chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, PPV, TDAP
Symptoms: Ageusia, Anosmia, Headache, Pyrexia, Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli; Anosmia; Ageusia; Pyrexia; Headache; This spontaneous report was received from a Consumer and refers to a 65-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included  hypertension,  renal disorder,  bladder disorder, and blood cholesterol increased. Concomitant medications included atenolol, furosemide, phenobarbital, amitriptyline, and trifluoperazine (TRIFLUOPERAZINE).   On 06-NOV-2023, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered intramuscularly in the left arm  as prophylaxis (lot #X014729 has been verified to be valid; expiration date not reported but upon internal validation established as 22-NOV-2024) (strength was not provided); covid-19 vaccine (COVID-19 VACCINE) injection, 0.5 milliliter, lot #5433MF001, administered intramuscularly in the left arm for covid-19 immunisation (strength, and expiry date were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), lot #25A2F, administered intramuscularly in the right arm  for an unknown indication (strength, dose, formulation, and expiry date were not provided).  On the same date, after the vaccination, the patient was unresponsive to stimuli, the patient received emergency services due to the event. Additionally, on an unknown date in November 2023, the patient experienced Anosmia, Ageusia, Pyrexia, and Headache. On an unknown date, the patient recovered from  the all the events.   The causal relationship between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event Unresponsive to stimuli was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported; Caller reported expired VAQTA was administered.; This spontaneous report has been received from a nurse, regarding a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 22-JAN-2024, the patient as vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a dose of 1 milliliter intramuscularly as prophylaxis (lot number: W028824, which was determined to be valid as syringe formulation, with an expiration date on 07-JAN-2024) (strength, scheme, anatomical location of administration) (Expired product administered).  No additional adverse event was reported.   No further information was provided.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Infection, Injection site mass, Staphylococcus test
Clinical narrative: After administration, the patient developed a bump at injection site; child picked at the bump and developed an infection; This spontaneous report as received from a health care professional (HCP) via a company representative and refers to a 14 year old male patient.   No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided.  In July 2023 the patient was vaccinated with 3rd dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  for prophylaxis (dosage, route, anatomical location, lot number and expiration date were not reported).         On an unknown date, the patient developed a bump at injection site (vaccination site mass).  Reporter stated the child picked at the bump and developed an infection (infection). The patient sought medical attention and an abscission was performed and child was given antibiotics as treatment. Reporter stated the child came past week and a test was done to see if it was Methicillin-resistant Staphylococcus aureus (MRSA) infection, however the results were pending.   The causality assessment between the adverse events and the suspect vaccine was not provided, however the HCP stated the infection was most likely developed due to picking at the bump.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Administered a Dose Of HEPLISAV-B To a Pregnant Woman; Initial report received on 29-Nov-2023  A registered nurse reported to the HEPLISAV-B Pregnancy Registry that a 24-year-old pregnant female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history and concomitant medications at the time of vaccination were reported. Allergies were unknown.  The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported. Gestational age was unknown.  On 18-Oct-2023, the pregnant patient received the first dose of HEPLISAV-B (Lot # 943187, expiration date 30-Nov-2025, and NDC # 43528-003-01) intramuscularly in the left deltoid. No side effects were reported.  Additional information was not provided.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Scratch
Clinical narrative: causing a scrach in patient; This non-serious case was reported by a other health professional and described the occurrence of scratch in a 3-day-old female patient who received Hepatitis B vaccine (batch number H3924, expiry date 04-DEC-2025) for prophylaxis. This case was associated with a product complaint.   On 14-JAN-2024, the patient received Hepatitis B vaccine (intramuscular). On 14-JAN-2024, less than a day after receiving Hepatitis B vaccine, the patient experienced scratch (Verbatim: causing a scrach in patient). On 14-JAN-2024, the outcome of the scratch was resolved.   It was unknown if the reporter considered the scratch to be related to Hepatitis B vaccine and hepatitis B vaccine pre-filled syringe device.  It was unknown if the company considered the scratch to be related to Hepatitis B vaccine and hepatitis B vaccine pre-filled syringe device.   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: 17-JAN-2024 The reporter stated that a plastic piece on syringe barrel came off during administration causing a scratch in patient. The patient was not treated. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: shaken forcefully/ Shingrix was shaken with force after reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a adult male patient who received Herpes zoster (Shingrix) (batch number JN242, expiry date 27-SEP-2025) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate reconstitution technique (Verbatim: shaken forcefully/ Shingrix was shaken with force after reconstitution). The outcome of the inappropriate reconstitution technique was unknown.   Additional Information: GSK Receipt date: 17-JAN-2024 The HCP (health care professional) reported that the Shingrix was shaken with force after reconstitution and was administered to the patient, which led to an inappropriate reconstitution technique. The HCP would like information on how to proceed and if patient needs to be revaccinated.  No PQC (product quality complaint) and no reactions were reported. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient accidentally received Bexsero (1st dose) and was given a 2nd dose of Menveo on the same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number M23G5, expiry date 30-NOV-2024) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 19th October 2021). Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 15-JAN-2024, the patient received the 2nd dose of Menveo. On 15-JAN-2024, an unknown time after receiving Menveo and an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: patient accidentally received Bexsero (1st dose) and was given a 2nd dose of Menveo on the same day). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 17-JAN-2024 A nurse reported that a patient accidentally received Bexsero (1st dose) and was given a 2nd dose of Menveo on the same day. The health care professional (HCP) consented to follow-up via email. The patient received 2nd dose of Menveo, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: she is still experiencing pain at injection site in her left arm; Describes the pain as a dull pain that prevents her from sleeping on her left side; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: she is still experiencing pain at injection site in her left arm) and pain dull (Verbatim: Describes the pain as a dull pain that prevents her from sleeping on her left side). The outcome of the injection site pain and pain dull were not resolved.   It was unknown if the reporter considered the injection site pain and pain dull to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain dull to be related to Shingrix.   Additional Information: GSK receipt date: 17-JAN-2024 The patient self reported this case for herself. The patient had her 1st dose of shingrix administered on October 2023. At the time of reporting the patient was still experiencing pain at injection site in her left arm. The patient described the pain as dull pain that prevents her from sleeping on her left side. The patient stated that the needle possibly hit a tendon in her left arm. The patient reported this to her chiropractor and upon exam the chiropractor stated placement of vaccine in left arm was administered correctly. No further information was known. The reporter did not consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bacterial infection, Imaging procedure abnormal, Laboratory test abnormal, Myalgia
Clinical narrative: bacteria in system - diagnosis; Swollen right side of face; Joint pain; muscle pain; vomiting; nausea; Pituitary gland "blown up"; UTI; This non-serious case was reported by a consumer via call center representative and described the occurrence of bacterial infection in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   In NOV-2023, the patient received Arexvy. On an unknown date, 5 hrs after receiving Arexvy, the patient experienced bacterial infection (Verbatim: bacteria in system - diagnosis), facial swelling (Verbatim: Swollen right side of face), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: muscle pain), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea), pituitary enlargement (Verbatim: Pituitary gland "blown up") and urinary tract infection (Verbatim: UTI). The outcome of the bacterial infection, facial swelling, pituitary enlargement and urinary tract infection were unknown and the outcome of the joint pain, muscle pain, vomiting and nausea were resolved.   It was unknown if the reporter considered the bacterial infection, facial swelling, joint pain, muscle pain, vomiting, nausea, pituitary enlargement and urinary tract infection to be related to Arexvy.     It was unknown if the company considered the bacterial infection, facial swelling, joint pain, muscle pain, vomiting, nausea, pituitary enlargement and urinary tract infection to be related to Arexvy.   Additional Information: GSK Receipt Date:17-JAN-2024 The patient received an Arexvy vaccine around holiday, 2023 (late November, 2023).  The patient reported that 5 hours later she was in the Emergency Department with nausea, vomiting, muscle and joint pain. A couple of hours later the right side of her face was swollen and imaging showed her pituitary gland was blown up. Lab reports showed bacteria in her system and she was diagnosed with a Urinary Tract Infection. The reporter did not consent to follow-up. Suspect start date was near the end of November, 2023. It was difficult to get information from this reporter. The reporter stated that she would ask doctor for permission for Glaxo smith Kline to contact them.  The reporter noted the case number and would call back with that information.
Sex: F
Vaccine: RSV
Symptoms: Nausea, Pituitary enlargement, Swelling face, Urinary tract infection, Vomiting
Clinical narrative: bacteria in system - diagnosis; Swollen right side of face; Joint pain; muscle pain; vomiting; nausea; Pituitary gland "blown up"; UTI; This non-serious case was reported by a consumer via call center representative and described the occurrence of bacterial infection in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   In NOV-2023, the patient received Arexvy. On an unknown date, 5 hrs after receiving Arexvy, the patient experienced bacterial infection (Verbatim: bacteria in system - diagnosis), facial swelling (Verbatim: Swollen right side of face), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: muscle pain), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea), pituitary enlargement (Verbatim: Pituitary gland "blown up") and urinary tract infection (Verbatim: UTI). The outcome of the bacterial infection, facial swelling, pituitary enlargement and urinary tract infection were unknown and the outcome of the joint pain, muscle pain, vomiting and nausea were resolved.   It was unknown if the reporter considered the bacterial infection, facial swelling, joint pain, muscle pain, vomiting, nausea, pituitary enlargement and urinary tract infection to be related to Arexvy.     It was unknown if the company considered the bacterial infection, facial swelling, joint pain, muscle pain, vomiting, nausea, pituitary enlargement and urinary tract infection to be related to Arexvy.   Additional Information: GSK Receipt Date:17-JAN-2024 The patient received an Arexvy vaccine around holiday, 2023 (late November, 2023).  The patient reported that 5 hours later she was in the Emergency Department with nausea, vomiting, muscle and joint pain. A couple of hours later the right side of her face was swollen and imaging showed her pituitary gland was blown up. Lab reports showed bacteria in her system and she was diagnosed with a Urinary Tract Infection. The reporter did not consent to follow-up. Suspect start date was near the end of November, 2023. It was difficult to get information from this reporter. The reporter stated that she would ask doctor for permission for Glaxo smith Kline to contact them.  The reporter noted the case number and would call back with that information.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received only adjuvant portion of Shingrix.; patient received only adjuvant portion of Shingrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JAN-2024, the patient received Shingrix. On 17-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only adjuvant portion of Shingrix.) and inappropriate dose of vaccine administered (Verbatim: patient received only adjuvant portion of Shingrix.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-JAN-2024 The reporter stated that a patient received only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Healthcare professional did not have the patient's initials or date of birth nor did she had vaccine details (lot or exp date). The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 31 years patient received a pediatric dose of Engerix-B; 31 years patient received a pediatric dose of Engerix-B; This non-serious case was reported by a consumer via call center representative and described the occurrence of adult use of a child product in a 31-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 12-DEC-2023, the patient received Engerix B pediatric (intramuscular, left arm). On 12-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 31 years patient received a pediatric dose of Engerix-B) and underdose (Verbatim: 31 years patient received a pediatric dose of Engerix-B). The outcome of the adult use of a child product and underdose 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: 18-JAN-2024 The reporter was a Certified Medical Assistant and reported that a 31 year old, patient received a pediatric dose of Engerix-B which led to Adult use of child product and underdose. The patient had not called back to report any issues. The reporter consented to follow up.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: Vaccination failure; tested positive for Pertussis; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 51-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number k9dx5, expiry date 08-JUN-2021) for prophylaxis.   On 15-APR-2019, the patient received Boostrix. On 16-JAN-2024, 1737 days after receiving Boostrix, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: tested positive for Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure and pertussis were unknown.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     It was unknown if the company considered the vaccination failure and pertussis to be related to Boostrix.   Additional Information: GSK Receipt Date: 19-Jan-2024 The reporter reported that the patient received Boostrix vaccine and tested positive for Pertussis.   The reporter stated that the patient was fully immunized and boosted. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Immunisation reaction, Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; positive for Pertussis; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 54-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On 16-JAN-2024, an unknown time after receiving Boostrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: positive for Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure and pertussis were unknown.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     It was unknown if the company considered the vaccination failure and pertussis to be related to Boostrix.   Additional Information: GSK Receipt Date: 16-JAN-2024  The GlaxoSmithKline was the reporter. The reporter stated that the patient had tested positive for pertussis. No further information was known. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule of pertussis were unknown at the time of reporting. This case is linked with US2024009489, same reporter.; Sender's Comments:  US-GSK-US2024009489:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: 4 patients tested positive for Pertussis/ suspected vaccination failure; 4 patients tested positive for Pertussis; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccination failure (Verbatim: 4 patients tested positive for Pertussis/ suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: 4 patients tested positive for Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure and pertussis were unknown.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     It was unknown if the company considered the vaccination failure and pertussis to be related to Boostrix.   Additional Information: GSK Receipt Date: 19-JAN-2024 GSK was the reporter. Reporter stated that the 4 patients had tested positive for pertussis. Unknown demographics, lot numbers, and dates. No further information was known. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset were unknown at a time of reporting. The case had been linked to the case US2024009488, reported by same reporter.; Sender's Comments:  US-GSK-US2024009488:same reporter
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a adult male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 11-SEP-2023, the patient received Engerix B. On 11-SEP-2023, an unknown time after receiving Engerix B and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the wrong vaccine administered 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: 19-JAN-2024 Medical assistant reported that a patient received his first Twinrix dose and he received Engerix B instead of Twinrix for the 2nd dose which led to wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix - Delayed second dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received HAB (Twinrix) (batch number H7RF2) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 3 JUL 2023, lot number H3SG9).   On 22-DEC-2023, the patient received the 2nd dose of Twinrix. On 22-DEC-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Delayed second dose.). The outcome of the drug dose administration interval too long 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: 19-JAN-2024 The healthcare professional reported that patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The healthcare professional asked about the recommended interval between the second and the third dose of Twinrix. The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: The patient had UTIs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URINARY TRACT INFECTION (The patient had UTIs) in an 88-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) in January 2021 and Moderna COVID-19 Vaccine (Dose 2) in February 2021. Past adverse reactions to the above products included No adverse reaction with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (The patient had UTIs). At the time of the report, URINARY TRACT INFECTION (The patient had UTIs) outcome was unknown.            Concomitant medication was not reported. It was reported the patient had not received her 2023 shot because of some issues with bacterial infections due to her age. The patient had UTIs and had been on antibiotics for them.
Sex: M
Vaccine: COVID19
Symptoms: Eustachian tube disorder
Clinical narrative: Trouble with Eustachian tubes after receiving the Moderna Covid; This spontaneous case was reported by a patient and describes the occurrence of EUSTACHIAN TUBE DISORDER (Trouble with Eustachian tubes after receiving the Moderna Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced EUSTACHIAN TUBE DISORDER (Trouble with Eustachian tubes after receiving the Moderna Covid). At the time of the report, EUSTACHIAN TUBE DISORDER (Trouble with Eustachian tubes after receiving the Moderna Covid) outcome was unknown.            No concomitant medication was reported.  The patient said that he had a modulation of pressure in his ears. It was not clear which Moderna vaccine the patient received. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-757650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757650:Invalid case
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site reaction
Clinical narrative: Injection site reaction; Fever; Extreme muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), PYREXIA (Fever), MYALGIA (Extreme muscle aches) and FATIGUE (Fatigue) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3919B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 19-Jan-2024, the patient experienced VACCINATION SITE REACTION (Injection site reaction), PYREXIA (Fever), MYALGIA (Extreme muscle aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), PYREXIA (Fever), MYALGIA (Extreme muscle aches) and FATIGUE (Fatigue) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After two weeks developed severe debleating chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After two weeks developed severe debleating chronic fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, the patient experienced FATIGUE (After two weeks developed severe debleating chronic fatigue). At the time of the report, FATIGUE (After two weeks developed severe debleating chronic fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications was not reported. it was reported that the event remains after almost 3 years.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal discomfort
Clinical narrative: The patient "feels like there is something in his throat, the thing in my throat, feels like someone has their finger pressed in my throat; he contracted Covid third time like 4 or 5 months ago; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL DISCOMFORT (The patient "feels like there is something in his throat, the thing in my throat, feels like someone has their finger pressed in my throat) and COVID-19 (he contracted Covid third time like 4 or 5 months ago) in a 44-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 57A2249) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (lost taste and smell which was not fully back) in 2020 and COVID-19 (lost taste and smell which was not fully back) in June 2022.    On 23-Nov-2022, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (The patient "feels like there is something in his throat, the thing in my throat, feels like someone has their finger pressed in my throat) and COVID-19 (he contracted Covid third time like 4 or 5 months ago). At the time of the report, OROPHARYNGEAL DISCOMFORT (The patient "feels like there is something in his throat, the thing in my throat, feels like someone has their finger pressed in my throat) and COVID-19 (he contracted Covid third time like 4 or 5 months ago) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The patient stated that he contracted Covid third time like 4 or 5 months ago and he still did not have taste and sense of smell fully back. The patient confirmed that he was not hospitalized and did not receive any treatment. LOT number was not legible on the vaccination card. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2024: Live follow-up received and updated patient's age.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: He was diagnosed with COVID-19 in DEC2023.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He was diagnosed with COVID-19 in DEC2023.) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 070H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot- 032M20A) on 08-Mar-2021, Moderna COVID-19 Vaccine (Dose 2, Lot- 044A21A) on 05-Apr-2021, Moderna COVID-19 Vaccine (Dose 3, Lot- 041J21A) on 27-Dec-2021, Moderna COVID-19 Vaccine (Dose 4 and Lot- 038A22A) on 06-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 09-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2023, the patient experienced COVID-19 (He was diagnosed with COVID-19 in DEC2023.). At the time of the report, COVID-19 (He was diagnosed with COVID-19 in DEC2023.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that A lot of people were sick. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-435737 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-435737:Wife case
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain; I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain; I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain), PARAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain) and HYPOAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2024, the patient experienced PAIN (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain), PARAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain) and HYPOAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain). At the time of the report, PAIN (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain), PARAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain) and HYPOAESTHESIA (I have been getting side effects of bad tingling, numbness, all in my arm to my chest to my back. I'm in a lot of pain) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness, itching and swelling at injection site; redness, itching and swelling at injection site; redness, itching and swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (redness, itching and swelling at injection site), VACCINATION SITE ERYTHEMA (redness, itching and swelling at injection site) and VACCINATION SITE SWELLING (redness, itching and swelling at injection site) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 24-Jul-2023.    On 19-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Jan-2024, the patient experienced VACCINATION SITE PRURITUS (redness, itching and swelling at injection site), VACCINATION SITE ERYTHEMA (redness, itching and swelling at injection site) and VACCINATION SITE SWELLING (redness, itching and swelling at injection site). At the time of the report, VACCINATION SITE PRURITUS (redness, itching and swelling at injection site), VACCINATION SITE ERYTHEMA (redness, itching and swelling at injection site) and VACCINATION SITE SWELLING (redness, itching and swelling at injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Some heart arrhythmia; This serious initial spontaneous safety report from country was received by Novavax on 20-JAN-2024 from a consumer via a company representative.  An female of an unspecified race and age was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 3 (third booster dose) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced some heart arrhythmia (PT: Arrhythmia) (Serious: Medically Significant). The individual was looking for a specialist, as she is avoiding her normal doctor.  At the time of reporting, the event outcome of Arrhythmia was not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Arrhythmia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Arrhythmia was assessed as serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported event is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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, 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 number unknown (boosters), Manufacturer Unknown), for COVID-19 Immunization; Flu, for Immunization; Rsv, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient took all the doses and the patient was sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016008 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400021178 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400023141 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400023145 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400023143 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400023144 Same reporter/vaccine/events, different patient;US-PFIZER INC-202400023142 Same reporter/vaccine/events, different patient;
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: first tested positive for COVID-19; first tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2024, outcome "unknown" and all described as "first tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Positive, notes: first tested positive for COVID-19; (07Jan2024) Negative; (08Jan2024) Negative, notes: retested; (09Jan2024) Negative, notes: retested; (17Jan2024) Positive, notes: returned positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient first tested positive for COVID-19 on 03Jan2024. Patient was took with PAXLOVID from 04Jan2024 to 08Jan2024 as Treatment of COVID-19. On 07Jan2024 I already had a negative antigen test, retested on 08Jan2024 and 09Jan2024 and both were negative. Today (17Jan2024) started feeling some mild common cold symptoms (sore throat, nasal congestion, fatigue), and decided to do a COVID test, just to rule it out. It returned positive. Retested and positive again. COVID rebounded 10 days after the first negative test.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. 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; Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received treatment for COVID-19 with Paxlovid from 09Jan2024 to 13Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events vaccination failure and COVID-19 cannot be ruled out.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Pharmacist.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 Treatment was Paxlovid with treatment start date on 08Jan2024 and treatment stop date on 13Jan2024. Rebound covid on 18Jan2024 and the patient was recovering.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID 19 cannot be ruled out.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline high cholesterol- untreated" (unspecified if ongoing); "Gluten sensitive" (unspecified if ongoing), notes: Known allergies: No, though gluten sensitive (undiagnosed - just , feel better when GF). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 at 16:00 in Left arm), administration date: 06Jan2023, when the patient was 60-year-old, for Covid-19 Immunization; 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Jan2024 to 12Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.