chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126900 and US2022126898, reported by same reporter.; Sender's Comments:  US-GSK-US2022126898:Same reporter US-GSK-US2022126900:Same reporter
Patient felt dizzy and wanted to sit down. When reaching for the chair, he passed out and fell to the floor. The patient was made as comfortable as possible. The patient kept hydrated with water and given ice for his forehead.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Cardinal refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State of Colorado for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Headache and dizziness  Diarrhea  Nauseated  Pain in arm and numbness from shoulder to elbow Fatigue
sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient compares her pain with that of her other flu shots. Concomitant medication was not provided by the reporter.  The treatment information was unknown.   This case was linked to MODERNATX, INC.-MOD-2021-026635 (E2B Linked Report). This case was linked to MOD-2021-026132 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-026635:Family member case
Medical Information Potential AE; Pain and swelling in her breast; Pain and swelling in her breast; Stated that her right nipple was uncomfortable; Stated that her right nipple was swollen; It feels like a lymph node; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 65-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced medical information potential AE on an unspecified date. The patient reported that she developed pain and swelling in her breast that has been ongoing for 3 days. She stated that she knew there are lymph nodes in the area but wanted to know if this was normal and how to treat the same. Caller also stated that a couple of days ago her right nipple was uncomfortable and was now swollen. Stated that it felt like a lymph node. She wanted to know if possible if it could be a lymph node. Seriousness of the events was reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Bruising around her injection site right arm; Feels hot and cold; Dizziness; Trouble walking because of dizziness; Feel unwell; Redness qround injection site; Tiredness; Occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness) and MALAISE (Feel unwell) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches). At the time of the report, VACCINATION SITE BRUISING (Bruising around her injection site right arm), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), DIZZINESS (Dizziness), GAIT DISTURBANCE (Trouble walking because of dizziness), MALAISE (Feel unwell), INJECTION SITE ERYTHEMA (Redness qround injection site), FATIGUE (Tiredness) and HEADACHE (Occasional headaches) had resolved.            No concomitant and treatment medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-138787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added reporter information.
Swollen lymph node; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 22Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 13May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and allergy induced asthma. The patient had no known allergies. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D) 50,000u 1x per week , 25xannax (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. 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 22Apr2021 at 00:00, 4 days after first dose, the patient had notice one swollen lymph node on the right side of her neck. It was still swollen for second dose. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills; mild nausea; lethargy; mild headache; difficulty sleeping; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection,Lot number and Expiry date:Unknown), dose 2 via an unspecified route of administration, administered in arm left on 31May2021 13:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization, (age at the time of vaccination was 37 years).Historical vaccination included, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 13:00 as 1st DOSE, SINGLE DOSE for COVID-19 immunization. No allergies were reported. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 31May2021 11:00, the patient experienced chills, mild nausea, lethargy, mild headache, difficulty sleeping. The events were assessed as non-serious. Outcome of the events were recovering at this point of time. Information on lot/Batch number has been requested.
This solicited report was received from a physician regarding a 60 year old male patient who was a part of a market research program. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2016, the subject received ZOSTAVAX (1 dose, injection, once) for Herpes zoster. It was reported that on an unspecified date in 2016, the patient came down with a 'self contained' injection site reaction and shingles. The outcome of the events was reported as recovered with sequelae 3 days after event onset (2016). The causal relationship between the events and ZOSTAVAX was unknown. Additional information is not expected due to lack of consent.
The day after my Second Covid vaccination 6/13/21, I noticed a stinging, burning sensation in my left arm from injection site down to my elbow. I figured it would go away after a few weeks, but it has persisted, and has even gotten a little worse as of today?s date 7/03/21 I have not been to the Doctor yet, but plan to to see if there is anything they can do.
Experienced chest pain  (sternum area) and elevated heart beat two days after second dose was administered.  By evening pain had intensified. Could not get through to primary provider so taken to hospital emergency room where he stayed for a total of 4.5 hours.  Tests included electrocardiogram, chest xray, and bloodwork; results all clear.  Staff administered tylenol.  Chest pain went away and has not returned.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 20 year old female patient with no drug reactions or allergies and with no medical history. On 01-FEB-2010 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot number was not reported). On 22-MAY-2013 the patient was vaccinated with the second dose of GARDASIL lot # H011350, esp. date February 2015, 0.5 ml, intramuscular. Concomitant therapies included albuterol. The patient became pregnant with Last Menstrual Period (LMP) in an approximately January 2013. After receiving her second dose of GARDASIL (on 22-MAY-2013), the patient reported to the nurse, that she was "14-16 weeks pregnant". On 22-MAY-2013 the patient had Purified Protein Derivative (PPD) test with positive result. There was no treatment given for the patient's events. The patient sought medical attention: saw the nurse. At the time of the report the patient outcome was not reported. The relatedness between PPD test positive and GARDASIL was not reported. Additional information has been requested.
Fever; Chills; headache; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (myalgia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  reported include ibuprofen and blood pressure medication.  Treatment medication include ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Bilateral lower extremity petechiae, initially on LLE (resolved in 48 hours) then developed petechiae on RLE (present x 24 hours when evaluated 8/5/13 in office), no bleeding/bruising, infant well other than thrush, no thigh mass/swelling.
Positive Covid Test; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid Test) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RAMIPRIL (ALTACE), ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM (CRESTOR), ZOLPIDEM TARTRATE (AMBIEN CR), PARACETAMOL (TYLENOL 8 HOUR), IBUPROFEN, ASCORBIC ACID (VITAMIN C ACID), BIOTIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid Test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid Test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: (Positive) Positive Covid Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; Pfizer Dose 5 14Sep2022, Moderna Dose 4 18Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (bootser), single (Lot number: GH9702) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2021 as dose 1, single (Lot number: 002C21A), in left arm, on 17May2021 as dose 2, single (Lot number: 034C21A), on 24Nov2021 as dose 3 (booster) single (Lot number: O31H21A) and on 18Apr2022 as dose 4 (booster), single (Lot number: 056A22A) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway" (unspecified if ongoing); "known allergies: many foods, but not life-threatening" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022, outcome "unknown", described as "Pfizer Dose 5 14Sep2022, Moderna Dose 4 18Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient. Vaccine received was reported as yes. Other medication in 2weeks was reported as no. Patient received Paxlovid treatment from 10Jan2023 to 15Jan2023 for Covid-19.
dizziness  BP 156/84    146/90/60 P: 62 o2 99%   #21 sent home
Two days after I received the shot I felt numbness in my cheeks and tingling and numbness in my arms.  It came and went but by Tuesday (four days after the vaccine) it had gotten worse to the point where I needed to lie down suddenly.  I saw the doctor that day and by the end of the week it had improved, but I got another flare up (less severe) of tingling and numbness in my face, arms and legs about 10 days after the vaccine.
Lightheaded, dizzy, fainted, possible seizure. Paramedic arrived and checked blood pressure and sugar. Blood pressure dropped when patient stood up and patient became dizzy again. Patient was taken to emergency room.
Slight rash; itchiness at site of injection; Dose number 5; Dose number 5; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 11Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: NORTRIPTYLINE. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 11Sep2022 at 11:00, outcome "unknown" and all described as "Dose number 5"; RASH (non-serious) with onset 15Sep2022 at 23:00, outcome "recovered" (Sep2022), described as "Slight rash"; VACCINATION SITE PRURITUS (non-serious) with onset 15Sep2022 at 23:00, outcome "recovered" (Sep2022), described as "itchiness at site of injection". Therapeutic measures were not taken as a result of rash, vaccination site pruritus. Additional information: No known allergies. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine received in four weeks of vaccination. Patient experienced slight rash, itchiness at site of injection. Area was about 3-4-inch diameter. Lasted no longer than 6 hours and then disappeared. Reporter's seriousness criteria was non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient called me on the morning of 12/4/14 with complaints of hives, swelling and visible edema. Told to go to urgent care and went that afternoon. Called me again on 12/9/14 and told me that the symptoms have resolved.
Bexsero was administered to a 69 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 20-JUL-2023, the patient received Bexsero. On 20-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero was administered to a 69 year old patient). The outcome of the inappropriate age at vaccine administration was 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: 24-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Case number PHEH2015US011125, is an initial spontaneous report received from a physician on 08 Jun 2015. This report refers to a 73 year old female patient. Historical condition was not reported. Concurrent condition included a bat bite. She received the second dose of RABAVERT (batch number: not reported) for post-exposure on 02 Jun 2015 at 11:00 AM. After the shot, she took some rest and then went to work. On the same day, around 9:00 PM, she developed a body temperature of 100.2 degree Fahrenheit. She also experienced body ache and sleepiness. The next morning she felt fine after treatment with TYLENOL. She was not hospitalized. Final outcome, seriousness and causality of the events were not reported.
PATIENT TOOK HER FIRST VACCINE  AT  THE CLINIC ON 03/11/2021 AND CAME  EARLY ON  03/29/2021 WHICH 18 DAYS LATER TO   RECEIVE  THE SECOND SHOT AND FIND OUT WHEN I WAS FILLING  OUT HER VACCINATION CARD
Give Meningoccal immunization on 09/17/2019. Immunization was not due until 11/12/2019 which is slightly under 2 months from now.  Last Dose 06/25/2015 - No adverse reactions
Had stuffy nose,; sore throat minor aches.; sore throat minor aches; Rapid Test 24Aug21 positive.; Rapid Test 24Aug21 positive.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient did rapid test 24Aug21 result was positive and on an unspecified date the patient had stuffy nose, sore throat and minor aches. It was reported that event took place after use of products. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 24Aug2021. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.