chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022 at 4:46 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022 at 4:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 25 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient received vaccine past its 30-day expiry date. The vaccine was administered up until it manufactured expiry date of 04 Apr 2022. The patient received booster dose. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24 Dec 2021. No treatment medication was reported by reporter.
ITP relapse - platelet drop >10,000 which lead to petechia, bleeding gums, bruising easily.
shooting pains in my legs/feet; shooting pain in legs/feet; 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 PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet) 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 PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet). At the time of the report, PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.  Event outcome was not reported.
UTI; This is a spontaneous report from a contactable consumer. An unknown age female patient received BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number were not reported) dose 2 via an unknown route of administration on 20Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient past drug therapy included BNT162B2 for COVID-19 immunisation on an unspecified date. The patient experienced UTI on an unspecified date. Caller stated that she received both doses of the Pfizer COVID-19 vaccine, her second one being administered on 20Feb2021 and has recently experienced a rough UTI. Caller stated that she was not prone to getting them and was wondering if they are connected to the vaccine. She stated that two of her family members have also had UTIs around the same time, within a month or so. She stated that she just recently went through a UTI, and she was not prone to them and it was a tough one. She stated she has to be on three different types of medications before it knocked it out and it lasted about two weeks. Caller stated that one family member was in the hospital and the reason was originally for a UTI, and her sister-in-law had to go to the emergency room for a UTI. She was looking for any connection to the vaccine and UTIs in the 55 year and older population. Caller stated she was curious if the vaccine has a part in it. Caller states they are around the same age. Caller stated she doesn't wish to complete a report for the 2 additional family members. Caller stated she will talk to them about that, she knows it was about the same time. Caller stated the one family member was hospitalized for the UTI, but now there are several other things. Caller stated that family member was in her early 80s, so she has other things happening also. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070858 same reporter/drug/AE with different patient;US-PFIZER INC-202101069940 same reporter/drug/AE with different patient
Headache, body aches, low grade fever, chills, nausea, vomiting for 7 hours.  Dull headache for 24 hours.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 01-APR-2014, patient received improperly stored VARIVAX dose 1, from lot # H018451 expiry date: 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
severe migraine, nausea, arm pain, muscle soreness and severe tinnitus started about 4 hours after the vaccine.  Migraines were treated with Nurtec and IV Toradol, and steroids.  That was required for both vaccination doses.  Tinnitus has not resolved and has been treated twice now with prednisone, which has been helpful but not resolved the issue. Tinnitus keeps triggering migraines and significantly impacting the ability to sleep.   I also started to have periodic joint pain and swelling in face, hands and feet.
Moderna given as first shot 09/01/2021. Pfizer given as second shot 10/06/2021.
Body aches, sore throat, site swelling, induration. Treatment ice, Tylenol.
Four episodes of hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Four episodes of hallucinations) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In June 2022, the patient experienced HALLUCINATION (Four episodes of hallucinations) (seriousness criterion medically significant). In June 2022, HALLUCINATION (Four episodes of hallucinations) had resolved.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a 93-year-old, female patient with no reported medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product with unspecified therapy dates. Patient experienced the unexpected serious (medically significant) event of hallucination (four episodes of hallucinations). The event hallucination (four episodes of hallucinations) occurred the same month with the administration of mRNA-1273 vaccine booster dose. No other information surrounding the event was reported. The outcome of the event was reported as resolved. The patient's advancing age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 93-year-old, female patient with no reported medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product with unspecified therapy dates. Patient experienced the unexpected serious (medically significant) event of hallucination (four episodes of hallucinations). The event hallucination (four episodes of hallucinations) occurred the same month with the administration of mRNA-1273 vaccine booster dose. No other information surrounding the event was reported. The outcome of the event was reported as resolved. The patient's advancing age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I got an eye infection "Herpetic Infection"; I got an eye infection "Herpetic Infection"; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (Lot Number: en6206), dose 1 via an unspecified route of administration, administered in left arm on Mar2021 at 01:30 PM (at the age of 51 years old) as single dose for covid-19 immunization. Medical history included heart, Pancretic divisium, thryoid, diabetic and known allergies included sulfa, diuretics and gabapentin. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient got an eye infection "Herpetic Infection" on Mar2021 at 02:00 PM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment for events included pills and eye drops. The outcome of events was recovering.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
The night after the second dose, I had difficulty sleeping, but that was not particularly unusual. By about 10 the next morning, I started getting joint aches in bilateral hip joints and sacral joints. By 10:30 I suddenly found myself lightheaded and had to sit down so as to not faint. Of note, I had just previous to this lightheadedness donned full PPE to work with a patient (gown, gloves, face shield, N95), not having yet worn it that morning. I did not faint, and was able to sit down for 15 minutes without a mask and drink ice water, but I was not safe to work with my patients (as a physical therapist). I left work and went home to sleep. I did not have a fever or chills. After a 3 hour nap, all of my symptoms resolved.  Additional information: I am pregnant, was 16 weeks pregnant at the time. All fetal imaging prior to the first vaccine and after the second vaccine have showed normal healthy development. I am due July 3
NO ADVERSE EVENT, ADMINISTRATION ERROR ONLY.  PRODUCT EXPIRED 2 DAYS PRIOR TO ADMINISTRATION.  NO SYMPTOMS
Chills; Fever; shortness of breath; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever) and the first episode of ARTHRALGIA (joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever), the first episode of ARTHRALGIA (joint pain) and the first episode of MYALGIA (Muscle pain). On 27-Mar-2021, the patient experienced the second episode of DYSPNOEA (shortness of breath), the second episode of MALAISE (not feeling great), the second episode of HEADACHE (Headache), the second episode of PYREXIA (Fever), the second episode of ARTHRALGIA (joint pain) and the second episode of MYALGIA (Muscle pain). On 19-Apr-2021, the patient experienced CHILLS (Chills). 19-Apr-2021, the patient experienced the third episode of PYREXIA (Fever) and the third episode of DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, last episode of MALAISE (not feeling great), the last episode of HEADACHE (Headache), the last episode of ARTHRALGIA (joint pain) and the last episode of MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (Chills), the last episode of PYREXIA (Fever) and the last episode of DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Influenza virus test: negative Negative. On 28-Mar-2021, SARS-CoV-2 test: negative Negative. On 31-Mar-2021, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: no new information
A PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR MORE THAN 6 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 29-NOV-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 29-NOV-2021, the patient experienced administration error. On an unspecified date, the patient experienced a punctured vial stored in the refrigerator for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and a punctured vial stored in the refrigerator for more than 6 hours was not reported. This report was non-serious.
Menactra was ordered for the patient and Prevnar was given.  Patient felt light headed after the shot and fully recovered.
Took flu shot on 11/2/12. That night my tooth began to bother me. The next day it was swollen & hurting badly. The left side of my jaw began to swell. By night it began to swell my chin and the right side of my face. I could not sleep and went to the hospital. If it were just my tooth on my left side, my whole head should not swell up.
Passed out, went unconscious. Fever. Fatigue. Hives. Headache.
Muscle pain began late in the afternoon on 7/24, along with a headache. The headache got progressively worse to the point that it awakened her in the evening and she took 2 TYLENOL. The morning of 7/25/18, she had to get up for 2 appointments. She stated her head throbbed continually and she felt out of herself. She made it to the first appointment but doesn't recall what was said to her. She immediately returned home and went to bed for the rest of the day.  She was exhausted. The headache subsided after lunch 7/25 and then she noticed her arm (at injection site) was swollen, red and hot. She stated the swelling went down to her elbow. She iced it and again took TYLENOL and went back to bed. By 7/26/18 most of her symptoms had subsided. She doesn't want to receive the 2nd dose.
Patient presented to the emergency room with chief complaint of right side abdominal  pain and and nausea. Primary problems were found to be right ureteral stone and urinary tract infection. Patient was admitted on 3/13/21 and while doing rapid COVID-19 testing on 3/13/21, was found to be positive. Patient denies any contact with COVID-19 and presented with no symptoms to suggest COVID-19 illness. Patient denied any fever, headache, loss of senses of taste or smell, muscle aches, fatigue, vomiting, constipation, or diarrhea.
6:30am Emesis x2  8:30 am  pale, unable to keep eyes opened,  pupils sluggish, head turned to left side, unresponsive, heart rate increasing Resident taken to hospital ER.
HOT AND COLD SENSATIONS ON BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 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. On 29-MAR-2021, the subject experienced hot and cold sensations on body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hot and cold sensations on body was not reported. This report was non-serious.
Case number PHEH2016US029333 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 70 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 Nov 2016. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline; No adverse event; Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline), ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma.    On 13-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 13-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline), ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline) and ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years).    No concomitant medications were reported.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received previous doses and both doses were Moderna.   She received the 1st dose on 22-Jun-2022. The lot number was AS1414B, dosage was 25 mcg. She received the 2nd dose on 22-Jul-2022. The lot number was AS1414B.   Pharmacy manager calling to report a patient received a diluted vaccine. Toddler was administered a vaccine that was diluted with 1.3 ml normal saline. Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years. The child was fine.   No treatment medication was provided.
Headache, Severe Brain Fog (would forget the name of the place I worked when talking on the phone), Emotional irregularity (crying), trouble sleeping but tired. Lasted for about 5 days.
This initial spontaneous case, received on 03-Oct-2017, reported by a pharmacist and concerns a 12-year-old adolescent female patient. The patient's medical history was not reported. On 03-Oct-2017, FLUCELVAX QIV was administered (dose: less than 0.5 ml, batch number: 195227 and expiry date: 31-May-2018, route of administration: intramuscular, anatomical location: left deltoid). On 03-Oct-2017, while administrating FLUCELVAX QIV, when the needle of the syringe was screwed to give the shot the Lori lock came apart, the needle and Lori lock ends up stuck in the patient's arm and it sprayed all over the skin (explicitly coded as syringe issue). The patient received partial dose (explicitly coded as under dose). It was reported that, there was no damage in the package condition or in the syringe (25 gauge, no signs of leakage), but broke when needle was inserted as the hub was loose. It was reported that, the product was stored in the original box until used and placed in a refrigerator. It was reported that, no adverse event was experienced by the patient. Based on the PTC (product technical complaint) (PTC reference number: 1025025) investigation performed, it was concluded that, FLUCELVAX with batch number: 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for syringes for luer lock separation during administration. The most likely root cause could be attributed to improper handling by the user. The reporter assessed the case as non-serious. Follow up report received on 13-Oct-2017: It was reported that, no adverse event was experienced by the patient. The route of administration and anatomical location was added. The narrative was amended accordingly. Follow up report received on 16-Nov-2017: The PTC Investigation results were updated. The narrative was amending accordingly.