chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: BELL'S PALSY (medically significant) with onset 2022, 3 days after the suspect product(s) administration, outcome "recovered" (2023), described as "Bells Palsey". Clinical course: Patient received COVID booster last year in Nov. Three days later patient got Bells Palsy. Patient called # where patient got it to let them know. They said they had a couple of other people report that too. We searched Pfizer about it, it said Yes, it could happen but there was not enough statistics to do a report. Patient was worried to get another vaccine, as patient was sick for 6 months. Patient's 84-year-old mother caught the Bells Palsy from patient two months after patient got it. It was a virus.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Hypersomnia
Clinical narrative: slept for 18 hours a day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 18 hours a day) and PAIN IN EXTREMITY (sore arm) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205EE23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (slept for 18 hours a day) and PAIN IN EXTREMITY (sore arm). At the time of the report, HYPERSOMNIA (slept for 18 hours a day) had resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient felt arm was not completely dysfunctional, but on the edge of being functional.  Treatment medications were not reported.  Company comment: This spontaneous case concerns a 79-year-old, male patient with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia (slept for 18 hrs a day) and non serious event of pain in extremity (sore arm). The events occurred after the fifth dose of Spikevax 2023-2024. As reported, following the most recent dose patient slept for 18 hours a day for the first 2 days. Patient also had quite a sore arm and felt he was not completely dysfunctional, but on the edge of being functional. No further information about the events was provided. The benefit-risk relationship of Spikevax 2023-2024 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-026680 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026680:Monovalent Dose
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypersomnia, Pain in extremity
Clinical narrative: slept for 18 hours a day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 18 hours a day) and PAIN IN EXTREMITY (sore arm) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205EE23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (slept for 18 hours a day) and PAIN IN EXTREMITY (sore arm). At the time of the report, HYPERSOMNIA (slept for 18 hours a day) had resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient felt arm was not completely dysfunctional, but on the edge of being functional.  Treatment medications were not reported.  Company comment: This spontaneous case concerns a 79-year-old, male patient with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia (slept for 18 hrs a day) and non serious event of pain in extremity (sore arm). The events occurred after the fifth dose of Spikevax 2023-2024. As reported, following the most recent dose patient slept for 18 hours a day for the first 2 days. Patient also had quite a sore arm and felt he was not completely dysfunctional, but on the edge of being functional. No further information about the events was provided. The benefit-risk relationship of Spikevax 2023-2024 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-026680 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026680:Monovalent Dose
Age: 24.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Bone pain, Brain fog, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: bone aches (back/ribs/arms); brain fog; congestion; fatigue; Mainly muscle aches (back/ribs/arms).; headache; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: johnson & johnson (Dose Number: 1, Batch No: 041A21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 01Apr2021, when the patient was 22-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch No: 017F21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 29Oct2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Oct2023 at 11:30, outcome "unknown"; MYALGIA (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "Mainly muscle aches (back/ribs/arms)."; BONE PAIN (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "bone aches (back/ribs/arms)"; BRAIN FOG (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023); NASAL CONGESTION (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "congestion"; FATIGUE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023); HEADACHE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023). Therapeutic measures were not taken as a result of bone pain, brain fog, nasal congestion, fatigue, myalgia, headache.  Additional information: Reported that, Mainly muscle and bone aches (back/ribs/arms). Also, headache and brain fog, congestion, and fatigue. The patient had no known allergies. As of 12Oct2023, it was reported that the reason for reporting delay was the uncertainty that patient's symptoms were necessarily from the vaccinations received on 09Oct2023. Patient stated "I began feeling mild symptoms the same day, but the worst on 10Oct2023. I am aware of the 24 hour period - but once my symptoms resolved on 11Oct2023, I felt more confident it may have been linked to either vaccination."  Follow-up (12Oct2023): This is a follow-up spontaneous report received in response to Non-HCP letter sent to consumer via email. Updated information included: course of events and events stop date.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Myalgia, Nasal congestion
Clinical narrative: bone aches (back/ribs/arms); brain fog; congestion; fatigue; Mainly muscle aches (back/ribs/arms).; headache; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: johnson & johnson (Dose Number: 1, Batch No: 041A21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 01Apr2021, when the patient was 22-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch No: 017F21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 29Oct2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Oct2023 at 11:30, outcome "unknown"; MYALGIA (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "Mainly muscle aches (back/ribs/arms)."; BONE PAIN (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "bone aches (back/ribs/arms)"; BRAIN FOG (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023); NASAL CONGESTION (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023), described as "congestion"; FATIGUE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023); HEADACHE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (11Oct2023). Therapeutic measures were not taken as a result of bone pain, brain fog, nasal congestion, fatigue, myalgia, headache.  Additional information: Reported that, Mainly muscle and bone aches (back/ribs/arms). Also, headache and brain fog, congestion, and fatigue. The patient had no known allergies. As of 12Oct2023, it was reported that the reason for reporting delay was the uncertainty that patient's symptoms were necessarily from the vaccinations received on 09Oct2023. Patient stated "I began feeling mild symptoms the same day, but the worst on 10Oct2023. I am aware of the 24 hour period - but once my symptoms resolved on 11Oct2023, I felt more confident it may have been linked to either vaccination."  Follow-up (12Oct2023): This is a follow-up spontaneous report received in response to Non-HCP letter sent to consumer via email. Updated information included: course of events and events stop date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Crepitations, Laboratory test, Memory impairment
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count, Basophil percentage
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Bilirubin conjugated abnormal, Bilirubin urine, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium, Blood sodium decreased
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Blood urea normal, Bordetella test negative, Carbon dioxide decreased, Confusional state, Coronavirus test negative
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Delirium, Enterovirus test negative, Eosinophil count, Eosinophil percentage decreased, Glomerular filtration rate
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Human metapneumovirus test, Human rhinovirus test
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Immature granulocyte count, Influenza A virus test negative, Influenza B virus test, Lipase, Liver function test
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage increased, Nitrite urine absent
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Nucleated red cells, Platelet count normal, Protein total normal, Protein urine absent, Red blood cell count decreased
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Red blood cells urine, Red cell distribution width normal, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respirovirus test negative
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Restlessness, Rubulavirus test negative, SARS-CoV-2 test, Specific gravity urine normal, Urine ketone body present
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Urobilinogen urine, White blood cell count normal, White blood cells urine, White blood cells urine negative, pH urine normal
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Confusional state, Head discomfort, Memory impairment
Clinical narrative: could not recall location of rooms in house or route to Emergency room; profuse crackles in my head (no pain); tremendous confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series completed, unknown manufacturer.), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "could not recall location of rooms in house or route to Emergency room"; HEAD DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "profuse crackles in my head (no pain)"; CONFUSIONAL STATE (non-serious) with onset Oct2023, outcome "unknown", described as "tremendous confusion". The events "could not recall location of rooms in house or route to emergency room", "profuse crackles in my head (no pain)" and "tremendous confusion" required emergency room visit.  Additional information: Patient ended up in the Emergency room on 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300171527 Different patient, same product (Dose 4), different events;
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; a patient who received PNEUMOVAX 23 at the age of 11 months and 4 days old.; This spontaneous report has been received from a health care professional (HCP) (conflicting information, also reported as a technician) concerning a 11-months-old patient of unknown gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 14-FEB-2011, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliters (ml), once, lot # 0993Z (has been verified to be a valid lot number, expiration date reported as 25-FEB-2012, but upon internal validation established as 05-JAN-2012) for prophylaxis (anatomical location, and route of administration were not reported). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for PROQUAD. Improperly stored vaccine was administered. No side effects reported. No other medical information known. HCP permission to contact obtained. See additional AE cases 02477408, 02477532, 02477541, and 02477561. No; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 19-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, lot #W012730, expiration date was validated as: 16-OCT-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) which showed temperature elevated to 6 degree Celsius for 7 hours. There's no previous temperature excursion. No other medical information known (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination
Clinical narrative: had received one varicella vaccine as a child; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 25-year-old female patient. The patient's concurrent conditions included systemic lupus erythematous (SLE). Concomitant medications were not reported. The patient denied history of chicken pox.   On an unspecified date, as a child, the patient received just on dose of varicella virus vaccine live (manufacturer unknown) (Lot #, expiration date, dose, frequency, anatomical location of vaccine, route of administration) for prophylaxis (Routine immunization schedule incomplete).      A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Nurse called to report TE for VARIVAX that occurred on 9/21/2023 and informed it was inadvertently administered on 9/25/2023. Administered lot unknown. No additional AE/PQC.   Names of vaccines involved - VARIVAX, Lot# X002101, Exp. 1/19/2023 and Lot; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-SEP-2023, varicella virus vaccine live (OKA/MERCK) (VARIVAX) had a temperature excursion at 14.1 Fahrenheit for 1 hour. No previous temperature excursion was reported. On 25-SEP-2023, the patient was vaccinated with the improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection (lot #X002101, expiration date: 19-JAN-2023 (upon internal review the expiration date was established as 19-JAN-2025); lot# X010535, expiration date: 11-APR-2023) administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE with PROQUAD.  Improperly stored.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 07-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) (lot number W029555 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD), expiration date 14-MAR-2024), administered for prophylaxis (dose number, frequency, and route of administration were not provided), after a temperature excursion (product storage error). No adverse effects reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion. Vaccine has been administered. No PQC. No additional information.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 13-OCT-2023, the patient was vaccinated with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: X006982, which was determined to be valid, with an expiration date on 07-MAR-2025) (strengths, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of unreported temperature during an unspecified period time. Previous temperature excursion was not reported.    No additional adverse event was provided.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Muscle pain all over my body and strongest in my back and the injection site; Severe headaches; Muscle pain all over my body and strongest in my back and the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches), MYALGIA (Muscle pain all over my body and strongest in my back and the injection site) and INJECTION SITE PAIN (Muscle pain all over my body and strongest in my back and the injection site) in a 38-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19.   On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced HEADACHE (Severe headaches) and MYALGIA (Muscle pain all over my body and strongest in my back and the injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (Muscle pain all over my body and strongest in my back and the injection site). At the time of the report, HEADACHE (Severe headaches), MYALGIA (Muscle pain all over my body and strongest in my back and the injection site) and INJECTION SITE PAIN (Muscle pain all over my body and strongest in my back and the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Treatment medications was not reported.  After the shot, the patient had severe headache behind the eye balls that continued throughout the day and into the evening. Additionally the patient had muscle pain all over the body and had back pain and the injection site pain. The patient received flu shot at the same time.  question 9 was left unanswered since the applicable option was not available in the decision tree.