chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Vaginal haemorrhage
Clinical narrative: bleeding and excessively and that is not normal / my granddaughter is bleeding to death; My granddaughter is in the hospital, 6 years old, vaginal bleeding after taking your freaking product; she is now having period so heavy that she has to go to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu vaccine (She had a flu vaccine a year ago but I don't blame the flu vaccine), for Immunization. The following information was reported: HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "bleeding and excessively and that is not normal / my granddaughter is bleeding to death"; VAGINAL HAEMORRHAGE (hospitalization), outcome "unknown", described as "My granddaughter is in the hospital, 6 years old, vaginal bleeding after taking your freaking product; she is now having period so heavy that she has to go to the hospital".  Clinical Course: Reporter stated that, no prior vaccinations within 4 weeks, she had a flu vaccine a year ago, but reporter don't blame the flu vaccine. No other medical conditions and concomitant medications, actually she was a perfectly healthy kid. She doesn't have to take anything. Reporter stated that, she was in the hospital. She took your shot and like thousand other girls, she started to bleed because of your shot. Every person that reporter had ever heard of (further clarifications unavailable, hence split not made), a female, who has taken your shot has had female problems and blood problems. No other conditions and other products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Memory impairment, Pyrexia, Rash, Wrong product administered
Clinical narrative: Rash under left breast; forgetful; Fever; feeling tired; received the bivalent formulation as dose 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 11:45 as dose 1, single (Lot number: GJ3277) at the age of 65 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "Hypo Thyroid" (unspecified if ongoing), notes: Hypo Thyroid. The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 31Oct2022 at 11:45, outcome "unknown", described as "received the bivalent formulation as dose 1"; PYREXIA (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "Fever"; RASH (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "Rash under left breast"; FATIGUE (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "feeling tired"; MEMORY IMPAIRMENT (non-serious) with onset 31Oct2022 at 16:00, outcome "recovering", described as "forgetful". Therapeutic measures were not taken as a result of rash, memory impairment, pyrexia, fatigue.  Additional Information: The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not receive any treatment for adverse event. The patient did not have covid prior to the vaccination. The patient was not tested for covid post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: started having fever and chills and went through that on Sunday and now she is having cold symptoms/tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (non-serious) with onset Oct2022, outcome "unknown", described as "started having fever and chills and went through that on Sunday and now she is having cold symptoms/tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2022) Positive, notes: She tested positive for Covid today. Clinical course: The patient had her booster shot last Friday (28Oct2022) and she just tested positive this morning (01Nov2022). She started having fever and chills and went through that on Sunday (in Oct2022) and now she is having cold symptoms. The patient asked if this could be the result of the booster or was it just a coincidence that she has Covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 26Jan2021 as dose 2, single (Lot number: EJ1686), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF88839) at the age of 68 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 17Jun2022 as dose 4 (booster), single (Lot number: 0554A22A), in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Jun2022, outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Positive, notes: Positive test with symptoms 5 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: 27Sep2022 / Moderna: 09Nov2021; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism. Concomitant medication(s) included: SERTRALINE; ARMOUR THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "Pfizer / BioNTech: 27Sep2022 / Moderna: 09Nov2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was taken as therapeutic measures for COVID-19 from 21Oct2022 to 26Oct2022. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6203), on 25Mar2021 as dose 2, single (Lot number: EL3248) and on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETIN, start date: Aug2021. Past drug history included: Doxycycline, reaction(s): "Drug allergy: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient took other medications in 2 weeks. Paxlovid was taken as Covid-19 treatment from 06Oct2022 and to 31Oct2022. Patient administered pantoprazole from Sep2022.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no other medication in 2 weeks, and he had no known allergies.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19, VARZOS
Symptoms: Ageusia, Off label use, Product use issue
Clinical narrative: I have lost some of my ability to taste. I can still taste some things, but it is all sort of muted. But I seem to have lost the ability to taste things that have a more subtle flavor.; Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022; Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 28Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 05Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022"; AGEUSIA (non-serious) with onset 30Oct2022, outcome "not recovered", described as "I have lost some of my ability to taste. I can still taste some things, but it is all sort of muted. But I seem to have lost the ability to taste things that have a more subtle flavor.". Therapeutic measures were not taken as a result of ageusia.  Additional information: She had lost some of my ability to taste. She can still taste some things, but it was all sort of "muted". But she seem to had lost the ability to taste things that had a more "subtle" flavor. For instance, I can't taste the flavoring of my sparkling water anymore, or the cinnamon in my cinnamon cereal.  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: 50.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19, VARZOS
Symptoms: Ageusia
Clinical narrative: I have lost some of my ability to taste. I can still taste some things, but it is all sort of muted. But I seem to have lost the ability to taste things that have a more subtle flavor.; Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022; Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 28Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 05Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "Shingles: 28Oct2022 Pfizer Bivalent: 28Oct2022"; AGEUSIA (non-serious) with onset 30Oct2022, outcome "not recovered", described as "I have lost some of my ability to taste. I can still taste some things, but it is all sort of muted. But I seem to have lost the ability to taste things that have a more subtle flavor.". Therapeutic measures were not taken as a result of ageusia.  Additional information: She had lost some of my ability to taste. She can still taste some things, but it was all sort of "muted". But she seem to had lost the ability to taste things that had a more "subtle" flavor. For instance, I can't taste the flavoring of my sparkling water anymore, or the cinnamon in my cinnamon cereal.  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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Vaccine brand=Other, vaccine brand other= Moderna; vaccine brand= Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "known allergies Dairy" (unspecified if ongoing), notes: known allergies Dairy. Concomitant medication(s) included: CHLORTHALIDONE, start date: 04Apr2021, stop date: 01Nov2022; METFORMIN, start date: 08Mar2021, stop date: 01Nov2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown", described as "Vaccine brand=Other, vaccine brand other= Moderna; vaccine brand= Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I test positive on a rapid (at home) test for 21 days total. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 18Jul2022 to 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.The causal association between the at-risk event interchange of vaccine products and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: A female, who has taken your shot has had female problems and blood problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient received BNT162b2 (BNT162B2), 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: BLOOD DISORDER (non-serious), outcome "unknown", described as "A female, who has taken your shot has had female problems and blood problems".  Additional information: Any prior vaccinations (within 4 weeks) was reported as  reporter stated, "Not within four weeks, no. She had a flu vaccine a year ago but he don't blame the flu vaccine." Other medical conditions and concomitant medications: Reporter stated, "No, actually she was a perfectly healthy kid. She doesn't have to take anything." Reporter stated, "I was just asking were you a representative of Pfizer population? You all were still trying to dodge the question. My granddaughter was in the hospital (Further clarification unknown hence hospitalization not checked as seriousness criteria), 6 years old, vaginal bleeding after taking your freaking product. I would just like to lodge a complaint which I know ain't do no good because body means you all to give wherever your shot. My daughter was stupid and gave my granddaughter a shot. A 6 year old girl does not have a period and she was now having period so heavy that she has to go to the hospital. So I was just curious as to what all safety it has." Treatment in response to adverse event: Reporter stated, "She was in the hospital. She took your shot and like thousand other girls, she was starting to bleed because of your shot. Every person that he have ever heard of (further clarifications unavailable, hence split not made), a female, who has taken your shot has had female problems and blood problems. That was why he wanted to call all to let you know this was not doing a good dang anyway. So that was why he was calling."   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received the vaccine, did not take any other medication in 2 weeks, had no known allergies. Anti-viral details: Product- COVID 19 Treatment, treatment start date-18Oct2022, stop date- 22Oct2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm was really sore; could not lift or stretch it without pain for 2 + months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes2" (unspecified if ongoing), notes: Diabetes2; "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Lichen sclerosus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; LOSARTAN POTASSIUM; METFORMIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 28Jan2022, outcome "recovered" (2022), described as "could not lift or stretch it without pain for 2 + months"; PAIN IN EXTREMITY (non-serious) with onset 28Jan2022, outcome "recovered" (2022), described as "left arm was really sore". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 11:00 as dose 1, single (Lot number: EN6199), in left arm and on 03Apr2021 at 11:00 as dose 2, single (Lot number: ER8730) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "prev heart attack" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any Other medication in 2 weeks.Anti-viral details: Product- COVID 19 Treatment,Brand-Paxlovid. Treatment Start Date: 24Oct2022. Treatment Stop Date: 29Oct2022.Indication: Treatment of Covid-19. No Known allergies.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: el3302), on 04Feb2021 as dose 2, single (Lot number: en5318), on 01Sep2021 as dose 3 (booster), single (Lot number: en0173) and on 09May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ROSUVASTATIN CALCIUM; PRILOSEC [OMEPRAZOLE]; ASPIRIN 81. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: Negative test on day 5; (Oct2022) Positive, notes: positive test 2 days afterwards. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid as treatment for COVID 19, Treatment start date was on 22Oct2022 and Treatment stop date was on 26Oct2022
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased
Clinical narrative: PSA went from 4.5 to 0.1; 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 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: gt3275) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing), notes: he takes vitamins and green tea. The patient took concomitant medications. 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 following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious) with onset 25Oct2022, outcome "unknown", described as "PSA went from 4.5 to 0.1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of prostatic specific antigen decreased. Additional information: On 25Oct2022 the patient got his 3rd booster of the bivalent Pfizer COVID vaccine and at the same time, within a few hours, he did a blood draw on his PSA and his PSA went from 4.5 to 0.1. He asked did the COVID shot affect his PSA (prostate specific antigen). The pharmacist didn't tell me, and my doctor can't tell me whether it affected it. He stated he had received 2 booster shots before plus the original 2 shots as the primary series. He has prostate cancer and that he was takng vitamins and green tea. Caller stated, he always thought that the vitamins and green tea brought the PSA down, but that shouldn't be that much, which is why he thought the COVID vaccine may have brought it down.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; 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 male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vertigo" (unspecified if ongoing), notes: got worse during early 2020. The patient's concomitant medications were not reported. Past drug history included: Meclizine, reaction(s): "no impact anymore it feels like", notes: Meclizine 25mg. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had". Additional information: He had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there was any links to case studies or general information about it. He suffer from vertigo pre COVID and it got worse during early 2020. He noticed every time he have gotten the vaccine he finally feel clear headed and not having a serious case of vertigo as he previously had. Meclizine 25mg has had no impact anymore it feels like, he had 5 shots already of. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Malaise, Somnolence
Clinical narrative: extreme fatigue/ exhausted/ tired; always sleepy; terrible depression; feeling sick; 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 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jun2022 (not ongoing). 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. The following information was reported: SOMNOLENCE (non-serious) with onset Oct2022, outcome "not recovered", described as "always sleepy"; FATIGUE (non-serious) with onset Oct2022, outcome "not recovered", described as "extreme fatigue/ exhausted/ tired"; MALAISE (non-serious) with onset Oct2022, outcome "not recovered", described as "feeling sick"; DEPRESSION (non-serious) with onset Oct2022, outcome "not recovered", described as "terrible depression". The event "feeling sick" required physician office visit.  Additional information: She got the bivalent vaccine on 06Oct2022 and has been exhausted for 2 weeks (as reported). She had to go to the dentist and that's when she started feeling sick. After that, she had a nurse come in and is in touch with her doctor. She is exhausted, tired and sleepy and has had terrible depression with it. It has lasted a long time. She was feeling a little better "yesterday" (31Oct2022) but "today" (01Nov2022), she is back to worse. Was wondering if maybe she got a bad batch of Pfizer vaccine. The events were assessed by the reporter as not serious.  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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Immunisation, Off label use
Clinical narrative: 5th dose; 5th dose; lost 50% of strength while trying to lift things; 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 male patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 4 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "5th dose"; ASTHENIA (non-serious), outcome "unknown", described as "lost 50% of strength while trying to lift things".  Additional information: The case was reported as non-serious. It was reported that the patient received his 5th dose of the COVID vaccine and in his vaccination card it's written as "BIB" (later confirmed it was for the Pfizer-BioNTech COVID 19 Vaccine bivalent formulation). According to the agent, the questions of the patient were several, he started to have an antibody reaction and wanted to know if the side effects were permanent, he wanted a prognosis with this, some advice on how to resolve this and wanted to contact some qualified professionals with experience in antibody reactions. During the transfer, the caller said he has lost 50% of strength while trying to lift things. The patient mentioned that he started to experience his side effects 5 after receiving the vaccine and confirmed that he wanted a medical advice for his adverse events.  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.
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red; Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red".  Additional information: It was reported that the patient has a reaction to Prevnar 20. The side effects are those that have been reported and is listed, however, the caller asked for the onset and duration of the side effects reported from Prevnar 20. Reporter mentioned that the patient was doing okay for a couple of days but then it started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, was not raised, but was really red.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: mysterious itching on shoulders and neck; she received the primary series of, First dose on 04May2021 and second dose on 23Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 23Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, First Doses; Unknown Location, probably Left Arm), administration date: 04May2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Jun2021, outcome "unknown", described as "she received the primary series of, First dose on 04May2021 and second dose on 23Jun2021"; PRURITUS (non-serious) with onset Jul2021, outcome "not recovered", described as "mysterious itching on shoulders and neck". The events "mysterious itching on shoulders and neck" required physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: Reports it was 'bad' in mid Aug2021. She tried numerous anti itch products which was not helpful. States it has not gotten any better or worse. It becomes really bad at night around 8:30 to 9pm. She went to numerous doctors (dermatologist; neurologist and allergist) and no one can figure out what's going on. Asking if long term itching has been reported. if there's any other report of the itching problem just to see if anybody else could have possibly related to the vaccine. Treatment received for the events includes, anti-Itch Creams, Steroid Creams, Gabapentin, tried to do a high Dose Prednisone Round, Ibuprofen and Ice Packs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Interchange of vaccine products, Pain, Pyrexia, Rash
Clinical narrative: Allergic type of reaction; rash flares; pain; fever; Dose 4 bivalent dose of Pfizer and Moderna dose 3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:00 as dose 4 (booster), single (Lot number: G16665) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 01, Batch number: 0I0M20A), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose: 02, Batch number: 0I2A21A), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose: 03, Batch number: O65F21A), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Oct2022 at 18:00, outcome "unknown", described as "Dose 4 bivalent dose of Pfizer and Moderna dose 3,2,1"; DRUG HYPERSENSITIVITY (non-serious) with onset 24Oct2022, outcome "not recovered", described as "Allergic type of reaction"; PYREXIA (non-serious) with onset 24Oct2022, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 24Oct2022, outcome "not recovered"; RASH (non-serious) with onset 24Oct2022, outcome "not recovered", described as "rash flares". The events "allergic type of reaction", "rash flares", "pain" and "fever" required physician office visit. It was unknown if therapeutic measures were taken as a result of drug hypersensitivity, rash, pain, pyrexia.  Additional information: Serious, seriousness criteria-Results in death, seriousness criteria-Life threatening, seriousness criteria-Caused/prolonged hospitalization, seriousness criteria-Disabling/Incapacitating, seriousness criteria-Congenital anomaly/birth defect reported as no. No other vaccine in four weeks. Adverse event reported as Allergic type of reaction rash flares, pain, fever. If COVID prior vaccination reported as Yes. If COVID tested post vaccination reported as No. No known allergies. No other medical history. Device Date was 01Nov2022.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: developed ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2, solution for injection), on 19Jan2021 as dose 1, single (Lot number: EL0142) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anal cancer", start date: 2013, stop date: Aug2013, notes: Pertinent Details: Chemo/Radiation Remission; "Heart disease", start date: 16Feb2016 (ongoing), notes: Pertinent Details: 3 stents placed; "Hypothyroid" (unspecified if ongoing); "Lipid high" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); PRAVASTATIN [PRAVASTATIN SODIUM] taken for lipids increased, start date: 2001 (ongoing); ASPIRIN 81 taken for cardiac disorder, start date: 2016 (ongoing); CO Q10, start date: 2001; PLAVIX taken for cardiac disorder, start date: 16Feb2016, stop date: 29Apr2022; VITAMIN C [CALCIUM ASCORBATE], start date: 2000; VITAMIN D [VITAMIN D NOS], start date: 2019; STATIN for 25 years; MULTI VITAMIN, start date: 2019. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "developed ringing in ears".  Additional information: After first vaccination 19Jan2021 developed ringing in ear, Doctors refused to address this cause because I had hearing lost.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) 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 Oct2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid start date: 22Oct2022, stop date: 26Oct2022. Adverse event: Very bad taste in mouth. Went away a day after she stopped. No known allergies. Device timestamp: 01Nov2022.  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Hypoaesthesia, Investigation, Magnetic resonance imaging
Clinical narrative: Nerve damage; Still have severe pain in both legs; Extreme numbness and weakness in both legs; Extreme numbness and weakness in both legs; Could hardly walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 at 12:00 as dose 2, single (Lot number: Ep7533) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6205, Vaccine Administration Time: 01:15 AM), administration date: 19Mar2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Numbness in left leg", "Numbness in left leg and foot". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 19Apr2021 at 12:00, outcome "unknown", described as "Could hardly walk"; HYPOAESTHESIA (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 19Apr2021 at 12:00, outcome "not recovered" and all described as "Extreme numbness and weakness in both legs"; NERVE INJURY (non-serious), outcome "unknown", described as "Nerve damage"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Still have severe pain in both legs". The events "extreme numbness and weakness in both legs", "could hardly walk", "nerve damage" and "still have severe pain in both legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, muscular weakness, gait disturbance, nerve injury, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Patient had no known allergies. About 3 Days after Dose 1 had numbness in left leg and foot About 10 Days after dose 2 had extreme numbness and weakness in both legs and could hardly walk Was about to go to ER but made appointment Dr. Patient had nerve damage from COVID 19 vaccination and reff. to Dr neurologist did tests. Treatment for condition nerve Damage will take about 1to1.5 years to recover from nerve damage 01Nov2022 Still have severe pain in both legs and for the past 3 weeks must use a Cane to walk 31Oct2022 Dr started treatment with for condition.