chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/28/01 patient went to the urgent care with complaints of nausea, vomiting, fatigue and rapid heart beat.  Was treated with an OTC medication and given referral to see Cardiology.  Rapid heart beat continued which also caused pt. to feel breathless on exertion.  Cardiology performed echocardiogram and found to have minor Mitral Regurgitation.  Was prescribed Toprol, however, pt. didn't tolerate this.  Developed migratory joint pain and swelling with muscle aches in mid January.  2/6/02 was evaluated by Rhematology with a dianosis of Reactive Artritis.  Was followed and treated with NSAID's and Prednisone.  Pt. tolerated NSAID's the best and was felt to have resolved reactive arthritis on visit of 6/27/02
Dose administered to 2 patients after more than 30 days stored in the refrigerator; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided.   This case was linked to MOD-2022-489166 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Significant FU appended- dose 1 and dose 2 details and patient details were added
Information has been received from a female licensed practical nurse who on 13-FEB-2008 was vaccinated with the second dose of GARDASIL. On 13-FEB-2008 the patient experienced soreness at the injection site. She reported that she thought the dose was administered subcutaneously. The outcome of the event was not reported. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old male patient who received BEXSERO. On 24th May 2018, the patient received the 2nd dose of BEXSERO. On 24th May 2018, 3 hrs after receiving BEXSERO, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 102 Degree F. The events were lasted for 2 days.
received her Moderna #1 on 3/10. She developed a Large Local Reaction at the vaccine injection site(left Deltoid) on 3/16. She was seen in Facility on the 19th and 22nd. It was resolving nicely on 3/22.
2/3/21 Within 10 minutes patient developed a hives in the injected arm, both shoulders and minor on opposite arm). It abated a bit with first Benadryl, spread some more to abdomen. A second dose of benadryl was given ? neither better nor worse. Allergist cleared her to go home and in 2-3 weeks will skin test her before time for second dose. Allergist is  MD
I had severe chest pain like almost as if someone was both sitting on my chest and stabbing me at the same time. My heart rate wouldn?t come down at all from 100. Which is very unusual for me because my normal rate is usually around 57-60 because I run a lot and I?m very active. I felt very light headed for the majority of the day. This is was all very alarming for me due to the fact that I had previous had to have an echo, and ultrasound, and a chest X-ray, as well as a heart monitor due to a potential heart related incident that occurred a couple years prior. I was fortunate enough after my 2nd dose to have my boyfriend mother, who?s a RN monitor me over night but I did wake up the next day with residual chest pain
nose bleeds; fever; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 05-Apr-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medications were provided.
Extreme soreness around shot area since receiving vaccine this morning. Brief numbness in legs occurring 20 minutes after vaccine was administered, and lasting for about 5-10 minutes.
Information has been received from a nurse practitioner concerning a 15-year-old female who in approximately 1997 was vaccinated with a dose of MMR II. Subsequently the patient experienced gradual/significant hearing loss. The patient now uses a bilateral hearing aid. The patient's gradual/significant hearing loss persisted. Unspecified medical attention was sought. There was no product quality complaint. Gradual/significant hearing loss was considered to be disabling. Additional information has been requested.
Pt came to  clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reaction associated with treatment of kidney stones. Allergist believed reaction was related to flomax or oxycodone (neither of these are injectable therapies. Vaccination given. Pt came to staff during the waiting period stating starting just minutes after the vaccination she started feeling of "dry throat." She also noted her heart beat was a little fast. No shortness of breath, no hives or any other signs of reaction. Pt was given diphenhydramine 25 mg orally at 1305.  At 1325 Pt reports she is feeling better (she is conversing with friend and laughing). She states she will leave here and f/u with allergist regarding whether or not she should receive 2nd vaccination dose.
Onset of pruritis and new skin rash on both legs on 11/17/2021. Received flu vaccine at work on 11/18/2021. Progression of rash to both legs, both arms, upper chest, neck, lower 2/3 face, ears and buttocks with worsening pruritis and swelling of legs, forearms, face, neck and ears over the following 10 days. No fever, lip or tongue swelling or  shortness of breath. Trial of over the counter 1% hydrocorticone cream, benadryl and zinc oxide cream and benadryl 25mg orally every 4 hours as needed - initally taken only at night beginning 11/19/2021 but increased use due to pruritis that made it difficult to sleep, required up to 5 times daily at most.  Saw dermatologist,  on 10/28/2021. Prescribed topical steroids - triamcinolone 0.1 % cream topically to affected areas bid for up to 2 weeks, hydrocortisone 2.5% to face bid for up to 2 weeks, clobetasoL 0.05 % cream to areas of intense pruritis bid for up to 2 weeks and oral prednisone taper (20 days): 60mg (6 pills) x 3 days, 50mg (5 pills) x 4 days, 40mg (4 pills) x 4 days, 30mg (3 pills) x 4 days, 20mg (2 pills) x 3 days, 10 mg (1 pill) x 2 days, then stop. Rash, edema and pruritis improving as of 11/4/2021, currently on 50mg prednisone orally daily and ongoing use of topical steroids. Lab work done 10/28/2021 and repeated 11/4/2021
Began with sudden worsening of baseline cognitive deficits about 1 month after the vaccine. Progressed to increased clumsiness and falls by June 2021. Falls escalated by August 2021 and he was seen multiple times in Neurology clinic. MRI was ordered. Ultimately diagnosed with transverse myelitis with a large lesion extending from T2-T12 and patient is now paraplegic with severe neuropathic pain in the feet. He has undergone two rounds of high dose steroids without benefit. He is approximately 6-9 months from symptom onset and has not made any progress, unable to ambulate, unable to move legs.
Facility manager called on 1-29-21 to inform me that patient had shortness of breath upon awakening at 6 am on 1-29-2021. Emergency Personnel were called and patient was taken by ambulance to the ER.
Patient reports symptoms began 2 weeks after administration of the 1st dose of Moderna COVID vaccine. Symptoms include: sharp chest pain, tightness in the chest, shortness of breath, and dizziness - pt expressed that symptoms worsened when he walked, the faster he walked the worse his symptoms, and by getting up after bending over. Patient was subsequently hospitalized and it was identified that the patient had a decreased EF and abnormal MRI of the heart, cardiologist suspected myocarditis. Patient was discharged with aspirin, atorvastatin, carvedilol, and Entresto as new start medications. Patient to have further workup outpatient by cardiologist.
Severe tremors throughout body lasting about 2 hours. Then, headache, ear pressure, sore throat lasting about 36 hours. Low grade fever around 100.9. Red, swollen, itchy at injection site.
My injection site started itching around 1/2 hour after receiving it.  About a week later I noted a 3 inch rectangular red raised itchy area around my injection site.  3/1/21 I noted a red raised rim around the itchy area.
ABOURT 10-15 MINUTES AFTER RECEIVING FLUVIRIN AND ZOSTAVAX PT EXPERIENCED INCREASED HEART RATE WHICH LASTED ABOUT 30 MINUTES OR LESS.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 68-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 01-NOV-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002457:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary and concomitant therapies were not reported. Pharmacist reported that patient was indicated for VARIVAX (Merck), accidentally received a dose of ZOSTAVAX instead. No adverse effect reported. Additional information has been requested.
Metallic taste in mouth and lips tingled for 2 days. Also, pruritus of back of throat.
She is running into a big issue basically, her body temperature dropped down to 91 degree; She is feeling high; This is a spontaneous report from a contactable consumer. A 58-years-old female patient (mother) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/Lot Number: EW0172; Expiration Date: 31Aug2021), intramuscular, administered in right arm on 11May2021 (at the age of 58-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included depression, gout, and high blood pressure. The patient's concomitant medications included colchicine, carvedilol and duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Batch/Lot Number not reported), via unspecified route administered on 20Apr2021 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 11May2021, 12 hours after the vaccination, it was reported that my mother was running into a big issue basically, her body temperature dropped down to 91 degree and it is from past 12 hours but she is feeling high. The patient underwent lab tests and procedures which included temperature dropped down: 91 on 11May2021. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history were provided by the reporter.    On 04-Jun-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. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non significant follow up
The injection itself was painful and done with a bit roughly. Shortly after I began experiencing pain at the site of injection. I was not concerned as I knew it was normal. However, the pain continued for days, till this day 9/27/2018. It is difficult to raise my left arm without any pain. Something as simple as taking off my shirt causes pain.
pt recv vax 21APR99 9AM & later in the day exp allergy/asthma sx, +nasal congestion, swollen lymph glands bilat axilla, no fever, no general malaise, no h/a, no aches;states sx lasted 3-4 days +tenderness @ site;
I had a terrible headache the day after my vaccine, expected. Three days later I had terrible dizziness. I expected it to go away. It never did. I am very very lightheaded on most days. Some days vertigo symptoms, mild nausea and moderate headaches. But everyday I?m severely lightheaded, not for a few minutes but hours to days. I can?t work or drive. This is very scary as it?s been months.
Pt is ventilator dependent ex premature pt w/severe development delay & hx of abnormal EEG in past that 9 days p/vax generalized sz lasting 2 hrs w/o response to Anticonvulsants;
swelling on my face; rash all over my body; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021 at 5:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 7:30 PM, the patient experienced SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling on my face), RASH (rash all over my body) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Meningococcal B vaccine for prophylaxis. On 2nd August 2018, the patient received the 1st dose of Meningococcal B vaccine. On 2nd August 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, her arm was pretty much useless. She could not lift it hardly at all without sending pain up and down the entire arm. The patient stated that, this experience was not supposed to be pleasant, but she must admit, she did not want to do this again. Like any other teenager, she had scoured the internet looking for a reason as to why she must went for a second does.
rash on face/rash on arms/rash on legs/forehead/pinpoint spots; rash on eyelid; rash on mouth palate; pinpoint spots, or petechiae-like; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 62-year-old male patient who received Rabies NVS (RabAvert) (batch number ARBA221A, expiry date 31st July 2022) for prophylaxis.   On 14th June 2019, the patient received RabAvert (intramuscular). On 14th June 2019, 20 min after receiving RabAvert, the patient experienced rash, eyelid rash, rash mouth and petechial rash. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the rash, eyelid rash, rash mouth and petechial rash were recovered/resolved.   It was unknown if the reporter considered the rash, eyelid rash, rash mouth and petechial rash to be related to RabAvert.  Additional details were provided as follows:  On 14th June, 2019 at 11:00 AM, the physician assistant reported that the patient receive the Rabavert for prophylaxis.  About 20 to 30 minutes later, the patient returned to the office and reported rash about the face, forehead, and eyelids. The rash then spread to the upper and lower extremities. The patient also experienced rash on the upper palate of the mouth. The rash was described as appearing like pinpoint spots, or petechiae-like.  The patient was given antihistamines and monitored and began to improve. The reporter consented to follow up.
Pt experienced redness and swelling at the injection site. He reported feeling tiredness. He went to the urgent care and they diagnosed him with cellulitis and prescribed antibiotics.
The vaccine administered to the patient was 13 days past the expiration date from when the vaccine had been put in the vaccine refrigerator.
Breakthrough covid infection 37 days after bivalent booster; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 50 milliliter. On 16-Oct-2022, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster) was resolving.            No concomitant medication was provided.  Reportedly, patient 2 parents and mother-in-la were having breakthrough infections, all also bivalent boostered, elderly and with no means of reporting and not sure of lot but all received Moderna bivalent booster the second week of September 2022.   It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Received an Expired Dose; Received Second Dose 10 Months After First Dose; Initial Report Received on 08-Apr-2021  A pharmacist in the reported that a 23 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 305 days after the first dose.   The patient reported having no known allergies.   No relevant concomitant medications were reported.    Between 1997 to 1998, the patient had received her 3-dose hepatitis B vaccines.  In Jun-2020, she was tested and found to have no antibodies and needed to be re-dosed for school.  On 08-Jun-2020, the patient received the first dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) to the left deltoid.   No adverse reactions were reported.  On 08-Apr-2021, 305 days after the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 933839, expiration date 28-Feb-2021 and NDC # not reported) which was expired.  No adverse reactions were reported.   No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
After administration on ZOSTAVAX; rash present on abdomen. Itching and redness at site of injection. Patient given diphenhydramine 50 mg PO and was monitored for 90 minutes. Patient left the office in stable condition. No progression of symptoms.