chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix first dose was administered on March 12th, 2024 and Second dose on October 28th, 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 42-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 12-MAR-2024).   On 28-OCT-2024, the patient received the 2nd dose of Twinrix. On 28-OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix first dose was administered on March 12th, 2024 and Second dose on October 28th, 2024). The outcome of the drug dose administration interval too long 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: 28-OCT-2024 The reporter had a question regarding a patient's dosing schedule for the Twinrix vaccine. The patient received 2nd dose of Twinrix vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter had just need to confirm that they did not need to restart.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, COVID-19, COVID-19 immunisation, Immunisation reaction, Injury
Clinical narrative: INJECTION CAUSE CLINICALLY SIGNIFICANT INCREASE IN MILD TO MODERATE DISEASE/SERIOUS DISEASE; THE EVIDENCE INDICATED THAT ALL THOSE THAT RECEIVED COVID-19 INJECTION HAVE DEVELOPED AN AUTOIMMUNE DISEASE; DEVELOPED MILD, MODERATE, SEVERE COVID-19 DISEASE WITHIN 2 MONTHS OF THE 1ST AND 2ND MRNA NANOPARTICLE INJECTION; PERMANENT INJURY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from an attorney: Documents were received in the form of legal documents and concerned multiple patients. The patients weight, height, and medical history were not reported. The patients were previously treated with elasomeran dose series (dose series 1) for covid-19 prophylaxis, and tozinameran (dose series 2) for covid-19 prophylaxis. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms (dose series 3), start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unknown date, the patients experienced injection cause clinically significant increase in mild to moderate disease/serious disease (immunization reaction) and was hospitalized (dose series 3). The evidence indicated that all those that received COVID-19 injection have developed autoimmune disease (dose series 3). Developed mild, moderate and severe covid-19 disease within 2 months of the 1st and 2nd mRNA nanoparticle injection and permanent injury (dose series 1). On an unspecified date, the patients experienced revaccination with different covid-19 vaccine (dose series 2). The patient died of immunisation reaction on an unspecified date. It was unknown if an autopsy was performed. Covid-19 injection have caused countless death, permanent injury, disability, It was intended to demonstrate to court that the covid-19 injection were dangerous. Developed mild, moderate, severe covid-19 disease within 2 months of the 1st and 2nd mRNA nanoparticle injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of autoimmune disorder, permanent injury, revaccination with different covid-19 vaccine and developed mild to moderate covid-19 was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: Medical assessement comment not required as the  case was processed as per legal case processing conventions; Reported Cause(s) of Death: INJECTION CAUSED CLINICALLY SIGNIFICANT INCREASE IN MILD TO MODERATE DISEASE/SERIOUS DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The suspect dosage text was reported as unknown.  It was reported that, there was a doctor's brother, who was also a doctor, who supposedly passed away from the shot. He might have had underlying things that aggravated it, but nobody came up with the truth on that stuff.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-776403 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776403:Doctor case; Reported Cause(s) of Death: passed away
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. He received the vaccine from the hospital, and he got the COVID-19 virus on 11 July 2022, then immediately went to the care center and they confirmed it was the COVID-19 virus. There was no complication from the Moderna vaccine shot and booster, it was taken 30 days apart. It was reported that he wears masks all the time while communicating with people. After receiving the vaccine there was no reaction. No treatment medication reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient confirmed that they got the vaccine last Nov 01 2024 and got high grade fever that lasted for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient confirmed that they got the vaccine last Nov 01 2024 and got high grade fever that lasted for 12 hours) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced PYREXIA (Patient confirmed that they got the vaccine last Nov 01 2024 and got high grade fever that lasted for 12 hours). At the time of the report, PYREXIA (Patient confirmed that they got the vaccine last Nov 01 2024 and got high grade fever that lasted for 12 hours) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.     Patient was taking blood thinners. Suspect vaccine dosage text was reported as unknown. Patient got high grade fever that lasted for 12 hours and 12 hours after got better and after another 12 hours he got fever again. Reporter causality was not reported. Treatment information was not provided.   This case was linked to MOD-2024-776572 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site induration, Vaccination site urticaria
Clinical narrative: pruritus; wheal on the site of injection with some induration in the middle.; wheal on the site of injection with some induration in the middle. The wheal measures 6 cm x 6.50 cm, round, approx 1 mm elevation; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (pruritus ), VACCINATION SITE INDURATION (wheal on the site of injection with some induration in the middle.) and VACCINATION SITE URTICARIA (wheal on the site of injection with some induration in the middle. The wheal measures 6 cm x 6.50 cm, round, approx 1 mm elevation) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Metastatic breast cancer (Breast cancer with met to T8) and Psoriatic arthritis.    On 02-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 03-Nov-2024, the patient experienced PRURITUS (pruritus ), VACCINATION SITE INDURATION (wheal on the site of injection with some induration in the middle.) and VACCINATION SITE URTICARIA (wheal on the site of injection with some induration in the middle. The wheal measures 6 cm x 6.50 cm, round, approx 1 mm elevation). At the time of the report, PRURITUS (pruritus ), VACCINATION SITE INDURATION (wheal on the site of injection with some induration in the middle.) and VACCINATION SITE URTICARIA (wheal on the site of injection with some induration in the middle. The wheal measures 6 cm x 6.50 cm, round, approx 1 mm elevation) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient's BMI was reported as 32 kg/m2. No relevant concomitant medications were reported. It was reported that the wheal was worsening and there was pruritus untreated. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Viral infection, X-ray
Clinical narrative: sore arm; viral infection; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (viral infection) and PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Fractured ribs in December 2023 and Kidney stones (two kidney stones in each kidney.) in May 2024. Concurrent medical conditions included Seasonal allergy.    In May 2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Oct-2024, the patient experienced VIRAL INFECTION (viral infection). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, VIRAL INFECTION (viral infection) was resolving and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Viral infection.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter.   He had a deep cough and congestion for over two weeks, starting on 22-OCT-2024. Upon consultation, the healthcare provider recommended a chest x-ray, diagnosed him with a viral infection, and prescribed steroids. The caller inquired about the level of protection offered by the vaccine he received in May-2024, as he planned to travel and prefers not to take the new formula prior to his trip. He expressed that while he would typically accept the possibility of a sore arm from the vaccine before traveling, he was concerned that it may provoke a more significant reaction this time.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial; when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 29Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), outcome "unknown", described as "tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out".  Additional information: Pharmacist had two Abrysvo vaccines that were defective and asked for a replacement. It was like the tip of syringe that was in it, was already broken. So, when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere. The collar on the syringe was loose and the adapter did not seem to fully penetrate the vial, which resulted in product leaking out. There were no glass shards. They had this happen at least 4 times, at first they thought they had done something wrong, but the last time pharmacist was the one that was mixing it. Pharmacist had mixed a lot of these since last year, she/he was sure of her/his ability to do so. The vaccine was not administered to any patient. Packaging was sealed and intact. Reporter stated there was a sample of the product available to be returned, if requested.   Causality for "tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial" and "when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400295997 same reporter/event, different device;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Minor joint pain; injection site soreness; This is a spontaneous report received from an Other HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 at 16:15 as dose 1, single (Lot number: LP1780) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Apr2001; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: May2004; MIDNITE, start date: Feb2011. Past drug history included: Aspirin, reaction(s): "drug allergy"; Neosporin, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (Dose 1, Lot number: EL3247, intramuscular, administered in arm left at 02:30), administration date: 24Feb2021, when the patient was 42-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Lot number: EN6203, intramuscular, administered in arm left at 14:35), administration date: 17Mar2021, when the patient was 42-year-old, for covid-19 immunization, reaction(s): "Ache", "Stiff neck", "headache", "migraine", "Vomiting", "Shaky feeling", "Tired feeling", "Joint pain"; BNT162b2 (Dose 3 (Booster), Lot number: FJ8757, intramuscular, administered in arm left at 17:30), administration date: 03Dec2021, when the patient was 43-year-old, for covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 4 (Booster), Lot number: GJ6665 administered in arm left at 19:00), administration date: 04Nov2022, when the patient was 44-year-old, for covid-19 immunization, reaction(s): "whole body muscle ache", "flu-like symptoms", "pain in left armpit lymh node", "Soreness at injection site", "fever", "chills"; comirnaty (2023-2024 formula)) (Dose 1, Lot number: HG9497 administered in arm left at 14:45), administration date: 19Dec2023, when the patient was 45-year-old, for covid-19 immunization, reaction(s): "migraine", "Soreness at injection site", "achy muscles and joint", "achy muscles and joint". The following information was reported: ARTHRALGIA (non-serious) with onset 01Nov2024 at 18:30, outcome "recovering", described as "Minor joint pain"; VACCINATION SITE PAIN (non-serious) with onset 01Nov2024 at 18:30, outcome "recovering", described as "injection site soreness". Therapeutic measures were not taken as a result of arthralgia, vaccination site pain. Additional information: the vaccine was given in the right upper arm. The patient did not receive any other vaccines within 4 weeks prior to COMIRNATY (2024-2025 FORMULA). The patient did not receive any other vaccines on the same date as COMIRNATY (2024-2025 FORMULA). No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300451963 Same patient, different dose/event;US-PFIZER INC-202201281010 Same patient, different dose/event;US-PFIZER INC-2021298201 Same patient, different dose/event;US-PFIZER INC-202101723124 Same patient, different dose/event;
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: fitting of actual syringe is loose, so when opens it, whole thing, liquid has already leaked out; fitting of actual syringe is loose, so when opens it, whole thing, liquid has already leaked out; leaked onto arm; leaked onto arm; This is a spontaneous report received from a Pharmacist.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Nov2024 as dose number unknown, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MECHANICAL ISSUE (non-serious), DEVICE LEAKAGE (non-serious) all with onset 01Nov2024, outcome "unknown" and all described as "fitting of actual syringe is loose, so when opens it, whole thing, liquid has already leaked out"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 01Nov2024, outcome "unknown" and all described as "leaked onto arm". Additional information: reporter got two products on 01Nov2024 from wholesaler, and the fitting of the actual syringe is loose, so when opened it, whole thing, liquid had already leaked out. This was the same issue with two Abrysvo vaccines. Reporter had the boxes and serial numbers. Scary part was, the whole pouch was sealed, product was not altered at all. This was the same for both Abrysvo vaccines with the issue. Asking about replacement. Reporter attempted to administer and leaked out, so put to the side, one of the Abrysvo vaccines leaked onto the lady's arm, clarified and confirmed one of the Abrysvo vaccines leaked onto a patient's arm. The Abrysvo had the presentation with the powder, adapter, and solvent. Threw away all of the components, only had the empty boxes for the two Abrysvo vaccines. Reporter had nothing to provide but the empty boxes. The device was not available for evaluation.  Causality for "fitting of actual syringe is loose, so when opens it, whole thing, liquid has already leaked out" and "leaked onto arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site irritation, Vaccination site swelling
Clinical narrative: The area where she inserted the needle is red and swollen, as though the vaccine was injected just under the skin and is now sitting there irritating my arm; The area where she inserted the needle is red and swollen, as though the vaccine was injected just under the skin and is now sitting there irritating my arm; The area where she inserted the needle is red and swollen, as though the vaccine was injected just under the skin and is now sitting there irritating my arm; The person who gave me the vaccine only inserted the needle a tiny bit, and not into the muscle; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Nov2024, outcome "unknown", described as "The person who gave me the vaccine only inserted the needle a tiny bit, and not into the muscle"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE IRRITATION (non-serious) all with onset 03Nov2024, outcome "unknown" and all described as "The area where she inserted the needle is red and swollen, as though the vaccine was injected just under the skin and is now sitting there irritating my arm". Therapeutic measures were not taken as a result of incorrect route of product administration, vaccination site erythema, vaccination site swelling, vaccination site irritation. Additional information: The person who gave patient the vaccine only inserted the needle a tiny bit, and not into the muscle. The area where she inserted the needle is red and swollen, as though the vaccine was injected just under the skin and is now sitting there irritating her arm. Facility where vaccine was administered was Pharmacy or Drug Store.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Swelling/tenderness of armpit on the side of injection site; Swelling/tenderness of armpit on the side of injection site; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 at 13:45 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anemia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing), notes: the fatigue - 20 years; "post illness (strep throat)" (not ongoing), notes: lasting years - the step lasted about 4 years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for covid-19 immunization, reaction(s): "extended fatigue (around 6 months)". The following information was reported: SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 09Oct2024, outcome "recovered" (18Oct2024) and all described as "Swelling/tenderness of armpit on the side of injection site". Therapeutic measures were not taken as a result of swelling, axillary pain. Additional information: patient had no known allergy. Swelling/tenderness of armpit on the side of injection site beginning the day after injection. Swelling was about the width of an egg and 1.5 Xs the length. Took 8 -10 days to resolve. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Rash pruritic
Clinical narrative: Random spots here and there on my arms, legs and a couple on my neck; They itch quite a lot; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Oct2024) for immunisation. The patient's illness at vaccination included: "Infection" (ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete), for Covid-19 immunisation. The following information was reported: RASH PRURITIC (non-serious) with onset Nov2024, outcome "unknown", described as "Random spots here and there on my arms, legs and a couple on my neck; They itch quite a lot". Additional information: the patient received Pfizer COVID booter vaccine in the afternoon of 29Oct2024. The patient had always had the Moderna. The patient stated taking antibiotic on the evening of 29Oct2024 for an infection. During the weekend, sometime around Saturday (02Nov2024), this Sunday (03Nov2024), patient started experiencing a lot of itching on body specially the arm, right arm. The patient had a pheromone of that looked like reaction break out, on the top of patient's back and then in the front on patient's chest and then, the patient had random spots here and there on the arms, legs and a couple on the neck and they itch quite a lot and so, with all the things that happened last week (Oct2024) plus in patient was in a marshy area for just a few moments and was also in a hotel and had been trying to figure out could he/she had had mosquito bites or bed bugs or anything like that but the patient thought this was potentially a reaction to this Pfizer Comirnaty.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Friend reported that his wife received the Comirnaty vaccine and stated itchiness sensation afterward; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 48-year-old female patient (not pregnant) 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 included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "Friend reported that his wife received the Comirnaty vaccine and stated itchiness sensation afterward". Therapeutic measures were not taken as a result of pruritus.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Back pain, Insomnia, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: fainting; experienced nausea and fainting; Could not sleep; upper left arm became extremely painful and stiff within a few hours of injection; upper left arm became extremely painful and stiff within a few hours of injection; severe pain in upper arm, neck and upper back; severe pain in upper arm, neck and upper back; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 as dose 1, single (Lot number: LM7786) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Oct2024 as dose 1, single), in right arm for immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LISINOPRIL; LIPITOR. No other vaccine in four weeks. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 22Oct2024, outcome "recovered" (2024) and all described as "severe pain in upper arm, neck and upper back"; VACCINATION SITE PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 22Oct2024 at 12:00, outcome "not recovered" and all described as "upper left arm became extremely painful and stiff within a few hours of injection"; INSOMNIA (non-serious) with onset 23Oct2024, outcome "recovered" (2024), described as "Could not sleep"; NAUSEA (non-serious) with onset 23Oct2024 at 03:00, outcome "recovered" (2024), described as "experienced nausea and fainting"; SYNCOPE (medically significant) with onset 23Oct2024 at 03:00, outcome "recovered" (2024), described as "fainting". Therapeutic measures were taken as a result of vaccination site pain, musculoskeletal stiffness, neck pain, back pain including alternating ibuprofen and tylenol. Clinical course: 22Oct2024: upper left arm became extremely painful and stiff within a few hours of injection. By evening/night, severe pain in upper arm, neck and upper back. Could not sleep, experienced nausea and fainting at 3am and again at 6am the next day. Pain diminished very slowly over the next week, but as of today (05Nov2024) still experiencing pain and stiffness in upper left arm that wakes patient up at night.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Syncope, Vaccination site pain
Clinical narrative: fainting; experienced nausea and fainting; Could not sleep; upper left arm became extremely painful and stiff within a few hours of injection; upper left arm became extremely painful and stiff within a few hours of injection; severe pain in upper arm, neck and upper back; severe pain in upper arm, neck and upper back; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 as dose 1, single (Lot number: LM7786) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Oct2024 as dose 1, single), in right arm for immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LISINOPRIL; LIPITOR. No other vaccine in four weeks. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 22Oct2024, outcome "recovered" (2024) and all described as "severe pain in upper arm, neck and upper back"; VACCINATION SITE PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 22Oct2024 at 12:00, outcome "not recovered" and all described as "upper left arm became extremely painful and stiff within a few hours of injection"; INSOMNIA (non-serious) with onset 23Oct2024, outcome "recovered" (2024), described as "Could not sleep"; NAUSEA (non-serious) with onset 23Oct2024 at 03:00, outcome "recovered" (2024), described as "experienced nausea and fainting"; SYNCOPE (medically significant) with onset 23Oct2024 at 03:00, outcome "recovered" (2024), described as "fainting". Therapeutic measures were taken as a result of vaccination site pain, musculoskeletal stiffness, neck pain, back pain including alternating ibuprofen and tylenol. Clinical course: 22Oct2024: upper left arm became extremely painful and stiff within a few hours of injection. By evening/night, severe pain in upper arm, neck and upper back. Could not sleep, experienced nausea and fainting at 3am and again at 6am the next day. Pain diminished very slowly over the next week, but as of today (05Nov2024) still experiencing pain and stiffness in upper left arm that wakes patient up at night.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial; when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), described as "tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial"; DEVICE LEAKAGE (non-serious), described as "when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out".  Additional information: Pharmacist had two Abrysvo vaccines that were defective and asked for a replacement. It was like the tip of syringe that was in it, was already broken. So, when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere. The collar on the syringe was loose and the adapter did not seem to fully penetrate the vial, which resulted in product leaking out. There were no glass shards. They had this happen at least 4 times, at first they thought they had done something wrong, but the last time pharmacist was the one that was mixing it. Pharmacist had mixed a lot of these since last year, she/he was sure of her/his ability to do so. The vaccine was not administered to any patient. Packaging was sealed and intact. Reporter stated there was a sample of the product available to be returned, if requested.   Causality for "tip of syringe that was in it, was already broken/collar on the syringe was loose and the adapter did not seem to fully penetrate the vial" and "when they went to screw it on the device to push the liquid in, it pushed the liquid everywhere/resulted in product leaking out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400290379 same reporter/event, different device;
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she has a rare blood disorder, it made her feel better such as doing the house chores.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A female 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 included: "rare blood disorder" (ongoing), notes: received regular and ongoing treatment. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she has a rare blood disorder, it made her feel better such as doing the house chores.".  Additional information: The patient mentioned that she had a rare blood disorder and received regular, ongoing treatment. She was curious about the contents of the new Pfizer COVID-19 shot because it made her feel better despite having a rare pre-existing condition, such as being able to do house chores. She stated that whenever she received the COVID-19 vaccine, she experienced a boost of energy, which was why she had been interested in contents of vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body surface area, COVID-19, Drug ineffective, Haemoglobin, Lymphocyte count
Clinical narrative: He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.; He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.; This is a spontaneous report received from a Physician, Program ID: .  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "chronic lymphocytic leukemia" (unspecified if ongoing); "hospitalized", start date: Apr2015 (unspecified if ongoing); "epididymitis", start date: 2015 (unspecified if ongoing), notes: It turned out to be epididymitis and he received antibiotics; "elevated lymphocytes" (unspecified if ongoing); "Allergies: Penicillins" (unspecified if ongoing); "sometimes has sweats at night" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics for Epididymitis. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.". The patient was hospitalized for drug ineffective, covid-19 (start date: Jan2022, discharge date: 2022, hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: Body surface area: (unspecified date) 2.08; (unspecified date) 2.07; Haemoglobin: (Mar2016) 14.5, notes: normal; Lymphocyte count: (unspecified date) elevated; (Mar2016) 11000; Platelet count: (Mar2016) 293000, notes: normal; Weight: (unspecified date) 193.2 lbs; (unspecified date) 192.2 lbs; (unspecified date) 194.4 lbs; White blood cell count: (Mar2016) 17.3. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: In Apr2015, he was hospitalized for what was initially thought to be a testicular torsion. It turned out to be epididymitis and he received antibiotics. Apparently, elevated lymphocytes were seen, and he was referred to a hematologist, Dr.. The patient told reporter he was diagnosed with chronic lymphocytic leukemia. This was in. He subsequently relocated to  and started seeing Dr. He states that he sometimes has sweats at night, but no other symptoms. He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated. He spent a total of about 2 weeks there. He received supplemental oxygen but was not in the ICU. He received Evusheld in Feb2022 and a second dose in March.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported DRUG INEFFECTIVE / COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Weight, White blood cell count
Clinical narrative: He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.; He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.; This is a spontaneous report received from a Physician, Program ID: .  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "chronic lymphocytic leukemia" (unspecified if ongoing); "hospitalized", start date: Apr2015 (unspecified if ongoing); "epididymitis", start date: 2015 (unspecified if ongoing), notes: It turned out to be epididymitis and he received antibiotics; "elevated lymphocytes" (unspecified if ongoing); "Allergies: Penicillins" (unspecified if ongoing); "sometimes has sweats at night" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics for Epididymitis. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated.". The patient was hospitalized for drug ineffective, covid-19 (start date: Jan2022, discharge date: 2022, hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: Body surface area: (unspecified date) 2.08; (unspecified date) 2.07; Haemoglobin: (Mar2016) 14.5, notes: normal; Lymphocyte count: (unspecified date) elevated; (Mar2016) 11000; Platelet count: (Mar2016) 293000, notes: normal; Weight: (unspecified date) 193.2 lbs; (unspecified date) 192.2 lbs; (unspecified date) 194.4 lbs; White blood cell count: (Mar2016) 17.3. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: In Apr2015, he was hospitalized for what was initially thought to be a testicular torsion. It turned out to be epididymitis and he received antibiotics. Apparently, elevated lymphocytes were seen, and he was referred to a hematologist, Dr.. The patient told reporter he was diagnosed with chronic lymphocytic leukemia. This was in. He subsequently relocated to  and started seeing Dr. He states that he sometimes has sweats at night, but no other symptoms. He was admitted to the hospital in Jan2022 for COVID-19, despite being fully vaccinated. He spent a total of about 2 weeks there. He received supplemental oxygen but was not in the ICU. He received Evusheld in Feb2022 and a second dose in March.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported DRUG INEFFECTIVE / COVID-19 cannot be ruled out
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: suffered anaphylactic shock; big fall white attempted riding my bicycle in town during family visit; could not stand on my feet; felt extremely cold; i woke up, felt pain all over my body; passed out; Initial information received on 31-Oct-2024 regarding an unsolicited valid serious Courtesy case received from a other health professional.  This case involves an unknown age male patient (14.732 cm and 101.9 kg) who passed out, suffered anaphylactic shock, big fall while attempted riding my bicycle in town during family visit, woke up, felt pain all over body, could not stand on feet and felt extremely cold after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 Drug hypersensitivity with bupivacaine, COVID-19 vaccine, mRNA-1273, LNP-S (moderna), Covid-19 vaccine, mRNA, cx-024414, LNP-S (Moderna), dapagliflozin, fentanyl, influenza a (H1N1) virus vaccine monovalent 2009, methylprednisolone, Opioids-Meperidine and Related, Polyethylene Glycol Analogues, preservative free, Tdap.   On an unknown date in Jun-2021, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 14-JUN-2021 the patient suffered anaphylactic shock (anaphylactic shock) ,big fall white attempted riding his bicycle in town during family visit (fall) (latency: few days approximately) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. On an unknown date in 2021 the patient passed out while talking to his son (loss of consciousness) and when he woke up, felt pain all over his body (pain), could not stand on his feet (dysstasia) and quickly layed down on floor where he could not get up for almost 2 hours and felt extremely cold (feeling cold) as if he was experiencing thyroid disorder (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Medically significant for loss of consciousness and anaphylactic shock .; Sender's Comments: Sanofi company comment for information received on 05-NOV-2024: This case involves an unknown age male patient (14.732 cm and 101.9 kg) who passed out and suffered anaphylactic shock after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. Additionally previous history of drug hypersensitivity to many products could be confounding factor.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Ageusia, Bell's palsy, Eyelid function disorder, Facial paralysis, Headache
Clinical narrative: Bell's palsy; Left side facial paralysis; Severe headache; Pain on left side of neck; She couldn't test; Couldn't blink her left eye; This spontaneous case, initially received on 29-Oct-2024 including additional information received on 29-OCT-2024, was reported by a non health professional and concerns an adult female patient.  At the time of the event the patient had High blood pressure, Asthma.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Flucelvax (TIV) for Flu vaccination, Influenza immunisation, Dose regimen: 0.5 ml, route of administration: not reported; Lot number: 946616. batch number reported as 946616. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Pain on left side of neck (outcome: Not recovered / Not resolved). On 22-Oct-2024, the patient experienced Bell's palsy (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved). Associated symptoms included: Left side facial paralysis, Severe headache, She couldn't test, Couldn't blink her left eye.  Consumer reported she came down with Bell's Palsy. The day after the vaccination she experienced severe headache and pain on left side of neck. Symptoms progressively got worse and she could not taste or blink her left eye. Her left side of her face was. She initially thought she was having a stroke. She went to ER on Saturday 26-ct-2024 and stroke was ruled out. They stated symptoms were related to flu vaccine.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Prednisone 50 mg  Reporter's assessment: The reporter considered the event(s) Bell's palsy and Pain on left side of neck related to the administration of Flucelvax (TIV) and considered events as non-serious.  Case correction (29-Oct-2024) upon internal review some changes were required so the event stroke was deleted , as it is mentioned that stroke is- ruled out. And the event facial paralysis, headache, couldn't taste and couldn't blink were assessed as symptoms of bell's palsy.; Reporter's Comments: Causality: Related for Bell's palsy and neck pain considering plausible temporal relationship (1 day after vaccination). Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.