chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was administered one dose of improperly stored Proquad; No adverse effects were reported; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's relevant medical history, previous allergies or drug reactions, concomitant medications and concurrent conditions were not disclosed.  On 30-JAN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, anatomical injection site and route of administration were not disclosed) for prophylaxis; lot # R015740 and expiration date  reported as 03-DEC-2019, but upon internal validation established as 02-DEC-2019.  It was reported that this vaccine had been on a temperature excursion and was stored at 21 °F during 19 hours; and it was also noted that there had been a previous temperature excursion of 96 hours at a temperature of 14 °F (6 °F - 14 °F).  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Hives on flank; heavier on opposite side from injection site; Rash on vaccine side of body under where purse strap rested/placed pressure; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03May2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history included nickel 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 vaccination. The concomitant medications included escitalopram oxalate (LEXAPRO), desogestrel/ ethinylestradiol (MIRCETTE) and women's gummy multivitamin, all from unknown dates for unknown indications and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), linalool (MANUFACTURER UNKNOWN)  and experienced allergy. On 04May2021, the patient experienced hives on flank, heavier on opposite side from injection site and rash on vaccine side of body under where purse strap rested/placed pressure. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives on flank and rash on vaccine side of body under where purse strap rested/placed pressure were resolving at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event occurred; per protocol, submitting VAERS for following reason: Client received Cansino Biotech vaccine (not approved by WHO) in  on 04/15/2021 Lot #A030521.  Client requesting Pfizer primary series and received dose 1 on this day 10/28/21. Approved by T3 lead
May 2021, my husband complained of memory issues and stated it got worse after getting the vaccine. On June 1, 2021, he completed suicide by hanging. In a note he left he stated that ?something in my brain went wrong.? That it was his ?failure to function at work and trying to remember things that did this to me.?
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 02-Dec-2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  No treatment information was provided.  This case contains information for the 37th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
DIZZINESS, NAUSEA REPORTED  HAD PT LAY ON GROUND AND ELEVATE FEET, PLACED COLD PACK ON FOREHEAD AND INSIDES OF WRISTS.  MONITORED BP  SHE ENDED UP NOT STAYING FOR THE END OF HER SHIFT- A FAMILY MEMBER PICKED HER UP AND WAS SENT HOME TO REST, IF SX GET WORSE SHE WAS TOLD TO SEEK MEDICAL ATTN
She was very tired slept most of the day (01/20/2012) and does not usually doesn't sleep that much. Very colicky 01/21/2012 cried unless she was asleep could not be soothed would did not eat very much. Seemed a little better 01/22/2012. Same senerio as 01/21/2012 happened again on 1/23/2012 cried for 5 hours befor having very painful runny diarrhea then slept. Also still on 1/23/2012 has hard bump at injection site.
The spot I got the shot swelled up like I Had a Golf Ball under my skin for a month my whole Shoulder was swelled up and pain. Shoulder still hurts it is a deep pain like in side bone. Secound month had spot on right side of gutt swell up that had a lot of Heart burn
Patient reports that has had shoulder pain since the vaccination. It started the morning after the vaccination and was not muscular. Patient indicated that rest and anti-inflammatory medications were used to manage symptoms. Exercise continues to cause pain in the shoulder similar to bursitis.
Tested positive for COVID on 9/14, was admitted to the hospital on 9/17/21
Pityriasis Rosea. Onset 1 week after vaccination. Full rash peaked 1mo after vaccination and lasted for another 1.5 months from peak. 3mo back to normal.
Mid July I started feeling tired, sick after I would eat and experiencing  bloating in my stomach and started having constipation issues and continued to feel bad.  And I went to have a check up in September 2021. They did blood work and everything was normal except my liver enzymes were high. They did an ultrasound of my liver and determined I had a fatty liver. They told me to change my diet to see if I would feel better. In November, I started feeling worse.  The week of Thanksgiving, I went back to the doctor. They noticed that my liver enzymes were even higher. They did a CT scan and they found 2 benign tumors in my liver. They found some other spots that were uncharacterized on the CT scan,  they were not sure what they were. The doctor told me to continue with the strict diet. I will  go for another check up in February 2022  to do an MRI, to see evaluate those spots, and compare and see if anything has changed from the prior test.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 45.81.  No concomitant medications were reported.  Batch number 031L20A administered on 12-Feb-2021 underwent temperature excursion with temperature range of 29, 35, 35 degrees Fahrenheit from 09:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient is a 59 y.o. female with past medical history of hypertension, hyperlipidemia, diabetes mellitus, coronary artery disease, chronic diastolic CHF, chronic hypoxemic respiratory failure on 3 L of oxygen through nasal cannula, end-stage renal disease on regular hemodialysis sessions, presented with viral syndrome 4 days duration   Covid-19 Virus Infection Chronic hypoxemic respiratory failure Presumed COPD Presumed obstructive sleep apnea Date of onset of symptoms: 12/14/2022 Symptoms present on admission: Fever chills, rhinorrhea, sore throat, productive cough of yellow sputum, shortness of breath generalized weakness and fatigue Date of covid positive test: 12/18/2022 Vaccination status: vaccinated Imaging: Chest x-ray no infiltrate Oxygen requirements on admission: 3 L NC of oxygen through nasal cannula Current oxygen requirements: 3L Medical therapy: steroids, rocephin, and zithromax, remdesivir.  Antibiotics were discontinued per ID Consultants following: Infectious disease consult Anticipated special isolation end date: 12/28/2022 Continue incentive spirometry and bronchodilators Outpatient pulmonary function test and sleep study   She finished 5 days of remdesivir 10 days of dexamethasone. Now on baseline 3 L nasal cannula during day.  CPAP at nighttime. Lung exam improved. Okay to be discharged home today.   Acute on chronic diastolic congestive heart failure History of coronary artery disease Echocardiogram 10/7/2022 showed normal EF 70%.  Grade 2 diastolic dysfunction.  Pulmonary hypertension RVSP 48 mmHg. Reduced average global longitudinal strain of -12.9%.  Pattern suggestive of cardiac amyloid. Left heart catheterization on November 2022 showed severe two-vessel coronary artery disease with successful percutaneous coronary intervention RCA ISR with POBA. Ultrafiltration with dialysis.  Currently close to euvolemic.  History of hypertension Discharge regimen with Imdur 30 mg daily, Coreg 25 mg twice daily, hydralazine 100 g 3 times daily and Clonidine patch weekly. Initially nifedipine 60 mg twice daily was stopped on admission, resumed at low-dose 30 mg daily. Blood pressure stable over last 24 to 48 hours before discharge.   Insulin-dependent diabetes mellitus Diabetic neuropathy Continue home dose Lantus 10 units nightly and insulin sliding scale. Hemoglobin A1c 6.2 Continue home gabapentin twice daily  End-stage renal disease on regular hemodialysis sessions Anemia of chronic disease Metabolic acidosis Nephrology consulted to resume HD and UF   Hyperlipidemia Atorvastatin 80 mg daily   Moderate protein calorie malnutrition Nutrition consult
Anaphylaxis Narrative:  Patient was observed in clinic for 15 minutes post vaccination and left stating no issues. Was later in parking lot and told someone she was having trouble breathing. 911 was called. Currently awaiting update.
Adverse event: patient reported rapidly beating heart 6-12 hours after vaccine while sleeping. Extreme concern. Lasted about 20 minutes. Reported to PCP week of 23 Aug 2021. Doctor recommended proceed second dose.
Noted by aunt to have tenderness and R thing swelling, limping. On 4/8/03 noted to be limping with increased tenderness to R ant thigh-now measures 13 1/ 8" circumferentially compared with 12 1/2" L thigh.
Experiencing high temperature since 12 hours; 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 PYREXIA (Experiencing high temperature since 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (Experiencing high temperature since 12 hours). At the time of the report, PYREXIA (Experiencing high temperature since 12 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         Experiencing high temperature since 12 hours
Patient states that his throat closed up, tonsils swollen, hard to swallow and aggravated his respiratory system and joint pain. Restless to sleep.
Information has been received from a nurse practitioner concerning a 13 year old female with no pertinent medical history and no drug allergies, who on 24-OCT-2010 was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). Concomitant therapy included MENACTRA and Tdap (also report as no concomitant therapy). On 26-OCT-2010 the patient experienced erythema at the injection site which presented 2 days post vaccination. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. At the time of the reporting, the patient not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Fever starting at 11:30pm.  Continued through the night with uncontrolled shivering and reached 103.7 degrees.  While trying to find an  urgent care facility that was open 24/7, fever finally broke around  4:30am so we stopped looking at that point.
received an expired vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 7th September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 20th September 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 20th September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 20th September 2021, patient received Rotarix, which was expired on 7th September 2021. No reactions was reported. Unknown patient identifiers. The reporter did not consent to follow up.
8:55 am, pt had redness, induration & itching at site of injection. 9:45 am, .4mm induration. 1:00 pm, pt's condition was improved.
Pulmonary embolism; Fast heart rate; Blood pressure, increase in blood pressure which she thinks that she got that from the vaccine; This is a spontaneous report from a Pfizer sponsored program via contactable female pharmacist (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary embolism, fast heart rate and lood pressure, increase in blood pressure which she thinks that she got that from the vaccine on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: increased on an unknown date, heart rate: fast on an unknown date. Outcome of the events was unknown.  Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Pulmonary embolism and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The evening after I received the first shot, the tricep on my right arm starting aching.  In the morning, the right side of my neck had a severe, burning pain.  It made it difficult to turn my head.  It was a couple of weeks before the pain subsided. The evening after I received the second shot, the tricep on my left arm starting aching.  A couple of days later, the back of my next starting aching.  It was not as sharp as with the first shot, but it also makes it difficult to turn my head.  It has now been several months.  The pain is not as severe as it was in the beginning, but it is still aching.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
arm  swelling; sore arm; red lump on arm; arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm), MASS (red lump on arm) and PRURITUS (arm itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELOXICAM (MOBIC) for Arthritis, DULOXETINE for Depression, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for GERD.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm) and MASS (red lump on arm). 04-May-2021, the patient experienced PRURITUS (arm itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm), MASS (red lump on arm) and PRURITUS (arm itchy) outcome was unknown.            This case was linked to MOD-2021-106480 (Patient Link).
Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick). At the time of the report, ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick) outcome was unknown.            No concomitant medication was reported.  Caller stated that after her husband received COVID boosters, he had many symptoms and was very sick.  No treatment information was provided.
Chest pain. Positive D-Dimer. Pulmonary Embolism.