chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient experienced a vagal response about 5 minutes after shot. patient seemed fine first few minutes was comforting friend who was nervous. lab who we share space with noticed he slumped he was out for less than a minute. pt said he felt like he feel asleep. technician very familiar with this reaction and monitored him closely. after he was stable place in an incline position in the blood draw room. patient states he did not eat or drink that am, and was a bit nervous. he was given water and food (after he was stable) we monitored him for over 30 minutes which he then left on his on accord feeling much better.
Arm  is swollen; Fever; Fatigue; Body ache; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Apr-2020 and the estimated date of delivery was 13-Jan-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 28-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the event included acetaminophen (Tylenol) 500 mg once.; Sender's Comments: This is a case of vaccine exposure during pregnancy and AEs of vaccination site swelling, pyrexia, fatigue, and myalgia for this 34-year-old female. Patient will continue to be contacted for further monitoring of the adverse events during pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
about 12 uncontrolled, profuse nosebleeds over 5 days starting April 8. Used OTC Afrin to stop them after about 10 April 8-9. Then had to use it to stop on on April 11 an once on April 12.  High  blood pressure reading when checked on April 9 after nosebleeds. Doubled HTN meds and then on April 14,  even higher  in spite of doubling HTN meds
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was provided.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
hand weakness; arm pain; neck pain; shoulder pain; hand discomfort; swollen fingers; swollen joints/swollen knuckles; painful joints; This case was reported by a nurse via call center representative and described the occurrence of limb discomfort in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (experienced reaction in the past,prior to receiving Shingrix where she could not control her body heat.).   On 10th December 2018, the patient received the 1st dose of Shingrix. On 10th December 2018, less than a day after receiving Shingrix, the patient experienced hands weakness of. In December 2018, the patient experienced limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain. On an unknown date, the outcome of the limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain were recovered/resolved and the outcome of the hands weakness of was not recovered/not resolved.   It was unknown if the reporter considered the limb discomfort, swelling of fingers, swollen joints, joint pain, hands weakness of, pain in arm, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on her left deltoid.  It was reported that, within a couple of days of receiving Shingrix, the patient experienced discomfort left hand, fingers became swollen, joints were swollen, painful joints.  Right away, after receiving Shingrix, the patient also experienced weakness in left hand to the point that she could not make fist. The pain radiated to her arm, left neck and left shoulder. She spoke with her physician and they opted not to give her the the second dose of Shingrix.  At the time of reporting, it was almost a year left discomfort and knuckles on her left hand had not gone down yet but they were still swollen. The patient was prescribed prednisone and steroid cream and she did not use either one. The reporter consented to follow up. The outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded in database).
pt recvd vax & 1-2 days p/inject had severe hot flashes & was diaphoretic; pt was seen by MD; sx lasted for 2 1/2 hrs & subsided;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose 3 (booster), single (Lot number: FC3138), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Apr2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "major back surgeries (10, incl. 3 fusions)" (unspecified if ongoing). Concomitant medication(s) included: ZOLPIDEM, start date: 31Mar2006; DIAZEPAM, start date: 31May2017; FISH OIL [FISH OIL;TOCOPHERYL ACETATE], start date: 30Jun2016; OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE], start date: 30Jun2016; PROBIOTIC 10, start date: 31May2015; VITAMIN E [TOCOPHEROL], start date: 31Jan2016; CALTRATE + D PLUS, start date: 30Sep2007; ASPIRIN [ACETYLSALICYLIC ACID], start date: 31Jan2020; MIRALAX, start date: 31May2020; TYLENOL, start date: 14Jun2022, stop date: 30Jun2022. Past drug history included: Prednisone; anti-malarials, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The vaccination start time for the vaccines was reported as for Dose 1: 02:00 PM, Dose 2: 01:00 PM, Dose 3 (Booster): 02:30 PM, Dose 4(Moderna): 12:30 PM. Patient also took Men's 1-A-Day 50+(Bayer brand), start date: 30Sep1997 (Lot no: 86896230) as concomitant.  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 the information currently available, a possible contributory role of the suspect drug to all the reported events drug ineffective, covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Advrs effect of pertuss vaccine, inc combin w pertuss, subs on 2016-01-12.
Patient received vaccine on 10/22 around 3:28 PM.  Patient presented to primary care office on 10/26 without an appointment stating that he had received the Shingles vaccine and requested to be seen for what he thought was a reaction to the vaccine. Patient noticed the rash on his arms and back. He noticed these 1 day after the vaccine was administered.  Rash is present on R arms and back and are vesicular. PCP diagnosed patient with herpes zoster and described it as textbook shingles infection. Patient is going to be treated with Valtrex and using advil and tramadol for pain.
Extremely hot, sore, swollen site of injection lasting ~1 week.  Headache, fever & chills started ~9pm with shaking lasting ~4hr.  Next morning headache, lethargic, no appetite & sick feeling lasting all day decreasing slowly for 4 days. Vertigo (mostly postural) & tinnitus. Note:  Tinnitis & occasional vertigo has continued from 1st series in February.
New onset of palpitations. EKG confirmed PACs and PVCs. No prior history of arrhythmias.
This spontaneous report was received from a pharmacist, via a company representative, concerning an elderly patient, older than 65 years old, of an unknown race. The patient's medical history, concurrent conditions, concomitant medications, drug reactions/allergies or historical drugs were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 dose #1, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, less than a year after the first dose, the patient received 1 injection of PNEUMOVAX 23 the second dose, for prophylaxis (strength, formulation, route of administration, anatomical location, lot # and expiration date were not reported). No adverse effects were reported.
pt had a recent hospitalization on 10/8/21 for COVID Pneumonia and respiratory failure; was positive for COVID on 10/8/21; was sent to Hospice; pt progressively declined; DNR; comfort measures only; pt found deceased in hospice facility
11:15 Dizzy 11:30 Swollen tongue, chest pressure, administered epinephrine. I was took to the ER, allergies, inflammation of face, redness of face, ncek and chest.
Skin clammy, gray; briefly seemed to lose consciousness w/ right arm twitching & eyes rolled back in head, retching (did not vomit), shaking. Left by ambulance; treated w/ IV @ hospital where symptoms reappeared w/ needlestick there, released same day. Patient stated after the vaccine he had only had a bowl of Cheerios that day to eat. Sister stated he has had the same rxn after blood draws.
child recv vax & during administration of vax some inadvertently splashed all over mom's face & went into eye & mouth;mom exp a little redness of rt eye;
Friday am: redness & burning --> begin to swell --> afternoon had red streaks --> continued to worsen --> Saturday am to walkin clinic --> Dx: cellulitis --> antibiotics. The client called and reported this sequence of events on 10/10/11 to RN coordinator.
Fever of 103 (highest recorded temp thus far as of 11/23 0038- still having sx; rigors; piloerection;  muscle spasms; arthralgia / myalgia; Headache, dizziness, insomnia, stuffy and runny nose, nausea, anorexia; stomach pain; flank pain;
Pregnant patient received the first dose of moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nausea, VITAMIN B6 and PRE NATAL FORMULA.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) 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.   No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 19-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
She said that  her arm was pretty bruised after her shot and she also said that it bled all night afterwards even though she had never bled from a vaccination before
Patient presents to the Emergency Department who was doing well up until she received COVID-19 vaccine at 1150. 15 minutes later patient started to experience throat tightening and tongue swelling. She was administered Epipen at 1217 by staff at vaccination clinic. EMS was called and prior to arrival at ER tongue swelling had subsided.
Received anthrax shot on 17APR07. Two days later developed hard bump and rash. Area has increased in size daily. Area red, itchy, swollen, and warm to touch.
29APR93 redness & itchiness around inject site; chills & fever that same day; 5MAy erythemia 1x2 cm w/central necrosis w/skin of dead tissue;
Body shaking, electricity (tingling), leg weakness, diagnosed with GBS (Guillian Barré Syndrome), left leg thrombosis blot clot, I've been suffering from this for 18 plus months.
Initial report received from a nurse on 12 Jan 2010: This patient was vaccinated with H1N1 2009 vaccine (influenza virus vaccine monovalent) (batch no: 102149P1) 0.25 ml intramuscular for immunisation, on 11 Jan 2010. The patient under 4 years of age was vaccinated with 0.25 ml dose of Novartis H1N1. No other information was provided at the time of this report.
extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Narrative:  Patient was previously COVID-19 positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 64 year old with a history of Heart Failure, Diabetes Mellitus II, Hypertension, Chronic Kidney Disease, GBS (2015),Depression, Low Back Pain. He was tested positive for COVID infection in March 2020. He declined hospitalization at that time. He had respiratory symptoms. He states he made a complete recovery. He also reports that he has kept himself isolated since that time. However, he tested positive again on admission on June 12 2020. He had dyspnea on presentation, but also had another explanation for the dyspnea, heart failure. On January 14, he developed violacious discolaration of his right hand, a skin finding associated with COVID. Other than this, he has been asymptomatic from the COVID infection. Pt was deceased on 4.12.2021.
severe vertigo attack 8/2021.  i?ve been suffering with and being treated for episodes of vertigo ever since that are increasing in frequency. now have dx of vestibular weakness on right side.  have dx of Ménière's disease. nystagmus.
passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; wiped out; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication, TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL and PRAVASTATIN.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (Inconclusive) result not mentioned.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included as EKG and discontinued Glipizide.  Company comment:This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on 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 MOD21-070319, US-MODERNATX, INC.-MOD-2021-068543 (E2B Linked Report).; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on 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. MOD21-070319: US-MODERNATX, INC.-MOD-2021-068543:wife case
pt inadvertently recv HIB & tetramune same day;w/in 1wk pt devel crying, vomiting & fever;pt was seen by MD & dx bronchiectasis & an ear infect;MD stated that this event was not a result of having the two HIB vax;
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000207303.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Pt woke next day with body aches, nausea low grade temp- shaking, finger tips cold and numb pt took 1000mg Tylenol and advised to go to urgent care- then left the clinics with out being seen.