chrisvoncsefalvay/vaers-outcomes huggingface dataset:
last year I got vaccinated against shingles and I still have the same problem/suspected vaccination failure; Last year I got vaccinated against shingles and I still have the same problem; I'm 3 years old and I still have the itch; I'm 3 years old/last year I got vaccinated against shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 3-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: last year I got vaccinated against shingles and I still have the same problem/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Last year I got vaccinated against shingles and I still have the same problem), pruritus (Verbatim: I'm 3 years old and I still have the itch) and inappropriate age at vaccine administration (Verbatim: I'm 3 years old/last year I got vaccinated against shingles).  The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 23-Aug-2023 The case was received from the patient via interactive digital media. The patient stated that good afternoon, he or she want to contact us and he or she need a phone number.  The patient stated that you treat the shingles problem.  Last year the patient got vaccinated against shingles and still had the same problem. The patient still had the itch.  The patient asked that how could he or she get rid of this problem. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Client c/o chest tightness.  Client states I am having a hard time breathing.  Client seen by EMS.  Vitals: B/P 133/85, HR 88,  Client verbalized that she had been anxious about receiving vaccine and that she is now able to breathe now that it's over and was cleared to go home by EMS.
Patient said she had a mild, red rash at injection site 1 day after vaccine administration.  No itching or pain was reported.  The rash went away on its own with no treatment within 1 day after it appeared.
Developed tinnitus; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus) and VACCINATION SITE PAIN (My arm was sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore). On 20-Apr-2021, the patient experienced TINNITUS (Developed tinnitus). At the time of the report, TINNITUS (Developed tinnitus) had not resolved and VACCINATION SITE PAIN (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was provided.  No treatment medication details was provided.  The patient experienced tinnitus which was a nuisance and not debilitating, two or three  weeks after the first dose of the vaccine.  On 04 Jun 2021 patient visited an audiologist and an ENT doctor.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event Pain in extremity, a causal relationship cannot be excluded. Concerning the event Tinnitus, very limited information regarding the event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-255375 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient details, event start date and i narrative supplement updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Pain in extremity, a causal relationship cannot be excluded. Concerning the event Tinnitus, very limited information regarding the event has been provided at this time.  Further information has been requested.
When injecting vaccine into patient's arm, vaccinator inadvertently brushed against needle with finger of non-injecting hand.  No needlestick of vaccinator.  Patient informed of incident immediately and follow up call made on the next day.
no adverse effect; they accidently gave a VARlVAX that had expired the previous day; This spontaneous report was received from a nurse and refers to a 12-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JAN-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T002842, expiration date: 23-JAN-2022, administered subcutaneously (strength was not provided) for prophylaxis (expired product administered) with sterile diluent lot # T014299, expiration date: 28-NOV-2022. The products had no temperature excursions. The patient had no known side effects (no adverse event).
I took a home COVID-19 test on March 3, 2023, as one of my colleagues had tested positive. I called my doctor's and asked for a PCR COVID-19 test because of my health conditions. They had someone come over with a test, I tested and waited for the results. My results came back at 9pm, showing that, I was positive. The doctor's office had a prescription of Paxlovid waiting for me to pick up at my pharmacy that I started today at noon. Currently it feels like a bad cold, runny nose, watery eyes.
This spontaneous report has been received from a nurse practitioner and referred to a 16-year-old female patient. The patient's relevant medical history, concurrent conditions and concomitant therapies, were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. Subsequently, on an unknown date, she received the second dose of GARDASIL (dose, frequency, route, lot number and expiration date were not reported) and the first dose of VARIVAX (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The patient did not present any adverse symptoms after this vaccinations. Then on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis and a dose of VARIVAX (dose, frequency, route, lot number and expiration date were not reported). Then, 15 minutes after the vaccination, the patient developed throat swelling, redness on her body, and shortness of breath. The patient had to remain in the facility for approximately 30 minutes after the vaccination, and the patient returned to normal on an unknown date. The Causality assessment between dyspnea, generalised erythema, and pharyngeal oedema with GARDASIL, GARDASIL 9, and VARIVAX was not reported. Additional information is not expected as there was no contact consent provided.
5 minutes p/recvd DTP; pt went limp; p/mom picked pt up muscle tone improved; pt was able to walk & seemed to have good co-ordination although appeared pale, felt nauseated; BP 90/40, HR 110 regular;
Anxious and urinating often at first. Seemed ok otherwise until 2/23/2021 when she started being twichy and then mentioned something very odd, "Oh no! The spaghetti is going to get him!(the dog) We have to take him to the vet and put him to sleep!" At that point I took her to the hospital and was admitted to the ER. Later was admitted to the Hospital proper, and blood work was done. Treatment was given as an antipsychotic olanzapine and seem to have worked.
Vomiting and colicky pain, found to be an intussusception that required air enema reduction.
Began with headache and achy joints. Swollen lymph nodes, and lower back pain came next.  Nausea and lack of appetite.  Low grade fever 100. Wiped me out - stayed in bed all day and then slept all night.   Most if the side effects are gone when I woke up on 8/25 excerpt headache (but that could be partially attributed to allergies).
Beginning 14 hours after injection, fever of 102.5, shaking, chills, GI pain, minimal nausea, resolved with Tylenol after several hours. The following day fever to 100.4 through the following night. The next day it had resolved.
t104 R: unconsolable crying x 2 hrs; pt fell asleep for 1 hr then 2 more hrs of unconsolable crying;
16 year old received first dose Moderna in error, so was given second dose Moderna as per CDC guidance.  No AE.
Injection Site swelling; Injection site pain; Painful Lymph Node in the left Armpit; Muscle aches; Low fever; General discomfort; All Side Effects listed in the Patient's Fact Sheet; Swollen Lymph Node in the left Armpit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (All Side Effects listed in the Patient's Fact Sheet), PAIN (Painful Lymph Node in the left Armpit) and LYMPHADENOPATHY (Swollen Lymph Node in the left Armpit) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety since an unknown date, Vitamin B12 deficiency since an unknown date, Insomnia since an unknown date and Hormone replacement therapy. Concurrent medical conditions included Depression (condition was worsening, treatment change to add additional antidepressant). Concomitant products included ALPRAZOLAM from 06-Jun-2011 to an unknown date for Anxiety, CYANOCOBALAMIN from 01-May-2020 to an unknown date for B12 deficiency anaemia, BUPROPION from 21-Feb-2017 to an unknown date for Depression, ZOLPIDEM TARTRATE from 13-Apr-2017 to an unknown date for Insomnia, ESTRADIOL from 10-Dec-2020 to an unknown date for Salpingo-oophorectomy NOS.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (All Side Effects listed in the Patient's Fact Sheet) and LYMPHADENOPATHY (Swollen Lymph Node in the left Armpit). On 14-Feb-2021, the patient experienced PAIN (Painful Lymph Node in the left Armpit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, Injection site pain and Injection site swelling, at an unspecified dose and frequency. On 14-Feb-2021, VACCINATION COMPLICATION (All Side Effects listed in the Patient's Fact Sheet) had not resolved. At the time of the report, PAIN (Painful Lymph Node in the left Armpit) was resolving and LYMPHADENOPATHY (Swollen Lymph Node in the left Armpit) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The additional information document received on 25-MAY-2021. Reporters information is added.  Patient demographic details were added.  First dose information is added. Concomitant drugs were added. Events were added.
Pt received vax on 5/30. Had febrile seizure on 6/9. Pt has had high temp previously with seizures. Pt also has measle rash on body.
Two days post vax pt developed a rash with redness at the injection site. The injection site was hot to touch and very tender. Pt had a fever of 101.
p/vax pt exp localized erythema & heat minimal induration which cont to inc in size to involve the entire lt leg;
Patient presented to vaccine clinic to receive second dose of Moderna on 4/19/21 with rash noted to head, neck, chest and back.  Reports rash developed approximately one week following administration of first Moderna vaccine which he received 3/22/21.  Reports the rash is very itchy.  Scalp red and irritated from scratching.  Consulted with medical director and deferred vaccination until rash could be evaluated further. Patient's rash was evaluated on 4/21/21.  Physician believes rash possibly due to Moderna vaccine as patient denies any changes to medications, soaps, etc.  Patient was prescribed Prednisone taper, Kenalog cream and Vistaril.  Patient reports a history of tinea versicolor and originally thought the itching/rash was a flare of tinea versicolor.  Patient also reports use of hair dye the day prior to vaccination and approximately 1 week following first vaccination.
The patient had local reaction at each of three sites; Jynneos administered intradermally; Case reference number US-BN-2022-003582 is a spontaneous case received from health care professional on 28-Sep-2022 via Company (reference number: USBAV22-1560) and concerns a patient of unknown demographic.   The patient's relevant medical history was not provided.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at a dose reported as 0.1 ml, intradermally (explicitly coded as 'Intradermal injection'), at an unknown anatomical site and for an unknown indication. As reported, three attempts of intradermal Jynneos vaccine were obtained with no wheal, but the patient had local reactions in each of three sites of product administration.  The outcome of the event was unknown.  The reporter assessed the event of 'local reaction' as non-serious and possibly related to Jynneos.  Additional information received from Bavarian Nordic on 28-Sep-2022 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos at a dose reported as 0.1 ml, intradermally, which is considered as intradermal injection, at an unknown anatomical site and for an unknown indication. On the day 0 after the vaccination, the patient experienced a non-serious event of local reaction. The event of local reaction is considered as listed according to the CCDS v1 and Agency, whilst intradermal injection is considered as listed per company convention. The patient's relevant medical history was not provided, and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Considering suggestive temporal relationship and known product safety profile, the event of local reaction has been considered as related to Jynneos. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos at a dose reported as 0.1 ml, intradermally, which is considered as intradermal injection, at an unknown anatomical site and for an unknown indication. On the day 0 after the vaccination, the patient experienced a non-serious event of local reaction. The event of local reaction is considered as listed according to the CCDS v1 and Agency, whilst intradermal injection is considered as listed per company convention. The patient's relevant medical history was not provided, and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Considering suggestive temporal relationship and known product safety profile, the event of local reaction has been considered as related to Jynneos. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Patient reports having bothersome muscle pain in the same deltoid in which she received the first dose of the Shingrix vaccine. The pain has bothered her off and on since getting the vaccine. The arm did not appear swollen, red, or warm. She was advised to seek medical attention with her primary care provider and hold off on getting the 2nd dose in the series until cleared by her provider.
same day felt run down "like crap". 1.5 hour later, felt heart palpitations. Nausea.  That night was sweating profusely.  Pain at injection site.  Was not able to lift left arm (site of injection) at all.  Following day, lost all control of left hand and experiencing tremors for about 10-15 minutes.  Arm still not feeling right (8 days later).  Still having palpitations and tenderness at injection site.  Injections site still hot, red itchy.
suspected Vaccination failure; 3rd outbreak got Ramsay Hunt syndrome, permanent effects to my face; Shinlges, this is 4th time. 3rd was in roof of mouth; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ramsay-hunt syndrome and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient asked for advice on what a person should do that had the two Shingrix shots in 2018 and just developed shingles again. This was the 4th time the patient had been diagnosed with shingle. The 3rd episode was on the roof of the mouth and developed into Ramsay Hunt Syndrome which cause permanent effect on his/her face. The patient stated that his/her healthcare provider did not expressed much interest. The patient had several nurses in family also had PhD in Biology. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Admission Date: 7/1/2022 Discharge Date: 7/6/2022  PRESENTING PROBLEM: Acute exacerbation of chronic obstructive pulmonary disease (COPD) (HCC) [J44.1] Acute respiratory disease due to COVID-19 virus [U07.1, J06.9] COVID-19 [U07.1]   HOSPITAL COURSE: The patient is an 83-year-old female recently hospitalized for acute CHF who presented back to the hospital with complaints of shortness of breath.  The patient was felt to be suffering from acute chronic obstructive pulmonary disease exacerbation that is likely related to acute COVID infection.  On presentation the patient was started on steroids, routine breathing treatments, and azithromycin.  The patient additionally was treated with IV remdesivir.  The patient was found to have acute respiratory failure requiring up to 5 L of oxygen.  At time of discharge patient was able to be weaned back to her baseline oxygen needs of 2 L, as needed with activity or sleep and while at rest was found to have appropriate saturations on room air.  The patient did have intermittent visual hallucinations felt to be related to either high-dose steroids or hospital delirium.  Patient's husband states she has been having some altered mental status at home even prior to hospitalization.  Question an element of underlying dementia that has been worsened by high dose steroids, hospitalization and limited sleep.
11:00 vac. Crying but consolably. Red swelling bilat to thighs. 15:40 Motrin given and cold packs applied.
Pt was light-headed, cool, clammy and had upset stomach, within 15 to 30 minutes after vax. Increased redness at site, 3 days later and remained sore.
Raised rash/bumps that almost look like a bunch of mosquito bites clustered together at the injection site. It is raised, warm to the touch, and very itchy-- this started a week after receiving injection #1.
Information has been received from a registered nurse concerning a patient who was vaccinated on 12-DEC-2007 with varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U). On 14-DEC-2007, the patient developed "a softball sized lump at the injection site." Additional information has been requested.
Case number PHEH2013US022636 is an initial spontaneous report received from a health care professional on 25 OCT 2013. This report refers to a 13-year-old female patient. She was given only MenCYW-135 liquid component of MENVEO (batch number: X12026) intramuscularly on 25 OCT 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
I received my vaccination in my left deltoid. 3 hours post-vaccination I developed swelling around my right eye. Vision was in fact. No other symptoms, I did not take anything to treat it. It is still present 1 day later, but seems to be improving on its own.
red rash two inches circular the whole way around around the inoculation site; red rash two inches circular the whole way around around the inoculation site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-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 RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation site). At the time of the report, VACCINATION SITE RASH (red rash two inches circular the whole way around around the inoculation site) and VACCINATION SITE ERYTHEMA (red rash two inches circular the whole way around around the inoculation site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.
Pt. stated that five hours after receiving flu shot he was sitting outside and noticed that his eyes were filled with yellow mucus, and his throat was itchy, sore and tight.  His chest also felt tight.  Took Benadryl and Motrin with good results, but woke up with chills and sweats in the middle of the night.  Felt improved the next day. Referred to PCP.