chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Fever, chills, pain at injection site, fatigue, tachycardia (150 bpm) 5 hours duration, afib , headache, and jaw pain occuring two days after injection.
Fever started 2 days following vaccine and lasted 3 days - fever was controllable with MOTRIN. Today client has red welts that itch on (R) arm, chest abdomen and both legs. (R) hand is swollen and red. OBGYN advised her to follow-up with primary physician.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2016 (reported as between 30-NOV-2016 and 01-DEC-2016),  the patient was vaccinated with a first dose of improperly stored VARIVAX (lot # M023383, expiration date: 11-MAY-2018) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 14.4 degrees Fahrenheit for 2 hours and 20 minutes. Additional information has been requested.
Typhoid Live Oral - After 2nd pill taken, massive migraine, violent vomiting and diarrhea leading to ER visit where she received IV fluids.  She was released but the only symptom that was relieved by this was the vomiting.  She has had intense pain in her head and abdomen since 1/10/23 when this all started.
About 5 hours after receiving the shot, I experienced moderate fatigue and moderate joint pain. I took a nap of about 4 hours. Woke up with severe joint pain and still tired. Took acetaminophen (1,000 MG), per pharmacy recommendation during vaccine administration if I were to develop side effects. Acetaminophen downgraded pain to mild. I ate dinner. About 3 hours later, I developed severe chills, shivering, joint pain, and muscle aches that lasted about 2 hours until I fell asleep. Had a temperature of 100. Woke up the next morning (today), still feeling moderately sore in joints and muscles but temperature is down to 99.1 and no chills or shaking. Took more Tylenol. Symptoms are mild as of now.
Shoulder pain 1st day.  Widespread severe joint/ muscle pain 2nd day.  Was unable to report on checkin.  Received the text to checkin 4 days after.  Checked in , left page to get verification code, went back to  page and got message that I had already completed the check-in .  I had not done so.
PATIENT WAS GIVEN AN UNDILUTED DOSE (0.2 ML) OF PFIZER PEDIATRIC COVID 19 VACCINE.
neuropathy in feet prior to start worsened and feet felt like boulders during the flare.; aching all over; Fatigue during flare; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.) (seriousness criterion medically significant), PAIN (aching all over) and FATIGUE (Fatigue during flare). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in feet prior to start worsened and feet felt like boulders during the flare.), PAIN (aching all over) and FATIGUE (Fatigue during flare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Flare was worsen after second dose and calmed down after Md gave her a steroid shot last week. MEd told her they are unsure if the flare is related to covid or the con-med isn't working because Xeljanz ( Tofacitinib) is been taking for 3 years. Md is concerned about recent study linking xelijanz ( Tofacitinib) and cancer.  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.  Action taken with mRNA-1273 in response to the event was not applicable.; 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.
*Intense itching more intense at night *Rash - bumps and whelps on arms, chest, shoulders, upper back, lower back and stomach *Redness of face on jaw and cheeks
Adverse effects began 3 to 4 hours after vaccination. Patient reports arm soreness with pain moving down arm and into chest, back and top of jaw. Patient got up and felt dizzy. Fell over and blacked out with eyes open for a few seconds. She does not remember falling over.
Patient in observation area began to feel "fuzzy" after vaccination.  Patients mother stated she has a history of fainting.  Patient was pale, diaphoretic, and limited responsiveness.  PHN place patient on cot and administered oxygen at 6 liters.  Vital signs of 109/73, HR 72, and 98% oxygen.  Patient on oxygen for 10 minutes.  Patient recovered well without concern.  Patient sent home in stable condition with her mother and told to call her MD if she has further concerns.
Coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported ,   No treatment medication was reported .
Two days after patient was given Zostavax immunization on 9/20/13, patient came in today 10/2/13 with circular redness. It has dissipated some. Patient says he has bumped injection site a few times, irritating spot.
Became dizzy and pale and experienced LOC <3seconds. Recovered well after oral fluids and comfort care.
Admission Date: 9/8/2022 Discharge Date: 09/16/2022  PRESENTING PROBLEM: Generalized weakness Chronic renal impairment, stage 4 (severe) Hyperglycemia due to diabetes mellitus Hyperosmolar hyperglycemic state (HHS) COVID-19 virus infection   HOSPITAL COURSE: Patient is an 87 year old female with past medical history of NIDDM2, gout, PAF, mechanical aortic valve on coumadin, diastolic heart failure and CKD 4 who presented to ED to the ED with generalized fatigue. She had been on prednisone  for 10 days leading up to admission for gout flare. In the ED, pt was found to have BS of 659, sodium of 129, normal AG, bicarb. pH was elevated and beta hydroxybutyrate of 1.08. Her CBC showed leukocytosis of 18. COVID positive and CXR showed no acute process. She was admitted for further treatment.   She was started on endotool and director of medical services was consulted. She was transitioned to basal bolus on 9/9 but did continue to be hyperglycemic. Her a1c was found to be elevated to 12.1. The director of medical services assisted with management of basal bolus insulin. Recommendations to discharge on Novolog 70/30. The patient's husband is also on 70/30 at home and they feel comfortable with the management/administration of this. She should follow up with the director of medical services, or with her PCP for further management of DM.    Regarding COVID diagnosis, she remained stable on room air. She did not require remdesivir or decadron. She was noted to have supratherapeutic INR but no active signs of bleeding. No reversal agent given but coumadin held. She subsequently became subtherapeutic, and was placed on heparin gtt while awaiting therapeutic INR. She was not a candidate for lovenox given CKD. Once INR therapeutic x 2 consecutive days, she was felt stable for discharge home. She was advised to have her INR checked on Monday 9/19 as her lab is not open over the weekend.    PT/OT evaluated and recommended discharge home with assist and HHC. She was discharged home in stable condition with her husband on 9/16. All follow up recommendations discussed in detail with the patient and her husband prior to discharge.
Patient is describing that he had to go urgent care 3 day following vaccine due to gout flare attack. he ended up in emergency room a week later. He is telling he has severe hypertension after getting covid short.
Information has been received from a physician concerning a 9 months boy who on an unspecified date was vaccinated with MMR II.  On 28-NOV-2009, the patient experienced mumps.  It was diagnosed on 04-DEC-2009 that the patient was afebrile.  It was also reported that the patient had lower jaw pain.  At the time of this report, the patient's outcome was not reported.  Follow-up information was received from the physician indicating that on 31-DEC-2009, the patient developed mumps.  It was diagnosed on 31-DEC-2009 that the patient had bilateral parotitis.  The first blood work on 31-DEC-2009 revealed IgM <1:10, and IgG 1.42.  No further information is available.
2-3 minutes after the GARDASIL injection, patient felt "funny" and looked pale. He felt faint. He was put in a supine position. BP 105/62 after 5 mn. BP 110/68. Patient observed for 40 minutes and remained stable. Pt called next day 24 hour later and he was normal.
NON - IC patient received Moderna full dose 0.5mL for B1 in error. Vaccination happened on 09/21/21 and discovered today as indicated in this report.
Tingling at site of injection; Feels tight at site of injection; Itchy kind of feeling at site of injection; Pain at site of injection; Red at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Tylenol.
The following morning woke up with 102° temp.  Needless to say I did not go to work.  Was out till following Monday. Along with a very bad headache.   To this day I have had a headache.   It comes and goes in intensity,  but always a headache.
PATIENT FAINTED ABOUT 5 MINUTES AFTER RECEIVING VACCINATION. PATIENT WAS SITTING ON A BENCH AFTER VACCINATION AND STATED SHE FELT LIKE SHE WAS GOING TO PASS OUT OR THROW UP. WE WERE ABLE TO CATCH HER BEFORE SHE FELL, LAID HER DOWN ON HER LEFT SIDE AND SHE WOKE BACK UP.  AFTER WAKING UP SHE SAID SHE IS PRONE TO FAINTING AND WAS VERY NERVOUS TO GET THE VACCINATION.  GOT THE PATIENT A BOTTLE OF WATER, SHE LAID ON THE BENCH AND DRANK THE WATER FOR ABOUT 20 MINUTES, SAT UP FOR A FEW MINUTES THEN LEFT THE STORE STATING SHE WAS FEELING FINE.
cried for 3hr straight 1/2tsp APAP given;fussy behavior started 1hr p/vax;pt would drift off to sleep for only min @ a time & wake up w/a jerk-screaming;cried intermittently from 7PM-2AM would then sleep 1hr & awake until 12noon on 13AUG96;
ALLERGIC REACTION; This spontaneous report received from a consumer via other manufacturer (Novo Nordisk Inc.) concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total (dose 1) administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. Non-company suspect drug included: Rybelsus (semaglutide) 3 mg (Miligram) (tablet, oral, batch number was not reported, expiry: unknown) 3 mg, 1 time every 1 day, therapy dates were not reported, and 7 mg, 1 time every 1 day, therapy dates were not reported for diabetes mellitus.  On an unspecified date, the patient experienced allergic reaction. On an unspecified date, he was hospitalized for a week and a half. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with semaglutide was not reported. The patient recovered from allergic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220821349-covid-19 vaccine ad26.cov2.s- Allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Seen in office on 3/14/2011 due to symptoms.  Per the patient:  the Left deltoid area was sore soon after the injection on the day of the injection. Went home and applied heating pad. Then the next day felt ill: Fatigue, Nausea, Dizziness, lightheadedness.  Near syncope, but no true syncope.  Then got cold but was running fever.  Tm 100.2. Ached all over. Headache. Loss of appetite.  Had palpitations and glands were swollen on 3/12/2011.  Better by 3/14/2011. Redness and swelling in left deltoid started on 3/13/2011--2 days after shot. Still very sore on 3/14/2011.  Both shots given in similar area.
I had tenderness in my am around the injection location, but later that day developed fatigue and headache.   The adverse reactions lasted until the morning of 1/14/2021.
Patient had a changein their stabilized PT/INR requiring a dosage change .  Patient had been stablilized for some time on a dosage and after getting moderna vaccine alteration had to be made in dosing to maintain paitient in theraputic range.
Dizzy for 4 days, migraine and weakness tiredness, 8 days later slight fever warmth at injection site..no rash yet. rash on first shot though.
Fatigue, weak, dizzy, lightheaded, slurring words, blurred vision, double vision, hearing off, smell and taste is a chemical smell and taste, memory lapse, arms and legs feel like jello, not eating, continually getting worse.
Pt says about 12 hours after she got the shot, she had nausea, shivers, body weakness, elavated temp (98.4 F) bad headache and yesterday the area was still swallen. The sore are is about 2-3 inches big and the redness around the area is about 5-7 inches big
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M036728 with expiry date of 20-MAY-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014176.
Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included TROSPIUM and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
RBC low; HCT low; HEM low; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 12Apr2021, the patient's red blood cells (RBC) were low, hematocrit (HCT) was low and hemoglobin (HEM) was low. The events resulted in the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events which included a treatment of hydration. The clinical outcome of the events RBC low, HCT low, and HEM low were recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021.    On 15-Oct-2021 at 8:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.  The vial did not undergo any temperature excursions.   This case was linked to MOD-2021-354542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant Follow up- Medical history updated
This spontaneous report was received from a registered nurse and refers to a 57-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with PROQUAD (albumin status was not provided) lot # N019251 with an expiration date 20-DEC-2018, subcutaneously for prophylaxis (anatomical location was not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.
Huge "bruise" swelling, hot to touch, itchy & painful on 11-16-10. On 11/17/10 Rx TYLENOL/ice BID x 4 days on 11/20-21 swelling started to decrease & bruising decreased but swelling & discoloration still present on 12/2/10 with mild tenderness.