chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: coughing; I got a temperature; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) and PYREXIA (I got a temperature) in an 82-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (dose 1) on 11-Mar-2021, Pfizer (dose 2) on 01-Apr-2021, Pfizer (dose 3) on 16-Oct-2021, Pfizer (dose 4) on 29-Apr-2022 and Pfizer (dose 5) on 20-Sep-2022. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Allergy (for years).    On 24-Sep-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 25-Sep-2024, the patient experienced COUGH (coughing) and PYREXIA (I got a temperature). The patient was treated with PARACETAMOL (TYLENOL) on 25-Sep-2024 at an unspecified dose and frequency. At the time of the report, COUGH (coughing) and PYREXIA (I got a temperature) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Patient had been taking the Pfizer and had no problems. Seems like the patient got a temperature after lunch. Patient was not able to describe her temperature but stated, she does not know, she just felt. The patient had not measured it. Patient was also coughing while speaking and clearing her throat during the conversation. Reporter causality was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain, Swelling
Clinical narrative: prolonged swelling; pain; firmness; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (prolonged swelling), PAIN (pain) and INDURATION (firmness) in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 18-Sep-2024, the patient experienced SWELLING (prolonged swelling), PAIN (pain) and INDURATION (firmness). At the time of the report, SWELLING (prolonged swelling), PAIN (pain) and INDURATION (firmness) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Sex: M
Vaccine: MENB
Symptoms: Concussion, Fall, Loss of consciousness
Clinical narrative: passed out; fell down; got a concussion from the fall; This is a spontaneous report received from a Physician from a sales representative.  A male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; FALL (non-serious), outcome "unknown", described as "fell down"; CONCUSSION (non-serious), outcome "unknown", described as "got a concussion from the fall". It was unknown if therapeutic measures were taken as a result of loss of consciousness, fall, concussion. A patient received Trumenba and then passed out, fell down, and got a concussion from the fall. This occurred "years and years ago".   The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event loss of consciousness and the suspect drug MENINGOCOCCAL GROUP B RLP2086 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.
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Thrombosis
Clinical narrative: blood clots; Post event, post vaccine yes to many foods; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FK9729), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; BENADRYL. Vaccination history included: BNT162b2 (DOSE 1, vaccine lot number: Ew0181, vaccine location: Upper Left Deltoid, facility type vaccine: Pharmacy), administration date: 19Jun2021, when the patient was 24-year-old, for COVID-19 immunization, reaction(s): "Guillain-Barre Syndrome", "brachial neuritis", "Anaphylactic reaction"; BNT162b2 (DOSE 2, vaccine lot number: Ew0168, vaccine location: Upper Left deltoid, facility type vaccine: Hospital), administration date: 13Jul2021, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, disability, life threatening) with onset Aug2022, outcome "not recovered", described as "blood clots"; FOOD ALLERGY (non-serious), outcome "unknown", described as "Post event, post vaccine yes to many foods". The patient was hospitalized for thrombosis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of thrombosis and included treatment with steroids, epinephrine, morphine, blood thinners.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400263342 same patient, different doses/events;
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: administered a pediatric dose of Havrix to an adult patient/ inappropriate dose; administered a pediatric dose of Havrix to an adult patient/ inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 64-year-old male patient who received HAV (Havrix pediatric) (batch number ZPK53, expiry date 04-MAR-2026) for prophylaxis.   On 18-SEP-2024, the patient received the 1st dose of Havrix pediatric. On 18-SEP-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Havrix to an adult patient/ inappropriate dose) and adult use of a child product (Verbatim: administered a pediatric dose of Havrix to an adult patient/ inappropriate age). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 18-SEP-2024 Licensed practical nurse explained that they administered a pediatric dose of Havrix to an adult patient earlier on the day of reporting, which led to an underdose and adult use of child product. According to reporter that would be the very first Hepatitis A vaccine that the patient received so far. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial flutter, Back pain, Headache, Heart rate
Clinical narrative: Experiencing bad headache 24 hr later now; Experiencing backache 24 hr later now; 6 hr post injection Novavax, sudden onset atrial flutter 163 beats/min; Arrythmia broke after 1 hr; This serious initial Spontaneous safety report was received by Novavax on 21-Sep-2024 from a Consumer or other non health professional via agency (ref. no. S-1000000376-NVAX).  A 72 year-old Male was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was not provided in the report.) on 20-Sep-2024.  The following medical history was reported: ERYTHROMYCIN ALLERGY, SVT, HTN, HYPERLIPIDEMIA, PRIOR HX OF A FLUTTER and NO TACHYARRYTHMIAS SINCE JULY 7,2024.   The following concomitant medications were reported: TDAP(tetanus vaccine toxoid), INFLUENZA VACCINE(influenza vaccine) and ELIQUIS(apixaban).  On 20-Sep-2024, 1 Hour after vaccination the patient experienced Arrythmia broke after 1 hr (Arrhythmia)(Serious: Other Medically Important Condition), 6 Hours after vaccination the patient experienced 6 hr post injection Novavax, sudden onset atrial flutter 163 beats/min(Atrial flutter). On 21-Sep-2024, 2 Days after vaccination the patient experienced Experiencing bad headache 24 hr later now(Headache) and Experiencing backache 24 hr later now(Back pain).  Relevant lab tests included: HEART RATE(Result: 163 heart beats per minute, Test Date: 20-Sep-2024).  At the time of reporting, the event outcome of Arrhythmia was Recovered/Resolved, Atrial flutter was Recovering/Resolving, Headache was Not Recovered/Not Resolved/Ongoing and Back pain was Not Recovered/Not Resolved/Ongoing.  The reporter assessed the causality between the vaccine and reported events Arrhythmia, Atrial flutter, Headache and Back pain as Possible.  There were a few discrepancies noted in the source document: Influenza vaccine was reported as received within 4 weeks of the Novavax COVID-19 vaccine, but the administration date reported was 10-Sep-2023. Conservatively captured as concomitant medication and past therapy. All events were reported as recovering in the structured field, but in the provided description the Arrythmia was reported as recovered, and the Headache and Back pain were reported as ongoing. Recovering was retained only for the Atrial flutter. Previous vaccination with Novavax vaccine was reported to be Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula). Captured as Novavax COVID-19 Vaccine, Adjuvanted according to the administration date.; Sender's Comments: This 72 year-old Male experienced Arrhythmia, Atrial flutter, Headache and Back pain after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Arrhythmia was assessed as serious.  The events Atrial flutter, Headache, and Back pain were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Arrhythmia, Atrial flutter, Headache and Back pain is considered Possible.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Uticaria on arms and legs; This is a spontaneous report received from an Other HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 at 16:15 as dose 1, single (Lot number: LM2222) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 20Sep2024 (Lot number: 946579), in left arm. The patient's relevant medical history included: "Dysmenorrhea" (unspecified if ongoing); "Allergic to food: monk fruit, mild seasonal outdoor" (unspecified if ongoing); "acne" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1.5/30; ADDERALL; ACCUTANE, stop date: 08Mar2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset 24Sep2024 at 12:00, outcome "not recovered", described as "Uticaria on arms and legs". Therapeutic measures were not taken as a result of urticaria.  Additional information included: "brand name" reported as TEVA for concomitant drug Junel Fe 1.5/30 tablets.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Gait disturbance, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Swollen lymph nodes; Feel bad/ not feeling too good; Coughing; Body ache like stiffness and pain/ Intense pain in the midsection part of my body; Body ache like stiffness and pain; Problem even walking upstairs; Still have nausea pain too; I have nausea also; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "nerve pain in your left foot" (unspecified if ongoing), notes: diabetes causes this nerve pain in foot. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GABAPENTIN taken for neuralgia. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "Feel bad/ not feeling too good"; COUGH (non-serious), outcome "recovering", described as "Coughing"; PAIN (non-serious), outcome "unknown", described as "Body ache like stiffness and pain/ Intense pain in the midsection part of my body"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Body ache like stiffness and pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Problem even walking upstairs"; NAUSEA (non-serious), outcome "unknown", described as "Still have nausea pain too; I have nausea also". Therapeutic measures were taken as a result of lymphadenopathy, feeling abnormal, cough.  Additional information: The patient got the vaccination in mid Nov2023. No vaccines administered on same date with the Pfizer vaccine. Consumer stated, "I have got problem with the Pfizer, the vaccination (Clarified as Pfizer COVID-19 Vaccine) had the side effects. I have a real, like I had swollen lymph nodes then I feel, I have to get rest because I feel bad and the, so I use Motrin and Aspirin for the lymph nodes, you know the swelling but it works for that. I used Alka seltzer and it is more milder and so that worked again". Not really rashes, but coughing and body ache like stiffness and pain. He have problem even walking upstairs and that is intense pain in the midsection part of body. He still have nausea pain too. He have nausea also. For the coughing he use Aspirin and Ibuprofen, cough syrup and  also cough drop and for swollen lymph nodes he use Motrin and aspirin, sometimes Tylenol if not feeling too good. All the above medication helped.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Swollen lymph nodes; Feel bad/ not feeling too good; Coughing; Body ache like stiffness and pain/ Intense pain in the midsection part of my body; Body ache like stiffness and pain; Problem even walking upstairs; Still have nausea pain too; I have nausea also; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "nerve pain in your left foot" (unspecified if ongoing), notes: diabetes causes this nerve pain in foot. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GABAPENTIN taken for neuralgia. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "Feel bad/ not feeling too good"; COUGH (non-serious), outcome "recovering", described as "Coughing"; PAIN (non-serious), outcome "unknown", described as "Body ache like stiffness and pain/ Intense pain in the midsection part of my body"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Body ache like stiffness and pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Problem even walking upstairs"; NAUSEA (non-serious), outcome "unknown", described as "Still have nausea pain too; I have nausea also". Therapeutic measures were taken as a result of lymphadenopathy, feeling abnormal, cough.  Additional information: The patient got the vaccination in mid Nov2023. No vaccines administered on same date with the Pfizer vaccine. Consumer stated, "I have got problem with the Pfizer, the vaccination (Clarified as Pfizer COVID-19 Vaccine) had the side effects. I have a real, like I had swollen lymph nodes then I feel, I have to get rest because I feel bad and the, so I use Motrin and Aspirin for the lymph nodes, you know the swelling but it works for that. I used Alka seltzer and it is more milder and so that worked again". Not really rashes, but coughing and body ache like stiffness and pain. He have problem even walking upstairs and that is intense pain in the midsection part of body. He still have nausea pain too. He have nausea also. For the coughing he use Aspirin and Ibuprofen, cough syrup and  also cough drop and for swollen lymph nodes he use Motrin and aspirin, sometimes Tylenol if not feeling too good. All the above medication helped.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Neck pain, Pain in extremity
Clinical narrative: the left side by her breast area the tissue feels kind of achy; pain on her neck area or achenes; my left hand is kind of like achy too but that was not injection site , just the arm itself , it's a little bit achy; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Adrenal adenoma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; VITAMIN D 2000; FAMOTIDINE; MIRTAZAPINE; FLUOXETINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Sep2024 at 14:00, outcome "not recovered", described as "my left hand is kind of like achy too but that was not injection site , just the arm itself , it's a little bit achy"; NECK PAIN (non-serious) with onset 24Sep2024 at 14:00, outcome "not recovered", described as "pain on her neck area or achenes"; BREAST PAIN (non-serious) with onset 24Sep2024 at 14:00, outcome "not recovered", described as "the left side by her breast area the tissue feels kind of achy". Therapeutic measures were taken as a result of breast pain, neck pain, pain in extremity.  Additional information: The patient took two times 325 mg of acetaminophen (TYLENOL) on 24Sep2024 and symptoms went away. On 25Sep2024 took acetaminophen again but the symptoms did not go away.   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: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2024, outcome "recovered" (Sep2024), described as "Arm pain". It was unknown if therapeutic measures were taken as a result of pain in extremity.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Arm soreness; fatigue; headache; chills; This is a spontaneous report received from a Physician.  A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Dilantin, reaction(s): "Allergies: Dilantin". The following information was reported: MYALGIA (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024), described as "Arm soreness"; CHILLS (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024); FATIGUE (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024); HEADACHE (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024). Therapeutic measures were taken as a result of myalgia, fatigue, headache, chills. Clinical course: Patient experienced rm soreness, fatigue, headache, chills for 36 hours after vaccination Patient has not received any other vaccine on the same date nor four weeks. Patient has received treatment with Ibuprofen. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Pain at the injection site; Generalized muscle pain; Fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2024 at 08:30 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 25Sep2024 as dose 1, single, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; SERTRALINE; FENOFIBRATE. The following information was reported: FATIGUE (non-serious) with onset 26Sep2024 at 03:00, outcome "recovering"; MYALGIA (non-serious) with onset 26Sep2024 at 03:00, outcome "recovering", described as "Generalized muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 26Sep2024 at 03:00, outcome "recovering", described as "Pain at the injection site". Therapeutic measures were taken as a result of vaccination site pain, myalgia, fatigue.  Additional information: treatment received for the adverse events included Advil.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: low grade fever; Chills; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 at 17:15 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: ACETAMINOPHEN oral taken for arthritis; IBUPROFEN oral taken for arthritis. The following information was reported: CHILLS (non-serious) with onset 24Sep2024, outcome "recovered" (25Sep2024); PYREXIA (non-serious) with onset 24Sep2024, outcome "unknown", described as "low grade fever". Therapeutic measures were taken as a result of pyrexia. Additional information: She got a low grade fever and had tad bit of chills. Low grade fever started on 24Sep2024 in the evening. Recovered through the morning and the day  but then around 3pm on 25Sep2024 she checked her temperature and it was up not quite one degree. She takes ibuprofen. She combines the acetaminophen and the ibuprofen for her arthritis. She took acetaminophen on Monday before she got the Comirnaty covid shot.  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: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter stated he had the Pfizer COVID-19 vaccine and in Aug2024 he had Covid and took Paxlovid. He wanted to know when he should receive the last dose of the Pfizer COVID-19 vaccine.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Herpes zoster
Clinical narrative: Guillain barre syndrome; shingles; 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain barre syndrome"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: when she administered it to the patient, the vaccine sprayed over the patient with no reported adverse event; Initial information received on 30-Aug-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had experienced, when nurse administered Influenza Vaccine to the patient, the vaccine sprayed over the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Have our first problem of the flu vaccine season. On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, dose, form and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) and while administration the nursing director gave the first shot. She checked to be sure that the syringe was correctly connected but when she administered it to the patient, the vaccine sprayed over the patient with no reported adverse event (accidental exposure to product) (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.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine administered to pregnant patient (with no reported adverse event); Initial information received on 28-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 31 years old female pregnant patient who received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (with no reported adverse event).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The patient received NFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE at 26 weeks of pregnancy, during third pregnancy trimester.  The date of last menstrual period was reported as 28-Feb-2024. The estimated due date is 28-Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 28-Aug-2024, the patient received a Dose 1 of suspect NFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE, Suspension for injection (lot UT84235A) (dose, strength and expiry: unknown) (exposure during pregnancy) (latency same day) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).   At time of reporting, pregnancy is still ongoing
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: COVID-19 Pfizer mRNA vaccine 6 mo-4 yr old IM (YELLOW cap) was constituted with sterile dilute 0.3 mL instead of 1.1
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: caller states his arm was sore and developed itchy rash on stomach and spread to his chest and around back, both arms and right leg. He still has a rash after 5 weeks. He has not seen physician for medical treatment yet but has an appt next week. He has been applying OTC ointment for the rash.
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: caller states his arm was sore and developed itchy rash on stomach and spread to his chest and around back, both arms and right leg. He still has a rash after 5 weeks. He has not seen physician for medical treatment yet but has an appt next week. He has been applying OTC ointment for the rash.
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: caller states his arm was sore and developed itchy rash on stomach and spread to his chest and around back, both arms and right leg. He still has a rash after 5 weeks. He has not seen physician for medical treatment yet but has an appt next week. He has been applying OTC ointment for the rash.
Age: 64.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt received 3 immunizations at a flu clinic on 9/26/24.  He inadvertently received a 65+ high dose flu shot instead of a regular dose flu shot since he is only 64 years old.  Spoke to pt on 9/27/24 and he reported no adverse effects, felt fine, and was going about his day normally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Incorrect route of product administration, Product preparation error
Clinical narrative: Inadvertently reconstituted MMRV with the flu vaccine contents and administered subcutaneously.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called us reporting injection site reaction including swelling and redness around much of the arm, it has gotten progressively worse over the last few days
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event at this time (3 days after the second administration). Patient received two doses of the same flu vaccine a month apart.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: COVID-19 Pfizer mRNA vac tris-sucrose PF 6 mo-4 yr 0.3 ml was constiuted with 0.3 mL diluent instead of 1.1
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: PATIENT STARTED TO DEVELOP SOME SYMPTOMS ON 09/26/2024 AROUND 5 PM IN THE EVENING. PATIENT DESCRIBED IT AS SUPERFICIAL SKIN REDNESS ON LEFT ARM/HAND, PATIENT DOES NOT EXPERIENCE FEVER OR PAIN. ALTHOUGH, PATIENT CLAIMS THAT THE INJECTION SITE IS NORMAL AND CLEAR. PATIENT WAS ENCOURAGED TO SEEK MEDICAL ATTENTION AND OTC PAIN RELIEF MEDICATIONS (TYLENOL OR IBUPROFEN) IF EXPERIENCING PAIN OR IF IT PROGRESSES TO WORSENED SYMPTOMS.
Age: 71.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Lymphadenopathy, Swelling of eyelid
Clinical narrative: Patient stated she experienced swollen eyes that could not be opened and swollen lymph nodes. She presented to her physician (unclear if physician reported the event). She stated the symptoms lasted 3 days. She informed our pharmacy on 9/27/24 during a COVID vaccination appointment.
Age: 69.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient said her arm got red and swollen the size of a baseball. It is also hot to the touch and itchy.
Age: 78.0
Sex: F
Vaccine: TYP
Symptoms: Decreased appetite, Erythema, Fatigue, Hot flush, Pharyngeal erythema
Clinical narrative: once she took first capsule after going to bed she started having hot flashes every hour during the night. Her cheeks are very hot and have been this way for over 12 hours. She has no fever but is tired. She had loss of appetite next morning but now has normal appatite. She says she feels like her cheeks and front of throat are a little red and hot but no itching. Can sooth it will cool rag but it does not go away. She called insurance nurse and provided this information and was told to follow up with her doctor if it continues. Her next dose is tomorrow night.
Age: 78.0
Sex: F
Vaccine: TYP
Symptoms: Skin warm
Clinical narrative: once she took first capsule after going to bed she started having hot flashes every hour during the night. Her cheeks are very hot and have been this way for over 12 hours. She has no fever but is tired. She had loss of appetite next morning but now has normal appatite. She says she feels like her cheeks and front of throat are a little red and hot but no itching. Can sooth it will cool rag but it does not go away. She called insurance nurse and provided this information and was told to follow up with her doctor if it continues. Her next dose is tomorrow night.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was wrongly administered flublok instead of fluzone by accident as she is 15 years old. No adverse events immediately after or a couple hours later when patient's mother, was called and notified of administering the wrong flu vaccine.  Manager  also notified of event.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: COVID-19 Pfizer mRNA vac tris-sucrose PF 6 mo-4 yr 0.3 ml was constituted with 0.3 mL diluent instead of 1.1
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Food aversion, Gait disturbance
Clinical narrative: 11pm, upset stomach loss of appetite. sometime overnight, felt like had seizure (post-ictal symptoms) no bed wetting or lip biting.    Taste aversion, loss of appetitie, fatigue  continuing friday 9/20 and saturday 9/21.  appetite returned after ;7 days. leg weakness since sunday 9/22-9/27 unstable gait.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Postictal state
Clinical narrative: 11pm, upset stomach loss of appetite. sometime overnight, felt like had seizure (post-ictal symptoms) no bed wetting or lip biting.    Taste aversion, loss of appetitie, fatigue  continuing friday 9/20 and saturday 9/21.  appetite returned after ;7 days. leg weakness since sunday 9/22-9/27 unstable gait.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient had a syncope episode within 1-2 minutes of receiving the 3 vaccines.  He did not fall and regained consciousness within 30 seconds.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient called into the office and left a VM stating that she is experiencing  the following to injection site area; redness, hot to touch, rash.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: After getting vaccine, same day around evening  patient started to have swelling and pain and still has bad swelling with pain
Age: 78.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Confusional state, Memory impairment
Clinical narrative: Patient states that after receiving the vaccination and leaving the facility, her memory was foggy. She stated that she could not remember where she parked her car. Then she went to the gas station, she thought she was in another town and didn't even get out of the vehicle.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Needle issue, Product administration error
Clinical narrative: Vaccine administration error: These two vaccines were given with a SQ needle instead of the proper 1'' inch needle by reporter (RPh).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: pt states she had a 5 inch red, swollen patch one day after getting vaccinated. pt can still move arm
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Quarter size knot at injection site, about a 3 inch red circle around injection site, and warm to touch.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Asthma, Chest X-ray, Condition aggravated, Fatigue, Heart rate
Clinical narrative: Per pt report she started feeling unwell and experiencing fatigue and asthma symptoms on 9/23/24, then on 9/24-9/25/24 pt had a self-reported low-grade fever, by 9/26 pt went to urgent care because she was feeling worse and felt like her asthma-like symptoms were getting worse. At urgent care they stated she had a fever of 100.3, heart rate of 122, and O2 at 92 and she was sent to the ER. The ER on 9/26 determined pt had pneumonia. Pt believes this was due to the RSV shot even though it did not appear as if the provider who treated her stated this. The pt stated that she is an NP and was not around anyone that was ill but had recently stopped taking her cetirizine and montelukast. The pt was started on antibiotics and asthma treatments on 9/27/24 and is now resting at home.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Laboratory test, Malaise, Pneumonia, Pyrexia
Clinical narrative: Per pt report she started feeling unwell and experiencing fatigue and asthma symptoms on 9/23/24, then on 9/24-9/25/24 pt had a self-reported low-grade fever, by 9/26 pt went to urgent care because she was feeling worse and felt like her asthma-like symptoms were getting worse. At urgent care they stated she had a fever of 100.3, heart rate of 122, and O2 at 92 and she was sent to the ER. The ER on 9/26 determined pt had pneumonia. Pt believes this was due to the RSV shot even though it did not appear as if the provider who treated her stated this. The pt stated that she is an NP and was not around anyone that was ill but had recently stopped taking her cetirizine and montelukast. The pt was started on antibiotics and asthma treatments on 9/27/24 and is now resting at home.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Immediate swelling and pain when Covid shot given.  Patient did not get dizzy or lightheaded, just pain in the injection area and puffed up like a hematoma at the injection site, plus bleeding. Pressure on area helped. Gave 75mg liquid diphenhydramine and ibuprofen 600mg.  Patient stayed 20 minutes and was feeling better when he left and will follow up 9-28 to see how he is doing.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Left ear tinnitus - no treatment. Constant ringing in the ear.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient is not having any true ADRs yet. Patient was injected with two doses of the same vaccination this year. She took two doses of the Flucelvax of the 2025-2025 dose on 09/04/2024 and 09/26/2024 as patient requested to have the dose on 09/26 not remembering that she already had gotten the vaccine earlier on 09/04/2024.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: red, hot, itchy, tender                   Benadryl                   no change
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a second seasonal flu shot. Pt denied any s/s or adverse reactions.
Age: 1.0
Sex: M
Vaccine: PNC15
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling 1 day after the vaccination.  Observed at home with no treatment or need for referral to urgent care or emergency room.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Swelling face
Clinical narrative: Patient received vaccination around 4:32PM.  Patient called around 6:20PM to report her jaw was swollen. Recommended she go to urgent care to have it checked out.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gastrointestinal disorder, Headache, Hyperhidrosis
Clinical narrative: Headache, chills, fever, sweating, stomach issues, heart racing, heart palpitations, dizziness
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Headache, chills, fever, sweating, stomach issues, heart racing, heart palpitations, dizziness
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fall, Haemorrhage, Head injury, Loss of consciousness
Clinical narrative: After vaccine administration, patient exited the vaccine room and reported feeling dizzy & unwell after a few moments. Patient lost consciousness a few seconds later, falling to the floor and suffering a bleeding head wound.  Patient regained consciousness approximately 5-10 later. EMS was on the scene evaluating the patient within 10 minutes. Patient walked off the scene under her own power, and was in good spirits as she left. Her partner drove her to the ER for further evaluation.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise
Clinical narrative: After vaccine administration, patient exited the vaccine room and reported feeling dizzy & unwell after a few moments. Patient lost consciousness a few seconds later, falling to the floor and suffering a bleeding head wound.  Patient regained consciousness approximately 5-10 later. EMS was on the scene evaluating the patient within 10 minutes. Patient walked off the scene under her own power, and was in good spirits as she left. Her partner drove her to the ER for further evaluation.
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Deafness, Dizziness, Nausea
Clinical narrative: The patient had a scheduled appointment for two vaccines (Covid-19 vaccine and Flu shot). She came to the pharmacy along with her parents who also came for the same vaccinations as well. The patient and patient's mother alongside said the patient would like to get both vaccines on the left arm since before she had them and felt fine. After the vaccines were received, a few minutes later the patient stated she was feeling dizzy, lightheaded, felt as if she was not able to hear anything, and started to feel nauseous at the same time. The mother called for help since she felt as if the patient was having a seizure and foam coming out of the mouth. The patient felt as it was her own spit instead of foam. The pharmacist called 911 for help immediately. EMS came and assessed patient, and EMS left without taking patient.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Extreme fatigue, muscle and joint pain, fever
Age: 36.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dyspnoea, Nausea
Clinical narrative: Administered MMR, Varivax, and Fluzone Trivalent within one minute. About 2 minutes later patient reported feeling nauseous and shortness of breath. I Placed an ice pack on upper back. 4 to 5 minutes later there was little improvement, so 911 was called, and an epinephrine pen made ready.  Paramedics arrived about 6 minutes later, and took patient outside to ambulance for observation.  To be best of my knowledge no further care was administered, and paramedics released the patient about 20 minutes later.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: patient was unaware she made appointment for moderna vaccine at this pharmacy. I only carry moderna or novavax I always make it a point to verbally state to all patient getting covid vaccine that they are receiving "new covid booster moderna" which I stated to her. She was on her cell phone during our vaccine encounter and may not have heard me. She called on 9/27/24 and stated she wanted pfizer vaccine and she was feeling sick from receiving the moderna vaccine. she was upset that I did not verify with her that she was getting moderna rather than pfizer. I apologize and notified her that i will report to vaers that she is feeling sick from getting the moderna spikevax 2024-2025 covid vaccine
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Patient had a rash at the injection site that turned into a rash that covered her entire body from face/neck to feet. Her trunk and between the legs were reported as being the worst. She was prescribed a oral steroid and zyrtec. The rash was still visible when she came in to report it to me on 9/27/24.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: THE PT IS LESS THAN 65 Y.O. HOWEVER, SHE WAS MISTAKENLY ADMINISTERED FLUZONE HD. THE PT STAYED AT THE PLACE OF THE CLINIC FOR ONE FULL HOUR WITHOUT REPORTING ANY SIDE EFFECTS.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Electrocardiogram normal, Fall, Gait disturbance
Clinical narrative: Patient was on the way out after receiving vaccines, she felt dizzy. she squatted down for minutes, when she tried to stand up, she fell. Staff let her sit on the floor and 911 was called. when EMT came, patient stated she be ok, and refused transport. EMT stated that they did check her EKG, everything is with in normal limit.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Fatigue, Induration, Injection site erythema, Injection site paraesthesia, Injection site warmth
Clinical narrative: Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 9/26/24
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 9/26/24
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia
Clinical narrative: Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 9/26/24
Age: 58.0
Sex: F
Vaccine: FLU3, PNC20, PNC20, UNK
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Left arm soreness and felt firm after injection was given. next day noted redness and warmth around injection site. Feels tingling in upper arm to elbow. Feels fatigue, fever 100 on 9/26/24
Age: 0.83
Sex: F
Vaccine: DTAP, IPV, PNC20
Symptoms: Vomiting
Clinical narrative: Vomiting onset day 2 after vaccines, lasting for 2-3 hours.
Age: 49.0
Sex: F
Vaccine: FLUC4, PNC20
Symptoms: Rash
Clinical narrative: PATIENT SAID SHE DEVELOPED A RASH AND HAS BEEN SELF - TREATING WITH DIPHENHYDRAMINE TABLETS