chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache; Muscle ache; Low-grade temperature/fever up to 101.4 F; fatigued; bone aches; Arm was sore; joints were sore; Body ache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "COPD" (ongoing). Concomitant medication(s) included: ADVAIR taken for chronic obstructive pulmonary disease; SPIRIVA [TIOTROPIUM BROMIDE MONOHYDRATE] taken for chronic obstructive pulmonary disease; PROAIR HFA. The following information was reported: HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "Muscle ache"; PYREXIA (non-serious), outcome "recovered", described as "Low-grade temperature/fever up to 101.4 F"; FATIGUE (non-serious), outcome "recovered", described as "fatigued"; BONE PAIN (non-serious), outcome "recovered", described as "bone aches"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm was sore"; ARTHRALGIA (non-serious), outcome "recovered", described as "joints were sore"; PAIN (non-serious), outcome "recovered", described as "Body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, myalgia, pyrexia, fatigue, bone pain, pain in extremity, arthralgia, pain.  Additional information: The patient had a very strong reaction to the Pfizer RSV vaccine consistent of fever up to 101.4 F for three days, bone aches, muscle ache, fatigue, very strong headache, vey fatigued and, a low-grade temperature. Her symptoms lasted for two weeks. The caller asks if she should get the RSV vaccine again. The patient believed the route of administration was intramuscular because her arm was sore, joints were sore. No other investigations. Took Codeine aspirin as treatment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Limb discomfort, Lymphadenopathy
Clinical narrative: Systemic reaction in your upper arm in lymph nodes; Systemic reaction in your upper arm in lymph nodes; Systemic reaction in your upper arm in lymph nodes; This is a spontaneous report received from an Other HCP from a sales representative.  A 60-year-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for pneumococcal immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), LIMB DISCOMFORT (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "Systemic reaction in your upper arm in lymph nodes". Therapeutic measures were taken as a result of hypersensitivity, limb discomfort, lymphadenopathy.  Clinical information: No other vaccine same date. No other vaccine in four weeks. Unknown if other medications in two weeks. Therapy of events included Steroids/antibiotic.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea at rest
Clinical narrative: have difficulty in breathing while he is asleep; he is having a heart issue; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 26-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA AT REST (medically significant), outcome "unknown", described as "have difficulty in breathing while he is asleep"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "he is having a heart issue". Clinical course: Patient was reporting his experience with the Pfizer Vaccine. He mentioned that when he was 24, he received the vaccine shot and now that he was 26, he was having a heart issue and have difficulty in breathing while he was asleep and he wanted to know if how many people have reported the same adverse events.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: hg4436), administration date: 12Oct2022, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: fk9895), administration date: 07Apr2022, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: ff2590), administration date: 08Oct2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: en6205), administration date: 07Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: el9267), administration date: 13Feb2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 11Feb2024 to 16Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: I was diagnosed with transverse myelitis after 3 doses of the mRNA COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "I was diagnosed with transverse myelitis after 3 doses of the mRNA COVID-19 vaccine".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures included Paxlovid from 04Feb2024 to 09Feb2024 were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "environmental allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid treat COVID 19 from 18Feb2024 to 22Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 12:00 as dose 1, single (Lot number: HH3897) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "tested positive for COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 10Feb2024 to 14Feb2024).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400053100 Same patient, different product/event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 19Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 21Feb2024 to 26Feb2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 17Feb2024 to 22Feb2024 as COVID 19 Treatment. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a Consumer or other non HCP.  An 87-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unnown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "recovered".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my left arm; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 at 16:30 as dose 2, single (Lot number: FA7484) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, in Left arm at 14:00, Lot number: EW0217), administration date: 10Jul2021, when the patient was 51-year-old, for COVID-19 immunisation, reaction(s): "pain in my left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "unknown", described as "pain in my left arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400028705 same patient, different vaccine dose/event;US-PFIZER INC-202300452208 same patient, different vaccine dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: dizziness and numbness in my feet; dizziness and numbness in my feet; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), HYPOAESTHESIA (non-serious), outcome "not recovered" and all described as "dizziness and numbness in my feet". Additional information: The dizziness and numbness in the patient's feet continues, some days worse than others. Patient reported that this has greatly changed patient's life and cannot explain how upset was about the things patient can no longer do.  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: Cardiovascular disorder
Clinical narrative: unspecified cardiovascular disease; This is a spontaneous report received from a Pharmacist from medical information team, Program ID:.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, sngle (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: CARDIOVASCULAR DISORDER (non-serious), outcome "unknown", described as "unspecified cardiovascular disease". Additional information: A mother, her sister and her son received the Comirnaty vaccine. After this, these three patients developed an unspecified cardiovascular disease. Reporter believed it to be genetic, due to the three of them getting the same disease after vaccination. Reporter stated they did not have comorbidities, but after some time the reporter specified that the mother had postural orthostatic tachycardia syndrome.   Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: EW0169) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number ER8732), administration date: 27Mar2021, when the patient was 66-year-old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054251 same reporter/patient/drug, different doses/AE;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 3 (booster), single (Lot number: FJ9943) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number ER8732), administration date: 27Mar2021, when the patient was 66-year-old, for COVID-19 immunisation, reaction(s): "pain"; BNT162b2 (Dose 2, single, lot number EW0169), administration date: 17Apr2021, when the patient was 66-year-old, for COVID-19 immunisation, reaction(s): "pain". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054251 same reporter/patient/drug, different doses/AE;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she had was just a little soreness; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: CJ2524) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 16Sep2022. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (1st dose, LOT: ER8732), administration date: 27Mar2021, for COVID-19 immunisation, reaction(s): "pain"; BNT162b2 (2nd dose, LOT: EW0169), administration date: 17Apr2021, for COVID-19 immunisation, reaction(s): "pain"; BNT162b2 (3rd dose, LOT: FJ9943, Anatomical Site of injection: right arm), administration date: 30Jun2022, for COVID-19 immunisation, reaction(s): "pain". The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "she had was just a little soreness".  Additional information: No more than the medication she has been taking for a long time. She took low dose blood pressure pill, she took medicine for asthma. Other than that, she took vitamins.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054251 same reporter/patient/drug, different doses/AE;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she had was just a little soreness; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: 081-634) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (1st dose, LOT: ER8732), administration date: 27Mar2021, for COVID-19 Immunization, reaction(s): "pain"; BNT162b2 (2nd dose, LOT: EW0169), administration date: 17Apr2021, for COVID-19 Immunization, reaction(s): "pain"; BNT162b2 (3rd dose, LOT: FJ9943, Anatomical Site of injection: right arm), administration date: 30Jun2022, for COVID-19 Immunization, reaction(s): "pain"; BNT162b2 (4th dose, LOT: CJ2524, Anatomical Site of injection: right arm), administration date: 16Sep2022, for COVID-19 Immunization, reaction(s): "pain"; influenza vaccine (Anatomical Site of injection: right arm), administration date: 16Sep2022, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "she had was just a little soreness".  Additional information: No more than the medication she has been taking for a long time. She took low dose blood pressure pill, she took medicine for asthma. Other than that, she took vitamins.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: pulse from 50 to 72 2/20 morning and 138 2/21 morning; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Feb2024 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: HEART RATE INCREASED (non-serious) with onset 20Feb2024, outcome "unknown", described as "pulse from 50 to 72 2/20 morning and 138 2/21 morning". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that just noting side effect. Got the 2023-24 shot 2/19 afternoon, pulse from 50 to 72 2/20 morning and 138 2/21 morning, down to 65 2/21 afternoon.  Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: Drug interaction; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2021SA122907 (Sanofi).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; dupilumab (DUPIXENT), on 10Oct2017 as 600 mg 1 x subcutaneous) subcutaneous, as 300 mg every other week) and on 07Apr2021) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown". The action taken for dupilumab was temporarily withdrawn.  Clinical course: it was reported that doctor informed patient that the Dupixent may have interfered with the COVID vaccine, while she was treated with Dupilumab (Dupixent) via medical device pre-filled syringe and COVID-19 vaccine. On 10Oct2017, the patient started taking Dupilumab solution of strength 150 mg/ml at a loading dose of 600 mg 1 X subcutaneous (with an unknown batch number) followed by maintenance dose of 300 mg every other week of Atopic Dermatitis, Unspecified delivered via pre-filled syringe. On 06Apr2021, the patient started taking Covid-19 vaccine dosage unknown (with an unknown batch number). The patient reported that she received her initial Pfizer Covid vaccine on 06Apr2021 then she took a dose of Dupixent on 07Apr2021. The doctor informed her that the Dupixent may have interfered with the Covid vaccine (drug interaction) (Latency: 3 years 5 months 19 days) and instructed her to hold off her Dupixent for 2 weeks after her second covid vaccine dose. The patient said she would be holding off Dupixent for a total of 6 weeks. The patients next covid vaccine dose is schedule on 02May2021. Dupixent is on hold. The patient's delivery was delayed due to weather and another shipment cannot be delivered until outside the 7 day window for her dose and advised her to skip that dose and continue on her regular dosing schedule.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Diabetic ketoacidosis, Dyspnoea, Fatigue, Glycosylated haemoglobin increased
Clinical narrative: I RECEIVED THE COVID VACCINATION. I BEGAN TO FEEL SHORT OF BREATH AND FATIGUED BUT DID NOT GO TO THE DOCTOR RIGHT AWAY. AFTER A FEW WEEKS, I SAW A CARDIOLOGIST WHO FOUND NOTHING WRONG WITH MY HEART. IN MARCH, I SAW MY PCP. MY BLOOD SUGAR WAS 400 AND A1C WAS 15. SHE GAVE MY ZIGDUO , WHICH MADE ME FEEL WORSE.  I WENT TO MY ENDO CRINOLOGIST WHO SENT ME TO THE ER. I WAS ADMITTED , IN DIABETIC KETOACIDOSIS.  I HAD NEVER HAD TROUBLE WITH MY BLOOD SUGARS UNTIL TAKING THE COVID VACCINATION. NOW I AM A TYPE 1 DIABETIC ON INSULIN. I BELIEVE THIS IS BECAUSE OF THE COVID VACCINATION.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: I RECEIVED THE COVID VACCINATION. I BEGAN TO FEEL SHORT OF BREATH AND FATIGUED BUT DID NOT GO TO THE DOCTOR RIGHT AWAY. AFTER A FEW WEEKS, I SAW A CARDIOLOGIST WHO FOUND NOTHING WRONG WITH MY HEART. IN MARCH, I SAW MY PCP. MY BLOOD SUGAR WAS 400 AND A1C WAS 15. SHE GAVE MY ZIGDUO , WHICH MADE ME FEEL WORSE.  I WENT TO MY ENDO CRINOLOGIST WHO SENT ME TO THE ER. I WAS ADMITTED , IN DIABETIC KETOACIDOSIS.  I HAD NEVER HAD TROUBLE WITH MY BLOOD SUGARS UNTIL TAKING THE COVID VACCINATION. NOW I AM A TYPE 1 DIABETIC ON INSULIN. I BELIEVE THIS IS BECAUSE OF THE COVID VACCINATION.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Child was here for HPV vaccine. Administered by MA without any issue. child had waited the full 20minutes and was sitting when he informed MA that he was feeling a little dizzy and nauseated. MA immediately notified myself and a provider so I went to the room where I grabbed the child who was stable but beginning to vomit. Supplied him with emesis basin, and tissues to clean up and some water to sip on. Did not faint, remained conscious the whole time, alert. Stated he had eaten but was a little nervous about the shot. VS. bp:105/70, T:98.1 p:74 R12 O2:98% Gave water to sip and had wait another 20 minutes until he felt well enough to go.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast cancer female
Clinical narrative: 3 series vaccines all given in right arm.  Cancer of the right breast diagnosed on 01/05/2023
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin discolouration
Clinical narrative: Patient reported full body rash days after receiving vaccine. Very itchy and left marks after days.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Muscle rigidity, Pallor, Posture abnormal, Seizure
Clinical narrative: Patient had been waiting after vaccine for about 5 minutes, stated didn't feel well. Pt then became pale, slouched, and became rigid; she appeared to be seizing for about 1 minute. Pharmacy called EMS who arrived as pt was recovering and was talking as her skin color returned to normal.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PATIENTS HAND IS SWOLLEN AND PAIN
Age: 28.0
Sex: F
Vaccine: COVID19, FLU4, PNC20
Symptoms: Condition aggravated, Dysarthria, Excessive eye blinking, Loss of consciousness, Seizure
Clinical narrative: Patient got 3 vaccines, Spikevax 12+, Fluarix, and Prevnar 20. Patient has a history of seizure, asthma and bronchitis. I suggested her to sit in lobby for at least 15 minutes. After 10 minutes, she walked to cash register and talked with my technician. Patient started slurry speech and blinking her eyes. I rushed to her and the moment I got to her, she started losing consciousness. I held her. My technicians helped me to guide her to correct position on floor to prevent from choking on her own vomiting if she had any (she did not vomit). Other technician called EMS. We called her aunt per her request. She got in and out of seizures. She was awake when the emergency team arrived. I contacted the store's liability line and they said that they would follow up with patient. I turned in the report to my company.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Skin discolouration, Vitiligo
Clinical narrative: She finished her second dose of COVID vaccine on 01/07/2022. In March' 22, we noticed her facial skin showing redness and white patches. She was diagnosed with Vitiligo in April' 22. she has been on treatment ever since. She used hydrocortisone ointment, tacrolimus ointment and opzelura. She still is battling with vitiligo which was triggered by COVID vaccine as there is no family history of vitiligo in family.
Age: 1.5
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient's mom was notified of incorrect immunization by Dr.
Age: 38.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had no adverse reaction.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Breakthrough COVID-19, Drug ineffective
Clinical narrative: I've always had my flu shots and Covid shots with Pfizer/I've made it 3 years before getting Covid; I've always had my flu shots and Covid shots with Pfizer/I've made it 3 years before getting Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've always had my flu shots and Covid shots with Pfizer/I've made it 3 years before getting Covid". Clinical course: the patient reported that this was his second time with COVID, and he had taken nirmatrelvir; ritonavir before. The patient had nirmatrelvir; ritonavir the last time he had COVID and "it really worked and why would he change what worked." The patient said he was prescribed nirmatrelvir; ritonavir again. The patient also noted that he always had his flu shots and Covid shots with Pfizer and never had a bad reaction and it seemed to work. The patient then stated, "I've made it three years before getting COVID, so it works." Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, RSV, COVID19-2, RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pain
Clinical narrative: Rash to right arm-COVID and RSV side. Rash to bilateral cheeks.
Age: 63.0
Sex: M
Vaccine: COVID19, RSV, COVID19-2, RSV
Symptoms: Rash
Clinical narrative: Rash to right arm-COVID and RSV side. Rash to bilateral cheeks.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old patient received BNT162b2 (BNT162B2), on 21Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in arm, on 14Mar2021 at 09:00 as dose 2, single (Lot number: EN208), in arm, on 16Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FA7485), in arm and on 07Feb2022 as dose 4 (booster), single (Lot number: FM0698), in arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis", start date: 2009 (ongoing), notes: Tried Ilumya, Now trying Skyrizi; "Psoriatic Arthritis", start date: 2009 (ongoing), notes: Tried Ilumya, Now trying Skyrizi. Concomitant medication(s) included: SKYRIZI [RISANKIZUMAB] taken for psoriasis, psoriatic arthropathy. Past drug history included: Ilumya for Psoriasis; Ilumya for Psoriatic Arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2022) Positive. Patient had the first and second dose at a shot clinic; and 4th dose (booster) was administered at pharmacy or drug store. Patient mentioned that even though had Covid 3 times, patient was alive with no long term side effects so far. Paxlovid helped greatly, but as a senior on social security the price was terrible. Patient mentioned the first time entire family got Covid. Patient was the last do test positive, no one felt very ill, no side effects.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in my left arm; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 10Jul2021 at 14:00 as dose 1, single (Lot number: EW0217) at the age of 51 years, 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 PAIN (non-serious) with onset Jul2021, outcome "unknown", described as "pain in my left arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400053934 same patient, different vaccine dose/event;US-PFIZER INC-202300452208 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: she was later diagnosed with arthritis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024NVX-US-000000266 (Novavax).  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "she was later diagnosed with arthritis". Additional information: an immunocompromised patient started treatment on an unreported date (the patient could not remember as "it had been months") with Pfizer BioNTech COVID-19 vaccine dose 1 for COVID-19 vaccination. It was reported the patient woke up 2 weeks after vaccination and her hands and feet hurt. On an unspecified date, she was later diagnosed with arthritis. It was reported her doctor said that "maybe the shot woke up some immune issues [she] had."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to patient was administered with only the diluent of acthib with no reported adverse event; Initial information received on 22-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2024SA063592 and 2024SA063578.  This case involves Child female patient (unknown age) who was administered with only the diluent of and no active ingredient of Hib (Prp/T) Vaccine [Act-Hib] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in November 2023, the patient received 0.5 ml, with only the diluent and no active ingredient of suspect Hib (Prp/T) Vaccine (Powder and solvent for solution for injection) (lot UJ835AA, expiry date 22-FEB-2024; strength, route, administration site not reported) for immunization with no reported adverse event (product preparation error) (latency: same day).  It was reported that "they got the last 4 doses of the vaccine and she has two vaccines left from that box and one vaccine in the box doesn't have a diluent to match it. So, she suspects that of the 4 doses given, one was given with only the diluent, she said they found out about this by doing an inventory. They are not sure which of the patients got only a diluent. she said that they wanted to let the last 4 patients know that they were possibly administered with only the diluent".  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: medication error due to inappropriate use due to patient was administered with only the diluent with no reported adverse event; Initial information received on 22-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2024SA063578 (CLUSTER) and 2024SA063592(CLUSTER).  This case involves a 1 years old female patient who was administered with only the diluent and no active ingredient of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknowdate in Dec-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ835AA) (expiry date:22-FEB-2024) (strength was not reported) via unknown route in unknown administration site for Immunization vaccine with no reported adverse event (product preparation error) (latency:same day).   It was reported "that they had one box with 5 doses of ACTHIB vaccine and Now she has two vaccines left from that box and one vaccine in the box doesn't have a diluent to match it. So, she suspects that of the 4 doses given, one was given with only the diluent"  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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB administered to a 15-month old patient but it was diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event.; Initial information received on 22-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who administered Haemophilus Type B (HIB) Vaccine [ ACT-HIB] which was diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid.  On 21-Feb-2024, the patient received a 0.5 ml of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (lot UJ852AB)(Expiry date: 13-Apr-2024) (Strength: Standard) via intramuscular route in the left thigh for Immunization diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event (product preparation error) (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: 19.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: mistakenly gave Ipol that expired on 15Feb2024 to a patient with no reported adverse event; Initial information received on 23-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 years old male patient who was mistakenly given IPV (VERO) [IPOL] that expired on 15-Feb-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: V1A121M; expiry date: 15-Feb-2024) (strength unknown) via unknown route in unknown administration site for Immunization.  On 22-Feb-2024 the patient was mistakenly given ipol that expired on 15-Feb-2024 to a patient with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Back pain, Chest pain, Neuralgia, Wrong product administered
Clinical narrative: nerve pains; given 0.1 mL of ipol instead of tubersol; chest pains; back pains; Initial information received on 27-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient was given 0.1 ml of IPV (VERO)[Ipol] instead of Tubersol  experienced chest pains, back pains, nerve pains.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received 0.1 ml  dose of suspect IPV (VERO) (Suspension for injection) (lot W1A101M) (expiry date:10-Feb-2025) via intradermal route in the right forearm for Immunization instead of Tubersol (wrong product administered) (latency: same day)  On 26-Feb-2024 the patient developed chest pains (chest pain) and back pains (back pain) (Latency: same day)   On 27-Feb-2024 the patient developed nerve pains (neuralgia) (latency: 1 day)   Action taken: Not applicable.  It was not reported that the patient received a corrective treatment for the events (chest pains, back pains, nerve pains).  At time of reporting, the outcome was Unknown for all the events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: Pprom on Monday morning at 35 weeks. My daughter also pprom at 34 weeks two days after tdap vaccine. Odd that both of my children were preemies due to pprom 1-2 days after tdap vaccine. Most recent pregnancy was seeing high risk mfm as well as obgyn- was having healthy normal pregnancy.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Fall
Clinical narrative: Was unable to stand up without help. Was unable to sit down  without falling down.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events. Incorrect vaccine given in error. HepA was given instead of Hib.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Brain fog, COVID-19, Cough, Dizziness, Glycosylated haemoglobin increased
Clinical narrative: Developed dizziness, positional vertigo & brain fog 1/30/24 in am & also COVID -19 positive in the evening of the same day. Symptoms were pretty worse first week.  Continue to have the dizziness & positional vertigo, intermittent, not with each chage in postion, at random. I am assuming it could be related to he vaccine. Since 10 days prior COVID -19 +, I had mild nasal congestion & mild/minimal dry cough and tested several times in the clinic ( I work as a PA- C in Urggent Care) and tested 3 times negative.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Nasal congestion, SARS-CoV-2 test positive, Vertigo positional, Vestibular function test normal
Clinical narrative: Developed dizziness, positional vertigo & brain fog 1/30/24 in am & also COVID -19 positive in the evening of the same day. Symptoms were pretty worse first week.  Continue to have the dizziness & positional vertigo, intermittent, not with each chage in postion, at random. I am assuming it could be related to he vaccine. Since 10 days prior COVID -19 +, I had mild nasal congestion & mild/minimal dry cough and tested several times in the clinic ( I work as a PA- C in Urggent Care) and tested 3 times negative.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, body aches, severe pain at injection site. All started to happen a few hours after injection.