chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event
Clinical narrative: No adverse reactions noted.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varivax was administered within 28 days of MMR administration. MMR was administered on 8/23/2023.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain and stiffness in neck that began about an hour after my vaccination and lasted about 6 weeks.  I sought medical attention after about 2 weeks and was prescribed a steroid for treatment at a Urgent Care facility. I also received 2 treatments at a chiropractor to help.
Age: 41.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was given a dose of MMRV instead of MMR.  Was not noticed until I went to chart the encounter.  Patient did not speak language, which made things difficult and tense.  We were trying to make sure he understood what we were trying to tell him about costs and his need for the other vaccines on his record.  He had an app on his phone, and he also called his friend to help out with the information.    Patient walked out of the office, and was at home when error was noticed.  In discussing with coordinator, it can be used off market and should not harm the patient.  Patient was not notified because of the necessity for app and friend to communicate the error.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Magnetic resonance imaging abnormal, Optic neuritis, Papilloedema, Vision blurred
Clinical narrative: Optic Neuritis  Right eye Blurry vision starting around 7/2/2020 worsened & seen by Ophthalmologist on 7/16/20 & noted to have optic disc edema  Hospitalized & tx with iv solumedrol x3 dys
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Antinuclear antibody, Atrial flutter, Biopsy, Borrelia test
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Cardioversion, Colonoscopy, Computerised tomogram, Cough
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cytokine test, Decreased appetite, Electrocardiogram, Exercise tolerance decreased, Full blood count
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Heavy metal test, Hydrocele, Inflammation, Inflammatory marker increased
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Interleukin level, Laboratory test, Mesenteric panniculitis, Metabolic function test, Muscle spasms
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Oedema peripheral, Panniculitis, Peripheral swelling, Positron emission tomogram
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Swelling, Ultrasound scan, Weight decreased
Clinical narrative: Began as swelling in left calf. Progressed to inflammation and swelling in both legs.  Reduced ability to walk and exercise to full extent.  Had atrial flutter in January that required a cardio version on 1/23/23 with no prior history.  Progressed to to inflammation in multiple sites. Bilateral hydraceles, Panniculitis in legs and mesenteric panniculitis.   Persistent dry cough. Weight loss. Loss of appetite. Muscle cramping. Nite sweats. Swelling in rectum. Edema in legs and abdominal bloating. Inflammation in abdominal cavity. High inflammatory markers. Admitted to hospital 3 time s for tests and care.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Somnolence
Clinical narrative: Symptoms began 3 days after vaccine, disruption to daily life, extremely high fever lasting 7 days so far, lethargic, not eating or drinking much, sleeping most of the day
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Chest pain, Pericarditis
Clinical narrative: Patient experienced chest pain.  He went to the ER and was diagnosed with Pericarditis.
Age: 5.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, Product administration error, Vaccination site pain
Clinical narrative: 09/06/2023: RN administered 0.5 ML Moderna Bivalent COVID-19 Vaccine to patient during scheduled Nurse Visit today @ 2:08 PM. Patient is 5Y 9M old and per CDC Guidelines should have received 0.25 ML dose of Moderna Bivalent COVID-19. Dr. notified of error. Medical Manager notified of error.   Attempted to contact patient's Mother to inform her of administration dosage error. No answer. Unable to leave message as voicemail not set up. Will attempt to contact Mother again at later time.  09/07/2023 09:21:13 AM >  Spoke to patient's mother. Informed her of COVID-19 Bivalent dosage error. Asked mother if patient experiencing any side effects from vaccination. Mother reports that the only thing patient complained of was that his arm was sore where he received his vaccination. Mother denies patient having any redness, swelling, or rash to injection sites. Mother denies patient having any other side effects from vaccination.  Mother states that patient went to school today. Reviewed with mother that patient could experience increased general side effects of COVID vaccination as a result of higher dose administered including: soreness, redness & swelling at injection site, muscle/joint pain, headache, fever, nausea, vomiting, rash, loss of appetite. Reviewed signs & symptoms of severe allergic reaction with mother. Advised mother to contact Clinic if patient experiences any concerning side effects. Reviewed emergency precautions with mother and advised if patient experiences any emergent symptoms or severe allergic response to go to ER immediately for evaluation. No further questions or concerns.
Age: 7.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: 09/06/2023: RN administered 0.5 ML Moderna Bivalent COVID-19 Vaccine to patient during scheduled Nurse Visit today @ 2:05 PM. Patient is 7Y 10M old and per CDC Guidelines should have received 0.25 ML dose of Moderna Bivalent COVID-19. Dr. notified of error. Medical Manager notified of error.   Attempted to contact patient's Mother to inform her of administration dosage error. No answer. Unable to leave message as voicemail not set up. Will attempt to contact Mother again at later time.  09/07/2023 09:21:13 AM MDT >  Spoke to patient's mother. Informed her of COVID-19 Bivalent dosage error. Asked mother if patient experiencing any side effects from vaccination. Mother reports that the only thing patient complained of was that his arm was sore where he received his vaccination. Mother denies patient having any redness, swelling, or rash to injection sites. Mother denies patient having any other side effects from vaccination.  Mother states that patient went to school today. Reviewed with Mother that patient could experience increased general side effects of COVID vaccination as a result of higher dose administered including: soreness, redness & swelling at injection site, muscle/joint pain, headache, fever, nausea, vomiting, rash, loss of appetite. Reviewed signs & symptoms of severe allergic reaction with Mother. Advised Mother to contact Clinic if patient experiences any concerning side effects. Reviewed emergency precautions with Mother and advised if patient experiences any emergent symptoms or severe allergic response to go to ER immediately for evaluation. No further questions or concerns.
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported red, raised circular area  near injection site. Warm to touch.
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient reported red, raised circular area  near injection site. Warm to touch.
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Cellulitis
Clinical narrative: Patient reported red, raised circular area  near injection site. Warm to touch.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: In early February, less than a month after receiving the Booster Shot at local Pharmacy, I noticed a ringing in my left ear.  This was something I never had it before. It is annoying but won't go away.  I reported to VAERS online soon after I became sure the connection  of it to the shot,  but my report was without a lot number.  I recently obtained it after some calling around including Moderna company. So this report shows the lot number for your record.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was only 52 years old
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was erroneously given Hep A vaccine when, instead, she was requesting the Hep B vaccine. No symptoms or adverse outcomes as a result of the mistake.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TD
Symptoms: Rash morbilliform, Rash papular, Rash pruritic
Clinical narrative: Parent called to report patient has rash on face, neck, chest, back, arms, and legs. Rask is raised, itchy, no fluid/drainage, no redness. Parent reported she asked her mom to look at rash and stated rash looked like measles. Parent reported she has not used any OTC meds (topical or oral) for rash and has only bathed child with DOVE body wash. Advised parent to take child to Urgent Care for evaluation of rash, and she may use mild OTC treatment for itching (e.g., calamine lotion, Benadryl topical cream/ointment, Aveeno bath). Also explained to parent that a VAERS report would be filed to report the reaction she has reported patient had to the vaccines.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Donor has 2.25 inch x 1 inch localized tenderness, redness, swelling, and warm to touch in left deltoid on 09/07/2023.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to arthropod bite, Injection site swelling, Injection site warmth, Syncope
Clinical narrative: This was Shot #2 in the Shingrex series Approximately 3 hours after shot, experienced swelling and heat in injection area. I considered this normal based on Shot #1. Approximately 12 hours after shot, fainted on kitchen floor with no history of fainting
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chronic kidney disease, Exercise tolerance decreased, Glomerular filtration rate decreased, Jaundice
Clinical narrative: Joint pain and body aches that lasted approximately 3-4 months.  Yellowed/jaundiced appearance, swelling/puffiness of face, decreased capacity for aerobic exertion - all of which endured 4-5 months.  Lab work completed in August 2021 (08/05/2021) that indicated chronic kidney disease range for eGFR (46).  eGFR was tested previously in December 2020 and tested in normal range (63).
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal, Pain, Swelling face, Yellow skin
Clinical narrative: Joint pain and body aches that lasted approximately 3-4 months.  Yellowed/jaundiced appearance, swelling/puffiness of face, decreased capacity for aerobic exertion - all of which endured 4-5 months.  Lab work completed in August 2021 (08/05/2021) that indicated chronic kidney disease range for eGFR (46).  eGFR was tested previously in December 2020 and tested in normal range (63).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: While prepping vaccines for patient, Men A was correctly prepped and given. TDAP was given incorrectly at time of vaccination. Patients arm was very sore for a few days. But since then has gotten better.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: Patient has soreness in the joint area of the left shoulder, Patient states that the injection site was above the muscle of the arm. It felt higher then usual and patient assumed it was how it is done now.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Ever expanding (now down to elbow) rash and swelling with warm itching
Age: 51.0
Sex: M
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 24Aug2023 to 29Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291329 same patient, different drug/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic asthma/Asthma" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Chronic idiopathic urticaria" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Semaglutide, reaction(s): "Known allergies: Semaglutide"; Linagliptin, reaction(s): "Known allergies: Linagliptin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 23Aug2023 to 28Aug2023.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5  to the event drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300291519 Same patient, different event/drug;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 09:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 at 18:00 as dose 1, single (Lot number: 012A218), in left arm, on 02Apr2021 at 18:00 as dose 2, single (Lot number: 048A21A), in left arm and on 17Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 069F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome (hypermobility)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022 at 09:00, outcome "recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2023, outcome "recovered" (28Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2023) positive, notes: First tested positive 23Aug2023; (28Aug2023) negative; (29Aug2023) negative; (30Aug2023) negative; (31Aug2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 23Aug2023 to 28Aug2023 for COVID-19 .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291483 same patient, different drug/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meniere's Disease" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2023, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 23Aug2023 to 28Aug2023.  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: Based on the available information and the known product safety profile, a causal relationship between the reported events Interchange of vaccine products, Drug ineffective, COVID-19 and suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300291342 same patient/reporter; different drug/AE;
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advair, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 25Aug2023 to 29Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Aug2023 to 31Aug2023.  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-202300292532 same patient/ reporter, different drug/event;
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injection site pain, Injection site pruritus, Vaccination site pain
Clinical narrative: Fatigue; headache; Pain at injection site; itchiness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Sep2023 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for immunisation. The patient's relevant medical history included: "Essential tremors" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VENLAFAXINE; BUSPAR; ATENOLOL; COLACE. The following information was reported: FATIGUE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2023, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious) with onset 02Sep2023, outcome "recovering", described as "itchiness at injection site". Therapeutic measures were not taken as a result of fatigue, headache, vaccination site pain, vaccination site pruritus.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site pruritus
Clinical narrative: Fatigue; headache; Pain at injection site; itchiness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Sep2023 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for immunisation. The patient's relevant medical history included: "Essential tremors" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VENLAFAXINE; BUSPAR; ATENOLOL; COLACE. The following information was reported: FATIGUE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2023, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 02Sep2023, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious) with onset 02Sep2023, outcome "recovering", described as "itchiness at injection site". Therapeutic measures were not taken as a result of fatigue, headache, vaccination site pain, vaccination site pruritus.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. Past drug history included: Cephalosporins, reaction(s): "Cephalosporins allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures Paxlovid Treatment (start date: 20Aug2023, stop date: 25Aug2023) were taken as a result of drug ineffective, covid-19.  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-202300292668 same patient different drug/events;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1, #2, #3: Pfizer / BioNTech/dose #4, #5: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Lot number: Cus397s) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: El9264), on 28Feb2021 as dose 2, single (Lot number: En602), in right arm and on 24Dec2021 as dose 3 (booster), single (Lot number: Fj8757), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jun2022 as dose 4 (booster), single (Lot number: Cj6ma1a) and on 07Sep2022 as dose 5 (booster), single (Lot number: As7143C), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: REPATHA, start date: 01Jan2020, stop date: 25Aug2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jun2022, outcome "unknown", described as "dose #1, #2, #3: Pfizer / BioNTech/dose #4, #5: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive.  Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19 from 26Aug2023 to 30Aug2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292506 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1, #2, #3: Moderna/Dose #4: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 05Feb2021 as dose 2, single (Lot number: 012M20A), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 076C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2022, outcome "recovered", described as "Dose #1, #2, #3: Moderna/Dose #4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 25Aug2023 to 29Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292559 same patient, different drug/event;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Antiviral details: Paxlovid was used from 25Aug2023 to 29Aug2023 for COVID-19 treatment.
Sex: F
Vaccine: COVID19, 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 27-year-old female patient (not pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 30Aug2023 to 01Sep2023.  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-202300293526 Same patient, different event/drug (Paxlovid Case);
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GL0446), in left arm and on 09Jul2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected glaucoma (current)" (unspecified if ongoing); "Inactive ulcerative colitis" (unspecified if ongoing); "Age-related enlarged prostate" (unspecified if ongoing); "Low blood pressure" (unspecified if ongoing); "Known allergies: No" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM SUPPLEMENT WITH VITAMIN D, start date: Jan2003, stop date: 27Aug2023; FLAXSEED OIL, start date: Jan2003, stop date: 27Aug2023; ASACOL, start date: Jan2003; INFLAVONOID INTENSIVE CARE, start date: Jan2013, stop date: 27Aug2023; PROBIOTIC COMPLEX, start date: Jan2018, stop date: 27Aug2023; CRANBERRY, start date: Jan2022, stop date: 27Aug2023; ALFUZOSIN, start date: Jul2022, stop date: 27Aug2023; SAW PALMETTO BERRY, start date: 01Jul2023, stop date: 27Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 27Aug2023 to 01Sep2023. Patient also received concomitant medications: Travaprost with start date Jan2015 and Multivitamin with start date Jan2003 and stop date 27Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293493 Same reporter/patient, different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 24Aug2023 to 29Aug2023 as treatment of COVID-19. Patient did not had 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-202300293484 same patient, different drug/event;
Age: 78.0
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 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in right arm and on 04May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3249), on 16Feb2021 as dose 2, single (Lot number: EL9265), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 26Aug2023 to 31Aug2023 were taken as a result of vaccination failure, covid-19.
Age: 26.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing), notes: Other medical history: PTSD, Anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: PTSD, Anxiety. 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". Therapeutic measures included Paxlovid from 30Aug2023 to 04Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: gh9702) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 24Aug2023 to 28Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293623 Same patient, different drug/AE;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Pfizer Dose: 2; Moderna: 3; 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 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ2524 SWY1523) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8733), in left arm and on 20Apr2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer Dose: 2; Moderna: 3". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 19Aug2023 to 23Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293584 same patient, different drug and different AE.;
Age: 50.0
Sex: F
Vaccine: COVID19, 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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Aug2023 to 27Aug2023,  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: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.