chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Fever, Tachypnea, CoughWheeze, Diarrhea, NauseaVomiting, c/o chills,fatigue. Told to follow up with primary care physician if promblems persist. Narrative:
Skin reaction; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events skin reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event skin reaction.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, skin reaction was unknown.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 07/14/21 and the second dose of Moderna COVID-19 Vaccine on 08/04/21 which is earlier than 28 days and outside of the 4-day grace period.  There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Information has been received from a consumer concerning her husband, a 75 year old male patient, with no known drug reaction/allergies and with a history of Parkinson's disease, who was vaccinated with ZOSTAVAX (Merck) 2 weeks ago. Concomitant therapy included Carbidopa/Levodopa, Simvastatin (manufacturer unknown), Aspirin and Terazosin. The consumer reported that "1 week ago". The patient developed cold symptoms, runny nose and cough. At the time of the report, the patient was recovering. The patient did not seek medical attention. Additional information has been requested.
Swelling to injection site right deltoid. Soreness to injection site. TX Tylenol Ice Pack.
5cm area of induration. Numbness in the lt. arm extending from shoulder to fingers.
C/O pain to her left arm. It is swollen and firm and red today. It is sore per MOTHER OF CHILD.
Report A0383620A was received from a nurse and prospectively describes a 20-year-old female who was vaccinated with hepatitis A vaccine inactivated and hepatitis B vaccine recombinant (TWINRIX) while in the first trimester of pregnancy.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  On 10/15/2002, the subject received her first injection of Twinrix.  On that date, an unspecified pregnancy test was positive.  Additional information was received on 05/13/2003.  The reporting nurse stated that the subject had known that she was pregnant at the time of immunization, and had already scheduled an elective abortion for reasons unrelated to Twinrix administration.  The subject proceeded with the scheduled abortion on 10/29/2002.  The subject returned for her second injection of Twinrix on 02/01/2003; no adverse experiences were reported after that injection.
ringing in the ear,heart pounding fast in my ear; Fever/Temperature of 105.5; hard time getting up to going to bathroom; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature. Concurrent medical conditions included Cancer. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ALLOPURINOL (ZYLOPRIM) and VITAMIN D NOS for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, Body temperature: 105.5 (High) 105.5.         Patient did state in the past they have Pre-mature Ventricular Contraction (PVC) but this time it was not like that since their blood pressure was normal. Patient also stated they did not decide to contact their HCP since the fever and other symptoms have been subsided. Patient did mention during the end of the call that they will contact their HCP since they have cancer and other underlying conditions.
Information has been received from a Licensed practical Nurse concerning unspecified patients of unknown age and gender. Nurse reported that since 30-JUL-2014, improperly stored M-M-R II (therapy type, lot#, dose, route and duration were unspecified) were administered to unspecified patients. No adverse effects were noted. Additional information has been requested.
First dose done Sunday, 12/27/2020- same day was fine. Sxs started that evening in middle of night- arm sore, headache, fever (would fluctuate from 100-101), chills, scatterbrained, joint pain, muscle aches, fatigue that lasted over 2 weeks.   Second dose done Friday, 01/15/2021- same day was fine. Sxs started that evening in middle of night- same sxs as above but more intensified. Literally could not get out of bed, chills were so bad- I was shaking look like I was convulsing. Fever went up to 103, Headache was more of a migraine but medication would somewhat subside it.  Booster done Friday, 11/26/2021- same day started feeling fatigue cpl hrs after I recv'd it. Sxs started that night as above (extreme joint and muscle aches as if I have Restless Leg Syndrome), fever, chills, headache, fatigue, scatterbrained BUT there were more side effects to add to the mix: loss of appetite and nausea. This headache NOTHING will help subside the pain and makes it very difficult to function at work and home. Had to call out work bc I was unable to sleep night before nor drive. It is now Thursday, 12/02 and I still have this headache with not much of an appetite and nausea.
Patient broke out into a rash after receiving vaccine. Rash appears to be resolved within 10 minutes.
Severe pain, moderate edema, warmth left upper arm at shot site. Pain treated with Tylenol 3, Percocet, Prednisone 50 mg for 5 days.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M044717 expiration date: 19-JUL-2019 and lot # N002720 expiration date: 12-MAY-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that the incorrect product storage had a time frame of 16 hours at 31°F or colder (21.7 °F). This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008873:
Diagnosis 1: Urticaria, unspecified (L50.9) Allergic rhinitis, unspecified (J30.9) Other pruritus (L29.8) Patient has urticaria for the past 2 weeks - probably as a response to the Covid vaccine's immune boost. Hives are usually harmless but annoying. Several factors can be causing chronic hives including physical (heat, cold, rubbing, pressure, inflammation or infection) and psychological (stress, anxiety) factors. For now the most important task is to get the itch and therefore hives under better control. I recommend daily prophylactic medication with Zyrtec and Xyzal once or twice per day. For break-through episodes, benadryl 25mg every 4-6 hrs. Diagnosis 1: Chronic cough (R05.3) Allergic rhinitis, unspecified (J30.9) Procedures ordered or performed: Allergy Skin Tests (95004): Results: all positive - dermatographism, DX 1: R05.3, DX 2: J30.9, Venipuncture, Routine (36415): DX 1: J30.9. DX2: L50.9. DX3: R05.3. Patient has less cough, but still nasal congestion. Skin testing today was positive for all including negative control - due to his dermatographism. I sent an allergy blood test instead. In the meantime he should restart the combination of flonase and azelastine nasal sprays and continue the montelukast at night. For his skin itch he can use Zyrtec or Xyzal as needed. I will give him a call with his blood allergy test results and we can discuss avoidance measure and possibly consider allergy shots for more permanent treatment. Environmental controls discussed:
The patient experienced no symptoms; An improperly stored VARIVAX was used on 12-FEB-2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies were not provided.  It was reported that on 10-JUL-2019, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S005080, which has been verified to be valid, expiration date validated as 19-FEB-2021) had a temperature excursion, therefore, the reporter mentioned that "the expiration date was changed to 10-OCT-2019". However, on 12-FEB-2020, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, vaccination scheme and site of administration were not reported), administered subcutaneously as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) used for administration was properly stored and was not expired. The patient experienced no symptoms.
6-16-2008 patient felt dizzy and had a hard time focusing, lasting a few minutes then went away.  This hasn't happened since, per patient. 06-15-2008 patient noticed Rash, redness, warm to touch and sore picky feeling in her right upper arm.  6-17-2008 patient came to health department.  Right upper arm red, swollen and warm to touch.  Patient referred to family physician.  Patient put on antibiotic Keflex and Benadryl and if not better by 6-18-2008 to return to family physicians again.
They gave me 0.5mL of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 026B21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.). On 22-Oct-2021, ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.) had resolved.            No concomitant medication provided.  No treatment information provided.   This case was linked to MOD-2021-361945 (Patient Link).
The patient had symptoms following her initial injection of the Moderna vaccine which resulted in her missing two days of work.  She experienced worsening fatigue after her second Moderna vaccination.  On 5/29/2021 she woke up with right-sided weakness and presented to her local hospital  for evaluation.  Evaluation for stroke was unremarkable.  In the beginning of 7/2021, she began to fall frequently stating that her legs would give out.  She endorsed worsening leg weakness, numbness, and an electric pain present from the knees down to her feet and within the rib cage and breast, on the right side in particular. In 9/2021, she began using her mother's motorized lift chair and wheelchair to move around. She was initially evaluated by a local neurologist who suspected polyneuropathy due to uncontrolled DM2 (A1c 14.8%), however reportedly had an EMG which  was concerning for CIDP.  She also endorsed new constipation and reduced urination since the onset of these symptoms. She also complained of fatigue, significant changes in vision, and unintentional weight loss ~40 lbs since 1/2021.  Her EMG from 10/21 showed prolonged distal latencies and markedly decreased amplitudes in the bilateral tibial and peroneal motor nerve conductions; the right sural potential was absent; she had evidence for active and chronic denervation in bilateral L2, L3-4, L5 and S1 muscles.  CSF on 10/29 showed protein 237, glucose 56, WBC 2, RBC 1.  Cervical spine MRI showed minimal degenerative changes.  Thoracic MRI was unremarkable.  Lumbar MRI was unremarkable.
Patient had vaccine administered on 9/26/14 at 1430 - at 2300 that eve. pt felt hot, thermometer not working correctly pt was delirious reported per mother vomited 2345 pm, slept the rest of the night, awoke acting normally.
Vaccine given 9/22/08 10:30 am side effect 5am 9/23/08 was fever - large left upper arm pain and swelling. WBC increased 13.5.  12/23/08 Reviewed hospital medical records of 9/17-9/26/2008. FINAL DX: prostate carcinoma; radical retropubic prostatectomy & bilateral pelvic lymphadenectomy; adverse reaction pneumovax vaccine. Records reveal patient experienced prostate cancer, underwent radical surgery w/o complication.  Received pneumovax on post op day 5.  Developed left shoulder injection site swelling, fever & leukocytosis on post op day 6.  Treated w/antibiotics. Resolved by post op day 9.  D/C to home with indwelling Foley catheter, on continued antibiotics.
Fever 1-1.3 degrees for 4 days, diarrhea 1 day, fatigue 4 days, head congestion 3-4 days, cough about 3 weeks, sore arm 2 days. Treated with acetaminophen, Tessalon Perle for cough, Coricidan HBP for congestion
Hives the day after in injection arm Red oval rash 8 days after vaccine at injection site
Dx w/intuss;occurred approx 4-5 days p/ vaccine;reduced by barium enema;
I had my vaccination on 05/01/2022. On 09/14/2022 I started to experience cough congestion body aches and low grade fever. I took a COVID-19 test at home on 09/15/2022 and it was Positive. I took Paxlovid for 5 days. I tested COVID-19 Negative on 09/25/2022.
Nose stuffed up; Face hurts; Ears stuffed up; Cough; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO161) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and ankylosing spondylitis. The patient had known allergies to penicillin. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), lamotrigine (LAMOTROGINE), levothyroxine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received celecoxib (CELEBREX) taken for unknown indication and experienced drug 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. On 14Apr2021 at 16:00, the patient's nose was stuffed up, her face did hurt, ears were stuffed up and had cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nose stuffed up, cough, face hurts and the event ears stuffed up were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with GARDASIL (route, dose, lot# and expiration date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
cellulitis; vaccination site rash; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (cellulitis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, CELLULITIS (cellulitis) and VACCINATION SITE RASH (vaccination site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment for the events included an antibiotic and then a steroid, oral prednisone for 5 days following which the reaction resolved within 48 hours.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe chest pains that lasted about 5 minutes also diarrhea . Pain in right arm. Fatigue also.
feel like I have the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feel like I have the flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (feel like I have the flu). At the time of the report, INFLUENZA (feel like I have the flu) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable  No concomitant medications reported. No treatment reported.
Patient noted on rounds to be in subjective distress. RN had given varicella vaccine (Varivax) @ 12:25. Shortly therafter patient c/o generalized itching, swelling of lips, and difficulty breathing. Assessed to be having anaphylactic response, patient was placed on continuous pulse oximetry, AFVSS with SpO2 >90%. Noted diffuse wheezing on exam, otherwise without abnormality. Patient was given Benadryl 25mg IMx1, Prednisone 40mg POx1, and albuterol neb treatment x1. Patient remained AFVSS, had prompt response to treatment and was continuously monitored without event. On reassessment 2 hrs later patient was well appearing and asymptomatic.
Fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine and experienced fever. The field representative indicated that she was at a conference and was provided information from two separate contacts for three adverse events reports. The reporter unable to obtain additional details. This was 1 of 3 cases reported by same reporter.
Since the vaccine, I have been having increased metallic taste in my mouth.  Somedays its heightened.  Increase in Saliva production and my mouth fills up.  Altered taste and loss of taste of food, beverages and spices.
I had vaccination on 04/06/2022. On the beginning of 06/2022 I started to experience Premature Ventricular Contractions. I contacted the Doctor that put me on the Eliquis because he is associated with a heart clinic. They put me on a Holter monitor they identified the sensations I was having was in fact Premature Ventricular Contractions with 500 episodes a day. The cardiologist said on 09/27/2022 that my tests and labs all look good.  I also started to experience symptoms of Phlebitis in 09/2022. I contacted my doctor and stated to double up on the Eliquis and to scale back on my exercise.  The Premature Ventricular Contractions gradually went away on their own.
DECLINE IN GLOMERULAR FILTRATION RATE; This spontaneous report received from a consumer concerned a 73 year old male. The patient's weight was 207 pounds, and height was 66 inches. The patient's concurrent conditions included: chronic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 21-JUL-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the patient experienced decline in glomerular filtration rate. Laboratory data included: Glomerular filtration rate (NR: not provided) 20. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, and Glomerular filtration rate (NR: not provided) 24. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from decline in glomerular filtration rate. This report was non-serious.
LITTLE BIT DECREASED APPETITE; FELT YOUNGER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical condition included a drug allergy when treated with zolpidem tartrate. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series: 1) on MAR-2021. The patient subsequently received covid-19 vaccine ad26.cov2.s (dose number in series: 2)  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, frequency 1 total, administered on 19-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced little bit decreased appetite and felt younger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little bit decreased appetite and felt younger was not reported. This report was non-serious.
pt recv vax & became dizzy & exp h/a, face flushed layed down w/feet elevated;p 80 regular;pt c/o feeling worse, pulse weak & 50;face red & warm, extremities cold & clammy;trouble breathing, pale, lips pale, bradycardia;dx vagus nerve respo