chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: had a patient, who was pregnant of about 33 weeks; patient was 38 YO; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F59KR, expiry date 22-FEB-2025) for prophylaxis.   On 03-OCT-2024 09:00, the patient received Arexvy. On 03-OCT-2024 09:00, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: patient was 38 YO). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: had a patient, who was pregnant of about 33 weeks). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 33 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 03-OCT-2024 The other health professional reported that they had a patient, who was pregnant of about 33 weeks, visited their office, and the recommendation of her Obstetrics and genecology for a RSV vaccination, and they did administer the GlaxoSmithKline vaccination, because they were not clear on the guidelines for pregnancy, since it look alike that they only recommended Pfizer at this time.  The other health professional reported that they wanted to know more about how may affect the patient, what the patient should expected and if there was any follow up of needed for the patient". The Vaccine Administration Facility was the same as Primary Reporter. The other health professional mentioned that the patient was 38 year old which led to product use in unapproved population, they didn't provide the due date.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Shingrix was prescribed by physician to a 17 years and 10 months old patient who is immunocompromised with ulcerative colitis.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 17-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and ulcerative colitis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: Shingrix was prescribed by physician to a 17 years and 10 months old patient who is immunocompromised with ulcerative colitis.). The outcome of the intercepted drug prescribing error was not applicable.   Additional Information: GSK Receipt Date: 03-OCT-2024 The pharmacist called to report Shingrix was prescribed by physician to a 17 years and 10 months old patient who was immunocompromised with ulcerative colitis. The vaccines had not been administered at moment of call. The vaccine administration facility was the same as primary reporter. The vaccine had not been administered yet, pharmacist called to request information and stated physician did not want to wait for patient to have 18 years of age which led to intercepted drug prescribing error.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: administered with a second dose of Arexvy on October 4th 2024/extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52R7B, expiry date 15-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on October 2023).   On 04-OCT-2024, the patient received the 2nd dose of Arexvy. On 04-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: administered with a second dose of Arexvy on October 4th 2024/extra dose). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 04-OCT-2024 The reporter reported that that the patient (who was also a Healthcare Provider) with underlying conditions was administered with a second dose of Arexvy vaccine which led to, extra dose administered. The reporter reported that the lot number and expiration date for the first dose of Arexvy vaccine (Respiratory Syncytial Virus vaccine) were unknown. It was also unknown by caller what underlying conditions did the patient had and if they started before or after the first dose of Syncytial Virus vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular discomfort, Rash
Clinical narrative: eyes was itchy, rashy and uncomfortable; eyes was itchy, rashy and uncomfortable; eyes was itchy, rashy and uncomfortable; This spontaneous case was reported by a patient and describes the occurrence of EYE PRURITUS (eyes was itchy, rashy and uncomfortable), RASH (eyes was itchy, rashy and uncomfortable) and OCULAR DISCOMFORT (eyes was itchy, rashy and uncomfortable) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PRURITUS (eyes was itchy, rashy and uncomfortable), RASH (eyes was itchy, rashy and uncomfortable) and OCULAR DISCOMFORT (eyes was itchy, rashy and uncomfortable). At the time of the report, EYE PRURITUS (eyes was itchy, rashy and uncomfortable), RASH (eyes was itchy, rashy and uncomfortable) and OCULAR DISCOMFORT (eyes was itchy, rashy and uncomfortable) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that in a week around the eyes was itchy, rashy and uncomfortable, Resolved in 7 weeks.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to MOD-2024-775067 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: high fever; extreme fatigue; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Oct-2024 and was forwarded to Moderna on 11-Oct-2024.      This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever) (seriousness criterion medically significant), FATIGUE (extreme fatigue) (seriousness criterion medically significant) and HEADACHE (headaches) (seriousness criterion medically significant). At the time of the report, PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches) had resolved.            The concomitant medication was not reported by reporter.   She took 6 doses of the Spikevax COVID-19 vaccine but experienced side effects like high fever, extreme fatigue, and headaches lasting 2-4 days after each dose.  The treatment medication was not reported by reporter. Company comment: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2024-775047 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Laboratory test, Vision blurred
Clinical narrative: weird feeling; version becoming blurry; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (weird feeling) and VISION BLURRED (version becoming blurry) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2024, the patient experienced VISION BLURRED (version becoming blurry). In October 2024, the patient experienced FEELING ABNORMAL (weird feeling). At the time of the report, FEELING ABNORMAL (weird feeling) and VISION BLURRED (version becoming blurry) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Customer had extra vaccine in box, fears a patient did not get their vaccine; Clinic had extra vial in Priorix box, not sure who only got the diluent; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Customer had extra vaccine in box, fears a patient did not get their vaccine) and inappropriate dose of vaccine administered (Verbatim: Clinic had extra vial in Priorix box, not sure who only got the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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: 18-SEP-2024 The clinic manager reported that customer had extra Priorix vaccine in box and feared a patient did not get their vaccine which was not serious. The patient did not receive any other products. It was reported that, the clinic found an extra vial in box no diluent. Not sure what exactly happened. As clinic had extra vial in Priorix box, the reporter was not sure that who only got the diluent, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Physician from a sales representative.  An adolescent male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: MYOCARDITIS (hospitalization), outcome "recovered". It was unknown if therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possibly contributory role of BNT162b2, BNT162b2 omi ba.4-5 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Skin reaction after vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN REACTION (non-serious), outcome "recovering", described as "Skin reaction after vaccination". Therapeutic measures were not taken as a result of skin reaction.  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
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site on their left arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly male patient received BNT162b2 (BNT162B2 NOS), in Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Unspecified number of doses (reported as "a bunch"), Anatomical location: Left arm, Lot #: Unknown), for COVID-19 immunization, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection site on their left arm".  Additional information: Caller and her husband after being administered with Pfizer COVID-19 Vaccine last April 2023 experienced pain at the injection site on their left arm longer than usual that lasted for a month. Caller was asking if Pfizer thought that getting all the COVID-19 Vaccines in the same arm would cause pain from building antibodies? She wanted to know if she got it in the other arm, would that make a difference? She was asking if they get it in their other arm, would they get less pain? Would the pain be the same? Pain lasts a little bit and goes away in a few days. Caller added that pain lasted for a month. Caller and her husband got a bunch of Pfizer Covid vaccines. They always get them in their left arm. Last time when they got the Covid vaccine they got it in the left arm and they both had pain from getting the vaccine that lasted a lot longer. It usually did away within a few days to a week at most but last time for her it lasted weeks before going away. She thought because she has had a lot of vaccines, and the antibodies built up. If they get another before the holiday if they got it in the other arm, would they have the same reaction? She prefers not to get it in her right arm but if we think there would be a noticeable difference in the right, she wanted to know that.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400275256 Different patients, Same reporter, drug, event.;US-PFIZER INC-202400275676 Same event, different patient, drug dose number;US-PFIZER INC-202400275677 Same patient, event, different drug dose number;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site on their left arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site on their left arm".  Additional information: Patient stated that she and her husband got a bunch of Pfizer Covid vaccines. They always get them in their left arm. They were seniors so was trying to keep up in a timely fashion. Last time when they got the Covid vaccine they got it in the left arm and they both had pain from getting the vaccine that lasted a lot longer.  Reporter and her husband after being administered with Pfizer COVID-19 Vaccine last April 2023 experienced pain at the injection site on their left arm longer than usual that lasted for a month. Stated it usually goes away within a few days to a week at most but last time for her it lasted weeks before going away. She thought because she has had a lot of vaccines, and the antibodies built up and asked if that was the case. Patient wanted to know if they get another before holiday if they got it in the other arm, would they have the same reaction. She preferred not to get it in her right arm but if there would be a noticeable difference in the right, she wanted to know that. There was nothing more than she has said, and she had no health problems, never had issues with getting the vaccine. Stated last time it lasted a lot longer.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400275256 Same patient, event, Different drug dose number.;US-PFIZER INC-202400275629 Same event, different patient, drug dose number;
Age: 56.0
Sex: F
Vaccine: COVID19, PNC20, COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Next day arm swelled; Next day low grade fever at times; Next day, redness spread down arm; Arm was burning hot next day/Arm began to get hot/arm extremely hot/burning hit (radiating heat); became red below injection site; arm started feeling heavy/arm felt heavy; felt fatigued; Arm starting hurting night of injection and began to get hot/arm pain increased; This is a spontaneous report received from an Other HCP.  A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Oct2024 at 09:30 as dose number unknown, single (Lot number: LC128l1) at the age of 56 years, in left arm for immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Bandaid adhesive allergies" (unspecified if ongoing); "Allergies to dust on rare occasions" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; COENZYME Q10 [UBIDECARENONE]; MULTIVITAMIN FOR WOMEN; METAMUCIL [PLANTAGO OVATA]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2024, outcome "recovering", described as "Arm starting hurting night of injection and began to get hot/arm pain increased"; BURNING SENSATION (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "Arm was burning hot next day/Arm began to get hot/arm extremely hot/burning hit (radiating heat)"; LIMB DISCOMFORT (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "arm started feeling heavy/arm felt heavy"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "became red below injection site"; FATIGUE (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "felt fatigued"; PERIPHERAL SWELLING (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day arm swelled"; PYREXIA (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day low grade fever at times"; ERYTHEMA (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day, redness spread down arm". Therapeutic measures were taken as a result of burning sensation, pain in extremity, vaccination site erythema, limb discomfort, fatigue, peripheral swelling, pyrexia, erythema.  Additional information: Patient arm started hurting night of injection and began to get hot. Her arm was burning hot next day, became red below injection site, arm started feeling heavy, and she felt fatigued. Next day, redness spread down arm, arm extremely hot (low grade fever at times, arm swelled, arm pain increased and burning hit (radiating heat, arm felt heavy). The doctor put her on antibiotic treatment as precaution. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19, PNC20, COVID19
Symptoms: Fatigue, Vaccination site cellulitis
Clinical narrative: Next day arm swelled; Next day low grade fever at times; Next day, redness spread down arm; Arm was burning hot next day/Arm began to get hot/arm extremely hot/burning hit (radiating heat); became red below injection site; arm started feeling heavy/arm felt heavy; felt fatigued; Arm starting hurting night of injection and began to get hot/arm pain increased; This is a spontaneous report received from an Other HCP.  A 56-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Oct2024 at 09:30 as dose number unknown, single (Lot number: LC128l1) at the age of 56 years, in left arm for immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Bandaid adhesive allergies" (unspecified if ongoing); "Allergies to dust on rare occasions" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; COENZYME Q10 [UBIDECARENONE]; MULTIVITAMIN FOR WOMEN; METAMUCIL [PLANTAGO OVATA]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2024, outcome "recovering", described as "Arm starting hurting night of injection and began to get hot/arm pain increased"; BURNING SENSATION (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "Arm was burning hot next day/Arm began to get hot/arm extremely hot/burning hit (radiating heat)"; LIMB DISCOMFORT (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "arm started feeling heavy/arm felt heavy"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "became red below injection site"; FATIGUE (non-serious) with onset 01Oct2024 at 15:00, outcome "recovering", described as "felt fatigued"; PERIPHERAL SWELLING (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day arm swelled"; PYREXIA (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day low grade fever at times"; ERYTHEMA (non-serious) with onset 02Oct2024, outcome "recovering", described as "Next day, redness spread down arm". Therapeutic measures were taken as a result of burning sensation, pain in extremity, vaccination site erythema, limb discomfort, fatigue, peripheral swelling, pyrexia, erythema.  Additional information: Patient arm started hurting night of injection and began to get hot. Her arm was burning hot next day, became red below injection site, arm started feeling heavy, and she felt fatigued. Next day, redness spread down arm, arm extremely hot (low grade fever at times, arm swelled, arm pain increased and burning hit (radiating heat, arm felt heavy). The doctor put her on antibiotic treatment as precaution. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; my arm is sore; chills; a mild fever; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Oct2024 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: QULIPTA, start date: 06Jan2021, stop date: 11Oct2024; FLU [INFLUENZA VACCINE] taken for immunisation, on 01Oct2024 as dose number unknown, single. Vaccination history included: comirnaty (2023-2024 formula) (DOSE 1, SINGLE; Intramuscular in Arm Left at 15:00), administration date: 17Oct2023, when the patient was 40-year-old, for Covid-19 Immunization, reaction(s): "Got covid shot and my arm hurt later as common after vaccines/my arm is sore", "Chills", "body aches", "a mild fever"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 07Dec2022, when the patient was 39-year-old, for Covid-19 Immunization, reaction(s): "Got covid shot and my arm hurt later as common after vaccines/my arm is sore", "Chills", "body aches", "a mild fever", "Headache"; comirnaty (DOSE 3 (BOOSTER), SINGLE; Lot: FH8030), administration date: 16Nov2021, when the patient was 38-year-old, for Covid-19 Immunization, reaction(s): "Arm pain/my arm is sore", "Chills", "body aches", "Fever/a mild fever", "Headache"; BNT162b2 (DOSE 1, SINGLE), administration date: 11Mar2021, when the patient was 37-year-old, for Covid-19 Immunization, reaction(s): "some mild arm tenderness as typical with vaccines/my arm is sore", "Chills", "body aches", "a mild fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 11Oct2024 at 17:30, outcome "recovering", described as "a mild fever"; PAIN (non-serious) with onset 11Oct2024 at 17:30, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 11Oct2024 at 17:30, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 11Oct2024 at 17:30, outcome "recovering", described as "my arm is sore". Therapeutic measures were not taken as a result of pain, pain in extremity, chills, pyrexia.  Additional information: Patient had no known allergies. Patient didn't receive any other vaccines on the same date as the Pfizer vaccine. She got her Covid vaccine today and her arm was sore, she had chills, body aches and a mild fever. This had happened to her each year when she had gotten her vaccine and she reported it each year as required but it normally passed within 24 hours. The patient did not require prolonged hospitalization as a result of any events.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: Itching in the palms; diarrhea; shoulder/arm pain; shoulder/arm pain; significant inflammation/redness/ tenderness at the site of BCG scar; significant inflammation/redness/ tenderness at the site of BCG scar; significant inflammation/redness/ tenderness at the site of BCG scar; This is a spontaneous report received from a Nurse.  A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Oct2024 at 10:00 as dose 1, single (Lot number: LN0589) at the age of 31 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 10Oct2024 at 12:00, outcome "recovering", described as "Itching in the palms"; DIARRHOEA (non-serious) with onset 10Oct2024 at 12:00, outcome "recovering", described as "diarrhea"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 10Oct2024 at 12:00, outcome "recovering" and all described as "shoulder/arm pain"; VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 10Oct2024 at 12:00, outcome "recovering" and all described as "significant inflammation/redness/ tenderness at the site of BCG scar". Therapeutic measures were not taken as a result of pruritus, diarrhoea, arthralgia, pain in extremity, vaccination site inflammation, vaccination site erythema, vaccination site pain.  Additional information: Patient did receive any other vaccines on the same date as the vaccine(s) for which you are reporting: No. Patient did receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting: No. Patient was taking any other medications within 2 weeks of the event starting: No. Device Date : 11Oct2024.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain
Clinical narrative: Itching in the palms; diarrhea; shoulder/arm pain; shoulder/arm pain; significant inflammation/redness/ tenderness at the site of BCG scar; significant inflammation/redness/ tenderness at the site of BCG scar; significant inflammation/redness/ tenderness at the site of BCG scar; This is a spontaneous report received from a Nurse.  A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Oct2024 at 10:00 as dose 1, single (Lot number: LN0589) at the age of 31 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 10Oct2024 at 12:00, outcome "recovering", described as "Itching in the palms"; DIARRHOEA (non-serious) with onset 10Oct2024 at 12:00, outcome "recovering", described as "diarrhea"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 10Oct2024 at 12:00, outcome "recovering" and all described as "shoulder/arm pain"; VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 10Oct2024 at 12:00, outcome "recovering" and all described as "significant inflammation/redness/ tenderness at the site of BCG scar". Therapeutic measures were not taken as a result of pruritus, diarrhoea, arthralgia, pain in extremity, vaccination site inflammation, vaccination site erythema, vaccination site pain.  Additional information: Patient did receive any other vaccines on the same date as the vaccine(s) for which you are reporting: No. Patient did receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting: No. Patient was taking any other medications within 2 weeks of the event starting: No. Device Date : 11Oct2024.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; chills; fever; vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Oct2024 at 13:45 as dose 1, single (Lot number: LM2221) at the age of 27 years for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 11Oct2024 as dose 1, single (Lot number: TFAA2436), in left arm for immunisation. The patient's relevant medical history included: "Peanuts and hazelnut allergy" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE], start date: 27Jan2024, stop date: 12Oct2024. The patient also took other concomitant therapy. The following information was reported: NAUSEA (non-serious) with onset 12Oct2024 at 16:45, outcome "recovering"; CHILLS (non-serious) with onset 12Oct2024 at 16:45, outcome "recovering"; PYREXIA (non-serious) with onset 12Oct2024 at 16:45, outcome "recovering", described as "fever"; VOMITING (non-serious) with onset 12Oct2024 at 16:45, outcome "recovering". Therapeutic measures were not taken as a result of nausea, chills, pyrexia, vomiting. Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the reported vaccines. The patient also took equate-brand allergy meds morning of 12Oct2024. She only drank water. The patient experienced nausea, chills, and fever set in throughout Yom Kippur fasting. After 16:00, nausea resulted in vomiting.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; 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)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2024 (unspecified if ongoing), notes: prescribed nirmatrelvir, ritonavir (PAXLOVID), but did not take it. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in 2024 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "COVID". The event "covid" required physician office visit. The clinical course was reported as follows: It was reported that the patient got the flu vaccine and then the COVID-19 vaccine (reported as: a month ago), and now has COVID. The doctor sent the prescription to the pharmacy for nirmatrelvir, ritonavir and then the insurance denied it due to a limit. The patient received nirmatrelvir, ritonavir last time he had COVID (Feb2024), but did not use it and left it at a cousin's house. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 2024, outcome "recovered" (2024), described as "Shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient said shortly after he received the COVID-19 vaccine, he presented with Shingles. The doctors he worked with said it was very possible it was from the Covid-19 vaccine. Patient said it was the Pfizer brand. Not sure, what treatment received for the adverse event. but he said he worked with doctors so he assumed he received some sort of treatment.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: I got the lymph node like the the armpit lymph node, which was super painful; I got the lymph node like the the armpit lymph node, which was super painful; very fatigued and tired; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "I got the lymph node like the the armpit lymph node, which was super painful"; FATIGUE (non-serious), outcome "unknown", described as "very fatigued and tired".  Additional information : It was reported that but the actual second year the patient asked for Pfizer, the second one he got the lymph node like the armpit lymph node, which was super painful for a couple of days, and in both situations. He got very, very fatigued and tired. because he guess his body was reacting to it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was boosted three weeks ago with the Pfizer vaccine. And it is now you know 3 weeks or so and I got Covid; I was boosted three weeks ago with the Pfizer vaccine. And it is now you know 3 weeks or so and I got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacture unknown, Primary series completed), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2024, outcome "unknown" and all described as "I was boosted three weeks ago with the Pfizer vaccine. And it is now you know 3 weeks or so and I got Covid". The patient underwent the following laboratory tests and procedures: Body temperature: 101; SARS-CoV-2 test: positive.  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: Asthma, Emphysema
Clinical narrative: asthma; emphysema; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 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: ASTHMA (non-serious), outcome "unknown"; EMPHYSEMA (non-serious), outcome "unknown".  Additional information: The patient said she has asthma and emphysema and she really needed to get an updated COVID shot because her last one was in December of last year. The patient stated that she went to a doctor's office that she hasn't been to because when she gets shots she has to lie down or she might faint, she also can't get them in pharmacies and her regular doctor's office doesn't get the COVID shot anymore. The patient further said that she found a family clinic that gave out the COVID shot, and they gave it to her today and she asked if she was getting the latest one and they said yes, and she asked the person that gave her the shot to fill out her vaccine card afterwards. The patient stated that the person declined and printed out something for her instead and when she got home, she found out that she may have received last year's vaccine. Created a manual AE form because the patient said that she took the Pfizer covid19 vaccine and she has asthma and emphysema.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400276069 same patient, different dose/event;
Age: 41.0
Sex: F
Vaccine: RSV
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Patient was admitted on 8/22/2024 (at the time she had a gestational age of 28 weeks and 6 days) for preeclampsia, chronic hypertension, and she was pregnancy with twins. While admitted her goal for delivery was gestational age 34 weeks. On 9/17/2024 she received Abrysvo (gestational age 32 weeks and 5 days). (about 24 hours after the vaccine) the patient experienced severe preeclampsia and had a cesarean section done.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Evening of vaccination and following day - significant fatigue. One day after vaccination - pain at injection site. Two days after vaccination -  very sore/swollen lymph node in armpit.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate irregular
Clinical narrative: Patient reported to our pharmacy clinic in suite 222 to receive her flu vaccine on 10/15/24. She requested the regular Flu shot and not the Flu shot for 65+ older due to a reported history of reactions to vaccines. After she received the requested regular flu shot from our caregiver, she reported shortness of breath and tightness of her chest. She reported that she had asthma and took doses of her personal albuterol inhaler at the time. Due to the concern of worsening side effects, patient was instructed to sit down for additional monitoring by our clinic. Patient was alert and conscious and was otherwise able to mobilize and verbalize her symptoms of discomfort. After about 10 minutes have elapsed, patient reported that her symptoms were still uncomfortable due to some tightness in her chest.   I had taken her pulse along the carotid artery as well as her radial artery to assess for additional symptoms and had trouble calculating her BPM due to an irregular rhythm that began to become regular after 2 minutes of assessment. I had an additional caregiver take her pulse after and she reported a regular rhythm. Due to continued reported symptoms of chest tightness and discomfort, we directed the patient to our emergency department. She was escorted in a wheelchair by one of our clinic caregivers who accompanied the patient and her partner to the main hospital where they were handed off to a triage nurse to assess for additional symptoms. Patient reports on 10/16/24 that the hospital had given her antihistamine and a steroid after she began to exhibit itchiness and that she went home by 5pm on 10/15/24 after having been directed to the hospital around 1:30pm.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MEN
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events; pt received third dose of shingles vaccine when the dose schedule is only supposed to be 2 vaccinations maximum. Patient was under the impression that he only received one vaccine, and we gave him his second dose. Upon leaving the clinic and reviewing his vaccination records, the patient already received his second dose, and the vaccination we gave him today was his third dose.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Atrioventricular block, Loss of consciousness, Pallor, Respiratory rate decreased, Speech disorder
Clinical narrative: From RN notes: "Around 2120, nursing staff reported resident appears different. Writer immediately assessed resident. Resident appears alert and mumbling words. Able to respond to verbally. VS as follows: HR 84, RR 7-18, O2 sat 73-95% RA, 97.4F, unable to get BP. Started on cont O2 @4.5L via mask, saturation 99%. Episodes of resident turning very pale, respirations slowed w/ periods of apnea noted. Lowered HOB and residents color and respirations returned. Res with pulse and chest rise/fall but remains unconscious." Resident was sent out of the facility via EMS and admitted to hospital with dx: Complete Heart Block ,per nursing notes.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Sleep disorder, Syncope
Clinical narrative: on 10/16/24 at around 1:00PM, patient felt nauseous and lightheaded. Patient crumpled and found herself on the floor. Patient took a 2 hour nap, drank some water and felt someway better. Patient stated that her arm was sore after the injection and was painful to sleep. Did not notice this when had this vaccine previously.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Per patient, feeling really sick with chills, fever overnight. Resolved over couple of days, but did not elaborate on specific timeline. Patient has previously only received Moderna for covid shots per discussion.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient reported pain in arm
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: about 30 minutes after patient got their vaccine and left for home. They called back stating that they developed a slow bleed at the vaccine site that would not cloth or stop. They had applied different Band-Aids  but the bleeding continued. Patient returned to the pharmacy and I dressed the would more securely.  And advised that if after they remove the dressing in about an hour and the bleeding is still happening to go to an urgent care for more treatment.  Patient is currently using Aspirin and Plavix, which could be the cause of this increased bleeding after vaccination.   Patient called back later in the day stating that bleeding had stopped.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient experienced dizziness and nausea a few minutes after getting vaccinated. Showed signs of syncope. Had patient follow treatment protocol for syncope by having him lie down on the floor, elevate legs and placed an ice pack in the neck area to help with blood flow to the brain. Patient felt better within 20 minutes and was discharged home.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Client felt tingling in arm around injection site. Redness was seen above the injection site. Benadryl 25 mg was administered. Fifteen minutes later, the redness was covering a larger area of the arm, it was getting hot, swollen and hard. Client was taken to ER by mother, no other treatment was given, and client was released.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reports bruising at the injection site with a ~2inch red circle around the bruise. Slightly itchy and warm. No other signs of allergic reaction (hives, shortness of breath, anaphylactic symptoms).  Unsure if caused by the flu or covid shot.
Age: 15.0
Sex: M
Vaccine: COVID19, IPV
Symptoms: No adverse event, Underdose
Clinical narrative: Pt received the wrong dose of COVID-19 Moderna (6mos-11 yr) for his age. He is 15 y/o. No immediate adverse effects noted.  No SOB, Rash etc. Pt, family made aware of incident right away. Pt was Vaccinated by RN
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Fatigue, Gait disturbance, Influenza virus test negative
Clinical narrative: No problems during vaccine in left arm with no reaction on skin or arm other than slight soreness. Evening on date of vaccine, felt  muscle ache, fatigue, chest tightness that continued following days. No fever. 3 days after vaccination, felt very, fatigued, weak and no strength trying to walk a short distance. Before vaccination, normal 3 mile walk 3-5 times week at avg 3 mph with no issues. 4 days after vaccination went to urgent care  with same symptoms. Neg for flu and covid. 6 days after vaccination symptoms better but still evident. Same on day 7. Seeking PCP care on day 8 or ER.