chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP .  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GJ3275), in right arm and on 18May2023 as dose 6 (booster), single (Lot number: GJ6796), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2023 at 11:15 as dose 7 (booster), single (Lot number: AU3921B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "breast cancer (lumpectomy, radiation)", start date: 2018 (unspecified if ongoing); "lymphedema (left arm after radiation)/lymphedema (right and left legs)" (unspecified if ongoing), notes: lymphedema (left arm after radiation)/lymphedema (right and left legs); "obesity" (unspecified if ongoing); "Severe spinal stenosis" (unspecified if ongoing), notes: Severe spinal stenosis; "torn meniscus (both knees)" (unspecified if ongoing), notes: torn meniscus (both knees). Concomitant medication(s) included: DILTIAZEM, start date: 10Dec2008; ANASTROZOLE, start date: 06Sep2018; DICLOFENAC, start date: 27Feb2004; NATURE'S BOUNTY CALCIUM WITH VITAMIN D3, start date: 14Mar2023; NORDIC NATURALS ULTIMATE OMEGA, start date: 16Feb2018; KIRKLAND SIGNATURE TRIPLE ACTION JOINT HEALTH, start date: 27Feb2004. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna, vaccine dose number=2; vaccine brand=Pfizer /BioNTech, vaccine dose number=3; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2021 as dose 1, single), in right arm, on 11May2021 as dose 2, single), in right arm and on 13Oct2023 as dose 5 (booster), single (Lot number: 3031280), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Vaccine brand other=Moderna, vaccine dose number=2; vaccine brand=Pfizer /BioNTech, vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Negative; (01Jan2024) Negative; (04Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech.; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Oct2023 as dose 6 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Apr2021; FLUOXETINE TEVA, start date: Oct2020. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Oct2023, outcome "unknown", described as "Vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Positive, notes: I tested positive again on 03Jan2024. Therapeutic measures were taken as a result of drug ineffective, covid-19.Treatment included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfamides" (unspecified if ongoing); "known allergies: Macrolides/known allergies: ketolides" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies: Cipro"; Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Dec202 to 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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. Past drug history included: Alendronate, reaction(s): "Known allergies: Alendronate". Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation; Covid-19 vaccine (Dose 2), for Covid-19 immunisation; Covid-19 vaccine (Dose 3), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received the Pfizer COVID-19 Vaccine before getting sick with COVID-19; received the Pfizer COVID-19 Vaccine before getting sick with COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "received the Pfizer COVID-19 Vaccine before getting sick with COVID-19". The event "received the pfizer covid-19 vaccine before getting sick with covid-19" required emergency room visit. 2 years ago she got sick with COVID-19 and ended in the ER because Paxlovid was not available back then.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Smear cervix, Ultrasound uterus
Clinical narrative: bleed vaginally; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have any other vaccinations within four weeks prior to administration of BNT162b2 omi xbb.1.5. Vaccination history included: COVID-19 vaccine janssen (DOSE 1), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Lot #: FF2593, Anatomical location: Left arm, Arthritis intensified more in the thumb area), administration date: 25Oct2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "affected the arthritis in her left hand"; BNT162b2 (DOSE 3 (BOOSTER), Administration time: In the morning, usually noon, Lot #: FS4989 (writing on card), Anatomical location: Probably right arm), administration date: 27Jun2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), Administration time: Sure before noon , Anatomical location: Right arm), administration date: 11Nov2022, when the patient was 70-year-old, for COVID-19 immunization; Influenza (About six weeks ago, at the end of Oct2023), administration date: Oct2023, when the patient was 71 years old, for Influenza immunisation. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 06Dec2023, outcome "recovered" (14Dec2023), described as "bleed vaginally". The patient started to bleed vaginally 24 hours after vaccination. The event lasted seven days. The event "bleed vaginally" required physician office visit. The patient went to gynecologist. The patient underwent the following laboratory tests and procedures: Smear cervix: (Dec2023) Nothing was wrong, notes: Uterus was textbook did not see anything; Ultrasound uterus: (Dec2023) Nothing was wrong, notes: Uterus was textbook did not see anything.   The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005419 Same patient and product, different dose and event;US-PFIZER INC-202400005411 Same patient and product, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Product administered to patient of inappropriate age
Clinical narrative: severely immunocompromised; I was given the incorrect vaccine. I was told that I received the children dosage of the COVID-19 Vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 04Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 04Jan2023, outcome "unknown", described as "I was given the incorrect vaccine. I was told that I received the children dosage of the COVID-19 Vaccine"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "severely immunocompromised". Therapeutic measures were taken as a result of immunodeficiency. The patient went to get the 2023-2024 Pfizer-BioNTech COVID-19 Vaccine the day before reporting day and received the phone call from the pharmacist last night saying she was given the incorrect vaccine. She was told that she received the children dosage of the COVID-19 Vaccine, and they did not understand what the options were because she needed the adult dose, the patient is an adult. The patient wanted to know what she can do now, because she was in the severely immunocompromised group of people. She had immunosuppression treatments every 7 weeks and her next one was due in 2 weeks so she was in her 2-week window, she could only get vaccines in her 2-week window because whenever she got her infusion, the immunosuppressant infusion you know it basically wipes everything out. So, then she had to wait an additional 7 weeks before she was back in that 2-week window again. 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: COVID19
Symptoms: Gastric cancer
Clinical narrative: had Stomach Cancer; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC CANCER (medically significant), outcome "unknown", described as "had Stomach Cancer". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna 23-24 dose 6 and Vaccine brand=Pfizer /BioNTech dose 5; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15May2022 at 15:00 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 at 13:00 as dose 1, single (Lot number: ER8729), in left arm, on 29Apr2021 at 12:00 as dose 2, single (Lot number: ER8735), in left arm and on 26Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Sep2023 at 17:00 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Sep2023 at 17:00, outcome "unknown", described as "vaccine brand other=Moderna 23-24 dose 6 and Vaccine brand=Pfizer /BioNTech dose 5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) very faint line, notes: Tested and the COVID line is very dark as compared to the very faint line that appeared 2 days ago; (05Jan2024) very dark, notes: Tested and the COVID line is very dark. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4  Moderna; This is a spontaneous report received from a Consumer or other non HCP .  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2023 as dose 5 (booster), single (Lot number: GJ6739) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8732), on 22Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jul2022 as dose 4 (booster), single (Lot number: 0141322A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Jul2022, outcome "unknown", described as "Dose Number: 4  Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative initially; (03Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from  26Dec2023 to 30Dec2023..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 025L20A), in right arm, on 13Feb2021 as dose 2, single (Lot number: 013W20A), in left arm, on 14May2022 as dose 3 (booster), single (Lot number: 004M21A), in left arm and on 22Sep2023 as dose 5 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "squamous cell carcinoma of skin" (unspecified if ongoing); "supraventricular tachycardia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: egg yolk" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, stop date: 28Dec2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (04Jan2024) very light positivity, notes: I retested on 04Jan and had a very light positivity; (05Jan2024) strongly positive, notes: more than the original positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna: 24Oct2023/ vaccine brand: Pfizer / BioNTech: 23Oct2022; This is a spontaneous report received from a Physician from product quality group.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), on 07Jan2021 as dose 2, single (Lot number: EL1283) and on 13Oct2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2023 as dose 5 (booster), single (Lot number: 3031633), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "hx of skin cancer" (unspecified if ongoing), notes: history of skin cancer. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2023, outcome "unknown", described as "vaccine brand other: Moderna: 24Oct2023/ vaccine brand: Pfizer / BioNTech: 23Oct2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: EW0162), in left arm and on 10May2021 as dose 2, single (Lot number: EW0183), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Nov2023 as dose 4 (booster), single (Lot number: 3032218), in left arm for covid-19 immunisation. The patient's relevant medical history included: "shellfish allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2023) Positive; (03Jan2024) Positive; (04Jan2024) Negative; (05Jan2024) Negative; (06Jan2024) Positive; (07Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Brain fog
Clinical narrative: losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words; covid fog; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 2, 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: AMNESIA (non-serious), outcome "unknown", described as "losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words"; BRAIN FOG (non-serious), outcome "unknown", described as "covid fog".  Additional information: The patient reported that he took 3 shots of the Pfizer covid vaccine (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) and he was losing his memory. He received the vaccine well over a year, maybe 2 years. He had a terrible experience after taking the shot. His memory keeps getting worse and worse. The side effects "started right off of the bat." He described his memory loss as "covid fog." Today, he was watching tv, and something he should have known came across; however, he couldn't remember what it was. He was forgetting words and it was really scaring the heck out of him. He stated that it has coincided with the shots. The side effects seemed to be getting worse, so fast. He reported that has spoken with many others who have experienced the same thing.  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-202300458025 same patient and drug, different dose and event;US-PFIZER INC-202400008699 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Brain fog
Clinical narrative: losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words; covid fog; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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: AMNESIA (non-serious), outcome "unknown", described as "losing his memory/his memory keeps "getting worse and worse."/couldn't remember/forgetting words"; BRAIN FOG (non-serious), outcome "unknown", described as "covid fog".  Additional information: The patient reported that he took 3 shots of the Pfizer covid vaccine (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) and he was losing his memory. He received the vaccine well over a year, maybe 2 years. He had a terrible experience after taking the shot. His memory keeps getting worse and worse. The side effects "started right off of the bat." He described his memory loss as "covid fog." Today, he was watching tv, and something he should have known came across; however, he couldn't remember what it was. He was forgetting words and it was really scaring the heck out of him. He stated that it has coincided with the shots. The side effects seemed to be getting worse, so fast. He reported that has spoken with many others who have experienced the same thing.  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-202400008698 same patient and drug, different dose and event;US-PFIZER INC-202300458025 same patient and drug, different dose and event;
Sex: U
Vaccine: RSV
Symptoms: Burning sensation, Coccidioidomycosis, Pain
Clinical narrative: had valley fever but of the medicine; my whole left side was shooting pain and burning. It better right now but in pain; my whole left side was shooting pain and burning. It better right now but in pain; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 28Dec2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COCCIDIOIDOMYCOSIS (non-serious), outcome "unknown", described as "had valley fever but of the medicine"; PAIN (non-serious), outcome "not recovered", BURNING SENSATION (non-serious), outcome "recovering" and all described as "my whole left side was shooting pain and burning. It better right now but in pain". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. Additional information: The patient reported having the RSV shot yesterday and that whole left side was shooting pain and burning. It better right now but in pain. The patient had valley fever but of the medicine.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal, Therapeutic response unexpected
Clinical narrative: when he gets his Covid shots (always Pfizer), he grows hair for about 6 weeks, then it's gone; when he gets his Covid shots (always Pfizer), he grows hair for about 6 weeks, then it's gone; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male 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: "Heart problem" (unspecified if ongoing); "alopecia universalis" (unspecified if ongoing), notes: Total baldness. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), HAIR GROWTH ABNORMAL (non-serious), outcome "unknown" and all described as "when he gets his Covid shots (always Pfizer), he grows hair for about 6 weeks, then it's gone".  Additional information: Was reading about Litfulo. The reporter's husband has alopecia universalis. Total baldness. Wish he could get this drug, but he has a heart problem. Wanted to let them know that when he gets his Covid shots (always Pfizer), he grows hair for about 6 weeks, then it's gone. He would love to get a Covid shot as much as possible. Just an observation, thought they would share.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: unexplained burning in her legs and arms only when she plays; pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 005570.  A 15-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 and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "unexplained burning in her legs and arms only when she plays"; PAIN (non-serious), outcome "unknown".  Additional information: The reporter's child is 15 years old and is an elite basketball athlete. She had the Covid shot and is experiencing unexplained burning in her legs and arms only when she plays. No medical professional can explain it. She has been to (PRIVACY) and they cannot give answers but all asked about the shot. The reporter asked if they could help them with any answers to counteract the symptoms the patient is experiencing. She's in pain and the reporter felt helpless.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: caller received the previous vaccines but still got covid and wondering if he can still get the updated vaccines; caller received the previous vaccines but still got covid and wondering if he can still get the updated vaccines; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caller received the previous vaccines but still got covid and wondering if he can still get the updated vaccines".  Clinical course: Created Manual because caller received the previous vaccines but still got covid and wondering if he can still get the updated vaccines. Sample not available, no special handling, no photos available and no medical device.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: given the ACTHIB with sterile diluent instead of the NaCL diluent with no adverse event; Initial information received on 05-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 8 months old female patient and reporter reported that HIB (PRP/T) Vaccine [ACT-HIB] was given with sterile diluent instead of the nacl diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Dec-2023, the patient received a dose 2 with a dose of 0.5 ml, once (TOTAL) suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection with sterile diluent instead of the nacl diluent (Frequency: once, strength: standard, expiry date: 29-Mar-2024 and lot UJ858AB) via intramuscular route in the right vastus lateralis as immunization (product preparation error) (same day latency).   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: 0.92
Sex: M
Vaccine: UNK
Symptoms: Autism spectrum disorder, Behaviour disorder, Speech disorder developmental
Clinical narrative: Autism, speech delay, behavioral problems
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Malaise, Pain, Productive cough, Pyrexia
Clinical narrative: On the evening of receiving the vaccine, patient had a low grade fever and felt "blah." She awoke next morning by coughing. She has been coughing since and "nothing helps it stop." She also is brining up mucus, has a runny nose, and body aches. It was suggested she contact her PCP.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Rhinorrhoea, Sleep disorder
Clinical narrative: On the evening of receiving the vaccine, patient had a low grade fever and felt "blah." She awoke next morning by coughing. She has been coughing since and "nothing helps it stop." She also is brining up mucus, has a runny nose, and body aches. It was suggested she contact her PCP.
Age: 55.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Injection site pain
Clinical narrative: patient reports he got the Hep A, Hep B and FLU vaccine on 10/20/23. Developed injection site pain afterwards and has had continuous injection site pain for the last 12 weeks.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: red arm at site of injection
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Headache, 54 hours so far; extreme dizziness, 40 hours so far; vomiting caused by dizziness, 16 hours
Age: 8.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: System was activated but no update was seen. Vaccines due was administrated. System updates showed after vaccine administration. Duplicate therapy was given. No adverse reaction noted and patient stable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: SEVERE HEADACHE ( BACK OF PATIENT HEAD) AND PAIN AT INJECTION SITE
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient got an additional dose of RSV, it appears he received a first dose on 10/26/2023 that nobody noticed in pre-verification
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: chronic tinnitus
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Nodule, Pruritus, Skin induration
Clinical narrative: Hard lump and large red itchy area occured after the patient recieved the vaccine
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Electroencephalogram, Focal dyscognitive seizures, Headache, Magnetic resonance imaging normal
Clinical narrative: Fever, Headache, Confusion, (AMS) Focal Seizures, such as Focal Aware and Focal Impaired
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Partial seizures, Pyrexia, Seizure like phenomena, Simple partial seizures
Clinical narrative: Fever, Headache, Confusion, (AMS) Focal Seizures, such as Focal Aware and Focal Impaired
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Immediate post-injection reaction
Clinical narrative: Hard impact when administered, burning sensation moving down when administered, slight burning immediately after, significant burning sensation in shoulder spreading to top and front side of shoulder at least 3-4" from injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC20, VARCEL
Symptoms: Angular cheilitis, Cough, Ear pain, Rash erythematous, Rash macular
Clinical narrative: Red macular rash on back about 5 hours after vaccines, with development of hives on arms, legs, and behind ears at approx 22 hrs after vaccines. Hives resolved without medication after approx. 2-3 hours. No wheezing or shortness of breath
Age: 1.0
Sex: M
Vaccine: HEPA, PNC20, VARCEL
Symptoms: Upper respiratory tract infection, Urticaria
Clinical narrative: Red macular rash on back about 5 hours after vaccines, with development of hives on arms, legs, and behind ears at approx 22 hrs after vaccines. Hives resolved without medication after approx. 2-3 hours. No wheezing or shortness of breath
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Bradycardia, Computerised tomogram head, Disorientation, Dyskinesia, Facial paralysis
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging head, Muscular weakness, Seizure
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Vomiting
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Angiogram, Blood culture negative, Bradycardia, Bradypnoea
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: C-reactive protein, CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Computerised tomogram, Culture negative, Dysarthria, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.