chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing Loss; Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today; Dizziness; Vertigo; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing Loss) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ringing in ears.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEAFNESS (Hearing Loss) (seriousness criterion medically significant), TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache). At the time of the report, DEAFNESS (Hearing Loss), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Headache) outcome was unknown and TINNITUS (Extreme ringing in the Ears/ buzzing all the time/tinnitus got worse as of today) had not 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.  No concomitant medications reported.  No treatment information provided.  Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile
15 cm diameter erythematous, edematous and painful patch - Allegra suspension, 1tsp. bid ordered. Mom called 6/9 to report area is almost totally back to normal. Child has no fever and is fine.
Information has been received from a health professional concerning a 15 month old male who on 23Feb2004 was vaccinated in the right thigh with a dose of varicella virus vaccine live. Concomitant vaccination the same day included a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in the left thigh and poliovirus vaccine in the right thigh. On 26Feb2004 the pt experienced breakthrough chickenpox. The pt's mother reported that he had 10 vesicles near the injection site of the right thigh. No fever was noted. No treatment and no lab diagnostic studies were required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a Medical Assistant via a company representative and refers to a 19 months old female patient. Medical history and concomitant medications were not provided. On 19-JUN-2017, the patient received an expired dose of VAQTA (lot # M011116; expiration 17-JUN-2017). No adverse effects were reported. Additional information has been requested.
Five days after given the 3 vaccines, his left upper arm became and red and blotchy. It covered about 5-7 inches in length and 3 inches in width. It looked like hives based on his reaction when he was an infant to penicillin.
Patient received J&J on 03/18/21, Moderna on 06/23/22, and Moderna 07/14/22. Currently no adversed effects or event reported.
1st dose COVID vaccine 1/30/21; developed shortness of breath 2/7/21; worsening symptoms SOA, falls, chest pain; seen in ED on 2/12/21; Admitted to Hospital for severe sepsis, acute respirator failure.
This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On an unknown date, in childhood, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient had a negative titer for MMR and also recently had exposure to one of the diseases (unspecified). The outcome of the events was unknown. The relatedness for the events was unknown for M-M-R II. Additional information has been requested.
Severe Injection site pain.  Fever, Body Aches, Uncontrollable Shivering. Dizziness.  On the first dose I got these Symptoms at 11:30pm then they subsided by 6:30 am with multiple doses of Tylenol.  I was able to return to work the next day.  The second night the symptoms returned around 11:00 and persisted until morning.  They went away with more Tylenol and all but the injection site pain did not return. On the second dose I had the same symptoms The same night as injection.  They did not go away with Tylenol, and continued through the entire next day.  Fever never broke.  Unable to go to work with fever over 100.  All symptoms persisted through the next night until morning when fever finally broke, and I was able to go to work.  That night the symptoms return overnight, but were gone in the morning, and all but the injection site pain did not return.  It has been 5 weeks since the first injection, and two weeks since my second, and I still have injection site pain and weakness in both of my arms.  It is not as severe as the first five days following injection, but still persistent and noticeable.
Severe pain in joints including swelling of left shoulder, collarbone and neck on left side initially. Hips, ankles and knuckles affected later. Nodules appeared on knuckles and ankle that appear to be fluid filled. Family doctor said they've seen the neck and shoulder swelling a couple of other times, but did not know what to do with the persistent joint pain/lumps. Two of these nodules are now painful and I will be going to an orthopedic doctor to address.  This has also occurred with my husband's hands at about the same time.  His vaccine was a few days after mine.
Extreme stomach pain, some diarrhea and headache.  Threw up one time.  Went to doctor the first day, had blood tests and urinalysis done.  Nothing definitive shown.  Second day went to school.  Third day it worsened and stayed home from school again.  Felt better by afternoon of third day.  Recurrent stomach pain has been on going since December.
Following day experienced flu-like symptoms until 5 pm, then was fine.  3 days after the shot, started experiencing tinnitus and still have it 10 days after shot.
At approximately 1625, patient reported a tingling sensation in the lips. Patient denied itchiness, rashes, hives, swelling of lips/tongue, difficulty breathing, and difficulty swallowing. Patient given water. Patient able to drink water. Patient reported similar reaction to first dose. Patient reported following up with primary care provider regarding first dose reaction. Patient stated "my doctor said it was okay to get the second shot". Patient reported no known allergies. Patient reported history of hypertension and current medications include metoprolol and amlodipine for hypertension. Patient offered intramuscular diphenhydramine. Patient agreed to intramuscular diphenhydramine. At 1627, RN assessed patient vital signs: 179/103 mmHg, pulse 70 beats/minute, and SpO2 97%. At 1634, RN administered 50 mg/1 ml intramuscular diphenhydramine in patient's right deltoid. Patient advised to wait for 30 minutes for further observation. At 1639, RN assessed patient vital signs: blood pressure 160/105 mmHg, pulse 69 beats/minute and SpO2 98%. At 1645, EMT assessed patient vitals signs: blood pressure 162/92 mmHg, pulse 64 beats/minute, and SpO2 96%. Patient reported feeling less tingling in the lips. At 1648, patient reported the tingling in the lips felt "very faint". At 1651, EMT assessed patient vital signs: blood pressure 150/92 mmHg, pulse 65 beats/minute, and SpO2 96%. At 1700, lead nurse assessed patient. Patient stated "the tingling is completely gone".  Patient denied swelling of lips/tongue, difficulty swallowing, and difficulty breathing. Patient denied drowsiness and reported she can drive herself home.  Lead nurse educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1703, patient left facility with unlabored respirations and steady gait.
pt recv vax 08FEB94 & devel some bleeding @ inj site; 2 hr later devel local swelling, a burning sensation in the deltoid, 1.5 ecchymotic area which was treated w/ice & burning pain from arm to neck; face flushed, dizziness, malaise;
believes they give her the wrong dosage for the booster; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster). On 29-Oct-2021, INCORRECT DOSE ADMINISTERED (believes they give her the wrong dosage for the booster) had resolved.            No concomitant medications were provided. No treatment medications were provided.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored VAQTA lot# K012457 with expiry date: 04-JUN-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Patient presented with diffuse petechiae, easy bruising and oral bruises. She has a history of stable ITP with her last required infusion of IVIG 12 years prior during pregnancy and monitors her CBC every 6 months. Her baseline platelet count is ~50-60k. She received treatment with dexamethasone 40 mg IVPB x 3 doses and IVIG 95 grams (1 gram/kg) IVPB x 2 doses.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 16 years old female patient patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first dose of GARDASIL (dose and lot # not unknown) on 29-JUL-2001. The second dose of GARDASIL (0.5 ml, intramuscular right deltoid, lot #:672233/1561AA, expiration date 26-AUG-2014) on 04-MAY-2012, the patient got MENACTRA on that day too. The patient's mother brought her to the doctor office on 18-JUL-2012 and urine pregnancy test performed and was positive. The patient was sent to ob/gyn specialist her for the follow up. No adverse effects reported. The patient became pregnant with an LMP of 06-JAN-2012 and an EDD of 12-OCT-12. Initial exposure to GARDASIL was at 17 week(s). The patient was exposed to GARDASIL during trimester 2 and 3. Additional information has been requested.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dos eof flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;
shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The action taken with Shingrix was unknown. The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 16-Mar-2023 The physician had a patient who got shingles before the 2nd dose appointment.  The patient would like to know the following as how often this happen (patients get shingles even after the initial dose has been administered), how long the patient need to wait to administer the 2nd dose if a patient had shingles in between the dose series and at what point the series need to be restarted if the patient has not receive the 2nd dose of Shingrix in over a year. The patient received Shingrix not too long ago, had shingles shortly after in a few months before 2nd dose in 6 months.  The provider wanted to know how long does she had to wait to administer the 2nd dose. The provider would like to know if it was been more than a year after the initial dose then what was the cutoff time for administering the 2nd dose and therefore restarting the series altogether. This was not pertaining to a particular patient. The provider wanted to know for her awareness as she encounters patients. There was no more information that the one provided in the message.  The adverse event was filed conservatively since it was mentioned that a patient got shingles after Shingrix and a possible late 2nd dose.  The reporter consented to follow-up. The case was linked with case US2023AMR042568, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR042568:same reporter
Started off with 3 fingers started tingling and partially numb, then that evening my arm started hurting and the night I could barely move it, it started burning by midnight and my fingers started being numb and tingling again. I took a Tylenol but it did nothing, I was up all night with my arm hurting an tingling. By Friday it started getting better, but Tuesday my fingers started tingling again and my arm still hurts some. I had an upset stomach on the day I got the shot and Friday.
I woke up Sunday and felt like I had a cold. I had a scratchy throat and runny nose and on Monday, I still had the sore throat, runny nose and body aches. On Tuesday, the symptoms triggered my asthma, and I was still having all of those symptoms even on Wednesday. On Thursday, most symptoms had gone away but I was having chest tightness and my asthma symptoms got worse. By Sunday I was having trouble breathing so I was using a peak flow meter even though my O2 sat stayed at 99%. My numbers are coming up with the peak flow meter and I am still taking Prednisone. I am feeling better, but my nose is still runny, and I still feel like I am having an asthma problem.
17 cm x 16 cm area of redness, swelling to elbow.  Indurated, itches, swelling.
patients were administered an "expired" vaccine; Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022.  Treatment medications were not reported.
Child was given Pfizer bivalent shot instead of the 2nd shot of the primary series. No Side effects have been reported as of now.
pt recvd vax & 2 1/2 hrs after vax, pt began to heave; pt out of it; face & body became purple; pt was sleepy in ER;
This case was reported by a healthcare professional and described the occurrence of injection site hemorrhage in a female subject aged between 40 and 49 years old who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 25 November 2008, the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown).  On 25 November 2008, at the time of the vaccination with FLUARIX, the subject experienced injection site hemorrhage, intramuscular formulation administered by other route and vaccine under dose.  The healthcare professional reported the subject received a FLUARIX vaccine.  The shirt of the subject was pulled up and tight on the skin.  It is believed that the vaccine may have been given subcutaneously and not all the vaccine was received due to forced blood eruption from the site due to possible shirt acting as a tourniquet.  At the time of reporting the events were resolved.
6MAY irritability; 7MAY hives?-DPH 1/2 tp qid PRN; 8MAY rash & low grade temp; nummular lesions effuse over abdo axillae; rash now on face; irritated eyes;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt recvd 3 doses of Engerix-B & did not convert; recvd a booster dose of Engerix-B; titer not checked yet;
HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.
Patient told me that she had not felt well since she got the high dose flu shot last week.  She was light headed and experienced syncope.  As result of syncope she fell and hit the back of her head and fractured her left hip.  Hip surgery ensued and was successfully performed.  Upon release from hospital she was moved to a rehabilitation facility where she died the next morning.  Patient attributed the syncope to the administration of the flu shot.
My arm was sore for a few days, then it felt fine. Today, the 27th, the injection site felt itchy and the muscle area felt hard. It was later in the evening when I realized the injection site was also warm and red.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.    This case was linked to MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704416:Master case
Felt sick with flu-like symptoms for 2 days. Slight fever. Body stiffness. Spent most of time in bed. Weakness in legs.
Pain-swelling in arm-red rash-Dr. prescribed antibiotic cephalexin 250 mg.  Therapy exercises-MRI-and x-rays.  Constant pain-had biofeedback for pain exercises-relaxation.  Have a large rotator cuff tear and a deltoid tear-constant pain. 6/3/08-records received-Seen on 1/16/07 C/O breast masses with history of breast cancer. Visit 3/29/07-C/O right leg pain with history of back pain for 5 1/2 months. 5/8/08 visit routine visit with C/O ecchymotic area on left arm, chronic left shoulder pain since tetanus injection 1/07.  Follow-up: Fluid collection in arm-came shortly after injectio torn deltoid muscle and massive rotator cuff tears.
Per patient: after SQ administration of ZOSTAVAX a red area appeared approximately half the size of upper arm. Approximately 3 cm hot and red area of actual injection site noted. Patient contacted her primary care due to size of effected area.