chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: Period on 2/18 was only 4 days, 3 days short. Period on 3/10 was 9 days, 2 days longer.  Period on 4/14, was a week early and 2 days short. Currently period on 5/2 is a week early. Since Feb. I am unable to eat pork. There is a difference I'm taste. Also certain smells, smell the same like what pork would smell like. Just recently had a papsmear and tested positive for HPV. I have tested positive for HPV since 2007. All papsmears prior to this one has been clear. I am also premenopausal at age 38, this wasn't so prior to thr vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: I began having symptoms of shingles (dermatome pain) on my right thorax beginning May 1, 2022 and broke out in the rash on May 4, 2022. Started Valacyclovir HCl on May 4, 2022.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: ASYMETRICAL RASH SEVERAL INCHES IN DIAMETER AROUND INJECTION SITE OF LEFT ARM
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema
Clinical narrative: RED AREA AROUND INJECTION SITE
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Migraine
Clinical narrative: Severe migraine headache x1 month Severe swollen, painful lymph nodes in neck and chest x2mos, mild since then
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Barium swallow, Blood test, Brain injury, Cerebellar stroke, Computerised tomogram
Clinical narrative: Cerebellar stoke.  Hospitalized at Hospital for 2 + weeks ( ICU for 5 days, med/surg floor 11 days) then transferred to Sharp Rees-Steely In-patient Brain Injury for 10 days.  Significant impairment on right side of body.  Unable to return to work (Director,  Bio-Pharamceutical CRO).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Impaired work ability, Intensive care, Laboratory test, Magnetic resonance imaging
Clinical narrative: Cerebellar stoke.  Hospitalized at Hospital for 2 + weeks ( ICU for 5 days, med/surg floor 11 days) then transferred to Sharp Rees-Steely In-patient Brain Injury for 10 days.  Significant impairment on right side of body.  Unable to return to work (Director,  Bio-Pharamceutical CRO).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Physical disability
Clinical narrative: Cerebellar stoke.  Hospitalized at Hospital for 2 + weeks ( ICU for 5 days, med/surg floor 11 days) then transferred to Sharp Rees-Steely In-patient Brain Injury for 10 days.  Significant impairment on right side of body.  Unable to return to work (Director,  Bio-Pharamceutical CRO).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: My menstrual cycle stopped for several months. My period generally came the 1st of the month each month and is almost always regular. (one time that I can recall it came twice in one month- other than that regular). My last period was 12/01/21. It did not come again until May 3, 2022. I did feel symptoms of a period each month around the 1st- cramping, headaches, PMS , water retention but then nothing.  (I didn't worry b/c I heard it was happening to other women and that it usually resolved itself at 4 months following the booster- which held true to me).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Pt reports tingling in fingers, hand/arm going numb
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Biliary dilatation, Chemotherapy, Hepatic enzyme increased, Jaundice
Clinical narrative: On 5/22/2021 presented to ER with abdominal pain and increased liver enzymes then again on 5/26/2021 with weight loss, abdominal pain and jaundice.  Work up revealed mass in pancreas and biliary dilation. Needed chemo and major surgery.  Surgery was on 05/05/2022
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatic mass, Surgery, Weight decreased
Clinical narrative: On 5/22/2021 presented to ER with abdominal pain and increased liver enzymes then again on 5/26/2021 with weight loss, abdominal pain and jaundice.  Work up revealed mass in pancreas and biliary dilation. Needed chemo and major surgery.  Surgery was on 05/05/2022
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Pancreatic carcinoma
Clinical narrative: On 5/22/2021 presented to ER with abdominal pain and increased liver enzymes then again on 5/26/2021 with weight loss, abdominal pain and jaundice.  Work up revealed mass in pancreas and biliary dilation. Needed chemo and major surgery.  Surgery was on 05/05/2022
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: Stroke
Age: 11.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt's dad reported on 5/5/22 that he lied about pt's dob on consent form at time of Pfizer vaccine primary series---pt was not 12+ y/o at the time of vaccine administration; this was prior to pediatric Covid-19 Pfizer being approved for EUA. No adverse event was reported, but Pfizer adult 12+ dose was administered to pt at time of vaccination in July and August, who was <12 y/o. We cannot confirm if said pt actually received vaccine series as dad is reporting dob was false on vaccine form at time of initial series, and we administered vaccine in good faith at the time of event.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Fever, trembling, headache, fatigue
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Auditory disorder, Dizziness, Hypotension, Loss of consciousness
Clinical narrative: Few seconds after injection the patient experienced a moderate Hypotensive reaction which included LOC for about a minute. immediate treatment involved Lying the  patient in bed and elevated legs. Other patient symptoms included dizziness, facial pallor, auditory disturbances, cold extremities, weakness, light headedness and auditory disturbances. Patient was provided with oral electrolytes and a salty snack.  Patient remained in the facility until all symptoms were resolved. Before Injection patient had completed donating Plasma.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Pallor, Peripheral coldness
Clinical narrative: Few seconds after injection the patient experienced a moderate Hypotensive reaction which included LOC for about a minute. immediate treatment involved Lying the  patient in bed and elevated legs. Other patient symptoms included dizziness, facial pallor, auditory disturbances, cold extremities, weakness, light headedness and auditory disturbances. Patient was provided with oral electrolytes and a salty snack.  Patient remained in the facility until all symptoms were resolved. Before Injection patient had completed donating Plasma.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Throat tightness
Clinical narrative: Patient starting complaining of tightness in the throat. Call 911 and she eventually went home after 30 minmutes saying she was feeling better.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Arm Right has swollen up the the size of a lemon, Turned red, start bruising, was told by all my nursing staff, That the nurse did not stick needle in the correct location of arm.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product use issue
Clinical narrative: ADMINSTERED ERROR:  Administered after use by date, no reaction
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINSTERED ERROR: Administered after use by date, no reaction
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINSTERED ERROR: Administered after use by date, no reaction
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINSTERED ERROR: Administered after use by date, no reaction
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient experienced fainting and was in the hospital after receiving the covid-19 vaccine. No additional information related to vaccine available at this time.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: Stroke on 4/11/2021. 8 days after vaccination. Spent 5 weeks in inpatient rehabilitation facility., right side of body still numb. cannot feel differences in temperatures ( hot or cold ) still have dizziness
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Sensory loss
Clinical narrative: Stroke on 4/11/2021. 8 days after vaccination. Spent 5 weeks in inpatient rehabilitation facility., right side of body still numb. cannot feel differences in temperatures ( hot or cold ) still have dizziness
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypersensitivity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; ALLERGY LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 43 year old female of an unspecified race. Initial information was processed along with the additional information received on 04-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: hodgkins disease (History of cancer), and the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm 07-APR-2021 for prophylactic vaccination. Age at time of vaccination 42 years old. On 22-OCT-2021 at 12:45 pm, the patient received additional, Non-company suspect vaccine (Moderna) (dose 1) (dose number in series: 2) (form of admin, route of admin were not reported, batch number: 011F21A, expiry: UNKNOWN) dose was not reported, administered to right arm for prophylactic vaccination .  On 08-APR-2022 at 12:45, the patient received, Non-company suspect vaccine (Moderna) (dose 2) (dose number in series: 2) (form of admin, route of admin were not reported, batch number: 048221A or 048Z21A, expiry: UNKNOWN) dose was not reported, administered to right arm for prophylactic vaccination. Concomitant medications included Red yeast rice pills. On 09-APR-2022, Saturday night, the patient had allergy like symptoms (Dose number in series: 2). On 10-APR-2022, the patient tested positive for COVID-19 coded as confirmed covid-19 infection (Dose number in series: 2) and confirmed clinical vaccination failure (Dose number in series: 1). On 10-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 19-APR-2022 and 21-APR-2022, the patient tested negative for COVID-19. On 23-APR-2022 and 27-APR-2022, COVID-19 virus test was Positive. Treatment medications included paxlovid for COVID-19, within 2 hours of testing positive from 10-APR-2022 to 14-APR-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and allergy like symptoms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229390; Sender's Comments: V0-20220504000-Covid-19 vaccine ad26.CoV-2.s - Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy alert test, Anaphylactic reaction, Polymers allergy
Clinical narrative: Recurring Anaphylaxis, 2-3x per week since receiving first dose; Testing positive for PEG allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non -healthcare professional). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01May2021 at 12:00 as dose 1, single (Batch/Lot number: Unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, disability, medically significant, life threatening) with onset 01May2021, outcome "not recovered", described as "Recurring Anaphylaxis, 2-3x per week since receiving first dose", POLYMERS ALLERGY (hospitalization, disability, life threatening) with onset 01May2021, outcome "not recovered", described as "testing positive for PEG allergy". The events "recurring anaphylaxis, 2-3x per week since receiving first dose" and "testing positive for peg allergy" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Allergy alert test: (01May2022) Positive, notes: confirmed the vaccine to be attributable to the adverse reactions. Therapeutic measures were taken as a result of anaphylactic reaction, polymers allergy.  Clinical information: Patient received vaccination facility in Drug store. The patient did not receive any other vaccines prior to the COVID vaccine. Covid test was not performed prior or post vaccination. No known allergies noted. Recurring Anaphylaxis, 2-3x per week since receiving first dose. No history of allergic reactions beforehand. After discussing with several doctors and specialists, and testing positive for PEG allergy they have confirmed the vaccine to be attributable to the adverse reactions. AE resulted in, Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment provided with Epi, prednisone, Allegra, loratadine, banophren.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Magnetic resonance imaging head, Tinnitus, Visual impairment
Clinical narrative: headache, ringing in ears, vision impairment,
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Chest discomfort, Cough, Fatigue, Nasopharyngitis
Clinical narrative: I have had 3 Pfizer COVID shots. I still got COVID twice; I have had 3 Pfizer COVID shots. I still got COVID twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had 3 Pfizer COVID shots. I still got COVID twice". Clinical course: The patient have had 3 Pfizer COVID shots. Patient still got COVID twice. The second time (Nov2021) her husband wanted to take her to the hospital, but she wouldn't let him.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: I have had 3 Pfizer COVID shots. I still got COVID twice; I have had 3 Pfizer COVID shots. I still got COVID twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had 3 Pfizer COVID shots. I still got COVID twice". Clinical course: The patient have had 3 Pfizer COVID shots. Patient still got COVID twice. The second time (Nov2021) her husband wanted to take her to the hospital, but she wouldn't let him.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have had 3 Pfizer COVID shots. I still got COVID twice; I have had 3 Pfizer COVID shots. I still got COVID twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had 3 Pfizer COVID shots. I still got COVID twice". Clinical course: The patient have had 3 Pfizer COVID shots. Patient still got COVID twice. The second time (Nov2021) her husband wanted to take her to the hospital, but she wouldn't let him.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received the 12+ dosage of 0.3ml/ 30mcg rather than the 5-11 dosage of 0.2ml/10mcg
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arrhythmia, Dizziness, Electrocardiogram abnormal
Clinical narrative: Light headed, low pulse ox, she fell to the ground
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Chest X-ray normal, Dizziness, Fall, Metabolic function test
Clinical narrative: Light headed, low pulse ox, she fell to the ground
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Troponin
Clinical narrative: Light headed, low pulse ox, she fell to the ground
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Pt reported flushing/sweating.   Pt had red/flushed face/cheeks and was warm to the touch.  Pt complained of feeling warm all over, Vitals: 133/76, 98, 16, 99% RA. Pt was given benadryl 25mg PO x1 at 11:40AM Mother reported that his cheeks appeared slightly swollen to her. I confirmed that he had never had a reaction to his previous Pfizer vaccines or to any other medication in the past. She reports he has no PMH takes no daily medications and has no allergies.   PE: Alert, oriented, no acute distress Heart RRR, no MRG no palpitations or irregular rhythm, 2+ pulse, brisk capillary refill Lungs CTAB without wheeze or rales, normal oxygen saturation Skin: Erythema of bilateral cheeks, no angioedema, no urticaria   Exam consistent with allergic reaction to vaccine. Administered 25mg Benadryl PO.   Re-checked patient 15-20 minutes later and he continued to do well with resolving facial erythema and no signs of anaphylaxis. He did not feel dizzy, faint, or short of breath. Repeat vitals were 125/73, 92bpm and oxygen 97%. He was observed to walk the hallway without any symptoms.   Discussed diagnosis with mother. Recommended Benadryl PRN q6h and present to the ER if he develops any signs of anaphylaxis. Mother indicated that she understands diagnosis and treatment. She stated that she understands language and refused interpreter on two separate occasions. Will note allergy in chart and report to VAERS. Pt stable and released from the vaccination site with mom at 12:13PM.  D/C instructions given.  Recommended f/u w/ PCP, follow up instructions provided
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Flushing, Hyperhidrosis, Musculoskeletal chest pain
Clinical narrative: Pt reported flushing/sweating.   Pt had red/flushed face/cheeks and was warm to the touch.  Pt complained of feeling warm all over, Vitals: 133/76, 98, 16, 99% RA. Pt was given benadryl 25mg PO x1 at 11:40AM Mother reported that his cheeks appeared slightly swollen to her. I confirmed that he had never had a reaction to his previous Pfizer vaccines or to any other medication in the past. She reports he has no PMH takes no daily medications and has no allergies.   PE: Alert, oriented, no acute distress Heart RRR, no MRG no palpitations or irregular rhythm, 2+ pulse, brisk capillary refill Lungs CTAB without wheeze or rales, normal oxygen saturation Skin: Erythema of bilateral cheeks, no angioedema, no urticaria   Exam consistent with allergic reaction to vaccine. Administered 25mg Benadryl PO.   Re-checked patient 15-20 minutes later and he continued to do well with resolving facial erythema and no signs of anaphylaxis. He did not feel dizzy, faint, or short of breath. Repeat vitals were 125/73, 92bpm and oxygen 97%. He was observed to walk the hallway without any symptoms.   Discussed diagnosis with mother. Recommended Benadryl PRN q6h and present to the ER if he develops any signs of anaphylaxis. Mother indicated that she understands diagnosis and treatment. She stated that she understands language and refused interpreter on two separate occasions. Will note allergy in chart and report to VAERS. Pt stable and released from the vaccination site with mom at 12:13PM.  D/C instructions given.  Recommended f/u w/ PCP, follow up instructions provided
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Swelling face
Clinical narrative: Pt reported flushing/sweating.   Pt had red/flushed face/cheeks and was warm to the touch.  Pt complained of feeling warm all over, Vitals: 133/76, 98, 16, 99% RA. Pt was given benadryl 25mg PO x1 at 11:40AM Mother reported that his cheeks appeared slightly swollen to her. I confirmed that he had never had a reaction to his previous Pfizer vaccines or to any other medication in the past. She reports he has no PMH takes no daily medications and has no allergies.   PE: Alert, oriented, no acute distress Heart RRR, no MRG no palpitations or irregular rhythm, 2+ pulse, brisk capillary refill Lungs CTAB without wheeze or rales, normal oxygen saturation Skin: Erythema of bilateral cheeks, no angioedema, no urticaria   Exam consistent with allergic reaction to vaccine. Administered 25mg Benadryl PO.   Re-checked patient 15-20 minutes later and he continued to do well with resolving facial erythema and no signs of anaphylaxis. He did not feel dizzy, faint, or short of breath. Repeat vitals were 125/73, 92bpm and oxygen 97%. He was observed to walk the hallway without any symptoms.   Discussed diagnosis with mother. Recommended Benadryl PRN q6h and present to the ER if he develops any signs of anaphylaxis. Mother indicated that she understands diagnosis and treatment. She stated that she understands language and refused interpreter on two separate occasions. Will note allergy in chart and report to VAERS. Pt stable and released from the vaccination site with mom at 12:13PM.  D/C instructions given.  Recommended f/u w/ PCP, follow up instructions provided
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Inner ear disorder
Clinical narrative: A sensorineural hearing loss happens when there is damage in my inner ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: PH8078), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "BP" (ongoing). The patient did not have any known allergies. The patient took concomitant medications and other medications in two weeks which included BP and diabetes. Vaccination history included: BNT162b2 (Dose 1, Lot number: EP6955, Location of injection: Arm left, Vaccine administration time: 10:00 am), administration date: 28Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EN0172, Location of injection: Arm left, Vaccine administration time: 11:00 am), administration date: 23Apr2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (disability, medically significant) with onset 10Apr2022 at 07:00, outcome "not recovered", described as "A sensorineural hearing loss happens when there is damage in my inner ear". Therapeutic measures were taken as a result of deafness neurosensory which included storied shots in inner left ear. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory
Clinical narrative: A sensorineural hearing loss happens when there is damage in my inner ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: PH8078), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "BP" (ongoing). The patient did not have any known allergies. The patient took concomitant medications and other medications in two weeks which included BP and diabetes. Vaccination history included: BNT162b2 (Dose 1, Lot number: EP6955, Location of injection: Arm left, Vaccine administration time: 10:00 am), administration date: 28Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EN0172, Location of injection: Arm left, Vaccine administration time: 11:00 am), administration date: 23Apr2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (disability, medically significant) with onset 10Apr2022 at 07:00, outcome "not recovered", described as "A sensorineural hearing loss happens when there is damage in my inner ear". Therapeutic measures were taken as a result of deafness neurosensory which included storied shots in inner left ear. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Extra dose administered, Interchange of vaccine products, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, bruising, blistering, stinging and pain. Still struggling today
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: Swelling, bruising, blistering, stinging and pain. Still struggling today
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Contusion, Pain, Swelling
Clinical narrative: Swelling, bruising, blistering, stinging and pain. Still struggling today
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: Transversal feeling; Lethargic; Exhausted; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy (radioactive iodine contrast), Overweight and Fatty liver.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted). At the time of the report, FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2022-555525 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site urticaria, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Transversal feeling; Lethargic; Exhausted; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy (radioactive iodine contrast), Overweight and Fatty liver.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted). At the time of the report, FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2022-555525 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy
Clinical narrative: Transversal feeling; Lethargic; Exhausted; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy (radioactive iodine contrast), Overweight and Fatty liver.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted). At the time of the report, FEELING ABNORMAL (Transversal feeling), LETHARGY (Lethargic) and FATIGUE (Exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2022-555525 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "crohn's disease" (unspecified if ongoing), notes: other medical history: crohn's disease, humira treated; "known allergies: crustaceans" (unspecified if ongoing), notes: known allergies: crustaceans. Concomitant medication(s) included: ALLEGRA. Past drug history included: Venofer, reaction(s): "Allergy: venofer", notes: known allergies: venofer. The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 08:30, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 02May2022 at 08:30, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Paxlovid (Lot number: FY5657) with start date of 23Apr2022 and stop date 28Apr2022 .It was reported that patient took any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "crohn's disease" (unspecified if ongoing), notes: other medical history: crohn's disease, humira treated; "known allergies: crustaceans" (unspecified if ongoing), notes: known allergies: crustaceans. Concomitant medication(s) included: ALLEGRA. Past drug history included: Venofer, reaction(s): "Allergy: venofer", notes: known allergies: venofer. The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 08:30, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 02May2022 at 08:30, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received Paxlovid (Lot number: FY5657) with start date of 23Apr2022 and stop date 28Apr2022 .It was reported that patient took any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nephritis, Vasculitis
Clinical narrative: Skin vasculitis with progression into systemic vasculitis with nephritis
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Computerised tomogram abdomen abnormal, Full blood count normal, Metabolic function test normal, Omental infarction
Clinical narrative: Developed sharp left lower quadrant pain sudden onset constant presented to Emergency Room after rest and over the counter medication did not help about four hours later.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst, Pregnancy test negative, Ultrasound scan vagina abnormal
Clinical narrative: Developed sharp left lower quadrant pain sudden onset constant presented to Emergency Room after rest and over the counter medication did not help about four hours later.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Lymph node pain, Nausea
Clinical narrative: Minor Fatigue, minor  headache, mild nausea, swelling and pain of limph nodes in left arm pit.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Minor Fatigue, minor  headache, mild nausea, swelling and pain of limph nodes in left arm pit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Skin discolouration, Vitiligo
Clinical narrative: Developed white patches on neck and underarm after second dose of Moderna  that two dermatologist confirmed as vitiligo.  However neither I not the doctors  connected these patches to the vaccine. Took the booster ( Moderna) in October and in two weeks developed extensive white patches all over abdomen and upper thighs. Dermatologist prescribed Tacrolimus ,  applied it topically for 3 months with no response. Help please!
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Respiratory tract congestion
Clinical narrative: Next morning, 5/29, woke very achy and headache. Very similar to previous doses, so didn't think anything of it.  Felt ok later in the day and on Saturday, 4/30,  Felt poor again on Sunday and Monday with aches, headache, and congestion.  Felt ok Tuesday and Wednesday. Woke on the 7th day (5/5/2022) feeling poor again (achy and headache and some congestion)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Fatigue, Influenza like illness
Clinical narrative: flu like reactions; chills; exhaustion; weakness; fell; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included RA. Concurrent medical conditions included Immunocompromised.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), CHILLS (chills), FATIGUE (exhaustion), ASTHENIA (weakness) and FALL (fell) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.   This case was linked to MOD-2022-557675, MOD-2022-557659 (Patient Link).
Sex: M
Vaccine: DTAP, HPV9, MEN
Symptoms: Fatigue, Injection site erythema, Pain in extremity
Clinical narrative: Her son had a reaction where his arm was very sore, developed redness at the injeciton site and was fatigue; Her son had a reaction where his arm was very sore, developed redness at the injeciton site and was fatigue; Her son had a reaction where his arm was very sore, developed redness at the injeciton site and was fatigue; This spontaneous report has been received from a staff member at a medical facility, regarding an 11-year-old male patient. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On approximately June 2021 (reported as within the last 8 to 10 months), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular as Human Papillomavirus (HPV) prevention (dose, dose number, anatomical location, lot number nor expiration date were provided), an unspecified meningococcal vaccine and a Tetanus, diphtheria and acellular pertussis(TDAP vaccine) (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID) (doses, routes of administration, anatomical locations, indications, lot numbers nor expiration dates were provided) as prophylaxis.  On an unknown date, the patient experienced a reaction where his arm was very sore (pain in extremity), there was redness at the injection site (vaccination site erythema) and was fatigued (fatigue). On an unknown date, the patient recovered from those events, which lasted for about a week.Furthermore, he was seen for follow up by pediatrician for evaluation (no information regarding this visit was reported).  The causal relationship between pain in extremity, vaccination site joint erythema and fatigue with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), meningococcal vaccine and TDAP vaccine (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID) was not reported.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse reporting improperly stored MMR II and VARIVAX in freezer; This spontaneous report was received from a nurse, referring to a 4-year-old child.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, it was reported that a nurse improperly stored measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) in the freezer (Product storage error). On 19-APR-2022 at 13:30, the patient received the first dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II), valid lot #U007684 with expiration date on 09-MAR-2023 (strength, and route of administration not provided); and varicella virus vaccine live (OKA/MERCK) (VARIVAX), valid lot #U028164, with expiration date on 09-SEP-2023 (strength, and route of administration not provided). Both vaccines were administered as prophylaxis. No adverse events were reported. No additional information was provided.  The causal assessment between the vaccines and the event were not reported.
Age: 4.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Cough, Ear infection, Pyrexia, Respiratory disorder, Sneezing
Clinical narrative: Caller stated that his daughter had ear infections, a fever, an upper respiratory illness, coughing, allergies, and sneezing; Caller stated that his daughter had ear infections, a fever, an upper respiratory illness, coughing, allergies, and sneezing; Caller stated that his daughter had ear infections, a fever, an upper respiratory illness, coughing, allergies, and sneezing; This spontaneous report was received from patient's father (also reported as "household"), referring to a an approximately 4-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2021, the patient received the first dose of measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD), (lot #T032144 has been verified to be valid), expiration date: 20-MAR-2022, (route of administration and anatomical location were not provided); and hepatitis b vaccine rhbsag (yeast) (ENGERIX-B) (manufacturer unknown) (strength, formulation, lot #, expiry date, and route of administration not provided). Both vaccines were administered as prophylaxis.   On an unspecified date in September 2021 (reported as "two and a half weeks later after the vaccines administration"), the patient's father reported that she was on and off sick (until the beginning of January 2022) and experienced ear infections, a fever (pyrexia), an upper respiratory illness(respiratory disorder), allergies (hypersensitivity, coughing) and sneezing. It was stated that these was kind of disturbing for the father, so he called asking what were the ingredients and site effects of the measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD). No additional adverse events or additional information were reported. At the reporting time, the outcome for all the events was not reported.  The causal relationship between the events and the vaccines were not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Improper storage of product in use; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; 14 patients received possibly improperly stored vaccines due to lack of temperature readings.; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 28-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, frequency, and route of administration were not provided); which lot # T028582 has been verified to be a valid lot number with expiration date: 04-MAR-2023, administered as prophylaxis. The administered dose of the vaccine possibly experienced a temperature excursion (product storage error) since 10-JAN-2022, due to lack of temperature readings (refrigerator and freezer temperatures were not recorded since that date). No previous temperature excursion occurred. There was no adverse event reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000467: US-009507513-2205USA000464: US-009507513-2205USA000503: US-009507513-2205USA000560: