chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Tenderness, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: soreness; Itchy area around the injection site; a very red, swollen & itchy area around the injection site.; a very red, swollen & itchy area around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer Covid Vaccines (Patient had 5 Pfizer Covid Vaccines since 2020 & never had an itchy rash. Just the soreness). Past adverse reactions to the above products included No adverse reaction with Pfizer Covid Vaccines.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness), VACCINATION SITE PRURITUS (Itchy area around the injection site), VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, TENDERNESS (soreness) and VACCINATION SITE PRURITUS (Itchy area around the injection site) had not resolved and VACCINATION SITE ERYTHEMA (a very red, swollen & itchy area around the injection site.) and VACCINATION SITE SWELLING (a very red, swollen & itchy area around the injection site.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received Covid booster vaccine 2 days ago along with flu shot. Just this morning, patient awoke with soreness (no big deal) & a very red, swollen & itchy area around the injection site. Patient applying Hydrocortisone Cream to help contain the itch. Patient just wanted to know how long will this last and if it gets worse, what should she do.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received with significant information. AE reference number added.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza
Clinical narrative: Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu; Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) and ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030701) for COVID-19 prophylaxis.     The patient never had COVID and got vaccines early.  The patient's past medical history included Carpal tunnel syndrome, Surgery (had other surgeries, gynocological surgery) and Knee replacement.    On 27-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 28-Oct-2023, the patient experienced INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) and ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Oct-2023, ARTHRALGIA (Joint pain but the pain was most pronounced in the area of both wrists where she had carpal tunnel syndrome) had resolved. At the time of the report, INFLUENZA (Patient described AE as only unusual and looked online for similiar reactions. Reaction was described as COVID vaccine flu) had resolved.            Concomitant medication not reported.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reaction was described as COVID vaccine flu that caused her to be a vegetable for one day. Joint pain but the pain was most pronounced in both wrists where she had carpal tunnel syndrome. She was wondering if the affects may be more pronounced in post-surgical patients, and if this experience may not be unusual others who've had surgery. Patient used an Advil/Tylenol mix and recovered within 36 hours. Patient claims it was her 6th vaccine, put the choices in below only go to the 5th dose. It took about 8 hours for symptoms to show up.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal discomfort
Clinical narrative: Top of arm at shoulder is red, hard and tender to touch or sleep on; Top of arm at shoulder is red, hard and tender to touch or sleep on; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Top of arm at shoulder is red, hard and tender to touch or sleep on) and MUSCULOSKELETAL DISCOMFORT (Top of arm at shoulder is red, hard and tender to touch or sleep on) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Top of arm at shoulder is red, hard and tender to touch or sleep on) and MUSCULOSKELETAL DISCOMFORT (Top of arm at shoulder is red, hard and tender to touch or sleep on). At the time of the report, ERYTHEMA (Top of arm at shoulder is red, hard and tender to touch or sleep on) and MUSCULOSKELETAL DISCOMFORT (Top of arm at shoulder is red, hard and tender to touch or sleep on) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had received Moderna booster 2 days ago.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received contains updated reporter details, patient initials and reference ID.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus, Vaccination site rash
Clinical narrative: face flushing; redness/It's like jawline, ear, redness in the face and comes and go throughout the day; itchiness; Covid arm with the rash at the sight of the injection; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna (Lot 051D22A) on 28-Oct-2022; for Product used for unknown indication: Flu shot the week before (shot the week before) in October 2023, Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Flu shot the week before, Moderna, Pfizer and Pfizer.    On 30-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection) was resolving and PRURITUS (itchiness) outcome was unknown.            No concomitant medication was reported. It was reported that patient tried lotions as well but nothing seems to help. Patient did not had any side effects with the first Moderna Booster they received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He has had previous covid 19 vaccines with a little soreness in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm) in an elderly male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm). At the time of the report, PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was unknown, the number of previous doses received by patient. Treatment information was not reported.   This case was linked to MOD-2023-748395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received and added references.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, olfactory, Parosmia
Clinical narrative: she is smelling things no one else can smell; sudden my sense of smell heightened or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: HALLUCINATION, OLFACTORY (medically significant) with onset Oct2023, outcome "unknown", described as "she is smelling things no one else can smell"; PAROSMIA (non-serious) with onset Oct2023, outcome "unknown", described as "sudden my sense of smell heightened or something".  Clinical course: Caller got the Covid vaccine shout about two weeks ago and nowshe was smelling things no one else can smell. She was experiencing that side effect where she could smell things that other people around her don't smell. So, she was calling to see if that was a side effect with the vaccine. She stated, "it was just odd because even with our furnace, when we first turned that on, she can smell something coming from the vent. She had the furnace man out that day. He and my husband can't smell anything. Like all of a sudden her sense of smell heightened or something. She would smell something and no one else around her could not even smell it. So, she did not know if it was her nose and she was just wondering if that was any kind of a possible side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site rash
Clinical narrative: round rash at site of injection approximately 1.5 (quotation mark); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 24Oct2023 at 06:30, outcome "not recovered", described as "round rash at site of injection approximately 1.5 (quotation mark)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site rash.  Additional Information: The patient had no other vaccine in four weeks. Other medications in two weeks reported: thyroid supplement, multivitamin, vitamin D, fish. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX, RVX
Symptoms: Malaise
Clinical narrative: Out of sorts for a couple days after receiving the combination of vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine (RSV VACCINE), on 24Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 24Oct2023, outcome "unknown", described as "Out of sorts for a couple days after receiving the combination of vaccines". It was unknown if therapeutic measures were taken as a result of malaise.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: vomiting; fatigue; generally feeling unwell; muscle pain; headache; joint pain; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; PHENTERMINE; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 27Oct2023, outcome "recovering"; MALAISE (non-serious) with onset 27Oct2023, outcome "recovering", described as "generally feeling unwell"; HEADACHE (non-serious) with onset 27Oct2023, outcome "recovering"; ARTHRALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 27Oct2023, outcome "recovering"; VOMITING (non-serious) with onset 27Oct2023, outcome "recovering". Therapeutic measures were not taken as a result of vomiting, fatigue, malaise, myalgia, headache, arthralgia, nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; fatigue; generally feeling unwell; muscle pain; headache; joint pain; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; PHENTERMINE; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 27Oct2023, outcome "recovering"; MALAISE (non-serious) with onset 27Oct2023, outcome "recovering", described as "generally feeling unwell"; HEADACHE (non-serious) with onset 27Oct2023, outcome "recovering"; ARTHRALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 27Oct2023, outcome "recovering", described as "muscle pain"; NAUSEA (non-serious) with onset 27Oct2023, outcome "recovering"; VOMITING (non-serious) with onset 27Oct2023, outcome "recovering". Therapeutic measures were not taken as a result of vomiting, fatigue, malaise, myalgia, headache, arthralgia, nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received the Pfizer COVID vaccine yesterday; I took a Covid test and it came positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 11:00 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: COVID-19 (non-serious) with onset Oct2023, 20 hrs after the suspect product(s) administration, outcome "unknown", described as "I received the Pfizer COVID vaccine yesterday; I took a Covid test and it came positive". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient received the Pfizer COVID vaccine yesterday; and took a Covid test and it came positive. Patient stated, "I received the Pfizer COVID vaccine yesterday at 11 o'clock in the morning and it is about 20 hours later,  took a Covid test and it came positive". It is the patient's question because patient got the vaccine yesterday. Further enquired, if it was showing positive because patient took the vaccine yesterday.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fear, Headache, Palpitations
Clinical narrative: Dizziness; little bit of headache; little bit of fever; may be one degree; Blurry vision; Imbalance; some wobbling on my feet; Palpitations; I am afraid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinsonism" (unspecified if ongoing), notes: I have a diagnosis of Parkinsonism. I take Carbidopa, Levodopa. Concomitant medication(s) included: LEVODOPA, CARBIDOPA taken for parkinsonism, start date: Oct2021. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 28Oct2023, outcome "unknown", described as "Blurry vision"; DIZZINESS (non-serious) with onset 28Oct2023, outcome "unknown"; FEAR (non-serious) with onset 28Oct2023, outcome "unknown", described as "I am afraid."; BALANCE DISORDER (non-serious) with onset 28Oct2023, outcome "unknown", described as "Imbalance; some wobbling on my feet"; PALPITATIONS (non-serious) with onset 28Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset 28Oct2023, outcome "unknown", described as "little bit of fever; may be one degree"; HEADACHE (non-serious) with onset 28Oct2023, outcome "unknown", described as "little bit of headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Dizziness; little bit of headache; little bit of fever; may be one degree; Blurry vision; Imbalance; some wobbling on my feet; Palpitations; I am afraid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinsonism" (unspecified if ongoing), notes: I have a diagnosis of Parkinsonism. I take Carbidopa, Levodopa. Concomitant medication(s) included: LEVODOPA, CARBIDOPA taken for parkinsonism, start date: Oct2021. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 28Oct2023, outcome "unknown", described as "Blurry vision"; DIZZINESS (non-serious) with onset 28Oct2023, outcome "unknown"; FEAR (non-serious) with onset 28Oct2023, outcome "unknown", described as "I am afraid."; BALANCE DISORDER (non-serious) with onset 28Oct2023, outcome "unknown", described as "Imbalance; some wobbling on my feet"; PALPITATIONS (non-serious) with onset 28Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset 28Oct2023, outcome "unknown", described as "little bit of fever; may be one degree"; HEADACHE (non-serious) with onset 28Oct2023, outcome "unknown", described as "little bit of headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Issue with the vaccine.  Pain with the vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Issue with the vaccine.  Pain with the vaccine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 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: ASTHENIA (non-serious) with onset 05Oct2023, outcome "unknown", described as "debilitating".  Additional Information: An adverse side effect from the latest COVID vaccine that has been somewhat debilitating since 05Oct when the vaccine was administered. Asked if that was common and if they have any advise on treatments.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient experienced injection pain.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Prior to vaccination, the patient was diagnosed with COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 29Oct2023, outcome "recovered" (Oct2023), described as "Patient experienced injection pain.". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Erythema, Rash papular
Clinical narrative: I had a little pimple on my forehead, on my skin; strange on my face; My wrist bone I have a red, it is not a bite; it is actually a small red bump that roots from the skin actually comes out of the skin and that happened at the same time; a little red 2 bumps; My wrist bone I have a red, it is not a bite; it is actually a small red bump that roots from the skin actually comes out of the skin and that happened at the same time; a little red 2 bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), on 26Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ACNE (non-serious) with onset Oct2023, outcome "unknown", described as "I had a little pimple on my forehead, on my skin; strange on my face"; RASH PAPULAR (non-serious), ERYTHEMA (non-serious) all with onset Oct2023, outcome "unknown" and all described as "My wrist bone I have a red, it is not a bite; it is actually a small red bump that roots from the skin actually comes out of the skin and that happened at the same time; a little red 2 bumps".  Additional information: The patient have the original vaccinations in the boosters and now had the new COVID vaccination on 26Oct2023 (Thursday morning). No ill effects at all, just now patient was sitting on the bed and felt like had a little pimple on the forehead and skin and thought that it's strange on the face, it is beginning pimples and then for whatever reason looked down and just above the wrist bone, patient have a red, it is not a bite but you think it would be a bite, it's actually a small little 2 red bumps that roots from the skin actually comes out of the skin and that happened at the same time. Is there some kind of allergic reaction. The patient doesn't normally have allergies and feels fine. The patient wanted to know if it's an allergic reaction, do the patient need to get something such as Benadryl or any other drug.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Swelling and bleeding at administration site that led to ER visit over that weekend (per pt's company HR)
Age: 49.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: After waited after the 15 minutes after the administration of the vaccines. Patient was about to check out and stated to the caregiver in the checck out area that she did not feel well and felt dizziness.  Patient was advised to sit down and it was taken to the room in wheel chair to laid down to recovery from the dizziness also stated that she felt some nausea. Patient never lost conciousness and was awake and able to follow instructions. Vital signs were monitor and enter in her medical record. Provider was notified. The episode last for about 5-7 minutes. Patient decided to go home after the dizziness and nause were gone. Patient was able to walk in her won with stable gate, oriented x 4, no shortness of breath no pain vital signs stable .A follow up call was done at 2:33pm  to see how patient was doing.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt c/o of nausea, vomiting and diarrhea
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Pt reported fever, chills, and soreness/pain at the sign of injection
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Eye movement disorder, Fall
Clinical narrative: Please see immunization administration sheet for lot numbers and site of administration. Pt here for MCV4 given in L deltoid.  As soon as bandaid was placed on arm pt eyes rolled up and he started to twitch and then started to slide out of the chair. As I got him to the floor I was calling for assistance to help lay him down. Staff came around the corner and finished helping to lay him down. He was an assisted fall and did not hit head. He started to punch me in the arm several times. He took approx 5 seconds to start coming around. Staff started to assess him while on the floor checking his vision and motor skills. Breathing and heart rate were regular.  We checked his bp which was at 111/68. He was then allowed to sit up which he tolerated well and stated he was no longer having dizziness or any other symptoms.  He then started to tell us that at the time that he went out he started having a dream about his brother hitting him.  He was able to answer all questions at that time and drink a cup of water.  After a few minutes we got him up into a chair where we kept talking to him and get more water down him.  After a few more minutes he was allowed to walk down the hall with no issues. Patient again reported feeling no dizziness or other symptoms and reported feeling "normal". Mom stated that he has been becoming dizzy with his blood draws for accutane as well but has never passed out before. Staff then released him to mom to go home.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Pain, Rotator cuff syndrome
Clinical narrative: Today, 11/7/23, pt came for visit to see me and reported severe left upper shoulder pain since flu vaccine above on 10/24. Felt like vaccine was placed too high and had instant pain and felt like something wasn't right. Gave it a few weeks to resolve but had persistent pain subacromial/upper deltoid, especially w/ movement. On exam, no swelling, redness, increased warmth, effusion. full passive range of motion, normal internal rotation, pain w/ adduction and cross arm movement. normal sensation, warmth to left arm, hand.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint range of motion decreased
Clinical narrative: Per patient feels like she has limited range of motion in arm going from left to right
Age: 84.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram, Ischaemic cerebral infarction, Magnetic resonance imaging
Clinical narrative: Small sub centimeter acute ischemic infarction on pons
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient came in today and said that she is still experiencing a sore arm from her vaccine on 10/23/23. Pain started the same day as immunized. Patient had annual appointment with her doctor 11/3/23 and mentioned still having a sore arm.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Generalized anxiety disorder and arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2 SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 24Oct2023 to 28Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/Symptoms worsened 31Oct evening. Symptoms included more coughing and nasal congestion. A rapid test was positive 01Nov AM; Treatment of COVID-19/Symptoms worsened 31Oct evening. Symptoms included more coughing and nasal congestion. A rapid test was positive 01Nov AM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023 at 19:00, outcome "recovering" and all described as "Treatment of COVID-19/Symptoms worsened 31Oct evening. Symptoms included more coughing and nasal congestion. A rapid test was positive 01Nov AM". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Negative; (30Oct2023) Negative; (01Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Anti viral details:[{product=COVID 19 Treatment, brand=Paxlovid,Treatment start date=22Oct2023,Treatment stop date=27Oct2023}]. Rebound. Rapid test was negative Saturday afternoon 28Oct. A second test was negative 30Oct AM. Symptoms worsened 31Oct evening. Symptoms included more coughing and nasal congestion. A rapid test was positive 01Nov AM. No Known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have shoulder pain from my vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: ARTHRALGIA (non-serious), outcome "unknown", described as "I have shoulder pain from my vaccine".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood triglycerides, Low density lipoprotein, Low density lipoprotein increased, Weight
Clinical narrative: LDL shot up 30 points.; Cholesterol level went up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stent placed", start date: 18Jul2023 (unspecified if ongoing); "CAV" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 02Oct2023 as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER)), for COVID-19 immunization. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset 25Oct2023, outcome "unknown", described as "Cholesterol level went up"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious) with onset 25Oct2023, outcome "unknown", described as "LDL shot up 30 points.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of low density lipoprotein increased, blood cholesterol increased. Additional information: Before she was not taking her medication as well as she should have been. However, now, she is taking it how should take it. Now she is eating better and lost a few pounds. She have been taking medication, eating better, exercising, going to cardiac rehab. Her LDL shot up 30 points. It was always in the 130s and now it's in the 160s. She was shocked that it went up to 160 from where it was. When she had blood work on her last report the LDL was 160 on 25Oct2023, that is when she found out cholesterol level went up. Prior to this, it was 136, and prior to that 133, and before that it was 124. All her cholesterol levels went up, but in particular LDL went up a lot. Triglycerides stayed the same practically. She could not understand why because she was eating better. Dropped pounds from last results and taking pills, the statins religiously. She knows she did not take it as well before. She is shocked this occurred and she believes it is due to the booster. She knows what her behaviour has been like with the last 3 test.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HD9835) at the age of 69 years, in left arm 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 (Manufacturer Unknown, DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, Primary Immunization Series Completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2023) Positive, notes: testing positive again on antigen self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Treatment included Paxlovid. Patient had no known allergies.
Age: 75.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Contusion, Feeling hot
Clinical narrative: blue bruises on the outsisde of the arm and also underneath all the way down to the wrist; feeling a little bit warm on the upper side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from medical information team.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Lot number: GJ5342) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: covid-19 vaccine (Dose 1, single, LOT#EN6200), administration date: 01Mar2021, when the patient was 72-year-old, for COVID-19 immunization; covid-19 vaccine (Dose 2, single, LOT#EN6207), administration date: 22Mar2021, when the patient was 73-year-old, for COVID-19 immunisation. The following information was reported: CONTUSION (non-serious) with onset 21Oct2023, outcome "not recovered", described as "blue bruises on the outsisde of the arm and also underneath all the way down to the wrist"; FEELING HOT (non-serious) with onset 21Oct2023, outcome "not recovered", described as "feeling a little bit warm on the upper side". The events "blue bruises on the outsisde of the arm and also underneath all the way down to the wrist" and "feeling a little bit warm on the upper side" required physician office visit. Therapeutic measures were not taken as a result of contusion, feeling hot.  Additional information: Patient received both the flu shot and the Pfizer Comirnaty 12+ 2023-2024 formulation on 14Oct2023.  A week later she had blue bruises on the outside of the arm and also underneath all the way down to the wrist, feeling a little bit warm on the upper side. The shots were given in the same arm, the left arm on the same day. Her whole arm is now a purplish black color, exactly like the color of an eggplant, from the top of arm/shoulder all the way down to the wrist. The color turned to dark purple and blackish and forearm from the top to the hand is whole black outside, inside of this still getting there. On the inside arm, the lower arm is little white there, but all the rest is purple, exactly eggplant colored. Her primary doctor said they've never seen this and didn't know. They knew all knew she was on warfarin, and they said its okay, and it was okay to take two of them together. She always followed all the guidelines. She has had all the previous Pfizer Covid vaccines before and asked if there something different in the new one. Patient is on warfarin (COUMADIN) but is a retired pharmacist and checks her blood levels (INR) for it everyday and adjusts the dose she takes accordingly.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Limb mass, Muscle mass
Clinical narrative: Mass in right shoulder; deltoid mass; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy: Naproxen". Vaccination history included: bnt162b2 (other vaccine same date details:, [{other vaccine same date product=Pfizer,, Other vaccine same date lot number=FM0173,, Other vaccine same date vaccine date=04Oct2022,, Other vaccine same date dose number=3,, Other vaccine same date vaccine location=Right, arm}]), administration date: 04Oct2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: LIMB MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "Mass in right shoulder"; MUSCLE MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "deltoid mass". The events "mass in right shoulder" and "deltoid mass" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb mass, muscle mass.