chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Brain fog, Dizziness, Fatigue, Loss of personal independence in daily activities, Nausea
Clinical narrative: started experiencing daily nausea and tachycardia, increased heart rate, dizziness, fatigue, and brain fog/autonomic autonomic disorder.; neurological diseases; Autoimmune disorder; Information has been received from a lawyer regarding a case in litigation, concerning a n adult female patient (pt) (exact age not provided).The pt's medical history, concurrent conditions, and concomitant medications were not provided. On 18-AUG-2015 (when she was 12-years old), the pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). Also, on 31-AUG-2016, she returned to health care provider, and during this appointment, her physician recommended the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), therefore, on an unknown date, she was vaccinated with the second dose of the suspect vaccine. On an unknown date following vaccination, the pt developed daily nausea, tachycardia, dizziness, fatigue, and brain fog. Based upon her chronic and severe symptoms, pt has been diagnosed with various medical conditions, including but not limited to Postural orthostatic tachycardia syndrome (POTS). Also, the pt had suffer serious autoimmune, autonomic, and neurological dysfunctions, and nervous system disorder. She stated that the first time she discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2020. As a result of her post-vaccine symptoms, the pt has been unable to engage in activities that a young person her age would normally enjoy. It was reported that before to received Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), she enjoyed playing basketball, softball, and taking dance classes, now she had to miss school or leave school early as she was unable to make it through class, therefore, she had to complete high school online due to her medical issues. Moreover, as a result of company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the pt has suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. The pt had not recovered from the aforementioned events, and it was considered the events were related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event considered Autoimmune disorder was determined to be a medically significant.  The reporter considered the events to be a disabling events.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: started experiencing daily nausea and tachycardia, increased heart rate, dizziness, fatigue, and brain fog/autonomic autonomic disorder.; neurological diseases; Autoimmune disorder; Information has been received from a lawyer regarding a case in litigation, concerning a n adult female patient (pt) (exact age not provided).The pt's medical history, concurrent conditions, and concomitant medications were not provided. On 18-AUG-2015 (when she was 12-years old), the pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). Also, on 31-AUG-2016, she returned to health care provider, and during this appointment, her physician recommended the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), therefore, on an unknown date, she was vaccinated with the second dose of the suspect vaccine. On an unknown date following vaccination, the pt developed daily nausea, tachycardia, dizziness, fatigue, and brain fog. Based upon her chronic and severe symptoms, pt has been diagnosed with various medical conditions, including but not limited to Postural orthostatic tachycardia syndrome (POTS). Also, the pt had suffer serious autoimmune, autonomic, and neurological dysfunctions, and nervous system disorder. She stated that the first time she discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2020. As a result of her post-vaccine symptoms, the pt has been unable to engage in activities that a young person her age would normally enjoy. It was reported that before to received Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), she enjoyed playing basketball, softball, and taking dance classes, now she had to miss school or leave school early as she was unable to make it through class, therefore, she had to complete high school online due to her medical issues. Moreover, as a result of company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the pt has suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. The pt had not recovered from the aforementioned events, and it was considered the events were related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event considered Autoimmune disorder was determined to be a medically significant.  The reporter considered the events to be a disabling events.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of GARDASIL 9 was administered; This spontaneous report was received from physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-JAN-2024, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dose, lot #1775809 was valid for formulation pre-filled syringe, expiration date: 18-AUG-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No patient symptoms have been reported. No temperature excursion. No additional adverse event (AE)/no product quality complaint (PQC) reported (No adverse event).
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: joint and aches throughout body; aches throughout body; Slight fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced generalized joint pain (Verbatim: joint and aches throughout body), general body pain (Verbatim: aches throughout body) and fever (Verbatim: Slight fever). The outcome of the generalized joint pain, general body pain and fever were not reported.   It was unknown if the reporter considered the generalized joint pain, general body pain and fever to be related to Arexvy.     It was unknown if the company considered the generalized joint pain, general body pain and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-JAN-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she had terrible joint and aches throughout body and slight fever. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: had stinging at the injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site stinging in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site stinging (Verbatim: had stinging at the injection site). The outcome of the injection site stinging was not reported.   It was unknown if the reporter considered the injection site stinging to be related to Arexvy.     It was unknown if the company considered the injection site stinging to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-JAN-2024 The patient self-reported this case. The doctor reported that she was traveled over the holidays and decided to get her RSV vaccination. The patient had stinging at the injection site.  The patient stated that she could not remember what the vaccine name was, but she did get it at a pharmacy. The reporter did not consent to contact.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: adult patient received 0.5ml dose of Engerix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of underdose in a adult patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B .5 ml. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: adult patient received 0.5ml dose of Engerix). The outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 The healthcare worker reported that an adult patient received 0.5ml dose of Engerix B, which led to underdose. No additional adverse event were reported.  No further information were reported. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Injection site swelling, Pruritus
Clinical narrative: large swollen about the size of a baseball, about 2 inches below the injection site; Itchy area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced local swelling (Verbatim: large swollen about the size of a baseball, about 2 inches below the injection site) and itchy skin (Verbatim: Itchy area). The outcome of the local swelling and itchy skin were not resolved.   It was unknown if the reporter considered the local swelling and itchy skin to be related to Arexvy.     It was unknown if the company considered the local swelling and itchy skin to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-Jan-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she had reaction was a large swollen and very itchy area about the size of a baseball about 2 inches below the injection site.  The patient stated that it was been there for 3 days and it was not getting any better and was not going away. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue). The outcome of the fatigue was not reported.   The reporter considered the fatigue to be related to Arexvy.     The company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt date: 06-JAN-2024 This case was reported via interactive digital media. The reporter reported that the vaccine had caused fatigue.
Sex: U
Vaccine: FLU4, HEP, HEPA, MENB
Symptoms: Product storage error
Clinical narrative: Vaccines had been exposed to the temperature of 27.95 degree fahrenheit/ possible administration after exposure to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Engerix B, Fluarix Tetra and Havrix. On an unknown date, an unknown time after receiving Bexsero, Engerix B, Fluarix Tetra and Havrix, the patient experienced incorrect storage of drug (Verbatim: Vaccines had been exposed to the temperature of 27.95 degree fahrenheit/ possible administration after exposure to freezing temperatures). The outcome of the incorrect storage of drug 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: 02-JAN-2024 The healthcare provider called to report a temperature excursion for Havrix, Bexsero, Fluarix QIV, and Engreix-B where vaccines had been exposed to the temperature of 27.95-degree Fahrenheit. The reporter was unsure if any of those doses had been administered to a patient after the excursion. There was possible administration of Havrix, Bexsero, Fluarix QIV, and Engreix-B vaccines after exposure to freezing temperatures, which led to incorrect storage of drug. The consent to follow up granted.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: The accidental administration of a pediatric dose in an adult patient; Adult use of a child product; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 02-JAN-2024, the patient received Engerix B pediatric. On 02-JAN-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: The accidental administration of a pediatric dose in an adult patient) and adult use of a child product (Verbatim: Adult use of a child product). 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: 04-JAN-2024 The registered nurse inquired about Engerix-B and wanted to know what information was available about any information about the accidental administration of a pediatric dose in an adult patient. The adult patient received a pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero stored at minus 2.4 C for 4 hours 8 minutes; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 29-DEC-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero stored at minus 2.4 C for 4 hours 8 minutes). The outcome of the incorrect storage of drug 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: 04-JAN-2024 The RN (registered nurse) requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 C for 4 hours 8 minutes. The patient received Bexsero vaccine which was not stored as per recommended storage condition on 29 December 2023, which led to an incorrect storage of drug. The reporter consented to follow up. This was 1 of the 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024001089:Same reporter/diferent product US-GSK-US2024001092:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product US-GSK-US2024001095:Same reporter/diferent product US-GSK-US2024001096:Same reporter/diferent product
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Menveo and Flulaval quadrivalent 2023-2024 stored at minus 2.4 C for 4 hours 8 minutes; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3KB9L, expiry date 30-NOV-2024) for prophylaxis.   Co-suspect products included Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 5DY5A, expiry date 26-JUN-2024) for prophylaxis.   On 03-JAN-2024, the patient received Menveo and FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Menveo and FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Menveo and Flulaval quadrivalent 2023-2024 stored at minus 2.4 C for 4 hours 8 minutes). The outcome of the incorrect storage of drug 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: 04-JAN-2024 The RN (registered nurse) requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 C for 4 hours 8 minutes. The patient received Menveo and Flulaval quadrivalent 2023-2024 vaccines which was not stored as per recommended storage condition on 29-DEC-2023, which led to an incorrect storage of drug. The reporter consented to follow up. This was 1 of the 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024001091:Same reporter/diferent product US-GSK-US2024001096:Same reporter/diferent product US-GSK-US2024001092:Same reporter/diferent product US-GSK-US2024001089:Same reporter/diferent product US-GSK-US2024001095:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm and soreness in the arm after receiving the Arexvy vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Pain in the arm and soreness in the arm after receiving the Arexvy vaccine). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The customer reported pain in the arm and soreness in the arm after receiving the Arexvy vaccine. The reporter consented to follow up.
Age: 0.75
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under the age of 10 received the 1-vial presentation of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 2R7L7, expiry date 31-DEC-2024) for prophylaxis.   On 08-JAN-2024, the patient received Menveo. On 08-JAN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: under the age of 10 received the 1-vial presentation of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 08-JAN-2024 The HCP (health care professional) reported a patient who was under the age of 10 received the 1-vial presentation of Menveo, which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient stated she received first dose of Shingrix on 05 November 2020 and second dose on 18 August 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 5th November 2020 received 1st dose).   On 18-AUG-2023, the patient received the 2nd dose of Shingrix. On 18-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient stated she received first dose of Shingrix on 05 November 2020 and second dose on 18 August 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 09-JAN-2024 The patient self-reported this case.  The patient stated that, she received second dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART ISSUES WERE EXPERIENCED AFTER THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose series- 1)(suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issues were experienced after the vaccine and stated issues aren't as bad as when they first were experienced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues were experienced after the vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Tinea pedis
Clinical narrative: ATHLETES FOOT; This spontaneous report received from a consumer concerned  a patient of male and unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date,  following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced athletes foot (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of athletes foot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Headache and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild injection site redness; Mild injection site swelling; Mild injection site pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity) and PYREXIA (Mild fever (100.4 to 101.2 °F)) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F, Mild fever..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not provided. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 23-Dec-2023 and 24-Dec-2023. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Headache and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild injection site redness; Mild injection site swelling; Mild injection site pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity) and PYREXIA (Mild fever (100.4 to 101.2 °F)) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), HEADACHE (Headache and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F, Mild fever..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not provided. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 23-Dec-2023 and 24-Dec-2023. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Cyanosis, Hypopnoea, Lethargy, Pulse abnormal, Pulse absent
Clinical narrative: Activities staff informed the nurse that resident had collapsed in the middle of hallway. The nurse assessed resident and noted to be cyanotic, no resp, no active pulse. CPR initiated immediately by assistance of staff, EMS called by this nurse when resident was discovered unresponsive. CPR continued until EMS arrived. EMS took over compressions immediately and transferred resident to MC. Upon departure resident was lethargic and had shallow respirations with a thready pulse.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Respiratory arrest, Resuscitation, Syncope, Unresponsive to stimuli
Clinical narrative: Activities staff informed the nurse that resident had collapsed in the middle of hallway. The nurse assessed resident and noted to be cyanotic, no resp, no active pulse. CPR initiated immediately by assistance of staff, EMS called by this nurse when resident was discovered unresponsive. CPR continued until EMS arrived. EMS took over compressions immediately and transferred resident to MC. Upon departure resident was lethargic and had shallow respirations with a thready pulse.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted to the hospital with covid on 1/1 and pt died on1/10
Age: 55.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient requested to pay cash for the Arexvy vaccine and after administration it was discovered that they did not meet the administration  age recommendations. Patient at the time of vaccination was 55 y/o recommended age is 60 y/o.  Patient was contacted, notified and advised to contact us for any further questions or concerns.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was to have a flu shot and given a covid-19 vaccine instead. The patient was brought by bus to the clinic. The clinic was given 6 different forms to look out for to get patients ready and asked to come out to the bus. Went out to the bus. And wrong medication for one of the patients was noted. Stopped the process and began again. A second verification was not done properly and the vaccine was administered to Patient. Did explained to Patient that she was being given COVID-19 and she made no refusal. Stated I was giving COVID-19 to the lady on the bus. No refusal was stated.  Patient was taken back to the facility.  Once the error was caught the facility was made aware. Patient has been on 4-hour checks since yesterday with no adverse reactions noted. We have called to check on the patient several times. The patient has had a COVID-19 vaccine in the past and no reaction was verbalized or acknowledged by the family. So far no adverse reaction has been noted.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever presented 3 hours after injection, broke out in hives, went to the ER, was given benadryl, rash and fever resolved.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  RTI-HS Subject ID was reported as 55069-77517 and AutoCruitment Subject ID was reported as 5472491.  Treatment medication was not reported.  Also, it has been reported that the symptom of mild injection site pain/mild injection site tenderness and headache were experienced anytime during the 2 days after vaccination on either Dec 24, 2023, or Dec 25, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Master case
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Amnesia, Injection site pain, Pain
Clinical narrative: She got her vaccine, it hurt when she initially got the shot which was normal, nothing vastly different.  Within a couple of days her arm started aching, not by pressing on it, but then it started hurting when she moved it a certain way.  She can feel a pain go.  She does not know if the needle went through a muscle or to the bone, but it still hurts her.  She did have some memory loss and has some trouble remembering names and words as she is 85, she would forget to pick up her dog, and forgot to feed her dog, and she was almost a near accident while driving.  Her sister-in-law saw her some pictures of her grandchildren and half an hour later she mentioned the pictures, but she did not remember seeing the pictures.  She did not go to her doctor.  The pain is not a steady pain and every once in a while when she got to do something she gets a sharp pain in the area of the vaccine.  Her memory has improved now.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Arthralgia, Axillary pain, Back pain, C-reactive protein, Chest X-ray
Clinical narrative: Patient completed 2nd Jynneos on 01/03/2024.  1st shot administered on 12/05/2023.  Patient reports that on 01/05/2024, he developed new pain in both knees and pre-existing back pain slightly worsened.  He also had a headache starting on 01/05.  Left axilla pain and swelling started on 01/05 or 01/06.  He had a dry cough starting on 01/07.  Reported fever at home on 01/09, but was afebrile during office visit on 01/10 (took Tylenol for axilla pain and headache).
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Condition aggravated, Cough, Electrocardiogram, Full blood count, Headache
Clinical narrative: Patient completed 2nd Jynneos on 01/03/2024.  1st shot administered on 12/05/2023.  Patient reports that on 01/05/2024, he developed new pain in both knees and pre-existing back pain slightly worsened.  He also had a headache starting on 01/05.  Left axilla pain and swelling started on 01/05 or 01/06.  He had a dry cough starting on 01/07.  Reported fever at home on 01/09, but was afebrile during office visit on 01/10 (took Tylenol for axilla pain and headache).
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Metabolic function test, Pyrexia, Red blood cell sedimentation rate, Swelling
Clinical narrative: Patient completed 2nd Jynneos on 01/03/2024.  1st shot administered on 12/05/2023.  Patient reports that on 01/05/2024, he developed new pain in both knees and pre-existing back pain slightly worsened.  He also had a headache starting on 01/05.  Left axilla pain and swelling started on 01/05 or 01/06.  He had a dry cough starting on 01/07.  Reported fever at home on 01/09, but was afebrile during office visit on 01/10 (took Tylenol for axilla pain and headache).
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: On Dec 29, 2023  I the clinic MA gave patient  an RSV vaccine (Arexvy) to pregnant patient.  I wasn?t aware that RSV vaccine needed to be abrysvo vaccine (maternal). Ptaient's EDD: 02/08/24
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: hives on body onset yesterday 01/10/2024, headaches onset Tuesday 01/09/2024 treated 01/11/2024 with prednisolone 15 mg/5mL 5 mL twice daily , dexamethasone 4 mg IM, diphenhydramine 25 mg IM
Age: 21.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient woke up the day after vaccines with a very stiff neck, painful, limited range of motion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait disturbance, Muscular weakness, Nausea
Clinical narrative: I experienced after receiving my second COVID-19 vaccine in July 2021, which included the following symptoms:   dizziness, nausea, facial swelling, vestibular symptoms, including vertigo, and balance issues. I experienced weakness in my legs and arms and could not walk more than two steps. I was unable to walk properly for one month.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vertigo, Vestibular disorder
Clinical narrative: I experienced after receiving my second COVID-19 vaccine in July 2021, which included the following symptoms:   dizziness, nausea, facial swelling, vestibular symptoms, including vertigo, and balance issues. I experienced weakness in my legs and arms and could not walk more than two steps. I was unable to walk properly for one month.
Age: 41.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: On Jan 2, 2024 I the clinic MA gave patient an RSV vaccine (Arexvy) to pregnant patient.  I wasn?t aware that RSV vaccine needed to be abrysvo vaccine (maternal). Patient's EDD: 02/24/24
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, HEPA, MMR, PNC15, VARCEL
Symptoms: Diarrhoea, Hypophagia, Malaise, Respiratory pathogen panel, Streptococcus test negative
Clinical narrative: per local ED report, patient presented to ED 1/8/24 with diarrhea, vomiting, malaise and decreased PO intake. Respiratory panel and strep PCR were completed and were negative. 1/10/24 patient presented to local ED via EMS unresponsive.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, HEPA, MMR, PNC15, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: per local ED report, patient presented to ED 1/8/24 with diarrhea, vomiting, malaise and decreased PO intake. Respiratory panel and strep PCR were completed and were negative. 1/10/24 patient presented to local ED via EMS unresponsive.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Diarrhoea, Hypophagia, Malaise, Polymerase chain reaction negative
Clinical narrative: per local ED report, patient presented to ED 1/8/24 with diarrhea, vomiting, malaise and decreased PO intake. Respiratory panel and strep PCR were completed and were negative. 1/10/24 patient presented to local ED via EMS unresponsive.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, HEPA, MMR, PNC15, VARCEL
Symptoms: Respiratory pathogen panel, Streptococcus test negative, Unresponsive to stimuli, Vomiting
Clinical narrative: per local ED report, patient presented to ED 1/8/24 with diarrhea, vomiting, malaise and decreased PO intake. Respiratory panel and strep PCR were completed and were negative. 1/10/24 patient presented to local ED via EMS unresponsive.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Chills, Dizziness, Dysgeusia
Clinical narrative: She got her vaccine at 10:15 and by 6:00 she started tasting this horrible taste in her mouth.  She felt her stomach had problems, was vomiting and pooping at the same time.  She felt faint and unlocked her door for her neighbor could come over.  She had been given reditabs for nausea and went to bed and her temp was 100 and stayed to that until last night.  Her normal is 97.6 and she is back to that today.  She had a headache, chills, sweaty and her blood sugar rose to 469.  She did have a Moderna vaccine in 2019 and was hospitalized and had to call the ambulance as she was throwing up and pooping at the same time, fever, chills and the same symptoms that she had with this one.  She could not stop the nausea and had thrown up for about 3 hours and was hospitalized at that time.  She went in on Friday and got out on a Monday morning.     She still has a headache today, but the nausea and diarrhea stopped yesterday.  The nausea stopped because she took the nausea medicine to make it stop.  She was up all night with the fever, and just felt horrible.  She tried to call her doctor but they are too busy to take her call, but is better due to having the nausea on hand from her going to her routine exam and knew she was going to get the shot and asked to have it on hand.  She does not feel like she is going to get any more of them.  She still feels very weak and tired with the slight headache.  She took 2 aspirin a while ago, but has not taken anything for the fever other than 2 aspirin when she saw that she had a fever, which was after the next morning.  She could not keep anything down and tasted the chemical taste in her mouth after each Moderna vaccine, this being the third time.  This did happen after the 2nd Moderna vaccine as well, but it was not as bad as this one.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gastrointestinal disorder, Headache, Hyperhidrosis
Clinical narrative: She got her vaccine at 10:15 and by 6:00 she started tasting this horrible taste in her mouth.  She felt her stomach had problems, was vomiting and pooping at the same time.  She felt faint and unlocked her door for her neighbor could come over.  She had been given reditabs for nausea and went to bed and her temp was 100 and stayed to that until last night.  Her normal is 97.6 and she is back to that today.  She had a headache, chills, sweaty and her blood sugar rose to 469.  She did have a Moderna vaccine in 2019 and was hospitalized and had to call the ambulance as she was throwing up and pooping at the same time, fever, chills and the same symptoms that she had with this one.  She could not stop the nausea and had thrown up for about 3 hours and was hospitalized at that time.  She went in on Friday and got out on a Monday morning.     She still has a headache today, but the nausea and diarrhea stopped yesterday.  The nausea stopped because she took the nausea medicine to make it stop.  She was up all night with the fever, and just felt horrible.  She tried to call her doctor but they are too busy to take her call, but is better due to having the nausea on hand from her going to her routine exam and knew she was going to get the shot and asked to have it on hand.  She does not feel like she is going to get any more of them.  She still feels very weak and tired with the slight headache.  She took 2 aspirin a while ago, but has not taken anything for the fever other than 2 aspirin when she saw that she had a fever, which was after the next morning.  She could not keep anything down and tasted the chemical taste in her mouth after each Moderna vaccine, this being the third time.  This did happen after the 2nd Moderna vaccine as well, but it was not as bad as this one.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: She got her vaccine at 10:15 and by 6:00 she started tasting this horrible taste in her mouth.  She felt her stomach had problems, was vomiting and pooping at the same time.  She felt faint and unlocked her door for her neighbor could come over.  She had been given reditabs for nausea and went to bed and her temp was 100 and stayed to that until last night.  Her normal is 97.6 and she is back to that today.  She had a headache, chills, sweaty and her blood sugar rose to 469.  She did have a Moderna vaccine in 2019 and was hospitalized and had to call the ambulance as she was throwing up and pooping at the same time, fever, chills and the same symptoms that she had with this one.  She could not stop the nausea and had thrown up for about 3 hours and was hospitalized at that time.  She went in on Friday and got out on a Monday morning.     She still has a headache today, but the nausea and diarrhea stopped yesterday.  The nausea stopped because she took the nausea medicine to make it stop.  She was up all night with the fever, and just felt horrible.  She tried to call her doctor but they are too busy to take her call, but is better due to having the nausea on hand from her going to her routine exam and knew she was going to get the shot and asked to have it on hand.  She does not feel like she is going to get any more of them.  She still feels very weak and tired with the slight headache.  She took 2 aspirin a while ago, but has not taken anything for the fever other than 2 aspirin when she saw that she had a fever, which was after the next morning.  She could not keep anything down and tasted the chemical taste in her mouth after each Moderna vaccine, this being the third time.  This did happen after the 2nd Moderna vaccine as well, but it was not as bad as this one.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: 1 HOUR AFTER VACCINES, CHLID HAD A SEIZURE AT HOME, MOM THEN TOOK CHILD TO ER.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray, Computerised tomogram head, Cytogenetic analysis, Electroencephalogram, Eye movement disorder
Clinical narrative: 1 HOUR AFTER VACCINES, CHLID HAD A SEIZURE AT HOME, MOM THEN TOOK CHILD TO ER.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Generalised tonic-clonic seizure, Lumbar puncture, Magnetic resonance imaging head, Metabolic function test, Muscle twitching
Clinical narrative: 1 HOUR AFTER VACCINES, CHLID HAD A SEIZURE AT HOME, MOM THEN TOOK CHILD TO ER.