chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Crepitations, Decreased appetite, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: On the morning following receiving the Anthrax Vaccine (April 13th at 6:00 am) I woke and went to the clinic. The symptoms that I had were a red sore and swollen throat, severe pain in the entire right arm (the arm I received the shot in), lack of appetite,pale complexion,  a heart rate of 112, a blood pressure of 130/82, and a temperature of 99.2 F. I was given 50 mg Benadryl, 800 mg of Ibuprofen, and placed on bed rest for 12 hours. The next morning (April 14th) I returned to the clinic and my symptoms were congestion, hot flashes, sore throat, lightheadedness, headaches, swollen lymph nodes and tonsils, fatigue, general weakness, a heart rate of 132, blood pressure of 120/79, and a temperature of 98.8 F. I was given  800 mg of Ibuprofen, and placed on light duty for 48 hours. Over the next few days my symptoms worsened and I began feeling severe chest pain, a pounding heart, and a dry cough. I returned to the clinic the evening of April 18th with worsened congestion, red sore swollen throat, loss of appetite, chest pain, pounding heart, dry cough, extreme pain when eating, crackling in my lower lungs, a heart rate of 110, and blood pressure of 138/92. I was sent to the hospital immediately where I received chest X-rays, and an EKG. I was diagnosed with Bronchitis with potential relations to the Anthrax Vaccine. I was prescribed Prednisone, Tessalon, and placed on light duty for 48 hours. . I was not tested for Covid, the Flu, or Strep due to no one around me experiencing symptoms, thus the Doctor concluded I was not contagious. These symptoms persisted but gradually got better up until May 1st.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Impaired work ability, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: On the morning following receiving the Anthrax Vaccine (April 13th at 6:00 am) I woke and went to the clinic. The symptoms that I had were a red sore and swollen throat, severe pain in the entire right arm (the arm I received the shot in), lack of appetite,pale complexion,  a heart rate of 112, a blood pressure of 130/82, and a temperature of 99.2 F. I was given 50 mg Benadryl, 800 mg of Ibuprofen, and placed on bed rest for 12 hours. The next morning (April 14th) I returned to the clinic and my symptoms were congestion, hot flashes, sore throat, lightheadedness, headaches, swollen lymph nodes and tonsils, fatigue, general weakness, a heart rate of 132, blood pressure of 120/79, and a temperature of 98.8 F. I was given  800 mg of Ibuprofen, and placed on light duty for 48 hours. Over the next few days my symptoms worsened and I began feeling severe chest pain, a pounding heart, and a dry cough. I returned to the clinic the evening of April 18th with worsened congestion, red sore swollen throat, loss of appetite, chest pain, pounding heart, dry cough, extreme pain when eating, crackling in my lower lungs, a heart rate of 110, and blood pressure of 138/92. I was sent to the hospital immediately where I received chest X-rays, and an EKG. I was diagnosed with Bronchitis with potential relations to the Anthrax Vaccine. I was prescribed Prednisone, Tessalon, and placed on light duty for 48 hours. . I was not tested for Covid, the Flu, or Strep due to no one around me experiencing symptoms, thus the Doctor concluded I was not contagious. These symptoms persisted but gradually got better up until May 1st.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Pain in extremity, Pallor, Palpitations, Pharyngeal erythema, Pharyngeal swelling
Clinical narrative: On the morning following receiving the Anthrax Vaccine (April 13th at 6:00 am) I woke and went to the clinic. The symptoms that I had were a red sore and swollen throat, severe pain in the entire right arm (the arm I received the shot in), lack of appetite,pale complexion,  a heart rate of 112, a blood pressure of 130/82, and a temperature of 99.2 F. I was given 50 mg Benadryl, 800 mg of Ibuprofen, and placed on bed rest for 12 hours. The next morning (April 14th) I returned to the clinic and my symptoms were congestion, hot flashes, sore throat, lightheadedness, headaches, swollen lymph nodes and tonsils, fatigue, general weakness, a heart rate of 132, blood pressure of 120/79, and a temperature of 98.8 F. I was given  800 mg of Ibuprofen, and placed on light duty for 48 hours. Over the next few days my symptoms worsened and I began feeling severe chest pain, a pounding heart, and a dry cough. I returned to the clinic the evening of April 18th with worsened congestion, red sore swollen throat, loss of appetite, chest pain, pounding heart, dry cough, extreme pain when eating, crackling in my lower lungs, a heart rate of 110, and blood pressure of 138/92. I was sent to the hospital immediately where I received chest X-rays, and an EKG. I was diagnosed with Bronchitis with potential relations to the Anthrax Vaccine. I was prescribed Prednisone, Tessalon, and placed on light duty for 48 hours. . I was not tested for Covid, the Flu, or Strep due to no one around me experiencing symptoms, thus the Doctor concluded I was not contagious. These symptoms persisted but gradually got better up until May 1st.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Respiratory tract congestion, Rest regimen, Tonsillar hypertrophy
Clinical narrative: On the morning following receiving the Anthrax Vaccine (April 13th at 6:00 am) I woke and went to the clinic. The symptoms that I had were a red sore and swollen throat, severe pain in the entire right arm (the arm I received the shot in), lack of appetite,pale complexion,  a heart rate of 112, a blood pressure of 130/82, and a temperature of 99.2 F. I was given 50 mg Benadryl, 800 mg of Ibuprofen, and placed on bed rest for 12 hours. The next morning (April 14th) I returned to the clinic and my symptoms were congestion, hot flashes, sore throat, lightheadedness, headaches, swollen lymph nodes and tonsils, fatigue, general weakness, a heart rate of 132, blood pressure of 120/79, and a temperature of 98.8 F. I was given  800 mg of Ibuprofen, and placed on light duty for 48 hours. Over the next few days my symptoms worsened and I began feeling severe chest pain, a pounding heart, and a dry cough. I returned to the clinic the evening of April 18th with worsened congestion, red sore swollen throat, loss of appetite, chest pain, pounding heart, dry cough, extreme pain when eating, crackling in my lower lungs, a heart rate of 110, and blood pressure of 138/92. I was sent to the hospital immediately where I received chest X-rays, and an EKG. I was diagnosed with Bronchitis with potential relations to the Anthrax Vaccine. I was prescribed Prednisone, Tessalon, and placed on light duty for 48 hours. . I was not tested for Covid, the Flu, or Strep due to no one around me experiencing symptoms, thus the Doctor concluded I was not contagious. These symptoms persisted but gradually got better up until May 1st.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: felt like I had COVID all over again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly patient received BNT162b2 (BNT162B2), on 01Feb2021 at 13:00 as dose 1, single (Lot number: EL8982) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (ongoing); "Pain" (ongoing); "Hyperparathyroidism", start date: 2010 (ongoing); "COVID-19 positive", start date: 24Nov2020 (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); DOXYCYCLINE (ongoing); AMLODIPINE taken for hypertension (ongoing); DULOXETINE taken for pain (ongoing). The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 01Feb2021, outcome "recovered" (07Feb2021), described as "felt like I had COVID all over again". Therapeutic measures were not taken as a result of suspected covid-19.  Clinical Course: Patient age at time of vaccination reported as 78, 79, 80, 81 (years). Patient administered covid-19 vaccine of dose 2 on 22Feb2021 (Lot: EL9267); Dose: 3 on 13Oct2021 (Lot: 30135BA); Dose: 4 on 19May2022 (Lot: FS4989) all via Intramuscular route. Doxycycline indicated for face (as reported). Also reported that 1st two vaccines hit hard that he felt like he had COVID all over again. Reported surgical removal of gland for Hyperparathyroidism (onset on 2010) on Jan2023 and COVID test positive 24Nov2020, in bed for 10 days. Got alone ok with boosters and vaccines until 03Apr2024. Then felt like he had COVID again but it was only 3 days. Seriousness of the event has been reported as 'Important medical event'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400098782 same patient/event, different dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: felt like I had COVID all over again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly patient received BNT162b2 (BNT162B2), on 01Feb2021 at 13:00 as dose 1, single (Lot number: EL8982) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (ongoing); "Pain" (ongoing); "Hyperparathyroidism", start date: 2010 (ongoing); "COVID-19 positive", start date: 24Nov2020 (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); DOXYCYCLINE (ongoing); AMLODIPINE taken for hypertension (ongoing); DULOXETINE taken for pain (ongoing). The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 01Feb2021, outcome "recovered" (07Feb2021), described as "felt like I had COVID all over again". Therapeutic measures were not taken as a result of suspected covid-19.  Clinical Course: Patient age at time of vaccination reported as 78, 79, 80, 81 (years). Patient administered covid-19 vaccine of dose 2 on 22Feb2021 (Lot: EL9267); Dose: 3 on 13Oct2021 (Lot: 30135BA); Dose: 4 on 19May2022 (Lot: FS4989) all via Intramuscular route. Doxycycline indicated for face (as reported). Also reported that 1st two vaccines hit hard that he felt like he had COVID all over again. Reported surgical removal of gland for Hyperparathyroidism (onset on 2010) on Jan2023 and COVID test positive 24Nov2020, in bed for 10 days. Got alone ok with boosters and vaccines until 03Apr2024. Then felt like he had COVID again but it was only 3 days. Seriousness of the event has been reported as 'Important medical event'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400098782 same patient/event, different dose;
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: pain/muscle still hurting; injured the nerve; when I move my left arm to now certain points, it was like six, seven level now it is two or three; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "knee and feet arthritis" (unspecified if ongoing); "spine arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster)), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster)), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "pain/muscle still hurting"; NERVE INJURY (non-serious), outcome "unknown", described as "injured the nerve"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "when I move my left arm to now certain points, it was like six, seven level now it is two or three". Therapeutic measures were not taken as a result of myalgia, nerve injury, joint range of motion decreased. Additional information: The patient received 5 Pfizer Vaccines and maybe need only advice because he do not think it is the vaccine itself responsible for this but he received the 5th Pfizer Vaccine (Pfizer COVID-19 Vaccine) on but was still in pain. He do not think it is Pfizer's fault but he think it is Pharmacist who hits his nerve and his muscle. It is still hurting not to that extent as before but it is months it is still hurting so he decided to go to find a doctor who would treat me. The patient thought it was it the Pharmacist who was talking while giving his 5th dose, the last time. He did not have any problem 4 times but the 5th time she hits the patient may be too high in the arm so may be she injured the nerve and whole muscle hurts when he move it. When he move his left arm to now certain points, it was like six, seven level now it is two or three. He believe that is the pharmacist's responsibility but he still want to go to particular specialist for MRIs and could be Orthopedics or muscle skeletal doctor maybe that will be the best.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Nerve injury, Pain
Clinical narrative: pain/muscle still hurting; injured the nerve; when I move my left arm to now certain points, it was like six, seven level now it is two or three; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "knee and feet arthritis" (unspecified if ongoing); "spine arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster)), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster)), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "pain/muscle still hurting"; NERVE INJURY (non-serious), outcome "unknown", described as "injured the nerve"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "when I move my left arm to now certain points, it was like six, seven level now it is two or three". Therapeutic measures were not taken as a result of myalgia, nerve injury, joint range of motion decreased. Additional information: The patient received 5 Pfizer Vaccines and maybe need only advice because he do not think it is the vaccine itself responsible for this but he received the 5th Pfizer Vaccine (Pfizer COVID-19 Vaccine) on but was still in pain. He do not think it is Pfizer's fault but he think it is Pharmacist who hits his nerve and his muscle. It is still hurting not to that extent as before but it is months it is still hurting so he decided to go to find a doctor who would treat me. The patient thought it was it the Pharmacist who was talking while giving his 5th dose, the last time. He did not have any problem 4 times but the 5th time she hits the patient may be too high in the arm so may be she injured the nerve and whole muscle hurts when he move it. When he move his left arm to now certain points, it was like six, seven level now it is two or three. He believe that is the pharmacist's responsibility but he still want to go to particular specialist for MRIs and could be Orthopedics or muscle skeletal doctor maybe that will be the best.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Joint range of motion decreased, Myalgia, Nerve injury
Clinical narrative: pain/muscle still hurting; injured the nerve; when I move my left arm to now certain points, it was like six, seven level now it is two or three; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "knee and feet arthritis" (unspecified if ongoing); "spine arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster)), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster)), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "pain/muscle still hurting"; NERVE INJURY (non-serious), outcome "unknown", described as "injured the nerve"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "when I move my left arm to now certain points, it was like six, seven level now it is two or three". Therapeutic measures were not taken as a result of myalgia, nerve injury, joint range of motion decreased. Additional information: The patient received 5 Pfizer Vaccines and maybe need only advice because he do not think it is the vaccine itself responsible for this but he received the 5th Pfizer Vaccine (Pfizer COVID-19 Vaccine) on but was still in pain. He do not think it is Pfizer's fault but he think it is Pharmacist who hits his nerve and his muscle. It is still hurting not to that extent as before but it is months it is still hurting so he decided to go to find a doctor who would treat me. The patient thought it was it the Pharmacist who was talking while giving his 5th dose, the last time. He did not have any problem 4 times but the 5th time she hits the patient may be too high in the arm so may be she injured the nerve and whole muscle hurts when he move it. When he move his left arm to now certain points, it was like six, seven level now it is two or three. He believe that is the pharmacist's responsibility but he still want to go to particular specialist for MRIs and could be Orthopedics or muscle skeletal doctor maybe that will be the best.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: pain/muscle still hurting; injured the nerve; when I move my left arm to now certain points, it was like six, seven level now it is two or three; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "knee and feet arthritis" (unspecified if ongoing); "spine arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation; Bnt162b2 (dose 3 (booster)), for COVID-19 immunisation; Bnt162b2 (dose 4 (booster)), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "pain/muscle still hurting"; NERVE INJURY (non-serious), outcome "unknown", described as "injured the nerve"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "when I move my left arm to now certain points, it was like six, seven level now it is two or three". Therapeutic measures were not taken as a result of myalgia, nerve injury, joint range of motion decreased. Additional information: The patient received 5 Pfizer Vaccines and maybe need only advice because he do not think it is the vaccine itself responsible for this but he received the 5th Pfizer Vaccine (Pfizer COVID-19 Vaccine) on but was still in pain. He do not think it is Pfizer's fault but he think it is Pharmacist who hits his nerve and his muscle. It is still hurting not to that extent as before but it is months it is still hurting so he decided to go to find a doctor who would treat me. The patient thought it was it the Pharmacist who was talking while giving his 5th dose, the last time. He did not have any problem 4 times but the 5th time she hits the patient may be too high in the arm so may be she injured the nerve and whole muscle hurts when he move it. When he move his left arm to now certain points, it was like six, seven level now it is two or three. He believe that is the pharmacist's responsibility but he still want to go to particular specialist for MRIs and could be Orthopedics or muscle skeletal doctor maybe that will be the best.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported PROQUAD was administered to one patient after a TE that occurred on 2APR2024; This spontaneous report was received from a registered nurse concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 02-APR-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection dose underwent a temperature excursion of 7.5 degrees Fahrenheit (F) during a time frame of 0 hours, 10 minutes and 0 seconds without previous temperature excursions.  On an unspecified date in April 2024 (reporter was unsure of date), the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, 1 dose, lot #X022919, expiration date: 12-MAR-2025 (dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (product storage error). No additional details provided. No additional adverse events were reported (no adverse event).  This report was considered to be non-valid due to lack of patient's identifiers.  Follow-up information has been received from the same Registered Nurse on 23-APR-2024. The reporter stated that the report was referred to a 3-years-old female patient, who had a birth weight of 3140 grams, and who at the time of vaccination was experiencing an illness reported as allergic cough. On 04-MAR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose 1, subcutaneously in her left tigh, lot number X012609, expiration date was not reported but updated after internal review was confirmed as 29-OCT-2024, purchased with public funds and applied in a private clinic by a trained HCP. The vaccine was stored in clinical practice and underwent a temperature excursion as a result of reading from a digital data logger, and was administered prior to viability confirmed.   This case was previously reported as non-valid case due to lack of patient's identifiers, however, upon follow-up information, the patient's information was reported, and the case at the time of report was confirmed as valid.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Zoster ophthalmicus; Information has been received from a lawyer regarding a case in litigation referring to an approximately 55 year old male patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 20-FEB-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot number were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a health care provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: zoster ophthalmicus. At the time of the report, the pt's outcome was unknown.   Upon internal review zoster ophthalmicus was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Vestibular neuronitis
Clinical narrative: Vestibular neuritis; Information has been received from a lawyer regarding a case in litigation referring to an approximately 56 year old male patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 08-MAR-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route on and lot number were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a health care provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: vestibular neuritis. At the time of the report, the pt's outcome was unknown.   Upon internal review vestibular neuritis was considered to be medically significant.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Felt like I had COVID all over again; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EL9267) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (ongoing); "Pain" (ongoing); "Hyperparathyroidism", start date: 2010, stop date: 2023, notes: Surgical removal of gland Jan2023 at (clinic name withheld).; "COVID", start date: 24Nov2020 (unspecified if ongoing), notes: COVID test positive 24Nov2020. Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing); DOXYCYCLINE (ongoing); AMLODIPINE taken for hypertension (ongoing); DULOXETINE taken for pain (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EL8982), administration date: 01Feb2021, for COVID-19 Immunization. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 22Feb2021, outcome "recovered" (25Feb2021), described as "Felt like I had COVID all over again". Therapeutic measures were not taken as a result of suspected covid-19.  Clinical Course: Patient age at time of vaccination reported as 78, 79, 80, 81 (years). Patient administered covid-19 vaccine of dose 1 on 01Feb2021 (Lot: EL8982); Dose: 3 on 13Oct2021 (Lot: 30135BA); Dose: 4 on 19May2022 (Lot: FS4989) all via Intramuscular route . Doxycycline indicated for face (as reported). Also reported that 1st two vaccines hit hard that he felt like he had COVID all over again. COVID test positive 24Nov2020, in bed for 10 days. Got alone ok with boosters and vaccines until 03Apr2024. Then felt like he had COVID again but it was only 3 days.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: ileocolic intussusception
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: accidentally administered a second dose of Arexvy to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KY9, expiry date 21-AUG-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 19-APR-2024, the patient received the 2nd dose of Arexvy (right deltoid). On 19-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: accidentally administered a second dose of Arexvy to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-APR-2024 and 25-APR-2024 The medical assistant reported that they accidentally administered a second dose of Arexvy to a patient which led to extra dose administered. No symptoms had been reported at this time. The reporter consented to follow up. Case US2024053394 was identified as follow-up to case US2024051404. Case US2024053394 was deleted due to being created in error. All future correspondence will be submitted to case US2024051404.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Influenza like illness, Malaise, Pyrexia, Skin warm
Clinical narrative: 4/17/24 flu-like symptoms - fever? temp., malaise 4/20/24 went to ER. left arm red, warm to touch with spreading erythema   Started on Augmentin 875mg PO BID x 10 days 4/23/24 Back in office, cephalexin 500mg BID x 10 days started.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Blood urine present, Vaginal haemorrhage, Vaginal mucosal blistering
Clinical narrative: Blood in urine and some blistering/blood from her vagina afterwards for a few days.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Somnolence
Clinical narrative: Reported Symptoms: 10013649:DROWSINESS; 10028350:MUSCLE WEAKNESS; Narrative: Other Relevant HX: Other: DROWSY; MUSCLE WEAKNESS
Sex: M
Vaccine: FLUX
Symptoms: Chest pain
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; Narrative: Other Relevant HX: Other: CHEST PAIN
Age: 73.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Death, Haemoglobin increased, Unresponsive to stimuli
Clinical narrative: Reported Symptoms: 10011906:DEATH; Narrative: Patient had same day surgery- excision of malignant lesion left pinna- on 10/24- outpatient procedure, no complications. Patient had a scheduled primary care visit 10/30 where he received routine vaccines- fluzone and boostrix. Patient's spouse notified facility of his death 11/2/23. He was found nonresponsive, no foul play no trauma- pronounced dead by EMS at 2335 on 11/2/23. Recently seen at outside facility- for elevated HgB on 10/20/23. At primary care visit HgB was 20.7, previously was 7.2 on 10/18. Patient also diagnosed with COPD-on oxygen therapy around-the-clock at 3L n/c. 1 PPD smoker x30 years-recent lung scan showed 2 small nodules in upper right lobe-observation *I do not believe there is correlation between the vaccines and the patients' death, however since his death was within 30 days from vaccines, reporting warranted Other Relevant HX: Other: DEATH
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Staring, Tremor
Clinical narrative: Patient was seen in the AM on 4/16/24 and administered the vaccines.  Mother reports that 24 hours post vaccine administration, child had 2 episodes of body shaking and staring oddly at her that lasted 3 seconds each time.
Age: 11.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Wrong product administered
Clinical narrative: 11 yr old was to receive tdap, Menveo and HPV...He had come in along with two other siblings. The 4yr old sibling was also to receive vaccines (Proquad and Kinrix).  I had scanned the 11 yr old label and verified correct pt. I scanned in the vaccines (tap, Menveo and HPV) They all scanned in correctly. I handed the Tdap to my co-worker to administer.  I set the Menveo and HPV down to put on gloves and get the bandaid.  I picked up what I thought was the Menveo and HPV and administered the vaccines.      After administering I realized I had picked up the 4  yr old vaccines-Proquad and Kinrix.     The physician was immediately notified of the mistake and so was the mother. Discussed side effects to look out for.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis
Clinical narrative: Cellulitis 15cmx8cm, afebrile
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure chronic, Cardiac monitoring, Electrocardiogram abnormal, Impaired quality of life
Clinical narrative: Months after vaccine I was diagnosed with sudden Chronic heart failure -30 % refraction rate. Had my heart valves checked and they were all clear Dr,s could not agree on reason of this sudden ailment that has considerably changed my life for the worst.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Ear pain, Tinnitus
Clinical narrative: Loud whooshing sound in both ears accompanied by pain and hearing loss in the right ear. It got progressively worse with each shot, but I didn't really put it together until after the 3rd shot (booster) when extreme pain and loudness got to where it interferes with everyday life.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Blood test normal, Borrelia test, Condition aggravated, Magnetic resonance imaging head normal
Clinical narrative: Within days after receiving the shot, hearing was severely affected and tinnitus increased substantially. ENT doctor has determined that there has been damage to auditory nerve.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Within days after receiving the shot, hearing was severely affected and tinnitus increased substantially. ENT doctor has determined that there has been damage to auditory nerve.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Injection site swelling, Malaise
Clinical narrative: Started having chills, shaking, and headache.  Overall general malaise. Temperature was 98.2 degrees. These symptoms lasted 36 hours. A rash developed at the injection site measuring about 5" long and 4" wide with swelling under it.  Severe itching in the left palm of the hand. The rash and itching are still occuring  3 days later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Tremor
Clinical narrative: Started having chills, shaking, and headache.  Overall general malaise. Temperature was 98.2 degrees. These symptoms lasted 36 hours. A rash developed at the injection site measuring about 5" long and 4" wide with swelling under it.  Severe itching in the left palm of the hand. The rash and itching are still occuring  3 days later.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Admit date: 4/22/2024  Discharge date: 4/30/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD  Reason for Admission: Acute on chronic hypoxemic and hypercapnic respiratory failure  Hospital Course:  This is a 57-year-old female with significant past medical history of chronic respiratory failure on 3 L by nasal cannula, chronic obstructive pulmonary disease, GERD, hypothyroidism, and anxiety/depression who presented to the dyspnea found to have acute on chronic hypoxemic and hypercapnic respiratory failure due to chronic obstructive pulmonary disease exacerbation and COVID pneumonia.  Acute on Chronic Respiratory Failure- at baseline COPD Exacerbation- resolved Covid Pna - required brief stay in intensive care unit for management of respiratory failure, however did not require intubation.  She required BiPAP initially throughout the day and then progressed to only nightly which is baseline for her - initially started on IV steroids, then progressed to oral prednisone.  She will be discharged on a 2 week taper - budesonide-formeterol inhaler, guaifenesin, ipratropium-albuterol, and roflumilast scheduled. Albuterol nebulizer prn - she completed 5 day course of ceftriaxone. Continued home azithromycin.  - palliative and hospice discussions were planned for goals of care discussions, however patient declined further discussion at this time Discharged to Home Healthcare
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Intensive care, Positive airway pressure therapy, Respiratory failure
Clinical narrative: Admit date: 4/22/2024  Discharge date: 4/30/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD  Reason for Admission: Acute on chronic hypoxemic and hypercapnic respiratory failure  Hospital Course:  This is a 57-year-old female with significant past medical history of chronic respiratory failure on 3 L by nasal cannula, chronic obstructive pulmonary disease, GERD, hypothyroidism, and anxiety/depression who presented to the dyspnea found to have acute on chronic hypoxemic and hypercapnic respiratory failure due to chronic obstructive pulmonary disease exacerbation and COVID pneumonia.  Acute on Chronic Respiratory Failure- at baseline COPD Exacerbation- resolved Covid Pna - required brief stay in intensive care unit for management of respiratory failure, however did not require intubation.  She required BiPAP initially throughout the day and then progressed to only nightly which is baseline for her - initially started on IV steroids, then progressed to oral prednisone.  She will be discharged on a 2 week taper - budesonide-formeterol inhaler, guaifenesin, ipratropium-albuterol, and roflumilast scheduled. Albuterol nebulizer prn - she completed 5 day course of ceftriaxone. Continued home azithromycin.  - palliative and hospice discussions were planned for goals of care discussions, however patient declined further discussion at this time Discharged to Home Healthcare
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Diffuse erythematous, raised rash. Started on extremities and spread to whole body within 48 hours.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Felt faint, profuse sweating immediately after injection.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Acute respiratory failure, Albumin CSF increased, Asthenia, CSF culture negative, CSF protein increased
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: CSF red blood cell count positive, CSF white blood cell count decreased, Computerised tomogram head normal, Endotracheal intubation, Gastroenteritis viral
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Incentive spirometry, Intensive care, Lung disorder
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Mechanical ventilation, Muscular weakness, Neurological decompensation
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Paraesthesia, Pneumonia aspiration, Positive airway pressure therapy, Productive cough, Sputum discoloured
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.
Age: 85.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Traumatic lumbar puncture, Treatment failure
Clinical narrative: 1. Guillain-Barré Syndrome: Presented to the ED on 2/22 with progressive LE weakness as a pins-and-needles on her arms.  neurology suspected GBS. Etiology unclear, but thought that GBS was precipitated by viral gastroenteritis on 2/19 vs RSV vaccine. Head CT, MRI of brain and spine was negative for source of presenting neurological condition. IVIG was started for 7 days with last date on 2/28.  LP results revealed elevated albumin consistent with albuminocytologic dissociation suggestive of GBS, elevated RBCs which was thought to be secondary to traumatic tap and culture negative with a protein of 104. Pt was intubated as discussed below, is now extubated. Her neurologic status continued to improve and she is gaining strength in upper and lower extremities. Plan to cont working with PT/OT and transfer to acute rehab  2. Hypoxic respiratory failure: Pt was intubated (not emergently) on 2/24 after failing BiPAP and Vapotherm. AHRF thought to be multifactorial in the setting of GBS and aspiration pneumonia. Extubated on 3/2 and reintubated for ventilatory support due to slow improvement in stamina. Pt was under the care of pulmonology/CCU while intubated. She was ultimately extubated on 3/8.  Following extubation the patient's respiratory function steadily improved.  She had a cough productive of yell yellow sputum which progressed to clear sputum and then eventually resolved completely by 3/19.  Patient worked with respiratory therapy and was compliant with using her incentive spirometer multiple times a day.  By 3/18 she no longer required supplemental oxygen.