chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 7 yr old white male with no known medication allergies who was vaccinated with a dose of varicella virus vaccine live. The RN reported that approx one year after being vaccinated, the pt developed a mild case of chickenpox. Unspecified medical attention was sought, but no treatment or lab/diagnostic testing was required. Subsequently, the pt recovered. The RN also reported that the pt's brother had a negative titer after being vaccinated with varicella virus vaccine live (WAES0406USA02249). Additional information is not expected.
swelling arm,  have cellulitis?; Hotter arm, have cellulitis?; redder arm, have cellulitis?; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the swelling arm, skin warm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, skin warm and erythema of extremities to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had his /her vaccine 5 days ago from reporting and experienced all the common side effects. After a couple days the patient's arm started feeling better but on reporting day the swelling increased, and it was hotter and redder than it was before. The reported wanted to know do he/she had cellulitis. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Developed Ringing in left ear.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 15Mar2021, the patient developed ringing in left ear. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event developed ringing in left ear was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt developed syncope and was non responsive for short time called 911. Paramedics monitored vitals for 30 minutes and patient left with father.
COUGH; RUNNY NOSE; This spontaneous report received from a patient concerned a female . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26. cov2. S(dose number in series 1) (suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination on right arm.It was unknown if the patient had any adverse event with the following covid-19 vaccine ad26.cov2.S. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number:unknown and expiry:unknown) dose was not reported, 1 total, administered on 07-JAN-2022 for prophylactic vaccination on right arm.The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JAN-2022, the patient experienced cough, and runny nose (dose number in series 2). On 11-JAN-2022, Laboratory data included: COVID-19 antigen rapid POC (point of care) test (BinaxNOW) (NR: not provided) negative. On 13-JAN-2022, Laboratory data included: COVID-19 antigen rapid POC (point of care) test (BinaxNOW) (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 11-JAN-2022, and was recovering from cough. This report was non-serious
Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. It was reported that the patient experienced flu like symptom, after receiving Shingrix.
developed fever 102.6F, severe dizziness, nausea, tightness in chest, confusion, increased headache. Large swollen redness at site injection.
I couldn't breath; coughing a lot; I can't do anything; feeling tired with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN for Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (I couldn't breath), COUGH (coughing a lot), IMPAIRED WORK ABILITY (I can't do anything) and FATIGUE (feeling tired with fatigue). At the time of the report, DYSPNOEA (I couldn't breath), COUGH (coughing a lot) and IMPAIRED WORK ABILITY (I can't do anything) outcome was unknown and FATIGUE (feeling tired with fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that the vaccine was administered 3 or 4 months ago. He could not breath and was sitting down for a month. He was coughing a lot. He had been feeling tired for about 4 months already, with fatigue. He cannot do anything. The symptoms started a week after the vaccination was given.   No treatment information was reported.
rash all over the body except her neck and head/Pityriasis Rosea/circular patches on back, buttock, legs, arms, and stomach/still getting little spots that are the same thing; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a female patient (reporter's daughter) A 22-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in arm on 23Jul2021 (at the age of 22-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications had included oral contraceptive birth control since either Sep or Dec2020. On 25Jul2021 the patient had experienced rash all over the body except her neck and head/Pityriasis Rosea/circular patches on back, buttock, legs, arms, and stomach/still getting little spots that are the same thing. It was reported patient is due to receive the second dose on Friday and wanted to know if she can receive the second dose of the vaccine. Reporter got response that if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision and advised caller rash is a side effect related to the vaccine but is considered a non-severe allergic reaction. Reporter reported that her daughter broke out in rash all over the body but was diagnosed with Pityriasis Rosea.  it was reported that patient got the Pfizer vaccine about two and a half weeks ago. She started breaking out in a rash and reported that It looks like ring worm. They thought it was ring worm at first. It is circular patches on back, buttock, legs, arms, and stomach. On 25Jul2021, the patient underwent lab test and procedures which included Biopsy/Pathology test and was diagnosed as Pityriasis Rosea. It is all over. She is still getting little spots that are the same thing. They were not as big and troublesome. The caller was enquiring about what are the chances it would get worse, should she do the second shot or just skip it all together or not. Hopefully she has some immunity. The patient had visited physician office. The clinical outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vomiting with severe pain in joints, especially spine.  Aching especially in joints.  Denies rash.  Attributes vomiting to severe pain rather than immediate effect of vaccines.
Vial was open for more than 12 hours post puncture; Patient was administered booster dose from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. The patient received the booster dose of Moderna COVID-19 Vaccine.  On 12-Apr-2022, the vial was initially stored in the refrigerator.  On 13-Apr-2022 at 8:00 am, the vial was first punctured and was administered on 14-Apr-2022 8:02 am. Post puncture the vial was stored in refrigerator at 4-5 °C. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8  to 25 degree Celsius = 46 to 77 F) was 30 min or less.  No symptoms were experienced by the patient.  No treatment medications were provided.
"COVID 19 arm" I had no side effects and then on the 7th day I woke up in the middle of the morning, my arm itching. It's got a knot and a rash and is a little painful to move. I contacted my doctor and he suggested I ice it and contact him if it lasted longer than a week or worsened
Headache, Myalgia, Fever, Diarrhea, seen in ED 1/25/2021
Excessive urination all day, chills, temp 98.7, 11:30 pm urination, 3AM urination, 5:11AM urination,  fainting, cut head on bathtub, spilled soap and fell an additional 2 times. Pt states she was unaware but was in the bathroom for over 40 minutes. Pt states it was approx. 24 hours after vaccination before she felt better.
This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided.
1605-Pt c/o fast heart rate.  Interpreter immediately with pt and nurse to translate.  Husband brought to pt.  BP-142/90 with heart rate 132.  Chest and face flush.  Received 25 mg benadryl po.  Pt stated she was feeling better.  1610-BP-124/82 with heart rate 117.  1615-Pt started c/o of heart racing again.  Heart rate 130 and pt now c/o sob and headache.  BP-140/84.
Case number PHEH2014US019824, is an initial spontaneous report from a consumer received on 01 Oct 2014. This report refers to a 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on from 28 Sep 2014. On 29 Sep 2014, she experienced life threatening allergy. She stated that her eyes, nose, head, neck and face were affected. She had itching in the face, face was red, eyes began to swell shut and it was hard to breathe. She called 911 and she went to the hospital (emergency room) on 30 Sep 2014. She was in the emergency department from 08:30 to 09:30. About 24 hours before the reaction, she received FLUVIRIN. Treatment was rendered with EPIPEN and in the hospital she was given other drugs (unspecified). She stated that, nobody told her the reaction was related to flu shot but nothing else in her life had changed. She informed that, she was told to carry an EPIPEN with her everywhere now. She did not spend the night in the hospital. The final outcome of the events was unknown. Seriousness was reported as life threatening and causality was not reported. She reported that, she does not have a primary physician. No additional details available.
passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.            Concomitant medicine include Birth control pills.  No treatment information were reported by the reporter.  Company Comment: This spontaneous case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of loss of consciousness. The event occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of loss of consciousness. The event occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Pt called 9/29/18 to report. Pain in arm. Swollen area above collarbone up 3 inches. Not red or hot. Light touch to neck feels like "muscle bruise". Patient called Dr. and Dr. said sounds like hit the lymph node. Pt reported she has never been given a shot so (vaccine administered) high in the shoulder given 1 or 2 inches higher than usual. Dr. said keep eye on it and if no fever then ice it. If fever develops go in to ER or call Dr. back this weekend.
Swelling; Itchiness; Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow), FEELING HOT (Warm to touch) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow) and FEELING HOT (Warm to touch). On 03-Feb-2021, the patient experienced SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness 4 inches/redness was 8x6inches which extended from shoulder towards elbow), FEELING HOT (Warm to touch) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Ice. Concomitant information not provided
tiredness; muscle pains; chills; nausea; diarrhea; headache; felt funny; This is the spontaneous report from a contactable consumer.  A 89-year-old female consumer reported that received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 22Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. She didn't have any effects on Monday, Tuesday, or Wednesday. On Thursday afternoon she felt funny. On Friday she got so sick. She has been sick ever since. She has tiredness, headache, muscle pain, chills, joint pain, diarrhea, and nausea. No fever. She is nauseated but nothing comes up. Seems like she can only keep a piece of bread down.  She is scheduled to get the second one on 15Mar20201 and she is afraid to do it. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Sepsis; A spontaneous report was received from a consumer post , concerning an approximately 55-year-old, male physician who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sepsis, resulting in death.  There was no medical history provided. There were no concomitant medications provided.  On an unknown date (Thursday), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   According to the post,  two days after vaccine administration, the patient died of sepsis on Saturday.    Action taken with mRNA-1273 in response to the event was not applicable.  The event, sepsis, was considered fatal.    The patient's date of death was not provided.  The cause of death was reported as sepsis.; Reporter's Comments: This case concerns a 55-year-old, male subject, who experienced a serious unexpected event of Sepsis. Sepsis occurred after first dose of mRNA-1273 vaccine administration. On an unknown date, two days after vaccine administration, the patient died of sepsis.  Treatment for the event was not provided. The patient's medical history was not provided. The patient is a physician. Concomitant product use was not reported.  Very limited information regarding this event has been provided at this time and no definite diagnosis or autopsy report have been provided. Based on the current available information and temporal association between the use of the product and the start date of the event of Sepsis, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sepsis
Swelling and pain in L axilla with pain radiating to chest. Actual injection site was not swollen or painful.
Local reaction redness swelling 4 cm x 5 cm Left thigh DTAP.
bad reaction; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 80 years old female patient who experienced bad reaction(Unevaluable event), while she received vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history included Hypersensitivity with allergic to egg and latex.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine with unknown lot number not reported in unknown administration site.  The patient developed a non-serious bad reaction (unevaluable event) following the administration of influenza quadrivalent recombinant vaccine.  Information on the batch number was requested .  (Other relevant tests included no lab data.)  Final diagnosis was bad reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for unevaluable event.
N/V/D, MYALGIA, HEADACHE, FEVER Narrative:  TEMPERATURE 102; SYMPTOMS LASTED APPROX  36 HR; EMPLOYEE MISSED 1 DAY OF WORK; PREVIOUS HX COVID-19 ILLNESS 12/2020  Other Relevant History:
This spontaneous report as received from a consumer refers to an unknown number of patients (babies) of unknown ages and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ, (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. The reporter stated that the babies who got the ROTATEQ, could have a life threatening adverse reaction. The outcome of vaccination complication was unknown. This is a linked case with 1506USA002070 from the same reporter. Additional information has been requested.
Rash - pruritic, papulovesicular rash to legs bilaterally.  Given 3.75ml Benadryl po at office.  Prescribed triamcinolone topically and prednisolone.
Skin all the way to the side of right of the injection site, the shoulder is very sore to the touch and some swelling.