chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging spinal abnormal, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient received the first Moderna vaccine on January 28th, 2021. Three days later, patient developed diffuse muscle ache and joint pain with significant stiffness limiting mobility (Knees, neck, shoulders, wrists, elbows, entire spine, and hip).  Despite these symptoms, patient did receive the second vaccine on 2/25/21. After that, the patient developed a fever and was seen in ED. Her symptoms continued to worsen. She continued to have persistent symptoms.   Patient was seen in the ER multiple times, and on the last ER visit, patient had MRI of her spine w/ and w/o contrast that showed:  1. Diffuse increased enhancement within the interspinous ligaments and medial posterior paraspinous musculature adjacent to the spinous processes from C1-C2 to the level of T2-T3, lower thoracic spine extending to the L5-S1 with associated reactive dorsal epidural venous plexus enhancement. Overall findings can be accentuated by fat-saturated postcontrast images however possibility of inflammatory/infectious myositis cannot be completely excluded. Correlation with clinical presentation and laboratory analysis is recommended. Short-term follow-up MRI of the spine with and without contrast should also be considered. 2. No definite spinal cord signal abnormality or postcontrast spinal cord enhancement. 3. Degenerative spondylitic changes in the lower cervical and lower lumbar spine as detail above.   Patient has received an EMG in March 2021 and was normal for motor and sensory nerves. Patient's EMG was not concerning for a myositis.    Other than that, patient has had a positive TPA and RPR screening; it's confirmed that she has had received treatment for syphilis. Her inflammatory markers are high with ESR at 69 and CRP > 13 two times.  She was referred to rheumatology clinic for the above findings.   At her initial visit in March 2021, our concern was for polymyalgia rheumatica after Moderna vaccination. We started 20 mg of prednisone daily. In April 2021, she had mild improvement in neck and back stiffness to where she was now able to walk but with a walker and her daily activities still impaired. We increased her prednisone to 60 mg daily. At this time, the patient also complained of L eye vision loss and L ear hearing loss. We referred to her to ophthalmology and audiology but she states she missed her appointments due to transportation.    At visit 5/24, she was doing a lot better and inflammatory markers had normalized. Plan was to taper prednisone to 50 mg daily for 2 weeks and 40 mg daily for 2 weeks. At visit on 6/21 she was doing better but still reporting some neck and pelvic girdle stiffness so prednisone tapered to 30 mg for 1 month then 20 mg daily and methotrexate 15 mg PO weekly added.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Polymyalgia rheumatica, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Scan with contrast abnormal
Clinical narrative: Patient received the first Moderna vaccine on January 28th, 2021. Three days later, patient developed diffuse muscle ache and joint pain with significant stiffness limiting mobility (Knees, neck, shoulders, wrists, elbows, entire spine, and hip).  Despite these symptoms, patient did receive the second vaccine on 2/25/21. After that, the patient developed a fever and was seen in ED. Her symptoms continued to worsen. She continued to have persistent symptoms.   Patient was seen in the ER multiple times, and on the last ER visit, patient had MRI of her spine w/ and w/o contrast that showed:  1. Diffuse increased enhancement within the interspinous ligaments and medial posterior paraspinous musculature adjacent to the spinous processes from C1-C2 to the level of T2-T3, lower thoracic spine extending to the L5-S1 with associated reactive dorsal epidural venous plexus enhancement. Overall findings can be accentuated by fat-saturated postcontrast images however possibility of inflammatory/infectious myositis cannot be completely excluded. Correlation with clinical presentation and laboratory analysis is recommended. Short-term follow-up MRI of the spine with and without contrast should also be considered. 2. No definite spinal cord signal abnormality or postcontrast spinal cord enhancement. 3. Degenerative spondylitic changes in the lower cervical and lower lumbar spine as detail above.   Patient has received an EMG in March 2021 and was normal for motor and sensory nerves. Patient's EMG was not concerning for a myositis.    Other than that, patient has had a positive TPA and RPR screening; it's confirmed that she has had received treatment for syphilis. Her inflammatory markers are high with ESR at 69 and CRP > 13 two times.  She was referred to rheumatology clinic for the above findings.   At her initial visit in March 2021, our concern was for polymyalgia rheumatica after Moderna vaccination. We started 20 mg of prednisone daily. In April 2021, she had mild improvement in neck and back stiffness to where she was now able to walk but with a walker and her daily activities still impaired. We increased her prednisone to 60 mg daily. At this time, the patient also complained of L eye vision loss and L ear hearing loss. We referred to her to ophthalmology and audiology but she states she missed her appointments due to transportation.    At visit 5/24, she was doing a lot better and inflammatory markers had normalized. Plan was to taper prednisone to 50 mg daily for 2 weeks and 40 mg daily for 2 weeks. At visit on 6/21 she was doing better but still reporting some neck and pelvic girdle stiffness so prednisone tapered to 30 mg for 1 month then 20 mg daily and methotrexate 15 mg PO weekly added.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spinal disorder, Spinal osteoarthritis, Treponema test positive, Walking aid user
Clinical narrative: Patient received the first Moderna vaccine on January 28th, 2021. Three days later, patient developed diffuse muscle ache and joint pain with significant stiffness limiting mobility (Knees, neck, shoulders, wrists, elbows, entire spine, and hip).  Despite these symptoms, patient did receive the second vaccine on 2/25/21. After that, the patient developed a fever and was seen in ED. Her symptoms continued to worsen. She continued to have persistent symptoms.   Patient was seen in the ER multiple times, and on the last ER visit, patient had MRI of her spine w/ and w/o contrast that showed:  1. Diffuse increased enhancement within the interspinous ligaments and medial posterior paraspinous musculature adjacent to the spinous processes from C1-C2 to the level of T2-T3, lower thoracic spine extending to the L5-S1 with associated reactive dorsal epidural venous plexus enhancement. Overall findings can be accentuated by fat-saturated postcontrast images however possibility of inflammatory/infectious myositis cannot be completely excluded. Correlation with clinical presentation and laboratory analysis is recommended. Short-term follow-up MRI of the spine with and without contrast should also be considered. 2. No definite spinal cord signal abnormality or postcontrast spinal cord enhancement. 3. Degenerative spondylitic changes in the lower cervical and lower lumbar spine as detail above.   Patient has received an EMG in March 2021 and was normal for motor and sensory nerves. Patient's EMG was not concerning for a myositis.    Other than that, patient has had a positive TPA and RPR screening; it's confirmed that she has had received treatment for syphilis. Her inflammatory markers are high with ESR at 69 and CRP > 13 two times.  She was referred to rheumatology clinic for the above findings.   At her initial visit in March 2021, our concern was for polymyalgia rheumatica after Moderna vaccination. We started 20 mg of prednisone daily. In April 2021, she had mild improvement in neck and back stiffness to where she was now able to walk but with a walker and her daily activities still impaired. We increased her prednisone to 60 mg daily. At this time, the patient also complained of L eye vision loss and L ear hearing loss. We referred to her to ophthalmology and audiology but she states she missed her appointments due to transportation.    At visit 5/24, she was doing a lot better and inflammatory markers had normalized. Plan was to taper prednisone to 50 mg daily for 2 weeks and 40 mg daily for 2 weeks. At visit on 6/21 she was doing better but still reporting some neck and pelvic girdle stiffness so prednisone tapered to 30 mg for 1 month then 20 mg daily and methotrexate 15 mg PO weekly added.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Cellulitis, Peripheral swelling
Clinical narrative: A couple hours after my 2nd vaccination,  I noticed my lower right leg,  below the knee was swollen and bright pink. There was no pain or sensitivity.   The next morning when using awoke the swelling was gone by I put in a jobst stocking to make sure.  Late in the day I took off the stocking and noticed it was damp.  I checked my leg and discovered it was covered with small blisters which were leeching fluid.  This was Saturday so couldn't go to my Dr.  I kept blotting the leg with paper towels.    Monday u went to my Dr's PA who had no clue what it was but have me an injection of an antibiotic called something like racing and a script for another Cephalexon. Neither did anything.    I went back 3 days later and was told to finish out the script.  I had an appointment with my podiatrist (who is excellent!) A few days later so I figured I'd let him posit on what it was since it started shortly after the 2nd vaccine.    He decided to take a culture of some of the fluid from one spot, other areas were very dry and the skin cracked all over.  He applied an Unna Boot to keep the swelling down.  I returned 5 days later to remove the boot and apply a new one.  When I got home he called saying the culture results had come in right after I left and they had found MRSA in the drainage (no clue where that came from) so he called in a script for tetracycline because the antibiotics if been given wouldn't touch it.     I came back 5 days later to replace the Unna Boot for a third time. He said it was looking better but still very dry and cracked with a could open blisters.     The next appointment they were able to reduce to a small gauze pad over the two spots. Skin still very dry and cracked like a desert floor.     A could weeks later u has two new blisters break out and another boot was applied.    My last visit a week ago I had another 2 spots break out and a pad applied.     It's been almost 5 months since the 2nd injection and I ask have patches of dry skin and occasional blisters bag out.  Last visit I was prescribed a new antibodies Nuzyra which seemed to help.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Blister rupture, Culture, Culture positive, Dry skin
Clinical narrative: A couple hours after my 2nd vaccination,  I noticed my lower right leg,  below the knee was swollen and bright pink. There was no pain or sensitivity.   The next morning when using awoke the swelling was gone by I put in a jobst stocking to make sure.  Late in the day I took off the stocking and noticed it was damp.  I checked my leg and discovered it was covered with small blisters which were leeching fluid.  This was Saturday so couldn't go to my Dr.  I kept blotting the leg with paper towels.    Monday u went to my Dr's PA who had no clue what it was but have me an injection of an antibiotic called something like racing and a script for another Cephalexon. Neither did anything.    I went back 3 days later and was told to finish out the script.  I had an appointment with my podiatrist (who is excellent!) A few days later so I figured I'd let him posit on what it was since it started shortly after the 2nd vaccine.    He decided to take a culture of some of the fluid from one spot, other areas were very dry and the skin cracked all over.  He applied an Unna Boot to keep the swelling down.  I returned 5 days later to remove the boot and apply a new one.  When I got home he called saying the culture results had come in right after I left and they had found MRSA in the drainage (no clue where that came from) so he called in a script for tetracycline because the antibiotics if been given wouldn't touch it.     I came back 5 days later to replace the Unna Boot for a third time. He said it was looking better but still very dry and cracked with a could open blisters.     The next appointment they were able to reduce to a small gauze pad over the two spots. Skin still very dry and cracked like a desert floor.     A could weeks later u has two new blisters break out and another boot was applied.    My last visit a week ago I had another 2 spots break out and a pad applied.     It's been almost 5 months since the 2nd injection and I ask have patches of dry skin and occasional blisters bag out.  Last visit I was prescribed a new antibodies Nuzyra which seemed to help.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: A couple hours after my 2nd vaccination,  I noticed my lower right leg,  below the knee was swollen and bright pink. There was no pain or sensitivity.   The next morning when using awoke the swelling was gone by I put in a jobst stocking to make sure.  Late in the day I took off the stocking and noticed it was damp.  I checked my leg and discovered it was covered with small blisters which were leeching fluid.  This was Saturday so couldn't go to my Dr.  I kept blotting the leg with paper towels.    Monday u went to my Dr's PA who had no clue what it was but have me an injection of an antibiotic called something like racing and a script for another Cephalexon. Neither did anything.    I went back 3 days later and was told to finish out the script.  I had an appointment with my podiatrist (who is excellent!) A few days later so I figured I'd let him posit on what it was since it started shortly after the 2nd vaccine.    He decided to take a culture of some of the fluid from one spot, other areas were very dry and the skin cracked all over.  He applied an Unna Boot to keep the swelling down.  I returned 5 days later to remove the boot and apply a new one.  When I got home he called saying the culture results had come in right after I left and they had found MRSA in the drainage (no clue where that came from) so he called in a script for tetracycline because the antibiotics if been given wouldn't touch it.     I came back 5 days later to replace the Unna Boot for a third time. He said it was looking better but still very dry and cracked with a could open blisters.     The next appointment they were able to reduce to a small gauze pad over the two spots. Skin still very dry and cracked like a desert floor.     A could weeks later u has two new blisters break out and another boot was applied.    My last visit a week ago I had another 2 spots break out and a pad applied.     It's been almost 5 months since the 2nd injection and I ask have patches of dry skin and occasional blisters bag out.  Last visit I was prescribed a new antibodies Nuzyra which seemed to help.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chills, Palpitations
Clinical narrative: Heart Palpitations; night sweat; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included High cholesterol from an unknown date to unknown date, and that is now normal. Concomitant medication within two weeks included rosuvastatin taken for an unspecified indication, start and stop date were not reported. Known allergies included Tetracycline and a large dose of a beta blocker made patient pass out. No other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 03Mar2021 at 15:15, patient experienced night sweat, chills, nausea (widely reported). And on 10Mar2021, 7 days after taking vaccine the patient experienced heart palpitations. Adverse events resulted in physician office visit or clinic visit. Patient received Metoprolol as treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Night sweats, Palpitations
Clinical narrative: Heart Palpitations; night sweat; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included High cholesterol from an unknown date to unknown date, and that is now normal. Concomitant medication within two weeks included rosuvastatin taken for an unspecified indication, start and stop date were not reported. Known allergies included Tetracycline and a large dose of a beta blocker made patient pass out. No other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 03Mar2021 at 15:15, patient experienced night sweat, chills, nausea (widely reported). And on 10Mar2021, 7 days after taking vaccine the patient experienced heart palpitations. Adverse events resulted in physician office visit or clinic visit. Patient received Metoprolol as treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Computerised tomogram, Fatigue, Lymphadenopathy, Tracheoscopy
Clinical narrative: losing my voice; doctor states voice box atropying; Fatigue; swelling lymph nodes; This is a spontaneous report from a contactable consumer reported for herself.    A 69-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 (Batch/Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, drug hypersensitivity (Allergies to SULFA DRUGS). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) metformin (METFORMIN); tramadol (TRAMADOL); bupropion hydrochloride (WELLBUTRIN). The patient previously took hydrocodone and experienced hypersensitivity. On 27Jan2021 patient received dose 1  of bnt162b2 anatomical location: arm left for covid-19 immunisation. The patient experienced losing my voice on 25Feb2021 18:00 with outcome of not recovered, doctor states voice box atropying on 25Feb2021 18:00 with outcome of not recovered, fatigue on 25Feb2021 18:00 with outcome of not recovered, swelling lymph nodes on 25Feb2021 18:00 with outcome of not recovered. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 antibody test: negative on 02Apr2021. Therapeutic measures: STERIOD SHOT, PENICILLIN SHOT, AUGMENTIN PROBIOTIC. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Prior to vaccination, was the patient diagnosed with COVID-19 :No
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vocal cord atrophy
Clinical narrative: losing my voice; doctor states voice box atropying; Fatigue; swelling lymph nodes; This is a spontaneous report from a contactable consumer reported for herself.    A 69-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 (Batch/Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, drug hypersensitivity (Allergies to SULFA DRUGS). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) metformin (METFORMIN); tramadol (TRAMADOL); bupropion hydrochloride (WELLBUTRIN). The patient previously took hydrocodone and experienced hypersensitivity. On 27Jan2021 patient received dose 1  of bnt162b2 anatomical location: arm left for covid-19 immunisation. The patient experienced losing my voice on 25Feb2021 18:00 with outcome of not recovered, doctor states voice box atropying on 25Feb2021 18:00 with outcome of not recovered, fatigue on 25Feb2021 18:00 with outcome of not recovered, swelling lymph nodes on 25Feb2021 18:00 with outcome of not recovered. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 antibody test: negative on 02Apr2021. Therapeutic measures: STERIOD SHOT, PENICILLIN SHOT, AUGMENTIN PROBIOTIC. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Prior to vaccination, was the patient diagnosed with COVID-19 :No
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Fatigue, Laryngeal atrophy, Lymphadenopathy, SARS-CoV-2 antibody test
Clinical narrative: losing my voice; doctor states voice box atropying; Fatigue; swelling lymph nodes; This is a spontaneous report from a contactable consumer reported for herself.    A 69-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 (Batch/Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, drug hypersensitivity (Allergies to SULFA DRUGS). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) metformin (METFORMIN); tramadol (TRAMADOL); bupropion hydrochloride (WELLBUTRIN). The patient previously took hydrocodone and experienced hypersensitivity. On 27Jan2021 patient received dose 1  of bnt162b2 anatomical location: arm left for covid-19 immunisation. The patient experienced losing my voice on 25Feb2021 18:00 with outcome of not recovered, doctor states voice box atropying on 25Feb2021 18:00 with outcome of not recovered, fatigue on 25Feb2021 18:00 with outcome of not recovered, swelling lymph nodes on 25Feb2021 18:00 with outcome of not recovered. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 antibody test: negative on 02Apr2021. Therapeutic measures: STERIOD SHOT, PENICILLIN SHOT, AUGMENTIN PROBIOTIC. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Prior to vaccination, was the patient diagnosed with COVID-19 :No
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Herpes zoster, Neuralgia, Paraesthesia
Clinical narrative: Shingles started on the right side of  face, above jaw; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8730) via an unspecified route of administration in the right arm on 23Mar2021 at 08:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history and had no known allergies to medications, food or other products. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), buspirone hydrochloride (BUSPAR) and fluoxetine hydrochloride (PROZAC) and multivitamin (unspecified) all for unspecified indications from an unknown date. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 02Mar2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 09:00 the patient experienced shingles which started on the right side on face above jaw. Symptoms started 3 days after her second vaccine and continue to present. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles which started on the right side of face above jaw and included treatment with VALTREX and 2.5% hydrocortisone (MANUFACTURER UNKNOWN). The clinical outcome of the event shingles which started on the right side of face above jaw was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles started on the right side of  face, above jaw; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8730) via an unspecified route of administration in the right arm on 23Mar2021 at 08:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history and had no known allergies to medications, food or other products. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), buspirone hydrochloride (BUSPAR) and fluoxetine hydrochloride (PROZAC) and multivitamin (unspecified) all for unspecified indications from an unknown date. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 02Mar2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 09:00 the patient experienced shingles which started on the right side on face above jaw. Symptoms started 3 days after her second vaccine and continue to present. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles which started on the right side of face above jaw and included treatment with VALTREX and 2.5% hydrocortisone (MANUFACTURER UNKNOWN). The clinical outcome of the event shingles which started on the right side of face above jaw was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Ringing in both ears; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 15:45 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 16:45 (started 2 hours after 1 dose), the patient experienced ringing in both ears and nausea. No therapeutic measures were taken for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events ringing in both ears and nausea were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Full blood count, Mouth ulceration
Clinical narrative: Mouth ulcerations; mouth swelling; General body aches; Sore throat; Fever of 102,8; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no allergies to medications, food, or other products. Patient did not received any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's body temperature was measured as 102.8 with unspecified units. On 05Apr2021, the patient underwent nasal swab test and the result was negative. On 25Mar2021 at 06:00, the patient had fever of 102.8, mouth ulcerations and swelling, general body aches, sore throat. This was still presented 8 days post vaccination. The patient went to emergency department on 04May2021 due to mouth swelling and ulcerations and fever. The adverse events also resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotic, lidocaine mouthwash (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) 600 mg on an unknown dates. The clinical outcome of the events of fever, mouth ulceration, mouth swelling, general body aches and sore throat was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Mouth ulcerations; mouth swelling; General body aches; Sore throat; Fever of 102,8; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no allergies to medications, food, or other products. Patient did not received any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's body temperature was measured as 102.8 with unspecified units. On 05Apr2021, the patient underwent nasal swab test and the result was negative. On 25Mar2021 at 06:00, the patient had fever of 102.8, mouth ulcerations and swelling, general body aches, sore throat. This was still presented 8 days post vaccination. The patient went to emergency department on 04May2021 due to mouth swelling and ulcerations and fever. The adverse events also resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotic, lidocaine mouthwash (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) 600 mg on an unknown dates. The clinical outcome of the events of fever, mouth ulceration, mouth swelling, general body aches and sore throat was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Mouth ulcerations; mouth swelling; General body aches; Sore throat; Fever of 102,8; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no allergies to medications, food, or other products. Patient did not received any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's body temperature was measured as 102.8 with unspecified units. On 05Apr2021, the patient underwent nasal swab test and the result was negative. On 25Mar2021 at 06:00, the patient had fever of 102.8, mouth ulcerations and swelling, general body aches, sore throat. This was still presented 8 days post vaccination. The patient went to emergency department on 04May2021 due to mouth swelling and ulcerations and fever. The adverse events also resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotic, lidocaine mouthwash (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) 600 mg on an unknown dates. The clinical outcome of the events of fever, mouth ulceration, mouth swelling, general body aches and sore throat was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Mouth swelling, Mouth ulceration, Oropharyngeal pain, Pain
Clinical narrative: Mouth ulcerations; mouth swelling; General body aches; Sore throat; Fever of 102,8; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no allergies to medications, food, or other products. Patient did not received any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's body temperature was measured as 102.8 with unspecified units. On 05Apr2021, the patient underwent nasal swab test and the result was negative. On 25Mar2021 at 06:00, the patient had fever of 102.8, mouth ulcerations and swelling, general body aches, sore throat. This was still presented 8 days post vaccination. The patient went to emergency department on 04May2021 due to mouth swelling and ulcerations and fever. The adverse events also resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotic, lidocaine mouthwash (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) 600 mg on an unknown dates. The clinical outcome of the events of fever, mouth ulceration, mouth swelling, general body aches and sore throat was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Mouth ulcerations; mouth swelling; General body aches; Sore throat; Fever of 102,8; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no allergies to medications, food, or other products. Patient did not received any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's body temperature was measured as 102.8 with unspecified units. On 05Apr2021, the patient underwent nasal swab test and the result was negative. On 25Mar2021 at 06:00, the patient had fever of 102.8, mouth ulcerations and swelling, general body aches, sore throat. This was still presented 8 days post vaccination. The patient went to emergency department on 04May2021 due to mouth swelling and ulcerations and fever. The adverse events also resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotic, lidocaine mouthwash (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) 600 mg on an unknown dates. The clinical outcome of the events of fever, mouth ulceration, mouth swelling, general body aches and sore throat was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Immediate post-injection reaction, Muscle tightness
Clinical narrative: Tightness in upper chest; Lower throat tightness; Shortness of breath; Itchiness in throat; upper chest and lower throat warmth; Right ear itchiness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included propranolol (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), lamotrigine (LAMICTAL), buspirone (MANUFACTURER UNKNOWN) and busperid all for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:15, immediately patient had a feeling of warmth and tightness in upper chest, lower throat and some shortness of breath, itchiness in throat and right ear. The shortness of breath subsided but the tightness continued and an itchiness in throat and right ear started and remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event tightness in upper chest, lower throat tightness, itchiness in throat, right ear itchiness and feeling of warmth was not recovered; while that of shortness of breath was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: Tightness in upper chest; Lower throat tightness; Shortness of breath; Itchiness in throat; upper chest and lower throat warmth; Right ear itchiness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included propranolol (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), lamotrigine (LAMICTAL), buspirone (MANUFACTURER UNKNOWN) and busperid all for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:15, immediately patient had a feeling of warmth and tightness in upper chest, lower throat and some shortness of breath, itchiness in throat and right ear. The shortness of breath subsided but the tightness continued and an itchiness in throat and right ear started and remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event tightness in upper chest, lower throat tightness, itchiness in throat, right ear itchiness and feeling of warmth was not recovered; while that of shortness of breath was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Pruritus, Throat irritation
Clinical narrative: Tightness in upper chest; Lower throat tightness; Shortness of breath; Itchiness in throat; upper chest and lower throat warmth; Right ear itchiness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included propranolol (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), lamotrigine (LAMICTAL), buspirone (MANUFACTURER UNKNOWN) and busperid all for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:15, immediately patient had a feeling of warmth and tightness in upper chest, lower throat and some shortness of breath, itchiness in throat and right ear. The shortness of breath subsided but the tightness continued and an itchiness in throat and right ear started and remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event tightness in upper chest, lower throat tightness, itchiness in throat, right ear itchiness and feeling of warmth was not recovered; while that of shortness of breath was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Tightness in upper chest; Lower throat tightness; Shortness of breath; Itchiness in throat; upper chest and lower throat warmth; Right ear itchiness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included propranolol (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), lamotrigine (LAMICTAL), buspirone (MANUFACTURER UNKNOWN) and busperid all for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:15, immediately patient had a feeling of warmth and tightness in upper chest, lower throat and some shortness of breath, itchiness in throat and right ear. The shortness of breath subsided but the tightness continued and an itchiness in throat and right ear started and remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event tightness in upper chest, lower throat tightness, itchiness in throat, right ear itchiness and feeling of warmth was not recovered; while that of shortness of breath was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site bruising, Injection site haematoma, Injection site pain, Nausea
Clinical narrative: Mild Nausea; Injection site bruised; Hematoma at site; Very painful all around injection site for 2 weeks; Extreme fatigue; Kept me from usual activities; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0011A) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, spondylolisthesis and bursitis. Concomitant medications included folic acid (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN), all from unknown date for unspecified indication and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and local anesthesia w/ 1% (weight by) lidocaine (MANUFACTURER UNKNOWN), both on unknown date for unspecified indication and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced mild nausea, injection site bruised, hematoma at site and very painful all-around injection site for 2 weeks. From 18Mar2021 to 20Mar2021, the patient had 3 days of extreme fatigue which kept her from usual activities. The patient resumed activities on fourth day (21Mar2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events nausea, injection site bruised, hematoma at site and very painful all-around injection site was recovered after 2 weeks on an unknown date in Apr2021 and the event extreme fatigue was recovered on 20Mar2021 while that of the event decreased activity was recovered on 21Mar2021.   No follow-up attempts are needed. No further information is expected.