chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP, RVX
Symptoms: Skin disorder, Swelling face, Urticaria, Wound
Clinical narrative: had facial swelling; redness; irritable; had low grade fever; struggling with skin problems; had eczema; flake into wounds; swollen lymph nodes in the back of his head and neck; possible allergy; hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 7-month-old male patient who received DTPa (Infanrix) (batch number TX77L) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   Concomitant products included mupirocin, triamcinolone, hydroxyzine, ketoconazole and fluocinolone acetonide (Fluocinolone).   On 04-APR-2024, the patient received Infanrix .5 ml and Rotavirus vaccine. On 05-APR-2024, 1 days after receiving Infanrix and Rotavirus vaccine, the patient experienced hives (Verbatim: hives). On an unknown date, the patient experienced facial swelling (Verbatim: had facial swelling), erythema (Verbatim: redness), irritability (Verbatim: irritable), low grade fever (Verbatim: had low grade fever), skin disorder (Verbatim: struggling with skin problems), eczema (Verbatim: had eczema), wound (Verbatim: flake into wounds), swollen lymph nodes (Verbatim: swollen lymph nodes in the back of his head and neck) and allergy (Verbatim: possible allergy). The outcome of the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy were not resolved.   It was unknown if the reporter considered the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Rotavirus vaccine.     It was unknown if the company considered the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Rotavirus vaccine.   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: 14-SEP-2024 The reporter reported that the patient had received Infanrix hexa along with the Rotavirus vaccine. The reporter mentioned that shortly after vaccination, their son had facial swelling and redness became irritable and had low grade fever. They struggled with skin problems since then. His dermatologist thought he had ongoing urticaria, but it was not typical bumps. Eczema developed after the shot, and sometimes it will be flaked into wounds. He also had 4 swollen lymph nodes in the back of his head and neck. They believed there might have been an ongoing immune response or possible allergy, but no consult to allergist had been made by doctors. The reporter mentioned that it all started after these vaccines and had been ongoing 4 months.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Malaise, Pain, Pyrexia
Clinical narrative: Got sick that night; Chills; Low grade fever; aches and pains; not getting appetite/ loss of apetite; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atopic dermatitis. Previously administered products included Dupixent with an associated reaction of chills (started 1st dose on 01-SEP-2022, solution for injection (300mg/2ml) at a dose of 300mg QOW subcutaneously). Concomitant products included dupilumab (Dupixent).   On 23-JUL-2024, the patient received Shingrix. On 23-JUL-2024, less than a day after receiving Shingrix, the patient experienced sickness (Verbatim: Got sick that night), chills (Verbatim: Chills), low grade fever (Verbatim: Low grade fever), pain (Verbatim: aches and pains) and appetite lost (Verbatim: not getting appetite/ loss of apetite). The outcome of the sickness, chills, low grade fever, pain and appetite lost were resolving.   The reporter considered the sickness, chills, low grade fever, pain and appetite lost to be related to Shingrix.     The company considered the sickness, chills, low grade fever, pain and appetite lost to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2024 The reporter reported that she received Shingrix vaccine (Shingles shot) and experienced low grade fever, aches and pains, got sick that night and kept getting chills and was not getting an appetite to eat anything/loss of appetite. The patient's concomitant disease, risk factor, past medical history, medical treatment, concomitant medication, vaccination and family history was not provided. Last time (from the date of reporting) she took a shot of Dupixent was on 11th July 2024. The patient wanted to know what she could do for feel better, pharmacist advised on over the counter medication to help with the fever and pains, also informed on how to try regulating the chills with heat regulation. It was not reported if the patient received a corrective treatment for the events.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Never been so sick for a few days after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Never been so sick for a few days after). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-SEP-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine because the doctor kept pushing it. The patient never been so sick for a few days after.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got my second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (receive 1st dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive  the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got my second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:15-SEP-2024 This case was self-reported by patient. This adverse event was reported via non-voice channel (Web Form). The patient never got the second dose of Shingrix the 1st dose had been more than two years. The patient asks should they start both all over again or just repeat the initial dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No additional information was available.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix administered to patient on August 30, 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received HAV (Havrix) (batch number 423NL, expiry date 19-NOV-2025) for prophylaxis.   On 30-AUG-2024, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix administered to patient on August 30, 2024). The outcome of the incorrect storage of drug was 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: 10-SEP-2024 Regular nurse reported Havrix, Kinrix, Pediarix, Engerix-B stored at 8.6C x 8 mins on August 28, 2024, no prior excursions.  Havrix administered to patient, which led to incorrect storage of drug  No other patient involvement with vaccines. Consented to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Device issue, Immediate post-injection reaction, Injury associated with device, Product complaint, Syringe issue
Clinical narrative: 1 syringe the plunger was difficult to push and the patient ended up getting stuck twice; 1 syringe the plunger was difficult to push and the patient ended up getting stuck twice; Product Complaint; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental needle stick in a patient who received Flu Seasonal TIV Quebec (Flulaval) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Flulaval. On an unknown date, immediately after receiving Flulaval, the patient experienced accidental needle stick (Verbatim: 1 syringe the plunger was difficult to push and the patient ended up getting stuck twice), syringe issue (Verbatim: 1 syringe the plunger was difficult to push and the patient ended up getting stuck twice) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was not reported and the outcome of the syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick and syringe issue to be related to Flulaval.     It was unknown if the company considered the accidental needle stick and syringe issue to be related to Flulaval.   Additional Information: GSK receipt date: 13-SEP-2024 The field representative from GSK (GlaxoSmithKline) called to report on behalf of the supply chain nurse at the facility. The nurse stated that she had 5 syringes of Flulaval vaccine that all came from the same lot number AE2J7. According to the nurse the plunger on 3 different syringes leaked out the back of it and could not be used. Also, 1 syringe the plunger was difficult to push and the patient ended up getting stuck twice which led to, accidental needle stick, syringe issue and pharmaceutical product complaint. On the 5th syringe the plunger fell out the back and vaccine leaked all out. The reporter did not consent to the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: just recently had his second dose administered (late dose.); This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: just recently had his second dose administered (late dose.)). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 13-SEP-2024 The patient received his first dose of Shingrix years ago and just recently had his second dose administered, which led to lengthening of vaccination schedule. Consent not asked
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Hypersensitivity, Syncope
Clinical narrative: That made her collapse; Had extreme allergic reactions that made her collapse; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (That made her collapse) in an 80-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and VARICELLA ZOSTER VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of VARICELLA ZOSTER VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (That made her collapse) (seriousness criterion medically significant) and HYPERSENSITIVITY (Had extreme allergic reactions that made her collapse). At the time of the report, SYNCOPE (That made her collapse) and HYPERSENSITIVITY (Had extreme allergic reactions that made her collapse) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company Comment: This is a spontaneous case concerning an 80-year-old female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of syncope, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. It was reported that patient had had extreme allergic reactions that made her collapse with previous vaccines as Pfizer, Moderna and J&J shingles. The outcome of the event was reported as unknown. Tozinameran COVID 19 vaccine and Varicella zoster vaccine were considered as co-suspect products. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Palsy) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Company comment-This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the expected serious (medically significant) AESI Bell´s palsy unknown days after a dose of SPIKEVAX COVID-19 VACCINE NOS (dose number not provided) was administered. No further information on risk factors, medical history, detailed clinical course, investigations, and treatment received were provided. The outcome of the event was reported as unknown. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: tachycardia; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (tachycardia) in a 61-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 80777-0110-96) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (COVID-19) on 23-Jun-2024.    On 17-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 18-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2024, Heart rate: at 170 for about 2 minutes..     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had a heart rate at 170 for about 2 minutes. The first episode occurred at 2 pm and the second at 6:30 pm. Since then, the patient got exhausted with an elevated heart rate during exercise. Normal activities were ok.  No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Headache, Illness, Pyrexia
Clinical narrative: could hardly walk was "wobbling all over the place"; She felt sick; she experienced 101.8 F fever; had a terrible headache; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (could hardly walk was "wobbling all over the place"), ILLNESS (She felt sick), PYREXIA (she experienced 101.8 F fever) and HEADACHE (had a terrible headache) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder and Arm paralysis.    On 18-Sep-2024 at 6:00 PM, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 19-Sep-2024, the patient experienced GAIT DISTURBANCE (could hardly walk was "wobbling all over the place"), ILLNESS (She felt sick), PYREXIA (she experienced 101.8 F fever) and HEADACHE (had a terrible headache). At the time of the report, GAIT DISTURBANCE (could hardly walk was "wobbling all over the place"), ILLNESS (She felt sick), PYREXIA (she experienced 101.8 F fever) and HEADACHE (had a terrible headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2024, Body temperature: 101.8 F.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient was getting all her shots since day 1. She said she had never gotten sick or anything after the shots before, but that time she experienced 101.8 F fever. She felt sick and could hardly walk was wobbling all over the place. She stated noticing the side effect the next morning (19Sept), had a terrible headache and even the reporting day she still had a bad headache. She does say it had improved and she feels better. These effects were worse the day before the reporting day. No treatment medication was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Electrocardiogram, Flushing, Pain
Clinical narrative: Mild Aches; flush in face at first-within 1-3 days, 4th day flush; light headed; pain in joints; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Mild Aches), FLUSHING (flush in face at first-within 1-3 days, 4th day flush), DIZZINESS (light headed) and ARTHRALGIA (pain in joints) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Type 2 Diabetes, food allergies, seasonal allergies, Abnormal ECG, Carotid artery disease, Hyperlipidemia, Hypertension, Sleep apnea, GERD,.  Concurrent medical conditions included Type 2 diabetes mellitus, Food allergy, Seasonal allergy, Carotid artery disease, Hyperlipidemia, Hypertension, Sleep apnea and GERD.    On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (Mild Aches), FLUSHING (flush in face at first-within 1-3 days, 4th day flush), DIZZINESS (light headed) and ARTHRALGIA (pain in joints). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Mild Aches), FLUSHING (flush in face at first-within 1-3 days, 4th day flush), DIZZINESS (light headed) and ARTHRALGIA (pain in joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Abnormal.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not experience any additional symptoms/events. Patient received medications Advil, extra strength Tylenol. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There were no lab data/results available.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Insomnia
Clinical narrative: blisters; difficulty sleeping; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), (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: BLISTER (non-serious), outcome "unknown", described as "blisters"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty sleeping".  Additional information: The reporter dialed in for her 61 year-old-son. Her son is immunocompromised and depressed. He received two vaccines from Pfizer. Caller mentioned that after receiving the vaccine, her son experienced difficulty sleeping at night and there are presence of blisters. wants to know what is happening to her son. They contacted their HCP and they said they haven't figured something out that can help him. She even reported this event to the FDA and she was instructed to get in touch directly with Pfizer.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jun2024, outcome "recovered" (2024) and all described as "got covid". Clinical course: Patient received 2023/2024 Comirnaty vaccine in May2024 and stated that he got covid on 23Jun2024 while he was on a (withheld). Caller was asking if he was able to receive the 2024/2025 Comirnaty vaccine or if there was a certain amount of time he needed to wait. Caller was able to mention that last 23Jun he was able to catch Covid when he visited abroad despite having a Comirnaty shot 2023-2024. However, he contracted COVID on 23Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feels bad every time gets the shot/vaccine; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774018.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (Dose 1), for COVID-19 immunization, reaction(s): "feels bad". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels bad every time gets the shot/vaccine".   Additional information: The caller stated that the first 2 vaccines that had are from Pfizer but was notable to verify. The caller was not able to provide any information regarding the vaccine such as the Lot number and which product was given to. The caller also shared that was feeling bad as well.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400123184 same patient/reporter/event, different dose;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Facial pain, Fatigue, Headache, Malaise
Clinical narrative: face ache; occasional mucus membrane-stuffy nose; malaise; 100.6 fever starting 10 hours after injection and ongoing/still have fever on day 2; Extreme fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Sulpha Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "100.6 fever starting 10 hours after injection and ongoing/still have fever on day 2"; FATIGUE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "Extreme fatigue"; FACIAL PAIN (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "face ache"; HEADACHE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered"; MALAISE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "occasional mucus membrane-stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, nasal congestion, malaise, pyrexia, fatigue, headache.  Additional information: Event reported as 100.6 fever starting 10 hours after injection and ongoing. Still had fever on day 2. Extreme fatigue and malaise, headache, face ache and occasional mucus membrane-stuffy nose. Facility where vaccine was administered was reported as other. Patient did not receive any other vaccines on the same date as the vaccine(s). Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: face ache; occasional mucus membrane-stuffy nose; malaise; 100.6 fever starting 10 hours after injection and ongoing/still have fever on day 2; Extreme fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Sulpha Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "100.6 fever starting 10 hours after injection and ongoing/still have fever on day 2"; FATIGUE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "Extreme fatigue"; FACIAL PAIN (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "face ache"; HEADACHE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered"; MALAISE (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 18Sep2024 at 19:00, outcome "not recovered", described as "occasional mucus membrane-stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, nasal congestion, malaise, pyrexia, fatigue, headache.  Additional information: Event reported as 100.6 fever starting 10 hours after injection and ongoing. Still had fever on day 2. Extreme fatigue and malaise, headache, face ache and occasional mucus membrane-stuffy nose. Facility where vaccine was administered was reported as other. Patient did not receive any other vaccines on the same date as the vaccine(s). Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Fatigue
Clinical narrative: extremely fatigued/ long term fatigue; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely fatigued/ long term fatigue".   Additional information: Already contacted physician, but the doctor had full schedule.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Moderate body aches; chills; mild nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 at 11:30 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Oesophageal achalasia" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, on 18Sep2024. Past drug history included: Antihistamines, reaction(s): "Hypersensitivity"; Levaquin, reaction(s): "Hypersensitivity"; Clindamycin, reaction(s): "Hypersensitivity". The following information was reported: PAIN (non-serious) with onset 21Sep2024 at 04:00, outcome "recovered" (21Sep2024), described as "Moderate body aches"; CHILLS (non-serious) with onset 21Sep2024 at 04:00, outcome "recovered" (21Sep2024); NAUSEA (non-serious) with onset 21Sep2024 at 04:00, outcome "recovered" (21Sep2024), described as "mild nausea". Therapeutic measures were not taken as a result of pain, chills, nausea. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood test, Decreased appetite, Fatigue, Illness, Malaise
Clinical narrative: Sick; Tiredness; Fever; Decreased appetite; Not feeling well; he feels bad; doesn't look well at all; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Sep2024 at 11:00 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "accident" (unspecified if ongoing), treated with "pain" medication. The patient took concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2024, outcome "not recovered"; PYREXIA (non-serious) with onset Sep2024, outcome "not recovered", described as "Fever"; MALAISE (non-serious) with onset Sep2024, outcome "not recovered", described as "Not feeling well; he feels bad; doesn't look well at all"; ILLNESS (non-serious) with onset Sep2024, outcome "not recovered", described as "Sick"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient received BNT162b2 omicron (kp.2) and a high dose (as reported) influenza vaccine on 18Sep2024. The patient got sick post vaccination. The patient experienced tiredness, fever, felt unwell and his appetite decreased. The patient was still experiencing the events at the time of the report.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, Weight
Clinical narrative: Sick; Tiredness; Fever; Decreased appetite; Not feeling well; he feels bad; doesn't look well at all; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Sep2024 at 11:00 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "accident" (unspecified if ongoing), treated with "pain" medication. The patient took concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2024, outcome "not recovered"; PYREXIA (non-serious) with onset Sep2024, outcome "not recovered", described as "Fever"; MALAISE (non-serious) with onset Sep2024, outcome "not recovered", described as "Not feeling well; he feels bad; doesn't look well at all"; ILLNESS (non-serious) with onset Sep2024, outcome "not recovered", described as "Sick"; FATIGUE (non-serious) with onset Sep2024, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient received BNT162b2 omicron (kp.2) and a high dose (as reported) influenza vaccine on 18Sep2024. The patient got sick post vaccination. The patient experienced tiredness, fever, felt unwell and his appetite decreased. The patient was still experiencing the events at the time of the report.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Feeling hot, Headache, Nausea
Clinical narrative: Sore arm; chills; headache; eye pain; body aches; hot; nauseated; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 at 13:30 as dose 1, single (Lot number: LM2210) at the age of 54 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "bees allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Hypersensitivity". Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot FH8027), administration date: 07Apr2022, when the patient was 52-year-old, for immunisation, reaction(s): "nausea", "aches", "sore arm"; comirnaty (Lot HF9275), administration date: 28Sep2023, when the patient was 53-year-old, for immunisation, reaction(s): "chills", "pain in arm", "sore aching body", "headache"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Lot GJ6742), administration date: 26Oct2022, when the patient was 53-year-old, for immunisation, reaction(s): "Body aches", "knot in arm", "hot and cold", "arm twitching", "headache", "nausea"; Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for immunisation; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for immunisation; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Sep2024, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 20Sep2024, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 20Sep2024, outcome "recovering"; EYE PAIN (non-serious) with onset 20Sep2024, outcome "recovering"; HEADACHE (non-serious) with onset 20Sep2024, outcome "recovering"; FEELING HOT (non-serious) with onset 20Sep2024, outcome "recovering", described as "hot"; NAUSEA (non-serious) with onset 20Sep2024, outcome "recovering", described as "nauseated". Therapeutic measures were not taken as a result of pain in extremity, chills, headache, eye pain, pain, feeling hot, nausea.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; chills; headache; eye pain; body aches; hot; nauseated; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 at 13:30 as dose 1, single (Lot number: LM2210) at the age of 54 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "bees allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Hypersensitivity". Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot FH8027), administration date: 07Apr2022, when the patient was 52-year-old, for immunisation, reaction(s): "nausea", "aches", "sore arm"; comirnaty (Lot HF9275), administration date: 28Sep2023, when the patient was 53-year-old, for immunisation, reaction(s): "chills", "pain in arm", "sore aching body", "headache"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Lot GJ6742), administration date: 26Oct2022, when the patient was 53-year-old, for immunisation, reaction(s): "Body aches", "knot in arm", "hot and cold", "arm twitching", "headache", "nausea"; Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for immunisation; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for immunisation; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Sep2024, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 20Sep2024, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 20Sep2024, outcome "recovering"; EYE PAIN (non-serious) with onset 20Sep2024, outcome "recovering"; HEADACHE (non-serious) with onset 20Sep2024, outcome "recovering"; FEELING HOT (non-serious) with onset 20Sep2024, outcome "recovering", described as "hot"; NAUSEA (non-serious) with onset 20Sep2024, outcome "recovering", described as "nauseated". Therapeutic measures were not taken as a result of pain in extremity, chills, headache, eye pain, pain, feeling hot, nausea.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: woke up during the night drenched in sweat; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; AMLODIPINE BESYLATE; FLUAD, on 12Sep2024 in right arm. Past drug history included: Codeine, reaction(s): "Hypersensitivity". Vaccination history included: Pfizer biontech covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for immunisation, reaction(s): "no adverse event". The following information was reported: NIGHT SWEATS (non-serious) with onset 20Sep2024, outcome "recovered" (20Sep2024), described as "woke up during the night drenched in sweat". Therapeutic measures were not taken as a result of night sweats. Additional information: event occurred at 01:00 AM. The patient previously received all covid shots manufactured by Pfizer. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site erythema
Clinical narrative: Arm soreness; injection site redness; mild headache; nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 17Sep2024 as dose number unknown, single. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Sep2024, outcome "not recovered", described as "Arm soreness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Sep2024, outcome "not recovered", described as "injection site redness"; HEADACHE (non-serious) with onset 20Sep2024, outcome "not recovered", described as "mild headache"; NAUSEA (non-serious) with onset 20Sep2024, outcome "not recovered". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema, headache, nausea.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Pharmacist from medical information team.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUAD taken for immunisation, on 01Oct2023 as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EM6203), administration date: Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot: EW0150), administration date: Apr2021, when the patient was 67  old, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FF2587), administration date: Oct2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: GH9694), administration date: Sep2022, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: "The patient is calling regarding Paxlovid. She mentioned that she is on her fourth day of taking the medication and this morning she tried and check with antigen testing kit twice and the results does shows both positive, both results are positive (Covid positive).  She also mentioned that she had five Pfizer vaccines (Later clarified as Pfizer COVID-19 Vaccine).  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy hives upper right arm and under arm; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 as dose 1, single (Lot number: LM2222) at the age of 66 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Cancer" (unspecified if ongoing), under monitoring. Concomitant medication(s) included: LOSARTAN POTASSIUM; ASPIRIN [ACETYLSALICYLIC ACID]; LATANOPROST; MAGNESIUM CITRATE. The patient also took other concomitant therapy. Past drug history included: Tedral, reaction(s): "Hypersensitivity"; Meloxicam, reaction(s): "Hypersensitivity"; Ibuprofen, reaction(s): "Hypersensitivity"; Bactrim, reaction(s): "Hypersensitivity"; Sumatriptan, reaction(s): "Hypersensitivity". The following information was reported: URTICARIA (non-serious) with onset 20Sep2024 at 22:00, outcome "not recovered", described as "Itchy hives upper right arm and under arm". Therapeutic measures were taken as a result of urticaria.  Additional information: The patient experienced itchy hives in the upper right arm and the under arm post vaccination. The patient self-medicated with 25 mg diphenhydramine (BENADRYL).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "Restless legs Syndrome (RLS)" (unspecified if ongoing); "Gastroesophageal reflux disease (GERD)" (unspecified if ongoing). Concomitant medication(s) included: PREVNAR 20 taken for immunisation, on 28Aug2024 as dose number unknown, single; OMEPRAZOLE; ATORVASTATIN; PRAMIPEXOLE; ROPINIROLE. Past drug history included: Drug, unspecified, reaction(s): "Hypersensitivity". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 20Sep2024 at 18:00, outcome "recovering", described as "Flu-like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: The flu-like symptoms began later in the day of the vaccination, 20Sep2024 and continued for another two days  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.