chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pruritus
Clinical narrative: swelling; skin irritation; itching of her vaginal tissue, buttocks; itching of her vaginal tissue, buttocks; urinary tract infection; yeast infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NVN-20231205-2275 (RA).  A female patient (unknown if pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 2016 (unspecified if ongoing); "skin sensitivities" (unspecified if ongoing); "allergies to chocolate, cinnamon" (unspecified if ongoing); "allergies to vanilla" (unspecified if ongoing); "allergies to skin adhesive" (unspecified if ongoing); "allergies to milk" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Minivelle, start date: 2016, for Hormone replacement, reaction(s): "excruciating vaginal pain", notes: The only time she has had an issues with Minivelle is when she is not on the medication. She forgotten to place a patch on, or got busy with life and went without a patch.; Minivelle, start date: 2016, for Hormone replacement, reaction(s): "severe vaginal atrophy", notes: The only time she has had an issues with Minivelle is when she is not on the medication. She forgotten to place a patch on, or got busy with life and went without a patch. The following information was reported: SWELLING (non-serious), outcome "recovered"; SKIN IRRITATION (non-serious), outcome "recovered"; VULVOVAGINAL PRURITUS (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "itching of her vaginal tissue, buttocks"; URINARY TRACT INFECTION (non-serious), outcome "recovered"; FUNGAL INFECTION (non-serious), outcome "recovered", described as "yeast infection". Therapeutic measures were taken as a result of swelling, skin irritation, vulvovaginal pruritus, pruritus, urinary tract infection, fungal infection.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: paxlovid treatment; paxlovid treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 13:15 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: "Hypertension" (unspecified if ongoing); "known allergies: sulfa containing antibiotic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical location: Arm Left, Batch/Lot Number: ej1685), administration date: 22Dec2020, when the patient was 67-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 2, SINGLE, Anatomical location: Arm Left), administration date: 11Jan2021, when the patient was 67-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Arm Left, Batch/Lot Number: 301358a), administration date: 21Sep2021, when the patient was 68-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm Left, Batch/Lot Number: fj9943), administration date: 03Apr2022, when the patient was 68-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Arm Left, Batch/Lot Number: gj6665), administration date: 11Oct2022, when the patient was 69-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Arm Left, Batch/Lot Number: gk1337), administration date: 12May2023, when the patient was 69-year-old, for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "paxlovid treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as paxlovid from 30Nov2023 to 06Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship to the suspect drug cannot be totally excluded for the event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to wasp stings" (unspecified if ongoing); "COVID-19", start date: 2022 (unspecified if ongoing), notes: I previously had COVID-19 in the summer of 2022. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 24Dec2020, when the patient was 36-year-old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Jan2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2023, outcome "recovered" (10Dec2023) and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2023) Positive; (10Dec2023) Negative, notes: Tested negative the evening of 10Dec. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 07Dec2023 and stop date 11Dec2023. Patient had symptoms on late at night on 05Dec and tested on 06Dec, was positive for COVID. Patient took Paxlovid on the evening of 06Dec and tested negative the evening of 10Dec. Patient had his last dose of Paxlovid that AM on 11Dec.  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-202200806706 same patient, different vaccine/doses/AE;
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness and dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness and dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 27Nov2023 to 08Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: As of 08Dec2023 I tested positive with COVID; As of 08Dec2023 I tested positive with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "unknown" and all described as "As of 08Dec2023 I tested positive with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2023) Positive.  Clinical information: Patient reported that they received the latest COVID shot on 21Nov2023 at the (Pharmacy name withheld). Comirnaty 30 MCG/0.3MK INJ PFIZ, NDC:00069-2362-10. Several days following that injection they began having one sided headaches that lasted 5 days. As of 08Dec2023 they tested positive with COVID and they immediately began having those same headaches on the right side of their head and forehead as well. It makes them question if this particular batch was safe, well tested. It seemed to be quite the coincidence.  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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, Malaise, Nasal congestion
Clinical narrative: 100° Fever 2 days; headache; congestion; sore throat; hoarseness; body aches; malaise; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 at 12:00 as dose 1, single (Lot number: HM7010) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for covid-19 immunization; Covid-19 vaccine (dose 2), for covid-19 immunization; Covid-19 vaccine (dose 3), for covid-19 immunization; Covid-19 vaccine (dose 4), for covid-19 immunization; Covid-19 vaccine (dose 5), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 08Dec2023, outcome "recovering", described as "100° Fever 2 days"; PAIN (non-serious) with onset 08Dec2023, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 08Dec2023, outcome "recovering", described as "congestion"; COUGH (non-serious) with onset 08Dec2023, outcome "recovering"; HEADACHE (non-serious) with onset 08Dec2023, outcome "recovering"; DYSPHONIA (non-serious) with onset 08Dec2023, outcome "recovering", described as "hoarseness"; MALAISE (non-serious) with onset 08Dec2023, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 08Dec2023, outcome "recovering", described as "sore throat". Therapeutic measures were not taken as a result of pyrexia, headache, nasal congestion, oropharyngeal pain, dysphonia, pain, malaise, cough. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no drug with allergy.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 100° Fever 2 days; headache; congestion; sore throat; hoarseness; body aches; malaise; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Dec2023 at 12:00 as dose 1, single (Lot number: HM7010) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for covid-19 immunization; Covid-19 vaccine (dose 2), for covid-19 immunization; Covid-19 vaccine (dose 3), for covid-19 immunization; Covid-19 vaccine (dose 4), for covid-19 immunization; Covid-19 vaccine (dose 5), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 08Dec2023, outcome "recovering", described as "100° Fever 2 days"; PAIN (non-serious) with onset 08Dec2023, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 08Dec2023, outcome "recovering", described as "congestion"; COUGH (non-serious) with onset 08Dec2023, outcome "recovering"; HEADACHE (non-serious) with onset 08Dec2023, outcome "recovering"; DYSPHONIA (non-serious) with onset 08Dec2023, outcome "recovering", described as "hoarseness"; MALAISE (non-serious) with onset 08Dec2023, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 08Dec2023, outcome "recovering", described as "sore throat". Therapeutic measures were not taken as a result of pyrexia, headache, nasal congestion, oropharyngeal pain, dysphonia, pain, malaise, cough. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no drug with allergy.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neurosarcoidosis, Uveitis
Clinical narrative: uveitis; Neurosarcoid; This is a spontaneous report received from contactable reporter(s) (Physician).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROSARCOIDOSIS (medically significant) with onset 2023, outcome "recovering", described as "Neurosarcoid"; UVEITIS (medically significant), outcome "recovering". The events "neurosarcoid" and "uveitis" required physician office visit. Therapeutic measures were taken as a result of neurosarcoidosis, uveitis. Clinical course: Reportedly, patient developed uveitis after Covid vaccine not sure about exact time, neurologist diagnosed Neurosarcoid in 2023. Patient was improving with medicines.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (BNT162B2) to the reported events cannot be excluded. Events are considered Related conservatively. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Blood test, Confusional state, Dizziness, Dysphagia
Clinical narrative: Dizziness; Short breath; have hard time breathing; Losing energy; Confusion; Hard time swallowing the food; Heart flips; feel confusion like 'nausea'; This is a spontaneous report received from a 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 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: Unknown), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Lot number: Unknown), in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "Short breath; have hard time breathing"; ASTHENIA (non-serious), outcome "unknown", described as "Losing energy"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion"; DYSPHAGIA (non-serious), outcome "unknown", described as "Hard time swallowing the food"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart flips"; NAUSEA (non-serious), outcome "unknown", described as "feel confusion like 'nausea'". The events "short breath; have hard time breathing", "hard time swallowing the food" and "heart flips" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphagia.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dyspnoea, Nausea, Palpitations
Clinical narrative: Dizziness; Short breath; have hard time breathing; Losing energy; Confusion; Hard time swallowing the food; Heart flips; feel confusion like 'nausea'; This is a spontaneous report received from a 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 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: Unknown), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Lot number: Unknown), in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "Short breath; have hard time breathing"; ASTHENIA (non-serious), outcome "unknown", described as "Losing energy"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion"; DYSPHAGIA (non-serious), outcome "unknown", described as "Hard time swallowing the food"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart flips"; NAUSEA (non-serious), outcome "unknown", described as "feel confusion like 'nausea'". The events "short breath; have hard time breathing", "hard time swallowing the food" and "heart flips" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphagia.
Age: 54.0
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 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received Paxlovid on 02Dec2023 till 06Dec2023 for the treatment of COVID-19. Other medication in 2 weeks was unknown.  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: 33.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-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 33 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 11Dec2023. 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.
Age: 73.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "cancer (recovered 1997)", stop date: 1997. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (08Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (08Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Nov2023 to 04Dec2023. 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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Covid-19 treatment from 30Nov2023 to 05Dec2023.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Your first Covid 19 vaccine fully cured my covid symptoms every time I got it (or a booster); Your first Covid 19 vaccine fully cured my covid symptoms every time I got it (or a booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. 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 included: "extreme fatigue" (unspecified if ongoing), notes: ~~~; "heart palpitations" (unspecified if ongoing); "severe brain fog" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Your first Covid 19 vaccine fully cured my covid symptoms every time I got it (or a booster)".  Clinical Information: It was reported that Patient was an early case of Covid and now have been diagnosed with long covid by the University of (Name withheld) health system. Patient created a detailed timeline of illness that I can share as well. Patient had extreme fatigue, heart palpitations, and severe brain fog. Your first Covid 19 vaccine fully cured my covid symptoms every time I got it (or a booster). Unfortunately the bivalent did not have the same effect. Is there any way to get original formula, I just want my life back. Please.  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-PV202300202270 same reporter and product, different dose and event .;
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Tinnitus; driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Primary Immunisation Series Complete), for COVID-19 Immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "driving me crazy". Additional information: The patient had his/her first Covid-19 vaccine of Johnson and Johnson, and his/her second shoot was Pfizer, in about 1 month after having it, patient developed Tinnitus, a very difficult, annoying, depressed, painful, sound inside his/her ears 24/7. This was driving him/her crazy.  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: M
Vaccine: RSV
Symptoms: Illness
Clinical narrative: He's been sick.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 60-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown,single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Last year he was on a ventilator for a couple months" (unspecified if ongoing); "he can go back in the hospital again" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: ILLNESS (life threatening), outcome "unknown", described as "He's been sick.". Therapeutic measures were taken as a result of illness. Clinical course: Patient has been sick. Patient was on a ventilator, He's been real sick, Last year he was on a ventilator for a couple months so he doesn't want to get RSV or pneumonia cause he can go back in the hospital again. 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, RSV
Symptoms: Blood pressure measurement, Decreased appetite, Malaise, Positron emission tomogram
Clinical narrative: not feeling well or eating well; not feeling well or eating well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2022-110563 (RA).  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "nodules", start date: Apr2023 (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing), notes: Preexisting history, prior to Lenvima; "radiation therapy", start date: 26Aug2023 (not ongoing), notes: Remained on lenvatinib mesilate (LENVIMA) without pause; "Endometrial Cancer diagnosis" (unspecified if ongoing). Concomitant medication(s) included: LENVIMA taken for endometrial cancer, start date: 02Mar2022 (ongoing); KEYTRUDA. The following information was reported: MALAISE (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "not feeling well or eating well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient voiced that her blood pressure had been steady around 111/76, also referred to previously reported respiratory syncytial virus (RSV) and COVID vaccines having received at the same time in October (Oct2023, exact date unknown and unknown type of COVID vaccine received) and not feeling well or eating well thereafter. The patient reported that she went through a one week round of radiation therapy starting on 26Aug2023 (and remained on lenvatinib mesilate (LENVIMA) without pause) and reported that around then she also had low blood pressure to 90/50 and also suspected that she had a cold, voiced that she had an appointment to see her healthcare professional and her blood pressure was now stable at 114/80. The patient reported that her blood pressure was now 118/71 now that she was no longer on radiation therapy. Previously reported positron emission tomogram (PET) scan results (Apr2023, exact date unknown) had shown nodules for which she had to undergo previously reported radiation therapy, also had low fiber and a preexisting history of Diverticulitis (prior to Lenvima).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Malaise, Pyrexia, Rash, Varicella
Clinical narrative: fever, rash, anorexia, malaise, chickenpox
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Only diluent was given, it was not mixed with the powder
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Inflammation, Pain, Swelling
Clinical narrative: Local pain, swelling, erythema, induration -- approximately 5cm diameter. No systemic hypersensitivity response.  Mild response, will be observational/supportive care at home. Possible this area of inflammation could be attributable to venous injury from the IM needle puncture, and not an allergenic response.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Wrong immunization given, Trumenba ordered, Bexsero given
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pulmonary thrombosis
Clinical narrative: PATIENT PRESENTED HERSELF AND SAID SHE WAS HOSPITALIZED ON 11/18/23 DUE TO RSV VACCINE HAD BLOOD CLOTS IN BOTH LUNGS,WE TRIED TO GET MORE INFORMATION FROM PRIMARY DOCTOR HOWEVER OFFICE STAFF WAS UNWILLING AND NOT CO-OPERATING TO RELEASE ANY INFO,EVEN AFTER REACHING OUT MULTIPLE TIMES
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error, Pyrexia
Clinical narrative: The vial was not diluted before giving 0.3ML dose. Later that evening while at home she developed a fever and was taken to the ER by her mother.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Abnormal behaviour, Blood test normal, Chest X-ray normal, Computerised tomogram normal, Decreased appetite
Clinical narrative: 12 hours: extreme tiredness, loss of appetite, incontinence 24-36 hours: incoherent, hallucinations, incontinence, instability-trouble walking 4th day: bizaar actions, hallucinations,  went to the ER (on a hospital watch for dementia symptoms, took a CT, X-ray of hip, Chest Xray, blood test: everything came back normal)  Symptoms resolved on 12/13/23 PCP has been alerted of reaction- to follow up on 12/18/23
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Gait disturbance, Hallucination, Incoherent, Incontinence
Clinical narrative: 12 hours: extreme tiredness, loss of appetite, incontinence 24-36 hours: incoherent, hallucinations, incontinence, instability-trouble walking 4th day: bizaar actions, hallucinations,  went to the ER (on a hospital watch for dementia symptoms, took a CT, X-ray of hip, Chest Xray, blood test: everything came back normal)  Symptoms resolved on 12/13/23 PCP has been alerted of reaction- to follow up on 12/18/23
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: X-ray of pelvis and hip normal
Clinical narrative: 12 hours: extreme tiredness, loss of appetite, incontinence 24-36 hours: incoherent, hallucinations, incontinence, instability-trouble walking 4th day: bizaar actions, hallucinations,  went to the ER (on a hospital watch for dementia symptoms, took a CT, X-ray of hip, Chest Xray, blood test: everything came back normal)  Symptoms resolved on 12/13/23 PCP has been alerted of reaction- to follow up on 12/18/23
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Trumenba ordered, Bexsero given
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Respiratory tract infection, Seasonal allergy, Upper respiratory tract infection
Clinical narrative: Severe allergy to pollen causing repeated upper respiratory tract infections.  Lthargy
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Erythema
Clinical narrative: reaction on arm, red circle
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Cervical dilatation, Exposure during pregnancy
Clinical narrative: Received RSV vaccine at 32weeks 5 days. Had contractions starting 2 days after. Presented to hospital on day 5 after receiving with confirmed dilation and thinning. Continuing still
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular symptom, Chest X-ray, Electrocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: Patient was diagnosed with , Pericarditis & Myocarditis after having heart attack like symptoms and being hospitalized for 5 days
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Ultrasound scan
Clinical narrative: Patient was diagnosed with , Pericarditis & Myocarditis after having heart attack like symptoms and being hospitalized for 5 days
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Pruritus
Clinical narrative: Cellulitis 15 cm x 16.5 cm to left arm. Patient endorsed it started itching the day after the administration of the vaccines. Patient was prescribed cephalexin (KEFLEX) 250 mg/5 mL suspension 280 mL 0 12/14/2023 12/21/2023 Sig: Take 10 mL by mouth 4 (four) times daily for 7 days and ibuprofen 100 mg/5 mL suspension 354 mL 0 12/14/2023 Sig: Take 18 mL by mouth every 6 (six) hours as needed for pain.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hemiparesis, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Patient developed extreme fatigue and muscle weakness after the first dose. Symptoms improved with acupuncture. Symptoms returned after the second dose of the vaccine.  Symptoms have continued and worsened. She has ongoing right sided weakness and numbness and ongoing fatigue. Symptoms have become debilitating.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck
Clinical narrative: Patient developed extreme fatigue and muscle weakness after the first dose. Symptoms improved with acupuncture. Symptoms returned after the second dose of the vaccine.  Symptoms have continued and worsened. She has ongoing right sided weakness and numbness and ongoing fatigue. Symptoms have become debilitating.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Seizure like phenomena
Clinical narrative: Patient had a seizure like episode after getting vaccine
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site pain, Insomnia, Joint range of motion decreased, Osteoarthritis
Clinical narrative: Patient complained of right shoulder pain 2 days after injection. No redness or swelling, rash or blistering. Patient reports decrease range of motion and inability to sleep due to pain.  Seen in clinic on 12/13 xray obtained and showed Mild right shoulder osteoarthritis without acute osseous abnormality.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: X-ray limb abnormal
Clinical narrative: Patient complained of right shoulder pain 2 days after injection. No redness or swelling, rash or blistering. Patient reports decrease range of motion and inability to sleep due to pain.  Seen in clinic on 12/13 xray obtained and showed Mild right shoulder osteoarthritis without acute osseous abnormality.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Presyncope
Clinical narrative: On 12/12/2023 at 10:30 am after administration of HPV vaccine pt had a near syncope episode. Symptoms improved when she was lying down. Oxygen, blood pressure, blood sugar in the normal range. Recommend monitoring at home advised to stay well-hydrated and eat regularly. On 12/13/2023 school nurse called mom stating pt passed out at school. Pt did not eat breakfast or lunch. Pt advised to eat regularly and stay hydrated. School note given to snack at school.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Dyskinesia, Fall, Loss of consciousness, Pallor, Seizure like phenomena
Clinical narrative: On 12/12/2023 at 10:30 am after administration of HPV vaccine pt had a near syncope episode. Symptoms improved when she was lying down. Oxygen, blood pressure, blood sugar in the normal range. Recommend monitoring at home advised to stay well-hydrated and eat regularly. On 12/13/2023 school nurse called mom stating pt passed out at school. Pt did not eat breakfast or lunch. Pt advised to eat regularly and stay hydrated. School note given to snack at school.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, HPV9
Symptoms: Tremor
Clinical narrative: On 12/12/2023 at 10:30 am after administration of HPV vaccine pt had a near syncope episode. Symptoms improved when she was lying down. Oxygen, blood pressure, blood sugar in the normal range. Recommend monitoring at home advised to stay well-hydrated and eat regularly. On 12/13/2023 school nurse called mom stating pt passed out at school. Pt did not eat breakfast or lunch. Pt advised to eat regularly and stay hydrated. School note given to snack at school.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Patient reported muscle tension in both arms. We offered him an epipen, he declined. We called 911. Parametics took him for an evaluation.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, Chronic lymphocytic leukaemia, Condition aggravated, Cough
Clinical narrative: Admit date: 12/10/2023  Discharge date:  12/14/23  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Cough  90 YO male  with history of CLL on Venclexta, CAD, and COPD who presented with increased productive cough for about 1.5 weeks.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Workup shows bacterial pneumonia, COVID positive, hypoxic  Community-acquired pneumonia, COVID 19 infection, hypoxia, sepsis IV Rocephin,, doxycycline, supplemental oxygen, respiratory toilet, Legionella and Streptococcus pneumoniae antigen in the urine are negative, blood cultures are pending IV remdesivir and Decadron 4 COVID 19 positive with hypoxia  Hypokalemia and hypo magnesemia-being supplemented and replaced  -CLL current immunosuppressive Venetoclax being had  Thrombocytopenia, anemia-related to CLL 12/12 worsened thrombocytopenia down to 38 K 12/13 platelet count further down to 35 K  -coronary artery disease, status post stent  -blood pressure, continue Flomax and Proscar  Remains non hypoxic, platelet count decreased to 35 K Discharged to Home
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokalaemia, Hypomagnesaemia, Hypoxia, Immunosuppressant drug therapy, Legionella test
Clinical narrative: Admit date: 12/10/2023  Discharge date:  12/14/23  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Cough  90 YO male  with history of CLL on Venclexta, CAD, and COPD who presented with increased productive cough for about 1.5 weeks.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Workup shows bacterial pneumonia, COVID positive, hypoxic  Community-acquired pneumonia, COVID 19 infection, hypoxia, sepsis IV Rocephin,, doxycycline, supplemental oxygen, respiratory toilet, Legionella and Streptococcus pneumoniae antigen in the urine are negative, blood cultures are pending IV remdesivir and Decadron 4 COVID 19 positive with hypoxia  Hypokalemia and hypo magnesemia-being supplemented and replaced  -CLL current immunosuppressive Venetoclax being had  Thrombocytopenia, anemia-related to CLL 12/12 worsened thrombocytopenia down to 38 K 12/13 platelet count further down to 35 K  -coronary artery disease, status post stent  -blood pressure, continue Flomax and Proscar  Remains non hypoxic, platelet count decreased to 35 K Discharged to Home
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Pneumonia, Pneumonia bacterial, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Admit date: 12/10/2023  Discharge date:  12/14/23  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Cough  90 YO male  with history of CLL on Venclexta, CAD, and COPD who presented with increased productive cough for about 1.5 weeks.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Workup shows bacterial pneumonia, COVID positive, hypoxic  Community-acquired pneumonia, COVID 19 infection, hypoxia, sepsis IV Rocephin,, doxycycline, supplemental oxygen, respiratory toilet, Legionella and Streptococcus pneumoniae antigen in the urine are negative, blood cultures are pending IV remdesivir and Decadron 4 COVID 19 positive with hypoxia  Hypokalemia and hypo magnesemia-being supplemented and replaced  -CLL current immunosuppressive Venetoclax being had  Thrombocytopenia, anemia-related to CLL 12/12 worsened thrombocytopenia down to 38 K 12/13 platelet count further down to 35 K  -coronary artery disease, status post stent  -blood pressure, continue Flomax and Proscar  Remains non hypoxic, platelet count decreased to 35 K Discharged to Home
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Streptococcus test negative, Thrombocytopenia
Clinical narrative: Admit date: 12/10/2023  Discharge date:  12/14/23  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Cough  90 YO male  with history of CLL on Venclexta, CAD, and COPD who presented with increased productive cough for about 1.5 weeks.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Workup shows bacterial pneumonia, COVID positive, hypoxic  Community-acquired pneumonia, COVID 19 infection, hypoxia, sepsis IV Rocephin,, doxycycline, supplemental oxygen, respiratory toilet, Legionella and Streptococcus pneumoniae antigen in the urine are negative, blood cultures are pending IV remdesivir and Decadron 4 COVID 19 positive with hypoxia  Hypokalemia and hypo magnesemia-being supplemented and replaced  -CLL current immunosuppressive Venetoclax being had  Thrombocytopenia, anemia-related to CLL 12/12 worsened thrombocytopenia down to 38 K 12/13 platelet count further down to 35 K  -coronary artery disease, status post stent  -blood pressure, continue Flomax and Proscar  Remains non hypoxic, platelet count decreased to 35 K Discharged to Home
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dyspnoea, Erythema, Impaired work ability, Loss of employment
Clinical narrative: I got the booster, the next day I got fired from my job the next day bc they thought I had covid but it was a reaction my arm swelled up. Pharmacy had me sit down but then sent me to the ER so they could check it out. They gave me a shot for the reaction I was having in my arm. I went home and rested. I wasn't allowed to go back to work. I still have shortness of breath, sinus issues with running nose, sneezing, and the red swelling in my arm did go away.  I am now wearing a heart monitor as of this morning to see if its my heart in relation to my shortness of breath. I will turn it back in Monday morning at the heart doctor.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rhinorrhoea, Sneezing
Clinical narrative: I got the booster, the next day I got fired from my job the next day bc they thought I had covid but it was a reaction my arm swelled up. Pharmacy had me sit down but then sent me to the ER so they could check it out. They gave me a shot for the reaction I was having in my arm. I went home and rested. I wasn't allowed to go back to work. I still have shortness of breath, sinus issues with running nose, sneezing, and the red swelling in my arm did go away.  I am now wearing a heart monitor as of this morning to see if its my heart in relation to my shortness of breath. I will turn it back in Monday morning at the heart doctor.