chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she's experiencing shoulder sore and feeling achy after she had her second dose; This is a spontaneous report from a contactable female consumer (Patient) via Pfizer sponsored program .   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shoulder sore and feeling achy after she had her second dose. The patient asked by the caller if it is okay to take Tylenol since she's experiencing shoulder sore and feeling achy after she had her second dose of Covid-19 vaccine. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Left arm soreness for about 5 days. Extreme fatigue the day after the vaccine. Body feels cold all the time, started noticing it around day 3.  My husbands tells me that my body always feel cool to touch ever since I got the second vaccine, even under thick comforter in bed for hours.  My body used to be very warm at night under the comforter.  Now it's always cool.  I also feel like I'm colder in general and have to wear a jacket inside the house (our thermostat hasn't changed).
Patient received Pfizer COVID vaccine on 7/29/21 and 10/28/21. On 3/13/22, patient admitted to our inpatient facility with acute metabolic encephalopathy and sepsis due to COVID19 infection. As of today (3/15/22), patient is still admitted in our med/surg unit.
Two bruises or rashes appeared on my left arm (near my shoulder) near the injection point.  I do not feel any pain or discomfort, but the marks are not healing or going away (after 9 days). I called my doctor,  and he recommended reporting the allergic reaction.
Developed 100F temperature. Allergic reaction. Local reaction with erythema and oedema. Could not rule out cellulitis. Treated her with Keflex.
Needs to take Diclofenac Sodium for arthritis inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included DICLOFENAC SODIUM for Inflammatory arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation). The patient was treated with DICLOFENAC SODIUM for Inflammatory arthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation) outcome was unknown.            Patient wanted to know if it's okay to take her medication as usual before getting the booster dose. She couldn't remember if she was taking the drug when she got the 1st and 2nd dose.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with a history of arthritis, who experienced the unexpected non-serious AESI of Arthritis (needs to take Diclofenac Sodium for arthritis inflammation). The patient received two doses of vaccine and the exact temporal association between the event and vaccine administration was not reported, therefore rechallenge was not applicable. The medical history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with a history of arthritis, who experienced the unexpected non-serious AESI of Arthritis (needs to take Diclofenac Sodium for arthritis inflammation). The patient received two doses of vaccine and the exact temporal association between the event and vaccine administration was not reported, therefore rechallenge was not applicable. The medical history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This is an initial spontaneous report from a contactable nurse. The nurse was reporting for a child. A male child patient (age and race unknown) received PREVNAR on 29FEB2012 at an unknown dose and frequency for unknown indication. Relevant medical history of the patient included acid reflux since an unknown duration. Relevant concomitant medications of the patient were unknown. It was reported that the patient was irritated, his acid reflux was getting worse and had poor appetite. Relevant laboratory tests were unknown. Therapeutic measures taken for the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report. Follow-up (29APR2012) Follow-up attempts completed. No further information expected.
pt was seen in the ER, positive for COVID; hx of CHF; has volume overload - pt refused treatment; pt passed away in the ER
pain and soreness at the sight of his pacemaker just below his pacemaker on the left side and it became increasingly worse; This is a spontaneous report from a contactable consumer (patient). A 91-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number and expiration date unknown), via an unspecified route of administration, administered in Arm Right on 05Feb2021 11:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure, prostate issues and tremor. The patient slipped and fell and cracked his head and broke his back about a year ago (but they repaired his back on an unknown date). The patient's concomitant medications included blood pressure medication from an unknown date at twice daily by mouth, Prostate medication from an unknown date and dose, tremor medication from an unknown date (from past 3-4 years) at 125mg taken once daily and ongoing. On 05Feb2021, the patient experienced pain and soreness at the sight of his pacemaker just below his pacemaker on the left side and it became increasingly worse and so severe he was taken to the ER. The patient was examined a blood work was done and an X-ray was taken, and they could not find anything wrong. Patient stated the pain was really heavy and took more than 48 hours for it to subside and patient continued to have some pain today. The patient was concerned he might be having a heart attack. He went to the hospital ER, they checked him out and everything was fine. He was sent home, but the pain has just gotten worse. The doctor pushed down just below the pacemaker and he thought he would go through the ceiling. The outcome of the events was reported as recovering at the time of report.  Follow-up attempts completed. No further information expected.
Fever; Chills; Generalised muscle aches; Localised erythema, Localised feeling of warmth; Injection site inflammation
Transient ischemic Attack; Double vision; Sore injection site; Red injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site). On 02-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) (seriousness criterion medically significant). On 01-Apr-2021, VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site) had resolved. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment of these events included aspirin, Lipitor and Plavix.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 21-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # L046900, expiration date 23-FEB-2017, intramuscular; dose was unknown). No adverse effect was reported. Additional information has been requested.
Patient received booster dose too soon after 2nd dose.  2nd dose was given on September 3, 2021, and patient got booster on 01/10/22.
Tight chest; Slept terrible the night after shot; Both arms kept falling asleep even though person was not laying on them funny; 2nd shot burned going in.; Hand and arm tingly; Body joints hurt/ache; Person feels ice cold; Terribly nauseous; Low grade fever (99.1 F).; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 03Nov2021 (Batch/Lot Number: E100176) at age of 41-years-old as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 14Oct2021 (Batch/Lot Number: 30155BA) at age of 41-years-old for COVID-19 immunization and experienced tight chest and shortness of breath 30 mins after shot. Lasted 2 hours. Patient was not pregnant. Facility type vaccine was workplace clinic. The patient experienced tight chest on 03Nov2021, 2nd shot burned going in on Nov2021, hand and arm tingly on Nov2021, body joints hurt/ache on Nov2021, person feels ice cold on Nov2021, terribly nauseous on Nov2021, low grade fever (99.1 f) on Nov2021, slept terrible the night after shot on 03Nov2021 and both arms kept falling asleep even though person was not laying on them funny on Nov2021. Clinical course reported as follow: Dose 2 Symptoms: tight chest about 20mins after shot. Tightness not as bad as dose 1. 2nd shot burned going in. Hand and arm tingly. Day after dose 2: Body joints hurt/ache. Person feels ice cold. Chest tight again. Terribly nauseous. Low grade fever (99.1 F). Slept terrible the night after shot. Both arms kept falling asleep even though person was not laying on them funny. No matter what sleep position, arms would fall asleep. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for the events. Outcome of the events was recovering.
Admit for COVID pna. Fully vaccinated 1/2021. O2, steroids, vit-c, vit-d, zinc, rocephin, doxy. Out of window for remdesivir. Improved and weaned to RA. Discharged home.
Pt stated she received vaccine in hospital after childbirth. Next day c/o painful, and rash around her abdomen. Raised hard and redness at site approx. 3 inch diam.
Cramping, fatigue, mood changes, ovarian cysts, continuous vaginal bleeding 10/2012-present.
aches; felt very bad; diarrhea; fever; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-454606, MOD-2022-451926 (Patient Link).
Sore arm, feeling sick, tired, painful lump under left arm, left neck lymph node painful swollen size of half an egg.
BRIEF HOSPITAL COURSE:  The patient was an unfortunate male, who was initially brought to the hospital after involved in a rollover motor vehicle accident.  He was injected from the vehicle.  He had numerous injuries as detailed above.  He was initially treated at the original hospital.  He did undergo a left-sided craniotomy with evacuation on September 9, 2022.  Respiratory pneumonia, encephalopathy, and anemia.  Tracheostomy and G-tube were replaced on September 15, 2022.  He underwent splenic artery embolization and thoracentesis on September 20, 2022.    On October 2, 2022, he was transferred to another hospital for further evaluation and management.  He was placed on ventilator weaning protocol.  He completed a course of Levaquin for pneumonia.  Oral vancomycin course was extended for C. difficile prophylaxis.  He was continued on heparin.  Tube feeds were continued.  DVT workup prophylaxis was continued.    Unfortunately, he really never made any sustained progress in weaning off the ventilator.  In the process of performing some followup CT scans for orthopedic reasons, he was found to have extensive osseous metastases.  He underwent a biopsy of the left sacrum on November 30, 2022.  This revealed an adenocarcinoma.  Oncology was consulted.  This was felt to be stage IV adenocarcinoma of unknown primary.  He was really not felt to be a candidate for any type of treatment.  After extensive discussions with the family, it was decided to make him DNR and withdraw care.  He was taken off the ventilator on January 6, 2023.  He was pronounced dead at 01:17 p.m.  Family aware.
Per pt request (due to previous reactions), a split dose was ordered at 1 week apart, no ae; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a patient (age and gender not reported) for whom a split dose was ordered at 1 week apart, (PT: Product prescribing error), for vaccine influenza usp trival a-b high dose subvirion vaccine [Fluzone high dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Note: the patient had previous reactions.  Concomitant treatment was not reported.  This case involves actual medication error due product prescribing error. It was reported that a split dose was ordered at 1 week apart, no ae (PT: Product prescribing error). It was not reported if the vaccine was administered or not.  At the time of reporting, the patient had no adverse event  Action taken was not applicable.  Outcome was not applicable.  Information about batch no requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a Registered Nurse (R.N.) concerning a 62 year old male who on 19-FEB-2009 was vaccinated subcutaneously in his left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot#662997/1619X).  "As of yesterday (on 09-APR-2009) the patient was complaining of blisters on his tongue and a very sore throat to the point where his teeth hurt.  He had one small blister outside of his mouth.  He went to his doctor and strep test he did proved negative.  He was put on antibiotics.  He has a low grade fever.  He didn't tell the doctor about the shot until today.  The patient called the health department today and the nurse told him to go back to his doctor and have them culture the rash."  Follow up information was received from a Registered Nurse (R.N.) concerning the patient with Penicillin allergy and a history of chickenpox when he was a young child who on 19-FEB-2009 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot number 662997/1619X).  The patient did not experience a rash post vaccination.  On 09-APR-2009 the patient went to see a physician because he developed multiple blisters both inside and outside of his mouth, on tongue, and in his throat.  He also reported that he was "in extreme pain", had pain when he swallowed and stated that his "teeth hurt".  The patient had a fever of 100 degrees Fahrenheit.  The patient's pain rated as 10 out of 10.  The patient was encouraged to see if the doctor could culture for varicella zoster.  Culture for strep was negative.  On 16-APR-2009, the patient was seen by his primary care physician who started him on anti-viral medications.  The physician stated the signs/symptoms were similar to zoster by did not feel it was zoster.  As of 17-APR-2009, the patient had not recovered.  On 20-APR-2009 the patient feeling better but still in pain.  It was reported that the patient was not recently exposed to chicken pox or shingles.  Additional information has been requested.
She got her vaccine, sat for the 15 minutes, and while leaving she was not feeling well, felt tired and wanted to just sit down.  She got home was having pains in her legs and arm and having a rapid heart beat.  She took a nap, grandmother woke her up and she face was swollen, glasses stuck to her arm, arm was swollen, her head was hurting, nauseated and her voice sounded different, rough, raspy dry voice.  Grandmother read the paperwork and saw all the side effects listed that she had.  She was then taken to the ER at Hospital.  She tried to contact her PCP but they have not returned her calls.  She was diagnosed with anaphylactic reaction and given Epinephrine, Sodium chloride, Diphenhydramine, Famotidine, Ondansetron Albuterol and the mask gave her a rash around her mouth.  She is still having pains in her arms and legs and grandmother is going to take her back to the ER.   She was not able to go to school as she was tired and in pain.      She went yesterday and got her allergy shots and has been sneezing and she let them know she had gotten the vaccine.    She feels that the nurse should have alerted her about the AE that she may get.  Grandmother said she would have refused it if she had known that.  Grandmother is concerned that this may affect her Factor VII factor.  She does have a hematologist .
Information has been received from a health professional concerning a female who on 13Dec05 was vaccinated with a 0.5ml IM dose of pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). On 13Dec05 the pt developed a red blotchy rash and there was itching at the injection site. There were no treatments for the condition. The status of the pt was reported as unk. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Within 5 minutes began swearing and became extremely warm. The nurse checked my blood pressure. It had gone to 170/90.  My BP is always on the low side of normal range and I'm usually cold. The raised blood pressure lasted 4 days.
No adverse reaction but vaccine admin error. Patient fist dose on 09/12/2021 was Pfizer.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included sterile diluent (MRK INJ). On 10-JAN-2018 the patient was vaccinated with improperly stored dose of ZOSTAVAX vial 19400 PFU (dose, units and frequency were unknown) (lot # N021170 and expiration date 27-OCT-2018) and properly stored sterile diluent (MRK INJ) (lot number and expiration date unknown by reporter). The temperature excursion was from 6°F to 14°F for 3 hours and 45 minutes. The previous excursion was from 15°F to 46°F for 8 hours. The digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) reported.
REACTION FROM MODERNA BOOSTER; This spontaneous report received from a patient with unknown age, gender, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiration date were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. It was unspecified whether patient had any adverse reaction on covid-19 vaccine ad26.cov2.s. The patient received non-company suspect mrna 1273 ( form of admin, route of admin, and batch number and expiration date were not reported) dose was not reported, every 1 total, therapy dates were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced reaction from moderna booster. Patient reported that they gave Moderna Booster and on the paper work it said JNJ Covid booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction from moderna booster was not reported. This report was non-serious. This report was associated with a product quality complaint:90000205636 and 90000205637. The suspected product quality complaint has been confirmed to be voided (did not meet product quality complaint criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.