chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional referring an approximately 12 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with a first dose of hepatitis a vaccine, inadvertently (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included first dose of MMR II (unknown), (dose, therapy type, route of administration, lot # and expiration date were not provided), and first dose of (Oka/Merck) (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided), both vaccines administered also on 04-AUG-2015. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. This is one of several reports from the same source. Additional information has been requested.
patient had COVID positive test or diagnosis; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (patient had COVID positive test or diagnosis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Imitrex), Drug allergy (Niacin), Diabetes, Congestive heart failure, Hypothyroidism and Colon cancer. Concomitant products included METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ASPIRIN [ACETYLSALICYLIC ACID], DONEPEZIL HYDROCHLORIDE (ARICEPT), PANCREATIN (CREON), ROSUVASTATIN CALCIUM (CRESTOR), FENOFIBRATE, LEVOTHYROXINE SODIUM (SYNTHROID), QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced COVID-19 (patient had COVID positive test or diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (patient had COVID positive test or diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided. Company comment: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization), unexpected AESI of COVID-19, approximately a month after the third dose of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment were reported. The benefit -risk relationship of mRNA -1273 is not affected by this report.   This case was linked to MOD-2022-628582, MOD-2022-628596 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization), unexpected AESI of COVID-19, approximately a month after the third dose of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment were reported. The benefit -risk relationship of mRNA -1273 is not affected by this report.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 51 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 2/14/2021 .   Tested positive on 4/6/21.   NOT hospitalized. Patient reported possible exposure to someone who was COVID positive.  Symptoms reported included:  Runny nose, loss of smell.  (no fevers)
Bad reaction; This case was reported by a consumer via sales rep and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had Shingles vaccination 5 months ago and had a bad reaction to the first shot, so the patient did not go back for the second shot. The patient asking whether there was a problem with that to the doctor but doctor was not sure.
Got shot 2/25/03, went home, had high fever-loss of appetite, hives-paleness, swelling of throat-weakness. Swelling of leg-shot was given-reaction treated antibiotics. Pt's fever grew to 107 in transport he became very ill, he was admitted into ICU, for treatment, on antibiotics, and later found it to be Streptococcus bacteria in his blood.
About three to four weeks after vaccine I started experiencing blurred vision and double vision. Went to doctor where after numerous of test that came back normal the only diagnosis the doctor could give is a muscle spasm.
became hot to touch about 12min p/vax;face flushed, red splotches on shoulders, face, neck & back;not raised;sl tightness in chest-no diff breathing;some nausea no vomiting;observed for about 1 1/2hr & felt better;
8x11cm area erythema, warmth and tenderness developed distal to injection site day after injection.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient received first dose of GARDASIL (dose, frequency and route were not reported) on 22-JUL-2014. On an unknown date in 2014, the patient received third dose of GARDASIL 3 weeks after receiving the second dose of GARDASIL. No adverse effects reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:52 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 37.53.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 15-Apr-2021, the excursion time on initial supply was 09 am, temperature was 34. Total 188 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 06-Apr-2021 and moved to clinic on 15-Apr-2021. 18 vials were moved to the clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report as received from a physician refers to a 4 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# M046140 with the expiration date of 27-SEP-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent a temperature excursion of 48 Fahrenheit degrees for 16 hours. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021; 1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021; No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021), COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and NO ADVERSE EVENT (No adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021), COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZUA) for COVID-19 vaccination.     The patient's past medical history included Cold.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
This spontaneous report as received from a Licensed Practical Nurse refers to a currently 3 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The reporting nurse stated that on unspecified dates, the patient was vaccinated with three doses of VAQTA 20/0.5 (units not reported), 0.5 ml, intramuscular (lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information is not expected, since there was no consent to follow up.
Employee became ill with sore throat and GI upset the day after receiving vaccine.  Led to sinus congestion and headache lasting up to 7 days.  Employee called off work on the 3rd day post vaccination to rest.
Patient received 2 doses of Sinovac  06/08/21 and 06/29/21. Patient did not disclose these vaccinations.  Received Pfizer 08/27/2021 and 10/08/2021 as indicated in this report.
About 10 days after my first dose of the Pfizer COVID-19 vaccine I started to develop what was later determined to be chillblains. I have never experienced this before. It started out feeling like a splinter was deep in a finger on my right hand. A pinpoint red dot then appeared and over days it grew in size until it looked like my finger had a red marker stain on it. This continued to progress on all digits of my right hand and then began on the left hand as well.  My symptoms were at their worst on Feb 4th. At this point they were swollen, painful, red and purplish, and itchy. As the inflammation worked its way to the surface it ended with a superficial callous-like sore. Symptoms have not returned.
Patient stated she felt dizzy, a little faint, hot and sweating, and her ears felt clogged.  Vitals were:  BP 86/50, O2 99%, HR 51.  Ice was applied to her forehead.  Patient ate candy from her purse and started feeling better.  She was feeling better and alert at 1300 hrs.  Patient verbalized she was fine and was cleared.
This initial spontaneous case, received on 19-Sep-2017, reported by a pharmacist and concerns a 52-year-old, adult, female patient. Patient's medical history was not reported. The pharmacist reported that, AFLURIA QUADRIVALENT about 100 doses were received, 20 doses were administered and three patients experienced the events. On 08-Sep-2017, the patient (1 of 3 patients) received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location was not reported). On 15-Sep-2017, after administration of AFLURIA QUADRIVALENT, the patient was extremely sick with the symptoms such as chills, headache, hot and cold flashed, night sweats. The patient also had nausea, fever and sweating (reported as sweats). It was reported that the patient could not get out of bed for five days. At the time of the report, the events chills, headache, nausea, fever and sweating were recovered, while hot and cold flashed, night sweats were not recovered. The reporter assessed the report as non-serious. Follow-up received on 27-Sep-2017: The date of vaccination (08-Sep-2017) and event onset date (15-Sep-2017) was updated. New events nausea, fever and sweats were added. The outcome of the events (chills, headache, nausea, fever and sweating) was updated. Narrative amended accordingly. Significant case correction was received on 11-Oct-2017: The patient's age in the narrative and case comment were added. Narrative amended accordingly.
Reactive arthritis ANA positive; Knee pain worsened; with swelling bilateral (b/l) lower extremity (LE); Lower extremity edema; Body aches; Positive for urinary tract infection (UTI); This is a spontaneous report from a contactable physician. A 21-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26May2021 at 10:22am, intramuscular in right arm (Lot: EW0178) for Covid-19 immunization and experienced knee pain and left knee pain with effusion. There were no concomitant medications. After the second dose, on 05Jul2021, knee pain worsened with swelling bilateral (B/L) lower extremity (LE), lower extremity edema, and body aches. Patient had reactive arthritis ANA positive on 12Jul2021. The events resulted in emergency room visit and physician office visit. Following with rheumatologist and sports medication (med), patient was currently under treatment with prednisone (pred-conservatively) and sulfasalazine. Lab tests on 05Jul2021, Complete blood count (CBC) with differential: Within normal limits, Comprehensive metabolic panel (CMP): Within normal limits, Covid-19 test: negative, Right lower extremity (RLE) Emergency Medicine Bedside Ultrasound (EMBU): Negative for deep vein thrombosis (DVT), Urine analysis (UA) complaint of (cx): Positive for urinary tract infection (UTI). On 10Jul2021, Cyclic citrullinated peptide (CCP IgG), Creatine Phosphokinase (CKP), C3/C4, Sedimentation rate, Urine analysis (UA) complaint of (cx): results were not reported. On 12Jul2021, Uric Acid, C-Reactive protein (CRP), Complete blood count (CBC) with differential, Lyme, Comprehensive metabolic panel (CMP), Sedimentation rate, Rheumatoid factor (RF): results were not reported. On 06Aug2021, Gonorrhea and Chlamydia screening test (GC/CT): result was not reported. Outcome of urinary tract infection was unknown. Outcome of the other events was not recovered.
Information has been received from a nurse concerning her 18 year old daughter who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. The patient had arm pain five days after receiving the vaccination. The patient did not seek medical attention. At the time of the report, the patient outcome was unspecified. No product quality complaint was involved. Additional information is not expected.
A Kinrix was given instead of a Pediarix.  Does was fine, pt was fine.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were inadvertently vaccinated with 2 doses of RECOMBIVAX HB injection, intramuscularly, lot # L038018, expiration date: 13-SEP-2017 (dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality was involved. This is one of two cases received from the same source. Additional information is not expected as the reporter did not wish further contact.
Within 2 hours I started severe vomiting which continued for at least 3 hours.  At the same time I could not open my eyes without the room spinning.  This kept up until I fell asleep.  I awaken about three hours later and vomited again.  Then went back to sleep. The next morning I was not nauseous or dizzy, but I had a slight fever, under 100 degrees and was very tired.   Did not eat anything until about 6 pm.   My stomach was upset most of the day.
Flu like symptoms on Third Day, throwing up fourth and fifth grade, sixth through 10th achy tired and and breathing problems continue through today
Severe, vesiculopapular rash on left thigh with watery d/c - red, weeping, thin-walled vesicles. FLUZONE given 2 days prior to presentation. Fussy child, afebrile.
7/7/2022 Blood test revealed Elevated TSH levels.  Doctor recommended taking levothyroxine to address this and bring levels back in to normal range.
15 minutes after felt lethargic, kept in observation 30 minutes, then went home and slept the remaining of the day.  Next day felt chilled and hot (no fever), lethargic, with myalgia.  Continues to experience pain in lower legs and lethargy.  Noted that symptoms associated with her Hoshimotos & Sjogren's including excessive sweating and muscle pain.  Noted increased pain medication use from QD to BID-TID since vaccination.  Reports increased sweating with normal activities and fatigue with activities that she normally was able to do before second injection.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concomitant therapy. On 05-DEC-2015, the patient was vaccinated with an expired dose of M-M-R II (lot # J014876 with expiration date on 21-NOV-2015, dose and route unknown) (expired product administered). No adverse effects were reported. Additional information has been requested.
Pt developed rash with redness and swelling, at site of vaccine admin. Treatment provided to patient included Benadryl and Zyrtec.
Patient received first dose on 4/24 with minimal/"normal" injection site reaction.  When given her second dose 5/28/2019 she had a severe injection site reaction. On inspection, immediately around the injection site was slightly yellow in color and then surrounded by a large red and inflammed area that started right above the inject site and spread down the upper arm to right above her arm crease. The patient complained of the area feeling bruised and hot to the touch and itching had just began approx 3 days after injection. The patient said it has not gotten any worse or area any larger. Of note the patient said she did have a headache and felt feverish 5/29 but may have been to lack of sleep from her arm discomfort. Follow up will be attempted in 24 to 48 hours to make sure the reaction is showing improvement. The patient has been advised to follow up and seek immediate medical attention if the area continues to worsen, including the area spreading, changing in color, increased pain
Patient admitted on 2/24/22, due to primary encounter diagnosis was COVID-19. Diagnoses of Hypoxia and Generalized weakness were also pertinent to this visit.
Pt. states that after receiving the Booster 3rd dose of Moderna 08/29/2021, started experiencing symptoms 08/31/2021 of tightness in the chest, shortness of breath, severe cough with mucus, numbness began around the left ear spreading throughout the left side of the face, and blisters located in the mouth. Primary communications 09/14/2021, still waiting for recommendations.
I received the vaccine at 11:  am on 01/04 Started feeling the joint/body aches in the afternoon around 4:oo pm and the soreness in my arm. then at night around 7 fever started at 102.0 took 1000mg Tylenol and took Advil alternate. The following day I thought i was okay, took shower, and went to work at 7:00 am but the temp screener sent me home of a 101.1 fever. at the same day throbbing headache and terrible body ache again makes me not going to sleep feeling the terrible pain body aches until today. I started taking Excedrin for the throbbing headache that helps a bit.
lung problems, weakness, loss of eating, loss of weight, sleep disorder, has to use inhaling machine, memory loss,
Narrative:  86 year-old male received Tdap booster shot on 11/9 at clinic. After the shot, he reported he was admitted to Medical Center for a week due to Guillain-Barre syndrome. After discharge from Medical Center, he was in Rehab Center. He was released on 11/27. No documented information information recorded about his hospital stay in Medical Center or Rehab.