chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 90 years old patient of unknown gender. The patient's concurrent condition included scoliosis. The patient's medical history included heart attack. On 28-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (lot#K000994, expiration date: 06-MAR-2015) in the right arm (circle one). Concomitant therapy included Influenza virus vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
BLOOD CLOT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This solicited report received from a consumer via PPSCVM000808: concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient advised that she got the vaccine, got a blood clot and then got covid (coded as suspected covid-19 infection, suspected clinical vaccination failure) (Covid was post taking Xarelto). It was not confirmed if other events were before or after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of the suspected covid-19 infection, blood clot and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related; and between rivaroxaban, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021089-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211021089-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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 20211021089-rivaroxaban-Blood clot. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211021089-rivaroxaban-Suspected clinical vaccination 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
Minor swelling and itching of my left hand and wrist, the bottom of my feet, and my lower lip, including numbness of the latter.
The Patient presented via EMS to the ED of local Hospital after cardiac arrest with ROSC on the 14th day after receiving her Covid booster shot.. Per report, pt had been feeling dizzy for a few days and was staying with family members, pt had a witnessed sudden collapse and CPR was initiated. EMS administered 3 rounds of Epi, gave Lidocaine and shocked x1 for Ventricular Tachycardia and ROSC was obtained. Pt was intubated in the field.  In the ED, pt was noted to be hypokalemic (1.3) and with elevated Lactate (13.3). CT Head is negative for acute findings. CT Chest PE, Abd and Pelvis prelim negative for PE, reports enterocolitis. Pt received Potassium repletion, Zosyn, Keppra, 1L NS bolus, calcium and magnesium, and started on Levophed and Propofol gtts.  Pt has been admitted to the ICU for further management.    Upon ICU arrival, Propofol was held for neuro assessment, pt is unresponsive to painful stimuli, pupils reactive, myoclonic jerks noted.  The patient did not improve (see below for EEG results) and was put on comfort care/hospice care starting on 2/4/2023. She was terminally extubated in the ICU on this date.
After the booster she was down for 4 days; It feels like she has covid since April; muscle weakness; changed her livelihood,it is very hard to live every day; pain; muscle fatigue; Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day) and PAIN (pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 002B21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of 400 mg. At the time of the report, ASTHENIA (After the booster she was down for 4 days), FEELING ABNORMAL (It feels like she has covid since April), MUSCULAR WEAKNESS (muscle weakness), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (changed her livelihood,it is very hard to live every day), PAIN (pain), MUSCLE FATIGUE (muscle fatigue), MYALGIA (Body ache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.             Treatment medication include Pain medicine.   This case was linked to MOD-2021-370162 (Patient Link).
After the second dose, the next day, I had heart "palpitations"  which seemed to go away but returned later, as already stated.
Severe Herpes Zoster infection following administration of Zostavax, in the same dermatome of the injection in an otherwise healthy person.
Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and intermittent chills)
PATIENT STATES THAT AFTER SHE RECEIVED THE VACCINE, SHE FELT ITCHY  ON HER THROAT, AND STARTED COUGHING. ANOTHER NURSE AS AN OBSERVER NOTICED PATIENT, AND HELPED ADMINISTERED 50 MG OF BENADRYL TO PATIENT.
nose was congested; throat was scratchy; really bad headache; feeling a lot of fatigue/feeling more tired than he usually is; severe allergic reaction/allergic reaction to the vaccine; fingers tingling; tongue felt abnormally large; bumps on his face, back, chest and stomach; pattient felt very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) in a 19-year-old male patient 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 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) (seriousness criteria medically significant and life threatening), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach), FEELING ABNORMAL (pattient felt very uncomfortable) and PAIN IN EXTREMITY (Sore arm). On 18-Jun-2021, the patient experienced NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) for Allergic reaction, at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 05-Jun-2021, HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach) and FEELING ABNORMAL (pattient felt very uncomfortable) had resolved. On 07-Jun-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use is not provided by the reporter.  Reportedly, patient stayed at hospital for one hour until treatment made effect.   The patient is thinking whether to take a second dose of moderna or not.  Company Comment:  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.
Extremely itchy all over body since the evening after the shot.  Swollen lip next morning and red rash under eyes following  morning.  Still itchy 5 days later.  Taking Benedral.  On 4th day after shot went to immediate care center and doctor prescribed prednizone 20 mg if itching becomes unbearable.  Trying to wait so prednizone does not negate vaccine.
Information has been received from a licensed vocational nurse (LVN) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K009756, exp. date: 09-JUL-2016; L015047, exp. 29-APR-2017; L020000, exp. 02-JUN-2017; L021214 exp 10-JUN-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm, redness around the injection site, I felt tired, had muscle pain, and felt slightly feverish.  I took 4, or 5 doses of 200 mg of Ibuprofen, over the 48 hour period following the vaccination to successfully reduce the impact of the side effects.
My whole upper arm has swelled up and I've had throbbing pain for 2 days. The pain extends all the way into my neck and arm pit. I've been having difficulty using that arm because of the pain. It is also hot to the touch. I have been using Tylenol and ice with little improvement.
hurt their humerus and shoulder on the left side; patient had a feel; Got the first dose on 03May2021 and has not gotten the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Fell and hurt their humerus and shoulder on the left side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL for Gout, LEVOTHYROXINE SODIUM (ELTROXIN) for Thyroid disorder, CLONIDINE, COLECALCIFEROL (VITAMIN D3), OLMESARTAN MEDOXOMIL (BENICAR), AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and MECOBALAMIN (NEUROMET [MECOBALAMIN]) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced LIMB INJURY (Fell and hurt their humerus and shoulder on the left side) (seriousness criterion hospitalization) due to FALL (had a feel) (serious criterion hospitalization). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Got the first dose on 03May2021 and has not gotten the second dose yet). The patient was hospitalized on 25-May-2021 due to LIMB INJURY. The patient was treated with Rehabilitation therapy for limb injury. At the time of the report, LIMB INJURY (Fell and hurt their humerus and shoulder on the left side), FALL (had a feel) and INTENTIONAL PRODUCT USE ISSUE (Got the first dose on 03May2021 and has not gotten the second dose yet) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Chymostatin. Second dose was scheduled on 01 June 2021 but was not able to get it because patient was in hospital. She remained in hospital till 2 weeks ago approximately.; 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 of fall and limb injury, a causal relationship cannot be excluded.   This report ralso efers to a case of Intentional product use issue for mRNA-1273, lot # 007B21A
Child was given Adacel and Menveo in left deltoid IM and Fluarix and Gardasil in right deltoid IM, in that order. Immediately following the last vaccine administration she showed no change in affect. About 1 min following last vaccine admin she stated she had a headache. Shortly after that she began to appear increasingly lethargic and stated she was hot. She did not ever completely become non-responsive but became very drowsy, pale and listless. She was consistently able to answer questions correctly through entire episode. Over about 10 minutes time she would become more and less near syncopal but never completely lost consciousness. After about 10 min she begin to recover and did not relapse. She did continue to c/o headache.
Pt admitted on 7/26 post seizure. Pt has a history of a right MCA stroke. Was found to have influenza A. Tested positive for COVID-19 on 8/2 after having fevers the day prior.
Confusion, brain fog, cold sweat on face and neck.  Unable to formulate sentence or to figure out how to anything such as figure out exits, not sure of whereabouts.
NECK SWELL UP AND NEVER WENT DOWN. NECK GETS REAL SORE WHEN I EXERCISE. LIGHT HEADED ON AND OFF.
Pfizer-BioNEtch COVID-19 Vaccine Patient felt dizzy while she was getting the COVID-19 vaccine.  Patient was waiting to get her vaccine and started feeling anxious, and started having palpitations.  These symptoms lasted for a few minutes and then subsided.  Patient went to ED for evaluation.   08:06am HR 61, NSR no STEMI. discharged at 8:36 am
Injection site pain; headache; body aches; feeling generally unwell; joint pain; This is a spontaneous report from a contactable other-hcp reporting for herself.  A 35-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH 9899), via an unspecified route of administration in the left arm on 21Dec2020 14:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included celecoxib (CELEXA, 20mg). The patient previously took thimerosal and experienced drug hypersensitivity. The patient experienced injection site pain, headache, body aches, feeling generally unwell and joint pain all on 22Dec2020 03:00 with outcome of recovering. No treatment was performed. The patient did not have COVID prior to vaccination nor COVID test post vaccination.
Left Forearm broke out with full body rash the next morning following a hep B vaccination. 3 days later patient went to urgent care to be evaluated. She was precribed Zantec, Hydroxyzine and Loratadine. The patient took the medications as prescribed. 14Apr14, the patient's condition had worsened and was seen again at an urgent care clinic. They took a blood draw, urine sample, and strep culture. She was given a 80mg steriod shot and presribed methylprednisolone tablets. The following day 15Apr14, the patients rash and swelling got much worse overnight. 16Apr14, the patient was seen by an on base physician and a referral was to a dermatology clinic. She was seen by a dermatology clinic on 17Apr14 and had 2 biopsies done. She was prescribed: Prednisone Taper, Clobetasol, Hydroyzine, Loratadine, Ranitadine. 28 Apr she was informed by the derm clinic that the biopsies were positive for allergic reaction.
Information has been received for the pregnancy registry for GARDASIL from a certified medical assistant concerning a 15 year old female patient who on 23-JAN-2009 received a first dose of GARDASIL and was pregnant.  Concomitant therapy included prenatal vitamins.  The patient's last menstrual period was on 27-DEC-2008 and the estimated delivery date is on 02-OCT-2009.  The patient had no previous pregnancies or full term deliveries.  On approximately 03-MAR-2009, the patient experienced a bacterial vaginosis and was treated with METRONIDAZOLE 500 mg twice a day since 03-MAR-2009.  Additional information has been requested.
20 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose). On 02-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL, lot number reported as M014939, expiry date 27-MAY-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Initial report received from a healthcare professional on 17 September 2014. A 69-year-old female patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (manufacturer: Sanofi Pasteur Inc) (batch number: U5015BA, expiry date: not reported), in her left deltoid on 03-Sep-2014 and a dose of pneumococcal vaccine, (manufacturer: other) (batch number: K007773, expiry date: not reported), in her right deltoid on 03-Sep-2014. On 05-Sep-2014, patient experienced bilateral upper extremity swelling, upper respiratory congestion and difficulty breathing. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Headache on and off since Friday, tingling in left arm (Friday about 1-2 hours after shot) right foot right hand (on Saturday-brief) sore left shoulder after shot but didn't last, some very very mild chest pain that doesn't last on Friday evening Saturday morning and Monday early afternoon.
15 month old patient received Kinrix; received Kinrix instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 705JF, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, 15 month old patient received Kinrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
I am 4 weeks pregnant; my due date is January 28. On May 20, I received the vaccine; on May 21, I experienced fatigue and muscle aches for the entire day.
Headache, restricted movement of left arm, low-grade fever, elevated blood pressure, eye discomfort, appetite loss.
Vaccinee is a non-responder p/receiving a series of 3 Engerix-B vax (20 MCG/CC, Deltoid on 2JAN90 lot no. 586A4, 2FEB90 lot no. 586A4 & 16JUL90.
Around 11:00pm night of immunizations, child with 103 temp, after alternating Tylenol and Motrin.  Morning of 2/1/08, child given Tylenol and Motrin simulatneously for fever of 104.  Fever did not decrease, taken to Medical Center.  Blood work, and many other tests ran.  Everything negative.  Pt. given Enema, 3 hours later fever broke.  Pt. dc'd to home.