chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chapped lips, Dry mouth, Lip swelling, Oral discomfort, Paraesthesia oral
Clinical narrative: 11/19/21-76 yo female presents with chief complaint of cough, nasal drainage, and sinus pressure x 6 days.  She has been taking Mucinex-DM and Robitussin to help with her symptoms. She states that her symptoms have been mild but she has been more concerned about her cough and worried about it going into pneumonia. She states that she is not having SOB but is having some tightness with her cough. Denies any trouble breathing.  She denies any known exposure to anyone that has tested positive to COVID-19. She is fully vaccinated. She reports having a fever of 99.9 but nothing other than that. She states that her cough is turning more into a "croupy" cough now. Denies any loss of taste or smell.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Paranasal sinus discomfort, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 11/19/21-76 yo female presents with chief complaint of cough, nasal drainage, and sinus pressure x 6 days.  She has been taking Mucinex-DM and Robitussin to help with her symptoms. She states that her symptoms have been mild but she has been more concerned about her cough and worried about it going into pneumonia. She states that she is not having SOB but is having some tightness with her cough. Denies any trouble breathing.  She denies any known exposure to anyone that has tested positive to COVID-19. She is fully vaccinated. She reports having a fever of 99.9 but nothing other than that. She states that her cough is turning more into a "croupy" cough now. Denies any loss of taste or smell.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus operation
Clinical narrative: 11/19/21-76 yo female presents with chief complaint of cough, nasal drainage, and sinus pressure x 6 days.  She has been taking Mucinex-DM and Robitussin to help with her symptoms. She states that her symptoms have been mild but she has been more concerned about her cough and worried about it going into pneumonia. She states that she is not having SOB but is having some tightness with her cough. Denies any trouble breathing.  She denies any known exposure to anyone that has tested positive to COVID-19. She is fully vaccinated. She reports having a fever of 99.9 but nothing other than that. She states that her cough is turning more into a "croupy" cough now. Denies any loss of taste or smell.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exfoliative rash, Headache, Injection site erythema, Insomnia, Rash
Clinical narrative: full body hives; "COVID arm" in left arm
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: full body hives; "COVID arm" in left arm
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature decreased, Burning sensation, Chills, Muscle spasms, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6204, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 29Apr2021 14:15 (Age at vaccination 37-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Medical history included epstein-barr virus infection, nerve damage left arm, allergies anything with eggs or soy from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid (VITAMINS C), colecalciferol (VITAMIN D [COLECALCIFEROL]), spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8734, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:15 (Age at vaccination 37-years-old) as dose 1, single for covid-19 immunization with the reaction I had full body aches, my body temp dropped to 96.1, I had chills every time I drank anything, I had horrible muscle cramps for 2.5 weeks. The patient experienced on both shots, within 24 hours I had full body aches and my body temp dropped to 96.1. I had chills every time I drank anything. Lasted 24 hours both times. After the 1st shot, I had horrible muscle cramps for 2.5 weeks. After the 2nd shot, within 5 days the taste buds on the back of my tongue got swollen and I feel like I've burnt my tongue on the back and sides of my tongue, but I haven't. Brushing my teeth and using mouthwash twice a day has not helped, neither has warm salt water rinses. My tongue also feels slightly swollen so I have been taking anti-inflammatory medicine. The patient underwent lab tests and procedures which included body temperature: 96.1 on dropped. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received vitamins C, D, Spirulina other medications within 2 weeks of 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. Therapeutic measures were taken for the events my tongue got swollen. The patient did not received treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6204, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 29Apr2021 14:15 (Age at vaccination 37-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Medical history included epstein-barr virus infection, nerve damage left arm, allergies anything with eggs or soy from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid (VITAMINS C), colecalciferol (VITAMIN D [COLECALCIFEROL]), spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8734, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:15 (Age at vaccination 37-years-old) as dose 1, single for covid-19 immunization with the reaction I had full body aches, my body temp dropped to 96.1, I had chills every time I drank anything, I had horrible muscle cramps for 2.5 weeks. The patient experienced on both shots, within 24 hours I had full body aches and my body temp dropped to 96.1. I had chills every time I drank anything. Lasted 24 hours both times. After the 1st shot, I had horrible muscle cramps for 2.5 weeks. After the 2nd shot, within 5 days the taste buds on the back of my tongue got swollen and I feel like I've burnt my tongue on the back and sides of my tongue, but I haven't. Brushing my teeth and using mouthwash twice a day has not helped, neither has warm salt water rinses. My tongue also feels slightly swollen so I have been taking anti-inflammatory medicine. The patient underwent lab tests and procedures which included body temperature: 96.1 on dropped. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received vitamins C, D, Spirulina other medications within 2 weeks of 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. Therapeutic measures were taken for the events my tongue got swollen. The patient did not received treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Muscle spasms, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6204, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 29Apr2021 14:15 (Age at vaccination 37-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Medical history included epstein-barr virus infection, nerve damage left arm, allergies anything with eggs or soy from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid (VITAMINS C), colecalciferol (VITAMIN D [COLECALCIFEROL]), spirulina platensis (SPIRULINA [SPIRULINA PLATENSIS]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8734, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:15 (Age at vaccination 37-years-old) as dose 1, single for covid-19 immunization with the reaction I had full body aches, my body temp dropped to 96.1, I had chills every time I drank anything, I had horrible muscle cramps for 2.5 weeks. The patient experienced on both shots, within 24 hours I had full body aches and my body temp dropped to 96.1. I had chills every time I drank anything. Lasted 24 hours both times. After the 1st shot, I had horrible muscle cramps for 2.5 weeks. After the 2nd shot, within 5 days the taste buds on the back of my tongue got swollen and I feel like I've burnt my tongue on the back and sides of my tongue, but I haven't. Brushing my teeth and using mouthwash twice a day has not helped, neither has warm salt water rinses. My tongue also feels slightly swollen so I have been taking anti-inflammatory medicine. The patient underwent lab tests and procedures which included body temperature: 96.1 on dropped. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received vitamins C, D, Spirulina other medications within 2 weeks of 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. Therapeutic measures were taken for the events my tongue got swollen. The patient did not received treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac aneurysm, Catheterisation cardiac, Chest pain, Computerised tomogram thorax, Electrocardiogram
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging heart, Myocarditis, Ultrasound scan
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac aneurysm, Cardiac disorder, Computerised tomogram, Inflammation
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Vaccination failure, X-ray
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac aneurysm, Cardiac discomfort, Catheterisation cardiac abnormal, Chest X-ray abnormal, Chest pain
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: 2 days later, heart attack symptoms, trouble breathing, chest pain, myocarditis, heart aneurisms
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain in extremity, Seizure, X-ray normal
Clinical narrative: 7-20-2021. CALLED ADVICE NURSEB WITH COMPLAINT OF UPPER LEFT ARM PAIN.X-RAY TAKEN CAME BACK NORMAL. 7-29-2021 WENT BY AMBULANCE TO ER AFTER A GRAND MAL SEIZURE AND LOSING CONSCIOUNSOUS LONGER THAN 7 MINS. GIVEN 15 DAY SUPPLY OF KEPPRA.. 7-31-2021 WENT TO ER ADMITTED 8-1-2021 SEDATED MRI CONDUCTED HAS BLEEDING IN THE BRAIN THAT WILL REQUIRE BRAIN SURGERY.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebral haemorrhage, Generalised tonic-clonic seizure, Injection site pain, Loss of consciousness
Clinical narrative: 7-20-2021. CALLED ADVICE NURSEB WITH COMPLAINT OF UPPER LEFT ARM PAIN.X-RAY TAKEN CAME BACK NORMAL. 7-29-2021 WENT BY AMBULANCE TO ER AFTER A GRAND MAL SEIZURE AND LOSING CONSCIOUNSOUS LONGER THAN 7 MINS. GIVEN 15 DAY SUPPLY OF KEPPRA.. 7-31-2021 WENT TO ER ADMITTED 8-1-2021 SEDATED MRI CONDUCTED HAS BLEEDING IN THE BRAIN THAT WILL REQUIRE BRAIN SURGERY.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, X-ray normal
Clinical narrative: 7-20-2021. CALLED ADVICE NURSEB WITH COMPLAINT OF UPPER LEFT ARM PAIN.X-RAY TAKEN CAME BACK NORMAL. 7-29-2021 WENT BY AMBULANCE TO ER AFTER A GRAND MAL SEIZURE AND LOSING CONSCIOUNSOUS LONGER THAN 7 MINS. GIVEN 15 DAY SUPPLY OF KEPPRA.. 7-31-2021 WENT TO ER ADMITTED 8-1-2021 SEDATED MRI CONDUCTED HAS BLEEDING IN THE BRAIN THAT WILL REQUIRE BRAIN SURGERY.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Antibody test, Anxiety, Blood test, Cognitive disorder
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Delusion, Depression, Drug screen, Electromyogram, Feeling of body temperature change
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Impaired work ability, Intrusive thoughts, Magnetic resonance imaging, Muscular weakness
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Obsessive-compulsive disorder, Pain in extremity, Panic attack, Paraesthesia, Paranoia
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Psychiatric symptom, Psychotic disorder, SARS-CoV-2 test negative, Taste disorder
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Urine analysis
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anxiety, Asthenia, Cognitive disorder, Delusion
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depression, Hallucination, Intrusive thoughts, Obsessive-compulsive disorder, Pain in extremity
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Paranoia, Psychotic disorder, SARS-CoV-2 test
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Schizophrenia, Visual impairment
Clinical narrative: acute onset psychosis with debilitating OCD; visions; delusions; hallucinations; paranoia; intrusive thoughts; Anxiety; Panic attacks; short term memory loss; depression; changes in cognitive ability; Rapidly progressed to acute onset psychosis; schizophrenia like symptoms; Left Arm Ache; Weakness from fingertip to shoulder; tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:00 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. There were no (none) medical history and concomitant medications. The patient previously took Imodium and experienced drug allergy (known allergies: Imodium). The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination was reported as yes. The reporter reported that 22Mar2021 11:00 the patient experienced, Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm. On 11Apr2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss, depression. The patient received treatment for the events as physical testing, mental therapy, medication. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021 and Nasal Swab, sars-cov-2 test NAT negative on 28May2021 Nasal Swab. The outcome for the events were reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Injection site pain, Intervertebral disc protrusion, Magnetic resonance imaging, Nerve compression, Pain in extremity
Clinical narrative: SORE ARM FOR TWO DAYS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neck surgery, and concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for two days. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM FOR TWO DAYS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neck surgery, and concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for two days. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Tested Positive for COvid via a PCR test on 13Nov2021; Tested Positive for COvid via a PCR test on 13Nov2021; mild flu like symptoms but no fever; Lost of taste and smell; Lost of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 23Mar2021, (at the age of 43-years-old) as dose 2, single and dose 1 via an unspecified route of administration on 02Mar2021, (at the age of 43-years-old) (Lot Number: EL3248) as dose 1, single for covid-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. On 12Nov2021, the patient experienced mild flu like symptoms, loss of taste and smell but no fever. Did not take any medications. The patient tested positive for covid via a PCR test on 13nov2021. The patient did not have covid prior to the vaccination. Patient tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks and also did not receive other medications in two weeks. The patient underwent lab tests and procedures which included sars-cov-2 PCR test positive (nasal Swab) on 13Nov2021. No therapeutic measures were taken as a result of the events. The outcome of the events was recovering.    Follow-up attempts were completed. No further information was expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Influenza like illness, Vaccination failure
Clinical narrative: Tested Positive for COvid via a PCR test on 13Nov2021; Tested Positive for COvid via a PCR test on 13Nov2021; mild flu like symptoms but no fever; Lost of taste and smell; Lost of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 23Mar2021, (at the age of 43-years-old) as dose 2, single and dose 1 via an unspecified route of administration on 02Mar2021, (at the age of 43-years-old) (Lot Number: EL3248) as dose 1, single for covid-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. On 12Nov2021, the patient experienced mild flu like symptoms, loss of taste and smell but no fever. Did not take any medications. The patient tested positive for covid via a PCR test on 13nov2021. The patient did not have covid prior to the vaccination. Patient tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks and also did not receive other medications in two weeks. The patient underwent lab tests and procedures which included sars-cov-2 PCR test positive (nasal Swab) on 13Nov2021. No therapeutic measures were taken as a result of the events. The outcome of the events was recovering.    Follow-up attempts were completed. No further information was expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral normal, Angiogram pulmonary normal, Asthenia, Biopsy artery normal, Catheterisation cardiac normal
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate