chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp ringing noise in ear still going; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy and Tinnitus.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 01-Mar-2021, the patient experienced TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired). At the time of the report, TINNITUS (Sharp ringing noise in ear still going) had not resolved and FATIGUE (Little tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, any known allergies or reactions, medical history or concomitant medications. In approximately 2014, (reported as two or three years ago), the patient was vaccinated with GARDASIL, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician was informed by the patient's mother that the patient with no prior history of seizures "experienced seizures three weeks after receiving GARDASIL". Due to the events, the patient sought medical attention. Therefore, she "was seen by a neurologist" on unspecified date and was diagnosed as epileptic and needed help showering on an unspecified date (reported as "now"). The patient received unspecified treatment for the event. At the time of reporting, the patient had not recovered from epilepsy. The causal relationship between the event and therapy with GARDASIL or GARDASIL 9 was not reported. Upon internal review epilepsy was considered to be a medically significant and disabling event. Additional information is not expected because there was no consent to contact physician.
Pain in the hips; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the hips) and MYALGIA (Myalgia ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Thyroid disorder. Concomitant products included LISINOPRIL for an unknown indication, THYROID.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ARTHRALGIA (Pain in the hips) and MYALGIA (Myalgia ). At the time of the report, ARTHRALGIA (Pain in the hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided
A report was received from a health care professional on 11 November 2003 concerning a 52 year old female vaccinee who experienced localized redness an unspecified length of time after inadvertently receiving a sub-optimal dose of Fluvirin intradermally on 11 November 2003. On 11 November 2003 the vaccinee received 0.1 ml Fluvirin intradermally. The vaccinee experienced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 25 November 2003: Follow up information received from a health care professional indicated that the vaccinee also experienced localized tenderness on 11 November 2003. The vaccinee recovered on 18 November 2003. Cross reference with: PJP200301050, PJP200301051.
With my endometriosis medicine I never get my period, haven't for years. Now since vaccine I have got it twice, 1st time day after my vaccine. Talked to my doctor and the vaccine is only connection to any change. Worried it might affect birth control for others.
Vaccine that administered beyond use date after the thaw process/Expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 22 years and 8 months. Concomitant medication of the patient was not reported.The patient did not experience any adverse reactions after the administration of vaccine.On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99. No treatment information was provided by the reporter
Information has been received from a registered nurse concerning her daughter, a 12 month old female with eczema and no drug reactions/allergies who on 14-JUL-2011 was vaccinated with the first dose of PROQUAD (Merck) (Lot # not reported). There was no concomitant medication. On 17-JUL-2011 the patient developed generalized rash. On 20-JUL-2011 the patient started intermittent fever. On 22-JUL-2011 the patient vomited. On 23-JUL-2011 the patient was seen by physician who described the rash as generalized, non-vesicular, and possibly viral in origin. No lab diagnostics study performed. No treatment given. At the time of reporting, the patient had not recovered. Additional information has been requested.
pt recv vax & 1hr post vax pt exp dizziness, lightheadedness, & redness, itching, inflammation, & welts @ the inj site;
Presented with SOB, fatigue; admitted with sepsis and acute respiratory failure due to COVID19 associated pneumonia. He was started on iv abx, iv steroids and remdesivir.  Also rec'd actemra and lovenox; breathing gradually improved; oxygen was weaned down to 2 L by NC. home oxygen has been arranged.
ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer; ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer; shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "a slow heart beat" (unspecified if ongoing), notes: a slow heart beat. The patient's concomitant medications were not reported. The following information was reported: RENAL CANCER (medically significant), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: since receiving your COVID vaccination, the patient have some minor Cardiac issues & have Kidney Cancer. The patient have never had any issues with patient's heart (other than a slow heart beat). The lower half of the patient heart has been damaged slightly. Enough to cause shortness of breath. Again, the patient have never had any Kidney issues.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
I positive for COVID-19 on 16NOV2022, I was coughing, I had some fatigue and congestion. I did not have a fever, I contacted my doctor and he prescribed me paxlovid. After taking the medication I started feeling better about 2 days later.
Acute chest pain; Elevated troponin 16; This is spontaneous report received from a contactable Healthcare professional. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 08Apr2021 13:15 (Batch/Lot Number: EW0151) (at 17-year-old) as first dose, single in arm left for COVID-19 immunisation. Other unspecified Pfizer vaccine was received via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW0170) as second dose, single in arm. Medical history included ongoing hospitalization (Vaccine received during existing hospitalization). The patient's other concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Other medications received within 2 weeks of vaccination was reported as unknown. On 02May2021 04:00 AM, the patient experienced acute chest pain and elevated troponin 16, he was admitted to hospital. It's reported AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization). Prior to vaccination, the patient was not diagnosed with COVID-19. On 02May2021, PCR Nasal Swab was performed and showed negative. Ketorolac tromethamine (TORADOL) and ibuprofen (MOTRIN) were received as treatment. Duration of hospitalization was 4 (discharged on 06May2021). The outcome of the event was resolved in May2021.; Sender's Comments: Based on the strong temporal relation, the association between chest pan, troponin increased and vaccine administration cannot be completely ruled out with the information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt has been vaccinated 2 times, the 2nd time being July, 1997. On 10/11/99 laboratory evaluation revealed a lack of response. Follow up data states the patient was vaccinated with influenza virus vaccine IM in the left deltoid on 10/08/1999. On 10/08/1999 the patient experienced bilateral upper arm discomfort, initial soreness at the site and then both shoulders became sore. The discomfort was 2-3 on a 1-10 scale. The patient recovered after approximately five weeks. No further information is available.
This spontaneous report as received from a consumer's mother refers to a currently 16 years old female patient. At age of eleven the patient was vaccinated with the complete series of GARDASIL dose unknown, intramuscularly. At age of fourteen the patient was vaccinated second time with the complete series of GARDASIL dose unknown, intramuscularly. On an unknown date, after second series of vaccination at age 14, the patient experienced dizzy and nauseas. She had stomach pains and anxiety. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. Additional information has been requested.
TTP-Thrombotic Thrombocytopenia Purpura-Confusion, bruising, renal, extreme tiredness, brain bleed, platelet count below 30k.
my arm was sore; I had a rash on where they gave the shot; This is a spontaneous report from a contactable Other Health Professional. An adult male patient of an unspecified age (age mentioned as 60-64 years) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm sore and had a rash on where they gave the shot, and he reported that he did not feel anything bad. The outcome of the events was unknown at the time of this report. The reporter causality between the event and bnt162b2 reported as related  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Broke out with shingles before Christmas; Still red; Itches terrible; Used everything to help the pain/ Nothing works; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd November 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than 2 months after receiving Shingles vaccine, the patient experienced shingles, erythema, generalized pruritus and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the erythema, generalized pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, erythema, generalized pruritus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot on November 2 and broke out with shingles before the holiday. The patient stated it was still red and itches terrible. The patient further stated the prescription helped some, the patient used everything to help the pain but nothing worked. The follow-up would not be possible as no contact details were available.
from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop     started yesterday. ? Neck Pain     right side. Yesterday noticed a facial droop without any arm weakness or change in gait.  No headaches.  Using some artificial tears but eye is getting more red and matting of eyelashes.  Having more right rhinorrhea, but that's been a chronic issues.  Feels like hearing is off in his right ear.  More neck soreness on the right.
Baby became listless and lethargic immediately after vaccine administration. Baby received PENTACEL along with PREVNAR (pneumococcal) and Rotavirus (oral) vaccine. Head was slumped over but baby was able to to be aroused by doctor when doctor shined light in pt eyes. Baby was mostly listless except when stimulated by repeated touch and light for about 15 minutes. Parents took baby home and said she was fussy later in the day, ate fairly normally that night and seemed to be doing better the next day.
Functional neurological disease; Reaction; This spontaneous case was received on 10-May-2022 from other non-health care professional (patient's mother) via regulatory agency (reference number: SEQW22-01387) and concerned a 6-year-old, female patient.   The patient's medical history and concomitant medications were not reported. Patient's mother stated that patient had received four previous influenza vaccinations in previous seasons, but her vaccination records were lost.   On an unknown date in 2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: one dose, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 14249221A, expiry date 30-Jun-2017. The patient was supposed to be receiving a second dose 30 days later per the guidelines.  On an unspecified date in 2017, shortly after receiving the first Afluria Quadrivalent vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease.  At the time of initial reporting, the patient had not recovered from the events. She was a 12-year-old and she was still experiencing this condition.   The reporter considered the events as related to Afluria Quadrivalent. As reported, patient had a severe reaction shortly after receiving Afluria vaccine.   The reporter considered the case as serious due to seriousness criterion of hospitalization.  Company comment: A 6-year-old, female patient received the suspect product Afluria Quadrivalent. Reportedly, shortly after receiving vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease. Information regarding medical history and relevant diagnostic findings was not provided. Due to lack of information provided and unclear temporal relationship, causality for the reported events is unassessable.; Reporter's Comments: As reported, patient had a severe reaction shortly after receiving Afluria vaccine.; Sender's Comments: A 6-year-old, female patient received the suspect product Afluria Quadrivalent. Reportedly, shortly after receiving vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease. Information regarding medical history and relevant diagnostic findings was not provided. Due to lack of information provided and unclear temporal relationship, causality for the reported events is unassessable..
very very sleepy; got covid in spring of 2022 after their last Moderna shot/had long covid; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid) and SOMNOLENCE (very very sleepy) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (2nd dose) on 11-Feb-2021, COVID-19 vaccine (1st dose, Lot: DU4M20A) on 04-Apr-2021 and COVID-19 VACCINE (Lot: 05E21A) on 29-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Blood pressure high, House dust mite allergy, Penicillin allergy, Allergy to molds, Allergy to plants (certain plants) and Allergic reaction to antibiotics (Reactions to different antibiotics). Concomitant products included CLONIDINE, METOPROLOL and AMLODIPINE for Blood pressure high.    On 21-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid). On an unknown date, the patient experienced SOMNOLENCE (very very sleepy). At the time of the report, POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid) and SOMNOLENCE (very very sleepy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 antibody test: 21,000 proteins.    It was reported that patient got covid in spring of 2022 after last moderna shot. She has had long covid and had a spike protein test and had 21,000 proteins. Patient could not get any tireder than they were right now. The only reaction had to the vaccine was that they were very very sleepy. when got covid it was the same problem they had. With long covid patient was physically exhausted.   Treatment medication was not reported.
Pt received AVA #1 on 4/30/07 without adverse effects. While overseas he received AVA #2 on 5/14/07 in the right triceps. Within 2-3 minutes he noted a burning sensation in the back of his neck immediately followed by a "massive" (12/10) right-sided frontal headache associated with N, dizziness and photophobia. The pt reported to medical on 5/16/09. He still had severe headache. Additionally, he complained of fatigue, disorientation, loss of memory, left leg numbness and one episode of diarrhea (no N, V, or fever). CBC, Chem 12, EPV IgG were normal. The pt was diagnosed with mild immunization reaction and anxiety. On 5/22/07 the pt was seen for fatigue, "crick" in his neck, inability to focus, and 2 brief episodes of abdominal pain with one episode of diarrhea. He was diagnosed with IBS and anxiety. On 6/8/07 the pt was seen for short term memory loss, fatigue, left leg numbness and new onset of "joints in hands locking up". The pt was diagnosed with depression. 8/07 the pt suffered a syncopal episode when he went from a sitting to a standing position. He was unconscious of 3-5 seconds. He had no visual changes, light headedness or palpitations prior to the event. After this event he started having intermittent "piercing" pain on the right side of his head with occasional photophobia and phonophobia (no N or V). The pt had a neurology consult (civilian) on 9/19/07 for complaints of left side weakness, headaches, gait disturbance and the recent syncopal episode. A lumbar puncture failed to yield any etiology to his problem. He was diagnosed with post infectious demyelinating disease. "The anthrax vaccination has been known to cause encephalitis and this could be the etiology of his problems". The pt states that he had a similar episode in 10/07 but was not examined. SEE NCS/EMG, EEG, MRI LS AND MRI BRAIN DONE 9/07-10/07. The pt was hospitalized from 2/27/08-3/7/08 for worsening of his left leg weakness and numbness. On 3/4/08 he had a 10 minute episode of right sided headache, LUE paresthesia, feeling hot and like his "heart was pounding". On 3/5/08 he had two hour episode of white "spots/flashes" in his right eye. The pt was treated with a 5 day course of IV SOLU-MEDROL with improvement of symptoms (return to baseline). Per neuro" "stroke workup was negative. Post viral demyelination, more likely ADEM based on MRI showing one lesion and no other white matter changes." SEE MRIs, CT, MRA, EKG ECHO, LABS DONE 2/27/08-05/20/08. Seen in neurology for follow-up on 10/6/08. Continued to complain of daily intermittent right sided headaches, left leg and arm weakness and numbness. SEE MRI 11/5/08. When seen 4/3/09 complained of slight worsening of his left sided weakness and mild urinary urgency. SEE MRIs 5/19/09-5/20/09. 10/7/09 seen by his PCM. Pt reported a syncopal episode 2 days prior. Pt state.
First day of vaccine I experienced ache at injection site which I thought was normal until the next day.  The next day I noticed increased pain and when I checked my arm I noticed a red circle around the injection site in upper left arm about the size of a silver dollar.  It feels hard underneath.  That evening the pain increased and during night, sleep interrupted due to pain.  Next day I experienced pain all day and in late afternoon, site began to itch.  Red circle was somewhat larger.  By the following night, the  pain decreased and itching was minor.  Today, redness is still there although faded and not as large.  Pain and itching has also decreased.