chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID+ 11/28/22.  Vaccination status - Pfizer x3 + Pfizer bivalent BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider: MD Admission Date: 11/28/2022 Discharge Date: Nov 30, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Aphasia [R47.01] Expressive aphasia [R47.01] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1]   HOSPITAL COURSE:  84 y.o. male presented from rehab after episode of lethargy, speech and visual distubrance during second therapy session of day.Found to be hypotensive with systolic pressures in the 60s. Neurologic status returned back to baseline by time he was seen in ED. Initially concern for TIA vs stoke. Neurology consulted.  CTH revealed no acute intracranial abnormality with mild chronic microvascular ischemic changes. MRI brain unremarkable. Incidentally COVID positive. UA positive and urince culture grew E.coli, pan-susceptible. Patient endorsed burning with urination and was started on 7 day course of antibiotics for UTI treatment (ceftriaxone inpatient with transition to cefuroxime on discharge). On further evaluation initial presenting episode thought to be vasovagal syncope secondary to hypotension. Unclear etiology of hypotension but likely setting of dehydration, therapy, COVID infection and UTI. Patient without any recurrence of symptoms and normotensive throughout admission. Orthostatic vitals negative. Recent echo 08/2022 reviewed  without any systolic or diastolic dysfunction, no aortic valve stenosis. PT/OT/PMR evaluated patient and recommended IPR. Patient medically stable for discharge to IPR 11/30.    Pt currently active inpatient at inpt rehab 11/30/22-
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A male patient of an unspecified age, race and ethnicity received, on an unknown date, pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose, for immunization (unsure if the patient received PREVNAR 13 or PNEUMOVAX). Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient, after receiving pneumococcal vaccination, eventually developed Guillain-Barre syndrome. Clinical outcome of the event was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "Guillian-barre syndrome" due to the information currently available.  More information such as medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Return of mild aches and pains associated with internal inflammation of upper and lower abdomen and pelvic area.  Similar aches and pains experienced when recovering from the abdominal surgery.   Difficult to urinate and move bowels again. Began taking an anti-inflammatory again.
Vaccines that were administered beyond use date after thaw process/ Expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process/ Expired vaccine administered) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process/ Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process/ Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 36 years 7 months.  No concomitant medication was reported by reporter.  It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted.  Patient got Moderna with vaccine  No patient involved with any adverse reaction.  No treatment medication was reported by reporter
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL on an unknown date (lot # and route were unspecified). On an unknown date the patient experienced nausea, fever and body aches. The outcome of body aches, fever and nausea was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (1208USA001866 and 1208USA001868). Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 62-year-old non-pregnant female patient with drug reaction/allergies to amoxicillin and prednisone. There was no information about the patient's medical histories provided. Concomitant therapies included atorvastatin, duloxetine hydrochloride, filgrastim, NEXIUM, sumatriptan and clonazepam. In September 2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular, lot # R012632 and expiration date: 15-JAN-2020 (exact dose was not reported) for history of pneumonia. In September 2018, the patient experienced low grade fever, pounding headache and welts on arm. The tramadol was given to the patient for headache. The outcome of the event was reported as recovered. The causality assessment between the event and PNEUMOVAX 23 was not provided.
At 11 PM, about an hour after I went to bed I woke up with extreme nausea. I knew I was likely going to vomit so I walked into the bathroom. I got down on my hands and knees to prepare to vomit in the toilet and that is when I blacked out. My husband heard me hit the floor and called out my name several times and got no response. He entered the bathroom and was able to arouse me as I was vomiting on the ground. I have no memory of the time between leaning over the toilet and being awakened by my husband while laying on the bathroom floor vomiting. I have never in my life fainted or blacked out in any way, so this was highly unusual.
Information has been received from a healthcare worker referring to "2 or 3" unspecified patients. Information regarding concurrent conditions and medical history was not provided. The "2 or 3" unspecified patients were vaccinated with doses of improperly stored VARIVAX (Merck) on unspecified dates since 14-APR-2015 (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Had pain at the injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and lethargy. On an unknown date, the outcome of the injection site pain and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain and lethargy to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in her left arm and had pain at the injection site and lethargy.  The reporter stated she received the COVID 19 vaccine, sometime after between the 1st and 2nd dose of the Shingrix vaccine. The reporter consent to follow up. For tolerance of 2nd dose refer case US2021AMR088731.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088731:Same reporter. 2nd dose.
About 12 hours after the injection I woke up in the night with my Left knee and ankle in severe pain. I started with a king and a headache. The next day my knee and ankle were fine and I tired and my migraine kicked in. I felt feverish and my arm was sore. everything seem to fade except my migraine continued for days, weeks, and I still have it! Nearly 3 weeks later?? I tried going back to work for two hours at a time, unsuccessfully! I was unaware that the side effects for last this long?? Please help!
Extreme nausea for 2 1/2 hours but could not vomit; Fever of 101 degrees for hours; Chills; Joint and Muscle pain; Joint and Muscle pain; Ache all over; some dizziness; felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 11:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's Lymphoma - in remission" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, on 13Sep2023 as dose 1, single; TRAMADOL; GABAPENTIN; NORCO; ATORVASTATIN. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine"; Lyrica, reaction(s): "Known allergies: Lyrica"; Prozac, reaction(s): "Known allergies: Prozac". Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Ache all over"; CHILLS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering"; NAUSEA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Extreme nausea for 2 1/2 hours but could not vomit"; PYREXIA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Fever of 101 degrees for hours"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 03Oct2023 at 02:00, outcome "recovering" and all described as "Joint and Muscle pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "felt like a bad flu"; DIZZINESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "some dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, pyrexia, chills, arthralgia, myalgia, pain, dizziness, influenza like illness. Additional information: 15 hours after receiving vaccine: Extreme nausea for 2 1/2 hours but could not vomit. This was the worst nausea she had ever had since she was a kid, fever of 101 degrees for hours, chills, joint and muscle pain, ache all over, some dizziness; all of this felt like a bad flu. The patient did not have covid prior vaccination. No covid tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient came into the nurse visit appointment to obtain fasting labs, biometric measurements, and receive her second recombinant shingles vaccine. During the visit, the patient asked if she could also receive her bivalent booster. Per patient, has not received "the new booster...only pfizer vaccines" and that she would like one if possible. Prior to administering the booster, RN screened patient by asking more questions to confirm she was a candidate for the booster. When the RN reviewed the patient's chart and history, the last covid vaccine the patient received was dated 10/20/2022, however the RN did not expand the vaccine in the chart to see that it was a Moderna Bivalent. This indicates that the patient had received a higher than  authorized dose per CDC. After patient received the additional dose, she was monitored for 20 minutes with no complaints of a reaction. RN contacted local Immunization Registry, CDC, and Moderna to obtain guidance soon after RN had discovered patient had a previous dose of the Bivalent Booster. Patient reported she is currently doing well. Patient verbalized understanding to seek emergency if she develops an adverse reaction. Patient was educated signs and symptoms of an adverse reaction.  Patient was contacted
07/29/04, per email: Had reaction raised lump with red bumps left arm where got shot. Saw nurse, no fever. Site larger than 1/2 dollar and raised 1/4 inch and bumps, warm to touch, not painful. Gave Ibuprofen yesterday mom states area coming down this AM.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 29-AUG-2014, the patient was vaccinated with the first dose of VAQTA, intramuscularly (lot number and dose not reported) and RECOMBIVAX HB (lot number, dose and route not reported). In approximately September 2014, the patient received the second dose of RECOMBIVAX HB on schedule. On 06-FEB-2015, to complete the series, the patient was inadvertently administered the second dose of VAQTA intramuscularly (lot number and dose not reported) and the third dose of RECOMBIVAX HB (lot number, dose and route not reported) which she stated was to soon for both products. No adverse effects were reported. Additional information has been requested.
Extensive Left Deltoid swelling, erythema, warmth.  Onset day after immunizations (Tdap, MMR in left arm).  Treated with ice, anti-inflammitories, antihistamines.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1808980, expiry: 15-FEB-2022) dose was not reported, 1 total, administered on right arm on 07-APR-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (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 and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered to right arm 09-NOV-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. No concomitant medications were reported.  On 31-MAY-2022, the patient experienced cough and felt chilly (suspected covid-19 infection and suspected clinical vaccination failure) (Dose number in series 2). On 01-JUN-2022, the patient experienced bad headache and fever (Dose number in series 2). On same day, the patient tested positive with home covid test which led to suspected clinical vaccination failure (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint; 90000233758.; Sender's Comments: V0: 20220601985- covid-19 vaccine ad26.cov2.s- suspected 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.
Large raised red hard knot on arm, approximately 3 inches x 2 inches oblong shaped. Arm spasms throughout the night, tingling in arm upon waking.
TOTAL HOSPITAL COURSE: Patient is a 76M PMHx of HTN, HLD, CKD, a-fib on Xarelto, h/o CVA 10 years ago, BPH, CHF (EF > 50%) presents with distal pancreatic mass, concerning for malignant mucinous cyst s/p laparoscopic converted to open distal pancreatectomy en bloc resection with splenectomy, partial gastrectomy, and partial colectomy on 11/9. Initially confused post-operatively, improved after pca, Dilaudid and Benadryl dc'd. Admitted to the ICU for required pressor  support and post-op monitoring and management.Diarrhea has resolved after Colace  dc'd. On 11/17 patient developed weakness and facial droop overnight concerning for stroke/TIA, self-resolved after 1 hr. Pt transferred to medicine, neurology consulted, started on edoxaban, ASA, atorvastatin. Meningococcal, and H.flu vaccines given, PPSV23 given. COVID booster given. CT head 11/19  encephalomalacia of the left cerebellum, otherwise neg. MRI deferred for staples  s/p abd surg. Patient had constipation which resolved with docusate and enema.  Given deconditioning and prolonged stay in hospital, over weekend patient  developed a possible mild pneumonia as evidenced by respiratory symptoms and an  elevated WBC(15.6). Patient remains stable and SAR would further assist in  clearance of secretions. He was also started on IV Zosyn, and WBCs downtrending  to 11.7 today. Will be transitined to Augmentin PO upon discharge to SAR.   Excision pathology from Surgery 11/19:       -   PANCREATIC PSEUDOCYST WITH ORGANIZING MURAL HEMATOMA.       -   LOW-GRADE PANCREATIC INTRAEPITHELIAL NEOPLASIA.       -   BACKGROUND CHRONIC PANCREATITIS.       -   SMALL ACCESSORY SPLEEN.       -   COLON, SPLEEN, AND STOMACH WITHOUT DIAGNOSTIC ALTERATION.       -   NO CARCINOMA IDENTIFIED.       -   NINE BENIGN LYMPH NODES.
10 minutes after vaccination. Patient fainted while in the doctor's office and was unable to get up. She continued to feel light headed for approximately 1 hour.
Continuing headache and nausea for almost a week after second dose of vaccine. Lasting much longer than other reactions.
Maculopapular rash on face trunk & legs fever 101.3 -  6 days after admin of vaccine.
Ulcers in her mouth; Mouth is extremely sore; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 14May2021 13:00 (at the age of 51-years-old) as dose 1, single for covid-19 immunisation. Medical history included Allergies: penicillin, Metastatic breast cancer from 2017 and ongoing, ongoing Immune compromised, Surgeries: double mastectomy for the metastatic breast cancer from Dec2016 to an unknown date and anxiety. Concomitant medications included adriamycin [doxorubicin] taken for breast cancer metastatic from an unspecified start date and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 15May2021 the patient experienced ulcers in her mouth and mouth is extremely sore. The patient reported ulcers in her mouth and asked if these are common and can she receive the second dose. She had seen her doctor and was prescribed Magic Mouth wash. The patient stated that she had a side effect after the first dose of the vaccine. Should she get the second dose. The patient was told that she should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. She reported tha she just received the vaccine this past Friday, 14May2021 at 1:00 pm and had ulcers on both sides of her mouth and theres a lot of them. The inside started to get sore Saturday evening then Sunday they were there and Monday and today they have gotten bigger over the course of the past several days. She says the ulcers started in the evening. The patient was undergoing chemotherapy. She called her doctor to tell him what was happening and was prescribed a mouthwash called Magic Mouthwash. She does not know the dosage of the Magic Mouthwash. She called her dentist too because it was in the mouth and sent him pictures of the inside of her mouth but he did not call anything in because she is on chemotherapy and he did not want anything to interact with the chemotherapy. The caller says her niece had the same experience but did not report it, her sister-in-law said her lips were really dry too and she did not correlate it to the vaccine. She stated that her own mouth is extremely sore. This is a clone master case, report 1 of 3. Therapeutic measures were taken as a result of ulcers in her mouth and mouth is extremely sore. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
ACUTE PAIN IN RIGHT ARM JOINT TO SHOULDER  -  SMALL AREA ACUTE PAIN IN RIGHT KNEE JOINT IN MIDDLE FRONT - VERY SMALL AREA
Many more lymph nodes and lung nodules than before; Many more lymph nodes and lung nodules than before and now it is in liver too; Enlargment in breast mass; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Enlargment in breast mass), PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BREAST MASS (Enlargment in breast mass). On 16-Feb-2022, the patient experienced PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too). At the time of the report, BREAST MASS (Enlargment in breast mass), PULMONARY MASS (Many more lymph nodes and lung nodules than before) and HEPATIC MASS (Many more lymph nodes and lung nodules than before and now it is in liver too) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, Positron emission tomogram: abnormal (abnormal) Not only the breast mass had greatly enlarged but there were many more lymph nodes and lung nodules than before and now it was in liver too..         No concomitant product was provided.  It was reported that this time results were much worse than before.  The patient was quite clear that the booster shots were certainly not safe for her and had resulted in her and now dealing with a fatal disease.  No treatment information was provided.   This case was linked to MOD-2022-508678 (Patient Link).