chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/16/21 0800 - Headache, enlarged lymph node under left arm 1300 - body ache, chills 1700 - temp = 102.4, took Acetaminophen 1000 mg, temp decreased to 98.4 by 1900 Felt ok but tired at 2000
I felt as if all the blood had been drained from my limbs and replaced with molten lead.
No adverse effect reported; inadvertently administered the second dose of MMR II; This spontaneous report was received from a nurse referring to a patient with unknown vaccination history. Information about concurrent condition, concomitant medication and medical history was not provided.   On 08-MAY-2019 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route were unknown; lot # R031679, expiration date 01-NOV-2020) for prophylaxis along with sterile diluent(STERILE DILUENT). On 31-MAY-2019, the patient was inadvertently administered the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route were unknown; lot # R036582, expiration date 17-DEC-2020) for prophylaxis along with sterile diluent(STERILE DILUENT) (Inappropriate dose of vaccine administered). No adverse effect reported. The outcome of the events was unknown. No PQC presented.
Patient was administered Covid-19 Bivalent (gray top) lot GJ6736 on 01/24/2023. The BUD was 01/11/2023.  -     ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into database prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and data reconciliation o Training on how to enter information into database when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Weakness; Dizziness; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included None.
Patient start walking unstable after getting up from vaccination table  loss consciousness after being sited on the chair but quickly regain consciousness shortly.
tested positive a week after his first dose; tested positive a week after his first dose; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive a week after first dose. The patient was scheduled on 07Mar2021 for his second dose and asked if what to do about it since he was tested positive. The patient underwent lab tests and procedures which included sars-cov-2: positive on an unknown date in 2021. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
10 minutes after administer the vaccine pt. started feeling her throat is closing up. Asked me to wait few minutes before using Epi-pen. Waited 5 minutes and administered Ep-pen 0.3mg IM. and called 911. took patient BP and HR (118/85- 98). Paramedics arrived and took over.  Patient has history of bee stings allergy
After receiving 3rd dose of Lymerix, developed nausea, vomiting and anxiety. Went to ED, was given IV Benadryl. returned to feeling normal over next hour. Was released to go home.
Pt came back to primary w/ swollen left arm. Rph referred pt. to clinic, was given LEVAQUIN and steroid. Arm was swollen and red.
This sontaneous report as recived from nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical hisotry was not reportd. On an unknon date unspecified number of patients were vaccinated with improperly stored (incorrect product storage) PEDVAXHIB (0.5 ml, once) (lotn umber unspecified), intramuscular. Concmoitant medicatinos were not reported. The reporter stated that the unspecified patients received doses of PEDVAXHIB between 10-AUG-2014 and 24-JAN-2015. No adverse efefcts (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was not reported. This case is linked to #1502USA000900 via same reporter link. Additional information has been requested.
Intense and sudden tinnitus in one ear or the other that lasts for 12 to 24 hours and causes a headache and nausea after a few hours. Usually starts to subside over the next few days and randomly repeats.
Headache and armpit pain/soreness on L side injection site. MILD, not severe.
Had the same side effects as with the first two shots (which he had in February; He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) outcome was unknown.            No concomitant and treatment information provided.   This case was linked to MOD-2021-354077, MOD-2021-354098 (Patient Link).
Patient felt like was going to pass out after receiving the Moderna vaccine but did not actually pass out. He was very light headed and then vomited. Patient says that he had passed out previously post vaccination on two occasions. After vomiting patient felt much better . He stated he had eaten 30 minutes prior to vaccination. He was awake and alert. He stayed 30 minutes after and then left with his mother.
Stiffness; Neurological reaction; Tremors,shook so bad had to go to bed; Scared to death; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), NEUROLOGICAL SYMPTOM (Neurological reaction), TREMOR (Tremors,shook so bad had to go to bed), FEELING ABNORMAL (Scared to death) and HEADACHE (Severe headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), NEUROLOGICAL SYMPTOM (Neurological reaction), TREMOR (Tremors,shook so bad had to go to bed), FEELING ABNORMAL (Scared to death) and HEADACHE (Severe headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), NEUROLOGICAL SYMPTOM (Neurological reaction), TREMOR (Tremors,shook so bad had to go to bed), FEELING ABNORMAL (Scared to death) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.   This case was linked to MOD-2021-141603 (Patient Link).; 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.
Case number PHEH2014US014494, is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications were not reported. Inadvertently she received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14022), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 15 Jul 2014 by nurse at her facility. No adverse event was reported following this administration error.
Pericarditis-super painful chest pain, lightheaded, dizzy, didnt feel I could stand properly, numbness in left arm to fingertips.  Took Colchicine for 30 days, was admitted to hospital.
She developed severe diarrhea 1-2 weeks after her second Moderna dose. Her symptoms have persisted since 4/2021 (now 8/2021). lab testing normal. She underwent colonoscopy with pathology showing lymphocytic colitis with possible early collagenous colitis
Magnetic reaction; 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 HYPERSENSITIVITY (Magnetic reaction) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Magnetic reaction). At the time of the report, HYPERSENSITIVITY (Magnetic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
No additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient on 3/11/2020.; This spontaneous report has been received from an office manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant medication.  On 11-MAR-2020, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (therapy type: Digital Data Logger), lot number S021322 and expiration date 09-JUL-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided). The sterile diluent (MERCK STERILE DILUENT) used for the reconstitution of the vaccine was properly stored.  The vaccine was stored at a temperature of -8.3 Celsius for a timeframe of 24 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This is one of the cases from the same reporter.; Sender's Comments:  US-009507513-2003USA005878:
Circular area ~2 inch diameter of erythema at the injection site.   Patient reports initially had a small red knot at the vaccine injection site She reports now having redness, swelling, and warmth at the injection site, which has spread No fever Had a headache with it Can't lay on that side when trying to sleep due to pain
She was sick; Missed her second dose within the time frame (3 weeks apart); This is a spontaneous report from a contactable consumer (patient) via Pfizer. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she missed her second dose within the time frame of 3 weeks because she was sick and inquired if she could proceed with her second dose. She also inquired if the second dose was stronger than the first dose. The clinical outcome of she was sick was unknown. The clinical outcome of she missed her second dose within the time frame was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No additional adverse effects reported.; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number S012036 which has been verified to be valid, expiration date reported and validated as 17-APR-2021) (dosage, vaccination scheme, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 15 degrees Fahrenheit (F) to 46 F: 32.9 F, during a time frame of 5 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse effects were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA005605: US-009507513-2007USA005952:
Initial misuse report received from a healthcare professional on 03 January 2014. It was reported that the patient had received YF-vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
She developed a "knot" under the skin almost immediately after the injection.  Within 2 hours, her injection site was erythematous, swollen and "feverish."  She presented to the local ER for treatment.  She was diagnosed with cellulitis of the arm and was given Keflex 500mg QID x 7 days.  No anaphylaxis.  Her arm has continued to be painful to move and the erythema, swelling and fever has moved down to mid-humeral to elbow.  No joint pain in elbow.  She saw her PCP  today and her antibiotics were changed to Clindamycin 300mg QID x 10 days.
Nausea, dizziness & vomiting during 12-24 hours after vaccines.
Patient received first dose of COVID vaccine at 1:10pm without issue. During his 15 minute waiting period post vaccination, at approx 1:15pm, patient experienced a syncopal event, + for striking his head. He never lost vitals, and promptly woke up. at 1:22pm, his vitals were initially BP 90/42, HR 45, pulse ox 100% on room air, and RR 16. He complained of dizziness and blurred vision, but was AOX3 with all cranial nerves intact. 911 was called for patient to be assessed. Vitals were then checked again at 1:29 pm, BP 110/62, HR 62, pulse ox 100%, RR 16.  At this time, all of patient's symptoms had resolved. EMS arrived at 1:39pm and checked his BS which was 114. At this point patient no longer wanted to go to ER. EMS spoke with on call provider who gave verbal okey for patient to no go to the ER, but gave strict ER precautions such as headaches, vomitting, vision changes, etc. Patient was able to teach back. Patient reports that this (passing out) frequently occurs to him anytime he has to get shots or blood work done and he has seeked medical attention afterwards before with no resolution. Patient left at 1:46pm. He walked home.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within 30-45 seconds of receiving IM Epinephrine, child started to feel better and was breathing more comfortably, with decrease in itchiness/rash/redness around face and neck and conjunctiva became clear again. Child also was able to swallow and "tongue and fingers of Rt hand felt normal again", per patient. EMS arrived within 5 minutes of being contacted and B.P. measurement repeated with pt. sitting up = 124/90 (post Epinephrine IM). Note: O2 sats = 100% with H.R. = 79/min post Epinephrine IM. Pt. then transported via EMS to ER to be examined for possible admission for observation status. Note: Pt received Epi-Pen Jr. i.e. 0.15 mg dose at our office today. I.M. vs Epi-Pen i.e. 0.30 mg dose. 8/11/08-records received for DOS 7/25/08-presented to ED with C/O reaction to vaccines. Received Benadryl in PCP office, no symptoms on arrival to ED. PE normal. Impression: Acute Allergic Reaction.
15-month-old patient received PENTACEL and DAPTACEL on the same day, with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15-month-old and unknown gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and daptacel on the same day, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date, lot number: unknown)  via unknown route in unknown administration site for Immunization.  On an unknown date the patient had an event of 15-month-old patient received pentacel and daptacel on the same day, with no reported adverse event (contraindicated product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was unknown if any lab data/ tests available.  It was reported, Physician reported that a 15 month old patient received PENTACEL and DAPTACEL on the same day. The caller was not able to provide any patient specific information due to time constraints and declined to provide any further information about the event at the time of the call. The caller stated that she currently has patients waiting in her office and did not have time to provide any further information. The physician was not aware of any adverse reactions and noted that the baby went to sleep for their usual nap time.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  Outcome: Unknown.    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.
HIVES; Warm at the injection site; Itchy at the injection site; Red circle at the injection site , with the shape of a pear; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (HIVES), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site , with the shape of a pear) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced URTICARIA (HIVES), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site , with the shape of a pear). At the time of the report, URTICARIA (HIVES), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site , with the shape of a pear) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       patient reported using medications for diabetes concomitantly. No treatment information was provided.
I experienced severe pain all over the morning after the vaccine, but the majority in the pain was in my hips. I'm still experiencing pain in my hip and other joints still, I had cortisone injections, and am having to be in physical therapy twice a week.