chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Maternal exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 05-AUG-2024, the patient received Tdap Vaccine (intramuscular). On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced vaccine exposure during pregnancy (Verbatim: Maternal exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Tdap Vaccine): 28 Weeks Pregnancy Exposure (Tdap Vaccine): To mother in third trimester Last Menstrual Period Date: 25-JAN-2024 Estimated Delivery/Due date: 31-OCT-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 30-OCT-2024 Nurse reported that a patient who was exposed to vaccines Influenza [Fluzone] and Tdap (Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid) in context of vaccine administered to pregnant patient. Data regarding this pregnancy were received prospectively, that was before pregnancy outcome was known. The reported vaccine administered to pregnant patient (with no reported adverse event) occurred at 31 weeks of pregnancy and the patient was exposed to Influenza Vaccine at 31 weeks of pregnancy and to Tdap at 28 weeks of pregnancy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancies.  The pregnant patient received a dose of suspect TDAP not produced by Sanofi Pasteur which led to vaccine exposure during pregnancy.
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Dizziness, Hypoacusis, Injection site pain, Loss of consciousness
Clinical narrative: Loss of consciousness / she passed out for about 5 to 10 seconds; Dizziness / felt dizzy; Hypoacusis / had a muffled sound in her ears; Injection site pain / Second vaccine (Novavax) hurts more than the Flucelvax; This spontaneous case, initially received on 05-Nov-2024, was reported by a health professional via health authority from Vaccine Adverse Event Reporting System (VAERS) (reference number 2796784-1)  and concerns an adolescent female patient.  No medical history or allergies were reported. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 07-Oct-2024, the patient received Flucelvax (TIV) for Influenza immunization, dose reported as 1 Route of administration: Intramuscular, anatomical location: right arm. Batch number reported as 946588.   Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), for COVID-19 immunization, dose reported as 1 Route of administration: Intramuscular, anatomical location: left arm. Batch number reported as 6024MF014A  Adverse reactions/events and outcomes: On 07-Oct-2024, the patient experienced Loss of consciousness / she passed out for about 5 to 10 seconds (Medically Significant, outcome: Recovered / Resolved, stop date: 07-oct-2024), Dizziness / felt dizzy (outcome: Recovered / Resolved,  stop date: 07-oct-2024), Hypoacusis / had a muffled sound in her ears (outcome: Recovered / Resolved,  stop date: 07-oct-2024), Injection site pain / Second vaccine (Novavax) hurts more than the Flucelvax (outcome: Recovered / Resolved; stop date: 07-oct-2024).  Patient reported second vaccine (novavax) hurt more than the Flucelvax. She got up after the vaccine and was about 25 feet away m the pharmacy and had a muffled sound in her ears. She then felt dizzy. Her mom reported she passed out for about 5 to 10 seconds. they grabbed the emergency kit and by the time she got to her less than a minute later she regained consciousness. she had her elevated her feet higher than her heart, placed an ice pack behind her head. After 15 minutes she was feeling better and she left. reporter spoke with mother an hour later and she said she was fine.  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: Seriousness and causality assessment was not provided by the reporter.  Follow-up (21-Nov-2024) received from a consumer: Indication for both suspect updated, Events stop date added and narrative updated accordingly.; Reporter's Comments: Causality: Related due to plausible temporal relationship (on same day of vaccination), of note covid 19 vaccine received at the same time can be considered as confounder.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Electromyogram normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: PATIENT RECEIVED THE FLU HIGH DOSE ON 10/1/24 AND ON 10/9/24 WENT TO THE ER DEPT WITH NEUROLOGICAL SYMPTOMS. SHE HAD NUMBNESS AND TINGLING IN HANDS AND LEGS AND ARMS. SHE HAD MUSCLE STIFFNESS. SHE FELL TO THE FLOOR. SHE HAD FOGGY VISION. THE ER MD DID MRI/CT SCAN AND EKG..  THE TEST DID NOT SHOW ANYTHING SO MD ATTRIBUTED IT TO THE FLU SHOT. SHE SPENT 2 DAYS IN THE HOSPITAL..SHE ALREADY SAW HER PRIMARY MD AND A NEUROLOGIST.. SHE WILL F/U WITH HER PRIMARY MD ON 12/17/24 ... ON 11/29/24 THE PATIENT TOLD ME THAT SHE IS SLIGHTLY BETTER
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT RECEIVED THE FLU HIGH DOSE ON 10/1/24 AND ON 10/9/24 WENT TO THE ER DEPT WITH NEUROLOGICAL SYMPTOMS. SHE HAD NUMBNESS AND TINGLING IN HANDS AND LEGS AND ARMS. SHE HAD MUSCLE STIFFNESS. SHE FELL TO THE FLOOR. SHE HAD FOGGY VISION. THE ER MD DID MRI/CT SCAN AND EKG..  THE TEST DID NOT SHOW ANYTHING SO MD ATTRIBUTED IT TO THE FLU SHOT. SHE SPENT 2 DAYS IN THE HOSPITAL..SHE ALREADY SAW HER PRIMARY MD AND A NEUROLOGIST.. SHE WILL F/U WITH HER PRIMARY MD ON 12/17/24 ... ON 11/29/24 THE PATIENT TOLD ME THAT SHE IS SLIGHTLY BETTER
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: PATIENT RECEIVED THE FLU HIGH DOSE ON 10/1/24 AND ON 10/9/24 WENT TO THE ER DEPT WITH NEUROLOGICAL SYMPTOMS. SHE HAD NUMBNESS AND TINGLING IN HANDS AND LEGS AND ARMS. SHE HAD MUSCLE STIFFNESS. SHE FELL TO THE FLOOR. SHE HAD FOGGY VISION. THE ER MD DID MRI/CT SCAN AND EKG..  THE TEST DID NOT SHOW ANYTHING SO MD ATTRIBUTED IT TO THE FLU SHOT. SHE SPENT 2 DAYS IN THE HOSPITAL..SHE ALREADY SAW HER PRIMARY MD AND A NEUROLOGIST.. SHE WILL F/U WITH HER PRIMARY MD ON 12/17/24 ... ON 11/29/24 THE PATIENT TOLD ME THAT SHE IS SLIGHTLY BETTER
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Neurological symptom, Paraesthesia, Vision blurred
Clinical narrative: PATIENT RECEIVED THE FLU HIGH DOSE ON 10/1/24 AND ON 10/9/24 WENT TO THE ER DEPT WITH NEUROLOGICAL SYMPTOMS. SHE HAD NUMBNESS AND TINGLING IN HANDS AND LEGS AND ARMS. SHE HAD MUSCLE STIFFNESS. SHE FELL TO THE FLOOR. SHE HAD FOGGY VISION. THE ER MD DID MRI/CT SCAN AND EKG..  THE TEST DID NOT SHOW ANYTHING SO MD ATTRIBUTED IT TO THE FLU SHOT. SHE SPENT 2 DAYS IN THE HOSPITAL..SHE ALREADY SAW HER PRIMARY MD AND A NEUROLOGIST.. SHE WILL F/U WITH HER PRIMARY MD ON 12/17/24 ... ON 11/29/24 THE PATIENT TOLD ME THAT SHE IS SLIGHTLY BETTER
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: injection high on my left arm at the pharmacy resulted in immediate pain during the administration; pain unlike previous vaccinations for flu, COVID, others. Approximately four hours after vaccine administration,  I developed  progressively severe and persistent pain in my left shoulder and left arm with severely limited range of  motion. The pain was intense and disrupted sleep.  I have no history of left shoulder problems. I contacted my PCP Dr the next morning and was advised to go to the emergency room. I was seen at emergency room, medical campus on Monday morning, November 25, 2024. X-rays of the left shoulder, a basic metabolic panel, C reactive protein, CBC, and ESR were completed. The diagnosis was acute pain of the left shoulder, reactive arthritis of the left shoulder. I was  discharged on the afternoon of Nov 25 and advised to follow up with orthopedic surgery and  D and prescribed oxycodone and prednisone.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Arthritis, Arthritis reactive, C-reactive protein, Full blood count
Clinical narrative: injection high on my left arm at the pharmacy resulted in immediate pain during the administration; pain unlike previous vaccinations for flu, COVID, others. Approximately four hours after vaccine administration,  I developed  progressively severe and persistent pain in my left shoulder and left arm with severely limited range of  motion. The pain was intense and disrupted sleep.  I have no history of left shoulder problems. I contacted my PCP Dr the next morning and was advised to go to the emergency room. I was seen at emergency room, medical campus on Monday morning, November 25, 2024. X-rays of the left shoulder, a basic metabolic panel, C reactive protein, CBC, and ESR were completed. The diagnosis was acute pain of the left shoulder, reactive arthritis of the left shoulder. I was  discharged on the afternoon of Nov 25 and advised to follow up with orthopedic surgery and  D and prescribed oxycodone and prednisone.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Metabolic function test, Pain in extremity, Product administered at inappropriate site
Clinical narrative: injection high on my left arm at the pharmacy resulted in immediate pain during the administration; pain unlike previous vaccinations for flu, COVID, others. Approximately four hours after vaccine administration,  I developed  progressively severe and persistent pain in my left shoulder and left arm with severely limited range of  motion. The pain was intense and disrupted sleep.  I have no history of left shoulder problems. I contacted my PCP Dr the next morning and was advised to go to the emergency room. I was seen at emergency room, medical campus on Monday morning, November 25, 2024. X-rays of the left shoulder, a basic metabolic panel, C reactive protein, CBC, and ESR were completed. The diagnosis was acute pain of the left shoulder, reactive arthritis of the left shoulder. I was  discharged on the afternoon of Nov 25 and advised to follow up with orthopedic surgery and  D and prescribed oxycodone and prednisone.
Age: 61.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Red blood cell sedimentation rate, Sleep disorder, X-ray limb
Clinical narrative: injection high on my left arm at the pharmacy resulted in immediate pain during the administration; pain unlike previous vaccinations for flu, COVID, others. Approximately four hours after vaccine administration,  I developed  progressively severe and persistent pain in my left shoulder and left arm with severely limited range of  motion. The pain was intense and disrupted sleep.  I have no history of left shoulder problems. I contacted my PCP Dr the next morning and was advised to go to the emergency room. I was seen at emergency room, medical campus on Monday morning, November 25, 2024. X-rays of the left shoulder, a basic metabolic panel, C reactive protein, CBC, and ESR were completed. The diagnosis was acute pain of the left shoulder, reactive arthritis of the left shoulder. I was  discharged on the afternoon of Nov 25 and advised to follow up with orthopedic surgery and  D and prescribed oxycodone and prednisone.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Want to scratch with my angle grinder; Suspected vaccination failure; got it about a week ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it about a week ago). On an unknown date, the patient experienced scratch (Verbatim: Want to scratch with my angle grinder). The outcome of the vaccination failure, shingles and scratch were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and scratch to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and scratch to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-OCT-2024 The case was received from the patient via interactive digital media. The reporter reported that he/she got it (shingles) about a week ago and he/she had the Shingles vaccine.  The reporter reported butt, hip and thigh, wanted to scratch with his/her angle grinder. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots after took the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots after took the Pfizer vaccine". The event "blood clots after took the pfizer vaccine" required physician office visit.  Clinical course: five people in reporter's primary care doctor's office also got blood clots after they received the first, the second injection, didn't know which one it was, that caused it but there is definitely a connection to that. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion
Clinical narrative: pulmonary coronary effusion; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLEURAL EFFUSION (hospitalization, life threatening), outcome "recovered", described as "pulmonary coronary effusion". Clinical details: patient was hospitalized for pulmonary coronary effusion after receiving the Pfizer Covid Vaccine, and almost passed away. Hospitalization prolonged was reported as no.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots after took the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots after took the Pfizer vaccine". The event "blood clots after took the pfizer vaccine" required physician office visit. Clinical course: five people in reporter's primary care doctor's office also got blood clots after they received the first, the second injection, didn't know which one it was, that caused it but there is definitely a connection to that. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report received from a Physician from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the implied temporal association, a causal relationship between suspect drug and the reported event Systemic lupus erythematosus cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site cellulitis, Injection site nodule, Injection site swelling
Clinical narrative: Achy; headache; fatigue; sore arm; huge knot, a lot of swelling at injection site; huge knot, a lot of swelling at injection site; cellulitis at injection site; This is a spontaneous report received from an unidentifiable Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tdap, for immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Achy"; HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovered" and all described as "huge knot, a lot of swelling at injection site"; VACCINATION SITE CELLULITIS (non-serious), outcome "recovered", described as "cellulitis at injection site". Therapeutic measures were taken as a result of pain, headache, fatigue, pain in extremity, vaccination site mass, vaccination site swelling, vaccination site cellulitis. Clinical course: Achy, headache, fatigue, sore arm, huge knot, a lot of swelling at injection site, and developed cellulitis at the injection site that spread down half arm and needed antibiotics. Lasted a week before it receded. This is a rare case but it was 10xs worse for patient then the TDAP.  Causality for "achy", "headache", "fatigue", "sore arm", "huge knot, a lot of swelling at injection site" and "cellulitis at injection site" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Achy; headache; fatigue; sore arm; huge knot, a lot of swelling at injection site; huge knot, a lot of swelling at injection site; cellulitis at injection site; This is a spontaneous report received from an unidentifiable Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tdap, for immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Achy"; HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovered" and all described as "huge knot, a lot of swelling at injection site"; VACCINATION SITE CELLULITIS (non-serious), outcome "recovered", described as "cellulitis at injection site". Therapeutic measures were taken as a result of pain, headache, fatigue, pain in extremity, vaccination site mass, vaccination site swelling, vaccination site cellulitis. Clinical course: Achy, headache, fatigue, sore arm, huge knot, a lot of swelling at injection site, and developed cellulitis at the injection site that spread down half arm and needed antibiotics. Lasted a week before it receded. This is a rare case but it was 10xs worse for patient then the TDAP.  Causality for "achy", "headache", "fatigue", "sore arm", "huge knot, a lot of swelling at injection site" and "cellulitis at injection site" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Type 2 diabetes mellitus
Clinical narrative: Type 2 diabetic; Hypertension; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "Type 2 diabetic"; HYPERTENSION (non-serious), outcome "unknown". Therapeutic measures were taken as a result of type 2 diabetes mellitus, hypertension. Clinical course: Patient took and patient's niece and patient to get the first round of two COVID shots/vaccines in about spring of 2022. Since then Patient had, shortly after become a type 2 diabetic, as well as hypertension, enough that patient now took Metformin 500mg twice a day, as well as 100 mg Losartin & also 5 mg Amlodipine every day. Patient never had hypertension before those two shots or Diabetes before those two shots. Naturally, patient was very concerned about patient's niece. But also patient's ourself.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site irritation
Clinical narrative: irritation at the injection site; Pregnant patient receive flublok; Initial information received on 19-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender pregnant patient received influenza quadrivalent recombinant vaccine [Flublok] and had irritation at the injection site. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported irritation at the injection site occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On an unknown date, the pregnant patient received unknown dose of suspect influenza quadrivalent recombinant vaccine injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Influenza (Exposure during pregnancy) (Latency same day).  On an unknown date the patient developed irritation at the injection site (vaccination site irritation) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  There was no relevant prenatal testing after exposure.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cold; Initial information received on 22-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-non-health professional .  This case involves a 66 years old female patient who experienced cold after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DUPILUMAB (DUPIXENT) for Asthma, allergies, cough.  On Unknown date in November 2024, the patient received suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination..  On Unknown date in NOV-2024 (latency: approx. a week) the patient had cold (nasopharyngitis).  It was reported patient stated that she takes Dupixent for allergies, cough, "to open up her lungs", and for asthma. Patient reports no shortness of breath but has been coughing, she has used her rescue inhaler for about 2 days in the past week, her asthma is somewhat controlled, reported that she has a cold right now,  she got a flu shot this week and that whenever she gets the flu shot, she gets a cold.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (cold).  At time of reporting, the outcome was Unknown for the event cold.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered only the DTAP-IPV liquid portion of PENTACEL, it had not been reconstituted with the ACTHIB powder portion with no reported adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2024SA339080.  This case involves patient of an unknown age and gender who was administered only the DTAP-IPV liquid portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], it had not been reconstituted with the ACTHIB powder portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered only the dtap-ipv liquid portion of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Suspension for injection) (lot: UK046AA, expiry date- 31-AUG-2025) via unknown route in unknown administration site for Immunization; it had not been reconstituted with the ACTHIB powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller would like to know how to proceed. Can the ACTHIB powder portion be administered separately to these patients with a separate diluent.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA339080:patient #1 US-SA-2024SA345211:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: nurse administered ACT-HIB with sterile water for injection, rather than the supplied 0.4% NaCl diluent with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age / gender patient who received HIB (PRP/T) vaccine [ACT-HIB] with sterile water for injection, rather than the supplied 0.4% NaCl diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Nov-2024, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- standard, expiry date- 20-Nov-0226 and lot 1973320) via unknown route in unknown administration site for Immunization which was administered with sterile water for injection, rather than the supplied 0.4% NaCl diluent with no reported adverse event (product preparation error) (latency- same day).  Reportedly, the patient's exact age is not known, but the reporter stated that it was a pediatric patient. About the therapy date, reporter was not 100% sure that the date was correct.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: MEN
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: menquadfi was given to a patient subdermally with no reported adverse event; MenQuadfi was administered in error instead of a TB test with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 57 years old female patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] subdermally in error instead of a tuberculin test [Tubersol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine for Immunization.  On an unknown date, the patient TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown route unknown for Tuberculin test. On 19-Nov-2024, the patient received 0.1 ml dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- unknown, expiry date- 30-Sep-2027 and lot U8193AB) via subdermal route in the left forearm (incorrect route of product administration) in error instead of a tuberculin test Solution for injection with strength 5-TU (tuberculin unit) (lot and expiry date not reported) with no reported adverse event (wrong product administered) (same day latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 34.7 F Duration: 15 minutes with no reported adverse event; Max/low temperature reached: 34.7 F Duration: 15 minutes with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] exposed to max/low temperature reached: 34.7 f duration: 15 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (unknown strength) with lot W1C831M and expiry date 21-Nov-2025 via unknown route in unknown administration site for prophylactic vaccination (immunization) (poor quality product administered) (Latency same day)   On 01-Nov-2024 the suspect IPV (VERO) exposed to max/low temperature reached: 34.7 f duration: 15 minutes with no reported adverse event (product storage error).  Reportedly, some of the products have been administered, including the punctured IPOL. Caller did not have patient specific information available at the time of the call since she did not know which patients received the product post excursion. Caller noted there were 3 doses left in the IPOL vial. Human error involved. Product was administered post excursion.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: baby should be given Hep B but was given ACTHIB vaccine instead inadvertently with no reported adverse event; patient received expired ACTHIB vaccine with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 months old male patient who should be given hepatitis B vaccine but was given HIB (PRP/T) vaccine [ACT-HIB] instead inadvertently and patient received expired ACT-HIB with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of expired HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (lot UK170AB, expiry date- 31-Oct-2021) once via unknown route in unknown administration site as prophylactic vaccination (Immunization) but should receive hepatitis B vaccine not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) with no reported adverse event (wrong product administered) (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only received the diluent portion of PENTACEL with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA344353 and US-SA-2024SA339080.  This case involves an unknown age and unknown gender patient who had only received the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) expiry date, strength, lot number not reported via unknown route in unknown administration site for Immunization and only received the diluent portion of pentacel with no reported adverse event (single component of a two-component product administered) (latency : same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA344353: US-SA-2024SA339080:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Acute psychosis, Anxiety, Delusion, Fear
Clinical narrative: Acute onset of due to Covid-19 vaccine: Psychosis, delusions, scared, extreme anxiety, Action taken: Hospital ER visit, psychological evaluation, therapist evaluation and appointments, psychiatrist evaluation and appointments, Treatment: anti-anxiety medication, sleeping medication.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme arm soreness, upper arm exterior swelling width of arm and 6in length, circular redness 4in diameter, heated area - started a couple hours after vaccine, increased following day, 4 days later still swollen, red, and sore however lessen by 2 in and a bruise at 1in width .5in length at injection site, increased muscle cramps
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Extreme arm soreness, upper arm exterior swelling width of arm and 6in length, circular redness 4in diameter, heated area - started a couple hours after vaccine, increased following day, 4 days later still swollen, red, and sore however lessen by 2 in and a bruise at 1in width .5in length at injection site, increased muscle cramps
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of product administration
Clinical narrative: an administration of Flulaval subcutaneous instead of IM to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced intramuscular formulation administered by other route (Verbatim: an administration of Flulaval subcutaneous instead of IM to a patient.). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024  The other health professional reported an administration of Flulaval subcutaneous instead of IM to a patient which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: flu vaccine from last year was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number XA4K5, expiry date 30-JUN-2024) for prophylaxis.   On 31-OCT-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On 31-OCT-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: flu vaccine from last year was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2024  The nurse reported that about a vaccine the flu vaccine from last year was expired and it was given on the day of reporting by accident which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inappropriate age; received Kinrix instead of plain Tdap and Hib vaccines; Patient got an extra dose of polio per nurse; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and Hib UNK (Hib vaccine) for prophylaxis.   On an unknown date, the patient received Kinrix, did not receive Tdap Vaccine and Hib vaccine. On an unknown date, an unknown time after receiving Kinrix and not applicable after receiving Tdap Vaccine and Hib vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age), wrong vaccine administered (Verbatim: received Kinrix instead of plain Tdap and Hib vaccines) and extra dose administered (Verbatim: Patient got an extra dose of polio per nurse). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2024  The nurse reported that a 2 years old patient received Kinrix instead of plain Tdap and Hib vaccines because she misread it which led to inappropriate age at vaccine administration and wrong vaccine administered.  The patient got an extra dose of polio as per nurse which led to extra dose administered.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority on 25-NOV-2024, referring to a female patient (age group was reported as 15-19 years old). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection and 3 doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR) for prophylaxis (all strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced pneumococcal infection. At the time of reporting, the outcome of the event was unknown. The action taken with both vaccines was not applicable.   The causal relationship regarding pneumococcal infection to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) was not provided.  Upon internal review, the event pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority referring to a female elderly (age: 65-69) patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2023, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2023, the patient developed pneumococcal infection. On an unknown date in 2023, the patient's streptococcus pneumoniae serotyping was tested as not available. At the time of reporting, the outcome of the event was unknown. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was not provided.   Upon internal review, the event of pneumococcal infection was determined to be medically significant.   Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority referring to a female adult (age: 50-54) patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2023, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2023, the patient developed pneumococcal infection. On an unknown date in 2023, the patient's streptococcus pneumoniae serotyping was tested as not available. At the time of reporting, the outcome of the event was unknown. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was not provided.   Upon internal review, the event of pneumococcal infection was determined to be medically significant.   Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to an Elderly male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccianted with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced Streptococcus pneumoniae pneumonia. At the time of reporting, the outcome was not known. The action taken was Not Applicable.  The causal relationship was unknown.   Upon internal review, the event was determined to be medically significant.