chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a dose of Havrix to a 3 year old male patient on 06Sep2024 when the patient pulled the needle out before the complete dose was injected; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 3-year-old male patient who received HAV (Havrix) (batch number LM99N, expiry date 04-MAR-2026) for prophylaxis.   On 06-SEP-2024, the patient received the 2nd dose of Havrix. On 06-SEP-2024, an unknown time after receiving Havrix, the patient experienced incomplete dose administered (Verbatim: a dose of Havrix to a 3 year old male patient on 06Sep2024 when the patient pulled the needle out before the complete dose was injected). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2024 The reporter reported when the patient pulled the needle out before the complete dose was injected.  The patient received 0.4 mL of the 0.5 mL dose, which led incomplete dose administered.  The patient's mother refused for the patient to receive the remainder of the dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Nausea, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/shingles; shingles; rash ( right flank side); right flank pain; nausea; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles), rash (Verbatim: rash ( right flank side)), flank pain (Verbatim: right flank pain) and nausea (Verbatim: nausea). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles, rash, flank pain and nausea were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, flank pain and nausea to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, rash, flank pain and nausea to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-SEP-2024 The patient stated that she received Shingrix 2 dose series (2-6 months between dose 1 and 2), she did not remembered the exact date and stated that it was about a year or year and a half ago.  The patient reported that a week ago she went to emergency room with right side flank pain and nausea and she was diagnosed with shingles.  The patient had given Valtrex and took her last dose on the day of reporting. The patient's rash was almost completely gone. This case was considered as suspected vaccination failure as details regarding time to onset for Shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix  (Dose 1 and 2).
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/shingles; shingles; rash ( right flank side); right flank pain; nausea; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles), rash (Verbatim: rash ( right flank side)), flank pain (Verbatim: right flank pain) and nausea (Verbatim: nausea). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles, rash, flank pain and nausea were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, flank pain and nausea to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, rash, flank pain and nausea to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-SEP-2024 The patient stated that she received Shingrix 2 dose series (2-6 months between dose 1 and 2), she did not remembered the exact date and stated that it was about a year or year and a half ago.  The patient reported that a week ago she went to emergency room with right side flank pain and nausea and she was diagnosed with shingles.  The patient had given Valtrex and took her last dose on the day of reporting. The patient's rash was almost completely gone. This case was considered as suspected vaccination failure as details regarding time to onset for Shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix  (Dose 1 and 2).
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number J327J, expiry date 19-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 07-SEP-2024, the patient received the 2nd dose of Shingrix. On 07-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 09-SEP-2024 The pharmacist stated a patient received the first dose of Shingrix in 2019 and the 2nd dose was administered on September 7, 2024, which led to lengthening of vaccination schedule. Consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number TF9HE) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (1st dose received on 12-NOV-2019).   On 04-SEP-2024, the patient received the 2nd dose of Shingrix. On 04-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 09-SEP-2024 A pharmacy technician contacted GSK to request information about how to proceed after patient received their second dose of Shingrix well beyond the six months. The person received a dose of Zostavax at an unknown time, and their first Shingrix dose and their second dose delayed than the recommended time interval, which led to lengthening of the vaccination schedule. The healthcare professional requested information about how to proceed, declined to receive follow up and accepted both the medical information and prescribing information. The vaccine administration facility was the same as primary reporter. This case had been link with US2024AMR112338, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR112338:Same reporter/unk patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immunisation reaction, Throat tightness
Clinical narrative: My throat closed up; I could not breathe; I had extreme reactions; This spontaneous case was reported by a patient and describes the occurrence of THROAT TIGHTNESS (My throat closed up), DYSPNOEA (I could not breathe) and IMMUNISATION REACTION (I had extreme reactions) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy to vaccine (Had allergic reaction to mRNA vaccines). Concomitant products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (My throat closed up), DYSPNOEA (I could not breathe) and IMMUNISATION REACTION (I had extreme reactions). At the time of the report, THROAT TIGHTNESS (My throat closed up), DYSPNOEA (I could not breathe) and IMMUNISATION REACTION (I had extreme reactions) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was reported that patient took her last Novavax vaccine on 30-Oct-2023. Treatment information was not reported   This case was linked to US-MODERNATX, INC.-MOD-2024-773491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773491:Same reporter (Healthcare provider)
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: Both lower leg calves were sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Both lower leg calves were sore) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1), MODERNA COVID-19 VACCINE (Dose 4), MODERNA COVID-19 VACCINE (Dose 3) and MODERNA COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE. Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.   On 07-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 08-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (Both lower leg calves were sore). At the time of the report, PAIN IN EXTREMITY (Both lower leg calves were sore) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   It was reported that patient experienced soreness, as if he had been doing squats. Walking had reduced soreness, but once sedentary. It was sore again when he stood up or got out of bed.  Patient also reported that soreness has continued that day, even when he was not walking. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue
Clinical narrative: its difficult to remove the rubber stopper on the Spikevax vaccine. Today, for the first time, it actually snapped off a piece of the plastic.; No adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of SYRINGE ISSUE (its difficult to remove the rubber stopper on the Spikevax vaccine. Today, for the first time, it actually snapped off a piece of the plastic.) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (its difficult to remove the rubber stopper on the Spikevax vaccine. Today, for the first time, it actually snapped off a piece of the plastic.) and NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (its difficult to remove the rubber stopper on the Spikevax vaccine. Today, for the first time, it actually snapped off a piece of the plastic.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleeding in the vaccine site after pulling out the vaccine from her arm; little bruised; always have a little bit of arm pain afterwards; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding in the vaccine site after pulling out the vaccine from her arm), VACCINATION SITE BRUISING (little bruised) and VACCINATION SITE PAIN (always have a little bit of arm pain afterwards) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding in the vaccine site after pulling out the vaccine from her arm), VACCINATION SITE BRUISING (little bruised) and VACCINATION SITE PAIN (always have a little bit of arm pain afterwards). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding in the vaccine site after pulling out the vaccine from her arm), VACCINATION SITE BRUISING (little bruised) and VACCINATION SITE PAIN (always have a little bit of arm pain afterwards) was resolving.        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 stated that the vaccinator might hit a blood vessel/something that led to the bleeding. The vaccinator provided aid to the bleeding by stating "She put a band aid on it. It ended, and it was blue. She always had a little bit of arm pain afterwards but it's just a little bruised and patient had no concern over the bleeding itself."   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-763333 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2024: Live follow up received: Reference ID added; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763333:Same patient, different product
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness; Swelling to left arm; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness) and PERIPHERAL SWELLING (Swelling to left arm) in an 83-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 04-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PERIPHERAL SWELLING (Swelling to left arm). On 05-Sep-2024, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) and PERIPHERAL SWELLING (Swelling to left arm) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported that symptoms were getting worse since first noted. She had huge red swelling on the arm which was not normal. Patient was in perfect health prior to vaccine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2024: Live follow-up received and updated event verbatim for Swelling arm, updated outcome of event and updated narrative.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Confusional state, Fatigue, Injection site rash, Nausea
Clinical narrative: fever; pains/aches; nausea; vertigo; brain fog; delayed onset rash at injection site; confusion; sore throat; heavy fatigue; tingling hands; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo) and BRAIN FOG (brain fog) in a 56-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042560) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 31-Mar-2020 and Ankylosing spondylitis. Concurrent medical conditions included Asthma and Hashimoto's thyroiditis.    On 04-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 05-Sep-2024, the patient experienced PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo), BRAIN FOG (brain fog), INJECTION SITE RASH (delayed onset rash at injection site), CONFUSIONAL STATE (confusion), OROPHARYNGEAL PAIN (sore throat), FATIGUE (heavy fatigue) and PARAESTHESIA (tingling hands). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram, every 6 hours. At the time of the report, PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo), BRAIN FOG (brain fog), INJECTION SITE RASH (delayed onset rash at injection site), CONFUSIONAL STATE (confusion), OROPHARYNGEAL PAIN (sore throat), FATIGUE (heavy fatigue) and PARAESTHESIA (tingling hands) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Paraesthesia, Pyrexia, Vertigo
Clinical narrative: fever; pains/aches; nausea; vertigo; brain fog; delayed onset rash at injection site; confusion; sore throat; heavy fatigue; tingling hands; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo) and BRAIN FOG (brain fog) in a 56-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042560) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 31-Mar-2020 and Ankylosing spondylitis. Concurrent medical conditions included Asthma and Hashimoto's thyroiditis.    On 04-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 05-Sep-2024, the patient experienced PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo), BRAIN FOG (brain fog), INJECTION SITE RASH (delayed onset rash at injection site), CONFUSIONAL STATE (confusion), OROPHARYNGEAL PAIN (sore throat), FATIGUE (heavy fatigue) and PARAESTHESIA (tingling hands). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram, every 6 hours. At the time of the report, PYREXIA (fever), PAIN (pains/aches), NAUSEA (nausea), VERTIGO (vertigo), BRAIN FOG (brain fog), INJECTION SITE RASH (delayed onset rash at injection site), CONFUSIONAL STATE (confusion), OROPHARYNGEAL PAIN (sore throat), FATIGUE (heavy fatigue) and PARAESTHESIA (tingling hands) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: anaphylactic reaction; got a hives of 11 millimeter; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; URTICARIA (medically significant), outcome "unknown", described as "got a hives of 11 millimeter". The patient underwent the following laboratory tests and procedures: Hives: 11, notes: mm. The patient stated she experienced a kind of an anaphylactic reaction after receiving the pneumococcal 13-val conj vac (dipht CRM197 protein) and she got a hives of 11 millimeter. Her doctor suggested to get a test for it. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Neurological symptom, Neuropathy peripheral, Post-acute COVID-19 syndrome
Clinical narrative: neuropathy; lot of post-COVID, long COVID symptom; neurological symptoms; COVID/last Pfizer vaccine (COVID-19 Vaccine) was received on 2021 and got COVID a year ago; COVID/last Pfizer vaccine (COVID-19 Vaccine) was received on 2021 and got COVID a year ago; This is a spontaneous report received from a Physician from medical information team.  A 37-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID/last Pfizer vaccine (COVID-19 Vaccine) was received on 2021 and got COVID a year ago"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "lot of post-COVID, long COVID symptom"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological symptoms". Clinical course: Caller had a question about a patient in her risk of getting the new COVID vaccine. Caller stated she basically had a really bad initial that was COVID when she got it early on, and had a lot post-COVID symptoms, she'd been to hospital multiple times, had a lot of neurological symptoms after COVID including neuropathy, chronic disease came. Upon asking caller if the patient took a pfizer COVID vaccine after getting this COVID infection. Caller stated her last Pfizer vaccine was looks like 2021, she had COVID a year ago but it wasn't initially back when she got it 2021 COVID first. Caller thought that these symptoms appeared before the patient got the COVID vaccine. Caller mentioned that this patient had a lot of post-COVID, long COVID symptom and added that it was about 3 years since the patient had a vaccine. The patient's last Pfizer vaccine (COVID-19 Vaccine) was received on 2021 and got COVID a year ago. They meant, her recent covid infection was a year ago. Reporter hung up the call abruptly. Hence, product details and other details could not be probed and limited information was available over the call.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Influenza like illness, Pain
Clinical narrative: left side low back pain; felt like I had the flu; tired/achy all overs; tired/achy all overs; This is a spontaneous report received from an Other HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 at 04:30 as dose 1, single (Lot number: Lm222) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Sep2024, outcome "recovering", described as "felt like I had the flu"; BACK PAIN (non-serious) with onset Sep2024, outcome "not recovered", described as "left side low back pain"; PAIN (non-serious), FATIGUE (non-serious) all with onset Sep2024, outcome "recovering" and all described as "tired/achy all overs". Therapeutic measures were not taken as a result of back pain, influenza like illness, pain, fatigue.  Additional information: The patient did not receive any other vaccines on the same date of Pfizer-COVID Vaccine. The patient did not receive any other vaccines within 4 weeks prior of Pfizer-COVID Vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. The patient reported that initially she felt like she had the flu for two days (tired/achy all overs) which subsided by concurrently and gradually developed left side low back pain which she never have, It had persisted nearly two weeks out. Device Date was 12Sep2024. No allergy was reported.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report received from a Consumer or other non HCP.  A 78-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 had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "Passed out". It was unknown if therapeutic measures were taken as a result of loss of consciousness. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Brain fog, Chest X-ray, Disturbance in attention, Electrocardiogram
Clinical narrative: muscle ache; rapid heartbeat; fatigue/Tired/Worn out; brain fog; high blood pressure; Very sick; Trouble concentrating; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle ache"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heartbeat"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue/Tired/Worn out"; BRAIN FOG (non-serious), outcome "not recovered"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; ILLNESS (non-serious), outcome "recovered", described as "Very sick"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Trouble concentrating". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension. Additional information: The patient reported side effects of muscle ache, rapid heartbeat, fatigue, and brain fog after having been administered the Pfizer COVID-19 vaccine. Upon further discussion, the patient described that he went to get EKG, as well as X-rays of chest and blood tests, but that all studies did not demonstrate to be the root cause of side effects. He still has brain fog and fatigue, but that he no longer has pulsating heart. He also referred to high blood pressure as a side effect, given that he takes medication for it. He reported he got his new COVID shot and within 24 hours he had really bad side effects such as muscle aches and fatigue the whole day. He did not have a fever but was very sick for about two or three days. It went away but he wanted to know how long these side effects were going to last because he is still feeling tired, fatigued, and worn out. He still has muscle ache occasionally, but the biggest was brain fog as he has trouble concentrating. It has been almost a week today (at time of reporting). He also had a rapid heartbeat too with it as well and it elevated his blood pressure, so he went to the doctor a couple days ago. They took blood tests and chest X-rays, and those were good. They also did EKG on his heart. Everything was good as far as that goes. But he just felt totally fatigued and brain fogged.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypertension, Illness, Myalgia
Clinical narrative: muscle ache; rapid heartbeat; fatigue/Tired/Worn out; brain fog; high blood pressure; Very sick; Trouble concentrating; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle ache"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heartbeat"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue/Tired/Worn out"; BRAIN FOG (non-serious), outcome "not recovered"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; ILLNESS (non-serious), outcome "recovered", described as "Very sick"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Trouble concentrating". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension. Additional information: The patient reported side effects of muscle ache, rapid heartbeat, fatigue, and brain fog after having been administered the Pfizer COVID-19 vaccine. Upon further discussion, the patient described that he went to get EKG, as well as X-rays of chest and blood tests, but that all studies did not demonstrate to be the root cause of side effects. He still has brain fog and fatigue, but that he no longer has pulsating heart. He also referred to high blood pressure as a side effect, given that he takes medication for it. He reported he got his new COVID shot and within 24 hours he had really bad side effects such as muscle aches and fatigue the whole day. He did not have a fever but was very sick for about two or three days. It went away but he wanted to know how long these side effects were going to last because he is still feeling tired, fatigued, and worn out. He still has muscle ache occasionally, but the biggest was brain fog as he has trouble concentrating. It has been almost a week today (at time of reporting). He also had a rapid heartbeat too with it as well and it elevated his blood pressure, so he went to the doctor a couple days ago. They took blood tests and chest X-rays, and those were good. They also did EKG on his heart. Everything was good as far as that goes. But he just felt totally fatigued and brain fogged.  Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills starting in the evening; Fever and chills starting in the evening; This is a spontaneous report received from a Pharmacist.  A 59-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Sep2024 as dose number unknown, single), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious), PYREXIA (non-serious) all with onset 12Sep2024 at 20:30, outcome "recovered" (13Sep2024) and all described as "Fever and chills starting in the evening". Therapeutic measures were taken as a result of chills, pyrexia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). The 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: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: transischemic attack (tia); This is a spontaneous report received from a Physician from a sales representative.  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 was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dizziness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "hypertension". The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "transischemic attack (tia)". It was unknown if therapeutic measures were taken as a result of transient ischaemic attack.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (KP.2) cannot be completely excluded for the reported event. The detailed clinical course and patient complete medical history would be helpful for further assessment. Case will be reassessed should additional information becomes available.  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.,Linked Report(s) : US-PFIZER INC-202400257049 same patient, different doses/events.;US-PFIZER INC-202400256984 same patient, different doses/events.;
Age: 41.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pneumonia, Vitamin D deficiency
Clinical narrative: Pneumonia; This is a spontaneous report received from an Other HCP. Other Case identifier(s): NUS2024US045252.  A 41-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 06Jun2019 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 06Jun2019 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset 22Oct2019, outcome "unknown". Clinical courses is as follows: the patient is up-to date-on vaccinations. They again discussed the possibility of prophylactic antibiotics, and patient did see infectious disease. He would like to foregot that at this time: 06Jun2019: Menveo and Trumenba; 22Oct2019: Pneumonia and Bexsero; 06Dec2019: Menveo and Bexsero, Vitamin D deficiency.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is no reasonable possibility that the event pneumonia was related to TRUMENBA due to the long latency period of more than 4 months and the lack of biological plausibility. This is more likely an incidental acquired infection.
Sex: U
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: non-segmental vitiligo; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), 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: VITILIGO (non-serious), outcome "unknown", described as "non-segmental vitiligo".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00226.  A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I'm curious if there's any date on if novavax has any effect on menstrual cycles. I had a rough time with Pfizer".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 16.0
Sex: U
Vaccine: FLU3, FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered FLUBLOK instead of FLUZONE to patients aged 16 years old  with no reported adverse event; administered FLUBLOK instead of FLUZONE to patients aged 16 years old  with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16-year-old and unknown gender patient who was administered influenza trivalent recombinant vaccine [Flublok TIV] instead of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Aug-2024, the 16-year-old patient received an unknown dose of suspect Influenza Influenza Trivalent Recombinant Vaccine Solution for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization instead of influenza USP trival A-B subvirion no preservative vaccine Suspension for injection with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, Pharmacist reported that they had administered FLUBLOK instead of FLUZONE to patients aged 13 and 16 years old and they wanted to have more information about it before ringing up the patients. Pharmacist mentioned that the patients have not reported any adverse reactions since the vaccination happened a week and a half ago.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA265207:02211212
Sex: F
Vaccine: FLUC3
Symptoms: Hyperhidrosis, Injection site rash, Injection site swelling, Injection site warmth, Migraine
Clinical narrative: currently breastfeeding (child born); at injection site, noticed raised solid red rash about 2 inches in diameter; warm to touch; at injection site, noticed raised solid red rash about 2 inches in diameter; woke up with sweating; developed migraine in late morning; This spontaneous case, initially received on 06-Sep-2024, was reported by a non health professional and concerns a(n) adult female patient.  Concomitant medication: refer to appropriate report section. Medical History Unknown  Administration of company suspect drug(s): On 04-Sep-2024 17:30, the patient received Flucelvax (TIV) for Indication not reported., Lot number: 946584, dise and route of administration not reported.  No additional suspect drugs.  Adverse reactions/events and outcomes: On unknown date, the patient experienced currently breastfeeding (child born ) (outcome: Not Reported). On 06-Sep-2024, the patient experienced developed migraine in late morning (outcome: Unknown). On 06-Sep-2024 02:00, the patient experienced woke up with sweating (outcome: Unknown). On 06-Sep-2024 18:00, the patient experienced at injection site, noticed raised solid red rash about 2 inches in diameter (outcome: Unknown), warm to touch (outcome: Unknown), at injection site, noticed raised solid red rash about 2 inches in diameter (outcome: Not Reported).  It was reported that:  An adverse event was reported after taking Flucelvax. Affected Person: Female, Age 33, currently breastfeeding (child born), currently taking Lexapro Flucelvax Lot 946584 Taken on 04-Sep-2024 at 17:30 at pharmacy On 06-Sep-2024, at 02:00, woke up with sweating On 06-Sep-2024, developed migraine in late morning, treated with Advil, with no improvement On 06-Sep-2024, at 18:00, at injection site, noticed raised solid red rash about 2 inches in diameter, warm to touch Rash dissipated within an hour of observation, but still warm and is starting to reappear No medical provider was engaged  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Advil  Reporter assessment: the reporter considred the events as non serious and did not provide a causality assessment; Reporter's Comments: The event Maternal exposure during breast feeding is not relatedo the suspect product All other events are related
Sex: F
Vaccine: FLUC3
Symptoms: Rash erythematous
Clinical narrative: currently breastfeeding (child born); at injection site, noticed raised solid red rash about 2 inches in diameter; warm to touch; at injection site, noticed raised solid red rash about 2 inches in diameter; woke up with sweating; developed migraine in late morning; This spontaneous case, initially received on 06-Sep-2024, was reported by a non health professional and concerns a(n) adult female patient.  Concomitant medication: refer to appropriate report section. Medical History Unknown  Administration of company suspect drug(s): On 04-Sep-2024 17:30, the patient received Flucelvax (TIV) for Indication not reported., Lot number: 946584, dise and route of administration not reported.  No additional suspect drugs.  Adverse reactions/events and outcomes: On unknown date, the patient experienced currently breastfeeding (child born ) (outcome: Not Reported). On 06-Sep-2024, the patient experienced developed migraine in late morning (outcome: Unknown). On 06-Sep-2024 02:00, the patient experienced woke up with sweating (outcome: Unknown). On 06-Sep-2024 18:00, the patient experienced at injection site, noticed raised solid red rash about 2 inches in diameter (outcome: Unknown), warm to touch (outcome: Unknown), at injection site, noticed raised solid red rash about 2 inches in diameter (outcome: Not Reported).  It was reported that:  An adverse event was reported after taking Flucelvax. Affected Person: Female, Age 33, currently breastfeeding (child born), currently taking Lexapro Flucelvax Lot 946584 Taken on 04-Sep-2024 at 17:30 at pharmacy On 06-Sep-2024, at 02:00, woke up with sweating On 06-Sep-2024, developed migraine in late morning, treated with Advil, with no improvement On 06-Sep-2024, at 18:00, at injection site, noticed raised solid red rash about 2 inches in diameter, warm to touch Rash dissipated within an hour of observation, but still warm and is starting to reappear No medical provider was engaged  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Advil  Reporter assessment: the reporter considred the events as non serious and did not provide a causality assessment; Reporter's Comments: The event Maternal exposure during breast feeding is not relatedo the suspect product All other events are related