chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Device issue, No adverse event
Clinical narrative: this event classifying this as a near miss event; issues with the syringe cap; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (this event classifying this as a near miss event), DEVICE ISSUE (issues with the syringe cap) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch nos. 3042913 and 8080473) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3042913, 8080473) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) dosage was changed to 1 dosage form. and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (this event classifying this as a near miss event), DEVICE ISSUE (issues with the syringe cap) and NO ADVERSE EVENT (No adverse effect). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (this event classifying this as a near miss event), DEVICE ISSUE (issues with the syringe cap) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that this report is out of an abundance of caution as no one was reported injured/exposed in this event classifying this as a near miss event.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem and FDA code 2921, IMDRF code A051104 which include Difficult to Open or Close Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2024: Live follow-up received contains non-significant information. Added reference numbers.
Sex: M
Vaccine: RSV
Symptoms: Pertussis, Vaccination failure
Clinical narrative: didn't get any noticeable relief; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION FAILURE (didn't get any noticeable relief) in a male patient of an unknown age who received mRNA-1345 (mRESVIA) (batch no. ASKU) for Whooping cough.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1345 (mRESVIA) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (didn't get any noticeable relief). At the time of the report, VACCINATION FAILURE (didn't get any noticeable relief) outcome was unknown.        The action taken with mRNA-1345 (mRESVIA) (Unknown) was unknown.   For mRNA-1345 (mRESVIA) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received RSV vaccine but not got any noticeable relief from condition of whooping cough. The reporter suggested to revise the geometric length down to approximately 3 inches and trial that. Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2024: Live follow up received which had no new information.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Heart rate increased, Loss of consciousness, Malaise
Clinical narrative: passed out/light headed/nauseous; sore arm; heart rate increased; did not sleep well; had a bump on their head following the fall.; feeling like they are sick; feel shaky; splotchy rash; sick headache; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 28-Apr-2023. Past adverse reactions to the above products included COVID-19 with Pfizer vaccine.   On 17-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 17-Oct-2024, the patient experienced LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased), POOR QUALITY SLEEP (did not sleep well), FALL (had a bump on their head following the fall.), MALAISE (feeling like they are sick), NERVOUSNESS (feel shaky), RASH (splotchy rash), HEADACHE (sick headache) and PYREXIA (low grade fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased), POOR QUALITY SLEEP (did not sleep well), FALL (had a bump on their head following the fall.), MALAISE (feeling like they are sick), NERVOUSNESS (feel shaky), RASH (splotchy rash), HEADACHE (sick headache) and PYREXIA (low grade fever) had not resolved.      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had no medical conditions, no allergies. Took vitamins and other OTC medications. The patient had very achy low-grade fever, felt like they were sick, headache, sore arm, heart rate increased which patient mentions happens when they have a fever. She had nauseous, lightheaded, passed out while trying to reach the kitchen chair. She had a bump on their head following the fall. Caller mentions that they felt OK after and had a normal active day. She had splotchy rash, that they would usually have that "almost at the end of whatever it is that makes them feel sick. She had shaky drained did not sleep well. She had their 6th vaccination series and that all their vaccines were Pfizer except for 2 times they took Moderna. One of their previous vaccines was taken on 28-Apr-2023 (Pfizer) and 2 weeks after they got COVID.   This case was linked to US-MODERNATX, INC.-MOD-2024-775651 (E2B Linked Report).; Reporter's Comments: Fall event was considered as not related to the vaccine as is a consequence of loss of consciousness event. The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775651:Husband case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity, Poor quality sleep, Pyrexia, Rash
Clinical narrative: passed out/light headed/nauseous; sore arm; heart rate increased; did not sleep well; had a bump on their head following the fall.; feeling like they are sick; feel shaky; splotchy rash; sick headache; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 28-Apr-2023. Past adverse reactions to the above products included COVID-19 with Pfizer vaccine.   On 17-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 17-Oct-2024, the patient experienced LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased), POOR QUALITY SLEEP (did not sleep well), FALL (had a bump on their head following the fall.), MALAISE (feeling like they are sick), NERVOUSNESS (feel shaky), RASH (splotchy rash), HEADACHE (sick headache) and PYREXIA (low grade fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out/light headed/nauseous), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased), POOR QUALITY SLEEP (did not sleep well), FALL (had a bump on their head following the fall.), MALAISE (feeling like they are sick), NERVOUSNESS (feel shaky), RASH (splotchy rash), HEADACHE (sick headache) and PYREXIA (low grade fever) had not resolved.      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had no medical conditions, no allergies. Took vitamins and other OTC medications. The patient had very achy low-grade fever, felt like they were sick, headache, sore arm, heart rate increased which patient mentions happens when they have a fever. She had nauseous, lightheaded, passed out while trying to reach the kitchen chair. She had a bump on their head following the fall. Caller mentions that they felt OK after and had a normal active day. She had splotchy rash, that they would usually have that "almost at the end of whatever it is that makes them feel sick. She had shaky drained did not sleep well. She had their 6th vaccination series and that all their vaccines were Pfizer except for 2 times they took Moderna. One of their previous vaccines was taken on 28-Apr-2023 (Pfizer) and 2 weeks after they got COVID.   This case was linked to US-MODERNATX, INC.-MOD-2024-775651 (E2B Linked Report).; Reporter's Comments: Fall event was considered as not related to the vaccine as is a consequence of loss of consciousness event. The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775651:Husband case
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anaphylactic shock
Clinical narrative: anaphylactic shock; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC SHOCK (anaphylactic shock) in a 63-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product AMOXICILLIN (AMOXIL [AMOXICILLIN]) for an unknown indication.    No Medical History information was reported.   On 08-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started AMOXICILLIN (AMOXIL [AMOXICILLIN]) (unknown route) 1 dosage form. On 19-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced ANAPHYLACTIC SHOCK (anaphylactic shock) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC SHOCK (anaphylactic shock) was resolving.            The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.  Patient experienced Anaphylactic Shock, after taking Amoxicillin. Have taken Amoxil many times and can only correlate the vaccine and a potential culprit. It is unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: In view of the long non-suggestive onset latency the causality of the event was assessed as not related to the vaccine. Co-suspect product AMOXICILLIN is a contributor for the event. The benefit -risk relationship of product is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Condition aggravated
Clinical narrative: bronchitis; Condition aggravated; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (bronchitis) and CONDITION AGGRAVATED (Condition aggravated) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Lung infection.    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 BRONCHITIS (bronchitis) and CONDITION AGGRAVATED (Condition aggravated). The patient was treated with Prednisone at a dose of 1 dosage form. At the time of the report, BRONCHITIS (bronchitis) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that she gets bronchitis every year and was on antibiotics.   This case was linked to US-MODERNATX, INC.-MOD-2024-775829 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2024: Live follow-up received contains non-significant information. Added reference numbers. On 24-Oct-2024: Live follow-up received. Added Medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775829:Same reporter different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Fall, Fatigue
Clinical narrative: fell to the floor; slight bruises on the left side of my face; lightheaded; fainted; body aches; chills; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. NDC: 80777-0110-96) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Spikevax (previous doses). Past adverse reactions to the above products included Vaccination adverse reaction with Spikevax.    On 20-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 microgram. On 21-Oct-2024, the patient experienced MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue). On 22-Oct-2024, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), FALL (fell to the floor), CONTUSION (slight bruises on the left side of my face) and DIZZINESS (lightheaded). On 22-Oct-2024, SYNCOPE (fainted), MYALGIA (body aches), FALL (fell to the floor), CONTUSION (slight bruises on the left side of my face), DIZZINESS (lightheaded), CHILLS (chills) and FATIGUE (fatigue) had resolved.            Concomitant medication was not reported. On Monday (21-Oct-2024), patient experienced body aches, fatigue and chills. Yesterday (22-Oct-2024), when patient woke up, patient felt lightheaded, fainted and fell on floor. Got up and tried to get to sofa to sit down but fainted second time and fell down again. Patient had slight bruises on the left side of face. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.   This case was linked to MOD-2024-775835 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Syncope
Clinical narrative: fell to the floor; slight bruises on the left side of my face; lightheaded; fainted; body aches; chills; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. NDC: 80777-0110-96) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Spikevax (previous doses). Past adverse reactions to the above products included Vaccination adverse reaction with Spikevax.    On 20-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 microgram. On 21-Oct-2024, the patient experienced MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue). On 22-Oct-2024, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), FALL (fell to the floor), CONTUSION (slight bruises on the left side of my face) and DIZZINESS (lightheaded). On 22-Oct-2024, SYNCOPE (fainted), MYALGIA (body aches), FALL (fell to the floor), CONTUSION (slight bruises on the left side of my face), DIZZINESS (lightheaded), CHILLS (chills) and FATIGUE (fatigue) had resolved.            Concomitant medication was not reported. On Monday (21-Oct-2024), patient experienced body aches, fatigue and chills. Yesterday (22-Oct-2024), when patient woke up, patient felt lightheaded, fainted and fell on floor. Got up and tried to get to sofa to sit down but fainted second time and fell down again. Patient had slight bruises on the left side of face. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.   This case was linked to MOD-2024-775835 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: HPV9
Symptoms: Complex regional pain syndrome
Clinical narrative: complex regional pain syndrome; This spontaneous report was received from a caller, concerning to a female patient between 9 to 11-year-old.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, scheme, route of  lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient experienced complex regional pain syndrome (CRPS) after completing the vaccination series. The outcome for the event was not provided.   The causal relationship between complex regional pain syndrome and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   This is one of several reports from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported; clinic calling regarding a 14 year old patient that received the second dose of VAQTA after 4.5 months of the first dose; This spontaneous report has been received from a health business professional regarding a 14-year-old male patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 20-OCT-2024 (after 4.5 months of the first dose), the patient was vaccinated with the second dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection for prophylaxis (strength, dose, route of administration, anatomical site, lot number and expiration date not reported) (inappropriate schedule of vaccine administered). No symptoms reported.  Causal relationship between the suspect vaccine and the events was unknown.
Sex: F
Vaccine: RSV
Symptoms: Erythema, Exposure during pregnancy, Urticaria
Clinical narrative: hives all over body; red all over her body; This is a spontaneous report received from a Physician from a sales representative.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive other vaccines on the same date as the Pfizer vaccine and did not receive other vaccines in four weeks of the Pfizer vaccine administration. The following information was reported: URTICARIA (medically significant), outcome "recovered", described as "hives all over body"; ERYTHEMA (medically significant), outcome "recovered", described as "red all over her body". Patient had hives all over body for 2-3 weeks. She was red all over her body. Therapeutic measures were taken as a result of urticaria, erythema which included steroids (Z pack).; Sender's Comments: As there is limited information in the case provided, the causal association between the events urticaria and erythema; and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I had an adverse reaction to the first one. It didn't feel well, but ok.; This is a spontaneous report received from a Nurse.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL0140) at the age of 30 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: YASMIN taken for contraception. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had an adverse reaction to the first one. It didn't feel well, but ok.". Therapeutic measures were not taken as a result of feeling abnormal. Additional information: there was no additional vaccines administered on same date of the Pfizer COVID-19 vaccine and no other vaccinations within four weeks prior taking the Pfizer COVID-19 vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400284284 same patient and suspect drug, different dose;US-PFIZER INC-202400284285 same patient and suspect drug, different dose;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Reaction to excipient, Urticaria
Clinical narrative: Hives; Intense itching; must been sensitive to perhaps what they are telling, the preservatives in the vaccine; must been sensitive to perhaps what they are telling, the preservatives in the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years intramuscular, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CRESTOR (ongoing). Vaccination history included: Bnt162b2 (dose number unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Oct2024, outcome "recovering", described as "Hives"; PRURITUS (non-serious) with onset 10Oct2024, outcome "recovering", described as "Intense itching"; HYPERSENSITIVITY (non-serious), REACTION TO EXCIPIENT (non-serious) all with onset 10Oct2024, outcome "recovering" and all described as "must been sensitive to perhaps what they are telling, the preservatives in the vaccine". The events "hives", "intense itching" and "must been sensitive to perhaps what they are telling, the preservatives in the vaccine" required physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus, hypersensitivity, reaction to excipient. Additional information: The patient have gotten all of the vaccines from Pfizer and on 10Oct2024, the patient started to break out in hive and intense itching and that is still going on. Patient still have hives. The patient went on prednisone for three days that helped but then it came back. So, she went to her doctor yesterday (22Oct2024) and she was on antihistamines three times a day and some heavy creams but she must have been she do not really know. She must been sensitive to perhaps what they were telling her, the preservatives in the vaccine. The patient never had any issues before and she have always had Pfizer.    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: Fatigue, Headache, Nasal congestion, Sinusitis, Vomiting
Clinical narrative: My nose was stumped up; thought maybe it was sinus or something and she gave me some nose drops; I was feeling really tired; Low headaches; I was spitting up; 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)), 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: FATIGUE (non-serious) with onset Oct2024, outcome "not recovered", described as "I was feeling really tired"; VOMITING (non-serious) with onset Oct2024, outcome "unknown", described as "I was spitting up"; HEADACHE (non-serious) with onset Oct2024, outcome "not recovered", described as "Low headaches"; NASAL CONGESTION (non-serious) with onset Oct2024, outcome "unknown", described as "My nose was stumped up"; SINUSITIS (non-serious) with onset Oct2024, outcome "unknown", described as "thought maybe it was sinus or something and she gave me some nose drops". Therapeutic measures were taken as a result of sinusitis.  Additional information: The consumer stated, on the 15th, patient received a COVID-19 shot (Comirnaty), and for a few days, patient felt really tired, and then it was kind of okay and patient started to had low headaches and patient thought that patient nose was stumped up and patient was spitting up but anyway when patient talked to, patient had a doctor appointment for something else and patient did not know and thought maybe it was sinus or something and she gave me some nose drops (Unspecified Medication) but patient was  still, had a headache and still had some problems. When clarified the question, was this something that others had experienced, or are patient symptoms unrelated to the vaccine. When again probed for the manufacturer of the COVID-19 shot, consumer confirmed as Comirnaty (Suspect captured as provided) and When clarified the date of vaccination, consumer stated, It was on October 15th, and now it was the 23rd and patient wondered if would still be having symptoms from that because it started, it was like the tiredness was back and the headache was back.  Batch/lot number is not provided, and it cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at injection site; fatigue; mild headache; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Oct2024 at 18:15 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 23Oct2024 as dose 1, single), in left arm for immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER, start date: 14May2024; LARIN FE, start date: 30Jun2024; SPIRONOLACTONE, start date: 19Aug2024. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Oct2024 at 22:00, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 23Oct2024 at 22:00, outcome "recovering"; HEADACHE (non-serious) with onset 23Oct2024 at 22:00, outcome "recovering", described as "mild headache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache.  Additional information: The reporter informed that the facility where vaccine was administered was at a Pharmacy or Drug Store. The patient did the not receive any other vaccines within 4 weeks PRIOR to the vaccines. The patient. The COMIRNATY NDC was 00069-2432-10 and Flublok was 49281-0724-10.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Electric shock sensation, Musculoskeletal stiffness, Tremor, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: slight numbness and stiffness in arm; slight numbness and stiffness in arm; Started as a mere sore arm; slight static shock feeling at injection site; having shaky right hand and difficulty keeping my hand steady; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Oct2024 at 17:15 as dose 1, single (Lot number: LM7786) at the age of 36 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 24Oct2024 as dose 1, single (Lot number: Aw1668b), in right arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (ongoing); "ADHD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Allergy: Shellfish" (unspecified if ongoing); "spinal disc replacement mobi-c 56 disc" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for intervertebral disc operation (ongoing); METFORMIN taken for type 2 diabetes mellitus (ongoing). The following information was reported: TREMOR (non-serious) with onset 24Oct2024, outcome "recovered with sequelae" (24Oct2024), described as "having shaky right hand and difficulty keeping my hand steady"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2024 at 17:35, outcome "recovered with sequelae" (24Oct2024), described as "Started as a mere sore arm"; ELECTRIC SHOCK SENSATION (non-serious) with onset 24Oct2024 at 17:35, outcome "recovered with sequelae" (24Oct2024), described as "slight static shock feeling at injection site"; MUSCULOSKELETAL STIFFNESS (non-serious), VACCINATION SITE HYPOAESTHESIA (non-serious) all with onset 24Oct2024 at 19:15, outcome "recovered with sequelae" (24Oct2024) and all described as "slight numbness and stiffness in arm". Therapeutic measures were not taken as a result of tremor, electric shock sensation, musculoskeletal stiffness, vaccination site pain, vaccination site hypoaesthesia.  Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which he was reporting. Patient reported that started as a mere sore arm, which began turning into a slight static shock feeling at injection site 20 minutes after dose. 2 hours after this, slight numbness and stiffness in arm. Pain was more substantial now. After returning home about 3 1/2 hours after the shot, Patient started having shaky right hand and difficulty keeping his hand steady. He took a gabapentin and a metformin after a snack. Gabapentine was for a spinal disc replacement mobi-c 56 disc. The metformin was for type 2  diabetes. Pain started to dissipate while not moving but shaking persisted for about 30 minutes after taking medications. (Never have had shaking in right arm or hand before) After this the arm had maintained stiffness and soreness stemming from injection site. It's been 5 hours now since injection and reporting potential symptoms/side effects.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: My left arm is so sore and swollen; I could hardly lift up my arm; My left arm is so sore and swollen; I could hardly lift up my arm; My left arm is so sore and swollen; I could hardly lift up my arm; 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)), on 21Oct2024 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 JOINT MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2024, outcome "not recovered" and all described as "My left arm is so sore and swollen; I could hardly lift up my arm". Therapeutic measures were taken as a result of vaccination site joint movement impairment, vaccination site pain, vaccination site swelling.  Additional information: Consumer stated, "just wanted to find out about reaction to the COVID-19 vaccine, where the injection site arm, left arm is so sore and swollen. patient just, got the shot on Monday (21Oct2024) I believe, today is what Thursday (24Oct2024), patient think it was third day, but it is so sore and patient was guessing that it is going to go away soon when looked up arm, before patient could hardly lift up arm. So, does it just fade away or what?". When paraphrased the concern, consumer stated, "Right, that is reaction from the COVID-19 shot (COVID-19 vaccine), by Pfizer. The consumer stated and asked, "Ok and then, I should just take Tylenol and Advil. That is what I have been doing. and asked suggest anything.  Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: he got really sick; This is a spontaneous report received from an Other HCP, Program ID.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), in Nov2022 as dose number unknown, 30 ug single (Batch/Lot number: unknown) at the age of 40 years intramuscular for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Nov2022 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he got really sick".  Additional information: The last time patient got the covid and flu vaccine together he got really sick. It was unknown what the symptoms were and unknown exact dates. Patient received covid vaccination in Nov2022 and it unknown if the patient received the 2023 vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough following COVID booster; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly 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: COUGH (non-serious), outcome "recovered", described as "Cough following COVID booster".  Additional information: Consumer developed a cough following the COVID booster that persisted.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction to vaccine 2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2024, outcome "unknown", described as "Allergic reaction to vaccine 2024".
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". Clinical course:  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: gave pt flu shot twice no side effect as of now
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 yo child received Cominarity 12 + vaccine in error. No adverse effects noted.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient does not report any adverse events at this time. This report is being submitted because she patient received 2 flu vaccines. Upon arrival patient requested a flu vaccination. She was eligible for a high dose, verbally confirmed with patient at time on check-in. Patient came back 2 hours later to update her Covid card, at which time I confirmed that she received a flu vaccination and not Covid. She insisted that she had requested a Covid vaccination and that she had already received her flu vaccination in September. I had not checked system at the time of check in.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Fluzone; Manufacturer: Sanofi; LotNumber: U8523AA; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 10/07/2024
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient complaint that she had to see a md day after the vaccine with a rash neck down, she got some steroid rx from md and it when away, had issues with previous covid vaccines as well
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Pt had a big black and blue at the injection site and around it
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dysphagia, Ear pruritus, Erythema, Headache
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Systemic: ear was itching and red, trouble swallowing, throat tight-Mild, Systemic: Headache-Mild, Additional Details: took benadryl and feels better, sx started at 5 am
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pyrexia, Throat tightness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Systemic: ear was itching and red, trouble swallowing, throat tight-Mild, Systemic: Headache-Mild, Additional Details: took benadryl and feels better, sx started at 5 am
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: patient received normal routine flu vaccine. after receiving and family appt was finished, pt was about to leave to exit the building when mom reports that patient seemed off and fainted/had a seizure. 911 was called and paramedics arrived to access the patient. patient was provided a chair to sit and both parents/staff pharmacist/police were watching patient until  paramedics arrived. When paramedics arrived, blood pressure was taken and patient was accessed. Declined transportation to hospital
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Vomiting-Severe, Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388533; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patinet recived a flu vaccine on 10/18. During the vaccination, patient experience tingling sensation starting from fingertip to ear, which lasted about 1 hr and faded away. On 10/19, patient was followed up by RX team. She described, if she felt tingling sensation during the vaccinaition was 10/10, today she is feeling only 1/10. Patient is experiencing injection site pain, muscle soreness, but she also describes that the pain is extended upto her ear. RX team will continue follow up
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Hypoaesthesia, Injection site pain, Injection site swelling, Mouth swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports numbness in first and second finger of left hand.  Also reports tingling in left arm and shooting pain from shoulder down to hand
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Paraesthesia, Swelling face, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports numbness in first and second finger of left hand.  Also reports tingling in left arm and shooting pain from shoulder down to hand
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Other Vaccines:  VaccineTypeBrand: COVID19 (Spikevax); Manufacturer: Moderna; LotNumber: 8080748; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 10/20/2024
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Other Vaccines:  VaccineTypeBrand: COVID19 (Spikevax); Manufacturer: Moderna; LotNumber: 8080748; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 10/20/2024
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Facial pain, Injection site pain, Neck pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Reported feeling like his arm had been punched. Reported pain on right side of neck and right cheek that lasted minutes.-Mild, Additional Details: Pt sat in exam room with provider for 5mn and then in exam waiting room for 10 mn without further AEs
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: pneumovax 23; Manufacturer: merck sharp & d; LotNumber: y009239; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Fever-Severe
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Headache, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: pain in upper shoulder-Medium, Systemic: Headache-Medium, Additional Details: vaccine looks to have been given in the correct location on the arm
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: administered covid vaccine in left arm, patient switched chair around to received flu shot in right arm. after administration, patient fainted in chair. caught patient and patient regained consiousness immediately. Patient did not report history on form. upon further inquiry, pt had history of fainting with blood draws. monitored patient for 20 minutes and monitored heart rate on watch. no other AEs occurred. informed pt to mark history of dizziness or fainting on vaccines in future, Other Vaccines:  VaccineTypeBrand: Pfzer COVID 24-25; Manufacturer: Pfizer; LotNumber: lm2224; Route: IM; BodySite: left arm; Dose: 1; VaxDate: UNKNOWN
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Systemic: Joint Pain-Severe
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Range of motion of left arm limited since injection, no improvement in pain since injection
Age: 55.0
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, General physical condition abnormal, Headache, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Mild, Systemic: Weakness-Mild, Additional Details: patient is ok overall. still has bruised arm at this point., Other Vaccines:  VaccineTypeBrand: fluad trivalent; Manufacturer: seqirus; LotNumber: 388498; Route: IM; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Sleep disorder
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Mild, Systemic: Weakness-Mild, Additional Details: patient is ok overall. still has bruised arm at this point., Other Vaccines:  VaccineTypeBrand: fluad trivalent; Manufacturer: seqirus; LotNumber: 388498; Route: IM; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN