chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Tremor
Clinical narrative: shaking; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (shaking) and CHILLS (chills) in an 82-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 INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.    Previously administered products included for Product used for unknown indication: COVID-19 Vaccine. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine.   On 30-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (unknown route) 1 dosage form. On 30-Sep-2024, the patient experienced TREMOR (shaking) and CHILLS (chills). At the time of the report, TREMOR (shaking) and CHILLS (chills) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Big red rash; It was very red until today/It was where they gave her the vaccine; It was very itchy/It was where they gave her the vaccine; Big red rash; It was very red until today/It was where they gave her the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Big red rash; It was very red until today/It was where they gave her the vaccine"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "It was very itchy/It was where they gave her the vaccine".  Additional information: it was not major, but it was on her arm where she was wound up and having a big red rash. Reporter was able to mention that it was because of the Pfizer COVID shot. It was where they gave her the vaccine. It was on her left arm, and it was very red until 25Sep2024 and beside the red it was very itchy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: fever; Her whole body is hurting; can hardly walk and had to walk with a walker; feeling really bad; Everything, including her bones hurt; Administered in left arm, has big bruise there, and was really sore; Administered in left arm, has big bruise there, and was really sore; muscle spasms; tiredness; headache; muscle pain; joint pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 51-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 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: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2024, outcome "unknown" and all described as "Administered in left arm, has big bruise there, and was really sore"; BONE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "Everything, including her bones hurt"; HEADACHE (non-serious) with onset Sep2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "joint pain"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "muscle pain"; MUSCLE SPASMS (non-serious) with onset Sep2024, outcome "unknown"; FATIGUE (non-serious) with onset Sep2024, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 26Sep2024, outcome "not recovered", described as "Her whole body is hurting"; GAIT INABILITY (non-serious) with onset 26Sep2024, outcome "unknown", described as "can hardly walk and had to walk with a walker"; FEELING ABNORMAL (non-serious) with onset 26Sep2024, outcome "not recovered", described as "feeling really bad"; PYREXIA (non-serious) with onset 26Sep2024, outcome "unknown", described as "fever". Therapeutic measures were taken as a result of gait inability.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Pain, Pyrexia
Clinical narrative: fever; Her whole body is hurting; can hardly walk and had to walk with a walker; feeling really bad; Everything, including her bones hurt; Administered in left arm, has big bruise there, and was really sore; Administered in left arm, has big bruise there, and was really sore; muscle spasms; tiredness; headache; muscle pain; joint pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 51-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 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: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2024, outcome "unknown" and all described as "Administered in left arm, has big bruise there, and was really sore"; BONE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "Everything, including her bones hurt"; HEADACHE (non-serious) with onset Sep2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "joint pain"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "muscle pain"; MUSCLE SPASMS (non-serious) with onset Sep2024, outcome "unknown"; FATIGUE (non-serious) with onset Sep2024, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 26Sep2024, outcome "not recovered", described as "Her whole body is hurting"; GAIT INABILITY (non-serious) with onset 26Sep2024, outcome "unknown", described as "can hardly walk and had to walk with a walker"; FEELING ABNORMAL (non-serious) with onset 26Sep2024, outcome "not recovered", described as "feeling really bad"; PYREXIA (non-serious) with onset 26Sep2024, outcome "unknown", described as "fever". Therapeutic measures were taken as a result of gait inability.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: fever; Her whole body is hurting; can hardly walk and had to walk with a walker; feeling really bad; Everything, including her bones hurt; Administered in left arm, has big bruise there, and was really sore; Administered in left arm, has big bruise there, and was really sore; muscle spasms; tiredness; headache; muscle pain; joint pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 51-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 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: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Sep2024, outcome "unknown" and all described as "Administered in left arm, has big bruise there, and was really sore"; BONE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "Everything, including her bones hurt"; HEADACHE (non-serious) with onset Sep2024, outcome "unknown"; ARTHRALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "joint pain"; MYALGIA (non-serious) with onset Sep2024, outcome "unknown", described as "muscle pain"; MUSCLE SPASMS (non-serious) with onset Sep2024, outcome "unknown"; FATIGUE (non-serious) with onset Sep2024, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 26Sep2024, outcome "not recovered", described as "Her whole body is hurting"; GAIT INABILITY (non-serious) with onset 26Sep2024, outcome "unknown", described as "can hardly walk and had to walk with a walker"; FEELING ABNORMAL (non-serious) with onset 26Sep2024, outcome "not recovered", described as "feeling really bad"; PYREXIA (non-serious) with onset 26Sep2024, outcome "unknown", described as "fever". Therapeutic measures were taken as a result of gait inability.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, Pulmonary congestion
Clinical narrative: Coughing and congested; congested/fluid in the back; Trouble breathing a little bit; Feeling sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in Sep2024 as dose number unknown, single) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), in Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Sep2024, outcome "not recovered", described as "Feeling sick"; DYSPNOEA (non-serious) with onset Sep2024, outcome "not recovered", described as "Trouble breathing a little bit"; PULMONARY CONGESTION (medically significant) with onset Sep2024, outcome "not recovered", described as "congested/fluid in the back"; COUGH (non-serious) with onset 25Sep2024, outcome "not recovered", described as "Coughing and congested".  Additional information: The patient took three shots on Tuesday and Wednesday (Sep2024) then started feeling coughing and someone told them that it was because of the fluid in the back, that's why the patient was coughing and congested. This has been going on for a while. At the time of the report, the patient was having trouble breathing a little bit. The patient took COVID-19 vaccine by Pfizer, influenza flu and the other one was TdaP tetanus vaccine. The patient did not know what was making her sick and did not know what to do. The patient did not know if they should go to the hospital.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: swelling; itching; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2024, outcome "unknown", described as "itching"; SWELLING (non-serious) with onset 2024, outcome "unknown".  Additional information: The caller wanted to know if Pfizer had any recommendations for treating side effects stemming from the COVID vaccine. She had received the Pfizer shot and experienced some swelling and itching. She wanted to know if she could use Benadryl cream on the affected area. The caller mentioned that she usually received the Moderna vaccine in the past and that they had provided this type of symptom management recommendation.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 93.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vaccination site erythema
Clinical narrative: Redness on the arm where shot was; This is a spontaneous report received from a Consumer or other non HCP.  A 93-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Sep2024 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 93 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 26Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; BISOPROLOL FUMARATE; TRIAMTERENE; ATORVASTATIN. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 27Sep2024, outcome "not recovered", described as "Redness on the arm where shot was". Additional information: also patient takes supplements. 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: Headache
Clinical narrative: describes HA that lasted on and off for 3 days; This is a spontaneous report received from a Nurse.  A 39-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LM2210), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 27Sep2024, outcome "recovering", described as "describes HA that lasted on and off for 3 days". Therapeutic measures were not taken as a result of headache.  Additional information: Co-Suspect: Sequiris, Lot:388527, left arm on 26Sep2024. The patient did receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting: No. The patient was taking any other medications within 2 weeks of the event starting: Unknown. Reported Event: describes HA that lasted on and off for 3 days. Device Date : 30Sep2024.   No follow-up attempts are possible.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Soreness in right arm; headache; slight nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Sep2024 as dose 1, single), in right arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TERBINAFINE, start date: 27Sep2024, stop date: Sep2024; METRONIDAZOLE, start date: 27Sep2024, stop date: Sep2024. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2024 at 02:00, outcome "recovering", described as "Soreness in right arm"; HEADACHE (non-serious) with onset 30Sep2024 at 02:00, outcome "recovering"; NAUSEA (non-serious) with onset 30Sep2024 at 02:00, outcome "recovering", described as "slight nausea". Therapeutic measures were not taken as a result of pain in extremity, headache, nausea.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eye swelling, Lip swelling, Oral pain, Swelling face
Clinical narrative: swelling of the lip, cheek, and eye on left side; swelling of the lip, cheek, and eye on left side; swelling of the lip, cheek, and eye on left side; mouth hurt; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right deltoid for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 27Sep2024 as dose number unknown, single), in left deltoid for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal. Vaccination history included: Moderna (DOSE 1), for covid-19 immunisation; Moderna (DOSE 2), for covid-19 immunisation; Moderna (DOSE 3 (BOOSTER)), for covid-19 immunisation. The following information was reported: ORAL PAIN (non-serious) with onset 27Sep2024, outcome "unknown", described as "mouth hurt"; LIP SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 28Sep2024, outcome "unknown" and all described as "swelling of the lip, cheek, and eye on left side"; EYE SWELLING (non-serious) with onset 28Sep2024, outcome "recovering", described as "swelling of the lip, cheek, and eye on left side". Therapeutic measures were taken as a result of lip swelling, swelling face, eye swelling, oral pain.  Additional Information: The patient got the BNT162b2 vaccine this time (in the afternoon) and had a reaction that she has never had before. Starting 27Sep2024 night, she noticed her mouth was hurting real bad, nothing looked bad. Then 28Sep2024, the swelling in the mouth area (as reported), cheek, and eye started. This occurred on 28Sep2024 and 29Sep2024. By the night before reporting (30Sep2024) however, the swelling had gone down everywhere except for the lips and cheek, this was still a little swollen. She started diphenhydramine hydrochloride (BENADRYL) on 28Sep2024. She took two doses on  28Sep2024 and two doses on 29Sep2024.     The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: Long-term Covid; Long-term Covid; Long-term Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-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), POST-ACUTE COVID-19 SYNDROME (medically significant) all with onset 2021, outcome "unknown" and all described as "Long-term Covid".  Clinical course: The reporter reporter's daughter took the Pfizer vaccine and she had long-term Covid from three years where the reporter took the Moderna shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: delivered myocarditis to my aunt and she died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 41-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal", described as "delivered myocarditis to my aunt and she died". The patient date of death was unknown. Reported cause of death: "delivered myocarditis to my aunt and she died". It was not reported if an autopsy was performed. Clinical course:  the reporter stated: "they delivered myocarditis to my aunt and she died, they didn't promise that but promised it was safe."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: delivered myocarditis to my aunt and she died
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: still got Covid; still got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still got Covid". Patient had been given several Pfizer shots for Covid and she still got Covid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive covid 4 times; tested positive covid 4 times; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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), outcome "unknown" and all described as "tested positive covid 4 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive; Positive; Positive; Positive.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received FLUZONE TIV instead of FLUZONE HD with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where patient inadvertently received Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] instead of Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] 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 2024, the patient received a dose of suspect Influenza usp trival a-b subvirion no preservative vaccine Suspension for injection  lot number not reported via unknown route in unknown administration site for Immunisation and received a dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation and inadvertently received fluzone tiv instead of fluzone hd with no reported adverse event (wrong product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion with no reported adverse event; was administered a dose of IPOL polio vaccine with no reported adverse event; Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves temperature excursion of IPV (VERO) [IPOL] and was administered to a 15 years old male patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Aug-2024, the patient received 0.5 ml of IPV (VERO) Suspension for injection (strength- unknown, lot W1C741M and expiry date- 17-Nov-2025) via intramuscular route in unknown administration site for prophylactic vaccination (poor quality product administered) (latency- same day) with no reported adverse event.  Reportedly, it was not known if the temperature excursion was due to the A/C (air conditioner) being down during that time or if the fridge door was open for too long. On 05-Sep-2024 nurse was informed about the temperature excursion. It was informed to the nurse that patient needed to repeat the dose of the Polio vaccine.  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-2024SA261334:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: DTAP-IPV component was given solo and was not mixed with the Hib component, with no reported adverse event; DTAP-IPV component was given solo and was not mixed with the Hib component,with no reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who had administered with Diphtheria/Tetanus/2 Ac Pertussis/IPV (Vero) Vaccine [Pentaxim] component was given solo and was not mixed with the HIB(PRP/T) component 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, the patient received a unknown dose of suspect Diphtheria/Tetanus/2 Ac Pertussis/IPV (Vero)/HIB (PRP/T) Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) and dtap-ipv component was given solo and was not mixed with the hib component, with no reported adverse event (product preparation error) and (single component of a two-component product administered)  (same day latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: She discarded one of the syringes, but did administer a short dose to a patient with no reported adverse event; Initial information received on 18-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient where reporter reported that she discarded one of the diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] syringes, but did administer a short dose to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2024, the patient received 0.4 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- 3CA07C1 and expiration date- 31-DEC-2025) via unknown route in unknown administration site (strength: not provided) for Immunisation and she discarded one of the syringes, but did administer a short dose to a patient with no reported adverse event (incorrect dose administered) (latency- same day).  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.
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: experiencing numbness of the arm; Initial information received on 19-Sep-2024 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional (patient's mother).  This case involves an unknown age male patient who was experiencing numbness of the arm after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Dupilumab (Dupixent).  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection lot U8465BA via unknown route in unknown administration site for Immunization (strength, dose and expiry date unknown).  On an unknown date the patient had experiencing numbness of the arm (hypoaesthesia) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Age: 88.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: nausea; almost pass out; severe dizziness causing her to almost pass out on day; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 28Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRESYNCOPE (non-serious) with onset 28Sep2024, outcome "recovering", described as "almost pass out"; DIZZINESS (non-serious) with onset 28Sep2024, outcome "recovering", described as "severe dizziness causing her to almost pass out on day"; NAUSEA (non-serious) with onset 29Sep2024, outcome "recovering". Therapeutic measures were not taken as a result of presyncope, dizziness, nausea. Additional information: Had severe dizziness causing her to almost pass out on day of vaccine hours later and nausea the next day.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Throat clearing, Throat irritation
Clinical narrative: need to clear throat constantly and itching of throat
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Patient was given a third dose of Men B when he was fully vaccinated and not due, due to having a legal name change and vaccine records not being reconciled.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: Pt had a generalized rash noted on 10/2/24 on the face, arms, trunk and legs with clear fluid filled areas and an erythematous base consistent with varicella disease.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Hoarse voice and weakened (softer) voice (NOTE: this same side effect occurred after last years Covid vaccination, but I didn't associate it as a side effect until experiencing it again this year).   It went away last year, and it may go away again this year.    I am not overly worried about it, but maybe I should be.  I mainly wanted to report it.  I don't see a lot number to be able to answer that part of the vaccine question.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Mammogram, Ultrasound scan
Clinical narrative: DX: swollen lymph nodes  due to Moderna vaccine.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate decreased, Loss of consciousness
Clinical narrative: After receiving the vaccine within 5 minutes the patient passed out. She regained consciousness within seconds but blood pressure was 90/30 and heart rate was in the 40s. After 25 minutes heart rate remained lower 50s-60s and she still felt lightheaded. She had trouble sitting up without feeling like she would pass out again. EMS was activated and taken to the ED
Age: 80.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with swelling, redness at left arm injection site and states he was seen at the ER and treated with antibiotics.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Pain, Pain in extremity
Clinical narrative: Extensive bruising on right upper arm all the way down to elbow.  First noticed 3 days after injection.  Sore when raising arm.  Sent to doctor to be seen.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Dizziness, Fall
Clinical narrative: Pt became light headed after shot and then fell down. Did not hit his head but was not alert for around 60 seconds to 90 seconds
Age: 23.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient pregnant. GA at time of injection. 32W1D EDD 1/07/2024 The area on her arm where the shot was became, firm, hot and red. She tried with massage, ice and heat with minimal improvement. This occurred with in one hour after administration. Injection was on 9/27/24. She reported the problem at her next appointment on 10/2/24. On the day it was reported she reported it is now much less red. Denies fever and chills. 10/2/24 doctor observation: 3cm area of redness. No induration or fluctuance. Cellulitis: suspect inflammatory response to infection. Reporting response. Plan to treat with keflex course possible cellulitis.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site urticaria
Clinical narrative: Patient received 2 vaccines above and developed hives on arm, localized near injection site w/i 15 minutes of administration. Recommend cetirizine daily x 1 week. By 1845, pt's symptoms improved and no other symptoms.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: I was at clinic on 10/2/2024 assisting with a mass flu vaccine clinic.  The nurse at the facility gave me patient's paperwork in order for me to administer his flu vaccine,  I gave him a dose of the Fluzone High Dose Flu Vaccine.  Later on during the clinic, another public health nurse was entering vaccines into the system and it was discovered that he had already received a flu vaccine on 9/13/2024 at another Clinic .  The facility nurse said she was not aware patient had received a flu shot on 9/13/2024.  I do not do a vaccine inquiry in the system during mass  fluvaccine clinics prior to delivering the vaccine d/t the sake of time.  Therefore, I did not know patient already had a flu shot.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received the flu shot twice, once on 7/30/2024 and on 10/2/2024
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Ear pain, Headache
Clinical narrative: Congestion, shortness of breath, severe headache and body ache, dizziness, severe throat and ear ache, green phlegm, fever and chills and inability to sleep lasting 3 days despite taking ibuprofen 600 mgs 3 times a day.  on 10/3 symptoms are improving after doing home remedies such as salt water gargle, nasal rinse, steam inhalation
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Congestion, shortness of breath, severe headache and body ache, dizziness, severe throat and ear ache, green phlegm, fever and chills and inability to sleep lasting 3 days despite taking ibuprofen 600 mgs 3 times a day.  on 10/3 symptoms are improving after doing home remedies such as salt water gargle, nasal rinse, steam inhalation
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Sputum discoloured
Clinical narrative: Congestion, shortness of breath, severe headache and body ache, dizziness, severe throat and ear ache, green phlegm, fever and chills and inability to sleep lasting 3 days despite taking ibuprofen 600 mgs 3 times a day.  on 10/3 symptoms are improving after doing home remedies such as salt water gargle, nasal rinse, steam inhalation
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE WAS GIVEN OUTSIDE OF THE RECOMMENDED TIME FRAME.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Incorrect dosage given to patient. Patient received Hep B pediatric
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3, RSV, TDAP
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: she said she had the dizziness around 24 hrs after having all 4 shots and fell down and hit her face, she came to the store on 9/30 to tell me about the incidents at the drive thru, her partner drove the car
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the influenza vaccine twice this season. Once on July 29 2024 and another one on September 25 2024. No adverse reactions occurred but patient received duplicate vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE GIVEN OUTSIDE OF THE RECOMMENDED TIME FRAME
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE GIVEN OUTSIDE OF RECOMMNEDED TIME FRAME
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV
Symptoms: Extra dose administered
Clinical narrative: Gave the baby 2 Pediarix doses instead of 1 Pediarix and 1 Pneumococcal Conjugate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient said felt extremely dizzy and lightheaded about 25 hours after administration
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt received 2 flu shots on 7/30/2024 and 10/2/2024
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 yo living at senior assisted living facility received high dose Fluzone .  She has no symptoms/side effects per coordinator at the facility
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Patient said her lymph nodes on her right side hurt after the covid shot and is still ongoing.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE WAS GIVEN OUTSIDE OF THE RECOMMENDED TIMEFRAME
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE GIVEN OUTSIDE OF THE RECOMMNEDED TIMEFRAME
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Migraine, Migraine with aura
Clinical narrative: I have had a headache every day since the shot. Some have developed into migraines requiring meds. One of these migraines had a scary aura. I?ve had migraines my whole life but not for over two weeks straight. I?ve never had a migraine with aura until now. Think there?s some chance the aura might relate to Corlanor use, but I was having a cluster of migraines too. Headache developed the night after I got the shot.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Immediately after the injection, my arm hurt more than it has in the past for flu vaccines. As the day went on, my arm became extremely sore and it was tingly all the way to my fingertips. Two days later I woke up, to get ready for work, and I could barely hold my deodorant with my left hand. My wrist/hand was very painful with any movement, and I had to take 800mg of Ibuprofen and wear a brace to work. As time progressed, I continued to get arthritic pain throughout my entire body. I had to wear wrist braces bilaterally while I slept, mornings were the worst and had to take 800mg Ibuprofen daily. I went and had compression therapy and red-light therapy. It helped a little. I had an IV infusion with a steroid and antioxidants to help reduce the inflammation on Sept 26th. I also started a vaccine detox from "Earthley" and on day 4, I broke out in a full body rash and my arthritic pain was 95% better.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Immediately after the injection, my arm hurt more than it has in the past for flu vaccines. As the day went on, my arm became extremely sore and it was tingly all the way to my fingertips. Two days later I woke up, to get ready for work, and I could barely hold my deodorant with my left hand. My wrist/hand was very painful with any movement, and I had to take 800mg of Ibuprofen and wear a brace to work. As time progressed, I continued to get arthritic pain throughout my entire body. I had to wear wrist braces bilaterally while I slept, mornings were the worst and had to take 800mg Ibuprofen daily. I went and had compression therapy and red-light therapy. It helped a little. I had an IV infusion with a steroid and antioxidants to help reduce the inflammation on Sept 26th. I also started a vaccine detox from "Earthley" and on day 4, I broke out in a full body rash and my arthritic pain was 95% better.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Palpitations, Tachycardia
Clinical narrative: After receiving the flu vaccine around 1030am I began to have some symptoms around 1:00pm. I started having heart palpitations, SOB, dizziness, tachycardia, heart rate was in the 130?s and high blood pressure. I am a registered nurse so was able to check myself out at work. When I came home my blood pressure was 162/105 and HR was 108. I take metoprolol for unknown sinus tachycardia after receiving the Covid vaccines and  have been on it for several years now and it?s under control with the metoprolol so I took my dosage plus an extra half pill. Two hours later my BP was 149/93 and HR 100 so I took another half metoprolol which was 50mg. I have never had a reaction before with a flu vaccine but this is the only explanation I have is that this is all related to the vaccine because nothing in my day should have triggered any of these issues.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Pyrexia
Clinical narrative: The day after his vaccine was received, he had a low grade fever of around 100 and did not really want to do anything. The tissue was hard 2 inches in diameter around the injection site, was very red and warm to the touch. The on call nurse said to massage the tissue and apply heat. The next morning, the red area had grown and was now 6 inches down the length of his arm and 3-4 inches wide. The hard knot was still there about 2 inches in diameter. I took him back to the doctor and they suggested Benadryl. The night, Wednesday the 25th, it continued to grow slightly. The morning of the 26th the red growth stopped. We are now 9 day past the injection date and his arm is still read about 5 inches in length and 3 inches in width. The red is lightening but still very noticeable. It is slightly warm to the touch but does not hurt.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: patient has swelling at injection site lasting one week. She went to see PCP on day 5.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested and received Fluad on 7/30/2024 and again on 9/30/2024. Patient received two doses of the Fluad. Patient confirmed that she experienced no adverse effects due to second dose of flushot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE GIVEN OUTSIDE OF THE RECOMMNEDED TIMEFRAME
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine given outside the recommended time frame.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE GIVEN OUTSIDE OF RECOMMENDED TIME FRAME
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine given outside of recommended timeframe
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine given outside of the recommended timeframe
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Discomfort, Herpes zoster
Clinical narrative: Shingles developed 6 days later.  Started with discomfort one day later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed fevers, right deltoid pain, erythema and swelling 2 days after administration of MMRV and DTaP/IPV.  Erythema worsened today and area now indurated. Pain has improved. Able to move right shoulder without limitation.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: Patient described rash on her back and chest.