chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DRY THROAT (dry throat), PAIN IN EXTREMITY (Sore arm), TONGUE ERUPTION (full body raised rash tongue and face) and RASH (full body raised rash tongue and face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.
THIS PATIENT EXPERIENCE MILD DIARRHEA IN THE MORNING AND SUBSIDED LATER IN THE DAY
>6wks post injection; Intermittent (dozens of times daily) pain (2 out of 10) at Injection location, Constant Pain (2 out of 10) in two different shoulder muscles, Intermittent (2-3 per day) pain (2-4 out of 10) then dead arm feeling in one of the two shoulder muscles.
Patient developed cellulitis that was resolved using Cephalexin 500mg, 1 capsule three times daily for 7 days. The rash resolved within 3 days of starting the cephalexin.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 09-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Pt states she experienced pain, redness, warmth to the touch at the injection site, from 7/11 thru 7/16 (5 days). Discomfort relieved with ice pack. Still is red, pain and warmth after 5 days and appears bruised. Skin began to peel, site raised and sore. On 7/30 on 7/31, sore "burst" and drained. Went to hospital and was treated with antibiotics and drain inserted. Cephalexin treatment continues.
Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 13-Aug-2021, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
"COVID arm" area around injection site. Circular and approximately two inches from actual injection center to the end of the circular rash. It is swollen, red, raised and warm to the touch. There are also small rash bumps around in and around the effected area. It is very sore, painful and extremely itchy.
fever (warm) didn't take temp 98.6;vomiting a few times;lethargic;did not see MD;no tx;
FEVER; LYMPH NODE PAIN; BODY ACHES/GENERALIZED BODY ACHES; SHIVERS/FEELING COLD; SWOLLEN LYMPH NODE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 168 pounds, and height was 74 inches. The patient's past medical history included: penicillin allergy, and other pre-existing medical conditions included: The patient had no known medical history and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced lymph node pain. On 06-OCT-2021, the patient experienced body aches/generalized body aches. On 06-OCT-2021, the patient experienced shivers/feeling cold. On 06-OCT-2021, the patient experienced swollen lymph node. On 07-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches/generalized body aches, and fever on 07-OCT-2021, and shivers/feeling cold on 06-OCT-2021, and had not recovered from swollen lymph node, and lymph node pain. This report was non-serious.
11 hours after my shot I was lying in bed trying to sleep. I noticed that my pulse  rate was very fast. I measured it using a stop watch. It was 105 / minute. My normal is around 60. I had no other symptoms. I took Alprazolem 5 mg and after 20 minutes my pulse slowed down. After an hour it went to 75. I fell asleep and was fine in the morning.
8 days after my shot my arm got all red and splotchy and itchy and tender and sore.  It felt hot.  The redness  covered about my palm size hand where I got the shot.
Chronic cough started sometime in March. At first I blamed allergies, but oral antihistamines and nasal steroids did nothing. I then blamed worsening GERD. I was constantly clearing my throat and coughing/choking all the time. It had been previously well controlled with OTC Nexium. My GI Dr scheduled an EGD. It showed gastritis and signs of GERD. My symptoms worsened and I found that albuterol would sometimes help my coughing fits. They continued to worsen to the point that I was using albuterol every 4 hours, gasping for air, wheezing, O2 dropping to the low 90s.  Three weeks ago, my PCP gave me samples of Breztri to see if it helped any. It immediately started working on day 1 and improved over time. I hardly have any symptoms while taking it. I had some pulmonary function tests done 2 days ago and was told my lungs were horrible, and they referred me to a pulmonologist. I do not smoke.
Moderna vaccine was given to 17 year old male, Moderna approved for 18 year old and older
Tested positive for COVID-19 after being vaccinated with all three doses of the Moderna.
Treat with erythema, swelling left upper extremity after TDAP.  Possible cellulitis. Patient discharged with Keflex and Vicodin. Patient treated in ER with Vicodin and Rocephin. Patient also reported dizziness, malaise, epistaxis.
Caller stated he tested positive for covid on 11Apr2021; Caller stated he tested positive for covid on 11Apr2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153), at the age of 52 years, intramuscular on 08Apr2021 17:00 and the first dose (Lot Number: EP7534) via intramuscular, administered on the left arm on 16Mar2021 16:15; both as a SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, ongoing gastrooesophageal reflux disease, ongoing blood cholesterol, gastric cancer from an unknown date and unknown if ongoing and pancreatic carcinoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for hypercholesterolaemia from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) taken for gastrointestinal disorder from an unspecified start date and ongoing; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for chronic obstructive pulmonary disease from May2019 and ongoing. The patient he tested positive for covid on 11Apr2021. It was stated that maybe he already had COVID in between the two shots. His question was, did the second shot still work or because he got COVID, it doesn't work. He has asked everyone even his doctors and no one can give an answer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
One week following the COVID 19 vaccine, patient developed a psoriatic arthritis flare up.  She has history of psoriatic arthritis; however reports it has been well controlled.   She had a change in her medication in 11/2020 and was started on Ixekizumab.  She is also taking Hydroxychloroquine.  States psoriasis rash under her nails is severe.  She also reports bilateral shoulder pain.  Taking Tylenol.
The second dose of the Hepatitis A series given was the adult vaccine, and not the pediatric Hepatitis A vaccine. No adverse reactions.
Spotting/vaginal bleeding began 2 days after first dose and lasted 1 week. Dry mouth began within minutes of first dose and lasted 2 weeks. Sore/itchy arm 1 week after first dose and lasted a few days.
Severe involuntary, uncontrollable seizure-like shaking started at 11 PM, exactly 14 hours after I got Pfizer booster shot on Thurs, Dec 9, 2021.  Up until that time, I had no negative side effects.  Lasted for two hours.  Unable to walk.  Unable to talk adequately.  Severe chills.  Unable to sleep.  On Day 2, Sat, Dec 10, 2021, I was only able to be up to walk to the bathroom.  Also on Day 2, severe muscle and joint pain that made it difficult to move and walk.  Nausea--ate & drank only saltine crackers & Ginger Ale.  Day 3 - much improved but only able to be up for 1.5 hours at breakfast and had to rest remainder of day.
Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) 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.   Concomitant medications were not provided.  Treatment information was not reported.   This case was linked to MOD21-129698, MOD21-129760, MOD21-129760, MOD21-129763, MOD21-129764, MOD-2021-285598 (Patient Link).
Patient was given vaccine at 17 years old - Nurse noticed age after vaccine given. (Name, DOB reviewed with patient, but nurse did not calculate age prior to vaccine).
Patient reported very painful around site of administration to the point where it hurt to move her arm. Swelling, redness. Area was warm. Patient stated arm continued to hurt more as time progressed.
p/vax pt exp flu sx, joint, hand, wrist & knee discomfort, lost energy, thrush of mouth, pain in hips & arch of feet;already present sinus infect;pt came down w/flu;
Pt was given the pediatric dose of Havrix instead of the adult dose. Per website pt was given another pediatric dose to complete adult dose of hep A vaccine.
Administration date of Moderna vaccine past the BUD; Product storage error for vaccine kept in storage >30days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and PRODUCT STORAGE ERROR (Product storage error for vaccine kept in storage >30days) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and PRODUCT STORAGE ERROR (Product storage error for vaccine kept in storage >30days). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and PRODUCT STORAGE ERROR (Product storage error for vaccine kept in storage >30days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.   This case was linked to MOD-2021-320876 (Patient Link).
Patient was given 0.5mL of Flu vaccination on 09/10/2018 at 11:30AM, no known symptoms or signs noted.
UNSPECIFIED SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified symptoms was not reported. This report was non-serious.
Pt received the 2nd dose of the Pfizer COVID19 vaccine on 1/19/21.  Pt. reports COVID like symptoms starting 4/11/21 and then tested COVID positive on 4/16/21. Pt. denies any known work or community exposure.
Patient developed enlarged (L) axillary lymph node about 5-6 cm in size in same area that vaccine was given within 24 hrs of vaccine administration.
Mild flu symptoms for a few days after injection. Swelling of right arm for 1 week, bruising below injection site  visible after 2 weeks.  Pain in right armpit after 3 weeks.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2000 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
63y.o. female with HX of T2DM, PE, HLD, and Hypertension presented to the ED with c/o shortness of breath, cough, and fever. Patient was on a one week cruise and returned 7 days ago. 5 days ago, she developed cough, fatigue, fever, and difficulty in breathing. She took a at home covid test which was positive today. Patient is Vaccinated X3 with booster a couple weeks ago. Denies chest pain and reports improvement in her breathing. Denies fevers, chills, nausea, emesis, sore throat, edema, and chest pain. Discussed with ID, plan of care discussed with RN, letter typed for patient's employer. Medically stable for discharge, she is agreeable
holding head to rt, dec appetite, inc sleeping, drooling on rt side & limp, no smiling or cooing; no fever, 12 hrs p/shot;
Headache, Myalgia, Arthralgia, Fever, Chills, Fatigue, Injection site pain, Rigors Narrative:  Other Relevant History:
I exp fatigue after Dose 2. I took a at home negative pregnancy test on 2/24 and I had positive test on 2/27. I miscarried on 3/7 which would have put me at 6 wks my estimated due date was the end of 10/2021.
Chronically elevated d-dimer, elevated risk of MI, CVA, DVT Currently treating with anticoagulants
Morning fatigue, Gastrointestinal problems, Nausea, Bloating, Cramping.
felt very cold; Chills; slept all day; didn't feel good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 11:00 (Lot number: ER2613) at the age of 85 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "blood pressure " (unspecified if ongoing). Concomitant medications included: AMLODIPINE BESYLATE taken for blood pressure abnormal (ongoing); HYDROCHLOROTHIAZIDE (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol (ongoing); HYDROXYCHLOROQUINE SULFATE taken for rheumatoid arthritis, start date: 02Mar2021 (ongoing). Vaccination history included: Bnt162b2 (First dose: Pfizer COVID-19 vaccine 02Mar2021 Lot number: EN6202. Left upper arm.), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: FEELING COLD (non-serious) with onset 28Mar2021, outcome "recovering", described as "felt very cold"; CHILLS (non-serious) with onset 28Mar2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 28Mar2021, outcome "unknown", described as "slept all day"; MALAISE (non-serious) with onset 28Mar2021, outcome "unknown", described as "didn't feel good". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Fever, body aches Nausea Severe dizziness   lightheadness    as of 5/6/2023 still occuring Went acute clinic 5/6/2023 and was told they would treat him since they did not give vaccine.
Client complains of eye pain, red watery eyes, light sensitivity beginning shortly after 1st dose of COVID vaccine, mostly resolving, then recurring again after 2nd dose. States he is nearly incapacitated with eye pain and light sensitivity now, unable to work. Has seen a provider at a local hospital and also an optometrist, with no diagnosis, and reports a negative CT scan.
pt recv vax 10JUL97 & devel hives;pt to clinic 18JUL97 c/o broken out in hives;to MD on 11JUL97 because broken out in hives on back, trunk & legs;MD stated pt was allerg to diphtheria;
Fever > 103 x 2 days. Irritable x 3 days. Decreased eating.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported. On or about 09-APR-2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, route of administration, anatomical location, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a physician at the physician office for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the pt had not recovered from herpes zoster. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was considered as related.
Narrative:  HISTORY OF PRESENT ILLNESS: The patient is a 49 y/o male with a PMH of HLD, HTN, and DM who presented to ED complaining of cough. The patient states that he began to feel unwell 2 days ago. He developed a day cough at that time with minimal SOB. He reports associated fatigue. He denies fever, N/V/D, chest pain. The patinet states he received two doses of Moderna covid vaccine Tmax in ED was 103.6F. No elevations in heart rate noted. Intermittent low normal oxygen saturations were observed but patient did not require oxygen. The patient was noted to be COVID positive. ALT 199 nd AST 170. CXR showed Mild cadiomegaly and pulmonary vascular congestion. HOSPITAL COURSE: patient was admitted to the hospital for acute hypoxic respiratory failure. He was started on steroids due to his hypoxia and elevated LFTs. Patient did well overnight and was able to wean off oxygen. Given brisk improvement, patient was deemed appropriate for discharge. DC plan was discussed with patient and he was deemed stable for DC. He was discharhrged on 12/14/21 in stable condition with a short course of steroids to go home on.
After 9 days injection, below injected area have rash.  Contacted my family doctor. Apply ice and 1% hydrocortisone  to reduce symptoms.
Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste/smell 01/02/21