chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient reported a positive reaction, these past colonoscopies had no polyps; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022L21A, 026O24A, 028N21A and 036A21A) for COVID-19 vaccination.     The patient had no allergies and had never been tested positive or diagnosed with COVID-19.  The patient's past medical history included Polyps (patient had  polyps since the last 17 years). Concurrent medical conditions included Blood pressure high (patient is on Blood pressure medication) and High cholesterol (patient is on High cholesterol medication).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: polyp (abnormal) patient had undergone 8 colonoscopies in the last 17 years and each report always had detected polyps and no polyps (normal) recent past colonoscopies had shown no polyps.         Concomitant medications included blood pressure medication and high cholesterol medication. No treatment information was provided.  On 24-Oct-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 06-Apr-2022, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient reported that the vaccination was the only positive thing that changed the patient's condition.
12AUG92 mom reported that t103 started 2-3 hrs p/inject; rt leg entire thigh was very swollen; cried for 3 hrs, unconsolably; administered APAP & cold compresses;
Boil at inoculation site 1 wk after shot. Calcified tendons at rt rotator cuff. Arthritic type pain at shot area.
Febrile seizures (two in 24 hours) after DTaP, Hib, Hepatitis B
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -1.11 Celsius Degrees for 80 hours, -3.0 Celsius Degrees for 1172 hours, 15 Celsius Degrees for 56 hours and 8.33 Celsius Degrees for 392 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
got one and did feel like shit after; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced got one and did feel like shit after after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient got one and did feel like shit after (feeling abnormal) (unknown latency) following the administration of influenza vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Fever developed that evening body twitching while sleeping (not a seizure) - vomited x3. No diarrhea holding down fluids. 11/19/09 home from school treated with TYLENOL. Sore arm no redness. Better on 11/20. Returned to school still warm.
received moderna booster 12/9 (initial vaccine was Jannsen), 12/10 developed left sided cervical lymph node enlargement and tinnitus in right ear, symptoms resolving, small effusion on right TM- did have allergic rhinitis a few weeks ago, no fevers or dizziness
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of covid-19.  Clinical information: All symptoms recovered by day 6 and tested negative on antigen test. Another antigen test done on day 8 which was negative.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker (unspecified) concerning a patient (age and sex not reported) who in approximately December 2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F).  In approximately December 2006, the patient experienced swelling and pain at the injection site and fever.  The outcome of the events was not reported.  This is one of several reports from the same source.  Additional information has been requested.
could not move; had aches and pains; felt so very cold; pinkish red rash on their torso that cleared up yesterday; Sick; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday) and ILLNESS (Sick) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ENALAPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, ERGOCALCIFEROL (VITAMIN D2), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache and Pain, at an unspecified dose and frequency. In January 2022, MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the booster they were sick with side effects for 2.5 days.   This case was linked to MOD-2022-453539, MOD-2022-453520 (Patient Link).
Fever, 100.5 with chills and body aches, couldn't sleep all night.  Headache and dizziness in the morning.  Took Tylenol in the morning to reduce fever, which worked.  It's only 10:45 AM now and I didn't get up until 9:30 AM.
Received a Janssen covid vaccine, indicated on consent form that she hadnt ever had a COVID vaccine but when entering her into system it was reported she had one dose of Pfizer COVID vaccine on 1/13/21
fatigue; diarrhea; fever; body aches; headaches; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever) and PAIN (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2012, the patient experienced CHILLS (chills). On 09-Apr-2021, the patient experienced FATIGUE (fatigue), DIARRHOEA (diarrhea), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as Anti Diarrhea   This case was linked to MOD-2021-073822, MOD-2021-073822 (Patient Link).
Narrative: Patient was administered the second dose of the Moderna COVID-19 vaccine. Of note, no ADRs were documented with his first dose. 2 days after administration of the second dose, the patient rapidly deteriorated and was hospitalized at a non-facility hospital for severe dyspnea; complete records are unavailable for review, however it is unclear what his course was while inpatient. Per records, he was placed on BiPAP within the ICU and a primary diagnosis was listed: J8410 - Pulmonary fibrosis, unspecified. The patient had a noted history of thrombocytopenia and multiple comorbidities including cardiomyopathy, anemia, and type 2 diabetes. The patient later passed away in the non-facility hospital, it is unclear whether he was even taken off of BiPAP prior to this.
Patient with development of nausea and non bloody emesis x1, Patient observed for 30 min post emesis without return of symptoms . ER precautions given .Patient without symptoms at time of discharge.
Site: Pain at Injection Site-Mild, Systemic: involuntary muscle movement at site of injection-Mild, Additional Details: involuntary spontaneous muscle movement only at injection site
sore arm; fast heartbeats like 110; weakness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient experienced sore arm, fast heartbeats like 110, tightness, and weakness. Outcome of the sore arm was recovered on Jan2021 after 2 days while of the remaining events was unknown.  Information about batch/lot number has been requested.
3 episodes of fecal incontinence, legs were so shaky that she couldn't get out of chair well, arm was red and sore for a few days. Symptoms resolved after 24 days
Patient called and reported today that he woke up at 2:30 am with Diarrhea, Tingling  in bilateral legs, upset stomach and trouble breathing.  Informed patient to contact his Doctors office.  Refused ER treatment last night.  Used nebulizers.  Still not feeling 100% at time of call.
Mild rash and bumps on face after 24 hours then it got worse by Saturday 10/19/2013. Tongue felt " funny" per patient. Advised to go to ER asap.
Reaction from Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction from Moderna shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 COMPLICATION (Reaction from Moderna shot). At the time of the report, VACCINATION COMPLICATION (Reaction from Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Information has been received from a physician's assistant concerning a 16 year old female who on 20-SEP-2007 and 05-DEC-2007 was vaccinated with a first a second dose of Gardasil.  On 05-DEC-2007 the patient went into the waiting room and fainted, fell to the floor.  Paramedics came in and the patient was out for about 20 seconds.  They elevated her legs and she seemed alright.  There was no major injury.  The representative (also reported as the nurse) called the patient's father on 08-DEC-2007.  Additional information has been requested.
Pain is not deliberating, but annoying; injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says; He says he has sore muscle feeling; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-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 an unknown date, the patient experienced IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling). At the time of the report, IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Tremble/ shake in the thumb on my right hand; Severe enough to interfere with any function of my right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 11:00 (Lot number: EW0153) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Family history included: low level tremble in hands does occur periodically" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; CETIRIZINE HCL. Past drug history included: Propranolol, reaction(s): "low blood pressure", notes: low blood pressure (side effect of propranolol). Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN5318, Administration date: 29Mar2021, Administration time: 09:00 AM, Dose number: 1, Vaccine location: Right arm), administration date: 29Mar2021, when the patient was 28 years old, for Covid-19 Immunization. The following information was reported: TREMOR (non-serious) with onset 17Apr2021 12:00, outcome "recovering", described as "Tremble/ shake in the thumb on my right hand"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 17Apr2021 12:00, outcome "recovering", described as "Severe enough to interfere with any function of my right hand". Therapeutic measures were not taken as a result of tremor, loss of personal independence in daily activities.  additional information: some low level tremble in hands does occur periodically and is common in patients family but does not interfere with function and patient haven't seen a physician for the issue. Patient did not receive other vaccine in four weeks. Adverse events Lasted roughly 2 hours beginning 25 hours post injection. Patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
After receiving vaccination, patient reported feeling light headed.  She was visibly pale, sweating and shaking.  We gave her ice water, candy, put an ice pack on her neck and within 15 minutes the patient was fine.  We rechecked her in 45 minutes and the patient was not having any recurring symptoms.
inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. 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.
VISION BLURRY AND HEADACHE WHEN TRY TO CONCENTRATE AND FOCUS ON OBJECT
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
COVID-19; foggy and tired in the head; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head). At the time of the report, COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.            No treatment information was provided.; Sender's Comments: This case concerns a 69-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  approximately 2 months after an unspecified dose of mRNA 1273 vaccine. The patient had Covid-19 and felt foggy and tired in the head, outcome of events are unknown. The rechallenge is not applicable as there is no information regarding the dose number.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
The following day after the vaccine, client had hive reaction localized under the flu-shot site on his left arm.
PT received 2nd dose of Pfizer and shortly after admission described sensation of hot flashes and tingling lips. PT was evaluated by medical staff and found to be slightly flushed with increased motor activity, speaking rapidly. HR 90's, RR 20, no wheezing and able to swallow own secretions/maintain airway. PT denied chest tightness, difficulty breathing or unusual swelling. PT was provided with ice packs with moderate, intermittent relief. She was also provided diphenhydramine 25mg PO, declined 50mg dose. PT reports a hx of hives of unknown origin associated with shaking for the past year requiring high dose Allegra and supplemental famotidine daily. PT followed by allergist and receives monthly Xolair injections, last 14 days ago. She reports sx's post vaccine are similar to baseline sxs with hives. She also reports a hx of anxiety/panic attacks. Husband present. PT declined EMS for eval and both PT and husband reported preference to drive to local ED. Report called to ED for inbound PT.