chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the months following the child's MMR, he developed an involuntary twitching of the left side of his face. He was seen by his pediatrician and a neurologist. Jan.2001 an MRI showed no abnormality.The  cause for the twitching remained unknown. The neurologist said it was most likely viral in nature and would heal. This was puzzling as our son had had no serious illness.  The 7th cranial nerve did heal, but we began to notice a lag in his beginning speech and increased "babbling". We thought perhaps it was due to his pacifier,but later when we took it away we saw no improvement. Winter 2002 he had a middle right ear infection. It became apparent he was hearing very little. We treated the infection, waited for the infection to clear and still noticed problems,then he was seen by his Pediatrician, ENT and an Audiologist. His middle ear was perfectly healthy, but there was concern about sensorineural hearing loss due to lack of OAE's. An Auditory Brainstem Response test was done and he was diagnosed in June 2002 of having bilateral sensorineural mild- moderate hearing loss. He now has hearing aids and is in speech therapy for the sounds he has not heard. I have no proof the MMR caused this loss, but I do know something caused damage to both the 7th and 8th cranial nerve and the first symptoms were noted shortly after his immunizations. also he has had no serious illness. I hesitate to repeat the MMR before kindergarten as I feel there is a greater risk to my son if he gets this injection than if he does not.I have not yet discussed this with my physician, but he is aware of th child's problems. 60 day follow-up state patient did recover from damage done to the facial nerve, but did not regain his hearing. The annual follow up received on 9/9/03 states he has moderate hearing loss and hearing aids both ears. He is in speech therapy.
Patient was given the diluent for the ROTARIX vaccine. The diluent given was not mixed with the powder ROTARIX. This took place on 6/18/2018. Upon inventory today is when it was observed that this action was done. The count did match. Upon further investigation it was revealed that only the diluent was given. Parent of child notified. Parent states patient has a rash on the back of her head, that started 3 days ago. Patient will come in on 7/2/18 for evaluation and re-vaccination.
Received vaccine on 8/5, noted non productive cough and temp on 8/6. Sent to hospital for vomiting coffee ground emesis on 8/7.
expired Daptacel vaccine is given to a patient, no adverse event; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to cases 2019SA124198, 2019SA124197, 2019SA124199 and 2019SA124200 (same reporter).  This case involves a five-years old female patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the left thigh on 05-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none   It was a case of actual medication error due to expired vaccine used.  No side effects reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Patient was observed for 30 minutes post vaccination. It was determined he was at baseline and no reaction was occuring. The following day the patient contacted our on-call nurse advice service stating shortness of breath and difficulty swallowing. He was advised to go to the ED. Patient was treated in the ED. He remained under observation for 8 hours before they determined patient was back to baseline and okay to discharge home.
Timeline: 9/26: Presented to ED w/ cat bite on her R elbow; received 7 day course of clindamycin and initiated rabies immunoglobulin (HRIG) and vaccine #1 (day 0); tetanus was UTD 9/29: Returned to ED for rabies vax #2 (day 3) 10/2: Completed clindamycin course 10/3: Returned to ED for rabies vax #3 (day 7) 10/5: Returned to ED w/ concern for possible allergic reaction - diffuse urticarial rash to face, neck, chest, arms, BLE; received IV diphenhydramine, solu-medrol 125mg, pepcid; discharged w/ diphenhydramine 25mg Q6H PRN and 5 day course of 20mg prednisone 10/7: Returned to ED w/ urticarial rash, as well as lip and throat tingling - treatment above   Received rabies vaccine PCEC formulation; due for 1 further booster on day 14 - 10/10.
Severe head pain - jaw, cheeks, nose, ears, forehead chills/sweats body aches fatigue Tylenol held severe symptoms at bay for 4 hours, but symptoms returned if Tylenol lapsed after the 4 hour period.  This lasted for 24 hrs. Less severe symptoms lasted 4 days.
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap.   Shingles diagnosed and started on Valacyclovir.  Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021  for  left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
Hospitalization on 11/21/21. Symptoms of fever, sob, fatigue, and difficulty breathing.
This spontaneous report was received from a medical assistant referring to approximately 15 year old male patient. Pertinent medical history and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with GARDASIL injection, route of administration defaulted to intramuscular (lot number, expiration date, frequency, strength and dose number were not reported). Concomitant medications were unspecified by the reporter. On an unknown date, the patient experienced headache, drop foot on right foot and degradation of nerves on the left foot after vaccinated with GARDASIL. It was confirmed that it was GARDASIL not GARDASIL 9. The patient sought medical attention via seeing multiple physicians and was admitted to an unspecified hospital for an unspecified length of time. The outcome of headache, drop foot on right foot and degradation of nerves on the left foot was reported as not recovered. Upon internal review drop foot on right foot was considered to be a medically significant event. Additional information is not expected.
In addition to pain and redness and soreness at the injection site, there has been mild headaches and muscle aches with large and painfully swollen lymph nodes in the neck, armpit and groin on the left/injection side of the body. Also a worsening of already existing tinnitus in one ear .
Ventricular tachycardia; He is getting light headed/dizzy; he feels like there is either a lump or something in his throat or somebody has their thumb on his Adam's apple; feel like somebody choked me and stuff like this; This is a spontaneous report from a contactable consumer (patient's parent). A male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 26May2021 (at an unspecified age) at 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 received on 03May2021 for COVID-19 immunization for which he started developing a cough, started not being able to sleep, started insomnia and tried to go to sleep and within an hour or two and his body jerks and wakes him back up. The patient has never had that before. It was reported that when the patient received his second vaccine, things stated to get worse and was getting lightheaded. The patient feels like there was either a lump or something in his throat or somebody has their thumb on his Adams apple and keeps pressing in. The patient woke up this morning and stated that he was dizzy, and he felt like somebody choked him and stuff like this. The patient can swallow okay but still feels like somebody was choking him with a thumb. Due to these, the patient went to the emergency room and they didn't do anything to the patient. Basically, the patient was just told to take 'breathing pills', which the patient cannot take because of ventricular tachycardia for which the patient was on special medicine. They did look up online and said that there was one side effect to the vaccine where somebody developed insomnia, so the doctor sent the patient home. The patient's parent called his family doctor and his heart doctor. The patient was supposed to have a test first thing in the morning for nuclear with nuclear medicine for a stress test since the patient cannot do the treadmill. They were concerned if the patient was having a side effect from the vaccine and if the patient should or should not have the nuclear medicine for the stress test. The way the patient's heart was, he must have that test. So, the reporter needs to know if this was a side effect and what they should do concerning the testing that he was supposed to have. The patient's test will be done on Sunday (unspecified date). Outcome of all the events was unknown.   Information on the lot/batch number has been requested.
Patient c/o throat tightening and feeling itchy after COVID vaccine dose. Has had anaphylaxis before and the symptoms were similar.  Vitals stable. Administered diphenhydramine 50 mg IM right deltoid and extended monitoring for 30 min post- Rx
Patient came to health department 2 days after vaccination with complaints of left bicep red, swollen, fever, chills unresolved started 04/06/2004. A febrile in our office on 4/7/04 and given Duricef 500mg BID. Seen by me on 4/8/04 with 7cm by 9cm oval erythema, central induration and sterile open abscess/blisters 3mm. Nurse follow up on 05/25/04:" Cellulitis, edema, tenderness".
Patient reported uncontrollable shaking, chills that lasted a couple of hours, She is okay now.
Polyarthralgia beginning 3-4 days after first injection involving hips, left shoulder, left knee, lumbar spine; had some pre-existing arthritic pain in left knee and lumbar spine, but noticeably worsened after 1st vaccine; began to improve several days before 2nd vaccine, then recurred/worsened acutely 2 days after 2nd vaccine.
Gave the patient a second dose of Hepatitis B vaccine on accident.  Vaccine had already been given the day before.
Patient stated he had a red face and it was puffy about 1.5 hours after vaccination. Patient was able to take some Benadryl and 2nd doses was fine.
patient was given PENTACEL without diluent with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional on 11-Nov-2020.  This case involves a 2 months 3 days old male patient was given pentacel without diluent with no adverse event (Product preparation issue), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication included Rotavirus, Prevnar, Hepatitis B.  On 09-Nov-2020, the patient received only the liquid part of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ536AA and expiration date: 24-Apr-2021) (Liquid- lot number: UJ395AA expiration date: 24-Apr-2021, and Powder- Lot number:  UJ159AA expiration date: 24-Apr-2021) 0.5 ml once via intramuscular route in right thigh for prophylactic vaccination.  On 09-Nov-2020, on the same day it was reported that the patient was given PENTACEL without diluent.  It was actual medication error case due to inappropriate dilution of medication.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
Temp 100.2, headache, fatigue, muscle or body aches and pain at site
I had very bad cough that was very productive, aches, pains, headaches, I could not swallow and was drooling really bad. I took a home COVID-19 test that came back negative, so I went to the local urgent care that tested me COVID-19, Influenza A & B that came back negative. I was given an antibiotic as it looked like what I had was an upper respiratory that did turn into pneumonia. I am getting better.
Arm is tight; Hot; Dull throbbing; Itchy; Red area as big as a baseball; Arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Arm was sore) in a 73-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.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 16-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 07-Feb-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is tight), VACCINATION SITE WARMTH (Hot), PAIN (Dull throbbing), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red area as big as a baseball) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 contains No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
site of the injection was swollen and itching; site of the injection was swollen and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of the injection was swollen and itching) and VACCINATION SITE SWELLING (site of the injection was swollen and itching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus, Blood pressure, Hyperlipidemia and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (site of the injection was swollen and itching) and VACCINATION SITE SWELLING (site of the injection was swollen and itching). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (site of the injection was swollen and itching) and VACCINATION SITE SWELLING (site of the injection was swollen and itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
08/03/2006 Phone call from mom stating welt on right thigh size of fifty cent piece.  08/04/2006 area on right thigh welt size of mom's hand.  Ibuprofen, if not helping by 08-05-2006 start Cephalexin.  08/05/2006 Cephalexin started.
PFIZER COVID-19 VACCINE EUA: The patient received an appropriately timed Pfizer/BioNTech COVID-19 vaccine dose. However, after the dose was administered and was to be documented, the presence of historical data indicating the patient had also received a Janssen COVID-19 vaccine dose previously was noted. The patient's vaccine history indicated she received the Janssen dose then subsequently received the Pfizer/BioNTech primary series.
At the injection site, it is itching a lot, a little puffy; welts at the injection site; itching area is getting wider and wider; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen). At the time of the report, VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
neuropathy; shingles; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 01-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around August 2014, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and neuropathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of neuropathy peripheral and shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Child fussy day of immun, temp 101 w/APAP 24 hrs p/immun child began high pitched screaming for 12 hrs; Screamed constantly would not nurse;
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were provided. Reporter stated that there was a confusion between expiration date printed in the carton and expiration date when the QR code was scanned. The product did not underwent any temperature excursion. Patient did not experienced any adverse event. Date the vial was initially stored in the refrigerator on 18-Oct-2021. This case was linked to MOD-2022-491837 (Patient Link).
Information has been received from a physician concerning a 46 year old female patient who 10 or more years ago in approximately 2000 was vaccinated with a dose of VARIVAX (Merck) (Lot# Unknown). The physician stated that the patient inquired about getting either VARIVAX (Merck) or ZOSTAVAX (Merck) for protection against chicken pox and/or shingles. The patient could not remember having chickenpox or varicella vaccine so physician did a titer and found that the patient did not have antibodies against varicella. When the results came back and were reported to the patient, the patient said that she did have a varicella immunization 10 or more years ago from another doctor. The physician also stated that she felt it was more likely the patient did not receive the immunization than she did not seroconvert. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.