chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; Patient received second dose of GARDASIL 9 outside of prescribing information; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 06-APR-2019 and 24-MAY-2019, the patient was subsequently vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot # and expiry date was not reported) for prophylaxis. On 24-MAY-2019, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) outside of prescribing information (inappropriate schedule of product administration). It was reported that the patient had not yet received the third dose. There was no adverse event reported.
experienced loss of taste; her arm became sore; swollen; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (experienced loss of taste), VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A821A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen). On an unknown date, the patient experienced AGEUSIA (experienced loss of taste). At the time of the report, AGEUSIA (experienced loss of taste), VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Bleeding and clothing. 10/07/2021- Present  Dizziness, feeling tired, headache feeling unwell and muscle pains. 11/04/2021
Within a couple of minutes experienced some dizziness; followed with a rapid heartbeat for about a minute. Pulse rate was approximately 120 bpm.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the right arm on 12Mar2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and cholesterol high. The patient had known allergies to medications, food or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications (unspecified) within two weeks prior to the vaccination. On 12Mar2021 at 10:15, within a couple of minutes the patient experienced some dizziness and then followed with a rapid heartbeat for about a minute. Pulse rate was approximately 120 bpm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness and heart rate increased was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
FATIGUE; Pain in hip; This is a spontaneous report reported from a contactable female reporter based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3831799-00).  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for hidradenitis. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fatigue and pain in hip on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was dose increased.  No follow-up attempts are needed. No further information is expected.
Pt. presented back to doctor office 2hr after vaccination - temp 98.1, BP 140/80, HR - 135, O2 - 92% on room air. Pt placed on O2 at 3L. Vitals monitored continuously. Given SOLUMEDROL 125 mg IM. Given 50mg BENADRYL IM. Given albuterol breathing treatment. Transported to ER. Pt stayed overnight. Discharged in stable condition.
I realize this isn?t an SAE, however: My menstrual period began a full 8 days early and was also different /heavier than normal. I am consistently 28 days on my cycle to this took me by surprise. After some googling  of similar items in the weeks after, it seems there may be other studies that are exploring whether this is a causal event. As such I?ve decided to report it. It?s just very odd to me because I am extremely like clockwork., so it took me by surprise. I mentioned it to my pharmacist today while getting my second shot and he suggested I report it said that perhaps you can keep track in case others are. I know there are external CDC studies that are apparently going on to try to investigate this abnormality. Thank you for your time.
left thigh redness since 3/22/10 however 4/2/10 area doubled in size and became hard and slightly swollen
This spontaneous report was received from a supervisor, referring to a currently 12 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 08-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Pt had itchy spots on torso approximately 2 hours after vaccination.  Director of Nursing administered 25mg of oral diphenhydramine.  Itching resolved.
Girl vomited after administration; This spontaneous report was received from a physician and refers to a female patient (reported as a girl) of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. Family history included brother's vomiting after administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in approximately 2015 (captured in case MARRS# 2002USA007623). On unknown date in approximately 2017 (reported as 2 or 3 years later after brother's vaccination), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, dose number, lot #, expiration date, route of administration was not reported) for prophylaxis. On unknown date, after the vaccine administration the girl vomited. The outcome of the event was unknown.  The causality assessment between vomiting and suspect therapy was not provided.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA009379: US-009507513-2002USA007623:
Having a head arch, chest pains and shortness of breath pulmonary embolism and was tested for COVID-19 and tested positive.
On March 30, 2018, My husband and I both recall his immediate reaction, because we went out to eat right after the Dr.'s appointment, and my 4 year old was acting berzerk, not his usual calm demeanor.  IN his car seat he wiggled arched his back and was trying to get out, and then for the next 5 hours he thrashed, climbed up chairs, walls, flailed, flopped, was emotional and crying, fussy, irritable and his eyes were glazed over. He seemed out of his mind.  After so may emotions he was exhausted and slept the rest of the afternoon and night. He was a little slower in his reactions the next day, and  the day after starting to get back to himself, but since then his changed from a very easy calm child and toddler to a wild constantly fidgeting and moving one. His personality changed.  Around 3 weeks later on April  26, 2018  my 4 year old had severe diarrhea for about 3 days. Friday night to Sunday.  On April 29,  2018 he was watching cartoons and  looked strange to me I went to look closer and he had blue lips, blue hands, arms, and feet. BLUE! I tried arousing him, he was lethargic and not very responsive, his eyes were glossed over and sort of in a stare. I called 911.  The  paramedics came and too noticed something wrong. His oxygen was low and his vitals were off so went to the ER.  (I told them he had a DTap shot about 3-4 weeks ago. But they said he was mildly dehydrated. They couldn't tell me why he had turned blue.  They didn't keep him for a stay or give him an IV, they sent us home in about 3 hours.
Fevers, 101.9, body aches, cough, difficulty breathing.  Still using Tylenol, vicks formula 44,  albuterol, fluticasone propionate nasal spray.
Patient has not had any direct effects from the 3 shot regimen for his COVID-19 vaccination.  He has had a few colds, courtesy of his 3 year old sister.  He has had 3 ear infections; the most recent of which was diagnosed on 3/20/2023.  In each instance of the cold, he did not have trouble breathing or have any extended period of time with a fever.   His colds have taken about 1 week to fully run their course.  Patient has never had to be hospitalized.  Patient started day care on 3/1/2023 going 3 days per week.  I decided to post this after speaking with a person from VSafe who followed up with me on what I had entered for the routine follow up post-vaccination.
pt recv vax 10JJUN96 & 15JUN96 pt exp fifth disease w/rash all over & 2 papules;No further details were provided;
Had a 104 fever, cold sweats, sore throat, and uncontrollable body shaking.
FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 days took tylenol
dizziness; hot and cold; diarrhea; extremely tired; feel somewhat disconnected; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:30(at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient reported allergy to medications and tended to not take any medications; 1 teaspoon of Robitussin and she could sleep for 2 days. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 04:00 the patient experienced that she woke up dizzy and dizziness was extremely bad until 05Apr2021. She was just slightly dizzy at the time of report. The patient experienced hot and cold still, diarrhea lasted 2 days, extremely tired and she still felt somewhat disconnected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events feeling hot and cold, tired and still feel somewhat disconnected was not recovered, the outcome of the event dizziness was recovering and the clinical outcome of the event diarrhea lasted two days and was recovered on an unknown date at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient states she became hot and flushed about 2 minutes after receiving vaccine.  The right side of her tongue became tingly.  The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache.  They had her rest for about 45 minutes and she felt better.  Her blood pressure came down to 130/90 and pulse was 100.  On 01/07/20 she still is experiencing a headache and body aches.  She has never felt short of breath.
The patient developed swelling to the left upper arm after vaccination. The mother used a cool compress and Tylenol as directed.
Daily splotchy rash and/or hives with dermatographism since 11/13/2021, continues to date of this report. The hives appear anywhere on my body, itch badly, cause lines to appear on my skin when itched, and disappear within an hour or two.  Sometimes I get red patches and streaks on my skin too, with or without the hives. The red splotchy patches feel hot but aren?t itchy.
Very fatigued; Severely sick; Slept the day and night; regurgitation; Chills; Fever (101F); Muscle pain; Nausea; Vomiting; Arm was extremely sore; Could not move arm; Lethargic; Didn't want to eat; So dizzy to the point that I couldn't walk because of the dizziness; Diarrhea; Shortness of breath; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain / myalgia, arm was extremely sore / pain in extremity, could not move arm / limb discomfort, lethargic, didn`t want to eat / decreased appetite, so dizzy to the point that i couldn't walk because of the dizziness / dizziness, nausea, vomiting, diarrhea, shortness of breath / dyspnea, chills, fever (101f) / pyrexia, kept on regurgitating, came very close to going to the er, very fatigued, severely sick / illness and slept the day and night / hypersomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient had muscle pain, arm was extremely sore and could not move arm. On 5 Feb 2021, after receiving the second dose, the patient had same muscle pain with extremely sore arm that she could not move the arm. She also felt lethargic, didn`t wanted to eat, was so dizzy to the point that she could not walk because of dizziness, had nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating and came very close to going to the emergency room. On 6 Feb 2021, the patient was very fatigued and severely sick that she slept the day and night.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle pain, arm was extremely sore, could not move arm, lethargic, didn`t want to eat, so dizzy to the point that i couldn't walk because of the dizziness, nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating, came very close to going to the er, very fatigued, severely sick and slept the day and night was unknown.
Patient noticed redness and itchy area yesterday 5/28/21 on left arm. I evaluated the area it was about 2 inches wide and 4-5 inches in length and warm to the touch. She said this didn't happen after the first dose and doesn't remember being bitten by anything or coming into contact with anything that could've caused the reaction. I recommended her to go to urgent care to have it evaluated and told her I would report to VAERS as well.
Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22; Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 065F21A, 047A21A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022 at 11:35 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2022 at 11:35 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 26-JUL-2022 and was first punctured on 27-JUL-2022 at 9:30AM. The vial was in a portable cooler with an ICE Pack with no temperature monitoring device, total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): less than 30 minutes and the vial did not undergo any temperature excursions. The patient had not reported any other adverse reactions or side effects after first, second and first booster dose. No treatment details was reported.
Patient stated he got severe diarhea 2 hrs after getting the vaccine. No immediate medical treatment was provided after observation of 15 minutes. Fact sheet and V-/Safe information  was given to him prior to getting the vaccine. Doing well after couple days.
Started with small red area late afternoon on 3-9-04. Once pt. awoke on 3-10-04 grandma noted redness with swelling from knee up to top of thigh starting to wrap around thigh. No temperature. Painful if touched. No vomiting.
Serious sore throat; Achiness; Runny nose; Felt horrible; Splitting headache; Throbbing neck glands on both sides; Swollen neck glands on both sides; Voice sounding like she has a cold; Unevaluable reaction; Left eye throbbing; A spontaneous report  was received from consumer, concerning herself, a 55-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unevaluable reaction, felt horrible, splitting headache, serious sore throat, left eye throbbing, runny nose, swollen neck glands on both sides, throbbing neck glands on both sides, voice sounding like she has a cold, and achiness.   The patient has a prior history of penicillin allergy.  On 16 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: F038A21A) via unknown route on left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, after receiving the vaccine, the patient felt like she stroke like symptoms such as swollen left side of the face, puffy left side of the face, drooling, could barely move and felt horrible and abnormal. She also had headache, throat pain, left eye pain, runny nose, swollen and painful neck gland.  She rested staying on bed having water and food. The patient returned to work on 18 Mar 2021.   The patient is nervous to take the second dose of vaccine and commented that she will probably not take the second dose in the future.   Action taken with mRNA-1273 in response to events was not provided.  Th events felt horrible, throbbing neck glands on both sides, runny nose, unevaluable reaction, serious sore throat and achiness were considered resolved. The events, splitting headache, swollen neck glands on both sides, voice sounding like she has a cold  and left eye throbbing were considered resolving.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Moderna 8/19/21, 9/15/21. Positive on 8/13/22
difficult in breathing; cough; This is a spontaneous report received from Pfizer. A contactable consumer reported for herself that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccine in Mar2021, the patient experienced a little bit difficult in breathing and little cough. It was unknown if any treatment was received for the reported events. The outcome of the events was unknown.  Information on lot number/batch number has been requested.
Nausea, severe local allergic reaction within hours of vaccination. Rx prednisone, antibiotics, pain relievers
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 13-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Symptoms were fever, splitting headache, shaking, almost passing out, constant aching across the body, hot and cold flashes (possibly due to fever). These all started taking place about 12 hours after the vaccination was administered and lasted for around 5-7 hours, possibly longer, but I managed to fall asleep at one point and felt much better upon waking up around 13 hours later.