chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intercranial hypertension; Swooshing was worse after the second shot; Condition aggravated; Dizziness/things like that; Pressure in my head; She was treated for an ear infection; her right ear started hurting bad; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) (seriousness criterion medically significant), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches). At the time of the report, INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) no brain tumor or blood flow issues..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided. Patient had seen a neurologist and he told that all her symptoms were due to intracranial hypertension. Patient was scheduled for spinal tap on 14-Sep-2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-307195 (Patient Link).; 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, a causal relationship cannot be excluded.
The customer called complaining that the room is spinning and she feel dizzy.  She was told to call her doctor.
Numbness and tingling in two fingers of right hand and minor tingling in other areas.  I was working on installing flooring and i associated the tingling with the work I was doing and didn't think anything of it as it seems minor but has not gone away since May etc.  It doesn't seem to be getting worse but it's constant numbness in  the tips of both fingers.
Patient received Prevnar13 on 01/27/2016 to right arm. Area is red and warm to touch. Localized to administration area. Patient denied pain or discomfort to site. No drainage or swelling.
Headaches; off and on ear pain; fever goes up and down; stuffed up; started coughing; Hard to swallow; sleeping a lot; 100.3 degree fever last night; chills that are ongoing; chest feels heavy (like asthma feeling); bumpy at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE NODULE (bumpy at the injection site), HEADACHE (Headaches), CHEST DISCOMFORT (chest feels heavy (like asthma feeling)) and COUGH (started coughing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     medical history not reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Jan-2021, the patient experienced INJECTION SITE NODULE (bumpy at the injection site) and CHEST DISCOMFORT (chest feels heavy (like asthma feeling)). On 17-Jan-2021, the patient experienced COUGH (started coughing), DYSPHAGIA (Hard to swallow), SOMNOLENCE (sleeping a lot), PYREXIA (100.3 degree fever last night) and CHILLS (chills that are ongoing). On 18-Jan-2021, the patient experienced HEADACHE (Headaches), EAR PAIN (off and on ear pain), PYREXIA (fever goes up and down) and NASAL CONGESTION (stuffed up). At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE NODULE (bumpy at the injection site), HEADACHE (Headaches), CHEST DISCOMFORT (chest feels heavy (like asthma feeling)), DYSPHAGIA (Hard to swallow), SOMNOLENCE (sleeping a lot), PYREXIA (100.3 degree fever last night), CHILLS (chills that are ongoing), EAR PAIN (off and on ear pain), PYREXIA (fever goes up and down) and NASAL CONGESTION (stuffed up) had resolved and COUGH (started coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified over the counter vitamins.  Treatment for the events included paracetamol.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information
more intense itching, especially on palms and bottom of feet; more intense lower back pain; mild muscle aches on my thighs; This is a spontaneous report from  a contactable consumer (patient). A 56-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm, on 28Feb2021 (at the age of 56 year old) as dose 2, single for COVID-19 immunisation. Medical history included high BP, high cholesterol, high thyroid and mild depression from  an unspecified date. Patient has known allergies to phenobarbital. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); duloxetine hydrochloride (CYMBALTA); gabapentin (GABAPENTIN); valsartan and atorvastatin calcium  all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9263, expiry date: unknown) via unspecified route of administration, in right arm on 31Jan2021 09:00 (age at vaccination: 56-years) as dose 1, single for COVID-19 immunisation and experienced low grade fever for 2 days, itching on her eyelids and pain in lower back joint. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive any other vaccine within 4 weeks. On 01Mar2021 20:00, patient experienced more Intense lower back pain and Itching, especially on palms and bottom of feet. Also, had mild muscle aches on her thighs. It was reported that patient had no fever. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures in response to the events included Tylenol and Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling and numbness and heaviness of the left side of my body (specifically arm and leg) on the affected/vaccinated side, drouth, and sleeplessness for about 2 hours
Site was red, hot and swollen. By morning of 12/20/2016 rash was larger, and arm ached very bad.  Put cold compresses, and gave her Tylenol. By 10:00 p.m. 12/20/16 the top site was 1 1/2" dia.  The bottom site is now 4" x 7", red, hot, hard, and now itching her. I put Benadryl cream on it as well for the itching.  Can't give her Benadryl pills as she takes trazodone 50 mg. for headaches.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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: "Generalized anxiety disorder" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Doxycycline, reaction(s): "Known allergies: Doxycycline"; Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Day 3 of illness; Negative, notes: Day 4 of illness; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was initiated as treatment from 22Jul2022 to 24Jul2022. Was unable to finish course after 2 full days of treatment due to side effects. Tested negative on home antigen day 3 and Day 4 of illness. On Day 6 she started having a cough, itchy throat, and runny nose. Tested again and was positive on home antigen test. Patient also took other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19 and the suspect drug BNT162b2 .
Patient had presented with Generalized weakness and fever.  Found to be positive for COVID-19 but has not manifested hypoxia to suggest the need for steroids or REMDESIVIR.  Therapies attempted to assess but patient had declined. Have encouraged patient to participate and he did finally work with physical therapy who recommended home with assist.   History of CAD (coronary artery disease) (Drug eluting stent LAD 6/2023) on ASPIRIN and CLOPIDOGREL.  Had mildly Elevated troponin values with flat delta, no acute findings on electrocardiogram.  No chest pain.  Likely demand phenomena.     Type 2 diabetes mellitus, without long-term current use of insulin HbA1c 6.9% on no medication.  Essential hypertension blood pressure controlled.  GERD (gastroesophageal reflux disease) proton pump inhibitor  Benign prostatic hyperplasia with urinary hesitancy TAMSULOSIN  CKD (chronic kidney disease) stage 4, GFR 15-29 ml/min stable with recent baseline.   Mild, chronic Normocytic anemia likely related to kidney disease.
Vesicular and Pustular rash, on trunk both arms and genital region.  Face spared.  No fever or systemic illness.  Pustules and lesions in different regions exhibitting the same stages of lesions as the primary immunization site.
Information has been received from a health professional  referring to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # l020004, expiration date 02-FEB-2017, dose, route and lot number not provided). Temperature was minus 9.2 C and there was previous temperature excursion then call was placed because of a "data logger". No adverse events  were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
given pneumo shot R deltoid. Given 11/6/01. started hurting that evening, Red and swollen on 11/7/01.
Information was received from an investigator regarding a 2 month old male who received his vaccinations on 04/25/2000. On 06/14/00, at age of 4 months, the patient died. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. Both the investigator and medical monitor consider this event not related to vaccine administration. This report of a serious, labeled event is being submitted to the FDA in a 15-day time frame, as requested by FDA. Autopsy also stated the infant had dermatitis, pulmonary edema and congestion.
pt recvd vax;6 hrs later pt became extremely pale,bluish around mouth x 5-10 mins;not related to fever,sz, on apnea;saw ems crew w/o intervention ,regained nl coloring;
This spontaneous report was received from a Healthcare Worker referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K010215, expiration date: 05-MAY-2017; lot # L035105, expiration date: 14-MAY-2017; Lot # K011562 expiration date: 08-APR-2017; (dose and route of administration were not reported). Administered doses of vaccines experienced a temperature excursion of 30 degrees Fahrenheit for 66 hours. This information was a result of a data logger. There were no previous excursions reported. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA"  Individual received the Pfizer Covid-19 vaccine. He began to feel dizzy and faint at 11:41 am. His vitals were 134/86, 20, 82 at 11:41 am. We applied chill towel to back of neck. B/P 104/84,20, 84 P, 98 % RA. 11:46 am. Individual report that he did not have breakfast and did not hydrate. Patient swallowing intact. He was given bottle of water. 1:58 pm vitals were 114/82, 99% SATS, 99, 18. Individual stated she felt better and was no longer dizzy. 2:04 pm vitals 118/84. 18, 72, 98% RA. After drinking 32 oz of water individual went home with family with no noted distress.
pt recvd vax;4 hrs later mom reports shallow breathing noted & redness lasting 15 mins over entire body & face;no crying;no fever;no er visit
Itching; Swelling; Redness, about the size of a lemon; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon). At the time of the report, VACCINATION SITE URTICARIA (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness, about the size of a lemon) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included Cold compresses and then warm the next day.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site swelling, vaccination site erythema and vaccination site urticaria are consistent with the known safety profile of mRNA-1273.
Pt recv vax on 11/13/98; on same day pt exp tenderness to vax site (LA)
Information has been received from a nurse concerning a 12 year old female with a history of syncope (similar response) with other injections who on 19-AUG-2008 was vaccinated intramuscularly with the with the first 0.5 ml dose of GARDASIL. On 19-AUG-2008 the patient experienced syncope. Subsequently, the patient recovered on the same day. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Immunization was the most painful I've ever had.  I expected a sore arm, but the soreness moved into my shoulder joint.  Have had 5 weeks of acupuncture, a PRP injection, and 6 weeks of physical therapy.  Nothing is helping.  My arm is in pain every minute of every day.  I cannot raise it up or move it back.  I get a painful sharp pain in the joint and a burning sensation, sometimes down to my elbow.  The pain now is getting worse - going from my elbow to the back of my left arm on my abdomen to the left side of my neck. Have never had a problem with either of my shoulders , and had no falls or any reason for this to happen. I believe it is directly related to the immunization itself or the way it was administered.
FEELING BAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling bad was not reported. This report was non-serious.
Pt has pain, redness and swelling on injection site of left arm for 4 days. Allergic to Tdap.
Patient came to the ED with complaints of cough, congestion, SOB, and wheezing.  She was admitted to the hospital with Covid symptoms.
Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from a consumer via other company (Pfizer, reference number 2016066188) on 10-Feb-2016. This case involves a 75-year-old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported) on an unspecified date of September 2015. It was reported that, patient had received a flu shot 9 years ago and developed a low grade fever and a rash and her arms and fingers were so swollen she could not move them. As a child patient received penicillin and broke out with a real bad rash, tape allergy and was in the hospital for 9 days after her cesarean delivery. Concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced arm felt like it was going to fall off and a huge hive/rash with a fluid build up that was the size of her hand, hives and itched for 2 or 3 weeks. Patient had no laboratory investigation and corrective treatment were not reported. The outcome of events was recovered. List of documents held by sender: none.
Patient became pale and diaphoretic, lost consciousness with pupils dilated, able to converse appropriately after he came to within 20-30 seconds, no neuro defects noted after consciousness returned.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, lethargy, headache, tremor and chills. On an unknown date, the outcome of the fever, lethargy, headache, tremor and chills were recovered/resolved. The reporter considered the fever, lethargy, headache, tremor and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported via GlaxoSmithKline field based Medical Science Liaison (MSL) who received by an email. The patient experienced fever (body temperature was recorded as 101 degree F), chills, shaking, headache and lethargy for the next 2 days after the vaccination. No further details were provided in the email communication from the reporter.
Patient reported chest pain that started on 3/30/21 at an unknown time after receiving covid vaccine.  Vital signs were stable and EKG was normal at time of presentation on 3/31/21. Suspected that complaint is unrelated to vaccine.
difficulty breathing; felt her throat swelling; felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable). On 02-Apr-2021, DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.