chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Panic attack, Posture abnormal, Respiratory rate increased, Seizure
Clinical narrative: Within 10 minutes after receiving the vaccination, patient reported headache and blurred vision. He was sweating with shallow wheezing breaths. He reported trouble breathing. While asking him questions, his head rolled back and his arms and legs began convulsing for a couple seconds. Epinephrine from the e-kit was administered and emergency services were called. Patient was moved to prone position on the floor, breathing quickly, with pale lips and complaints of numb fingers. Emergency services arrived, were informed of events, and took over. They determined he was probably having a panic attack, although he did not report nerves regarding the vaccination. Patient had never experienced a reaction to previous vaccinations. Panic or fear of initial headache and blurred vision may have elevated reaction. Patient eventually left with family.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Wheezing
Clinical narrative: Within 10 minutes after receiving the vaccination, patient reported headache and blurred vision. He was sweating with shallow wheezing breaths. He reported trouble breathing. While asking him questions, his head rolled back and his arms and legs began convulsing for a couple seconds. Epinephrine from the e-kit was administered and emergency services were called. Patient was moved to prone position on the floor, breathing quickly, with pale lips and complaints of numb fingers. Emergency services arrived, were informed of events, and took over. They determined he was probably having a panic attack, although he did not report nerves regarding the vaccination. Patient had never experienced a reaction to previous vaccinations. Panic or fear of initial headache and blurred vision may have elevated reaction. Patient eventually left with family.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Arthritis, Back pain, Chills
Clinical narrative: For about 2 hours, symptoms included nothing more than pain and swelling in and around the injection site. After 2 hours, symptoms included achy, painfully swollen joints in the hips, back, shoulders, and knees. Fever began to rise. Chills. After 3 hours, symptoms included dizziness and blurred vision, nausea, and the aforementioned symptoms. After 5 hours, symptoms included stomach and head migraines. Fever continued to rise. Inability to stand due to intense vertigo, For the next 8 hours, symptoms included feverish dreams, severe vertigo, cold sweat, chills, diarrhea, nausea, further inflammation of joints, backache, confusion, and throwing up in the mouth. The next morning, symptoms slowly declined. For the following week, upset stomach, severe vertigo, and dizzy headache remained.  Remaining symptoms 1 month later include dizziness and headache. Possibly unrelated remaining symptoms include decreased nerve sensitivity in the lower legs, especially left leg (never noticed before the vaccine, ability to feel pain in leg has declined, and as a dancer, the patient noticed this).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Confusional state, Diarrhoea, Dizziness, Dysstasia
Clinical narrative: For about 2 hours, symptoms included nothing more than pain and swelling in and around the injection site. After 2 hours, symptoms included achy, painfully swollen joints in the hips, back, shoulders, and knees. Fever began to rise. Chills. After 3 hours, symptoms included dizziness and blurred vision, nausea, and the aforementioned symptoms. After 5 hours, symptoms included stomach and head migraines. Fever continued to rise. Inability to stand due to intense vertigo, For the next 8 hours, symptoms included feverish dreams, severe vertigo, cold sweat, chills, diarrhea, nausea, further inflammation of joints, backache, confusion, and throwing up in the mouth. The next morning, symptoms slowly declined. For the following week, upset stomach, severe vertigo, and dizzy headache remained.  Remaining symptoms 1 month later include dizziness and headache. Possibly unrelated remaining symptoms include decreased nerve sensitivity in the lower legs, especially left leg (never noticed before the vaccine, ability to feel pain in leg has declined, and as a dancer, the patient noticed this).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Joint swelling, Migraine, Nausea
Clinical narrative: For about 2 hours, symptoms included nothing more than pain and swelling in and around the injection site. After 2 hours, symptoms included achy, painfully swollen joints in the hips, back, shoulders, and knees. Fever began to rise. Chills. After 3 hours, symptoms included dizziness and blurred vision, nausea, and the aforementioned symptoms. After 5 hours, symptoms included stomach and head migraines. Fever continued to rise. Inability to stand due to intense vertigo, For the next 8 hours, symptoms included feverish dreams, severe vertigo, cold sweat, chills, diarrhea, nausea, further inflammation of joints, backache, confusion, and throwing up in the mouth. The next morning, symptoms slowly declined. For the following week, upset stomach, severe vertigo, and dizzy headache remained.  Remaining symptoms 1 month later include dizziness and headache. Possibly unrelated remaining symptoms include decreased nerve sensitivity in the lower legs, especially left leg (never noticed before the vaccine, ability to feel pain in leg has declined, and as a dancer, the patient noticed this).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Pyrexia, Vertigo, Vision blurred
Clinical narrative: For about 2 hours, symptoms included nothing more than pain and swelling in and around the injection site. After 2 hours, symptoms included achy, painfully swollen joints in the hips, back, shoulders, and knees. Fever began to rise. Chills. After 3 hours, symptoms included dizziness and blurred vision, nausea, and the aforementioned symptoms. After 5 hours, symptoms included stomach and head migraines. Fever continued to rise. Inability to stand due to intense vertigo, For the next 8 hours, symptoms included feverish dreams, severe vertigo, cold sweat, chills, diarrhea, nausea, further inflammation of joints, backache, confusion, and throwing up in the mouth. The next morning, symptoms slowly declined. For the following week, upset stomach, severe vertigo, and dizzy headache remained.  Remaining symptoms 1 month later include dizziness and headache. Possibly unrelated remaining symptoms include decreased nerve sensitivity in the lower legs, especially left leg (never noticed before the vaccine, ability to feel pain in leg has declined, and as a dancer, the patient noticed this).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: For about 2 hours, symptoms included nothing more than pain and swelling in and around the injection site. After 2 hours, symptoms included achy, painfully swollen joints in the hips, back, shoulders, and knees. Fever began to rise. Chills. After 3 hours, symptoms included dizziness and blurred vision, nausea, and the aforementioned symptoms. After 5 hours, symptoms included stomach and head migraines. Fever continued to rise. Inability to stand due to intense vertigo, For the next 8 hours, symptoms included feverish dreams, severe vertigo, cold sweat, chills, diarrhea, nausea, further inflammation of joints, backache, confusion, and throwing up in the mouth. The next morning, symptoms slowly declined. For the following week, upset stomach, severe vertigo, and dizzy headache remained.  Remaining symptoms 1 month later include dizziness and headache. Possibly unrelated remaining symptoms include decreased nerve sensitivity in the lower legs, especially left leg (never noticed before the vaccine, ability to feel pain in leg has declined, and as a dancer, the patient noticed this).
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Atrioventricular block second degree, Blood test, Cardiac stress test normal, Chest pain
Clinical narrative: 3 days after recieving my second dose I passed out. I became nauseous and tried to go to the bathroom to vomit but instead I fell and I was in and out of conciousness. During that time I defecated myself and began to vomit as well. I went to the ER in an ambulance they ran many test everything came out okay I was diagnosed with syncope,once I was stable they sent me home. I followed up with a doctor at my DR office (my doctor didn't have space to see me for a while) she refered me to a cardiologist because I was still feeling off, I was dizzy and my blood pressure was a little low. The cardiologist ran many test but everything was basically inconclusive. Fast foward to August I still have not felt like myself. On August 4th I was working a normal shift when I started to feel pain in my chest. I finished my shift and went right to the ER where they admitted me with Acute Pericaditis. To this day even with the madication I still have pain and trouble with my breathing.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Consciousness fluctuating, Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram ambulatory abnormal
Clinical narrative: 3 days after recieving my second dose I passed out. I became nauseous and tried to go to the bathroom to vomit but instead I fell and I was in and out of conciousness. During that time I defecated myself and began to vomit as well. I went to the ER in an ambulance they ran many test everything came out okay I was diagnosed with syncope,once I was stable they sent me home. I followed up with a doctor at my DR office (my doctor didn't have space to see me for a while) she refered me to a cardiologist because I was still feeling off, I was dizzy and my blood pressure was a little low. The cardiologist ran many test but everything was basically inconclusive. Fast foward to August I still have not felt like myself. On August 4th I was working a normal shift when I started to feel pain in my chest. I finished my shift and went right to the ER where they admitted me with Acute Pericaditis. To this day even with the madication I still have pain and trouble with my breathing.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Feeling abnormal, Hypotension, Loss of consciousness, Nausea
Clinical narrative: 3 days after recieving my second dose I passed out. I became nauseous and tried to go to the bathroom to vomit but instead I fell and I was in and out of conciousness. During that time I defecated myself and began to vomit as well. I went to the ER in an ambulance they ran many test everything came out okay I was diagnosed with syncope,once I was stable they sent me home. I followed up with a doctor at my DR office (my doctor didn't have space to see me for a while) she refered me to a cardiologist because I was still feeling off, I was dizzy and my blood pressure was a little low. The cardiologist ran many test but everything was basically inconclusive. Fast foward to August I still have not felt like myself. On August 4th I was working a normal shift when I started to feel pain in my chest. I finished my shift and went right to the ER where they admitted me with Acute Pericaditis. To this day even with the madication I still have pain and trouble with my breathing.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pericarditis, Syncope, Troponin, Vomiting
Clinical narrative: 3 days after recieving my second dose I passed out. I became nauseous and tried to go to the bathroom to vomit but instead I fell and I was in and out of conciousness. During that time I defecated myself and began to vomit as well. I went to the ER in an ambulance they ran many test everything came out okay I was diagnosed with syncope,once I was stable they sent me home. I followed up with a doctor at my DR office (my doctor didn't have space to see me for a while) she refered me to a cardiologist because I was still feeling off, I was dizzy and my blood pressure was a little low. The cardiologist ran many test but everything was basically inconclusive. Fast foward to August I still have not felt like myself. On August 4th I was working a normal shift when I started to feel pain in my chest. I finished my shift and went right to the ER where they admitted me with Acute Pericaditis. To this day even with the madication I still have pain and trouble with my breathing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration, Rash
Clinical narrative: 4 days after second dose I developed a burning rash on my legs, from ankle to knee. It does not itch, just burns under my skin like nerve pain, day and night.; 4 days after second dose I developed a burning rash on my legs, from ankle to knee. It does not itch, just burns under my skin like nerve pain, day and night.; Inappropriate schedule of vaccine administered; 4 days after second dose I developed a burning rash on my legs, from ankle to knee. It does not itch, just burns under my skin like nerve pain, day and night. Last week, almost 2 months later, I have developed a similar rash on my arms.; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 01Mar2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included pulmonary embolism and lung cancer. Concomitant medications taken within two weeks of vaccination included warfarin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN), both taken from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 28Feb2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021, four days after second dose the patient developed a burning rash on her legs, from ankle to knee. It did not itch, just burned under her skin like nerve pain, day and night. On an unknown date in 2021, the previous week of report, almost 2 months later, the patient had developed a similar rash on her arms. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events four days after second dose developed a burning rash on her legs, from ankle to knee; it did not itch, just burned under her skin like nerve pain, day and night; the previous week of report, almost two months later, developed a similar rash on her arms was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Large persistent  rash over torso, upper legs, and buttock region; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0175) via an unspecified route of administration in the right arm on 28Apr2021 at 00:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. 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. The patient did not receive any medication within two weeks of vaccination. On 01May2021 at 00:00, the patient experienced large persistent rash over torso, upper legs and buttock region. Therapeutic measures were taken as a result of reported event which included treatment with Benadryl or used calamine lotion. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large persistent rash over torso, upper legs and buttock region was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the back - looked like small pimples.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, lichen sclerosis and psoriasis. 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. Concomitant medications included colecalciferol (VITAMIN D), naproxen sodium (ALEVE), multivitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) all from unknown date for unknown indication and unknown if ongoing. The patient previously took morphine(MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 30Apr2021 at 11:00, the patient experienced rash on her back - looked like small pimples. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on the back - looked like small pimples was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypoaesthesia, Muscle tightness, Pain
Clinical narrative: body aches; Tight shoulder and upper back and neck; Numbness on left side of face.; Bone and body aches; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 10:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 26Apr2021, the patient experienced bone and body aches, tight shoulder and upper back and neck, numbness on left side of face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bone and body aches, tight shoulder and upper back and neck, numbness on left side of face was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: tingling in tongue; no taste; Numb lips; Numb lips and tongue about 1/2 hourafter injection; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 17:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included hepatopancreatobiliary diseases (HPB) and penicillin allergy. The patient previously took ciprofloxacin and Bactrim and experienced allergy to the medications. 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. The patient received medications within two weeks of vaccination, but the medications were unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 17:45, the patient experienced numb lips and tongue about half an hour after injection, no taste and fatigue. On 30Apr2021, next day, numbness returned plus tingling in tongue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event numb lip and tongue, no taste, fatigue next day numbness returned plus tingling in tongue was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: memory loss; Brain fog; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on an unknown date and month in 2021 as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. 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. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced brain fog and memory loss. The patient had a hard time finding words and short-term memory had been affected. The patient does not normally need to make lists or add things to calendar and right now if patient did not do that, patient did not remember at all and could not recall important things for work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event brain fog and memory loss was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: Bleeding gums; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient had bleeding gums. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event bleeding gums was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine instead of 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 45-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Feb2021 at 13:00 (at the age of 40-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had known allergies to adhesive and imitrex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and estradiol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Jan2021 at 13:00 (at the age of 40-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 14:30, the patient experienced sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and fatigue was recovered on an unknown date in 2021.   No follow-up attempts are possible. Information about lot number cannot be obtained. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injected in left arm, and where they vaccinated have a red spot.; Injected in left arm, and where they vaccinated have a red spot and its swollen.; Injected in left arm, and where they vaccinated have a red spot and its swollen and causing pain.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 17:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient had known allergies to codeine and carbamazepine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included baclofen (BACLOFENE), trazodone (MANUFACTURER UNKNOWN) and venlafaxine hydrochloride (EFFEXOR); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 17:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 08:00, the patient experienced red spot and swelling where she got injected and it caused pain. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the events red spot and swelling where she got injected and it caused pain was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus rhythm, Supraventricular extrasystoles
Clinical narrative: Sinus rhythm with supraventricular ectopy; Sinus rhythm with supraventricular ectopy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 62-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 62-year-old)as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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. The patient did not receive any concomitant medications. On 01Apr2021 at 23:00, the patient underwent electrocardiogram (EKG) with sinus rhythm and supraventricular ectopy which were always normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events sinus rhythm with supraventricular ectopy were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; headache; nausea; Pain in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included vegetable allergy (Raw carrot allergy). 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 COVID-19 vaccine. Concomitant medications were not reported. On 01May2021 at 02:00, the patient experienced fever, chills, headache, nausea, pain in arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, nausea, pain in arm was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Inflammation
Clinical narrative: reports calcification bumps on her arms distal to elbows prior to start got bigger; md told her that her inflammation levels went down; This is a spontaneous report from a from a contactable other hcp via Pfizer-sponsored program.  A 66-years-old female patient received second dose of 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 on 17Apr2021(at the age of 66-year-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of 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 on an unspecified date as dose 1, single for covid-19 immunization. Patient reported her md advised her to hold xeljanz for one week before and one week after each of her two covid-19 vaccinations. Reported her second vaccination was on 17Apr2021, and she re-started xeljanz on 20Apr2021 and she also reported the calcification bumps on her arms distal to elbows prior to start got bigger during holds, unknown after re-start. She reported, md told her that her inflammation levels went down after start of therapy 27Dec2020, did not specify blood labs or values. md aware. The clinical outcome of events were unknown.  No follow attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Very heavy periods; Early periods; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8736) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and mango allergy. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA 24 HOUR) and fluticasone propionate (FLONASE) (OTC- over the counter), all for an unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient period was clockwork and getting periods every 25-26 days and she tracked it. The patient was on the medications before the vaccine and had her period regularly. On 03Apr2021, the patient experienced period came three days early and it was very heavy. The clinical outcome of the events of experienced period came three days early and very heavy periods was Not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Tongue and mouth is going numb; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A consumer reported for a female patient (reporter's mother-in-law) of an unspecified age who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 02May2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 11Apr2021 for covid-19 immunization. The patient experienced tongue and mouth were numb on 02May2021. The reporter asked if the event was normal, or she need to her mom-in-law to the hospital. There were medical questions addressed by the program forwarded/referred to medical information. Customer and/or medical inquiry forwarded or referred to MI. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Hypoaesthesia, Hypoaesthesia oral, Nausea
Clinical narrative: Her lips went numb; Vomiting; Low grade fever; Nausea; Shakes; Weakness; Numbness; Tingling/sensation as when she go to the dentist or fall asleep on her arm; nerve pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 55-Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration on 14Apr2021, as dose 1, single (at the age of 55-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Immediately after the vaccine on 14Apr2021, patient lips went numb and had to be observed. She then experienced vomiting, low grade fever, nausea, shakes, and weakness which then resolved in 7 days. She called today (on an unspecified date in 2021) about numbness/tingling/nerve pain that started two weeks after the vaccine on the left side of the body, which was where the vaccine was administered. Her whole left upper quadrant was numb and tingling from her waist to the tip of her left ear lobe including her hand, arm, fingers, under her breast, back and left side of the neck. She described the sensation as when she went to the dentist or fall asleep on her arm. She had bloodwork on an unspecified date (Monday) and it all came back normal. She did not have a pinched nerve. She was scheduled for an MRI today. She was calling to see if these side effects of numbness, tingling and nerve pain have been reported and how to treat the side effects. The outcome of the events her lips went numb, vomiting, low grade fever, nausea, shakes, and weakness were resolved on 21Apr2021 and outcome for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia, Pyrexia, Tremor, Vomiting
Clinical narrative: Her lips went numb; Vomiting; Low grade fever; Nausea; Shakes; Weakness; Numbness; Tingling/sensation as when she go to the dentist or fall asleep on her arm; nerve pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 55-Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration on 14Apr2021, as dose 1, single (at the age of 55-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Immediately after the vaccine on 14Apr2021, patient lips went numb and had to be observed. She then experienced vomiting, low grade fever, nausea, shakes, and weakness which then resolved in 7 days. She called today (on an unspecified date in 2021) about numbness/tingling/nerve pain that started two weeks after the vaccine on the left side of the body, which was where the vaccine was administered. Her whole left upper quadrant was numb and tingling from her waist to the tip of her left ear lobe including her hand, arm, fingers, under her breast, back and left side of the neck. She described the sensation as when she went to the dentist or fall asleep on her arm. She had bloodwork on an unspecified date (Monday) and it all came back normal. She did not have a pinched nerve. She was scheduled for an MRI today. She was calling to see if these side effects of numbness, tingling and nerve pain have been reported and how to treat the side effects. The outcome of the events her lips went numb, vomiting, low grade fever, nausea, shakes, and weakness were resolved on 21Apr2021 and outcome for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Numbness in his right foot on the same side he received the injection; burning sensation to his foot; This is a spontaneous report from a contactable consumer (provider).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The reason for no lot number was because complainant hung up abruptly. Medical history and concomitant medications were not reported. It was stated that, the patient who received the first Pfizer vaccine about 2 weeks ago has got some numbness in his right foot on the same side he received the injection and he thought that this was a side effect, it was a kind of burning sensation to his foot, his one foot. The patient was concerned about next vaccine. The outcome for the events was unknown at the time of report.  Limited information was available over the call. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days but I have experienced irregular; heavier menstrual spotting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This 23-years old female consumer (patient) reported for herself that:  A 23-years-old female (non-pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 12:15 (at the age of 23-years-old) (Lot Number: ER8734) as DOSE 2, SINGLE for covid-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. Medical history was reported as no. There were no known allergies reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection) dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:15 (Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient had not been tested for COVID-19. On 06May2021, 12:00 AM the patient experienced woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days but I have experienced irregular and heavier menstrual spotting.  The clinical course as follows, it was reported that 1 full day after the second dose of the Pfizer vaccine, I woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days, but I have experienced irregular and heavier menstrual spotting when I am not supposed to be. I was not stressed, so I cannot correlate between the two. It's odd that this was not considered a side effect to the vaccine and women have not been fore warned that they could possibly experience early-on spotting before their period until it happens, and women worry about this abnormality. There was no treatment received for the events. Device date was reported as 06May2021. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Head discomfort, Headache, Hyperacusis
Clinical narrative: Tingling on right side (face, arm, hand, leg, foot); Numbness on right side (face, arm, hand, leg, foot); Sensitivity to noise; weakness on right side (face, arm, hand, leg, foot; Head fuzzy; Head pressure; headaches; Ears ringing; Pain (face, arm, hand, leg, foot); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 21Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient did not have any relevant medical history. 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 21Apr2021 at 19:00, the patient experienced head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Tinnitus
Clinical narrative: Tingling on right side (face, arm, hand, leg, foot); Numbness on right side (face, arm, hand, leg, foot); Sensitivity to noise; weakness on right side (face, arm, hand, leg, foot; Head fuzzy; Head pressure; headaches; Ears ringing; Pain (face, arm, hand, leg, foot); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 21Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient did not have any relevant medical history. 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 21Apr2021 at 19:00, the patient experienced head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.