chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug effect decreased; Injection site reaction; Swollen joints; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication information was provided.  On unknown dates, patient experienced HUMIRA stopped working, reaction at injection site and joints to swell in back, neck and jaw with HUMIRA(ADALIMUMAB).   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  '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.
Swelling around eyes upon waking up at 1130. Itching with welts started around 1300 around elbows and on legs.
One hour after shot (left arm by nurse record, right arm according to patient), he described tingling and numbness of hands, purple color of right index finger, then tingling of toes. That night he got body aches all over, headache, fatigue and slight fever at 100F. 2 days later on July 5 he had worse pains of left arm, elbow and hand and malaise. Burning and tingling of hands and feet continued for weeks. On July 23 left foot was more painful, left big toe and right index finger turned purple.
Large, painful  (golf-ball size) swollen lump  in armpit of vaccinated arm.
Numbness and paresthesias of Rt cheek (mild), followed by gradual worsening and Rt facial weakness over next 72 hrs or so. Saw neurologist 8/1/13, dx w Bell's palsy. 8/2 am began Prednisone 60 mg tapering course and Doxycycline x 3 wks (previous erythema migrans several years previously; recent deer tick exposure). Sx persist but improving. Also had marked local reaction w erythema and induration (have photo).
swelling @ inj site, cont screaming fro 930AM-2PM;ice pack applied to inj site & oral fluid;pt settled down & cont to improve over 24hr
My lymphoid under my arms were swollen for weeks. I went to the doctor to see what was going on. I used warm compresses to relieve the discomfort. I got sick with a respiratory virus on 01/25/2023. I went to a clinic and got a prescription for prednisone. As of today, I continue to have a cough.
Noted at 5:37pm on 1/18/2021 with a temperature of 100.0 degrees Fahrenheit. Acetaminophen  650mg once administered. Temperature at 7:03pm on 1/18/2021 was 98.6 degrees Fahrenheit. No other side effects noted.
Nausea, diarrhea, fatigue. Treated with lots of rest, probiotics. Symptoms have continued for 5 days so far.
This spontaneous case, initially received from other health professional (nurse) on 22-Jan-2018, concerns a 06-month-old infant male patient. The patient had no medical history. The patient did not receive any concomitant medications. On 22-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: anterolateral thigh, batch number: 195235, expiry date: 31-May-2018) under age of 04-year-old. It was reported that, no adverse event was noted after the vaccination. The reporter assessed the event as non-serious.
Vaccine #2 Thursday Aug 5th, 3:10pm  Friday August 6th: Fever 100.5, chills, aches, headache, fatigue.  Sunday August 8th, 2:30om: Sudden onset dizziness/lightheadedness, weakness in extremities. Feeling like I'm going to pass out off and on for the rest of the day. Monday August 8th:  slight feeling of dizziness/lightheadedness, not as severe as Sunday, but still feel off.
This registered pharmacist reported that a 101 year old male patient was given on injection of ZOSTAVAX (lot number 670617/0618AA) (dose and route not reported) on 20-OCT-2012. The patient had not relevant medical history or relevant concomitant medications. The patient's relevant past drug history was unknown. The pharmacist discovered that the ZOSTAVAX that was given to the patient had expired on 26-JUl-2012. It was unknown if there was any relevant laboratory data. As of 30-OCT-2012, the patient had not been revaccinated and the outcome of his getting the expired ZOSTAVAX was unknown. Additional information has been requested.
Patient had soreness at the injection site and states that he still cannot lift his arm above his shoulder and does not have normal range of motion of the left arm.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a day receiving ENGERIX B, the patient experienced nausea, vomiting and rash to be related to ENGERIX B. Additional details were reported as follows: The case was received from a medical distributor. The age at vaccination was not reported. This case was 4 of the 5 cases, reported by same reporter.
none  no changes,  follow up phone call on 8/16/2022 with mom  with  no problems noted
pt recv vax 1995 & exp allergic rxn that consisted of an immed rash all over the body w/no SOB;reporter stated pt was not in distress;no further details were provided;
After vaccine, patient was being monitored for 15 minutes and noticed rash forming around where vaccine was given. Pt. stated it did not hurt or itch and she had no trouble breathing or any other symptoms. Advised pt. to take benadryl if it felt itchy or started having any other symtoms. Advised pt to call MD if they felt or saw any further adverse side effects.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were high pressure injection injury of finger of left hand, diarrhea, elevated BP without diagnosis of hypertension.
A little bit itching at the injection site, it comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.            No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
Temperature 101-102, hoarseness, pale week, rapid heart beat. Treatment: Tylenol, close observation, follow-up call.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: h/o anaphylaxis to flu shot, allergist recommended receiving COVID vax, preferably Moderna. Came prepared w/ benadryl, EpiPen, water. Pt stated she was aware and consenting to receiving vaccine. We advised for her to sit in the observation for at least 30 minutes. After receiving vaccine, she began getting red and itchy at the neck, traveled to arms and up to face. Trunk and upwards red and itching. Gave 2 benadryl at beginning of rxn, +1 as it worsened &called EMS - pt refused care
Pt recvd 1st hep B vax 14JUN90 & 2nd 17JUL90; exp aching arm & burning w/ movement.
Pt was given IPV he developed redness and 7 + ? down his R leg. He was given Dimetapp and watched rash and redness went away witin 30 mins.
Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected
requested medical records, but never received them; pt had a positive COVID test on 9/8/21; per death certificate, pt died in the hospital with the causes of death being COVID 19 and Hypoxic Respiratory Failure
Patient assessed for requested vaccines. MMR requested per immunization requirements. She had not had an MMR and it had been required. A Varicella vaccine had been administered by a pharmacy on 9/20/2022. Since Varicella and MMR are both live vaccines, they should have been given 4 weeks apart. The patient did not have any adverse effects, but vaccines was not given per recommendations.
Around 10pm 10/2/13 pt began feeling pain/numbness in pneumo arm and injection site became hot/inflamed. Pt took "pain med." Came to pharmacy 10/3/13 at 1:30pm - RPh noted redness/inflammation in 4-5 inch area around injection site. Saw nurse practitioner at MD office who recommended she go to ER for possible cellulitis. ER MD said no cellulitis. Saw MD today and MD told her to continue w/ compresses and wrote Rx for antibiotic if needed.
PATIENT EXPERIENCED FEVER, SWEATS, EXHAUSTION, FATIGUE, SHORTNESS OF BREATH, AND LACK OF APPETITE FOR 7 DAYS FOLLOWING IMMUNIZATION. TODAY HE FEELS ABOUT 95% BETTER.
Vaccine expired six days prior to administration. Contacted medical directors, patient advised of vaccine expiration. Additional dose not recommended at this time.
pt recv vax 19AUG96 & devel lesions;it was reported that pt was exposed to chickenpox outbreak in daycare;31MAY97 the lesions were crusted & scabbed;
2 year old female started running fever on 13th (T 103-104)& continued fever thru 7/16/08. Rechecked & WBC 1.6. Rechecked WBC on 7/18-WBC 2.8. Returned 7/25/08 with maculopapular skin lesion that spread over body.
Noted to have shallow breathing, trouble sitting up. Had generalized tonic-clonic seizures over 8 minutes. Noted to have fever 37.7 in ER.
Fever 101F times 1 week, Eosinophil increased 72, felt ill. 3X5X1 induration @ site. SOB and chest pain times few days.
potential administration of expired vaccine/ administration of expired vaccine; temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the vial were stored in the refrigerator on 08-Oct-2021 and 05-Nov-2021. Also, it was reported that, both the vials were stored in an ultracold freezer since 08-Sep-2021. The second vial was moved from ultracold freezer to normal freezer on 26-Oct-2021. The vials stayed within recommended frozen storage temperatures until day of administration (05-Nov-2021).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up received includes updated lot number, additional event, drug start date, expiry date.
Large, hot swollen injection sight (3 inches by 6 inches) starting 48 hours after injection, Pain and swollen lymph nodes in left armpit.  Pains shooting down injection arm all the way to the end of fingers.    Heart pain, Pain across both shoulders and up into neck/back of head.  Joint pain and fever (low)
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. In July 2017, the patient received BEXSERO. In July 2017, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to BEXSERO. Additional details were reported as follows: This case was reported by a Licensed Nurse Practitioner (LPN). The age at vaccination was not reported. About 2 hours before the time of reporting, the nurse reported that within the past 2 weeks the patient received a dose of BEXSERO. The next day of vaccination, the patient returned to the office for redness, heat, and pain at the injection site. No further related details were provided by the reporter. The reporter gave permission to contact her at the clinic, if necessary. This case had been linked with case US2017113731, reported by the same reporter.
Within 5 minutes of VARIVAX subcut -> 10 cm splotchy red area on thigh with hot center - given BENADRYL & observed rash continued to spread to trunk & face.
I was fine for the first 4 days after the vaccine aside from a sore shoulder. On the 4th day, I started having chills. I had a temperature of 102.3. My skin got very blotchy and white, which they called mottling. It would last 3-4 hours. As quickly as it started, it went away, and I felt like I was on fire. My temperature dropped to 94 and I was shaking. Then 3-4 hours after that I was halfway back to normal. I had an upset stomach and couldn't eat. Over the 15 days this lasted, I lost 15 lbs. I went to the doctor and a COVID test which was negative. The doctor advised to continue with the Tylenol and Advil because he was unsure what to do. Every 3-4 hours, this cycle would start all over again. During the fever, my hands would turn white as if they got frostbite all the way up my arms. All of this went away miraculously about 3 days before my 2nd dose. I was feeling good for those few days. Since then, I have had difficulty breathing, pain in my back and center of my chest. I also have lack of energy, and headaches. I went to the doctor where a chest x-ray was done. The x-ray came back as possible pneumonia. I was sent for a CT which showed thickening in the lungs. I was then sent for a stress test, echocardiogram which both came back normal.
Left deltoid was red, hot and swollen 5cm X 5cm, within 24 hours of Prevnar.
Extreme fatigue - for 72 hrs starting day two post injection. Cold sore - Herpes Simplex 1 on upper lip.  Had not had cold sore in 20+ years
I had inflammation of my joints.  My shoulder, neck, all the way down my arm to my fingers. My leg, kneecaps and my ankles were swollen as well. I had no strength in my hands. I went to the ER. They did an MRI, and a CT scan.  They did not diagnose with anything. They want me to go to my primary care about this. My neck stays stiff if I don't have any medication for it. The pain can be 10 out of 10 at times.
Developed thrombocytopenia purpura within 6 weeks of administration of vaccine.
Numbness in toes going up to ankles and back of legs with burning sensation. Nerve spots on back of thighs and under both arms. Diagnosed with Guillain barre syndrome
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender, that the pharmacist had heard of. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and lot number not reported), subcutaneous for prevention. On an unknown date the patient complained of a larger than normal swelling in the upper left arm. The patient did not seek medical attention. The outcome of larger than normal swelling in the upper left arm was unknown. The causal relationship was not reported. Additional information is not expected.
Received vaccine on 11/2/09 2 weeks ago from today. 11/16/09 - Patient states her hands had started shaking about 1 week ago - had never noticed the shaking before.
supposed to receive a "booster dose" 6 months after the first dose but never made the appointment; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October or November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not applicable for this report. The patient reported missed dose adverse event (AE) for SHINGRIX during a call regarding a SHINGRIX medical information inquiry.  The patient received a dose of SHNGRIX and was supposed to receive a booster dose (it should be 2nd dose) 6 months after the 1st dose but never made the appointment for the booster dose (2nd dose) which led to incomplete course of vaccination. No further AE information and no product quality complaint (PQC) was reported. Physician information was unknown. No contact details were provided.
Received 5 yo vaccines today, kinrix, MMR and var.  Rash developed about 20 minutes after they left the clinic.  Very itchy.  Started on neck and went to his leg and his arm.  Rash is on the left that MMR was given. The patient is a 4 year old male who presents with a complaint of a skin rash. Got KG vaccines an hour ago, and mom noted itchy rash at injection site and on chin and on arm. Feels ok, no trouble breathing. Got MMR on R leg. Mom feels like the rash was hives, as her other child has had hives. He is not egg allergic and feels good. Has had all other prior vaccines without problem.  Hives have now come and gone, but were present beneath chin, on R thigh medial to the injection site, and on R lateral elbow. He had a cough and crusty nose before shots and neither have worsened. He has no joint pain, odd oral sensations, shortness of breath, fever or malaise. Child recalls (and nurse Lainie concurs) that Lainie wore gloves to give Kinrix and Var in L thigh; he cannot recall if gloves were worn for R injection of MMR. No systemic signs of reaction, but mom gives a good hx of hives on the side of body where MMR was given. We have disc to watch for oral itching, cough, pallor, wheezing or any changes and to go directly to Ed if any occur. For tonight, I would avoid Benadryl unless he is actively itching so we can monitor the natural hx of the rash.
Extremely dizzy; Can't walk without falling - he is on a wheelchair; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair). At the time of the report, DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: clear (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed steroids (unspecified) after 5 days of dizziness and walking difficulty. The reporter states that the steroids helped a little, but the patient never recovered. The patient's HCP recommended the patient receive the second dose. Unknown if the patient received.
Patient given GARDASIL- fainted after getting it, patient complained of headache prior to fainting.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Narrative: 85 y/o male Hospice patient on comfort care with hx COPD, HFpEF, prostate CA w /mets to bone, thrombocytopenia, DM2/neuropathy expired per Agency on 3/10/2021.