chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unilateral neck pain, redness pain of left wrist then redness and pain changes to the right wrist and back to left again. No redness, pain at injection site.
By 5/15/21, I had noticed symptoms of what has been identified as oral lichen planus, presenting as bilateral  ulcers/lesions on the outer side of molar gingiva and buccal mucosa (white striations as well).  Symptoms: pain in mouth affecting eating, speech, jaw's range of motion. Hot, spicy, or acidic foods are especially painful.  I saw a dentist today has prescribed a topical steroid ointment.
PT. WAS GIVEN AN UNDILUTED PEDIATRIC DOSE INSTEAD OF AN ADULT DOSE.
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 19-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 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. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the 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. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Product administration error; 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 PRODUCT ADMINISTRATION ERROR (Product administration error) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Patient was given her second dose of PFIZER covid vaccine lot number ER8732. Patient has a history of SLE, Breast CA and Autoimmune hepatitis. After the first dose of vaccine patient had felt unwell. 15 minutes after 2nd dose patient stated that she felt like her neck glands felt like they were swelling. At this time she was placed on the exam table. BP 100/65 P70.  As patient was experiencing symptoms she was given 0.3mg IM Epinephrine and 50mg IM Benadryl. Patient was continuously monitored and after 20 minutes patient stated that symptoms had subsided. Patient denied any chest pain or SOB during this period. Repeat BP 120/80 HR 95. After a further 15 minutes no symptoms so patient was released with instructions to dial 911 if symptoms return. Advised patient have someone drive her home but no one in area. Patient was A and O X 3 with no drowsiness, ambulating well so discharged home.
Sudden onset of wheezing and stridors cough. Nurse follow up on 09/14/04 states: "Allergic reaction."
shot #1 on 17-Nov-2020 but has not yet received Shingrix shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose rceived on 17th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021000082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000082:Same reporter
FREQUENT HEADACHES WHICH ARE HIGH INTENSITY AND DISRUPTIVE TO ACTIVITIES OF DAILY LIVING.
Patient received shot on 10/22/17. Patient stated symptoms (frozen shoulder) began a month later. Patient visited doctor's office and orthopedic surgeon and received treatments with NSAIDs, etc. No surgery needed. Patient report incident to pharmacy on 05/22/18 so VAERS filled out.
Symptoms began 11/4, 1 hour after receiving  3rd dose of J&J Covid vaccine.  Began with dry mouth, feeling sleepy.  11/5 Muscle ache over entire body, increased head ache, Fever around 101 degrees, chills and loss of apatite. 11/6 still feeling the same and started taking Theraflu and began having N/V.  11/7 Fever decreased and was able to keep soup down, muscle ache began to decrease. 11/8 Called off from work due to feeling tired, worn out, HA and cough began. Cough is a dry itchy nagging type of cough which is some what continuous.  11/9 Returned to work, muscle ache is decreased, cough is present and sinus pressure to the frontal lobe.
I received the vaccine and then stood up. They told me to go wait for 15 minutes. As soon as I started walking, I started feeling dizzy. I could feel how the vaccine traveled through my veins, my left arm up, go down to my heart and then go up my throat. I started feeling nauseous. I said I didn't feel well. They instructed me to go sit but I barely made it there. I felt as if I was about to faint, I was sweating. A nurse came and offered water. I couldn?t breathe well. I had to remove my mask because I wasn't getting enough air. The water came and I started feeling better. Within 5 minutes I was feeling well.   That day outlet a bit of body ache. Took a NyQuil and went to bed. The next day my arm was sore and had a small headache. The third day I was perfect.
Blister has been developing on right arm where the patient received a shot; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to peanuts and sulfonamide allergy. 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. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) 25 mg once daily from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced blister has been developing on right arm where the patient received a shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 09Jun2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event blister has been developing on right arm where the patient received a shot was unknown at the time of this report.
nausea, dizzy, twitching of hand past taking vaccine (same happened 1st dose)
I had a seizure 30 minutes later in my doctors office. Followed by multiple, infrequent seizures over the next 4 months. I was hospitalized because of this and my new heart problem. I had a resting heart rate of 110, and was having high and low blood pressures.
Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes).    No patient reported being pregnant. Patient did not report being immunocompromised.  Patient received the 2nd booster of the Moderna vaccine. Patient do not have any medication record. Date the vial initially stored in the refrigerator was on 29Jul2022. Date and time vial first punctured was on 01Aug2022 at 09:30 am. Date of administration of vaccine was on 1st 02Aug2022 at 10 am and administered every 15 minutes after 10 am until 11 am. The vial stored in room temperature post puncture. The vial did not undergone any temperature excursions. Patient did not report having side effects.  No treatment medications were reported.
Information has been received from a registered nurse concerning a patient who on 03-FEB-2007 was vaccinated with the first dose of Gardasil. The patient had not yet received the second dose. The second dose was delayed since the patient developed mononucleosis in 2007. The outcome was not reported. Additional information has been requested
Dizziness, lightheaded, unable to focus visually, fatiuge, swelling and itching at the vaccination site 2 weeks post vaccine
itchy; rash on her stomach; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date unknown) for prophylaxis.   The patient's past medical history included leukemia, shingles (healing, outbreak with PHN) and post herpetic neuralgia (pre-vaccination). Concurrent medical conditions included immunocompromised. Concomitant products included allergy medication {nos} (Allergy Pill) and silver (Silver Solution).   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced itchy rash. On 3rd May 2019, the patient experienced rash. On an unknown date, the outcome of the itchy rash and rash were unknown.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On next day of receiving Shingrix, the patient developed an intermittently itchy rash on her entire left arm. At the time of call, the patient reported that she had a rash on her stomach of unknown cause. At the time of the call, the symptoms were not reported to be resolved. The reporter given the permission for physician contact.   Follow up information received from physician on 31st July 2019: The patient's demographic details were updated. The patient was not pregnant. The batch number of the suspect vaccine was updated. The patient's concomitant medication included Gabapentin, Losartan, Levothyroxine and Oxcarbazepine. The patient had chronic lymphoid leukemia since August 2009, post herpetic neuralgia (pre-vaccination), which were continuing, shingles since 16th March 2019, which was not continued. On 24th April 2019, the patient received 1st dose of 0.5 ml Shingrix intramuscularly. On 25th April 2019, the patient experienced itchy rash. The patient experienced rash on her stomach, which resolved on an unknown date. No diagnostic tests were performed. The events were managed with Aveeno, hydrocortisone, cetirizine/ loratadine. On 4th May 2019, the event itchy rash resolved. The VAERS details were updated. The reporter considered the itchy rash and rash to be related to Shingrix. This case had been linked with case US2019AMR142803, reported by the same reporter.
It was red, hot & raised at first.  As Fri, Sat & Sun continued it was getting hotter, bigger, raised & there is a HUGE knot on my right arm where I received the tetanus shot.  I also got a flu shot on my left arm. I had the same symptoms but not nearly as severe.  I had zero pain at the time of the flu shot & I felt the tetanus (but was completely tolerable).  I see that all the symptoms are expected with the tetanus & while worrisome I have a friend who is a nurse who told me it is common with the tetanus.   It is currently 5 days later.  It is still a very large bump (at least an inch high) & it is a very, very hard knot, hot & red although improved.  It was VERY painful this weekend.  I've had lots of shots & various vaccines & never had a reaction like that.  If it doesn't improve greatly over the next few days I will go back to the doctor.
positive for COVID; positive for COVID; This is a spontaneous report received from contactable consumer.   A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0161), on 31Jul2021 as dose 2, single (Lot number: EW0161) and on 04Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history included: "she got sick with Covid", start date: 2020, stop date: 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "positive for COVID". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: test for the COVID and fluid and the fluid was negative; (unspecified date) positive, notes: the COVID came back positive; (01Mar2023) positive, notes: positive for COVID last night. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (Lot number: GF7317 and expiration date: Apr2023). Clinical course: The reporter stated his wife (this patient) got all of the Pfizer vaccines primary and boosters (Pfizer COVID-19 Vaccine) and then since diagnosed with COVID; still got COVID. The patient has had COVID much before this was the second time for her. The patient went to an emergency medical shop, there was a physician there and they give a test for the COVID and fluid and the fluid was negative but the COVID came back positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300093945 Same reporter, product and events, different patient.;
Information has been received from a licensed practical nurse concerning an 8 month and 19 days old patient who was vaccinated PO with the third 2 ml dose of ROTATEQ vaccine. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a healthcare office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 17-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection (strength, dose and route of administration were not provided) (lot # L015280, expiration date: 30-APR-2017). The temperature excursion was of 48F and the time frame was 120 hours. There was no previous temperature excursion. The temperature excursion was not detected by a digital data logger. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Immediately after receiving shot: light-headed, nausea. The next day approximately 28 hours after shot: fatigue, nausea, fever, muscle aches, chills, skin sensitivity, flu-like symptoms, swollen injection site on right arm, extreme pain when moving right arm, headache. Symptoms worsened until the next day when they improved. Symptoms were gone within 48 hours.
This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes virus infection (had a history of Herpes). On 25th March 2019, the patient received SHINGRIX. On 28th March 2019, 3 days after receiving SHINGRIX, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved. It was unknown if the reporter considered the herpes virus infection to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient did not have lot or expiration date. The patient received SHINGRIX and he developed a herpes outbreak on his chin. The event was ongoing at the time of this report.
having a cold and just took hercovid vaccine; This is a spontaneous report received from a contactable health care professional (patient) and a consumer. A 53-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included Hemolytic Anemia. Concomitant medications were unknown. The patient previously received tofacitinib citrate (XELJANZ XR) at 11mg, once daily, oral route for Hemolytic Anemia. The patient reported she's planning to start therapy- unknown date- currently having a cold and just took her covid vaccine. MD visit next Monday, not planning to start until discussed with MD. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Headache chills, h/a, fatigue , arm injection site local reaction, Narrative:
first injection: 01/08/2021, booster 1 - 02/05/2021, bosster 2  - 8/25/2021 Recurring symptoms:  low energy, brain fogginess, weight gain
Fever of 103 Degrees Fahrenheit, Malaise, Cough, Nausea, No Appetite
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-APR-2015 the patient was vaccinated with a dose of expired ZOSTAVAX (lot # not reported, expired on 26-FEB-2015), 0.65 ml, once, subcutaneously. No adverse events were reported. Additional information has been requested.
Patient is a 56 year old male who has completed a 15 minute observation period with the following signs and symptoms of an adverse reaction: dizzyness . #1  in series administered.   Vitals:  06/17/21 1714 06/17/21 1725 06/17/21 1745 06/17/21 1809 BP: 115/77 117/78 128/78 111/75 Pulse: 79 88 90 75 Resp: 15 18 15 18 SpO2: 96% 96% 96% 97%   Action(s) taken: monitored for 45min. No improvement. refused to go to ED or urgent care. Still feels dizzy, advised to go to ED. Patient agreed.Called paramedics. Blood sugar checked,445. Sent to ED Patient advised to discuss second dose considerations with a clinician and have a driver for 2nd dose appt