chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took PAXLOVID from 14Jan2024 to 18Jan2024 for the events. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "benign prostatic hyperplasia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin". Vaccination history included: moderna (DOSE NUMBER UNKNOWN, SINGLE, Vaccine administration time=11:00 AM, Vaccine location=Left arm), administration date: 24Sep2022, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Positive; (Jan2024) Negative, notes: Retested negative on day 12; (Jan2024) Positive, notes: On day 14 symptoms returned and I tested positive again. Therapeutic measure of Paxlovid (lot number: GK2920) from 13Jan2024 to 17Jan2024 taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 17Jan2024 to 21Jan2024 No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Lot number: HF9300) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Day 11, test result was a faint positive - - next day full symptom and strong positive test with Covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Jan2024 to 19Jan2024.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a Nurse.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HF9275) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not experienced COVID-19 before the vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); UNKNOWN MANUFACTURER), for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2024, outcome "recovered with sequelae" and all described as "Tested positive for COVID". The clinical course was reported as follows: The patient tested positive for COVID on 21Jan2021 after a Biovax (nasal swab) test, although she got the latest booster. Starting 18Jan2024, she experienced sore throat, chills, body aches, headache, nausea, vomiting, diarrhea, cough, runny nose, sneezing, loss of taste and smell. The patient underwent laboratory tests and procedures as aforementioned. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Neurodermatitis
Clinical narrative: Prurigo Nodularis Eruption; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: NEURODERMATITIS (non-serious) with onset May2023, outcome "not recovered", described as "Prurigo Nodularis Eruption". Therapeutic measures were taken as a result of neurodermatitis. Additional information: the patient was diagnosed with Prurigo Nodularis Eruption. She believed the vaccine has cause it and she had been diagnosed for eight months and stated that it ruined her life. She had to wear long sleeve pants shirts to cover it off and she is taking Dupixent. She wanted Pfizer to prescribe her something to help with these side effects. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE oral; KIRKLAND SIGNATURE MATURE MULTI oral; FISH OIL NATURE MADE oral; VITAMIN C [ASCORBIC ACID] oral from Amazon Elements; VITAMIN D [VITAMIN D NOS] oral from Nature Made; ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral; MELATONIN oral. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "recovered" (31Dec2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Positive; (31Dec2023) Negative. This was the patient's first time getting COVID, he tested positive on 26Dec2023 with symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Per HCP direction, the patient started a 5 day course of PAXLOVID as treatment of COVID-19 from evening of 26Dec2023 to 31Dec2023. The patient felt better except for lingering cough and tested negative for COVID on 31Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400024844 Same patient, different drug and event;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Headache, Hot flush, Pain in extremity
Clinical narrative: back hurts so bad; left upper arm felt hot; Headache; left arm sore; spine hurt so badly/ spine hurt from her neck to her tailbone, terrible pain; felt flushed/hot/overheated; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Jan2024 as dose 1, single (Lot number: HM7006) at the age of 79 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset Jan2024, outcome "not recovered", described as "felt flushed/hot/overheated"; SPINAL PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "spine hurt so badly/ spine hurt from her neck to her tailbone, terrible pain"; PAIN IN EXTREMITY (non-serious) with onset 18Jan2024, outcome "recovered" (24Jan2024), described as "left arm sore"; HEADACHE (non-serious) with onset 19Jan2024, outcome "not recovered"; BACK PAIN (non-serious) with onset 20Jan2024, outcome "not recovered", described as "back hurts so bad"; FEELING HOT (non-serious) with onset 20Jan2024, outcome "recovered" (25Jan2024), described as "left upper arm felt hot". Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of pain in extremity, feeling hot.  Additional information: Patient got her COVID-19 shot on 17Jan2024 and reported on 24Jan2024 that she is still experiencing headache and her spine hurt so badly. Her spine hurt from her neck to her tailbone, terrible pain. As of 25Jan2024, patient reported she is experiencing unrelenting headache and back hurts so bad that it is excruciating and has worsened. Back Pain is there when she awakes. She used a Heating pad religiously, mineral ice at 4:00am she put on castor oil for arthritis. She will go for accupuncture to see if she can get some relief; her back hurts. She did not want all of this pain. When she got the Covid 19 injection there was no pain, redness or swelling for the first 24 hours. She has been trying to hydrate, drink a lot of water. Patient started Tylenol 325mg daily for unrelenting headache. No treatment given for sore left arm sore and left upper arm felt hot.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: back hurts so bad; left upper arm felt hot; Headache; left arm sore; spine hurt so badly/ spine hurt from her neck to her tailbone, terrible pain; felt flushed/hot/overheated; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Jan2024 as dose 1, single (Lot number: HM7006) at the age of 79 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset Jan2024, outcome "not recovered", described as "felt flushed/hot/overheated"; SPINAL PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "spine hurt so badly/ spine hurt from her neck to her tailbone, terrible pain"; PAIN IN EXTREMITY (non-serious) with onset 18Jan2024, outcome "recovered" (24Jan2024), described as "left arm sore"; HEADACHE (non-serious) with onset 19Jan2024, outcome "not recovered"; BACK PAIN (non-serious) with onset 20Jan2024, outcome "not recovered", described as "back hurts so bad"; FEELING HOT (non-serious) with onset 20Jan2024, outcome "recovered" (25Jan2024), described as "left upper arm felt hot". Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of pain in extremity, feeling hot.  Additional information: Patient got her COVID-19 shot on 17Jan2024 and reported on 24Jan2024 that she is still experiencing headache and her spine hurt so badly. Her spine hurt from her neck to her tailbone, terrible pain. As of 25Jan2024, patient reported she is experiencing unrelenting headache and back hurts so bad that it is excruciating and has worsened. Back Pain is there when she awakes. She used a Heating pad religiously, mineral ice at 4:00am she put on castor oil for arthritis. She will go for accupuncture to see if she can get some relief; her back hurts. She did not want all of this pain. When she got the Covid 19 injection there was no pain, redness or swelling for the first 24 hours. She has been trying to hydrate, drink a lot of water. Patient started Tylenol 325mg daily for unrelenting headache. No treatment given for sore left arm sore and left upper arm felt hot.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: pain along the jaw line; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 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: PAIN IN JAW (non-serious) with onset 2021, 3 weeks after the suspect product(s) administration, outcome "unknown", described as "pain along the jaw line".  Additional information: Patient thought 1st dose was in Feb2021, then 3 weeks later got the reaction.  Batch/lot number is not provided, and it cannot be obtained.
Age: 52.0
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; manufacturer unknown), for COVID-19 immunization. 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 included Paxlovid from 15Jan2024 to 20Jan2024.  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: Allergy to vaccine
Clinical narrative: allergic to reaction due COVID Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to reaction due COVID Vaccine".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025195 same reporter/patient/drug, different event;
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She lost her husband; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 76-year-old 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: "diabetic" (unspecified if ongoing), notes: I know he was a diabetic so, but I can't tell you what medicine.". The patient took concomitant medications. The following information was reported: DEATH (death), outcome "fatal", described as "She lost her husband". The patient date of death was 13Dec2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that "The patient (Reporter) called and mentioned that she lost her husband. She buried her husband on 29Dec and buried her brother on Tuesday 23Jan. She buried two family members recently so, I am reporting death just in case. Her brother was this last Tuesday. "I didn't ask if they took the medication because she reported that and I am just reporting that. I am not going to fall. No, she just called to, enrolling the program and mention that but I don't know if they took the medication."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025249 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: lost her husband
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Buried her brother on Tuesday; 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 and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant) with onset 23Jan2024, outcome "fatal", described as "Buried her brother on Tuesday". The patient date of death was 23Jan2024. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that "The patient (Reporter) called and mentioned that she lost her husband. She buried her husband on 29Dec and buried her brother on Tuesday 23Jan. She buried two family members recently so, I am reporting death just in case. Her brother was this last Tuesday. "I didn't ask if they took the medication because she reported that and I am just reporting that. I am not going to fall. No, she just called to, enrolling the program and mention that but I don't know if they took the medication."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025242 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Buried her brother on Tuesday
Sex: U
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: I lost my taste bud; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 immunisation series complete, manufacturer unknown), for COVID-19 immunisation. The following information was reported: TONGUE DISORDER (non-serious), outcome "unknown", described as "I lost my taste bud".  Additional information: the patient had the Pfizer Booster shot (unspecified booster shot), been over a year prior to this report. The patient lost taste bud.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Ear discomfort, Influenza like illness, Malaise, Respiratory tract congestion
Clinical narrative: Flu-like symptoms, does not feel well, has been in bed for two day; Flu-like symptoms, does not feel well, has been in bed for two day; Congestion; Stopped up left ear; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): UNT-2024-001078 (Regulatory Authority).  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; treprostinil sodium (TYVASO), on 21Aug2023 as 64 µg, four times a day (qid)) resp inhalation for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: DILTIAZEM; OPSUMIT; TADALAFIL; FUROSEMIDE; OXYGEN. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), outcome "recovering" and all described as "Flu-like symptoms, does not feel well, has been in bed for two day"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "recovering", described as "Congestion"; EAR DISCOMFORT (non-serious), outcome "recovering", described as "Stopped up left ear". The action taken for treprostinil sodium was unknown. Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient had flu like symptoms and was taking antibiotics Z-PAK (azithromycin), and prednisone. She had a little left-over congestion (respiratory tract congestion), had a stopped up left ear (ear discomfort), but right now (at the time of reporting) was feeling amazing compared to last week. Action taken with Tyvaso DPI was not reported for the events of respiratory tract congestion and ear discomfort. At the time of reporting, the outcome of respiratory tract congestion and ear discomfort was considered as resolving. The reporter did not provide causality for the event of influenza like illness with Tyvaso DPI. The reporter's causality for the event of influenza like illness with respiratory syncytial virus vaccine was considered to be possibly related. The reporter did not provide causality for the events of respiratory tract congestion and ear discomfort.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She had covid in Oct2023; She had covid in Oct2023; This is a spontaneous report received from a Nurse.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "She had covid in Oct2023". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202201022060 same reporter/patient/drug, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: developed COVID-19 infection; developed COVID-19 infection; This is a spontaneous report received from a consumer. An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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 (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed COVID-19 infection". Clinical course: The patient developed COVID-19 infection after receiving her last updated vaccine booster dose in Sep2023. She received a total of 4 vaccination doses thus far.  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: Anaphylactic shock, Biopsy skin, Ear pain, Internal haemorrhage, Magnetic resonance imaging
Clinical narrative: anaphylactic shock; inflammation in the brain; internal bleeding; severe migraine; chronic migraine; ear ringing and pain; ear ringing and pain; severe body rash; skin rash; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-757761 (Moderna).  A female patient (age: 59, unit: unknown) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "not recovered"; NONINFECTIVE ENCEPHALITIS (medically significant), outcome "not recovered", described as "inflammation in the brain"; INTERNAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "internal bleeding"; MIGRAINE (non-serious), outcome "not recovered", described as "severe migraine; chronic migraine"; TINNITUS (non-serious), EAR PAIN (non-serious), outcome "not recovered" and all described as "ear ringing and pain"; RASH (non-serious), outcome "not recovered", described as "severe body rash; skin rash". The events "anaphylactic shock", "inflammation in the brain", "internal bleeding", "severe migraine; chronic migraine", "ear ringing and pain" and "severe body rash; skin rash" required emergency room visit. It is unknown if the patient experienced any additional symptoms/events. The patient underwent the following laboratory tests and procedures: Biopsy skin: allergy to vaccine; Magnetic resonance imaging: chronic migraine and inflammation. It is unknown if there were additional lab data/results available. Therapeutic measures were taken as a result of anaphylactic shock, noninfective encephalitis, internal haemorrhage which includes epi pen, surgery. The patient cannot take medications now due to many allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Noninfective encephalitis, Rash, Tinnitus
Clinical narrative: anaphylactic shock; inflammation in the brain; internal bleeding; severe migraine; chronic migraine; ear ringing and pain; ear ringing and pain; severe body rash; skin rash; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-757761 (Moderna).  A female patient (age: 59, unit: unknown) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "not recovered"; NONINFECTIVE ENCEPHALITIS (medically significant), outcome "not recovered", described as "inflammation in the brain"; INTERNAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "internal bleeding"; MIGRAINE (non-serious), outcome "not recovered", described as "severe migraine; chronic migraine"; TINNITUS (non-serious), EAR PAIN (non-serious), outcome "not recovered" and all described as "ear ringing and pain"; RASH (non-serious), outcome "not recovered", described as "severe body rash; skin rash". The events "anaphylactic shock", "inflammation in the brain", "internal bleeding", "severe migraine; chronic migraine", "ear ringing and pain" and "severe body rash; skin rash" required emergency room visit. It is unknown if the patient experienced any additional symptoms/events. The patient underwent the following laboratory tests and procedures: Biopsy skin: allergy to vaccine; Magnetic resonance imaging: chronic migraine and inflammation. It is unknown if there were additional lab data/results available. Therapeutic measures were taken as a result of anaphylactic shock, noninfective encephalitis, internal haemorrhage which includes epi pen, surgery. The patient cannot take medications now due to many allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Asthma, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse; I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse; I have a lung disease called mac lung disease; COPD; Not asthma but asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: NEUROPATHY PERIPHERAL (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse"; MYCOBACTERIUM AVIUM COMPLEX INFECTION (medically significant), outcome "not recovered", described as "I have a lung disease called mac lung disease"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD"; ASTHMA (medically significant), outcome "unknown", described as "Not asthma but asthma". Therapeutic measures were taken as a result of mycobacterium avium complex infection, chronic obstructive pulmonary disease, asthma. Additional information: Caller called in to get information about the Abrysvo vaccine. During the call caller stated "I have a lung disease called mac lung disease and COPD (Chronic obstructive pulmonary disease) and not asthma but asthma. And recently in the last few months my breathings gotten worst I use to be on oxygen all day but I do have to use it at night, I keep coughing up stuff that I never did before and hard to breath. Caller later stated on the call "I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Mycobacterium avium complex infection, Neuropathy peripheral, Productive cough
Clinical narrative: I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse; I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse; I have a lung disease called mac lung disease; COPD; Not asthma but asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: NEUROPATHY PERIPHERAL (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse"; MYCOBACTERIUM AVIUM COMPLEX INFECTION (medically significant), outcome "not recovered", described as "I have a lung disease called mac lung disease"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD"; ASTHMA (medically significant), outcome "unknown", described as "Not asthma but asthma". Therapeutic measures were taken as a result of mycobacterium avium complex infection, chronic obstructive pulmonary disease, asthma. Additional information: Caller called in to get information about the Abrysvo vaccine. During the call caller stated "I have a lung disease called mac lung disease and COPD (Chronic obstructive pulmonary disease) and not asthma but asthma. And recently in the last few months my breathings gotten worst I use to be on oxygen all day but I do have to use it at night, I keep coughing up stuff that I never did before and hard to breath. Caller later stated on the call "I'm still trying to get my life back they took my legs, my neuropathy is 10 times worse, my leg is 100 times worse".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "heart attack". Reporter indicated that he had known of product side effects. He said he had a friend hospitalized with heart attack after vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product preparation error
Clinical narrative: TENIVAC, was accidently reconstituted with the lyophilized powder in the Shingrix vaccine (with no reported adverse event); TENIVAC, was accidently reconstituted with the lyophilized powder in the Shingrix vaccine and administered (with no reported adverse event); Initial information received on 19-Jan-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac], was accidently reconstituted with the lyophilized powder in the shingrix vaccine and administered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine Rge (Cho) (Shingrix) for Prophylactic vaccination.  On 21-Dec-2023, the patient received a standard dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL (Frequency- once) (lot number, expiry date- not reported) via intramuscular route in the right arm for Immunization which was accidently reconstituted with the lyophilized powder in the shingrix vaccine (with no reported adverse event) (product preparation error) and administered (with no reported adverse event) (poor quality product administered) (latency- same day). Information on the batch number was requested.  Pharmacy intern, reporting that TENIVAC, was accidently reconstituted with the lyophilized powder in the Shingrix vaccine. They are questioning the efficacy of the Tenivac and the need to readministered. Caller did not have many details about the event. Batch/lot number requested, not available at the time of call. Caller states they have already reached out to GlaxoSmithKline but no recommendations were given regarding the efficacy of Tenivac.  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Brain stem stroke, Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: Experienced 1 ponischemic stroke to the PONS ON THE LEFT SIDE OF BRAIN JUNE 30 2023. Er physician says that he has experienced several up untill then and probably didn't notice them ...then in July of 2023 passed and hemoraged a whole bunch of bloody raspberry embolisms in toilet and turned and promptly had several tiny strokes the following day ..causing severe impairments from memory loss falling instability unable to toilet and unable to shower unable to speak correctly...just a plethora of injury from the clotting to the brain
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysarthria, Embolism, Fall, Gait disturbance
Clinical narrative: Experienced 1 ponischemic stroke to the PONS ON THE LEFT SIDE OF BRAIN JUNE 30 2023. Er physician says that he has experienced several up untill then and probably didn't notice them ...then in July of 2023 passed and hemoraged a whole bunch of bloody raspberry embolisms in toilet and turned and promptly had several tiny strokes the following day ..causing severe impairments from memory loss falling instability unable to toilet and unable to shower unable to speak correctly...just a plethora of injury from the clotting to the brain
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Imaging procedure, Ischaemic stroke, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: Experienced 1 ponischemic stroke to the PONS ON THE LEFT SIDE OF BRAIN JUNE 30 2023. Er physician says that he has experienced several up untill then and probably didn't notice them ...then in July of 2023 passed and hemoraged a whole bunch of bloody raspberry embolisms in toilet and turned and promptly had several tiny strokes the following day ..causing severe impairments from memory loss falling instability unable to toilet and unable to shower unable to speak correctly...just a plethora of injury from the clotting to the brain
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: any adverse issues or side effects from the administration; a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 12/21/2023; This spontaneous report was received from a Medical assistant, referring to a 12-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 21-DEC-2023, the patient was vaccinated with a vaccine involved in a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection, at a dose of 0.5 milliliter, administered for prophylaxis (lot #X019196 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) expiration date was reported and upon internal validation has been established as: 25-APR-2025; vaccination scheme, anatomical location of vaccination, strength, and route of administration were not provided). Excursion initiated in 04-DEC-2023, with a temperature of 54.3 Fahrenheit (F) for 9 hours and 32 minutes; on 05-DEC-2023, with a temperature of 57.7 F for 15 hours and 30 minutes; on 06-DEC-2023, with a temperature of 50.2 F for 5 hours; on 07-DEC-2023, with a temperature of 30.6 F for 1 hour and 55 minutes and at 52.7 F for 11 hours and 3 minutes; on 11-DEC-2023, with a temperature of 48.4 F for 1 hour and 47 minutes. The patient did not report any adverse issues or side effects from the administration (no adverse event).  This is one of 28 cases from the same reporter. ; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015310: US-009507513-2401USA015367: US-009507513-2401USA015363: US-009507513-2401USA015453: US-009507513-2401USA015498: US-009507513-2401USA015507: US-009507513-2401USA015517: US-009507513-2401USA015540: US-009507513-2401USA015557: US-009507513-2401USA015591: US-009507513-2401USA015605: US-009507513-2401USA015622: US-009507513-2401USA015627: US-009507513-2401USA015649: US-009507513-2401USA015651: US-009507513-2401USA015674: US-009507513-2401USA015687: US-009507513-2401USA015695: US-009507513-2401USA015699: US-009507513-2401USA015710: US-009507513-2401USA015731: US-009507513-2401USA015739: US-009507513-2401USA015760: US-009507513-2401USA015762: US-009507513-2401USA015463:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction
Clinical narrative: Injection site reaction and myalgia; Injection site reaction and myalgia; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction and myalgia) and MYALGIA (Injection site reaction and myalgia) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 24-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction and myalgia) and MYALGIA (Injection site reaction and myalgia). At the time of the report, VACCINATION SITE REACTION (Injection site reaction and myalgia) and MYALGIA (Injection site reaction and myalgia) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient did not experience any additional symptoms/events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There were no lab data/results available. Treatment medication was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Blood test, Blood triglycerides, COVID-19
Clinical narrative: had hair loss after vaccination; 2 bold spots, quarter size each, on her scalp. She referred to it as Alopecia Areata; She had positive COVID test/very sick; both sides of neck, where the lymph nodes were swelled up and is still swollen; First Primary monovalent dose on 10-JUL-2021 and 2nd Primary monovalent dose on 07-OCT-2021 administered; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She had positive COVID test/very sick ), ALOPECIA (had hair loss after vaccination), ALOPECIA AREATA (2 bold spots, quarter size each, on her scalp. She referred to it as Alopecia Areata), LYMPHADENOPATHY (both sides of neck, where the lymph nodes were swelled up and is still swollen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 10-JUL-2021 and 2nd Primary monovalent dose on 07-OCT-2021 administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 078C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 10-JUL-2021 and 2nd Primary monovalent dose on 07-OCT-2021 administered). On 09-Oct-2021, the patient experienced LYMPHADENOPATHY (both sides of neck, where the lymph nodes were swelled up and is still swollen). In October 2022, the patient experienced COVID-19 (She had positive COVID test/very sick ). In 2023, the patient experienced ALOPECIA AREATA (2 bold spots, quarter size each, on her scalp. She referred to it as Alopecia Areata). On an unknown date, the patient experienced ALOPECIA (had hair loss after vaccination). The patient was treated with BARICITINIB (OLUMIANT) (oral use) at a dose of 2 milligram once a day. At the time of the report, COVID-19 (She had positive COVID test/very sick ), ALOPECIA (had hair loss after vaccination) and ALOPECIA AREATA (2 bold spots, quarter size each, on her scalp. She referred to it as Alopecia Areata) had not resolved and LYMPHADENOPATHY (both sides of neck, where the lymph nodes were swelled up and is still swollen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 10-JUL-2021 and 2nd Primary monovalent dose on 07-OCT-2021 administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, SARS-CoV-2 test: Positive. On an unknown date, Blood test: normal. On an unknown date, Blood triglycerides: Only Triglycerides were high 321. On an unknown date, Thyroid function test: normal.         No concomitant medication was reported.