chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Aura, Cognitive disorder, Dysarthria, Headache
Clinical narrative: Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Slurrred speech; Sound sensitivity; Lack of cognition; Debilitating; It affected her job/work; light sensitivity; Auras; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 32-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in left upper arm on 23Mar2021 15:00 as dose 2, single (at the age of 32-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) intramuscularly in left upper arm on 03Mar2021 15:26 as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other (Civic Center). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Prior vaccinations within 4 weeks was reported as none. Vaccine was not administered at Military Facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history was reported as None. The concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000) daily. Patient experienced headaches that had been occurring daily since 23Mar2021 20:00. Since the second shot (23Mar2021 20:00), migraines had increased in frequency and intensity. Headaches occurred the evening of the second dose (23Mar2021 20:00). The headaches persisted and series of migraines set on 23Mar2021 20:00. This caused slurred speech, auras, light & sound sensitivity, lack of cognition on an unspecified date in 2021. It affected her job/work and was debilitating on an unspecified date in 2021. She sought help from her primary care and also a second opinion in Apr2021. It had continued, despite medications (multiple trials), massaging to try and release tension, and physical therapy. The headaches were daily and migraines occur frequently. Patient was prescribed with sumatriptan and Topomax for migraines along with physical therapies. Medications to try and disrupt migraine patterns had not worked. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The lab tests and procedures included COVID-19 (Rapid PCR test) with result as negative on 06Feb2021. The outcome of the events was not resolved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Loss of personal independence in daily activities, Migraine, Photophobia, SARS-CoV-2 test
Clinical narrative: Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Slurrred speech; Sound sensitivity; Lack of cognition; Debilitating; It affected her job/work; light sensitivity; Auras; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 32-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in left upper arm on 23Mar2021 15:00 as dose 2, single (at the age of 32-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) intramuscularly in left upper arm on 03Mar2021 15:26 as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other (Civic Center). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Prior vaccinations within 4 weeks was reported as none. Vaccine was not administered at Military Facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history was reported as None. The concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000) daily. Patient experienced headaches that had been occurring daily since 23Mar2021 20:00. Since the second shot (23Mar2021 20:00), migraines had increased in frequency and intensity. Headaches occurred the evening of the second dose (23Mar2021 20:00). The headaches persisted and series of migraines set on 23Mar2021 20:00. This caused slurred speech, auras, light & sound sensitivity, lack of cognition on an unspecified date in 2021. It affected her job/work and was debilitating on an unspecified date in 2021. She sought help from her primary care and also a second opinion in Apr2021. It had continued, despite medications (multiple trials), massaging to try and release tension, and physical therapy. The headaches were daily and migraines occur frequently. Patient was prescribed with sumatriptan and Topomax for migraines along with physical therapies. Medications to try and disrupt migraine patterns had not worked. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The lab tests and procedures included COVID-19 (Rapid PCR test) with result as negative on 06Feb2021. The outcome of the events was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bedridden, Body temperature, Chills
Clinical narrative: I had a 104.2 temperature/ Fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; the first time had the swelling at the injection site; Last time I had lot of redness at the injection site into my arms; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) reported that a patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EP6955), via an unknown route of administration on an unknown date as Dose number unknown, Single for COVID-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and COVID-19 in Dec2020 to Jan 2021. Concomitant medications were not reported. On an unknown date, the patient had a 104.2 temperature/ fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; dizziness; weakness; injection site pain; tiredness; headache; muscle pain; chills; joint pain; the first time had the swelling at the injection site; last time I had lot of redness at the injection site into my arms; nausea; feeling unwell. The patient had a bad case of Covid for the whole month from the middle of December from the middle to the January, I was not hospitalized I just ended up in the emergency room. I had all the symptoms for 2 days and today I just feel tired and last time I was bed for 2 days and I was tired and now I was bed for 2 days. The patient confirmed that, "I had after I got both of my Pfizer Vaccine". The outcome of the events was unknown.  No follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: I had a 104.2 temperature/ Fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; the first time had the swelling at the injection site; Last time I had lot of redness at the injection site into my arms; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) reported that a patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EP6955), via an unknown route of administration on an unknown date as Dose number unknown, Single for COVID-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and COVID-19 in Dec2020 to Jan 2021. Concomitant medications were not reported. On an unknown date, the patient had a 104.2 temperature/ fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; dizziness; weakness; injection site pain; tiredness; headache; muscle pain; chills; joint pain; the first time had the swelling at the injection site; last time I had lot of redness at the injection site into my arms; nausea; feeling unwell. The patient had a bad case of Covid for the whole month from the middle of December from the middle to the January, I was not hospitalized I just ended up in the emergency room. I had all the symptoms for 2 days and today I just feel tired and last time I was bed for 2 days and I was tired and now I was bed for 2 days. The patient confirmed that, "I had after I got both of my Pfizer Vaccine". The outcome of the events was unknown.  No follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I had a 104.2 temperature/ Fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; the first time had the swelling at the injection site; Last time I had lot of redness at the injection site into my arms; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) reported that a patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EP6955), via an unknown route of administration on an unknown date as Dose number unknown, Single for COVID-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and COVID-19 in Dec2020 to Jan 2021. Concomitant medications were not reported. On an unknown date, the patient had a 104.2 temperature/ fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; dizziness; weakness; injection site pain; tiredness; headache; muscle pain; chills; joint pain; the first time had the swelling at the injection site; last time I had lot of redness at the injection site into my arms; nausea; feeling unwell. The patient had a bad case of Covid for the whole month from the middle of December from the middle to the January, I was not hospitalized I just ended up in the emergency room. I had all the symptoms for 2 days and today I just feel tired and last time I was bed for 2 days and I was tired and now I was bed for 2 days. The patient confirmed that, "I had after I got both of my Pfizer Vaccine". The outcome of the events was unknown.  No follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Limb discomfort
Clinical narrative: Cant make fist with left hand; Taste is off (food taste bad); This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 24May2021 09:00 (at the age of 63 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, multiple allergies, diverticulosis and hashimoto's disease. The patient was allergic to antibiotics, cats and fish. The patient did not receive any other medications in two weeks of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. On an unknown date in May2021, the patient was unable to make fist with left hand and taste was off (food taste bad). The outcome of events was unknown.  The lot number for the vaccine [BNT162b2], was not provided and will be requested during follow up
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Malaise
Clinical narrative: lightning zaps in my head; headache; brain fog; numbness in my hand and arms; fatigue; big sense of being "unwell"; Random shooting pains; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 05Apr2021 at 10:45 (Batch/Lot Number: EW0151) as dose 1, single, (at the age of 39 years-old) and dose 2 via an unspecified route of administration, administered in the left arm on 26Apr2021 at 10:45 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 39 years-old) for COVID-19 immunisation.  The patient had no relevant medical history.  It was unknown if the patient was pregnant. It was unknown if the patient had COVID prior to the vaccination. It was unknown if the patient had been tested for COVID post vaccination. There were no concomitant medications.  There were no prior vaccinations within 4 weeks. The patient experienced lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains; all on an unknown date. The events required an emergency room visit.  The clinical course is as follows: the patient went to the emergency room after a cascade of scary effects. The patient's head felt like it was bleeding internally. The patient had numbness in her hands and arms for about a month. The patient had a headache for about a month. The patient felt out of her body (brain fog), fatigue and a very big sense of being "unwell". Random shooting pains, lightning zaps in her head. The patient did not undergo any relevant tests. The events did not require the initiation of new medications, other treatment or procedure. The patient recovered from the events lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains on 06Jun2021.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Trigeminal neuralgia
Clinical narrative: lightning zaps in my head; headache; brain fog; numbness in my hand and arms; fatigue; big sense of being "unwell"; Random shooting pains; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 05Apr2021 at 10:45 (Batch/Lot Number: EW0151) as dose 1, single, (at the age of 39 years-old) and dose 2 via an unspecified route of administration, administered in the left arm on 26Apr2021 at 10:45 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 39 years-old) for COVID-19 immunisation.  The patient had no relevant medical history.  It was unknown if the patient was pregnant. It was unknown if the patient had COVID prior to the vaccination. It was unknown if the patient had been tested for COVID post vaccination. There were no concomitant medications.  There were no prior vaccinations within 4 weeks. The patient experienced lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains; all on an unknown date. The events required an emergency room visit.  The clinical course is as follows: the patient went to the emergency room after a cascade of scary effects. The patient's head felt like it was bleeding internally. The patient had numbness in her hands and arms for about a month. The patient had a headache for about a month. The patient felt out of her body (brain fog), fatigue and a very big sense of being "unwell". Random shooting pains, lightning zaps in her head. The patient did not undergo any relevant tests. The events did not require the initiation of new medications, other treatment or procedure. The patient recovered from the events lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains on 06Jun2021.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Electric shock sensation, Fatigue, Feeling abnormal
Clinical narrative: lightning zaps in my head; headache; brain fog; numbness in my hand and arms; fatigue; big sense of being "unwell"; Random shooting pains; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 05Apr2021 at 10:45 (Batch/Lot Number: EW0151) as dose 1, single, (at the age of 39 years-old) and dose 2 via an unspecified route of administration, administered in the left arm on 26Apr2021 at 10:45 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 39 years-old) for COVID-19 immunisation.  The patient had no relevant medical history.  It was unknown if the patient was pregnant. It was unknown if the patient had COVID prior to the vaccination. It was unknown if the patient had been tested for COVID post vaccination. There were no concomitant medications.  There were no prior vaccinations within 4 weeks. The patient experienced lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains; all on an unknown date. The events required an emergency room visit.  The clinical course is as follows: the patient went to the emergency room after a cascade of scary effects. The patient's head felt like it was bleeding internally. The patient had numbness in her hands and arms for about a month. The patient had a headache for about a month. The patient felt out of her body (brain fog), fatigue and a very big sense of being "unwell". Random shooting pains, lightning zaps in her head. The patient did not undergo any relevant tests. The events did not require the initiation of new medications, other treatment or procedure. The patient recovered from the events lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains on 06Jun2021.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Malaise, Vaccination complication
Clinical narrative: lightning zaps in my head; headache; brain fog; numbness in my hand and arms; fatigue; big sense of being "unwell"; Random shooting pains; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 05Apr2021 at 10:45 (Batch/Lot Number: EW0151) as dose 1, single, (at the age of 39 years-old) and dose 2 via an unspecified route of administration, administered in the left arm on 26Apr2021 at 10:45 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 39 years-old) for COVID-19 immunisation.  The patient had no relevant medical history.  It was unknown if the patient was pregnant. It was unknown if the patient had COVID prior to the vaccination. It was unknown if the patient had been tested for COVID post vaccination. There were no concomitant medications.  There were no prior vaccinations within 4 weeks. The patient experienced lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains; all on an unknown date. The events required an emergency room visit.  The clinical course is as follows: the patient went to the emergency room after a cascade of scary effects. The patient's head felt like it was bleeding internally. The patient had numbness in her hands and arms for about a month. The patient had a headache for about a month. The patient felt out of her body (brain fog), fatigue and a very big sense of being "unwell". Random shooting pains, lightning zaps in her head. The patient did not undergo any relevant tests. The events did not require the initiation of new medications, other treatment or procedure. The patient recovered from the events lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains on 06Jun2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Retching, SARS-CoV-2 test
Clinical narrative: A really bad dry cough that started 3 days after the injection and it has not gone away weeks later. I have to sleep sitting up in order to not cough and gag all night.; A really bad dry cough that started 3 days after the injection and it has not gone away weeks later. I have to sleep sitting up in order to not cough and gag all night.; This is a spontaneous report from a contactable consumer (the patient). A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration, administered in the arm right on 26Apr2021 at 17:00 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 19:30, the patient experienced a really bad dry cough that started three days after the injection and it had not gone away weeks later. The patient had to sleep sitting up in order to not cough and gag all night. The patient had none of this before the vaccine. Therapeutic measures were taken as a result of the dry cough which included treatment with inhaler. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 test via nasal swab and the result was negative on 09May2021. The clinical outcome of the events bad dry cough that started three days after the injection and it had not gone away weeks later, had to sleep sitting up in order to not cough and gag all night was not recovered at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Biopsy, Inflammation, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Muscle pain; swelling of tissue; Muscles bunch like a charlie horse and don't go away for weeks; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 68-year) in Left Arm on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included lupus (The patient stated she was told years ago she had lupus, but recent in-depth testing says she don't), from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN); atorvastatin; ascorbic acid, copper gluconate, tocopheryl acid succinate, xantofyl, zeaxanthin, zinc oxide (AREDS 2 VISUAL ADVANTAGE); silicon dioxide (VIVISCAL [SILICON DIOXIDE]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Penicillin and Plaquenil and experienced drug allergies. It was reported that the patient received the second dose of BNT162B2 (Lot number: EN6208) administered in Left arm on 18Mar2021 for COVID-19 immunization. Historical vaccine includes Flu (influenza vaccine) administered within fourweeks of COVID vaccine, in left arm on an unspecified date in Jan2021. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 02Mar2021 the patient experienced muscle pain, swelling of tissue, muscles bunch like a muscle spasm and don't go away for weeks, the MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. It was reported that she has seen 4 Drs. and now she was scheduled to see an allergist. The patient underwent lab tests and procedures on an unspecified date which included biopsy and magnetic resonance imaging: The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. Therapeutic measures were taken as a result of the adverse events, patient was treated with Prednisone. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Myositis, Swelling
Clinical narrative: Muscle pain; swelling of tissue; Muscles bunch like a charlie horse and don't go away for weeks; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 68-year) in Left Arm on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included lupus (The patient stated she was told years ago she had lupus, but recent in-depth testing says she don't), from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN); atorvastatin; ascorbic acid, copper gluconate, tocopheryl acid succinate, xantofyl, zeaxanthin, zinc oxide (AREDS 2 VISUAL ADVANTAGE); silicon dioxide (VIVISCAL [SILICON DIOXIDE]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Penicillin and Plaquenil and experienced drug allergies. It was reported that the patient received the second dose of BNT162B2 (Lot number: EN6208) administered in Left arm on 18Mar2021 for COVID-19 immunization. Historical vaccine includes Flu (influenza vaccine) administered within fourweeks of COVID vaccine, in left arm on an unspecified date in Jan2021. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 02Mar2021 the patient experienced muscle pain, swelling of tissue, muscles bunch like a muscle spasm and don't go away for weeks, the MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. It was reported that she has seen 4 Drs. and now she was scheduled to see an allergist. The patient underwent lab tests and procedures on an unspecified date which included biopsy and magnetic resonance imaging: The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. Therapeutic measures were taken as a result of the adverse events, patient was treated with Prednisone. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Dyspnoea, Electrocardiogram, Investigation
Clinical narrative: chest pressure, tightness; shortness of breath; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old non pregnant female patient first dose of received bnt162b2 (Solution injection; Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on 21May2021 at 13:15 PM (at the age of 50-year-old) as single for covid-19 immunisation. Medical history included Hodgkin's lymphoma, pneumonitis, heart attack and stent. Concomitant medications included unspecified medication in two weeks. The patient previously took tramadol and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with covid prior to vaccination. Patient was not tested for covid tested post vaccination. On 23May2021 at 08:00 AM, patient experienced chest pressure, tightness and shortness of breath. Over next week, it steadily got worse, and patient ended up in the emergency room on 02Jun2021. The patient underwent lab tests and procedures which included computerised tomogram scan, EKG, blood work; result was unknown and Covid-19 test positive. Therapeutic measures were taken as a result of chest pressure, tightness and shortness of breath. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chest pressure, tightness; shortness of breath; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old non pregnant female patient first dose of received bnt162b2 (Solution injection; Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on 21May2021 at 13:15 PM (at the age of 50-year-old) as single for covid-19 immunisation. Medical history included Hodgkin's lymphoma, pneumonitis, heart attack and stent. Concomitant medications included unspecified medication in two weeks. The patient previously took tramadol and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with covid prior to vaccination. Patient was not tested for covid tested post vaccination. On 23May2021 at 08:00 AM, patient experienced chest pressure, tightness and shortness of breath. Over next week, it steadily got worse, and patient ended up in the emergency room on 02Jun2021. The patient underwent lab tests and procedures which included computerised tomogram scan, EKG, blood work; result was unknown and Covid-19 test positive. Therapeutic measures were taken as a result of chest pressure, tightness and shortness of breath. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Ping pong size knot at vaccine site; Site warm to touch; Always itchy; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration in the left arm on 20May2021 at 15:30 (age at vaccination 48-year-old, Pregnant at Time of Vaccination: No) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obesity, all from an unknown date and unknown if ongoing. The patient did not receive any concomitant medication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 09:00, the patient experienced ping pong size knot still at vaccine site 2 weeks after vaccinated, site still warm to touch and always itchy at the time of reporting. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events ping pong size knot at vaccine site, site warm to touch and always itchy was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Ear pain, Ear swelling, Hypoacusis, Hypoaesthesia
Clinical narrative: Left ear canal is swollen; Left ear canal is swollen - there is some pain; muffled hearing; soreness at injection site; face tingling (possible partial numbness it's hard to tell).; Head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities; Left eye area feels like it's being pulled at, like the skin is being stretched; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 07Jun2021 11:45 as dose 1, single for COVID-19 immunization (at the age of 25-year-old, non-pregnant). Facility type was Public Health Clinic. Medical history included seasonal allergies and known allergies from Penicillin, levofloaxcin, clarithromycin, most fruits, celery, lettuce. Concomitant medication(s) included Multi Vitamin, cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen (MOTRIN [IBUPROFEN]); chlorphenamine maleate, paracetamol, phenylephrine. Patient did not receive any other vaccine in four weeks. Patient had no Covid prior vaccination and Covid was not tested post vaccination. The patient experienced tingling on left side of head after 3 mins after vaccine injection, left ear canal was swollen - there was some pain and the swelling was causing muffled hearing, soreness at injection site, face tingling (possible partial numbness it was hard to tell), head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities, left eye area feels like it's being pulled at, like the skin was being stretched on 07Jun2021 11:45. It was unknown if patient received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Left ear canal is swollen; Left ear canal is swollen - there is some pain; muffled hearing; soreness at injection site; face tingling (possible partial numbness it's hard to tell).; Head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities; Left eye area feels like it's being pulled at, like the skin is being stretched; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 07Jun2021 11:45 as dose 1, single for COVID-19 immunization (at the age of 25-year-old, non-pregnant). Facility type was Public Health Clinic. Medical history included seasonal allergies and known allergies from Penicillin, levofloaxcin, clarithromycin, most fruits, celery, lettuce. Concomitant medication(s) included Multi Vitamin, cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen (MOTRIN [IBUPROFEN]); chlorphenamine maleate, paracetamol, phenylephrine. Patient did not receive any other vaccine in four weeks. Patient had no Covid prior vaccination and Covid was not tested post vaccination. The patient experienced tingling on left side of head after 3 mins after vaccine injection, left ear canal was swollen - there was some pain and the swelling was causing muffled hearing, soreness at injection site, face tingling (possible partial numbness it was hard to tell), head, face (especially both cheeks and jaw area), arms, and legs tingle at various times and intensities, left eye area feels like it's being pulled at, like the skin was being stretched on 07Jun2021 11:45. It was unknown if patient received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Spotting/vaginal bleeding; This is a spontaneous report from a non-contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 (age at vaccination 37 years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took celebrex and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Apr2021as dose 1, single for covid-19 immunisation. The patient experienced spotting/vaginal bleeding on 27May2021. Patient visited Doctor or other healthcare professional office. The patient underwent lab tests and procedures which included Nasal Swab was negative on 01Jun2021. The patient did not receive any treatment for occurred events. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Furuncle, Rash pruritic
Clinical narrative: experienced boils on skin groin area, ankle, and face/head; itchy bumps on legs and long recovery from bruising; itchy bumps on legs and long recovery from bruising; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 (age at vaccination 45-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no Known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination 45-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested COVID-19 post vaccination. On 01Jun2021, the patient experienced boils on skin groin area, ankle, and face/head. Also, itchy bumps on legs and long recovery from bruising. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: A marble size lump at the injection site that is still there 7 weeks later; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729) via intramuscular route administration, administered in arm left on 22Apr2021 13:00 (at the age of 63-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had no Known allergies. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via intramuscular route administration, administered in arm left on 01Apr2021 (at the age of 63-year-old) at dose 1, single for covid-19 immunisation. Patient did not have other vaccine in four weeks, other medications in two weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 22Apr2021 13:00 the patient experienced a marble size lump at the injection site that is still there 7 weeks later. Patient did not receive treatment for the adverse event. Outcome of the event was not resolved.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Headache, Neck mass, Ultrasound scan
Clinical narrative: Developed cyst on left side of neck/It is a soft, movable lump/the mass; Developed cyst on left side of neck/It is a soft, movable lump/the mass; mild headache; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 18-year-old) as dose 2, single for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing, shellfish allergy from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration in left arm on 03Apr2021 at 11:15 (at the age of 18-year-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that 1 Tylenol 1 day after 2nd dose (25Apr2021) for a mild headache and developed cyst on left side of neck 1 week after 2nd dose (01May2021 at 09:00). It was a soft, movable lump that formed suddenly and has not changed in size since it developed (as of "today", 11Jun2021). She got an ultrasound and would need a MRI to determine what the mass is made of. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The treatment of developed cyst on left side of neck/it is a soft, movable lump/the mass was reported as unknown and TYLENOL was given for mild headache. The outcome of developed cyst on left side of neck/it is a soft, movable lump/the mass was reported as not resolved and mild headache was unknown.  Follow-up attempts are completed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I have not had a period for 5 years because of naxplanon birth control but have been having periods every 3 weeks since I got the vaccine.; This is a spontaneous report from a contactable consumer or other non-hcp reported about herself (patient).    A 22-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in right arm as dose 1, single on 25Feb2021 17:45 (at the age of 22-year-old) for covid-19 immunisation. The patient had no medical history and known allergies. Patient's past drug history included naxplanon for birth control. The patient's concomitant medications were not reported. Patient did not have a period for 5 years because of naxplanon birth control but have been having periods every 3 weeks since she got the vaccine (23Mar2021). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. No treatment was received for the event. At the time of this report, outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: light vaginal bleeding/spotting comparable to a light period; This is a spontaneous report from a contactable physician (patient). A 39-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 06Apr2021 at 17:30 (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included asthma and covid-19. The concomitant medications of the patient included mometasone furoate (FLONASE [MOMETASONE FUROATE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), vitamin d3 (VITAMIN D3) and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN) on ana unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 09Apr2021, the patient experienced light vaginal bleeding/spotting comparable to a light period. Therapeutic measures were not taken as a result of event. The patient recovered from the event on ana unspecified date in 2021.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.