chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated heart rate, body aches, joint pain, light headedness. Took Aleve PM. All side effects resolved except for body aches at this time.
This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a elderly male patient who received SHINGRIX. The patient's past medical history included respiratory disorder. Concurrent medical conditions included artificial cardiac pacemaker user (Implanted pacemaker prior to receiving SHINGRIX) and asthma. Concomitant products included ARNUITY ELLIPTA and PRADAXA. In February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced bronchitis. On an unknown date, the outcome of the bronchitis was recovering/resolving. The reporter considered the bronchitis to be unlikely related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient started having some respiratory problems and in March was diagnosed with bronchitis. He asked what the time frame was for receiving the 2nd dose, and if he should go ahead and get it. The patient was provided with the dose and schedule information from the PI and suggested that he spoke with his physician in regards to receiving the 2nd injection. The patient stated that he had respiratory problems which he clarified as being asthma, before receiving SHINGRIX, but he developed bronchitis in March. The patient recently started on ARNUITY but only started six days ago and it was prescribed for his asthma. Patient did not think that there was any causality for him being diagnosed with bronchitis and simply called to find out the dosing schedule for the vaccine. The patient had denied permission to contact their physician.
A volunteer inadvertently administered this vaccine to a 17yo (ineligible for Moderna).
Patient developed focal left sided facial tingling for approx 1.5 hours following vaccine administration. No other associated symptoms. Tingling self resolved.
Soon after vaccination in left deltoid, "the injection site began to swell, was red, hot to touch and painful; swelling went down in 2-3 days. On day 5 after injection, the site began to swell again, was red and hot and itchy.  It all went away on the January 9 - 10th weekend."
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 28-OCT-2013 at 08:45 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed to approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Pt began to feel lightheaded.   Stood up to call nurse then lost consciousness, falling to the ground, scraping his face on the concrete. Pt had facial abrasions.  Was transported to Urgent Care.
Patient experienced a brief episode of syncope. Recovered in a very short period of time (ie: <10 seconds).
overlapping DTaP and IPV doses at his 2 month visit because male patient received both pediarix and pentacel at his 2 month visit; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received overlapping dtap and ipv doses at his 2 month visit because patient received both DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) at his 2 month visit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 13-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5572AB via unknown route in the left thigh.  On 13-Mar-2019, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.   It was case of actual medication error due to Extra dose administered.  It was not reported whether the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
3 skin rashes, baseball size. Treated with BENADRYL, no effect. Lasted 2 weeks-itchy at times. Red rash- 2 patches on legs, 1 patch on back. No exposure to poison ivy.
Information has been received from a registered nurse referring to her daughter, a 12 month old female patient. On 21-MAR-2016, the patient was inadvertently administered her first dose of VARIVAX (Merck) and PROQUAD (Merck) concomitantly in the same (left) leg (route, dose, lot# and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357:  US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1709USA011980: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Received vaccine 9/17/18 at 1055. Noticed rash starting under (L) arm that evening. Rash also appeared on chest and then right clavicle area. C/o itching.
Left armpit swollen and hard around lymph node developed approximately 21 hrs after vaccine administration. Hurts with movement and no movement. Took 1000mg of Tylenol at onset of symptoms and 400 mg of ibuprofen 3 hours later with no symptomatic improvement.  Around the same time, severe left ear pain that is sharp and stapping developed
weakness in the legs; This is a spontaneous report from a contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 06Apr2021 (Batch/Lot Number: ER8734) as 1st dose, single (at the age of 63 years old) for COVID-19 immunisation.  Medical history included ongoing high blood pressure diagnosed 4 to 5 years ago, ongoing diabetes diagnosed 10 years ago and ongoing bone cancer diagnosed about 2 years ago.  The patient's concomitant medications were not reported.  The patient experienced was in and out for different things. He was hospitalized for weakness in the legs on 28Apr2021. Patient was supposed to get second COVID19 vaccine on 28Apr2021 but was hospitalized for unrelated issues. The patient wants to know where to get second dose. The outcome of the event was unknown.
Vaccine was placed in freezer on 12/6 and was not removed until 1/3/22.
Patient reported erythema and itching at the injection site, several days after vaccination. Patient did not take any medications or seek medical care. Symptoms subsided within 24 hours on its own.
Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long; Rash; swelling in lymph nodes on side where the injection was; tired; 102.5 fever; mild shortness of breathe which elevating her head with pillows helped; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was) and FATIGUE (tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006-T21A and 038-A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE for Thyroid disorder.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever). On 07-May-2021, the patient experienced RASH (Rash). On 08-May-2021, the patient experienced CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 102.5 (abnormal) 102.5 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114421 (Patient Link).
Pt recvd DTP/OPV/HIB on 26MAY & had fever that evening a sleepless noc & 4 hrs episode of unconsolable high pitched screaming the next morning; fever resolved 29MAY;
Recipient of vaccine complained of itching/hives from her nect to her feet about 8 hrs post immunization initially just itching, progressing to hives over several days was treated in ER 10/27/06 with "steroid shot". Patient recovered well.
vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022; Patient Administered Expired Doses; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 006D21A and 939906) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prozac).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022). At the time of the report, PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patent's date of birth was reported as 3/85/1999. No concomitant medication information was provided.  The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial, they had not noticed it had already expired. The vaccine was stored in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials are 26 doses No treatment medication information was given.
I received the vaccine shot on 12/23/20 at 3 pm.  By 12/24/20, I had pain in my left arm that radiated to my neck and back on the left side.  Over the past 4/5 days, I continue to have pain in my left arm, back and neck
started getting sick; Throwing up; heart rate is up; Slight fever; diarrhea; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Jan2021 as single dose for COVID -19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient started getting sick, and was throwing up, heart rate is up, slight fever, diarrhea, all on an unspecified date.  The patient underwent lab tests and procedures which included heart rate up like 135 on an unspecified date.  The outcome of  events was unknown.
I had a headache day two that lasted the entire day with a maximum amount of ibuprofen taken.  Headache subsided on day three.  Joint pain started on day 3 with the worst pain occurring  in my left hip.  My feet have felt heavy since then.  I have stumbled a few times which is not normal for me.  The heaviness feel seems to be improving  everyday.
fever over 104 ax (est 105+) 4-6 hrs p/vax;
Mom called me on 9/4/03. Stated pt received her shots on 9/2/03. She now has a "hard spot that is red, hot and itchy" to her upper right arm where the vaccine was given. I encouraged Mom to continue to monitor, if no improvement or worsens to contact MD.
Patient given incorrect does 0.25ml rather than 0.5ml.  The vial of vaccine used was NDC :80777027505.
COVID arm - rash/swelling/itching  for about  1 week; started about 1 week after injection
11 y/o F was administered  30mcg of Pfizer vaccine. Parents were notified. Parents report no adverse reaction.
Intense headache, severe abdominal pain, pain at injection site that radiated up into left clavicle and left jaw/ear, fever over 101, intense chills/shaking, heart rate over 100,  total body achiness, lethargy.  Each day since injection symptoms have decreased, however remain present today 4/4/2021.
Vaccination was Friday morning. Woke up Saturday with chills, nausea, vomiting, fever of 102.1, and fatigue, along with sore arm. Sunday morning, all had resolved except sore arm and fatigue. Sunday evening, I was laying in bed and found everytime I took a deep breath- even a shallow one- I had shooting  debilitating and sharp pain in my lung . It was absolutely terrible and I have never experienced this prior or since.  The episode lasted about an hour, and then resolved. Visited my doctor and she said it was likely due to the vaccine.
nausea, emesis, acute dehydration, acute renal failure, hospital-acquired pneumonia
Her symptoms included burning head pain, brain pain, burning feet pain, dizziness to the point of not being able to stand up, fever, all over low energy, severe nausea without vomiting, overall feeling of malaise, diarrhea, joint pains, muscle pains, stuffy nose, bloody nose, increased bruising easily.  continuous now to have symptoms relating to her vaccine injury to any one of the above listed vaccines administered on the day in June.
103.6 temp for 48 hours after shot. Severe  body aches, chills, headache, nausea, vomiting
On 12/18/01 at 16:30, the pt presented with sudden onset of lethargy and weakness. His temperature was 100.7F; he was fine until about 15:00. The pt was transferred via EMS to another facility. Dx: Tuberous Sclerosis.
has basic chills and possible fever and tiredness that she has with all of the other three covid vaccines but she said two days later she developed and  rash and itching all over her body except her legs only she didn't have rash at all. She went to an urgent care and they gave her prednisone, zyrtec and Z-pak. She said she never had any SOB or any other symptoms. Just noticed a knot on her arm when she first got the vaccine. She said she will be getting a booster if CDC  encourages and rather have a reaction than getting covid.
This spontaneous report as received from a registered nurse refers 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 provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M047666 with expiration date 24-OCT-2019 and lot # N000238 with expiration date 25-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA008700: US-009507513-1707USA008699: US-009507513-1707USA008701:
Patient was given Yellow Fever vaccine. Ten minutes later, he began to have generalized itching, red eyes, and eventually hives and wheezing. He was then given IM epinephrine twice, oral BENADRYL, oral prednisone 20mg, and 2 puffs of albuterol inhaler. He was observed in office for 90 mins before discharge and given Rx for prednisolone to continue at home.
Went into SVT with chest pain the next day after receiving second vaccine. The patient was cleaning her bedroom.
Intense chills for 24 solid hours; Fever; Muscle and joint pain; Joint pain; Extreme fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 02:00, the patient experienced intense chills for 24 solid hours, fever, muscle and joint pain, extreme fatigue, brain fog continuing for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event Intense chills for 24 solid hours was resolved with lasting effects on 01Apr2021 at 02:00. The clinical outcome of fever, muscle and joint pain, extreme fatigue was resolved with lasting effects on an unknown date in 2021, whereas brain fog was resolved with lasting effects on 05Apr2021 for about 5 days. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
coughing; fever of 99.1; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 immunization.  The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever of 99.1"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356566 same reporter/drug, different patient/AE.;
Parent lied about age when given first dose COVID-19 vaccination. Staff discovered when entering into system and saw the match.
flu; Initial information received on 26-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Social Media.  This case involves patient of unknown age and gender who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient experienced flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was 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.