chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 4:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 23-Mar-2021,vaccine moved to fridge and vaccine BUD date was reported as 22-Apr-2021.  Condition of vaccine prior to administration was reported Not frozen.   On 27-Mar-2021,vaccine excursion time were 9am and 10am at 35 degree F temperature. On 28-Mar-2021,vaccine excursion time was 10am at 35 degree F temperature. On 29-Mar-2021,vaccine excursion time was 10am at 35 degree F temperature. On 30-Mar-2021,vaccine excursion time was 9am at 33 degree F temperature. On 31-Mar-2021,vaccine excursion time was 8am at 32 degree F temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
first dose had me on deaths bed; could not move for 2-3 weeks/could not move the arm without sharp pain going down the whole body; arm hurt for 2 weeks/I could not move my arm; had severe migraines for 2-3 weeks; Adverse reactions to the vaccine; reaction made very sick/ Iwas very sick; had a sinus infection; slept all day everyday; not feeling well; could not get out of bed; refused the second dose; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (first dose had me on deaths bed) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (first dose had me on deaths bed) (seriousness criterion medically significant), VACCINATION COMPLICATION (Adverse reactions to the vaccine), ILLNESS (reaction made very sick/ Iwas very sick), MOBILITY DECREASED (could not move for 2-3 weeks/could not move the arm without sharp pain going down the whole body), SINUSITIS (had a sinus infection), PAIN IN EXTREMITY (arm hurt for 2 weeks/I could not move my arm), MIGRAINE (had severe migraines for 2-3 weeks), SOMNOLENCE (slept all day everyday), MALAISE (not feeling well), BEDRIDDEN (could not get out of bed) and INTENTIONAL DOSE OMISSION (refused the second dose). At the time of the report, NEAR DEATH EXPERIENCE (first dose had me on deaths bed), VACCINATION COMPLICATION (Adverse reactions to the vaccine), ILLNESS (reaction made very sick/ Iwas very sick), MOBILITY DECREASED (could not move for 2-3 weeks/could not move the arm without sharp pain going down the whole body), SINUSITIS (had a sinus infection), PAIN IN EXTREMITY (arm hurt for 2 weeks/I could not move my arm), MIGRAINE (had severe migraines for 2-3 weeks), SOMNOLENCE (slept all day everyday), MALAISE (not feeling well), BEDRIDDEN (could not get out of bed) and INTENTIONAL DOSE OMISSION (refused the second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medication information provided.  No relevant treatment medication information provided.  Patient had refused for second dose as first dose had him on deaths bed.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
No adverse event; patient received a booster dose instead of a first dose of a Primary dose.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported that a patient was mad and frustrated because she received a booster dose instead of first primary care series dose. No treatment medications were reported.
facial flushing; muscle soreness in upper left arm and left shoulder; pain in right hand; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 22Feb2021 09:00 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history was none. The patient's concomitant medications were not reported. On 22Feb2021 12:00, the patient experienced facial flushing, muscle soreness in upper left arm and left shoulder and pain in right hand. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the reported events. The patient recovered from the events on unspecified date in 2021.    No follow-up attempts are needed. No further information is expected.
pt recvd vax; pt exp soreness; area around inject site was hot to touch; & she exp pain in her shoulder & neck;
Woke up with a High fever of 102.8 on same day vaccine was administered at approximately 11pm. Patient was very lethargic and complained of severe headache and eye pain. Fever got worse at 5 am the next day. About 104 degrees. Continued lethargy all day and fevers, headache and vomiting.
developed itching on both legs, took 25 mg benadryl, hives started developing on upper torso even after benadryl was on board.  Patient called the pharmacy at 6:15 that evening and asked what next step should be.  He was advised to go to an acute care clinic to be evaluated.  Patient was seen that evening around 7:00  and given dexamethasone 10mg as a single dose, pepcid 20mg,  cetirizine 10 mg. After receiving medications, symptoms were resolved and did not reappear.  Patient was advised to follow up with PCP the following day which was done
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.
Seizure beginning with R arm shaking, subsequently whole body shaking, unresponsive, lasted ~5-7 minutes.  EMS called, arrived 10 minutes after onset at which point shaking stopped.  Another 25 sec episode of whole body shaking in ambulance.  Not back to baseline when first arrived in ED (irritable, not tracking, minimally responsive to mom's voice) but at baseline prior to discharge.
site injection pain; muscle in arm pain; tiredness; foggy head; Chest muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 15:15 (at the age of 38-years) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and experienced allergies. On 05Jan2021 04:15, the patient experienced injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain. The patient did not receive any treatment for the events. Since vaccination, the patient had not been tested for COVID-19. The outcome of the events injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain, was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt recv vax on 4/29/99; on 5/1/99 pt exp local rxn of warmth/ erythema/ induration
Initial report received from a physician on 29 Dec 2010: This patient was vaccinated with reconstituted MENVEO (batch number 100022) 0.5 ml intramuscularly on 09 Dec 2010. Immediately after vaccination, he experienced redness, swelling and pain at the injection site which lasted four days. The outcome of the events was recovery as of 13 Dec 2010.
hives/urticaria 1 week after 2nd vax; present x 3 days then recurred weekly  2 addn weeks
Within 24 hours, I had diarrhea, blurry vision and within 48hours, I started having bloody diarrhea and stomach pain. after a month of scans, ultrasound ,blood and stool sample, I had a sigdioscopy and the Gastroenterologist confirmed I have ulcerative colitis, an autoimmune disease. No one in my family has this.  I was put on steroids, medications ,rectal foam nothing worked. So last week, I started a biologic infusion and now will be self injecting from May. I have a life long illness which I didn't have before.
administered expired menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 46 years old female patient who was administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2022, the patient received a  0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine(unknown formulation, strength (batch lot number: U6952AB expiry date :09-Jun-2022) via unknown route in unknown administration site for immunization.  On 16-Jun-2022 (latency :same day)the patient developed a non-serious event of administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
mom states pt became fussy 5MAY96 @ 1AM;tenderness&swelling devel esp on rt side of face&neck on 6MAY95;devel incoordination&became incoherent on 7MAY96 not being able to stand up or eyes track when woke up 7MAY96;taken to ER t100.3
Patient states woke up this morning with 3 red, itch welts on L arm, 3 welts on L leg, and 1 welt on L side. Welts were not there at time  patient went to bed last night. Patient called in around 11:00am, no more had appeared since the time she woke up.
Fever, chills, severe body joint aches, headache started 10am day of injection lasting until 1/10/21.  Improvements started 01/09/21 late afternoon.  Some aches remain on 1/10/21 but minimal in comparison
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment - Anti-viral details: Paxlovid, Treatment start date 26Jun2022 and Treatment Stop date 30Jun2022, Indication included Treatment of COVID-19.
A couple hours after injection, about 3 inches below injection site became swollen and a red patch formed in a circular shape. The swelling progressed and size increased over the next couple of days until it resolved 3 and a half days later. Arm was also hard to lift and painful.
diaphoresis, hypertension, erythema, shortness of breath, severe back and muscle pain
Hotness at injection site; Tenderness at injection site; Itchiness at injection site; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE WARMTH (Hotness at injection site), TENDERNESS (Tenderness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Dec-2021. On 14-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hotness at injection site), TENDERNESS (Tenderness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Adverse event, at a dose of UNK (4 times every 6 hrs). On 14-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 20-Apr-2021, VACCINATION SITE WARMTH (Hotness at injection site), TENDERNESS (Tenderness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was six weeks pregnant at the time of vaccination.
Presented to ED w/chief c/o vomiting; tested COVID positive 4 days prior to arrival w/ symptoms of cough, hypoxia, SOB; admitted for PNA d/t COVID-19; tx w/abx, remdesivir, ascorbic acid, steroids, zinc; pt remained in afib despite being on IV cardizem t/o stay w/worsening kidney function; pt made DNR d/t poor prognosis and expired 1/19.
Pt received DTaP in left thigh on 4/13/00. The pt experienced a knot the size of a quarter, a 3" bruise at the injection site. The knot has resolved, bruise remains.
This spontaneous report was received from a physician refers to a 60-year-old female patient. The patient's current conditions included IA nephropathy and urinary tract infection (UTI). The patient's medical history included renal transplant. The patient's other medications included immunosuppressive therapy VIZ: prednisone 5mg, tacrolimus 3mg (AM) and 2mg (PM), MMF, ascorbic acid and gabapentin. The patient's previous vaccination included PREVNAR (lot #, expiry date not reported). On an unknown date on 30th November 9:45 AM, the patient was vaccinated with PNEUMOVAX 23 lot # R018136. On the same day of vaccine administration at 1:15 PM, the patient experienced local reaction, erythema, feeling hot, peripheral swelling and pain in extremity. The patient was treated with BENADRYL, MOTRIN 100mg. The patient was not allowed non-steroidal anti-inflammatory drugs in higher amounts, which slowed down the recovery. The outcome of local reaction, erythema, feeling hot, peripheral swelling and pain in extremity was unknown. The causality for the adverse events with the suspect drugs were not reported.
Beginning about a day after vaccination, pain/soreness in the vaccinated (left arm), limiting ease of movement, including raising the arm above the shoulder. It felt like a rotator cuff injury. It resolved 4 days after the onset of pain.
Vaccine was administered after expiration date 4/1/22. Moderna confirmed the vaccine maintained activity.
At 3:30 pm, I (a registered nurse) was administering the Rotateq vaccine to an infant. After delivering half of it slowly, I paused and the baby sneezed, thereby spraying much of it into both of my eyes, with slightly more into the right eye. I immediately rinsed my eyes in the sink, but started having a tingling sensation, which progressed within a minute or two into a ground glass like pain. Then I began to cough uncontrollably, which lasted for hours, until I lost my voice altogether. MY eyes became very red and my face also became very red. I felt generally unwell. Due to the significant pain in my eyes, I was advised by one of our pediatricians to go immediately to Urgent Care, where my eyes were irrigated with two liters of saline. I was given Patanol and sent to another MD the next day. The Merck company was of little help, including the Merck pediatrician. I spent 4 hours at Occupational medicine and was told my eyes would improve gradually and that the chemicals in the vaccine were irritants to my eyes. My eyes improved slightly, but 6 days later I am still having an uncomfortable itching sensation. I was told to wear goggles and a face shield from now on with that vaccine. I believe everyone should have to do that.   I do not know the name of the patient, since I had to leave work abruptly.  Vaccines that are safe enough for babies, should be safe enough for the nurses administering them.
Headache, dizziness, recurring worse after 2nd dose of vaccine. 1st episode started 2 weeks after 1st dose.
Measels type rash all over body from head to toe. The child was taken to the hospital and to a private Doctors office. The child was treated with Benadryl and prednisone but the rash has not gone away.
25 yo F new hire in our outpatient clinic.  Minutes  s/p MMR and varicella injection LVN administering reports patient slouched back in chair and head went back in spastic movements (10-20 sec) then patient leaned forward, pale and clammy, able to talk, breath, RR 30, Pulse 50s/60s.  LVN called for help. Unable to get BP due to distance from wall equipment. Clinic NP (me)  walk in and witnessed similar episode repeat of head back/spastic movements, then patient sat forward, was pale, c/o nausea and numb hands., Had dry heaves. EMS called/arrived within 5 min. No known Hx of cardiac hx, seizures, DM, Pregnancy, recent illness. Stated no hx of vaccine reactions or issues with injections or blooddraws.  EMS stated EKG normal. Patient left via Gurney with EMS. Reportedly declined going to hospital via ambulance and was driven by roommate in private car to ED.   Assessment includes s/p seizure episode vs. Cardiogenic syncopal episode/vasovagal.