chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Dec2023 to 28Dec2023. No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; adult patient was administered PROQUAD outside the age of PI; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 24-OCT-2023, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) injection, unk, lot #W030849, expiration date: 26-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Biopsy artery, Giant cell arteritis
Clinical narrative: asthma infections; Giant cell arteritis/Temporal; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 30145RA) at the age of 80 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroiditis" (ongoing); "High cholesterol" (ongoing); "High Blood pressure/Hypertension" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EK9231), administration date: 08Jan2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EL3249), administration date: 10Feb2021, when the patient was 79-year-old, for COVID-19 Immunization. The following information was reported: GIANT CELL ARTERITIS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Giant cell arteritis/Temporal"; ASTHMA (non-serious), outcome "unknown", described as "asthma infections". The patient underwent the following laboratory tests and procedures: Biopsy artery: (16Nov2021) GCA Bilateral, notes: Confirms GCA Nov2021. Therapeutic measures were taken as a result of giant cell arteritis.  Clinical course: Following the first booster vaccine, a new condition (autoimmune) was diagnosed-temporal (GCA) arthritis. Treatment included oral prednisone and asthma infections. Treatment continued -1.5 years. Per CDC guideline, being immunocompromised, patient had 4 additional Covid booster vaccines on 02Mar2022, 06Sep2022, 17May2023 and 27Sep2023. Total of 7 vaccinations. She has had two very different autoimmune diagnoses within the past 3 years-Giant cell arthritis (temporal arthritis) 2021; and Leukocytoclastic vasculitis with some systemic involvement, 2023. Both conditions were proceeded by Pfizer Covid booster vaccinations. It appears that the vaccines were a trigger for both conditions by proximity of Covid vaccinations and symptoms disease onset. (She found the forms somewhat confusing to decipher).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (disability), outcome "unknown", described as "sick". Clinical course: Caller was immunosuppressed and did all vaccines and boosters (as reported, possibly discrepant information) four years ago and still end up getting it. And his doctor at the time were assisting his recovery, now, couple of years later and he got sick. Also, caller mentioned that it will cost him 1700 and he was disabled.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoacusis
Clinical narrative: took all of the vaccine except for the updated and got covid; took all of the vaccine except for the updated and got covid; having a hard time hearing; This is a spontaneous report received from a Consumer or other non HCP.  A male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took all of the vaccine except for the updated and got covid"; HYPOACUSIS (non-serious), outcome "unknown", described as "having a hard time hearing". Clinical course: Caller took all of the vaccine except for the updated and got covid. Caller mentioned that he is thanking that he get through it and wants to know if he can still get the vaccine. Created Manual AE because caller mentioned that he is having a hard time hearing and might have been due to the vaccines he took previously.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Dysstasia, Gait inability, Guillain-Barre syndrome, Movement disorder
Clinical narrative: guillain barre syndrome; Not being able to stand or walk by themself; unable to move legs; Initial information received from Regulatory Authority on 01-Jan-2024 regarding an unsolicited valid  serious Courtesy case received from a consumer/non-health care professional.  This case involves a 79 years old female patient who experienced not being able to stand or walk by themself, unable to move legs and guillain barre syndrome after receiving vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [TYVASO DPI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included RIOCIGUAT (ADEMPAS).  In 2023, the patient started taking TYVASO DPI (TREPROSTINIL SODIUM) at a dose of 48 ug QID (with an unknown formulation, strength, expiry date, batch number) for Pulmonary arterial hypertension. In 2023, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On 14-NOV-2023 the patient developed not being able to stand or walk by themself (dysstasia) , guillain barre syndrome (guillain-barre syndrome) and unable to move legs (gait inability) (latency: approximately same day) following the administration of INFLUENZA VACCINE. and TYVASO DPI.  TREPROSTINIL SODIUM (TYVASO DPI) was continued. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  An corrective treatment was received for the events (Not being able to stand or walk by themself, unable to move legs, guillain barre syndrome).She was in the hospital for approximately a month and was discharged on an unreported date in Dec 2023, and was now in rehabilitation.  At time of reporting, the outcome was Unknown for all the events.  Seriousness Criteria : The patient was hospitalized for all the events. ended in DEC-2023 The patient was discharged in December 2023. Medically significant for the event guillain barre syndrome.; Sender's Comments: Sanofi Company Comment dated 04-Jan -2024 : This case involves a 79 years old female patient who experienced not being able to stand or walk by themself, unable to move legs and guillain barre syndrome after receiving vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [TYVASO DPI].Further information regarding Past medical history,  concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed. Further, the patient concurrent condition would be cofounding factor for this event.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient has been accidentally administered with two doses of fluzone high-dose qiv with no rpeorted adverse event; Initial information received on 04-Jan-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 79 years old female patient who has been accidentally administered with two doses of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no rpeorted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Jan-2024, the patient has been accidentally administered with two doses of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (lot U8135CA; Expiry Date: JUN-2024)  via intramuscular route in the both doses on  left deltoid for Immunization with no rpeorted adverse event (extra dose administered) (latency: on 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.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Partial seizures, Polymerase chain reaction negative, Pyrexia, Rash, Rash papular
Clinical narrative: High fever and a papular truncal and face rash. Seen in Emergency room on 1/5/24 for a focal seizure. Rash resolved 1/8/2024.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral test negative
Clinical narrative: High fever and a papular truncal and face rash. Seen in Emergency room on 1/5/24 for a focal seizure. Rash resolved 1/8/2024.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Cyst
Clinical narrative: Patient seen orthopedic specialist due to ongoing shoulder pain and development of a cyst at the administration site on 12/22/2023. Patient had a follow up appointment with is PCP on 01/08/2024 with everything seeming to have resolved since specialist visit except for the developed cyst.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Skin indentation
Clinical narrative: Patient states vaccination caused an indentation in skin (similar to being poked but skin doesn't retract back). She says she was found unconscious the day after immunization and spent a week in the hospital, not giving much detail as to what symptoms she was experiencing in the hospital.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Blood bilirubin increased, Injection site erythema, Injection site infection, Injection site swelling, Monocyte count
Clinical narrative: Redness, Swelling and Infection in the upper left arm between shoulder and the elbow over an area of approximately   4" X 2"
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Neutrophil count, Platelet count decreased, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Redness, Swelling and Infection in the upper left arm between shoulder and the elbow over an area of approximately   4" X 2"
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to the patient outside of recommended age guidelines. No adverse events are being reported.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: fever, rash/itching/pain at injection site.
Age: 73.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Injection site pain
Clinical narrative: Patient has  came into pharmacy every couple of weeks complaining of arm pain where RSV vaccine was given. No issue with other arm or vaccination site of the flu vaccine. Patient has not needed to be seen by a physician for said pain, but wants to keep pharmacy informed.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: patient complained arm pain after injection
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient arrived and asked for a flu shot. After verifying patient information and that she wanted a flu shot, a flu shot was given. Then patient stated i meant to say I wanted a Covid shot, I already had a flu shot this year. Patient had a flu shot on 10/9/2023.  Patient did not have any adverse reactions that day or in the following days even though she received a 2nd flu vaccine.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Swelling of eyelid
Clinical narrative: Patient called approximately 24 hours after receiving the vaccine and stated her eyelids were swollen. No itching or pain.  Patient was advised to take Benadryl and to seek medical attention if symptoms persisted or other issues arose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear congestion, Tinnitus
Clinical narrative: I had a similar reaction to last year though not as severe. Mainly, fullness and pain in both ears and some additional hearing loss which I trust will return to close to normal. The tinnitus in both ears from last year got much louder and more annoying. Fullness has been bad and pain deep in both ears, though an Urgent Care doctor saw no signs of damage and washed out one of my ears. I've been taking flonase inhaler (prescribed last year), liquid Zyrtec, and 15-20 mg of prednisone after the pain started.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I am on rural travel with Dr. on a quarterly trip. Vaccine was given to the health aide who is also a patient of ours. The patient was notified that I had given her a high dose flu instead of a normal dose flu vaccine by mistake. I had let our immunization department know of this and they said it was okay that I had given her the high dose by mistake, but I had to report it. The patient says they feel fine and had no adverse reactions throughout the day.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Myalgia, Pain
Clinical narrative: Patient reported pain in right arm 2-3 days following vaccine administration.  Pain originally localized to right deltoid muscle.  Pain has persisted and patient describes as sharp at times, worsens with movement and limits movement because of discomfort. Pain also present in bicep and triceps muscles near the elbow also on the right arm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reported pain in right arm 2-3 days following vaccine administration.  Pain originally localized to right deltoid muscle.  Pain has persisted and patient describes as sharp at times, worsens with movement and limits movement because of discomfort. Pain also present in bicep and triceps muscles near the elbow also on the right arm.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pruritus
Clinical narrative: Itchiness all over body
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: injection burned when given.shoulder became sore and started to stiffen. went back to pharmacy . said to ice it . didn't do anything.as some time went by i lost ROM. and pain to elbow became more agitated. loss of strength.arm feels restless tingling sensations. throbs what seems to be injection site.if overused arm and hand become shaky.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Musculoskeletal stiffness, Pain, Paraesthesia, Restless arm syndrome, Shoulder injury related to vaccine administration
Clinical narrative: injection burned when given.shoulder became sore and started to stiffen. went back to pharmacy . said to ice it . didn't do anything.as some time went by i lost ROM. and pain to elbow became more agitated. loss of strength.arm feels restless tingling sensations. throbs what seems to be injection site.if overused arm and hand become shaky.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Tremor
Clinical narrative: injection burned when given.shoulder became sore and started to stiffen. went back to pharmacy . said to ice it . didn't do anything.as some time went by i lost ROM. and pain to elbow became more agitated. loss of strength.arm feels restless tingling sensations. throbs what seems to be injection site.if overused arm and hand become shaky.
Age: 23.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Fluorescence angiogram abnormal, Magnetic resonance imaging head, Pyrexia, Retinal white dots syndrome, Scan with contrast
Clinical narrative: Multiple Evanescent White Dot Syndrome (MEWDS) following Fever.  Fever began approx 12 hours after injection, blind spots began appearing and worsened over next 48 hours. Have been healing, but still persist 2.5 months later.
Age: 23.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Visual field defect
Clinical narrative: Multiple Evanescent White Dot Syndrome (MEWDS) following Fever.  Fever began approx 12 hours after injection, blind spots began appearing and worsened over next 48 hours. Have been healing, but still persist 2.5 months later.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: 20 hours after vaccination, severe nausea vomiting requiriing medications to control vomiting. 24 hours after vaccination severe diarhea ,, headache and low grade fever with fatigue.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: 20 hours after vaccination, severe nausea vomiting requiriing medications to control vomiting. 24 hours after vaccination severe diarhea ,, headache and low grade fever with fatigue.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza, Insomnia
Clinical narrative: Very bad symptoms similar to a terrible flu. Severe chills, fever, bad muscle and body aches, pounding terrible headache.  I couldn't sleep because I was miserable. Side effects eased today (Jan 9) but are not completely gone.                       Note: I had similar side effects to the first shot but this second shot was much worse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Very bad symptoms similar to a terrible flu. Severe chills, fever, bad muscle and body aches, pounding terrible headache.  I couldn't sleep because I was miserable. Side effects eased today (Jan 9) but are not completely gone.                       Note: I had similar side effects to the first shot but this second shot was much worse.
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a kinrix at 11 months old
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Neurological symptom
Clinical narrative: Patient received Spikevax on 11/03/2023 and soon after developed s/s of Guillan Barre Symptoms.  I am a retail pharmacist at Pharmacy responsible for dispensing medications to Center (LTCF) where patient was admitted for rehab/recovery from GBS.  Pt currently still admitted to Center for recovery.
Age: 80.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site scab
Clinical narrative: PER PATIENT 4 DAYS AFTER SHE GOT SCAB AT THE INJECTION SITE. SHE HAS SHOWN IN TO HER PRIMARY CARE DOCTOR BUT THEY HAVENT DONE ANYTHING. SHE SAYS SHE TRIED TO TREAT IT WITH NEOSPORIN SHE SAYS IT HASNT COMPLETELY HEALED. PHARMACIST RECOMMENDED HER TO SEE DERMATOLOGIST. SHE REPORTED THIS ON 1-8-2024 WHEN SHE CAME IN FOR A COVID VACCINE MODERNA
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: After receiving vaccine, patient fell in pharmacy lobby, was unresponsive for a few seconds then came back to normal. Patient stated he had not eaten recently.  Sr Tech called 911 and a friend of the patient called his mother to inform her.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Approximately 3.5 weeks after the vaccines, I woke up in the night two nights in a row with absolute burning pain in the exact location I received the vaccines. It lasted approximately 1-2 minutes each time.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deep vein thrombosis, Fibrin D dimer increased, Full blood count abnormal, Leukocytosis
Clinical narrative: Right femoral vein deep vein thrombosis with rigors and acute leg swelling. Now on anticoagulation with apixaban
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Neutrophil count, Peripheral swelling, Procalcitonin, White blood cell count increased
Clinical narrative: Right femoral vein deep vein thrombosis with rigors and acute leg swelling. Now on anticoagulation with apixaban
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Flushing, Immediate post-injection reaction
Clinical narrative: immediate and continued right shoulder pain; an hour later fatigue, sleepiness, dizziness; 5 hours later extreme nausea and flushing
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Somnolence
Clinical narrative: immediate and continued right shoulder pain; an hour later fatigue, sleepiness, dizziness; 5 hours later extreme nausea and flushing
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Patient reported development of swelling of the upper lip which occurred about 24 hours after vaccine administration. Patient denied difficulty breathing or swelling of the throat.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: it does hurt a bit; arm is swollen; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: PAIN (non-serious), outcome "unknown", described as "it does hurt a bit"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is swollen".  Additional Information: Reporter mentioned that she is upset because she got her vaccine and thought that vaccine was administered incorrectly. She always get all Pfizer COVID vaccines it does hurt a bit but this time, when the vaccine was administered her arm is swollen the next day and it seems that the pharmacist injected the vaccine.The caller confirmed that she got the Abrysvo vaccine, and her arm got swollen. She also stated that she got the Pfizer COVID-19 vaccine and had the same reaction.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: RSV, RSV
Symptoms: Acute kidney injury, Atrial fibrillation
Clinical narrative: Discomfort in chest; Discomfort in stomach; Atrial fibrillation; Overdose; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 87-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5S27E) for prophylaxis.   Concurrent medical conditions included increased blood pressure, benign prostatic hyperplasia and hypothyroidism. Concomitant products included atenolol, doxazosin and levothyroxine.   On 27-DEC-2023, the patient received Arexvy 1 ml. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Overdose). On 02-JAN-2024, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced chest discomfort (Verbatim: Discomfort in chest) (serious criteria hospitalization) and stomach discomfort (Verbatim: Discomfort in stomach) (serious criteria hospitalization). The outcome of the atrial fibrillation was not resolved and the outcome of the chest discomfort and stomach discomfort were not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-JAN-2024 The patient experienced discomfort in chest and stomach.  The patient went to emergency room and was admitted.  The patient had electrocardiogram which showed atrial fibrillation and glomerular filtration rate was low.  The patient received 1 ml of Arexvy instead of 0.5 ml which led to overdose. The patient gave permission to contact.
Sex: M
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Atrial fibrillation, Chest discomfort, Electrocardiogram abnormal, Glomerular filtration rate decreased
Clinical narrative: Discomfort in chest; Discomfort in stomach; Atrial fibrillation; Overdose; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 87-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5S27E) for prophylaxis.   Concurrent medical conditions included increased blood pressure, benign prostatic hyperplasia and hypothyroidism. Concomitant products included atenolol, doxazosin and levothyroxine.   On 27-DEC-2023, the patient received Arexvy 1 ml. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Overdose). On 02-JAN-2024, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced chest discomfort (Verbatim: Discomfort in chest) (serious criteria hospitalization) and stomach discomfort (Verbatim: Discomfort in stomach) (serious criteria hospitalization). The outcome of the atrial fibrillation was not resolved and the outcome of the chest discomfort and stomach discomfort were not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-JAN-2024 The patient experienced discomfort in chest and stomach.  The patient went to emergency room and was admitted.  The patient had electrocardiogram which showed atrial fibrillation and glomerular filtration rate was low.  The patient received 1 ml of Arexvy instead of 0.5 ml which led to overdose. The patient gave permission to contact.
Sex: M
Vaccine: RSV, RSV
Symptoms: Incorrect dose administered
Clinical narrative: Discomfort in chest; Discomfort in stomach; Atrial fibrillation; Overdose; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 87-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5S27E) for prophylaxis.   Concurrent medical conditions included increased blood pressure, benign prostatic hyperplasia and hypothyroidism. Concomitant products included atenolol, doxazosin and levothyroxine.   On 27-DEC-2023, the patient received Arexvy 1 ml. On 27-DEC-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Overdose). On 02-JAN-2024, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced chest discomfort (Verbatim: Discomfort in chest) (serious criteria hospitalization) and stomach discomfort (Verbatim: Discomfort in stomach) (serious criteria hospitalization). The outcome of the atrial fibrillation was not resolved and the outcome of the chest discomfort and stomach discomfort were not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, chest discomfort and stomach discomfort to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-JAN-2024 The patient experienced discomfort in chest and stomach.  The patient went to emergency room and was admitted.  The patient had electrocardiogram which showed atrial fibrillation and glomerular filtration rate was low.  The patient received 1 ml of Arexvy instead of 0.5 ml which led to overdose. The patient gave permission to contact.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered an expired dose of PNEUMOVAX23 w/ no TEs--NOT SUPPORTED by post-expiry memo. No symptoms reported. No additional AE/PQC.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-DEC-2023, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/dose, lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No temperature excursion (TE) was reported. No symptoms were reported (No adverse event).  Follow up information was received from an office practice manager on 04-JAN-2024. A 70-year-old female patient was vaccinated by the physician with an expired vaccine. Clinical staff had not disposal of expired vaccination. They gave to physician expired medication to administer. No reaction or interaction patient aware. The patient was informed that physician spoke with pharmaceutical manufacturer company and the vaccine was non-effective. There was no product quality complain  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, therefore it is being sent to Distribution.
Age: 42.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; Inadvertent administration of PROQUAD to a 42 yr old isntead of MMRII and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 42-year-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.      On 13-NOV-2023, the patient was inadvertent vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter, lot # X018576, expiration date 05-JAN-2025, for prophylaxis (route was not reported), instead of dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) (wrong product administered). No adverse effects nor product quality complaint were reported.
Age: 17.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP reports a 17 year old female received one dose of PEDVAXHIB on 12/21/2023.; This spontaneous report was received from Other Health Professional and refers to a 17-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-DEC-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, once, administered for prophylaxis (Product administered to patient of inappropriate age) lot # W034364, expiry date:20-JUN-2025,  (route of administration was not provided).  Confimed no symptoms or sIde effects reported. No additional adverse event (AE) was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 54-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032472) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 17-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The patient was diagnosed with Bell's Palsy in ER. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.  Company Comment: This is a spontaneous case concerning a 54-year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) expected AESI of Bell's. The event occurred approximately 50 days after a dose of SPIKEVAX 2023-2024 PFS (dose number were not provided). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was reported as recovering. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; positive Binax result on 25-NOV-2023; Received dose 1 of Novavax on 16-OCT-2023; Treatment of COVID-19; positive Binax result; Got sniffles; On 26-NOV-2023, this serious initial spontaneous safety report from the country was received from a consumer via a pharmaceutical company and was received by Novavax on 18-DEC-2023.   An individual of an unspecified race, age and sex was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 1 (dose 4 of COVID-19 vaccine) in the left arm on 16-OCT-2023 at 15:00.  The following medical history was reported: Blood cholesterol increased, Hiatus hernia, Hypersensitivity, Iron deficiency anaemia and Obesity. The individual was previously vaccinated with Pfizer/ BioNTech vaccine dose 1 on 04-Oct-2022 and another Pfizer/ BioNTech vaccine on an unspecified date, and Moderna booster, dose 1 (elasomeran) on 04-APR-2023.   The following concomitant medications were reported: escitalopram, pravastatin, amlodipine from 08-MAY-2023, pantoprazole, chlorthalidone, vitamin D2, potassium chloride extended release and clobetasol ointment.  On 16-OCT-2023, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant).  On an unspecified day in NOV-2023, the individual required treatment of COVID-19 with an unspecified Pfizer product and received treatment from 06-NOV-2023 until 11-NOV-2023 (PT: Breakthrough COVID-19). On 25-NOV-2023 at 15:00, 1 month 8 days after vaccination, the individual got sniffles (PT: Rhinorrhoea) and had a positive Binax result.  Relevant lab tests included: SARS-CoV-2 test (Result: Negative; 24-NOV-2023) and SARS-CoV-2 test (Result: Positive; 25-NOV-2023).  At the time of reporting, the event outcomes of Rhinorrhoea and Breakthrough COVID-19 were not recovered/not resolved, Vaccination failure was recovered/resolved and event stop date was 16-OCT-2023.  Lot number was not provided in the report.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Brain fog
Clinical narrative: losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words; covid fog; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), 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: AMNESIA (medically significant), outcome "unknown", described as "losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words"; BRAIN FOG (medically significant), outcome "unknown", described as "covid fog".  Additional information: The patient reported that he took 3 shots of the Pfizer covid vaccine (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) and he was losing his memory. He received the vaccine well over a year, maybe 2 years. He had a terrible experience after taking the shot. His memory keeps getting worse and worse. The side effects "started right off of the bat." He described his memory loss as "covid fog." Today, he was watching tv, and something he should have known came across; however, he couldn't remember what it was. He was forgetting words and it was really scaring the heck out of him. He stated that it has coincided with the shots. The side effects seemed to be getting worse, so fast. He reported that has spoken with many others who have experienced the same thing.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400008698 same patient and drug, different dose and event;US-PFIZER INC-202400008699 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: Transient Global Amnesia/There are 400 cases identified, including my wife; This is a spontaneous report received from a Physician.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: TRANSIENT GLOBAL AMNESIA (medically significant) with onset 2023, outcome "unknown", described as "Transient Global Amnesia/There are 400 cases identified, including my wife". Clinical Course: Reporter wished to speak with Pfizer as PRIVACY concerning Transient Global Amnesia as a signal associated with Pfizer and Moderna COVID vaccine. There were 400 cases identified, including his wife. He was an academic Neurologist at (name withheld).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event TRANSIENT GLOBAL AMNESIA  and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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 notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered, Incorrect route of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: mistakenly administered IPOL to patient instead of the intended Tuberol with no reported adverse event; mistakenly administered IPOL intradermally with no reported adverse event; mistakenly administered 0.1 ml IPOL to patient with no reported adverse event; Initial information received on 05-Jan-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 33 years old female patient who was mistakenly administered 0.1 ml IPV (VERO) [IPOL] intradermally instead of the intended tuberol with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jan-2024, the patient received 0.1 ml dose of suspect IPV (VERO) Suspension for injection of lot W1C751M via intradermal route in the right forearm as prophylactic vaccination (immunization), instead of the intended tuberol with no reported adverse event (wrong product administered) (incorrect route of product administration) (incorrect dose administered) (latency: same day) following the administration of IPV (VERO).  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: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: I now have Tinnitus. My ears started ringing 3 days after the vaccination and have not stopped to date. The Covid vaccines are the only vaccinations I have had since childhood.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives head to toe
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for improperly stored vaccine administration of ROTATEQ. No side effects reported. Date of administration was 04JAN2024.; HCP calling to report AE for improperly stored vaccine administration of ROTATEQ. No side effects reported. Date of administration was 04JAN2024.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1933911, expiry date: 18-APR-2024) was stored at a temperature of 52.7 degree Fahrenheit (F) for 8 hour 31 minutes. There was no previous temperature excursion. On 04-JAN-2024, after temperature excursion, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid orally (dose not provided) as prophylaxis (product storage error). No side effects were reported (no adverse event). There was no other medical information known. Operator of device was a healthcare professional.  This is one of 3 reports received from the same reporter.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: very tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, several hours after receiving Arexvy, the patient experienced tiredness (Verbatim: very tired). The outcome of the tiredness was not resolved.   The reporter considered the tiredness to be possibly related to Arexvy.     The company considered the tiredness to be possibly related to Arexvy.   Additional Information: RA Receipt Date: 03-JAN-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient got inoculation earlier on the day of reporting and now (at the time of reporting) after several hours, he/she felt very tired. The reporter suspected it was probably from the vaccine and this confirmed that probability. The follow-up could not be possible as no contact details were available.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: A patient received only the diluent; Inappropriate preparation of medication; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F3Z39, expiry date 25-APR-2026) for prophylaxis.   On 29-DEC-2023, the patient received Arexvy. On 29-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: A patient received only the diluent) and inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: RA Receipt Date: 03-JAN-2024 The pharmacy manager called in requesting data about the procedure to follow after a patient received only the diluent.  The reporter did not consent to receive follow up and only gave partial information about the event, vaccine and patient.  The vaccine administration facility was the same as primary reporter. The patient received only diluent of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.