area; lacrimal of his eye is swollen; got too hot; headache; felt like faint; stomach ache; right arm sore was swollen and tender to touch; right arm sore was swollen and tender to touch; right arm sore was swollen and tender to touch; where molars are that it hurt so bad; behind his mouth where his molars are that there is a hole which started six days ago. Stated that the hole looked white now; This is a spontaneous report from a contactable consumer (reported for himself). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 02Feb2021 at 10:00 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at other. Medical history included ongoing asthma (Asthma diagnosed since birth). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 on the same day of vaccine vaccination. The patient experienced right arm sore was swollen and tender to touch on 02Feb2021 at 13:00, stomachache at 20:00, headache, felt like faint at 21:00, got too hot on 03Feb2021 at 21:00, like there is a bead in it/lacrimal of his left eye is swollen like a little bead in there, was red/area of lacrimal of left eye red, black skin in his lacrimal area, lacrimal of his eye is swollen on 11Feb2021 at 09:00, sore eye and his eye were tender to the touch, lacrimal of his eye is swollen like a little bead in there, hard and tender to touch on 11Feb2021 at 16:00, right arm sore was swollen and tender to touch on an unspecified date in Feb2021 and where molars are that it hurt so bad, behind his mouth where his molars are that there is a hole which started six days ago. stated that the hole looked white now on an unspecified date in 2021. No treatment was given for the events. The outcome of the events stomachache, headache, felt like faint was resolved on 03Feb2021 and right arm sore was swollen and tender to touch was resolved on 04Feb2021, got too hot, behind his mouth where his molars are that there is a hole which started six days ago. stated that the hole looked white now were resolving, like there is a bead in it/lacrimal of his left eye is swollen like a little bead in there, was red/area of lacrimal of left eye red, lacrimal of his eye is swollen, lacrimal of his eye is swollen like a little bead in there, hard and tender to touch, where molars are that it hurt so bad were not resolved and other events was unknown.  Follow-up attempts completed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Physician).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
I become extremely drowsy about 2 hours after receiving the shot. I couldn't fight it.
Admitted complaining of coughh, SOB, and generalized weakness. COVID-19 pneumonia complicated by acute hypoxemic respiratory failure, antibiotic coverage with ceftriaxone and doxycycline, IV steroids, Remdesivir, Refused Bari. Disposition: Unfortunately patient decided to leave against medical advice despite my best efforts to convince him to stay as he still required 6 L of oxygen on nasal cannula