chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Thrombosis, Vaccination failure
Clinical narrative: COVID-19; COVID-19; got a blood clot in lower leg; 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 10Nov2023 as dose 1 (toppac), single (Lot number: HG4675) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. 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 Jan2024, outcome "unknown" and all described as "COVID-19"; THROMBOSIS (medically significant) with onset Jan2024, outcome "unknown", described as "got a blood clot in lower leg". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient got a blood clot in lower leg around the same time as the COVID, probably started a day or two after COVID and before starting the Paxlovid. Patient received Paxlovid (Lot number: GK2960) from 27Jan2024 to 31Jan2024 as treatment of COVID-19.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.   Blood clot in lower leg more likely represents an intercurrent medical condition associated with the old age patient underlying predisposition to thrombotic occurrence including thrombosis complication secondary to COVID 19.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 64.0
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 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization. The patient had no known allergy.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid from 29Jan2024 to 02Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, 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 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient had no relevant medical history. No known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2024) positive; (24Jan2024) negative; (30Jan2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 20Jan2024 to 24Jan2024. The patient tested positive for Covid on 20Jan2024 and started taking nirmatrelvir, ritonavir (PAXLOVID) the same day. The patient finished taking it on 24Jan and was testing negative and had no symptoms. Then, on 30Jan, she woke up with major congestion and a sore throat and tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: COVID-19, Vaccination failure
Clinical narrative: caught Covid even though vaccinated; caught Covid even though vaccinated; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "erosive gastritis" (unspecified if ongoing), notes: erosive gastritis; "Covid" (unspecified if ongoing), notes: not think the vaccines were out yet, when she got Covid the first time; "immune compromised" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; RSV VACCINE taken for immunisation as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single.  Concomitant products also included being treated with medicine for high cholesterol and erosive gastritis. Vaccination history included: pfizer COVID vaccine (DOSE 1, SINGLE), administration date: 12Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 2, SINGLE), administration date: 09Mar2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 23Aug2021, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 18Apr2022, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 5 (BOOSTER), SINGLE), administration date: 03Dec2022, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 6 (BOOSTER), SINGLE), administration date: 15May2023, when the patient was 75-year-old, 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 "caught Covid even though vaccinated". This time, the patient really did not know where she got it, must have been from the market. These days, with Covid being so dangerous, and her being immune compromised, rarely goes out or leaves apartment.  She did go out last Wednesday and again with helper, Friday, became very fatigued (2024). The patient was just prescribed the Paxlovid and did not have the medication.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: COVID-19
Clinical narrative: caught Covid even though vaccinated; caught Covid even though vaccinated; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "erosive gastritis" (unspecified if ongoing), notes: erosive gastritis; "Covid" (unspecified if ongoing), notes: not think the vaccines were out yet, when she got Covid the first time; "immune compromised" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; RSV VACCINE taken for immunisation as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single.  Concomitant products also included being treated with medicine for high cholesterol and erosive gastritis. Vaccination history included: pfizer COVID vaccine (DOSE 1, SINGLE), administration date: 12Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 2, SINGLE), administration date: 09Mar2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 23Aug2021, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 18Apr2022, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 5 (BOOSTER), SINGLE), administration date: 03Dec2022, when the patient was 75-year-old, for COVID-19 Immunization; pfizer COVID vaccine (DOSE 6 (BOOSTER), SINGLE), administration date: 15May2023, when the patient was 75-year-old, 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 "caught Covid even though vaccinated". This time, the patient really did not know where she got it, must have been from the market. These days, with Covid being so dangerous, and her being immune compromised, rarely goes out or leaves apartment.  She did go out last Wednesday and again with helper, Friday, became very fatigued (2024). The patient was just prescribed the Paxlovid and did not have the medication.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (dose 5 (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 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: took 2 antigen tests hours apart. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient took Paxlovid for 4 days straight. He felt better. He stayed isolated till he was negative on test. The patient took 2 antigen tests hours apart and was negative.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Contusion, Interchange of vaccine products
Clinical narrative: one moderna vaccine and 1 Pfizer vaccine; had a bruise for 3 weeks; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-744033 (MODERNA), US-MODERNATX-MOC20231005000063 (MODERNA).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 7, single (Batch/Lot number: unknown) for covid-19 immunisation; andusomeran (SPIKEVAX XBB.1.5), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Dose 1), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 2), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 3), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 4), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 5), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 6), for COVID-19 immunization. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "had a bruise for 3 weeks"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "one moderna vaccine and 1 Pfizer vaccine".  Additional information: The patient had received one Moderna vaccine and 1 Pfizer vaccine. Has about the same side effects with both. It was reported that the patient has received 7 Pfizer COVID-19 vaccines. He got a flu shot 1 month ago and had a bruise for 3 weeks following that.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19, Felt Sick, Tired; COVID 19, Felt Sick, Tired; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MODERNATX-MOC20231129000075 (MODERNA).  A 76-year-old female patient received BNT162b2 (COMIRNATY), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) 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 09Oct2023, outcome "recovered" (16Oct2023) and all described as "COVID 19, Felt Sick, Tired". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 2 home tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has had 3-4 doses with the most recent dose in OCT2022 (Pfizer). Never had a reaction until contracted COVID-19 from 09OCT2023 until 16OCT2023. The patient took Paxlovid. Felt sick, tired, under the weather. The patient did not have a fever. The patient had 2 home tests that were positive for COVID-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: I was preparing Abrysvo for injection and the glass syringe broke; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HP1193, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "I was preparing Abrysvo for injection and the glass syringe broke". Additional information: the pharmacist experienced an issue with Abrysvo, while preparing for injection and the glass syringe broke. The pharmacist is requesting for replacement.    Causality for "i was preparing abrysvo for injection and the glass syringe broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 84 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2022 as dose 4 (booster), single (Lot number: FK9895) intramuscular, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3302) intramuscular, in arm, on 07Feb2021 as dose 2, single (Lot number: EL9261) intramuscular, in arm and on 20Sep2021 as dose 3 (booster), single (Lot number: FF8839), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL oral taken for hypertension, start date: 1998 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2023) Positive, notes: Test: Home test; (07Sep2023) Negative, notes: After 5 days of Paxlovid; (08Sep2023) Positive, notes: Rebound; (15Sep2023) Positive, notes: Rebound continues; (17Sep2023) Negative, notes: Symptoms abate. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient's COVID infection and her Paxlovid dosage and her "rebound" experiences were basically identical with her husband own. She was 3 years younger than her husband.
Sex: U
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy, Graves' disease, Parathyroid disorder, Thyroid function test, Weight
Clinical narrative: Graves' disease/ Graves; TED/ Thyroid eye disease; Parathyroid disorder/ Complications left me without functioning parathyroid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GRAVES' DISEASE (medically significant), 4 months after the suspect product(s) administration, outcome "unknown", described as "Graves' disease/ Graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), 4 months after the suspect product(s) administration, outcome "unknown", described as "TED/ Thyroid eye disease"; PARATHYROID DISORDER (medically significant), outcome "unknown", described as "Parathyroid disorder/ Complications left me without functioning parathyroid". The patient underwent the following laboratory tests and procedures: Thyroid function test: TED with Thyroid levels exceeding measurable level; Weight: Rapid loss. Therapeutic measures were taken as a result of graves' disease, endocrine ophthalmopathy. Clinical course: Shortly after the patient received the COVID vaccine, experienced rapid weight loss, shakiness, sweating, sleeplessness and Vision impairment. 4 months later, was diagnosed with Graves and TED with thyroid levels exceeding measurable levels. Eyes enlarged and loss of Vision. Had surgery 25May2023 to remove thyroid but complications left the patient without functioning parathyroid and now no thyroid.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Moderate injection site pain/ Moderate muscle pain/ Joint pain with some interference with activity/Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; Mild injection site redness; Mild injection site swelling; Moderate fever (101.3 to 102 °F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Jan2024 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: HEADACHE (non-serious) with onset 24Jan2024, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Joint pain with some interference with activity"; FATIGUE (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate fever (101.3 to 102 °F)"; VACCINATION SITE PAIN (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate injection site pain/ Moderate muscle pain/ Joint pain with some interference with activity/Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; MYALGIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Therapeutic measures were taken as a result of headache. Additional information: Events were experienced anytime during the 2 days after the vaccination, which occurred on Wednesday, Jan 24, 2024 and Thursday, Jan 25, 2024. Malaise/feeling sick not present. No nausea/vomiting present.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Moderate injection site pain/ Moderate muscle pain/ Joint pain with some interference with activity/Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; Mild injection site redness; Mild injection site swelling; Moderate fever (101.3 to 102 °F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Jan2024 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: HEADACHE (non-serious) with onset 24Jan2024, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Joint pain with some interference with activity"; FATIGUE (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 24Jan2024, outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate fever (101.3 to 102 °F)"; VACCINATION SITE PAIN (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate injection site pain/ Moderate muscle pain/ Joint pain with some interference with activity/Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; MYALGIA (non-serious) with onset 24Jan2024, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Therapeutic measures were taken as a result of headache. Additional information: Events were experienced anytime during the 2 days after the vaccination, which occurred on Wednesday, Jan 24, 2024 and Thursday, Jan 25, 2024. Malaise/feeling sick not present. No nausea/vomiting present.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  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: ARTHRALGIA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Joint pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset 25Jan2024, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 25Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)". Additional information: Events reported to have occurred on 25Jan2024 and 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  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: ARTHRALGIA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Joint pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset 25Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset 25Jan2024, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 25Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)". Additional information: Events reported to have occurred on 25Jan2024 and 26Jan2024.  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: PNC13
Symptoms: Headache
Clinical narrative: Intolerance; severe headaches; Allergies: Prevnar 13; This is a spontaneous report received from a Physician, Program ID.  A 77-year-old female patient 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: "Diabetic" (unspecified if ongoing); "Allergies: Statins-hmg-coa Reductase Inhibitors" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing); "Allergies: Natural Rubber" (unspecified if ongoing); "Allergies: Spandex" (unspecified if ongoing); "Rash" (unspecified if ongoing), notes: Latex, Natural Rubber: Rash, Avocado: Rash, Spandex: Rash; "Itching" (unspecified if ongoing), notes: Latex, Natural Rubber: Itching; "Allergies: Avocado" (unspecified if ongoing); "Avocado: Stomach pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica [pregabalin], reaction(s): "Allergies: Lyrica [pregabalin]"; Compazine [prochlorperazine edisylate], reaction(s): "Allergies: Compazine [prochlorperazine Edisylate]"; Compazine [prochlorperazine edisylate], reaction(s): "Compazine [prochlorperazine Edisylate]: Rash"; Prochlorperazine maleate, reaction(s): "Allergies: Prochlorperazine Maleate"; Prochlorperazine maleate, reaction(s): "Prochlorperazine Maleate: Rash"; Farxiga [dapagliflozin], reaction(s): "Allergies: Farxiga [dapagliflozin]"; Farxiga [dapagliflozin], reaction(s): "Farxiga [dapagliflozin]: Swelling". The following information was reported: DRUG INTOLERANCE (non-serious), outcome "unknown", described as "Intolerance"; HEADACHE (non-serious), outcome "unknown", described as "severe headaches"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergies: Prevnar 13".  Additional information: Reported that, Patient cannot have Prednisone because she is diabetic. Stated she developed severe headaches for a couple of days after taking. Wanted this added as an intolerance to this medication.  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.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Oral mucosal eruption
Clinical narrative: Oral rash; Allergies; This is a spontaneous report received from a Physician, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL MUCOSAL ERUPTION (non-serious), outcome "unknown", described as "Oral rash"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergies".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: small blisters on hands/ wrists and ankles/feet; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE (ongoing); CARVEDILOL (ongoing); TRAZODONE (ongoing); PARNATE (ongoing). Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), administration date: 2021, for COVID-19 immunisation, reaction(s): "small blisters on hands/ wrists and ankles/feet". The following information was reported: BLISTER (non-serious) with onset 07Mar2021, outcome "not recovered", described as "small blisters on hands/ wrists and ankles/feet". Therapeutic measures were not taken as a result of blister.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007619 same patient/product, different dose number/event;US-PFIZER INC-202400035655 same patient/product, different dose number/event;
Sex: U
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: woke the next morning with a loud ringing in my ears which hasn't gone away since; Initial information received from Regulatory Authority on 25-Jan-2024 regarding an unsolicited valid non-serious courtesy case received from a patient.  This case involves an unknown age and unknown gender patient who stated woke the next morning with a loud ringing in my ears which hasn't gone away since after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 29-Nov-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U8203CA) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 30-Nov-2023 the patient had an event of woke the next morning with a loud ringing in my ears which hasn't gone away since (tinnitus) (latency: 1 day) following the administration of influenza quadrival A-B vaccine.  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved for the event.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Product preparation error
Clinical narrative: did not reconstitute the ACT-HIB, and only administered the 0.4% NaCl diluent to the patient with no reported adverse event; patient is receiving his 3rd dose of Act-HIB at 9-months old/patient is a bit late to 3rd dose with no reported adverse event; Initial information received on 01-Feb-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old male patient where reporter reported that HIB (PRP/T) VACCINE [ACT-hib] did not reconstitute the act-hib, and only administered the 0.4% nacl diluent to the patient with no reported adverse event and patient is receiving his 3rd dose of act-hib at 9-months old/patient is a bit late to 3rd dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jan-2024, the patient received 0.5 ml dose 1 of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot- UJ864AB) via intramuscular route in unknown administration site (strength and expiration date: not provided) for Immunisation (product preparation error) and (inappropriate schedule of product administration) (latency- same day) (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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUC3
Symptoms: Anaphylactoid reaction, Hypersensitivity
Clinical narrative: Anaphylactic type reaction; Has severe allergies; Severe reaction; This spontaneous case was received on 31-Jan-2024 from Pfizer, Ins (reference number: 202400026253) reported by other non-healthcare professional and concerned male patient of unreported age.  The patient's medical history included medulloblastoma brain cancer. The patient's concurrent condition included unspecified thyroid condition through the radiation and growth disorder. The patient's concomitant medications included levothyroxine for unspecified thyroid condition through the radiation, homatropine for growth, Genotropin (somatropin) for unreported indication and unspecified brain cancer treatment and chemotherapy. The patient's historical vaccines included Fluzone (batch number: UI856A8) on an unspecified day in 2017, for unreported indication, after which the patient had an allergic reaction.  On an unspecified day in Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, anatomical location, route of administration and indication: not reported). The batch number reported was 370664.  On an unspecified day, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced severe allergic reaction. As reported the patient switched to Genotropin (somatropin) and had a severe allergies. It was stated that was not the pan in concern, but the medication. The patient was allergy tested with couple of options for the flu vaccine and he reacted in a such way that they gave every pen and said this was an anaphylactic type reaction and so every medication that he needs to injectable. The patient started having the reaction after he went through brain cancer treatment and chemotherapy.  The outcome of the events of anaphylactic type reaction and allergic reaction was unknown.  The reporter did not provide a causality assessment.  The event of anaphylactic type reaction was considered to be medically significant by a Physician within CSL Seqirus's Pharmacovigilance Department.  Company comment: A patient of unreported age developed anaphylactic type reaction and allergic reaction an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. More information regarding patient's diagnostic and laboratory findings is needed. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.; Sender's Comments: A patient of unreported age developed anaphylactic type reaction and allergic reaction an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. More information regarding patient's diagnostic and laboratory findings is needed. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: flu-like symptoms; painful on her right arm formed, about 1 inch under the injection site; warm on her right arm formed, about 1 inch under the injection site; red patch on her right arm formed, about 1 inch under the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of shingrix.).   On 26-JAN-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 27-JAN-2024, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), injection site pain (Verbatim: painful on her right arm formed, about 1 inch under the injection site), injection site warmth (Verbatim: warm on her right arm formed, about 1 inch under the injection site) and injection site erythema (Verbatim: red patch on her right arm formed, about 1 inch under the injection site). On 28-JAN-2024, the outcome of the influenza-like symptoms was resolved (duration 1 day). The outcome of the injection site pain, injection site warmth and injection site erythema were resolving.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2024 The patient self-reported this case for herself. The patient received her 2nd shingrix vaccine in her right arm. The patient reported that she had flu-like symptoms that started on Saturday and resolved on Sunday. The patient reported on Saturday a 2 inch by 2 inch painful, warm, red patch on her right arm formed about 1 inch under the injection site. The patient reported it seemed a little better on the day of reporting, but it had not resolved. The patient did not consented to follow up.