chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroid disorder
Clinical narrative: has an auto-immune disease, involving her thyroid; This is a spontaneous report from a Pfizer sponsored program support via a contactable pharmacist. A 18-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 18-year-old) as 1 ST DOSE, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced that she has an auto-immune disease, involving her thyroid. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Autoimmune Thyroid Disorder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Second dose of vaccine received April 26/ test is positive yesterday; Second dose of vaccine received April 26/ test is positive yesterday; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 26Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (Solution for injection, Batch/lot number: not reported) on an unknown date. Patient reported that a church member had covid hence decided to have a covid test yesterday. lab test included on covid test: Positive on 27May2021. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received BNT162B2, (COMIRNATY, lot #: EL3302), via an unspecified route of administration, administered in Arm Left on 25May2021 14:17 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced anaphylactic shock on 26May2021 22:00, It lasted for about 30 hours for her daughter and got worse over time until her entire body was red and swollen on May2021. Caller stated they went to the Emergency Room and her daughter was given an epi pen and steroids because antihistamines were not helping. Caller mentioned later in the call that her daughter went to her doctor on 27May2021 at 1300 for this, to Urgent Care on 27 May2021 at 2100 for this; and finally to the Emergency Room today 28May2021 at 0200 and was treated in the emergency room and not admitted to the hospital. Caller stated her daughter was improving since being treated at the Emergency Room. Patient went to physician Office. No relevant tests was reported. Outcome of the events were not recovered.  Follow up needed, further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive today on asymptomatic screening for SARS-CoV2; Tested positive today on asymptomatic screening for SARS-CoV2; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in Arm Right on 22Feb2021 (Batch/Lot Number: EN6203) as 1st dose, single dose, and dose 2 via an unspecified route of administration in right arm on 17Mar2021 (Batch/Lot Number: EN6208) as 2nd dose, single dose for COVID-19 immunisation at hospital. Medical history included Crohn's disease and COVID-19. Concomitant medication received within 2 weeks of vaccination included ustekinumab (STELARA) taken for an unspecified indication. The patient previously took vedolizumab and experienced drug hypersensitivity. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to COVID vaccine. On 29May2021 the patient reported as, 'He was fully vaccinated with Pfizer and tested positive today on asymptomatic screening for SARS-CoV2. The infection leads to rescheduling a surgical procedure'. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29May2021 Nasal Swab. No treatment was received. Outcome of the events were unknown.; Sender's Comments: The event COVID19 is mostly likely an intercurrent condition. Based on temporal relation, the association between onset of event COVID 19 and vaccination cannot be ruled out.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Electrocardiogram ST-T segment abnormal, N-terminal prohormone brain natriuretic peptide increased, Pulmonary embolism, Troponin increased
Clinical narrative: Bilateral pulmonary embolism with evidence of R Heart Strain
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Myalgia, Neck pain, Pain
Clinical narrative: A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps  Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction.  The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Somnolence
Clinical narrative: A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps  Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction.  The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The 2nd dose was originally scheduled on 17May2021. I would like to know when I can get the second dose of the vaccine.; I tested positive; I tested positive; This is a spontaneous report from a contactable other hcp (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 26Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13May2021, the patient was tested positive for covid-19. The patient received the 1st dose of the vaccine on 26Apr2021, and on 13May2021, patient was tested positive. The results came back negative on 28May2021. The 2nd dose was originally scheduled on 17May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13May2021, sars-cov-2 test: negative on 28May2021. Patient would like to know when can get the second dose of the vaccine. The outcome of the event tested positive was recovered on 28May2021 and unknown for other events.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event drug ineffective and covid-19 cannot be ruled out.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Circumstance or information capable of leading to medication error, Colitis ulcerative
Clinical narrative: ulcerative colitis flare; their physician advised them not to take the second dose.; This is a spontaneous report from a contactable other health care professional. A 40-years-old male patient received bnt162b2 (COVID-19 VACCINE, Manufacturer Unknown, Batch/Lot number: not reported), dose 1, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ, Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date at 10 mg twice daily for ulcerative colitis flare. Medical history included colitis ulcerative. Reportedly, patient reports their physician recently increased their dose back to 10mg twice daily due to an ulcerative colitis flare while on 5mg twice daily. The patient's concomitant medications were not reported. Patient reports the exacerbation correlated with the timing of their first COVID19 vaccine (unknown manufacturer) so their physician advised them not to take the second dose. On an unspecified date, the patient experienced ulcerative colitis flare and their physician advised them not to take the second dose. Outcome of the events was unknown.  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient became ill 4 days after second vaccination and was hospitalized.; This is a spontaneous report from a contactable consumer reported for himself.   An adult male patient received the second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient became ill 4 days after second vaccination and was hospitalized for 4 days. The outcome of the event was recovering.  A treatment was performed for the event. The event was considered serious life threatening.  Information on the lot/batch number has been requested
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anaphylactic shock, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: severe anaphylactic shock; Unconscious; This is a spontaneous report from a contactable consumer (patient). This 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 73-year-old) (Batch/Lot Number: EN6200) as single dose (unknown if first or second dose) for COVID-19 immunisation and bendamustine from an unspecified date, 5th dose in what was to be a series of 12, for Waldenstrom's macroglobulinaemia. Relevant medical history included Waldenstrom's macroglobulinaemia. The patient's concomitant medications were not reported.  The patient previously took bendamustine for Waldenstrom's macroglobulinaemia (the patient received 12 doses over 6 months 2 years ago). On 03Mar2021, the patient experienced severe anaphylactic shock and loss of consciousness; the events were considered serious as life-threatening. The patient specified that 5 days after the vaccine, the patient was undergoing chemotherapy with bendamustine. He had Waldenstrom's macroglobulenemia. This was his 5th dose in what was to be a series of 12. He had received 12 doses over 6 months 2 years prior to this report. During the treatment, the patient went into severe anaphylactic shock. He was unconscious in about 10 seconds from the onset of his first symptoms. He was treated on site and transferred to an E.R.  The severity of the event and the fact that both drugs were playing around with his immunoglobulins led him to file this report. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a nasal swab on an unspecified date which was negative. He recovered from the events on an unspecified date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dysmenorrhoea, Heavy menstrual bleeding, Nausea
Clinical narrative: dysmenorrhea (Severe-Grade3); menorragie (severe-grade 3); stay in bed all day1 after the 2nd dose; Nausea (moderate); fever (max 100F); body aches and chills (mild, both).; body aches and chills (mild, both).; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173) via an unspecified route of administration in right arm on 03May2021 at single dose for covid-19 immunization. Medical history included Unilateral post-oophorectomy, history of endometriosis. Patient was allergic to dextromethorphan, cat and dust. Concomitant medication included iron, ergocalciferol (VIT D), ascorbic acid (VIT C), zinc, elderberry (sambucus nigra) and probiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took dextromethorphan and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) for covid-19 immunisation. On 04May2021, around twenty hours post second dose the patient experienced symptoms which started and intensified to the point of incapacitation that stay in bed all day one after the second dose, moderate nausea, severe-grade3 dysmenorrhea, severe-grade 3 menorrhagia, fever (max 100F), mild body aches and mild chills. Dysmenorrhea and menorrhagia stopped on day two post second dose. The menstrual symptoms were unusual and occurred for the first time. In addition, mostly menorrhagia occurred again at the next period that started two days ago. No treatment was given for the events. On 17Mar2021, the patient underwent lab tests and procedures which included polymerase chain reaction: negative. The outcome of event was recovered on an unspecified date in May2021 date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polymerase chain reaction, Pyrexia
Clinical narrative: dysmenorrhea (Severe-Grade3); menorragie (severe-grade 3); stay in bed all day1 after the 2nd dose; Nausea (moderate); fever (max 100F); body aches and chills (mild, both).; body aches and chills (mild, both).; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173) via an unspecified route of administration in right arm on 03May2021 at single dose for covid-19 immunization. Medical history included Unilateral post-oophorectomy, history of endometriosis. Patient was allergic to dextromethorphan, cat and dust. Concomitant medication included iron, ergocalciferol (VIT D), ascorbic acid (VIT C), zinc, elderberry (sambucus nigra) and probiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took dextromethorphan and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) for covid-19 immunisation. On 04May2021, around twenty hours post second dose the patient experienced symptoms which started and intensified to the point of incapacitation that stay in bed all day one after the second dose, moderate nausea, severe-grade3 dysmenorrhea, severe-grade 3 menorrhagia, fever (max 100F), mild body aches and mild chills. Dysmenorrhea and menorrhagia stopped on day two post second dose. The menstrual symptoms were unusual and occurred for the first time. In addition, mostly menorrhagia occurred again at the next period that started two days ago. No treatment was given for the events. On 17Mar2021, the patient underwent lab tests and procedures which included polymerase chain reaction: negative. The outcome of event was recovered on an unspecified date in May2021 date.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Depression, Fatigue, Feeling abnormal
Clinical narrative: Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Brain fog/gotten worse; Fatigue /gotten worse; This is a spontaneous report from a contactable other health professional (registered nurse reporting for her son).A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.On an unspecified date, A week or two later after first dose he started getting a lot of fatigue and brain fog and became depressed and anxious over the last few months. The patient had second dose 09Mar2021. States it has just gotten worse. Caller wants to know if this has been reported or if this could be related to the vaccine. The outcome of the events was not recovered.  Information about batch/lot number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of anxiety aggravated, depression worsened, brain fog, brain fog condition worsened and fatigue aggravated with the suspect product of BNT 162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Jugular vein thrombosis
Clinical narrative: blood clot in jugular vein; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-037222).   A 66-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on 28Jan2021 as a SINGLE DOSE,UNKNOWN for covid-19 immunization. The patient's past medical history included cardiac disorder NOS, Allergy (Brilinta) and vascular stent insertion. The patient's concomitant medications were not reported. On an unknown date, the patient experienced blood clot in jugular vein. On 03-Feb-2021, the patient started ELIQUIS (batch no. ABQ5833S) (oral), 5 milligrams twice a day as treatment for the event. On an unknown date, the dose was changed to 2.5 milligram twice a day. The outcome of the event was unknown.  No follow-up attempts are possible, no further information expected.; Sender's Comments: Based on limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Jugular vein thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Limb discomfort
Clinical narrative: lethargy; Severe heaviness in limbs; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 24May2021 as single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included lithium chloride 400 mg twice a day, sertraline hydrochloride (ZOLOFT 150 mg) at 150 mg, quetiapine fumarate (SEROQUEL 200 mg) at 200 mg and lorazepam (ATIVAN 1 mg) at 1 mg. Caller reported that she received vaccine last Monday. She took the following medications: lithium, ZOLOFT, SEROQUEL and ATIVAN. Caller would like to know if there was a possible interaction with those medications and would like to know if there was a drug interaction with lithium chloride. Caller reported that she was experiencing lethargy and severe heaviness in limbs. The caller was fine she had felt lethargic to a degree that she was concerned. The caller also had severe heaviness in her limbs. The caller declined to file a safety report, no further information or details were captured at this time. The caller was provided with phone number, option 3, and hours of operation of Monday through Friday, 8 AM to 8 PM EST, 9 AM to 3 PM Saturday and Sunday, prior to warm transfer. Seriousness reported as No. Outcome of the events was recovered on an unspecified date in May2021.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: difficulty of breathing and tiredness are among the commonly reported adverse events after more than 2 weeks of getting the 2nd dose; more frequently now.; difficulty of breathing and tiredness are among the commonly reported adverse events after more than 2 weeks of getting the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in right arm on 13May2021 at 11:00 (at the age of 48 years old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing asthma (diagnosed with asthma when she was 13 years old) and ongoing chronic obstructive pulmonary disease (diagnosed with COPD 4-5 years ago). Family Medical History Relevant to AE(s): ongoing Heart Disease. Relevant Tests: None. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient took ProAir (Twice daily for 5 years or longer) and Albuterol (puffs twice daily for 5 years or longer) for asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No adverse events following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in Arm Right on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient got her second dose of the Pfizer Covid-19 Vaccine on 13May2021 and ever since she felt extremely tired and her difficulty of breathing worsened. The patient was supposed to go to work but was so tired that she went home and just went to sleep. Patient felt tired all the time and while she was driving, stated that COVID-19 vaccine was bothering her breathing. The patient reported that she had asthma and COPD and was using her medication more frequently now. The patient reported that when she woke up on 14May2021, she could not breathe. The patient reported that she sat down for a minute to rest because it was hard to get air. She reported that she had already used her inhaler twice today, 01Jun2021. The patient reported that she was supposed to use the ProAir inhaler (lot number: DAE90A) twice daily but had been using it 5, 6, 7, or 8 times daily since receiving the second dose of the COVID-19 vaccine. Instead of using 2 puffs, she took 4-5 puffs because the prescribed 2 puffs twice daily was not working. The patient reported that she would get a few minutes of relief after using the ProAir inhaler. Adverse event did not require a visit to emergency room/ Physician Office. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Eating disorder, Nausea, Vomiting
Clinical narrative: nausea; vomiting; dehydration; weakness; She is not really able to really eat or drink; This is a spontaneous report from a contactable consumer (patient's daughter) from a Pfizer-sponsored program COVAX US Support. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0161 and Expire Date: unknown) via an unspecified route of administration in right arm on Saturday 29May2021 (reported as at like 14:00-14:15), as a single dose for covid-19 immunisation at Shopping mall, operated by the state. Medical history included ongoing diabetes, obesity, and heart stent. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) at a dose of 81mg (lot no: P123777, expiry date: Jan2023, UPC:8113169958) and clopidogrel bisulfate (PLAVIX) 75mg once daily both received while hospital discharge on 05May2021 for heart stent (heart disorder). Patient previously received Penicillin (this was years ago, onset date since she was a child) which made to lose her pigmentation and had allergy. Patient had no previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within four weeks prior to vaccinations. Family medical history relevant to adverse event was none. On 31May2021 around 12:00, the patient had onset of nausea and vomiting. These both events were persistent, with dehydration and weakness ongoing relative to not being able to keep anything down. She was not really able to really eat or drink. She can't really take her medicine and due to her condition, having a heart stent she has to take blood thinner Plavix and Aspirin. The events were not resulted in emergency room and physician office but has a follow-up doctor's appointment but not related to these adverse events. The outcome of event eating disorder was unknown and for other events was not recovered.  Additional information requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: LT(left) foot toe pain. Rheumatoid arthritis?; LT(left) foot toe pain; This is a spontaneous report from a contactable nurse (patient). A 76-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 76 years of age), intramuscular, administered in Deltoid Left on 08Feb2021 at noon (Batch/Lot Number: EM9810) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included hypertension from 1980 and ongoing; and toes diagnosis of bursitis before the 1st Covid vaccine. Concomitant medications included enalapril taken for blood pressure increased and amlodipine (AMLODIPINE) taken for blood pressure increased, both from an unspecified start date and ongoing. The toes diagnosis of bursitis may have actually been RA (Rheumatoid Arthritis) beginning - before the 1st Covid vaccine. The patient experienced "LT (left) foot toe pain. Rheumatoid arthritis?". Onset date was 18Feb2021. The LT (left) foot toe pain was reported as not serious which required Physician office visit. The second dose of the vaccine was given on 28Feb2021.The patient had RA (Rheumatic arthritis) with an onset on 05Mar2021 which the patient had not recovered from. The RA was reported serious per Persistent/significant disability/ incapacity. The patient received Prednisone 6 day tab (tablet) for the RA. Therapeutic measures were taken as a result of the event LT (left) foot toe pain; with unknown outcome. Treatment: Yes, Orthotic, Diagnosis bursitis.; Sender's Comments: The information provided is limited to make a meaningful medical assessment. The reported event is likely an intercurrent medical condition and unrelated to BNT162B2. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cold sweat, Computerised tomogram, Concussion, Dehydration
Clinical narrative: fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years).  The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fall, Hypophagia, Malaise
Clinical narrative: fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years).  The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Skin laceration
Clinical narrative: fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years).  The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder, Skin warm
Clinical narrative: Almost a leopard look, not like a regular rash.; There is a strange pattern on the upper half of her right thigh, very warm.; There is a strange pattern on the upper half of her right thigh, very warm.; This is a spontaneous report from female consumer (patient's mother). This old female consumer (patient's mother) reported patient (daughter). A 23-year-old female patient (age at vaccination: 23 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number was not reported and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 01Jun2021 at 09:30, as a single dose for COVID-19 immunization. The patient was taking Pfizer Covid Vaccine because just for health protection and for work. Vaccine administered was not at facility. There was no history of previous immunization with the Pfizer vaccine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient's medical history included patient breaks out in hives (so they were just wanting to watch her closely with this), allergic to amoxicillin, and Keflex family of medicines (patient was 3 years old). There was no family medical history relevant to adverse events and no other relevant tests. Concomitant medications included amoxicillin and keflex (CEFALEXIN MONOHYDRATE). The reporter was calling on behalf of her daughter who received the first dose of the Pfizer Covid 19 vaccine about an hour ago. About an hour and a half ago, there was a strange pattern on the upper half of her right thigh, whole area feels very warm on 01Jun2021. Almost a leopard look, not like a regular rash on an unknown date. She just wanted to get Pfizer's input and see about the side effects seen and stated they noticed it like 5 minutes ago, it's staying steady right now. The reporter asked has this been reported as a side effect and did she need to get her in to see someone or did we need to get ready for an allergic reaction. The reporter got response as I would not be able to say if she was having a severe allergic reaction or not and suggested they reach out to her HCP to ask if she needs to come in to be seen or if they should go to the emergency room. There was a product complaint. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Magnetic resonance imaging, Seizure
Clinical narrative: major seizure within minutes of receiving shot; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at 14:00 (at the age of 78 years), in left arm, for COVID-19 immunization. The first dose of BNT162B2 was given on 12Feb2021 at 12:00 PM in left arm (at the age of 78 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified statin drug and blood pressure medicine. On 05Mar2021 the patient experienced major seizure within minutes of receiving shot. The event required Emergency room/department or urgent care and ended up on ventilator in ICU. Treatment received included lorazepam (ATIVAN), intubation, ventilator, CT scan, MRI, EEG. The event was reported as serious as required hospitalization for 6 days and was life-threatening. Event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphoedema, Swelling
Clinical narrative: Lymphedema; swelling; her arm looks like it's a foot thick; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included breast cancer (no chemo but radiation). The patient's concomitant medications were not reported. Reporter states 30% of the patients had cancer and radiation. They get the same side effect she has, some in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs belong on an elephant. arm started 3-4 days after her vaccine, her arm looks like it's a foot thick, and her other arm is perfectly normal. states the only thing we have in common was no chemo but radiation. The outcome of the event lymphedema was reported as not recovered and rest of the events was unknown.  Information on lot/batch number has been requested