chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: serious fatigue; pain; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; 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.  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Sep2023 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: FATIGUE (non-serious), outcome "unknown", described as "serious fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain"; VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen"; CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "The left side of her chest, stomach and back are paining". The events "serious fatigue", "pain", "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen" and "the left side of her chest, stomach and back are paining" required physician office visit. Therapeutic measures were taken as a result of fatigue, vaccination site pain, vaccination site erythema, vaccination site swelling, chest pain, abdominal pain upper, back pain.  Additional information: patient reported that after vaccination she had a lot of severe fatigue for a few weeks but the beginning ahead pain, redness around the injection site and site was swollen but then she had pain in left side of chest, stomach and in left side of her back and she stated that the injection site is still pink after over a month. The doctor advised her to take ibuprofen and also cortisone (Advil). She used ibuprofen and cortisone cream for over a week .  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 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: ILLNESS (non-serious) with onset 28Oct2023, outcome "recovered", described as "sick". Additional information: The patient received the vaccine, and he was sick for two days.  The patient's wife stated he "reacts to everything."    The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; 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 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 was not reported. Concomitant medication(s) included: DUPIXENT (ongoing). Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation; Bnt162b2 (Dose 2, single), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown".  Additional information: Reporter was asking if the current COVID drug being made now was active or inactive. Reporter clarified inquiry and asked if vaccine was a live vaccine. Reporter was taking Dupixent every other week and could not take any live vaccines. Stated she took 2 of the Pfizer COVID vaccines and a Pfizer booster and developed a rash. Stated they never discovered what the rash was from. Stated just in case it was due to Pfizer COVID vaccine, she would avoid the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms for a week with a fever; Flu like symptoms for a week with a fever; 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 74-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation, reaction(s): "adverse event". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PYREXIA (non-serious) all with onset Oct2023, outcome "recovered" and all described as "Flu like symptoms for a week with a fever". The event "flu like symptoms for a week with a fever" required physician office visit.  Additional information: Reporter asked where can she find the vaccine that was grown in a mammalian cell instead of an egg cell? She has had reactions in the past to the Pfizer BioNTech COVID 19 vaccine, which lasted a week or two, so her immunologist said for her to try and find a vaccine that has been grown in a mammalian cell. She thinks she would not have a reaction to it. She reported that that she has had reactions in the past to the Pfizer-BioNTech COVID-19 Vaccine which lasted for a week or two for her. Reporter stated, No, she did not know product details, she can told them the date. She think it was 10,20, something, last week, but she did not know the exact date. She did not know where it was, just a moment. Reporter stated she did not know where she got this one. Reporter will not be able to provide the facility details. reporter did not known time of vaccination. Reporter stated, she did not have diabetes and she was not taking any hypertension medications. Reporter further stated, she told her she had doctors appointment in a few minutes, she had to go to, she need to get off the phone.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Paraesthesia, Pruritus
Clinical narrative: started having like involuntary muscle movements on different parts of body like legs, arms, face shoulders, stomach, etc.; started feeling itchiness all over body without getting any redness on skin; sometimes felt like a needle on some parts of body like hands or feet or back or neck, etc.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 15Aug2022 at 11:30 as dose 1, single (Lot number: FP7137) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 17Aug2022 at 22:45, outcome "not recovered", described as "sometimes felt like a needle on some parts of body like hands or feet or back or neck, etc."; PRURITUS (non-serious) with onset 17Aug2022 at 22:45, outcome "not recovered", described as "started feeling itchiness all over body without getting any redness on skin"; DYSKINESIA (non-serious) with onset 17Aug2022 at 22:45, outcome "not recovered", described as "started having like involuntary muscle movements on different parts of body like legs, arms, face shoulders, stomach, etc.". The events "started having like involuntary muscle movements on different parts of body like legs, arms, face shoulders, stomach, etc.", "started feeling itchiness all over body without getting any redness on skin" and "sometimes felt like a needle on some parts of body like hands or feet or back or neck, etc." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of dyskinesia, pruritus, paraesthesia. Reportedly, the patient had some steroids and some kind of allergy medication.  Additional information: The patient did not have Covid prior to vaccination and he was not tested positive post vaccination. Reportedly, no known allergies or other medical history. Also, no other vaccine in four weeks or other medications in two weeks.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, Urticaria
Clinical narrative: fever; itchy scratchy hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "itchy scratchy hives"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of urticaria, pyrexia.  Additional information: Caller is a consumer calling about the Covid-19 vaccine for last year. His mother had a reaction to the Flu vaccine and to the Covid-19 vaccine from last year. They treated her with cortisone and pain killers. Reporter said that he thinks they had her on a prednisone taper.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Malaise
Clinical narrative: Chills; Headache; Diarrhea; not feeling too well right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: CHILLS (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "unknown"; DIARRHOEA (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 2023, 3 days after the suspect product(s) administration, outcome "unknown"; MALAISE (non-serious) with onset 2023, outcome "not recovered", described as "not feeling too well right now".  Additional information: She was 80-year-old and had the COVID-19 Vaccine. Three days later she got sick: Got the chills, headache, and now had diarrhea. She was not feeling too well right now. Alternative phone number provided was her husbands number. Provides her husbands name as (Name: Withheld).   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: Big time vertigo; Killer headache; Queasy stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 27Oct2023, outcome "recovering", described as "Big time vertigo"; HEADACHE (non-serious) with onset 27Oct2023, outcome "recovering", described as "Killer headache"; NAUSEA (non-serious) with onset 27Oct2023, outcome "recovered" (30Oct2023), described as "Queasy stomach". Therapeutic measures were not taken as a result of vertigo, headache, nausea.  Additional information: Patient was calling about the latest Pfizer covid vaccine he had and states he was calling to report adverse reactions and he had the vaccine last Wednesday on 25Oct2023 and then on Friday 27Oct2023 he woke up that morning with a killer headache and big-time vertigo and a queasy stomach and he was ok now but it came out of the blue and it could be a coincidence. For the headache, states initially no it was not ongoing, and it was just a little spacey but it was definitely getting better; On Friday and Saturday he had to turn the TV way down and told his wife not to be loud and clarified the headache was just about gone and was getting better. Vertigo: It was just slightly where what he was doing was not stumbling around like he was on Friday and the vertigo was definitely improved. Queasy stomach: It was not ongoing and states it resolved today and he was still queasy yesterday. No other medical conditions to include and states he was pretty healthy. No treatment required for the reported events, and he just thought it would go away and it did. There were no other products administered to patient.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), 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 EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; not body ache so much anything like that just it really tired/ Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "not body ache so much anything like that just it really tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "not body ache so much anything like that just it really tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "not body ache so much anything like that just it really tired/ Tiredness".  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Tired", "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Tired", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "not body ache so much anything like that just it really tired/ Tiredness", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patien, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Lot number: HG2649), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 0 breast cancer", start date: 2019 (unspecified if ongoing). No Known allergies. Concomitant medication(s) included: TAMOXIFEN taken for breast cancer; IBUPROFEN. Vaccination history included: moderna (Vaccine administration date: 22Nov2022, Vaccine lot number: A57147B, Vaccine dose number: 5, Vaccine location: Left arm), administration date: 22Nov2022, when the patient was 55-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose 4 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1 Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2 Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Oct2023) Positive, notes: Retested positive on 29Oct2023. Retested positive on 29Oct2023, symptoms returned 27Oct2023. The patient received PAXLOVID as Treatment from 15Oct2023 to 20Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Mild bronchial asthma" (unspecified if ongoing); "Known allergies: drugs with opiates" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: moderna covid-19 vaccine (Dose 1, Batch/Lot No: 031M20A, Location of injection: Arm Left), administration date: 09Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 2, Batch/Lot No: 012A21A, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 67-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 3, Batch/Lot No: 039F21A, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 68-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 4, Batch/Lot No: 001M21A, Location of injection: Arm Left), administration date: 14Apr2022, when the patient was 68-year-old, for COVID-19 Immunization; covid-19 vaccine (Dose 5, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 28Sep2022, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Patient first developed COVID symptoms on 21Oct2023 which worsened the next day and she tested positive on 22Oct2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 22Oct2023 to 26Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High blood pressure; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient received bnt162b2 (BNT162B2), on 15May2021 as dose 4 (booster), single (Lot number: EW0167) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 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: HYPERTENSION (non-serious) with onset 20Oct2021, outcome "not recovered", described as "High blood pressure". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension. Additional information: Dose received: More than 3. High blood pressure reported to Dr (name withheld) on 20Oct2021, and amlodipine prescribed by Dr 15Sep2022. Ae treatment: Amlodipine 10mg If No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Memory impairment, Mental disorder, Somnolence
Clinical narrative: Knocked him out; when someone was talking to him about something he could not remember what they were talking about; messing with his head so bad/ wiped him out mentally; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "knocked him out", "when someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Knocked him out"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about"; MENTAL DISORDER (non-serious), outcome "unknown", described as "messing with his head so bad/ wiped him out mentally"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "takes away his ability to concentrate"; SOMNOLENCE (non-serious), outcome "unknown", described as "He will need to sleep it off over the weekend".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4  of his doses have had exact same thing. He will need to sleep it off over the weekend.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355612 same patient/drug/AEs and different dose;
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Memory impairment, Mental disorder, Somnolence
Clinical narrative: Knocked him out; when someone was talking to him about something he could not remember what they were talking about; messing with his head so bad/ wiped him out mentally; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "Knocked him out", "When someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "Knocked him out", "when someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend". The following information was reported: SOMNOLENCE (non-serious) with onset 2022, outcome "unknown", described as "He will need to sleep it off over the weekend"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Knocked him out"; MENTAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "messing with his head so bad/ wiped him out mentally"; DISTURBANCE IN ATTENTION (non-serious) with onset 2022, outcome "unknown", described as "takes away his ability to concentrate"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4  of his doses have had exact same thing. He will need to sleep it off over the weekend.    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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355612 same patient/drug/AEs and different dose;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid Rebound - 4 days after using Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for treatment.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive again for Covid on 01Nov2023 (have same symptoms as I had two weeks ago. Headache, congestion and malaise); Tested positive again for Covid on 01Nov2023 (have same symptoms as I had two weeks ago. Headache, congestion and malaise); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Tested positive again for Covid on 01Nov2023 (have same symptoms as I had two weeks ago. Headache, congestion and malaise)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 19Oct2023 to 24Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 at 04:45 as dose 1, single (Lot number: HF9298) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 30Oct2023 as dose 1, single; FISH OIL; VITAMIN D NOS; COQ 10; TURMERIC [CURCUMA LONGA]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset 01Nov2023 at 07:00, outcome "recovering" and all described as "injection site was itchy, warm to touch, and turned black & blue approx. 2 days after". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site warmth, vaccination site discolouration.  Additional Information: Comirnaty dose was received as more than 3 doses. The patient did not experience COVID prior to vaccination and was not tested positive post vaccination. The patient has no allergies that she was aware of. Other medication in two weeks included multi vit. and simv
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 contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 26Sep2023 as dose 5, single (Lot number: HG4680), in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if 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; 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient started Paxlovid for COVID 19 Treatment on 24Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure, COVID-19  cannot be excluded
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: VUMERITY, start date: 01Mar2021. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 24Oct2023 to 29Oct2023. Clinical course: Patient had no known allergies  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-202300356700 same patient, different drug /event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment-PAXLOVID; COVID 19 Treatment-PAXLOVID; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: GG7223) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation, reaction(s): "no adverse event"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation, reaction(s): "She had horrible intense itching to the booster for 6 weeks". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment-PAXLOVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356590 same patient, different drug/AE.;US-PFIZER INC-202300357092 Same patient/product, different dose/events;US-PFIZER INC-202300357093 Same patient/product, different dose/events;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "High BP" (unspecified if ongoing); "MDD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "cancer in remission" (unspecified if ongoing), notes: no active treatment, have been NED for 8 years. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 15Nov2022, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 15Mar2023, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Arm Left), administration date: 17Jun2023, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Arm Left), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Oct2023 to 30Oct2023.  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-202300356717 Same patient, different product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received bnt162b2 (BNT162B2), in Aug2022 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. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown"; SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown". Clinical course: Patient stated that all right the last time patient did't have the records on the many more in (withheld) but the last it was a year and half ago, let says that was in late Aug2022 and he was hospitalized because of this Covid. Patient confirmed that Comirnaty shot was administered in Aug2022.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mixed connective tissue disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Drug allergy: bactrim"; Clindamycin, reaction(s): "Drug allergy: clindamycin". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 23Oct2023 to 28Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300357315 same reporter/patient, different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 71-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in right 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 Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 27Oct2023 to 01Nov2023 .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.