chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got covid after her second dose of the Moderna vaccine; deafness; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (deafness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEAFNESS (deafness) (seriousness criterion medically significant). In June 2021, the patient experienced COVID-19 (got covid after her second dose of the Moderna vaccine). At the time of the report, DEAFNESS (deafness) had not resolved and COVID-19 (got covid after her second dose of the Moderna vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient started experiencing Deafness after having Covid-19. The patient is in her eighties.  Company Comment: This case concerns an elderly female patient with no relevant medical history, who experienced the unexpected serious event of deafness, and the non-serious AESI event of COVID-19. The date of onset of deafness was not reported. COVID-19 occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The rechallenge for deafness is not applicable as the outcome of the event is unknown. Patient´s age (reported as "in her eighties") could be a confounding factor for deafness. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly female patient with no relevant medical history, who experienced the unexpected serious event of deafness, and the non-serious AESI event of COVID-19. The date of onset of deafness was not reported. COVID-19 occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The rechallenge for deafness is not applicable as the outcome of the event is unknown. Patient´s age (reported as "in her eighties") could be a confounding factor for deafness. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 75 years old female patient who experienced swelling in her left forearm up to her clavicle and heat, redness and pain in this arm, entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. On 12-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AA, expiry date: 09-Apr-2019 in the left deltoid. On 12-Sep-2018, the patient developed a non-serious swelling in her left forearm up to her clavicle on that same night, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious heat, redness and pain in this arm and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The Caller called to report this incidence in case this lot was contaminated. Relevant tests were not reported. Final diagnosis was heat, redness and pain in this arm and swelling in her left forearm up to her clavicle and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected. The patient received an unspecified antibiotics as corrective treatment. The outcome of the events was not reported. List of documents held by the sender: none.
Left deltoid: red and swollen 12x12 cm lesion. No warmth . No tenderness.
Sterile water for injection was used as diluent instead of sodium chloride. Pfizer recommended revaccinating as there are no stability studies with sterile water. Parent said they would reach back out about decision to revaccinate. No adverse effects at this time.
11 days after my booster I starting with itching on my scalp which then traveled down to my upper back, chest and arms. It went away for a few hours with Benadryl but returned the next afternoon and hasn?t gone away since. I have been on steroids for over a month now as it is the only thing that takes the itch away, however, the redness still keeps popping up all over my body.  Additionally I had several occasions where I experienced numbness on my forehead and lips. I also have to use an albuterol inhaler daily now, sometimes multiple times a day because my airways feel restricted.
Headache, vomiting,  body aches, muscle spasms, sweating, chills, extreme fatigue cannot stay awake more than an hour all started about 7 hours after vaccine and are continuing still... almost 48 hrs post vaccine
4 hours after injection: Nausea, slight fever, fatigue, inflammation in joints, headache, dizziness  24 hours after injection: Hives on skin on arms, legs, and torso  48 hours after injection: Hives remained, larger rash spread  72 hours after injection: Hives and rash had spread on entire torso and up the neck
Moderna COVID-19 Vaccine EUA Very itchy skin with circular blisters and other rash appeared 1 week after vaccination.  On back, shoulders, and legs.  Extremely itchy and may bleed if scratched.  Swollen feet appeared a few days after onset of rash, including swollen, red toes that are sensitive to touch and feel hot.  Patient does have occasional gout and guttate psoriasis, however, no symptoms reported prior to vaccination.  Patient has no fever.
Product storage error temperature too low with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 55 years old female patient who experienced product storage error temperature too low with no reported adverse event while receiving vaccine Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine (Flu vaccine VII) for Immunisation.  On 24-Mar-2022, the patient received Dose: 2 , 0.5 ml dose of suspect Diphtheria-2/tetanus/5 AC pertussis vaccine (with unknown formulation and strength) (lot C5873AA, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization.  On 24-MAR-2022 the patient developed a non-serious product storage error temperature too low with no reported adverse event (product storage error) following the administration of Diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    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 the guidelines. 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.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitants were reported. no treatment medications was provided
This spontaneous report as received from a licensed practical nurse refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose GARDASIL (lot # L007560, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 11/13/18, the patient reportedly began to have symptoms reported as following: Severe pain in Left Deltoid area and most of upper left arm/shoulder the night of the injection followed by several weeks of the same symptoms. Pain reportedly decreased some at about one month and decreased more at about 2 months. Recovery reportedly plateaued and has not gotten any better since at about the 2 month mark. There was reportedly no redness, or inflammation present at the injection site. Inject was thought to have been given high when band aid was removed to shower that same night. Pain is reportedly described as an extremely sore muscle with sharp stabbing pain when extending in several different directions or when pushing up on the arm. Pt reports a dull achy pain even when at rest for several months. Which stopped and led to a sense of numbness feeling inside arm area with some tingling down to the pinky. Pt reports some muscle weakness as well. Pt was seen by OT with reports of continued discomfort with range of motion. (approximately 21 visits). MRI results reviewed by Dr on 3/20/19 with plan for surgical intervention planned.
This case was reported by a physician and described the occurrence of hive in a 17-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On Friday 28 March 2014, the subject received 1st dose of HAVRIX (unknown route, right arm). On Sunday 30 March 2014, 2 days after vaccination with HAVRIX, the subject experienced hive. The subject was treated with BENADRYL but the hive came back. At the time of reporting the event was unresolved.
WITHIN MINUTES PATIENT WAS PALE, SWEATY AND UNRESPONSIVE, FELL TO HIS SIDE ON THE BENCH, EYES ROLLED BACK AND SHAKING /JERKING WERE WITNESSED. AMBULANCE WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL. WITHIN A FEW MINUTES, WITH ASSISTANCE AND USE OF ICE PACKS ON HEAD, NECK AND PALMS , PT SLOWLY RETURNED TO NORMAL BEFORE AMBULANCE ARRIVED
Bells Palsy  was diagnosed at hospital  at the ED  was prescribed steroid, antiviral, and pain medication for up to 10 days and it has only been 5 days since then. The only improvement seen is that the head pain in the back of the ear has gone but the right side of the face being droopy is still the same.
Suspected vaccination failure; I got the vaccine then a few years later I got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine then a few years later I got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the vaccine then a few years later experienced shingles, but the vaccine helped not having the pain or itch like some. The patient knew they were there but they didn't bother them. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Client reported feeling nauseous and lightheaded as well as having a headahe during the 15 minute waiting period after receiving his vaccine. Client's vital signs taken at 1553 and were BP 148/90, P 99, O2 97% and R 16. Client was given some water and animal crackers. Client was encouraged to drink fluids and stay hydrated. Client continued to report having nausea, dizziness, and a headache. Blood pressure was reassessed at 1610 and was 178/100. PHN questioned if client had high blood pressure and client reported, "It runs in my family." PHN educated client that his BP was quite elevated, and PHN explained that a diastolic BP of 100 usually occurs over time. PHN advised client to go to walk in if his symptoms do not improve, but PHN strongly recommended client follow up with his primary care provider in regards to his elevated blood pressure. Client told PHN that he would most likely go to the walk in. Client verbalized understanding. Client left clinic with his wife who was giving him a ride. On 6/18/2021 at 1014 PHN placed call to client to see how client was feeling today. Call went straight to voicemail. PHN requested call back.
got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself.     A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and "had close contact with someone who was positive". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy.  Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated "I had close contact with someone who was positive." He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated "they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?" The outcome of the event COVID 19 was unknown, of other events was recovering.
Tingling chills, muscle ache, headache, bouts of nausea, completely weak and  feeling like falling over, drowsiness
Started having frequent palpations requiring multiple visits and tests to be done. Unknown cause of palpations, but could be related to any number of things such as the oral birth control pills that were started that same month that the palpations started (April) or gneral stress. Due to it being a new medical problem since my Covid vaccination, though 3 months later, I felt as though I should report it in my VSafe text for tracking/research purposes, though I do not personally think it is related to the Covid vaccine. Determined ultimately that the PVCs are not be pathologic and only need to treat the symptoms if desired. No cardiac abnormalities on EKG or Echo.  Of note, I was called after reporting these new symptoms on the VSafe text, but forgot to return the call promptly so decided to fill in online form.
This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. Information regarding relevant medical history and concurrent condition were not reported. "About a year ago", in approximately 2015, the patient completed the vaccination series for VARIVAX (Merck) (dose, lot# and route not reported). On an unknown date, the patient received an extra dose of VARIVAX (Merck) (lot # and route not reported) beyond what was recommended in the prescribing information (off label use and extra dose administered). No adverse experience reported. The outcome of the events was unknown. This is one of two reports refers to the same patient (related case ID: 1601USA007074). Additional information is not expected because there was no reporter's and health care professional's contact information provided.
Breakthrough case admission after 2 vaccines Moderna 4/13/21 Lot# 043B21A; Moderna 5/10/21 Lot# 005C21A
Pt reported "itchiness and a hardness" in the upper right arm in the evening of 12/29/20. She reported that it was worse in the morning  so she stopped in at the employee health office to have the area checked because she received the Pfizer BioNTech COVID 19 vaccine on 12/21/2020 in that arm and she was afraid it might be something in the vaccine that caused the itching and hardness. On exam she had a large round area of redness that was warm to touch and very firm. It was approximately 3" by 3" just below where she had the injection. She was sent to the ED for exam by a doctor, who determined it was allergic urticaria. He mentioned that he did not suspect it was related to her vaccine. He discharged her with a prescription for Keflex 500mg q six hours for seven days and benadryl OTC 1-2 tabs every six hours for three days.
Spoke with the patient on 8/19/2017 in the afternoon when she reported that she had been given pneumococcal vaccine and had redness, soreness at the injection site with fever. The fever had been up to 102 F. She had called on Friday when she was recommended to take TYLENOL but she reported that the fever has continued but had started to get better on TYLENOL. Since, she is immunocompromised, I asked her to go to nearest ER to get evaluated and if she did not want to go to ER which seemed the case to me (as she was somewhat better), she should continue TYLENOL and keep herself hydrated. She denied any localizing symptoms of URTI/LRTI/UTI. Denied any chills, night sweats. I recommended her to keep a low threshold to go to ER which she understood.
adverse event : pfizer vaccine 19 5 - 11 y was not diluted prior to administration ,  treatment : pharmacist called pfizer for advise , he was told to tell  the mother to monitor  the patient to see if there where any adverse reactions  outcome : the pharmacist called the mother a day later and the mother said that the child was doing great and had no adverse events
Fever on day 1 after the vaccine 102 Ongoing headache still Fever on day7-9 ranging from 101-103 with tyelonol  neck ache day 7-9 Sore throat day 7-9 Ear ache day 7-9 R arm weakness day 7-9
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 56 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure (controlled)" (unspecified if ongoing), notes: controlled; "high cholesterol (controlled)" (unspecified if ongoing), notes: controlled. Concomitant medication(s) included: LOSARTAN, start date: 01Apr2022, stop date: 25Apr2022; CHLORTHALIDONE, start date: 01Apr2022, stop date: 25Apr2022; ATORVASTATIN, start date: 01Apr2022, stop date: 25Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive; (02May2022) Negative, notes: rebound congestion on day 13 and positive COVID test, after negative COVID test on day 7; (08May2022) Positive, notes: rebound congestion on day 13 and positive COVID test, after negative COVID test on day 7. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Information: The patient had no Known allergies. Anti-viral COVID-19 Treatment details included Paxlovid from 25Apr2022 to 30Apr2022.
erythema 4x6 centimeters in the arm that received ZOSTAVAX; Sore in the arm that received PNEUMOVAX 23; Palpitations; light-headedness; This spontaneous report was received from a Nurse prescriber refers to a 66 year old female patient. The patient's historical medication included carisoprodol (SOMA) with which patient developed drug reaction/allergy. The patient's concurrent condition included drug allergy. The patient's concomitant medications and pertinent medical history were unknown. On 15-MAY-2019, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) on one arm along with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on another arm at unspecified locations for prophylaxis (dosing details, lot # and expiration date not reported). On 16-MAY-2019 (reported as in 24 hours'), the patient developed erythema of 4 x 6 centimeters in the arm that received zoster vaccine live (ZOSTAVAX) (vaccination site erythema) and developed sore in the arm that received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination site pain). On an unknown date in May 2019, the patient developed palpitations and light headedness (dizziness). On an unknown date in May 2019, the patient underwent electrocardiogram (EKG). The patient sought medical attention and received treatment for the events. On 17-MAY-2019, the patient visited a clinic complaining of injection site reactions, palpitations and light-headedness. Outcome of the events was unknown. The reporter's causality assessment was not provided.
Headache Local symptoms: Pain-discomfort. General symptoms: Headaches, fatigue, feet pain, tingling in extremities. Narrative: