chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Patient had severe sharp pain running down her arm from her shoulder to her elbow immediately following injection. The bicept muscle was spasaming multiple times for about 10 minutes after injection. Patient's vital signs were normal once paramedics arrived and all symptoms had resolved, except for a tingleing in three of her finger tips. She opted to take the ambulance to the hospital just to be sure that everything checked out
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was accidentally given HPV vaccine twice in same visit as 1 was intended for twin sibling  had NO adverse events or side effects from receiving 2 doses in same visit
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a third dose of Shingrix. No known adverse events have been noted at time of this submission.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a third dose of Shingrix. No known adverse events have been noted at time of this submission.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient has already received Spikevax (Moderna COVID vaccine) on 10/26/23, the newest COVID vaccine per guidelines. This vaccine was administered in error.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19-2, UNK
Symptoms: Dyspnoea, Rash, Rash erythematous
Clinical narrative: Two days after vaccine I started getting red pin head sized dots on limbs and buttocks, they got bigger dime size and have multiplied, and continue. I have no itching or pain.  Saw my dermatologist, Dr., who prescribed a steroid cream which I am taking not for six weeks.  Rash is still with me and continues to duplicate, my breathing is a bit harder.  I looked at different rashes and it looks like pityriasis rosea.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Atrial flutter, Cardioversion, Electrocardiogram abnormal
Clinical narrative: Atrial Flutter,,  electric defibrillator plus IV meds , hospitalized for 12 hours,
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient had no adverse effects. Patient received a 2nd Hep A shot 2 months after receiving the first dose. Should have received 2nd dose 6 months after the first.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: Sudden onset of tinnitus
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Cerebrovascular accident, Echocardiogram normal, Electrocardiogram normal, Hemiparesis, Lipids normal
Clinical narrative: Patient received flu vaccine in Sept 2023 and COVID/RSV vaccines on the same day in Nov 2023. 2 weeks after receiving the COVID/RSV vaccines, patient developed left arm/left leg weakness and was found to have a right ACA stroke on MRI. Patient was fully functional prior to this hospitalization and was only taking medications for hypothyroid and supplements for osteoporosis.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Magnetic resonance imaging head abnormal, Muscular weakness
Clinical narrative: Patient received flu vaccine in Sept 2023 and COVID/RSV vaccines on the same day in Nov 2023. 2 weeks after receiving the COVID/RSV vaccines, patient developed left arm/left leg weakness and was found to have a right ACA stroke on MRI. Patient was fully functional prior to this hospitalization and was only taking medications for hypothyroid and supplements for osteoporosis.
Age: 66.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Anxiety, Blood iron decreased, Blood oestrogen increased, Blood potassium decreased, Blood sodium decreased
Clinical narrative: Stuffed up nose, went to Urgent Care twice for symptoms, given drugs and nasal spray.  Legs, ankles, feet went cold from the inside out, skin was not cold.  Saw vascular doc and it was not a vascular problem.  Huge appetite which continues today.  Had several blood draws, elevated white blood cells, low potassium, low sodium and low iron all showed up on report.  No longer felt like myself prior to vaccination, now I am anxious and depressed. Prior to vaccination A1C was 5.67, not it is 6.2.  Writing my name became difficult, neuology problem?  it still comes and goes.  Cognitive memory was different, felt like Alzheimers, could no longer track conversations.  No longer drive on the freeway, my husband drives me lots of places.
Age: 66.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Cognitive disorder, Depressed mood, Dysgraphia, Feeling abnormal, Glycosylated haemoglobin increased
Clinical narrative: Stuffed up nose, went to Urgent Care twice for symptoms, given drugs and nasal spray.  Legs, ankles, feet went cold from the inside out, skin was not cold.  Saw vascular doc and it was not a vascular problem.  Huge appetite which continues today.  Had several blood draws, elevated white blood cells, low potassium, low sodium and low iron all showed up on report.  No longer felt like myself prior to vaccination, now I am anxious and depressed. Prior to vaccination A1C was 5.67, not it is 6.2.  Writing my name became difficult, neuology problem?  it still comes and goes.  Cognitive memory was different, felt like Alzheimers, could no longer track conversations.  No longer drive on the freeway, my husband drives me lots of places.
Age: 66.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Impaired driving ability, Increased appetite, Memory impairment, Muscular weakness, Nasal congestion
Clinical narrative: Stuffed up nose, went to Urgent Care twice for symptoms, given drugs and nasal spray.  Legs, ankles, feet went cold from the inside out, skin was not cold.  Saw vascular doc and it was not a vascular problem.  Huge appetite which continues today.  Had several blood draws, elevated white blood cells, low potassium, low sodium and low iron all showed up on report.  No longer felt like myself prior to vaccination, now I am anxious and depressed. Prior to vaccination A1C was 5.67, not it is 6.2.  Writing my name became difficult, neuology problem?  it still comes and goes.  Cognitive memory was different, felt like Alzheimers, could no longer track conversations.  No longer drive on the freeway, my husband drives me lots of places.
Age: 66.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Peripheral coldness, White blood cell count increased
Clinical narrative: Stuffed up nose, went to Urgent Care twice for symptoms, given drugs and nasal spray.  Legs, ankles, feet went cold from the inside out, skin was not cold.  Saw vascular doc and it was not a vascular problem.  Huge appetite which continues today.  Had several blood draws, elevated white blood cells, low potassium, low sodium and low iron all showed up on report.  No longer felt like myself prior to vaccination, now I am anxious and depressed. Prior to vaccination A1C was 5.67, not it is 6.2.  Writing my name became difficult, neuology problem?  it still comes and goes.  Cognitive memory was different, felt like Alzheimers, could no longer track conversations.  No longer drive on the freeway, my husband drives me lots of places.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Moderate severe local reaction, doesn't appear to be cellulitis. Right thigh redness, no streaking, tender.  7x7cm area
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Laboratory test, Muscle spasms
Clinical narrative: Leg cramp Fatigue Rash Heart Palpitations dizziness Know have chronic joint pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: Leg cramp Fatigue Rash Heart Palpitations dizziness Know have chronic joint pain
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient scheduled her annual flu shot and completed her questionnaire/consent online through her health portal. Patient was asked by RN on arrival if she had received her flu shot for this flu season and patient stated No. After administering the flu vaccine, Nurse pulled up the patient's immunization record to print it and noticed that patient had received Fluzone Quadrivalent on 11/13/23 (Lot # U8192AA, Left Deltoid). When patient was told that she had, in fact, already received her flu vaccine, she was very apologetic stating that she forgot that she had come in to get the vaccine. This nurse spoke with patient 12/5/23 who denied any adverse reactions of affect from 2nd vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product expiration date issue
Clinical narrative: ADMINISTRATION ERROR: Expiration date on EW0185 had been extended 3 months from 8/30/21 to 11/30/21. On 12/1/21, at our weekly vaccine clinic, we did not catch midnight expiration from 11/30 to new month of 12/1. A total of 56 doses were administered during our 3 hour clinic (3PM-6PM) - 6 first doses, 2 second doses, 48 booster doses. *Although technically a new month and considered "expired", had we been in a 31 day month the lot would still be considered in date - the month time-frame is arbitrary in that a month can be 28, 30, or 31 days. *Expired status of administered vaccine was based on manufacturer's exp date - not expired past admix/prep time once reconstituted.  *Vaccine had been stored in ultracold freezer until use  I have included a list of the patients who received this lot number on that date.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Reporter was 34 weeks pregnant at the time she received the vaccine.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy (right arm). On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant at the time she received the vaccine.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Last Menstrual Period Date: 28-MAR-2023 Estimated Delivery/Due date: 02-JAN-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date:29-NOV-2023 The reporter was a pregnant woman who received Arexvy shot in her right arm and she was doing fine.  The reporter was 34 weeks pregnant at the time she received the vaccine. The patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Reporter was 34 weeks pregnant at the time she received the vaccine.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy (right arm). On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant at the time she received the vaccine.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Last Menstrual Period Date: 28-MAR-2023 Estimated Delivery/Due date: 02-JAN-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date:29-NOV-2023 The reporter was a pregnant woman who received Arexvy shot in her right arm and she was doing fine.  The reporter was 34 weeks pregnant at the time she received the vaccine. The patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Reporter was 34 weeks pregnant at the time she received the vaccine.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy (right arm). On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant at the time she received the vaccine.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Last Menstrual Period Date: 28-MAR-2023 Estimated Delivery/Due date: 02-JAN-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date:29-NOV-2023 The reporter was a pregnant woman who received Arexvy shot in her right arm and she was doing fine.  The reporter was 34 weeks pregnant at the time she received the vaccine. The patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women; pharmacy was out of Abrysvo and pregnant patient received Arexvy; pregnant patient 34year old received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number c9gb5, expiry date 30-MAR-2025) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: pharmacy was out of Abrysvo and pregnant patient received Arexvy ) and inappropriate age at vaccine administration (Verbatim: pregnant patient 34year old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-NOV-2023 The registered pharmacist reported a pregnant patient 34year old received Arexvy on 20th November 2023 which led to Inappropriate age at vaccine administration.  The pharmacist was not the one who administered it. It was a certified technician but was reviewed and signed off on by pharmacist on duty that was currently on vacation so caller is unable to share specific details of how this may have occurred.  She states the pharmacy was out of Abrysvo and she thinks there might be some miscommunication since only Abrysvo is indicated for pregnant women and received Arexvy, which led to Wrong vaccine administered.  She states they were going to have a talk today at the pharmacy with the technicians regarding this since she thinks they might not know that only one of the RSV vaccines was approved for use in pregnant women. When asked, RPh was unsure what week of pregnancy the patient is in or when her delivery date is but thinks it is probably 32-26 weeks given that is when they administer Abrysvo and they will verify this with patients. Consented to follow up
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women; pharmacy was out of Abrysvo and pregnant patient received Arexvy; pregnant patient 34year old received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number c9gb5, expiry date 30-MAR-2025) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: pharmacy was out of Abrysvo and pregnant patient received Arexvy ) and inappropriate age at vaccine administration (Verbatim: pregnant patient 34year old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-NOV-2023 The registered pharmacist reported a pregnant patient 34year old received Arexvy on 20th November 2023 which led to Inappropriate age at vaccine administration.  The pharmacist was not the one who administered it. It was a certified technician but was reviewed and signed off on by pharmacist on duty that was currently on vacation so caller is unable to share specific details of how this may have occurred.  She states the pharmacy was out of Abrysvo and she thinks there might be some miscommunication since only Abrysvo is indicated for pregnant women and received Arexvy, which led to Wrong vaccine administered.  She states they were going to have a talk today at the pharmacy with the technicians regarding this since she thinks they might not know that only one of the RSV vaccines was approved for use in pregnant women. When asked, RPh was unsure what week of pregnancy the patient is in or when her delivery date is but thinks it is probably 32-26 weeks given that is when they administer Abrysvo and they will verify this with patients. Consented to follow up
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women; pharmacy was out of Abrysvo and pregnant patient received Arexvy; pregnant patient 34year old received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number c9gb5, expiry date 30-MAR-2025) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: pharmacy was out of Abrysvo and pregnant patient received Arexvy ) and inappropriate age at vaccine administration (Verbatim: pregnant patient 34year old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: She states the pharmacy was out of Abrysvo and she thinks there may be some miscommunication since only Abrysvo is indicated for pregnant women). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 27-NOV-2023 The registered pharmacist reported a pregnant patient 34year old received Arexvy on 20th November 2023 which led to Inappropriate age at vaccine administration.  The pharmacist was not the one who administered it. It was a certified technician but was reviewed and signed off on by pharmacist on duty that was currently on vacation so caller is unable to share specific details of how this may have occurred.  She states the pharmacy was out of Abrysvo and she thinks there might be some miscommunication since only Abrysvo is indicated for pregnant women and received Arexvy, which led to Wrong vaccine administered.  She states they were going to have a talk today at the pharmacy with the technicians regarding this since she thinks they might not know that only one of the RSV vaccines was approved for use in pregnant women. When asked, RPh was unsure what week of pregnancy the patient is in or when her delivery date is but thinks it is probably 32-26 weeks given that is when they administer Abrysvo and they will verify this with patients. Consented to follow up
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Cardio-respiratory arrest, Hyperhidrosis, Hypotension
Clinical narrative: On 12/05/23, 51 yo F presented to clinic for Nurse Only visit for vaccination. At 0947, pt received Covid-19 Vaccine 50mcg/0.5ml (>=12yrs)Moderna (SPIKEVAAX COVID 23-24 formula) 0.5 mL in left deltoid (Lot #8059072; Exp: 04/30/2024). Pt had received 5 previous COVID vaccinations without incident. Within 10 minutes of injection, pt turned pale with diaphoresis, hypotension (BP: 70/45), bradycardia (HR: 30s), and slow to respond. Pt assisted to supine position and began experiencing seizure-like activity with audible breathing. EMS called, O2 applied via nasal cannula and gentle chest compressions started with improved heart rate. EMS arrived, placed and IV and started IV fluids. BP improved to 112/34. Pt never lost consciousness and was talking and answering questions at time of transport to ED. Per ED notes: "Pt stable on arrival to ED". "lab work reviewed and is reassuring, EKG is unremarkable. Pt discharged from ED with "Final diagnoses: Syncope, unspecified syncope type".
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Electrocardiogram normal, Hyperhidrosis, Hyporesponsive to stimuli, Hypotension
Clinical narrative: On 12/05/23, 51 yo F presented to clinic for Nurse Only visit for vaccination. At 0947, pt received Covid-19 Vaccine 50mcg/0.5ml (>=12yrs)Moderna (SPIKEVAAX COVID 23-24 formula) 0.5 mL in left deltoid (Lot #8059072; Exp: 04/30/2024). Pt had received 5 previous COVID vaccinations without incident. Within 10 minutes of injection, pt turned pale with diaphoresis, hypotension (BP: 70/45), bradycardia (HR: 30s), and slow to respond. Pt assisted to supine position and began experiencing seizure-like activity with audible breathing. EMS called, O2 applied via nasal cannula and gentle chest compressions started with improved heart rate. EMS arrived, placed and IV and started IV fluids. BP improved to 112/34. Pt never lost consciousness and was talking and answering questions at time of transport to ED. Per ED notes: "Pt stable on arrival to ED". "lab work reviewed and is reassuring, EKG is unremarkable. Pt discharged from ED with "Final diagnoses: Syncope, unspecified syncope type".
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Pallor, Seizure like phenomena, Syncope
Clinical narrative: On 12/05/23, 51 yo F presented to clinic for Nurse Only visit for vaccination. At 0947, pt received Covid-19 Vaccine 50mcg/0.5ml (>=12yrs)Moderna (SPIKEVAAX COVID 23-24 formula) 0.5 mL in left deltoid (Lot #8059072; Exp: 04/30/2024). Pt had received 5 previous COVID vaccinations without incident. Within 10 minutes of injection, pt turned pale with diaphoresis, hypotension (BP: 70/45), bradycardia (HR: 30s), and slow to respond. Pt assisted to supine position and began experiencing seizure-like activity with audible breathing. EMS called, O2 applied via nasal cannula and gentle chest compressions started with improved heart rate. EMS arrived, placed and IV and started IV fluids. BP improved to 112/34. Pt never lost consciousness and was talking and answering questions at time of transport to ED. Per ED notes: "Pt stable on arrival to ED". "lab work reviewed and is reassuring, EKG is unremarkable. Pt discharged from ED with "Final diagnoses: Syncope, unspecified syncope type".
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional (reported as primary care) via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2310USA002275), concerning a 11-year-old female patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 09-JUL-2003, patient was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 22-OCT-2013, the patient was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).; Sender's Comments:  US-009507513-2310USA002275: US-009507513-2311USA005952: US-009507513-2311USA006630:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional (reported as primary care) via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2310USA002275), concerning a 6-months-old female patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 05-SEP-2002, the patient was vaccinated with a first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 07-NOV-2002, the patient was vaccinated with a second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 24-JAN-2003, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered) and on 19-MAY-2004, she was vaccinated with the fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Extra dose administered).; Sender's Comments:  US-009507513-2310USA002275:Source case: 2310USA002275 US-009507513-2311USA006377: US-009507513-2311USA005952:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Muscle disorder
Clinical narrative: muscles in his arms, legs, and abdominal muscles not working; He was bleeding and had to call emergency services.; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (He was bleeding and had to call emergency services.) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer ((lot number EL9261)) on 05-Feb-2021, Pfizer ((lot number EN6200)) on 26-Feb-2021, Pfizer ((lot number FS2589)) on 30-Sep-2021, Pfizer ((lot number FJ9943)) on 12-Apr-2022, Pfizer ((lot number KR26843)) on 01-Oct-2022, Pfizer ((lot number KR26843)) on 12-May-2023 and Flu (Flu in September). Past adverse reactions to the above products included No adverse event with Flu, Pfizer, Pfizer, Pfizer, Pfizer, Pfizer and Pfizer.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HAEMORRHAGE (He was bleeding and had to call emergency services.) (seriousness criterion medically significant). On 20-Oct-2023 at 3:00 AM, the patient experienced MUSCLE DISORDER (muscles in his arms, legs, and abdominal muscles not working). On 23-Oct-2023, HAEMORRHAGE (He was bleeding and had to call emergency services.) had resolved. At the time of the report, MUSCLE DISORDER (muscles in his arms, legs, and abdominal muscles not working) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that in the night at about 3am after that dose he woke up with his muscles in his arms, legs, and abdominal muscles not working. He slid off the bed and wedged himself between his nightstand and bed. The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case concerning a 74-year-old male patient with no medical history reported, who experienced the serious (per medically significant) unexpected event of Haemorrhage which occurred on the same day after a dose of mRNA-1273.815 for COVID-19 Vaccination. It was reported that in the night at about 3am after that dose he woke up with his muscles in his arms, legs, and abdominal muscles not working. It was also reported that he slid off the bed and wedged himself between his nightstand and bed, an ambulance took him to the hospital where he was not given any medications or treatments. Cardiac tests were performed but results were not provided. His symptoms significantly improved after 2 days. By the 3rd day he was able to get out of bed on his own. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain, Pain in extremity, Pyrexia
Clinical narrative: achiness; low grade fever; Arm soreness; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achiness) and PYREXIA (low grade fever) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 03-Dec-2023, the patient experienced PAIN IN EXTREMITY (Arm soreness), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low grade fever). On an unknown date, the patient experienced PAIN (achiness). At the time of the report, PAIN IN EXTREMITY (Arm soreness), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achiness) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided by the reporter.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Hyperhidrosis, Irritability, Vaccination site erythema
Clinical narrative: Red spots on thigh of vaccine area. Lots of irritability, followed by sweating with no fever. Everything except the red dots have  resolved.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Injection site swelling, Oropharyngeal pain, Somnolence
Clinical narrative: Extreme fatigue/tiredness sleepy following day I have a sore throat and repeat of tiredness.  Slight soreness on injection site, very mild.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: leg pain; hip pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (hip pain) in a 54-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (hip pain). At the time of the report, PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (hip pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient had hip pain and leg pain at least three weeks. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided by the reporter.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient was scheduled for their second dose of VAQTA on 30NOV2023 but did not receive the dose due to "being sick."; This spontaneous report was received from a nurse concerning an 18-month-old female patient. The patient's concurrent condition, medical history, and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection for routine vaccination (dose, lot#, expiry date, route of administration and anatomical location not reported).   On 30-NOV-2023, the patient did not receive the scheduled for the second dose of hepatitis A vaccine, inactivated (VAQTA) due to "being sick" (Illness). It was unknown whether the patient sought medical attention or received treatment for the event. No additional information was known. No additional adverse event (AE) was reported. At the reporting time, the patient had not recovered from Illness. The action taken with hepatitis A vaccine, inactivated (VAQTA) was withdrawn with negative dechallenge.  The causal relationship between Illness and hepatitis A vaccine, inactivated (VAQTA) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: the patient has not reported an other AEs. No PQC/additional AE reported; Physician reported that a member of her medical team inadvertently reconstituted the VARIVAX with the incorrect diluent before administering the dose today; Dose administered after reconstitution with incorrect diluent; This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection as prophylaxis (dose, lot#, expiry date, route of administration and anatomical location not reported).   On 30-NOV-2023, a member of the medical team inadvertently reconstituted 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) with the incorrect diluent before administering the dose (this was the patient's second dose in the series) (dose, lot#, expiry date, route of administration and anatomical location not reported) (product preparation error, incorrect product formulation administered). No other/additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza, Nasopharyngitis, Product availability issue, Vaccination failure
Clinical narrative: tiny outbreaks/suspected vaccination failure; tiny outbreaks; Cold; Flu issue; shortage in my area at that time; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: tiny outbreaks/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: tiny outbreaks), cold (Verbatim: Cold), influenza (Verbatim: Flu issue) and product availability issue (Verbatim: shortage in my area at that time). The patient was treated with aciclovir sodium (Acyclovir). The outcome of the vaccination failure and product availability issue were unknown and the outcome of the shingles, cold and influenza were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, cold and influenza to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, cold and influenza to be related to Shingrix and Shingrix.   Additional Information: RA Receipt Date: 29-NOV-2023 The patient was self-reported. The patient had the Shingrix vaccine about five years ago and there was a shortage in his/her area at that time and he/she could not get the second dose until eleven months after the first (instead of three to six months).  Since that time, the patient had tiny outbreaks that seem to happen whenever he/she had a cold or flu issue and start taking acylclovir when it happens and keep it on hand. The patient wanted to know was it okay or should he/she retake the Shingrix vaccination series and had asked doctors and pharmacists and they were not sure. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Epistaxis, Headache, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site; headache; feeling muscle ache in his upper right chest near the shoulder; bleeding in his right nostril; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-NOV-2023, the patient received Arexvy (left deltoid). On 28-NOV-2023, 1 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: Soreness at injection site), headache (Verbatim: headache), musculoskeletal chest pain (Verbatim: feeling muscle ache in his upper right chest near the shoulder) and epistaxis (Verbatim: bleeding in his right nostril). On 28-NOV-2023, the outcome of the epistaxis was resolved. The outcome of the injection site pain, headache and musculoskeletal chest pain were unknown.   It was unknown if the reporter considered the injection site pain, headache, musculoskeletal chest pain and epistaxis to be related to Arexvy.     It was unknown if the company considered the injection site pain, headache, musculoskeletal chest pain and epistaxis to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-NOV-2023 The patient self-reported this case. The patient Arexvy vaccine in upper left arm and today (on the day of reporting) he felt muscle ache in his upper right chest near the shoulder. He also had headache and soreness at the injection site on day of reporting. The patient also had bleeding in right nostril. The reporter did not consent to follow up.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: received Engerix-B adult dose to child; received Engerix-B adult dose to child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-month-old female patient who received HBV (Engerix B adult) (batch number FR334, expiry date 24-AUG-2024) for prophylaxis.   Concurrent medical conditions included heart disorder (corrected transposition of great vessels to heart). Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX).   On 28-NOV-2023, the patient received Engerix B adult. On 28-NOV-2023, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: received Engerix-B adult dose to child) and overdose (Verbatim: received Engerix-B adult dose to child). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: RA Receipt date: 29-NOV-2023 A reporter reported that Medical assistant administered a adult Engerix dose to a 6 month old child with a heart issue (corrected transposition of great vessels to heart) as their second dose instead of Recombivax.  Patient had been behind schedule and received their first dose of Recombivax at 4 months and yesterday at their 6 month visit received Engerix-B adult dose.  A 6 month old patient received adult Engerix dose which led to Overdose and Adult product administered to child. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: felt like "a truck ran through her whole body; arm hurt; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt like "a truck ran through her whole body), PAIN IN EXTREMITY (arm hurt), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like "a truck ran through her whole body), PAIN IN EXTREMITY (arm hurt), CHILLS (chills) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (felt like "a truck ran through her whole body), PAIN IN EXTREMITY (arm hurt), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported the patient got her first shot at around 2pm in the afternoon and had chills by 9pm. At 2am "that night," the patient had a fever, which broke at about 8am the next morning. The patient felt like "a truck ran through her whole body." She got more chills the whole day. When the patient got her second shot, around 11 am, she had the same symptoms, but this time her arm hurt, and the symptoms lasted longer. The patient reported she never had COVID-19.
Age: 82.0
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: got my flu shot . made me feel bad for about a week, red spot showed up about the size of a dime where the injection was given it has remained till this date (12/02/2023) I had reported it earlier this year but never heard back. I had showed it to my physician. I think I will fore go this years shot.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Rhinorrhoea, Sneezing
Clinical narrative: 2 days after getting the new shingrix vaccine for shingles, and continuing ever since, I have been sneezing occasionally and constantly having a runny nose. Medicinally I take simvastatin/exitamibe, ramipril, and eliquis. I have mild AFIB
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Persistant pain in (L) arm for 5 weeks after. same numbness in (L) arm. Pain (L) arm deltoid area, numbness in (L) axillary region and distally on upper arm.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and warmth with some swelling in Right arm, at and around deltoid area.
Age: 75.0
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Right posterior deltoid with erythema and nodular induration at site. No drainage, but did have some before.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Chest X-ray, Computerised tomogram abdomen normal, Death, Echocardiogram abnormal
Clinical narrative: Patient received vaccine 10/31. Started having nausea, fatigue 11/1. Presented to the ER 11/4 in cardiogenic shock.  EKG with some inferolateral ST elevation with ST depression in aVR indicative of possible pericardial involvement. Echo with  significant impairment, small pericardial effusion. Admitted to the ICU on pressors, was intubated, but ultimately passed 11/5
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram ST segment depression, Electrocardiogram ST segment elevation, Endotracheal intubation, Fatigue
Clinical narrative: Patient received vaccine 10/31. Started having nausea, fatigue 11/1. Presented to the ER 11/4 in cardiogenic shock.  EKG with some inferolateral ST elevation with ST depression in aVR indicative of possible pericardial involvement. Echo with  significant impairment, small pericardial effusion. Admitted to the ICU on pressors, was intubated, but ultimately passed 11/5
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Nausea, Pericardial effusion, Systolic dysfunction, Troponin
Clinical narrative: Patient received vaccine 10/31. Started having nausea, fatigue 11/1. Presented to the ER 11/4 in cardiogenic shock.  EKG with some inferolateral ST elevation with ST depression in aVR indicative of possible pericardial involvement. Echo with  significant impairment, small pericardial effusion. Admitted to the ICU on pressors, was intubated, but ultimately passed 11/5
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Patient complained of fatigue.  He states he felt generalized fatigue and out of breath.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: PATIENT STATED THE ARM INJECTED WITH AREXVY IS NUMB AND HAVE ALOT OF DIFFICULTY MOVING IT