chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Dyspnoea, Musculoskeletal chest pain, Pain
Clinical narrative: I got this sharp pain in the left side chest wall muscle; I found it difficult to breathe normally; extreme pain the muscle pain was so sharp and dibilitating; Monday night it woke me up in the middle of night its excruciating pain.; This is a spontaneous report received from a contactable consumer (patient). This 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported; Expiration Date: Jul2021), via an unspecified route of administration on 10May2021 (at the time of vaccinations 59-year-old) as single dose for COVID-19 immunisation. The patient received paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension, hyperlipidaemia, gastrooesophageal reflux disease all from an unknown date and unknown if ongoing. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 10May2021 (at the time of vaccinations 59-year-old) as single dose for COVID-19 immunisation. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN); atorvastatin; bupropion; celecoxib (CELEBREX); hydroxyzine pamoate; metoprolol; nystatin; nitroglycerin taken for an unspecified indication, start and stop date were not reported; pantoprazole as needed; quetiapine fumarate (SEROQUEL); sertraline; sucralfate 1 gm, twice a day and all the concomitant medication were taken for an unspecified indication, and start and stop date were not reported. The patient experienced she got this sharp pain in the left side chest wall muscle and she found it difficult to breathe normally on 14May2021, extreme pain the muscle pain was so sharp and debilitating, Monday night it woke her up in the middle of night its excruciating pain on May2021. Treatment received was captured as No. There was no Investigation Assessment. The outcome for all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest pain, Dyspnoea, Myalgia, Sleep disorder
Clinical narrative: I got this sharp pain in the left side chest wall muscle; I found it difficult to breathe normally; extreme pain the muscle pain was so sharp and dibilitating; Monday night it woke me up in the middle of night its excruciating pain.; This is a spontaneous report received from a contactable consumer (patient). This 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported; Expiration Date: Jul2021), via an unspecified route of administration on 10May2021 (at the time of vaccinations 59-year-old) as single dose for COVID-19 immunisation. The patient received paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension, hyperlipidaemia, gastrooesophageal reflux disease all from an unknown date and unknown if ongoing. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 10May2021 (at the time of vaccinations 59-year-old) as single dose for COVID-19 immunisation. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN); atorvastatin; bupropion; celecoxib (CELEBREX); hydroxyzine pamoate; metoprolol; nystatin; nitroglycerin taken for an unspecified indication, start and stop date were not reported; pantoprazole as needed; quetiapine fumarate (SEROQUEL); sertraline; sucralfate 1 gm, twice a day and all the concomitant medication were taken for an unspecified indication, and start and stop date were not reported. The patient experienced she got this sharp pain in the left side chest wall muscle and she found it difficult to breathe normally on 14May2021, extreme pain the muscle pain was so sharp and debilitating, Monday night it woke her up in the middle of night its excruciating pain on May2021. Treatment received was captured as No. There was no Investigation Assessment. The outcome for all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling, Headache, Ocular hyperaemia, Pain in extremity
Clinical narrative: extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; headaches; some body fatigue; I felt minimal pain In my arm the day of the actual vaccination/ arm completely sore; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 02Jun2021 14:30 (Batch/Lot Number: EW0186) as a single dose for COVID-19 immunisation.  Medical history included depression, migraine, and allergy. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included ephedrine sulfate (EFEDRINA [EPHEDRINE SULFATE]) taken for migraine, and fexofenadine hydrochloride (ALLEGRA) taken for allergy; both with start and stop date not reported.  The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient reported she felt minimal pain in her arm the day of the actual vaccination (02Jun2021). The next day she woke up with her arm completely sore and some body fatigue and headaches (03Jun2021), then the third day she woke up around 4 am with an extremely swollen left eye that was red and also itched (04Jun2021). She took Benadryl and applied ice for the swelling, and it was now 12:30 pm (on 04Jun2021) and the eye was still itchy and swollen. The reporter assessed the events as non-serious. The patient reported she was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling, Fatigue, Headache, Ocular hyperaemia
Clinical narrative: extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; headaches; some body fatigue; I felt minimal pain In my arm the day of the actual vaccination/ arm completely sore; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 02Jun2021 14:30 (Batch/Lot Number: EW0186) as a single dose for COVID-19 immunisation.  Medical history included depression, migraine, and allergy. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included ephedrine sulfate (EFEDRINA [EPHEDRINE SULFATE]) taken for migraine, and fexofenadine hydrochloride (ALLEGRA) taken for allergy; both with start and stop date not reported.  The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient reported she felt minimal pain in her arm the day of the actual vaccination (02Jun2021). The next day she woke up with her arm completely sore and some body fatigue and headaches (03Jun2021), then the third day she woke up around 4 am with an extremely swollen left eye that was red and also itched (04Jun2021). She took Benadryl and applied ice for the swelling, and it was now 12:30 pm (on 04Jun2021) and the eye was still itchy and swollen. The reporter assessed the events as non-serious. The patient reported she was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; extremely swollen left eye that was red and also itched; headaches; some body fatigue; I felt minimal pain In my arm the day of the actual vaccination/ arm completely sore; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 02Jun2021 14:30 (Batch/Lot Number: EW0186) as a single dose for COVID-19 immunisation.  Medical history included depression, migraine, and allergy. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included ephedrine sulfate (EFEDRINA [EPHEDRINE SULFATE]) taken for migraine, and fexofenadine hydrochloride (ALLEGRA) taken for allergy; both with start and stop date not reported.  The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient reported she felt minimal pain in her arm the day of the actual vaccination (02Jun2021). The next day she woke up with her arm completely sore and some body fatigue and headaches (03Jun2021), then the third day she woke up around 4 am with an extremely swollen left eye that was red and also itched (04Jun2021). She took Benadryl and applied ice for the swelling, and it was now 12:30 pm (on 04Jun2021) and the eye was still itchy and swollen. The reporter assessed the events as non-serious. The patient reported she was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain, Paraesthesia, Swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Impaired quality of life, Myalgia, Pain in extremity
Clinical narrative: The pain and current condition of my arm was non-existent prior to my 2nd Covid 19 vaccination.  Injection site pain and swelling lingered with second vaccine injection, worsening over the following couple weeks to where I had to apply lidocaine pain patches (purchased on shelf at pharmacy) and apply heating pad or ice in order to sleep. Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm. Has progressed steadily over three months after vaccination. It?s painful everyday, I cannot dress myself easily, or exercise where any significant   movement/rotation of my arm are needed. The pain is also often sudden, sharp and jarring all over if I move certain common ways - then sometimes a steady dull ache when I?m sitting still. Always painful when i sleep. Working at my computer at my desk is very painful after a couple of hours so I have to take frequent breaks.  I don?t have medical insurance, so I waited for the condition to subside. About 2 weeks later I went to my Urgent Care, April 30, 2021, who wrote an order for an X-ray. Results showed inflamation around rotator cuff tendon. Making another appointment to determine whether nerve damage was done during administration of Second Vaccination, as this was the clear beginning of all of the pain and current symptoms affecting my left arm and shoulder. Just taking 1 week of oral steroid medication so far with no relief from symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Injection site pain, Injection site swelling, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: The pain and current condition of my arm was non-existent prior to my 2nd Covid 19 vaccination.  Injection site pain and swelling lingered with second vaccine injection, worsening over the following couple weeks to where I had to apply lidocaine pain patches (purchased on shelf at pharmacy) and apply heating pad or ice in order to sleep. Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm. Has progressed steadily over three months after vaccination. It?s painful everyday, I cannot dress myself easily, or exercise where any significant   movement/rotation of my arm are needed. The pain is also often sudden, sharp and jarring all over if I move certain common ways - then sometimes a steady dull ache when I?m sitting still. Always painful when i sleep. Working at my computer at my desk is very painful after a couple of hours so I have to take frequent breaks.  I don?t have medical insurance, so I waited for the condition to subside. About 2 weeks later I went to my Urgent Care, April 30, 2021, who wrote an order for an X-ray. Results showed inflamation around rotator cuff tendon. Making another appointment to determine whether nerve damage was done during administration of Second Vaccination, as this was the clear beginning of all of the pain and current symptoms affecting my left arm and shoulder. Just taking 1 week of oral steroid medication so far with no relief from symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Rotator cuff syndrome, Sleep disorder, X-ray limb abnormal
Clinical narrative: The pain and current condition of my arm was non-existent prior to my 2nd Covid 19 vaccination.  Injection site pain and swelling lingered with second vaccine injection, worsening over the following couple weeks to where I had to apply lidocaine pain patches (purchased on shelf at pharmacy) and apply heating pad or ice in order to sleep. Range of motion is severely impacted in my left arm now, extending to my elbow with shooting pain down the arm. Has progressed steadily over three months after vaccination. It?s painful everyday, I cannot dress myself easily, or exercise where any significant   movement/rotation of my arm are needed. The pain is also often sudden, sharp and jarring all over if I move certain common ways - then sometimes a steady dull ache when I?m sitting still. Always painful when i sleep. Working at my computer at my desk is very painful after a couple of hours so I have to take frequent breaks.  I don?t have medical insurance, so I waited for the condition to subside. About 2 weeks later I went to my Urgent Care, April 30, 2021, who wrote an order for an X-ray. Results showed inflamation around rotator cuff tendon. Making another appointment to determine whether nerve damage was done during administration of Second Vaccination, as this was the clear beginning of all of the pain and current symptoms affecting my left arm and shoulder. Just taking 1 week of oral steroid medication so far with no relief from symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Blood thyroid stimulating hormone, C-reactive protein, Dizziness, Echocardiogram
Clinical narrative: Menstrual lasted two and a half weeks; Vestibular neurontitus; Dizziness; Head pressure; Heart palpitations; Unbalance; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 15Apr2021 at 17:15 as dose 1 single (at the age of 48-year-old) for COVID-19 immunization. Medical history included ongoing High blood pressure (Start: 6 years ago, her doctor said if she keeps losing weight she can go off of it). Family relevant medical history relevant to AE was reported as none. Concomitant medication included oral lisinopril 10 mg, daily (10 mg, tablet, once a day) from Oct2020 to an unspecified date for blood pressure high, vitamins count (not clarified further). On 16Apr2021, patient experienced menstrual lasted two and a half weeks, vestibular neurontitus, dizziness, head pressure, heart palpitations. On an unspecified date in Apr2021, patient experienced unbalance. Patient was calling about the covid vaccine. She had her first vaccine on 15Apr2021 at 5:15 and symptoms started the following day, on 16Apr2021. Twelve hours after she started having major side effects and she is still dealing with them three months later. Event menstrual lasted two and a half weeks and started 12 hours after on 16Apr2021. It was two and half weeks and then she got her regular one 2 days after. No treatment she made a phone call to her gynecologist. Event vestibular neurontitus, spelling as provided by caller. It affected the nerve in her inner ear causing dizziness, head pressure, unbalance, and heart palpitations. She was diagnosed by the ENT, she got an audiogram to make sure it did not affect her hearing on an unspecified date in 2021. It did not affect her hearing. Now for the past 6 weeks she has been going to dizziness and balance therapy. Treatment received as vestibular therapy for the events dizziness, head pressure. Treatment for heart palpitations: for 48 hours she had a Holter monitor put on and an echocardiogram resulted as unknown results done on an unspecified date in Apr2021. Patient did not visit emergency Room. Adverse events resulted to visit Physician Office. Patient stated she was improving. Patient received her second one (Lot: EW0168) was at 4:15 in evening on 06May2021. Description of the event, comment, or concern as provided by the reporter was adverse reactuib. Reporter seriousness for all the events was unspecified. The outcome of the event menstrual lasted two and a half weeks was recovered on 02May2021, heart palpitations was recovered on 25Apr2021 and outcome of the event unbalance was unknown and outcome of the other events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Menstrual disorder, Palpitations, Tinnitus, Vision blurred
Clinical narrative: Menstrual lasted two and a half weeks; Vestibular neurontitus; Dizziness; Head pressure; Heart palpitations; Unbalance; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 15Apr2021 at 17:15 as dose 1 single (at the age of 48-year-old) for COVID-19 immunization. Medical history included ongoing High blood pressure (Start: 6 years ago, her doctor said if she keeps losing weight she can go off of it). Family relevant medical history relevant to AE was reported as none. Concomitant medication included oral lisinopril 10 mg, daily (10 mg, tablet, once a day) from Oct2020 to an unspecified date for blood pressure high, vitamins count (not clarified further). On 16Apr2021, patient experienced menstrual lasted two and a half weeks, vestibular neurontitus, dizziness, head pressure, heart palpitations. On an unspecified date in Apr2021, patient experienced unbalance. Patient was calling about the covid vaccine. She had her first vaccine on 15Apr2021 at 5:15 and symptoms started the following day, on 16Apr2021. Twelve hours after she started having major side effects and she is still dealing with them three months later. Event menstrual lasted two and a half weeks and started 12 hours after on 16Apr2021. It was two and half weeks and then she got her regular one 2 days after. No treatment she made a phone call to her gynecologist. Event vestibular neurontitus, spelling as provided by caller. It affected the nerve in her inner ear causing dizziness, head pressure, unbalance, and heart palpitations. She was diagnosed by the ENT, she got an audiogram to make sure it did not affect her hearing on an unspecified date in 2021. It did not affect her hearing. Now for the past 6 weeks she has been going to dizziness and balance therapy. Treatment received as vestibular therapy for the events dizziness, head pressure. Treatment for heart palpitations: for 48 hours she had a Holter monitor put on and an echocardiogram resulted as unknown results done on an unspecified date in Apr2021. Patient did not visit emergency Room. Adverse events resulted to visit Physician Office. Patient stated she was improving. Patient received her second one (Lot: EW0168) was at 4:15 in evening on 06May2021. Description of the event, comment, or concern as provided by the reporter was adverse reactuib. Reporter seriousness for all the events was unspecified. The outcome of the event menstrual lasted two and a half weeks was recovered on 02May2021, heart palpitations was recovered on 25Apr2021 and outcome of the event unbalance was unknown and outcome of the other events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Balance disorder, Dizziness, Echocardiogram, Head discomfort
Clinical narrative: Menstrual lasted two and a half weeks; Vestibular neurontitus; Dizziness; Head pressure; Heart palpitations; Unbalance; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 15Apr2021 at 17:15 as dose 1 single (at the age of 48-year-old) for COVID-19 immunization. Medical history included ongoing High blood pressure (Start: 6 years ago, her doctor said if she keeps losing weight she can go off of it). Family relevant medical history relevant to AE was reported as none. Concomitant medication included oral lisinopril 10 mg, daily (10 mg, tablet, once a day) from Oct2020 to an unspecified date for blood pressure high, vitamins count (not clarified further). On 16Apr2021, patient experienced menstrual lasted two and a half weeks, vestibular neurontitus, dizziness, head pressure, heart palpitations. On an unspecified date in Apr2021, patient experienced unbalance. Patient was calling about the covid vaccine. She had her first vaccine on 15Apr2021 at 5:15 and symptoms started the following day, on 16Apr2021. Twelve hours after she started having major side effects and she is still dealing with them three months later. Event menstrual lasted two and a half weeks and started 12 hours after on 16Apr2021. It was two and half weeks and then she got her regular one 2 days after. No treatment she made a phone call to her gynecologist. Event vestibular neurontitus, spelling as provided by caller. It affected the nerve in her inner ear causing dizziness, head pressure, unbalance, and heart palpitations. She was diagnosed by the ENT, she got an audiogram to make sure it did not affect her hearing on an unspecified date in 2021. It did not affect her hearing. Now for the past 6 weeks she has been going to dizziness and balance therapy. Treatment received as vestibular therapy for the events dizziness, head pressure. Treatment for heart palpitations: for 48 hours she had a Holter monitor put on and an echocardiogram resulted as unknown results done on an unspecified date in Apr2021. Patient did not visit emergency Room. Adverse events resulted to visit Physician Office. Patient stated she was improving. Patient received her second one (Lot: EW0168) was at 4:15 in evening on 06May2021. Description of the event, comment, or concern as provided by the reporter was adverse reactuib. Reporter seriousness for all the events was unspecified. The outcome of the event menstrual lasted two and a half weeks was recovered on 02May2021, heart palpitations was recovered on 25Apr2021 and outcome of the event unbalance was unknown and outcome of the other events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation delayed, Palpitations, Vestibular neuronitis
Clinical narrative: Menstrual lasted two and a half weeks; Vestibular neurontitus; Dizziness; Head pressure; Heart palpitations; Unbalance; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 15Apr2021 at 17:15 as dose 1 single (at the age of 48-year-old) for COVID-19 immunization. Medical history included ongoing High blood pressure (Start: 6 years ago, her doctor said if she keeps losing weight she can go off of it). Family relevant medical history relevant to AE was reported as none. Concomitant medication included oral lisinopril 10 mg, daily (10 mg, tablet, once a day) from Oct2020 to an unspecified date for blood pressure high, vitamins count (not clarified further). On 16Apr2021, patient experienced menstrual lasted two and a half weeks, vestibular neurontitus, dizziness, head pressure, heart palpitations. On an unspecified date in Apr2021, patient experienced unbalance. Patient was calling about the covid vaccine. She had her first vaccine on 15Apr2021 at 5:15 and symptoms started the following day, on 16Apr2021. Twelve hours after she started having major side effects and she is still dealing with them three months later. Event menstrual lasted two and a half weeks and started 12 hours after on 16Apr2021. It was two and half weeks and then she got her regular one 2 days after. No treatment she made a phone call to her gynecologist. Event vestibular neurontitus, spelling as provided by caller. It affected the nerve in her inner ear causing dizziness, head pressure, unbalance, and heart palpitations. She was diagnosed by the ENT, she got an audiogram to make sure it did not affect her hearing on an unspecified date in 2021. It did not affect her hearing. Now for the past 6 weeks she has been going to dizziness and balance therapy. Treatment received as vestibular therapy for the events dizziness, head pressure. Treatment for heart palpitations: for 48 hours she had a Holter monitor put on and an echocardiogram resulted as unknown results done on an unspecified date in Apr2021. Patient did not visit emergency Room. Adverse events resulted to visit Physician Office. Patient stated she was improving. Patient received her second one (Lot: EW0168) was at 4:15 in evening on 06May2021. Description of the event, comment, or concern as provided by the reporter was adverse reactuib. Reporter seriousness for all the events was unspecified. The outcome of the event menstrual lasted two and a half weeks was recovered on 02May2021, heart palpitations was recovered on 25Apr2021 and outcome of the event unbalance was unknown and outcome of the other events was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Malaise, Post viral fatigue syndrome
Clinical narrative: a significant decrease in his functioning for Myalgic Encephalomyelitis/Chronic Fatigue Syndrorme (ME/CFS); a significant decrease in his functioning for Myalgic Encephalomyelitis/Chronic Fatigue Syndrorme (ME/CFS); a significant decrease in his functioning for Myalgic Encephalomyelitis/Chronic Fatigue Syndrorme (ME/CFS); a profound weakness not experienced to this degree prior and a worsening of post-exertional malaise (PEM); This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 06Apr2021 02:00 PM (at 32-year-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing ME/CFS & PEM (Myalgic encephalomyelitis/ Chronic fatigue syndrome and Post-exertional malaise). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 16Mar2021 02:00 PM (at 32-year-old) as dose 1, single for COVID-19 immunization. On 26Apr2021 at 08:00 AM, 15 days after the patient's 2nd dose, he experienced a significant decrease in his functioning for Myalgic Encephalomyelitis/Chronic Fatigue Syndrorme (ME/CFS). Specifically, a profound weakness not experienced to this degree prior and a worsening of post-exertional malaise (PEM). No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac failure, Computerised tomogram
Clinical narrative: I died at home in the morning of April 10th at approx. 10:30 am my husband had to give me CPR and revive me. Then in rescue squad I died again and the EMTs had to revive me. Then at the hospital i was in the Trauma room, they sent me to get a CT Scan and I died for 5 minutes on the CT table. Then spent 3 days in a medical comma on a ventilator in ICU, then 4 days in  a hospital room.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Intensive care, Mechanical ventilation, Medical induction of coma, Resuscitation
Clinical narrative: I died at home in the morning of April 10th at approx. 10:30 am my husband had to give me CPR and revive me. Then in rescue squad I died again and the EMTs had to revive me. Then at the hospital i was in the Trauma room, they sent me to get a CT Scan and I died for 5 minutes on the CT table. Then spent 3 days in a medical comma on a ventilator in ICU, then 4 days in  a hospital room.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspepsia, Electrocardiogram normal
Clinical narrative: Heartburn; Inflamation; Soreness in pectoral muscles; slight pain also in pectoral muscles.; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186) via unspecified route of administration, administered in Arm Left on 06Jul2021 at 10:30 as single dose for covid-19 immunisation. Vaccination facility type was Doctor's office/Urgent care. No prior vaccinations reported. Medical history included olfacto genital dysplasia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0182) via unspecified route of administration, administered in Arm Left on 25May2021 10:30 as single dose for covid-19 immunisation. On 07Jul2021 at 10:00, the patient experienced inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles. Also have heartburn started on 08Jul2021 and the patient have never had that before. Heartburn on 08Jul2021 and on 09Jul2021. The adverse event was required in a visit to Physician office. The patient had no treatment received for the adverse events. The outcome of the event Heartburn recovered on 09Jul2021 and recovering from the events inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dyspepsia, Inflammation, Pain
Clinical narrative: Heartburn; Inflamation; Soreness in pectoral muscles; slight pain also in pectoral muscles.; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186) via unspecified route of administration, administered in Arm Left on 06Jul2021 at 10:30 as single dose for covid-19 immunisation. Vaccination facility type was Doctor's office/Urgent care. No prior vaccinations reported. Medical history included olfacto genital dysplasia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0182) via unspecified route of administration, administered in Arm Left on 25May2021 10:30 as single dose for covid-19 immunisation. On 07Jul2021 at 10:00, the patient experienced inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles. Also have heartburn started on 08Jul2021 and the patient have never had that before. Heartburn on 08Jul2021 and on 09Jul2021. The adverse event was required in a visit to Physician office. The patient had no treatment received for the adverse events. The outcome of the event Heartburn recovered on 09Jul2021 and recovering from the events inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Tingle/needle feeling in hands, feet, legs; Itchy scalp; 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, Lot/batch no: EW0162) via unspecified route in the left arm on 23Jun2021 at 16:30 (at the age of 50-years) as dose 1, single for COVID-19 immunization.Medical history was none. There were no known allergies. Patient received balance of nature within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 25Jun2021at 07:00, patient experienced tingle/needle feeling in hands, feet, legs, itchy scalp, patient would be making a doctor appointment. The patient did not receive any treatment for events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: left leg from his hip to his foot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 21Mar2021 (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing slight high blood pressure (this has been going on 10-15 years but was not on medication for it) and trouble with back (last 40 years, but his doctor says his leg has nothing to do with that). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 01Mar2021, as a single dose for COVID-19 immunization. The patient reported that on 15Apr2021, he experienced left leg from his hip to his foot. He did not have a prescribing doctor. It happened about two weeks after the second shot. He developed quite a bit of pain in his left leg from his hip to his foot. This was a pain he has never had before. It mostly happens at rest. It was there all day long, but it came and goes. It was worse at night and sitting through the day. It was persisting. He went to the doctor. It was severe pain in his leg. Outcome of the event was not recovered.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: left leg from his hip to his foot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 21Mar2021 (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing slight high blood pressure (this has been going on 10-15 years but was not on medication for it) and trouble with back (last 40 years, but his doctor says his leg has nothing to do with that). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 01Mar2021, as a single dose for COVID-19 immunization. The patient reported that on 15Apr2021, he experienced left leg from his hip to his foot. He did not have a prescribing doctor. It happened about two weeks after the second shot. He developed quite a bit of pain in his left leg from his hip to his foot. This was a pain he has never had before. It mostly happens at rest. It was there all day long, but it came and goes. It was worse at night and sitting through the day. It was persisting. He went to the doctor. It was severe pain in his leg. Outcome of the event was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Muscular weakness, Paraesthesia, Pruritus, Rash
Clinical narrative: LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE  POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Muscle spasms, Pain, Paraesthesia
Clinical narrative: LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE  POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Peripheral swelling, Rash pruritic, Skin atrophy, Weight decreased
Clinical narrative: LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE  POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Computerised tomogram normal, Diplopia, Impaired work ability, Vision blurred
Clinical narrative: 10 min after receiving vaccine my vision became blurry and my stomach was upset. I felt like I was going to pass out. They had to put me in a recliner with wet washcloths on my. Almost 3 weeks later I am still having vision loss.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blindness, Computerised tomogram head, Dizziness, Laboratory test abnormal
Clinical narrative: 10 min after receiving vaccine my vision became blurry and my stomach was upset. I felt like I was going to pass out. They had to put me in a recliner with wet washcloths on my. Almost 3 weeks later I am still having vision loss.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination abnormal, Vision blurred
Clinical narrative: 10 min after receiving vaccine my vision became blurry and my stomach was upset. I felt like I was going to pass out. They had to put me in a recliner with wet washcloths on my. Almost 3 weeks later I am still having vision loss.