chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Electrocardiogram, Parosmia
Clinical narrative: Chest pressure, from the inside out, smelling urine, front like I just swam for hours in a chlorine pool
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy on 6/20/22 complained that her left arm is still hurting for 3 weeks now contributing it to the vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Lymphadenopathy, Swelling face
Clinical narrative: Swollen right gland under ear, causing facial swelling, pain on the right side of face, and earache. Went to Urgent Care on Monday morning 6/13 and was given antibiotics which started to help relieve swelling within 24 hours.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Contusion
Clinical narrative: I have been developing bad bruising in places I have no injuring or had any impact to. I have the in multiple places in my body. I went to a walk in clinic today for bloodwork.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: SEVERE HEADACHE, LIGHT SENSITIVITY, HARD LUMP AT INJECTION SITE, RED SKIN REACTION, FELT HOT AROUND INJECTION SITE.  ONSET WAS WITHIN 12 HOURS OF SHOT AND TOOK 5 PLUS DAYS TO RESOLVE.  PATIENT DID NOT SEEK MEDICAL ATTENTION.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: SEVERE HEADACHE, LIGHT SENSITIVITY, HARD LUMP AT INJECTION SITE, RED SKIN REACTION, FELT HOT AROUND INJECTION SITE.  ONSET WAS WITHIN 12 HOURS OF SHOT AND TOOK 5 PLUS DAYS TO RESOLVE.  PATIENT DID NOT SEEK MEDICAL ATTENTION.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient presented a COVID-19 Vaccine Record card with only the primary series listed. Patient stated she had not received her first booster. When entering the patient's vaccine information from 6/17/2022, we discovered the patient was not truthful and had already received her 1st booster. She is under 50 and did not list any immunocompromising condition on her paperwork, therefore, she is not eligible to receive her 2nd booster.
Sex: U
Vaccine: PPV
Symptoms: Chills, Headache, Mobility decreased, Nausea, Neck pain
Clinical narrative: Sudden pain, immobility in left arm, hand and fingers; onset around 6:30 p.m. Pain radiates from arm to neck. Two x 500mg Acetaminophen taken. Nausea without emesis and headache; onset around 7 p.m.  4 ounces hot water decoction of fresh ginger slices consumed. Chills (no fever); onset around 8:40 p.m.
Sex: U
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Sudden pain, immobility in left arm, hand and fingers; onset around 6:30 p.m. Pain radiates from arm to neck. Two x 500mg Acetaminophen taken. Nausea without emesis and headache; onset around 7 p.m.  4 ounces hot water decoction of fresh ginger slices consumed. Chills (no fever); onset around 8:40 p.m.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient did not have an adverse reaction.  This VAERS submission is to report that patient was administered an expired vaccine (outside of the 12 hour window allowed to be left in room temperature).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after receiving vaccine (roughly 4-5 min)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Patient reported a large bruise nearby the site of injection, first noted on Sunday, 6/12/22. Pt was unsure weather it was a side effect 10 days after the shot or something else that was causing it. Pt also described a feeling of "a knot" underneath the bruise when examined it with her fingers. Pt was referred to contact and consult with her provider.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Insomnia, Myalgia
Clinical narrative: Started with muscle pain in left arm., from shoulder to elbow.  , Then headache started. Took 1 Advil Liqui-gels 200 mg. Headache stooped and arm pain eased up. Then nausea almost vomited dinner about 5:30.. I felt cold outside even though temp was in 80's/. Went to bed about 9:30 and I was freezing, shirving. Was under 2 quilts and still shivering. Could not sleep and headache was back. About 11:30 I took another Advil and fell asleep Woke up at 7:30 am with no symptoms. .
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Started with muscle pain in left arm., from shoulder to elbow.  , Then headache started. Took 1 Advil Liqui-gels 200 mg. Headache stooped and arm pain eased up. Then nausea almost vomited dinner about 5:30.. I felt cold outside even though temp was in 80's/. Went to bed about 9:30 and I was freezing, shirving. Was under 2 quilts and still shivering. Could not sleep and headache was back. About 11:30 I took another Advil and fell asleep Woke up at 7:30 am with no symptoms. .
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait disturbance, Magnetic resonance imaging, Pain
Clinical narrative: First dose 11/11/21 and started feeling pain 11/13/21. Days after my 11 year old received vaccine she felt right hip pain of unknown origin.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user, X-ray
Clinical narrative: First dose 11/11/21 and started feeling pain 11/13/21. Days after my 11 year old received vaccine she felt right hip pain of unknown origin.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine was given after the vial had been left on the counter at room temp. for longer than recommended. There were no adverse events following the injection.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Ejection fraction, Ejection fraction abnormal, Magnetic resonance imaging heart
Clinical narrative: EJECTION FRACTION LOW NORMAL RANGE; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a physician concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No significant past medical history and no medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 36 years old. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced chest pain, and shortness of breath. On an unspecified date, the patient experienced ejection fraction low normal range. Laboratory data (dates unspecified) included: Cardiac MRI does not show evidence of pericarditis or myocarditis, Ejection fraction low normal range, and Troponin normal, no evidence of pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and shortness of breath, and the outcome of ejection fraction low normal range was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: EJECTION FRACTION LOW NORMAL RANGE; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a physician concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No significant past medical history and no medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 36 years old. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced chest pain, and shortness of breath. On an unspecified date, the patient experienced ejection fraction low normal range. Laboratory data (dates unspecified) included: Cardiac MRI does not show evidence of pericarditis or myocarditis, Ejection fraction low normal range, and Troponin normal, no evidence of pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and shortness of breath, and the outcome of ejection fraction low normal range was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Seizure, Vaccination site pain
Clinical narrative: She got her vaccine at 1:00 PM, she ate and drank enough.  The next day at 1:00 PM she was a theater and did not feel very well, and was going to the bathroom and halfway up the stairs she felt dizzy.  She then had an Aura, with her is a curious smell.  She got on top of the steps, when down an elevator and told them that she was going to have a seizure, which she was helped with two people. They helped her lie down, and they called an ambulance and she woke up in the hospital.  They kept her a few hours, gave her the Vimpat and was sleepy.  The next day she felt Okay.  This also happened with her 3rd shot as well.  24 hours after the vaccine she had a seizure.  She sat down with her friend after the 2nd one, he could not understand what she was saying, called the ambulance and then woke up about 4 hours later in the hospital. Hospital.    She has not had any other reactions, and does take her Vimpat which is seizure medicine.  She only had the reaction with the 2 boosters.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aura, Dizziness, Malaise, Parosmia, Seizure
Clinical narrative: She got her vaccine at 1:00 PM, she ate and drank enough.  The next day at 1:00 PM she was a theater and did not feel very well, and was going to the bathroom and halfway up the stairs she felt dizzy.  She then had an Aura, with her is a curious smell.  She got on top of the steps, when down an elevator and told them that she was going to have a seizure, which she was helped with two people. They helped her lie down, and they called an ambulance and she woke up in the hospital.  They kept her a few hours, gave her the Vimpat and was sleepy.  The next day she felt Okay.  This also happened with her 3rd shot as well.  24 hours after the vaccine she had a seizure.  She sat down with her friend after the 2nd one, he could not understand what she was saying, called the ambulance and then woke up about 4 hours later in the hospital. Hospital.    She has not had any other reactions, and does take her Vimpat which is seizure medicine.  She only had the reaction with the 2 boosters.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Contusion, Pustule, Swelling, Urticaria
Clinical narrative: around arms and seeming on nerves of arms uticaria; extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Ehler-danlos" (unspecified if ongoing), notes: Ehler-danlos; "allergies" (unspecified if ongoing), notes: allergies; "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing); "hyper mobility" (unspecified if ongoing), notes: hyper mobility; "pencilling allergy" (unspecified if ongoing), notes: pencilling allergy; "nuts, tree nuts allergy" (unspecified if ongoing), notes: nuts, tree nuts allergy; "peanuts allergy" (unspecified if ongoing), notes: peanuts allergy. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "capsaicin: Drug allergy". Vaccination history included: BNT162b2 (Dose 2, around  arms and seeming on nerves of arms uticaria), administration date: 15Mar2021, when the patient was 51-year-old, for Covid-19 immunization, reaction(s): "around  arms and seeming on nerves of arms uticaria", "extreme itching"; Bnt162b2 (Dose 1, around  arms and seeming on nerves of arms uticaria), when the patient was 51 years old, for Covid-19 immunization, reaction(s): "around  arms and seeming on nerves of arms uticaria"; Bnt162b2 (Dose 1, extreme itching), when the patient was 51 years old, for Covid-19 immunization, reaction(s): "extreme itching"; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: URTICARIA (disability), outcome "recovered with sequelae", described as "around arms and seeming on nerves of arms uticaria"; PRURITUS (disability), outcome "recovered with sequelae", described as "extreme itching". The events "around arms and seeming on nerves of arms uticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (16Jun2022) Pending, notes:. Therapeutic measures were taken as a result of urticaria, pruritus.  Clinical Course: Since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms uticaria and extreme itching that in Jun2022 is still here. Treatment received for the adverse event was Ointments prescribed, added allergy medication. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, had the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: around arms and seeming on nerves of arms uticaria; extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Ehler-danlos" (unspecified if ongoing), notes: Ehler-danlos; "allergies" (unspecified if ongoing), notes: allergies; "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing); "hyper mobility" (unspecified if ongoing), notes: hyper mobility; "pencilling allergy" (unspecified if ongoing), notes: pencilling allergy; "nuts, tree nuts allergy" (unspecified if ongoing), notes: nuts, tree nuts allergy; "peanuts allergy" (unspecified if ongoing), notes: peanuts allergy. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "capsaicin: Drug allergy". Vaccination history included: BNT162b2 (Dose 2, around  arms and seeming on nerves of arms uticaria), administration date: 15Mar2021, when the patient was 51-year-old, for Covid-19 immunization, reaction(s): "around  arms and seeming on nerves of arms uticaria", "extreme itching"; Bnt162b2 (Dose 1, around  arms and seeming on nerves of arms uticaria), when the patient was 51 years old, for Covid-19 immunization, reaction(s): "around  arms and seeming on nerves of arms uticaria"; Bnt162b2 (Dose 1, extreme itching), when the patient was 51 years old, for Covid-19 immunization, reaction(s): "extreme itching"; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: URTICARIA (disability), outcome "recovered with sequelae", described as "around arms and seeming on nerves of arms uticaria"; PRURITUS (disability), outcome "recovered with sequelae", described as "extreme itching". The events "around arms and seeming on nerves of arms uticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (16Jun2022) Pending, notes:. Therapeutic measures were taken as a result of urticaria, pruritus.  Clinical Course: Since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms uticaria and extreme itching that in Jun2022 is still here. Treatment received for the adverse event was Ointments prescribed, added allergy medication. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, had the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Contusion, Pustule, Swelling, Urticaria
Clinical narrative: Seeming on nerves of arms uticaria; Extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: Nuts, Tree nuts" (unspecified if ongoing), notes: Known allergies: Nuts, Tree nuts; "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts; "Migraine" (unspecified if ongoing); "Ehler-danlos" (unspecified if ongoing), notes: Ehler-danlos; "Allergies" (unspecified if ongoing), notes: Allergies; "Tonsillectomy" (unspecified if ongoing); "Adenoidectomy" (unspecified if ongoing); "Hypermobility" (unspecified if ongoing), notes: Hypermobility. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "Known allergies: Capsaicin", notes: Known allergies: Capsaicin. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Extreme itching", "Seeming on nerves of arms uticaria". The following information was reported: PRURITUS (disability) with onset Mar2021, outcome "not recovered", described as "Extreme itching"; URTICARIA (disability) with onset Mar2021, outcome "not recovered", described as "Seeming on nerves of arms uticaria". The events "seeming on nerves of arms uticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: COVID test type post vaccination: Nasal swab; (16Jun2022) Pending, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of urticaria, pruritus.  Clinical Course: Since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms uticaria and extreme itching that in Jun2022 is still here. Treatment received for the adverse event was Ointments prescribed, added allergy medication. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Seeming on nerves of arms uticaria; Extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: Nuts, Tree nuts" (unspecified if ongoing), notes: Known allergies: Nuts, Tree nuts; "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts; "Migraine" (unspecified if ongoing); "Ehler-danlos" (unspecified if ongoing), notes: Ehler-danlos; "Allergies" (unspecified if ongoing), notes: Allergies; "Tonsillectomy" (unspecified if ongoing); "Adenoidectomy" (unspecified if ongoing); "Hypermobility" (unspecified if ongoing), notes: Hypermobility. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "Known allergies: Capsaicin", notes: Known allergies: Capsaicin. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Extreme itching", "Seeming on nerves of arms uticaria". The following information was reported: PRURITUS (disability) with onset Mar2021, outcome "not recovered", described as "Extreme itching"; URTICARIA (disability) with onset Mar2021, outcome "not recovered", described as "Seeming on nerves of arms uticaria". The events "seeming on nerves of arms uticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: COVID test type post vaccination: Nasal swab; (16Jun2022) Pending, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of urticaria, pruritus.  Clinical Course: Since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms uticaria and extreme itching that in Jun2022 is still here. Treatment received for the adverse event was Ointments prescribed, added allergy medication. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Contusion, Pustule, Swelling, Urticaria
Clinical narrative: seeming on nerves of arms urticaria; extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Ehlers-Danlos" (unspecified if ongoing), notes: Ehler-danlos; "allergies" (unspecified if ongoing), notes: allergies; "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing); "Hyper mobility" (unspecified if ongoing), notes: Hyper mobility; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts; "Known allergies: nuts, tree nuts" (unspecified if ongoing), notes: Known allergies: nuts, tree nuts. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "Known allergies: capsaicin", notes: Known allergies: capsaicin. The following information was reported: PRURITUS (disability) with onset 11Mar2021, outcome "recovered with sequelae", described as "extreme itching"; URTICARIA (disability) with onset 11Mar2021, outcome "recovered with sequelae", described as "seeming on nerves of arms urticaria". The events "seeming on nerves of arms urticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab; (16Jun2022) Pending, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of urticaria, pruritus. It was reported that since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms urticaria and extreme itching that in June 2022 is still here. Patient was prescribed Ointments and added allergy medication. Patient did not have COVID prior vaccination. Patient had known allergy with Coprocessor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: seeming on nerves of arms urticaria; extreme itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Ehlers-Danlos" (unspecified if ongoing), notes: Ehler-danlos; "allergies" (unspecified if ongoing), notes: allergies; "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing); "Hyper mobility" (unspecified if ongoing), notes: Hyper mobility; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts; "Known allergies: nuts, tree nuts" (unspecified if ongoing), notes: Known allergies: nuts, tree nuts. The patient's concomitant medications were not reported. Past drug history included: Capsaicin, reaction(s): "Known allergies: capsaicin", notes: Known allergies: capsaicin. The following information was reported: PRURITUS (disability) with onset 11Mar2021, outcome "recovered with sequelae", described as "extreme itching"; URTICARIA (disability) with onset 11Mar2021, outcome "recovered with sequelae", described as "seeming on nerves of arms urticaria". The events "seeming on nerves of arms urticaria" and "extreme itching" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab; (16Jun2022) Pending, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of urticaria, pruritus. It was reported that since 3 days prior to 2nd shot given at 15Mar2021 withheld Hospital around arms and seeming on nerves of arms urticaria and extreme itching that in June 2022 is still here. Patient was prescribed Ointments and added allergy medication. Patient did not have COVID prior vaccination. Patient had known allergy with Coprocessor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; SIGNIFICANT BITTER FLAVOR; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 43 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: major depression, borderline blood pressure, hyperthyroid, obesity, and sulfa allergy, and patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, administered in left arm on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 41 years old. On 29-OCT-2021, the patient received additional booster dose of pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 3203080, expiry: unknown) dose was not reported, administered on left arm for prophylactic vaccination. Age at time of vaccination 42 years old. Concomitant medications included bupropion hydrochloride, fluoxetine hydrochloride, hydrochlorothiazide, levothyroxine sodium, and lisinopril.  On 15-MAY-2022, the patient tested positive for covid-19 (confirmed clinical vaccination failure) (Dose number in series 1) with postnasal, cough, fatigue, aches symptoms (confirmed covid-19 infection) (Dose number in series 2).  The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered first dose on 16-MAY-2022 and last dose on 20-MAY-2022 for treatment of covid-19. On 16-MAY-2022, Patient experienced significant bitter flavor that lasted around 6 hours whenever she took the pills (Dose number in series 2). On 23-MAY-2022, Patient tested negative for covid-19. On 27-MAY-2022, patient again tested positive for covid-19 with symptoms recurrence (postnasal, cough, fatigue, aches) (Dose number in series 2). On 03-JUN-2022. patient again tested positive with symptoms (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and significant bitter flavor was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000236180.; Sender's Comments: V0-20220631781-COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; SIGNIFICANT BITTER FLAVOR; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 43 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: major depression, borderline blood pressure, hyperthyroid, obesity, and sulfa allergy, and patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, administered in left arm on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 41 years old. On 29-OCT-2021, the patient received additional booster dose of pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 3203080, expiry: unknown) dose was not reported, administered on left arm for prophylactic vaccination. Age at time of vaccination 42 years old. Concomitant medications included bupropion hydrochloride, fluoxetine hydrochloride, hydrochlorothiazide, levothyroxine sodium, and lisinopril.  On 15-MAY-2022, the patient tested positive for covid-19 (confirmed clinical vaccination failure) (Dose number in series 1) with postnasal, cough, fatigue, aches symptoms (confirmed covid-19 infection) (Dose number in series 2).  The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered first dose on 16-MAY-2022 and last dose on 20-MAY-2022 for treatment of covid-19. On 16-MAY-2022, Patient experienced significant bitter flavor that lasted around 6 hours whenever she took the pills (Dose number in series 2). On 23-MAY-2022, Patient tested negative for covid-19. On 27-MAY-2022, patient again tested positive for covid-19 with symptoms recurrence (postnasal, cough, fatigue, aches) (Dose number in series 2). On 03-JUN-2022. patient again tested positive with symptoms (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and significant bitter flavor was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000236180.; Sender's Comments: V0-20220631781-COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Approximately 2 hours later I had a high pitch noise in my left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 12:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEGA-3 [OMEGA-3 NOS]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162b2 (Dose 3 (booster), single, Batch/Lot No: FH8030, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 24Nov2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Batch/Lot No: EP7534 Jul2021, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1, single, Batch/Lot No: EN6203 Jun2021, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: TINNITUS (disability) with onset 10Jun2022 at 14:00, outcome "not recovered", described as "Approximately 2 hours later I had a high pitch noise in my left ear". The event "approximately 2 hours later i had a high pitch noise in my left ear" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (14Jun2022) normal; Computerised tomogram: (Jun2022) Negative. Therapeutic measures were taken as a result of tinnitus.  Clinical course: The patient received 2nd booster at noon on Friday, 10Jun2022. Approximately 2 hours later she had a high pitch noise in her left ear. This noise has not subsided and it was 6 days later. she had no underlying health conditions. she had never had this happen to me ever. she called her doctor the day after the booster and he prescribed a 3 day dose of prednisone at 40mg. she took the steroids on Saturday night, Sunday afternoon and Monday morning. She went to see him on Monday morning (3 days after the booster). My ears and nose were perfect. She received a hearing test 4 days after the booster and my hearing is normal. On Wednesday (5th day after the booster) the noise was so bad she went to the Emergency Room. She had finished the 3 day course of steroids on Monday morning. At the Emergency Room they ordered a CT scan that came back negative. The attending doctor put me on a 5 day course of prednisone. 60mg on day 1 and then 4 days of 40mg per day. she had no relief so far. Ae treatment she have been put on Prednisone with no relief. The patient did not taken any other vaccine in four weeks. COVID prior vaccination. The patient did not tested COVID post vaccination. device timestamp: 16Jun2022.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Tinnitus
Clinical narrative: Approximately 2 hours later I had a high pitch noise in my left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 12:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEGA-3 [OMEGA-3 NOS]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162b2 (Dose 3 (booster), single, Batch/Lot No: FH8030, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 24Nov2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Batch/Lot No: EP7534 Jul2021, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1, single, Batch/Lot No: EN6203 Jun2021, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: TINNITUS (disability) with onset 10Jun2022 at 14:00, outcome "not recovered", described as "Approximately 2 hours later I had a high pitch noise in my left ear". The event "approximately 2 hours later i had a high pitch noise in my left ear" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (14Jun2022) normal; Computerised tomogram: (Jun2022) Negative. Therapeutic measures were taken as a result of tinnitus.  Clinical course: The patient received 2nd booster at noon on Friday, 10Jun2022. Approximately 2 hours later she had a high pitch noise in her left ear. This noise has not subsided and it was 6 days later. she had no underlying health conditions. she had never had this happen to me ever. she called her doctor the day after the booster and he prescribed a 3 day dose of prednisone at 40mg. she took the steroids on Saturday night, Sunday afternoon and Monday morning. She went to see him on Monday morning (3 days after the booster). My ears and nose were perfect. She received a hearing test 4 days after the booster and my hearing is normal. On Wednesday (5th day after the booster) the noise was so bad she went to the Emergency Room. She had finished the 3 day course of steroids on Monday morning. At the Emergency Room they ordered a CT scan that came back negative. The attending doctor put me on a 5 day course of prednisone. 60mg on day 1 and then 4 days of 40mg per day. she had no relief so far. Ae treatment she have been put on Prednisone with no relief. The patient did not taken any other vaccine in four weeks. COVID prior vaccination. The patient did not tested COVID post vaccination. device timestamp: 16Jun2022.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, HPVX
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: they may have given the wrong vaccine to the wrong age group pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2; pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2.; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 9-year-old female patient received BNT162b2 (BNT162B2), on 09Jun2022 at 15:45 as dose number unknown, single (Lot number: FP4554, Expiration Date: Nov2021) at the age of 9 years, in right deltoid for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 19Oct2021 as unk, single (Batch/Lot number: unknown) and on 09Jun2022 at 15:45 as unk, single (Lot number: 1780876, Expiration Date: 09Nov2023) intramuscular, in left deltoid. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (medically significant) with onset 09Jun2022, described as "pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2."; OFF LABEL USE (medically significant) with onset 09Jun2022, described as "they may have given the wrong vaccine to the wrong age group pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2".  Clinical course: It was reported that, she stated that she had given wrong vaccine to wrong age group on Thursday. As her age was 9-years-old she need to go for the COVID vaccine (gray top) later they clarified that they had pulled the COVID vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2. They followed the CDC recommendation, did not repeat the dose and she come back 21 days from the second and will get a booster. It was reported that one dose was given from the vial and the rest was wasted. and the child was on appointment for a nurse. As child came in for the HPV and was given the COVID vaccine while there because she was there for injection only.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, HPVX
Symptoms: Off label use, Wrong technique in product usage process
Clinical narrative: they may have given the wrong vaccine to the wrong age group pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2; pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2.; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 9-year-old female patient received BNT162b2 (BNT162B2), on 09Jun2022 at 15:45 as dose number unknown, single (Lot number: FP4554, Expiration Date: Nov2021) at the age of 9 years, in right deltoid for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 19Oct2021 as unk, single (Batch/Lot number: unknown) and on 09Jun2022 at 15:45 as unk, single (Lot number: 1780876, Expiration Date: 09Nov2023) intramuscular, in left deltoid. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (medically significant) with onset 09Jun2022, described as "pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2."; OFF LABEL USE (medically significant) with onset 09Jun2022, described as "they may have given the wrong vaccine to the wrong age group pulled the Covid vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2".  Clinical course: It was reported that, she stated that she had given wrong vaccine to wrong age group on Thursday. As her age was 9-years-old she need to go for the COVID vaccine (gray top) later they clarified that they had pulled the COVID vaccine (gray top) 5-11 thinking it was the orange, diluted it and the dose given was 0.2. They followed the CDC recommendation, did not repeat the dose and she come back 21 days from the second and will get a booster. It was reported that one dose was given from the vial and the rest was wasted. and the child was on appointment for a nurse. As child came in for the HPV and was given the COVID vaccine while there because she was there for injection only.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Electrocardiogram ambulatory, Laboratory test
Clinical narrative: Re-appearance of Afib following 4 years post ablation without any Afib detected. Rapid Afib began about 24 hours following vaccination.; 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), on 08Jun2022 at 10:30 as dose 3 (booster), single (Lot number: FN2908) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure: under med, control.; "medical tape adhesives" (unspecified if ongoing), notes: known allergies: some medical tape adhesives,Amlodipine. Concomitant medication(s) included: LISINOPRIL; HCT; ATORVASTATIN. Past drug history included: Amlodipine, reaction(s): "Drug allergy", notes: known allergies: some medical tape adhesives,Amlodipine. Vaccination history included: covid-19 vaccine (Vaccine Brand: Johnson & Johnson, Dose Number: 1, Batch/Lot No: 1805018, Vaccine Administration Date: 13Mar2021, Vaccine Administration Time: 09:00, Location of injection: Arm Right), administration date: 13Mar2021, when the patient was 69-year-old, for COVID-19 immunisation; moderna covid-19 vaccine (Vaccine Brand: Moderna, Dose Number: 2, Batch/Lot No: 051F21A, Vaccine Administration Date: 12Nov2021, Vaccine Administration Time: 17:00, Location of injection: Arm Left), administration date: 12Nov2021, when the patient was 70-year-old, for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 09Jun2022 at 10:45, outcome "not recovered", described as "Re-appearance of Afib following 4 years post ablation without any Afib detected. Rapid Afib began about 24 hours following vaccination.". The event "re-appearance of afib following 4 years post ablation without any afib detected. rapid afib began about 24 hours following vaccination." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: (2022) Unknown results, notes: Now on Holter monitor @24 hours. Therapeutic measures were taken as a result of atrial fibrillation with unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination.. Visited ER on 2 successive days. Stress Echocardiogram in 2 weeks to see if he was still a candidate for another Ablation procedure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.