chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty of breathing; Chest pain; sore in the arm; Headache; Chills; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty of breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued). On 05-Sep-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and CHEST PAIN (Chest pain). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty of breathing) had not resolved and CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 06-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  Patient did lab tests on the heart, lungs, took blood pressure, took blood, and everything was normal.  Additional information about patient's past COVID-19 infection include that she did not have any fever but a light headache for only one day. Patient did not  feel difficulty of breathing, just a little chill, lost smell and ached for 1 day. Patient just stayed at home for 14 days.   Patient doesn't have a history of heart problems, myocarditis/pericarditis.
Red swollen (L) arm 5cm x 5cm. Red swollen (R) arm 3cm x 3cm.
still not feeling well; chills in the hands; low grade fever; general tiredness/after sleeping all night he still wakes up feeling tired; muscle aches in the legs; he nevere takes naps but has had to take anaps; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 45-Years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was still not feeling well, experienced chills in the hands, low grade fever, general tiredness and muscle aches in the legs. He stated he never took naps but has had to take a naps, and after sleeping all night he still woke up feeling tired. He had two Covid tests, and both were negative. At the time of this report outcome of still not feeling well was not recovered and other events was captured as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Generalized rash 30 min post injection followed by mild throat swelling. Rash and swelling lasted 2 hours then spontaneously resolved.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Date of refrigeration of vaccine was 07-May-2021.   This case was linked to MOD-2021-363789 (Patient Link).
Swelling and tenderness at vaccine site; Swelling and tenderness at vaccine site; This is a spontaneous report from a contactable non-healthcare professional reported for herself that. This 33-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247) via an unspecified route of administration at left arm on 22Jan2021 02:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism and seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), BUSPIRONE HYDROCHLORIDE (BUSPAR), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced swelling and tenderness at vaccine site on 23Jan2021 06:00 AM. No treatment was received for the adverse events.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. Seriousness criteria was reported as non-serious.
Within few days of first vaccine I noted a tremor in left hand then dystonia began to show its ugly side.
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 30th September 2021) for prophylaxis.   On 15th July 2022, the patient received the 2nd dose of Shingrix. On 15th July 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 18-Jul-2022 Reporters comment: The reporter was a healthcare professional from doctor's office. The reporter reported that the patient received by error a Shingrix expired dose. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix vaccine, which was already expired, which led to expired vaccine used. This case was linked with case US2022104395, reported by the same reporter.; Sender's Comments:  US-GSK-US2022104395:Same reporter
received a pediatric dose of Engerix-B; received a pediatric dose of Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B) (batch number DD7k7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Aug-2022 Reporter's comment: The pharmacist reported that an adult patient inadvertently received a pediatric dose of Engerix-B on 18th August 2022, during post-exposure vaccination.  The healthcare professional said that follow-up via phone call would be okay.  The reporter left follow-up section black due to standard follow-up methods being postal and email. The consent to follow-up was granted. Additional Supportive Information: An adult patient inadvertently received pediatric dose instead of an adult one, which led to accidental underdose and adult use of a child product.
This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L013068; expiry: 14-APR-2017) (dose and route unspecified). No medical history, concurrent conditions or concomitant therapies were reported. Healthcare worker states that these unspecified vaccinations occurred between 30-DEC-2015 and 03-FEB-2016. Temperature: -11.8C. Time frame: 1903 minutes (or 31 hours, 43 minutes). There was previous temperature excursion and the time frame was cumulative score since 30-DEC-2015. The call was because of a data logger. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from office manager and refers to unspecified patients of unknown demographics. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were not provided. It was reported that, on an unknown dates, an unspecified amount of patients were administered improperly stored VARIVAX (lot#N000683, expiration 06-JAN-2019; lot N007930, expiration 08-MAR-2019) reconstituted with properly stored STERILE WATER DILUENT (unknown lot, unknown expiration). Concomitant medication included sterile diluent. Administered vaccine experienced the temperature excursion of 9°C to 8°C for 1 Hour; -14°C to -10°C for 1 Hour 30 Minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of incorrect product storage and no adverse event were unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA003049.
Low grade fever; Aching back; Aching legs; Headache; Fatigue; General feeling of being out of it; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 03May2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Concomitant medications included metoprolol (METOPROLOL 25 ER) and had received it within 2 weeks of vaccination for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 12Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On 03May2021 at 22:00, (at 48 hours after second shot) the patient was still experiencing low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it". The patient's side effects began about 12 to 14 hours after shot was administered. The clinical outcome of the events low grade fever, aching back and legs, headache, fatigue, and a general feeling of being "out of it" were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Penicillin allergy added as medical history in tab and narrative.
A serious spontaneous report of seizure has been received from a consumer concerning a 11-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 20-Oct-2010, patient received FLUMIST. The patient received FLUMIST at her school. On 25-Oct-2010, patient experienced a seizure at 6:30 AM. It lasted for 15 seconds with no breathing for a minute. The patient went to ER. The patient had a CT scan with results not reported. On 04-Nov-2010, patient was scheduled with neurologist. The outcome of the event seizure was unknown.
CLL; 2nd dose: 18Mar2022, 3rd dose: 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Depression" (ongoing); "Weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: QUETIAPINE oral taken for depression (ongoing); VENLAFAXINE oral taken for depression (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 24Nov2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Route of administration: Intramuscular), administration date: 18Mar2022, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Apr2022, described as "2nd dose: 18Mar2022, 3rd dose: 08Apr2022"; CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Jul2022, described as "CLL". Therapeutic measures were taken as a result of chronic lymphocytic leukaemia which included intravenous Obinutuzumab from 08Sep2022 to 09Feb2023 and oral Venetoclax from 29Sep2022 and ongoing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (04May2023): This is a spontaneous follow-up report received from a contactable Other HCP reported in response to the HCP letter sent via follow up letter. Updated information: case was upgraded to serious (medically significant), suspect drug coding, reaction data (description of event Inappropriate schedule of product administration and new event of CLL), and further clinical details  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 provided, a causal relationship between suspect drug BNT162B2 and event chronic lymphocytic leukemia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300059072 same patient, different vaccine dose/event;US-PFIZER INC-202300079837 same patient, different vaccine dose/event;
This spontaneous report as received from a medical assistant refers to a currently 15 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) dose, route, lot# and expiration date were not provided. On an unknown date (it was supported as 'as the patient was little') the patient experienced unspecified reaction post receipt of VARIVAX (Merck). The outcome of the event was not provided. Relatedness between the event and VARIVAX (Merck) was not reported. This case is linked to 1412USA002018 (same patient link). Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter reported that nasty poison's flu shot killed the patient last January. Reported Cause(s) of Death: Unknown cause of death.
On day 6 after the second shot , the right side of head (face and scalp) became uncontrollably itchy and burning.  Only the right side of my face including right ride of the nose and chin and right eye, cheek and ear.
Headache, Myalgia, Fever, injection site pain Narrative:  Employee reported fever 99 degrees 12/23/20 and 1/13/21.  Mild headache 1/13/21. Injection site pain. Did not seek medical attention for symptoms.  Other Relevant History:
Within 24-36 hours after Hep B vaccine, hoarsness, scratchy throat, congestion, cough, lymph nodes swollen, fever. Happened with both shots 03/16/2005 and 04/19/2005.
This spontaneous report as received from a healthcare professional, concerning to a 20 month old male patient. The patient had no known pertinent medical history, drug reactions/allergies. On 30-MAR-2013, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, Lot # H018423 (expiry date on 08-OCT-2014). Other suspect therapies included MMR II (received in separate sites) (Lot # and expiration date were not reported). Concomitant therapies included PREVNAR. It was reported that the patient developed shingles following vaccination with VARIVAX (Merck). The reporter stated that the patient was brought to the office at the time of reporting, with a case of shingles described as patches of a vesicular rash on the right posterior buttock extending to the right posterior thigh that was painful to the touch. The healthcare worker reported that the shingles rash started about a week ago (approximately on 26-NOV-2013) and that the shingles rash was reported to have gotten worse (unspecified what worse described) over the last couple of days. The patient was treated with acyclovir cream for the event. The patient had not recovered at the time of the report, and the relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Patient experienced dizziness and felt as though she was going to faint. Numbness in arm injection was given in left. Difficulty breathing when trying to speak, very pale. 911 called - patient started to recover on her own. 911 assessed and patient was able to go home with family. Asked by 911 to follow up with primary physician.
8 days after first vaccination developed a red rash around the injection site and severely swollen lymph nodes in the right axillary area and collarbone area. Rash increased in size over 1-2 days and I experiences pain in the lymph nodes. Sought urgent care treatment on 1/1 (one day after rash appearing) and was told to monitor. Rash and swollen nodes persisted and I was seen again at urgent care on 1/4 and was started on antibiotics x7 days for possible infection.
Completed COVID vaccine series May 2021. Patient COVID positive lab result October 15, 2021.
Hot/cold feeling; Sweating; Flu like symptoms; Chills; Fever; bad headache; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired). On 11-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired) had resolved.            No concomitant product reported by reporter. No treatment medication reported by reporter. Side effects lasted for about 24 hours. No side effects are present at the time of the call.
02/07/22 presents to EC ED for "Covid virus infection, hypoxia". PMHx of "emphysema, CVA, HLP, Takotsubo cardiomyopathy, GERD, Gastric ulcer"
I have guttate psoriasis.  It usually is about 3 - 5 spots on either of my legs.  I had 3 spots on right leg prior to getting Pfizer Booster.  Two days after getting the booster I broke out on both my legs and both my arms with too many to count.  Several came to a head while others are still there under my skin.  I did take photos of my arms.  As of today 12/2/21 I still have several open on my legs and others are visible under the skin on my arms. I had no reaction to first and second shots.
HA, runny nose, sore throat, muscle ached, welts at injection site.
MD, who is father of pt, reported that she had fever up to 102F on 12/14/02 and 12/15/02 and a rash on her entire body, resembling measles. She does no have a fever today, 12/16/02, but the rash is continuing.
I filled out Barr?s form immediately after the shot a minute later I became super dizzy.  The nurse told me they needed to watch me longer and gave me water and an orange. The orange tasted horribly. After about an hour they said I could go home. After I got home I have had cold chills all night. Slept a lot left arm is painful and looks like I have a slight rash on it tried to update initial health report but could not
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received FLUARIX QUADRIVALENT. On 28th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 28th September 2016, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved. The reporter considered the anaphylaxis to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient required an emergency visit for anaphylaxis. The healthcare professional did not have product information or date of birth of the patient.
Erythematous and edematous at R upper arm. Benadryl, ice
Pt became very pale and felt faint immediately following the vax. Approximately 5 minutes later she passed out, had a brief convulsion and regained consciousness within minutes.
As soon as vaccine given, it felt like my arm was on fire. Did not report it because no other s/s until 1/28 in the AM, fever 102.1, shaking chills, migraine, vomiting, skin pain , sever arm pain. Unable to keep fluids down. In bed for 2 days. Missed 2 days of work.