chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Throat irritation
Clinical narrative: fever; chills; muscle aches; scratchy throat; can't taste or smell; can't taste or smell; sinus infection/sinus infection off and on; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 39-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date in 2021 for COVID-immunization for no events reported. The patient experienced fever, chills, muscle aches, scratchy throat, can't taste or smell on Sep2021 and sinus infection/sinus infection off and on an unknown date 2021. Caller reports she had her second Pfizer Covid 19 dose on Wednesday. Wants to know if someone can tell her some of the side effects and how long they last. Has had a sinus infection off and on and on Wednesday was fine when she got the shot, now since then she has had a scratchy throat. She told the pharmacist this and was told to go ahead and get the vaccine and she called her doctor. She has had fever, chills, and muscles aches and saw that they were common, but now she could not taste or smell right. Therapeutic measures were taken as a result of events. The outcome for event fever and chills was recovered on an 16Sep2021 while muscle aches and scratchy throat was unknown and rest was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with all 3 doses; This is a spontaneous report from a contactable consumer, the patient from a Pfizer sponsored program Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder and cancer. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced sore arm with all 3 doses. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and would be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Heart rate increased, Hypersensitivity, Migraine, Mouth swelling
Clinical narrative: Had severe migraines.; Also body aches all over the body; Allergic reaction in the face; swelling mouth, nose and ears; swelling mouth, nose and ears; swelling mouth, nose and ears; Rapid heartbeats; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old non pregnant female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 1, single, and via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 2, single for covid-19 immunisation.  The patient medical history was not reported. The patient did not have known allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and has the patient been tested for COVID-19 Since the vaccination. There were no concomitant medications.  On 22Aug2021 the patient experienced had severe migraines, also body aches all over the body, allergic reaction in the face, swelling mouth, nose and ears and rapid heartbeats. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Had severe migraines.; Also body aches all over the body; Allergic reaction in the face; swelling mouth, nose and ears; swelling mouth, nose and ears; swelling mouth, nose and ears; Rapid heartbeats; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old non pregnant female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 1, single, and via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 2, single for covid-19 immunisation.  The patient medical history was not reported. The patient did not have known allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and has the patient been tested for COVID-19 Since the vaccination. There were no concomitant medications.  On 22Aug2021 the patient experienced had severe migraines, also body aches all over the body, allergic reaction in the face, swelling mouth, nose and ears and rapid heartbeats. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Panic attack, Vertigo
Clinical narrative: vertigo; dizziness; anxiety; panic attacks; This is a spontaneous report from a contactable consumer (reporter's father) . A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, his main concern right now is his dizziness, vertigo, anxiety, panic attacks and he also mentioned that his Dad who got also the Pfizer-BioNTech Covid19 Vaccine is beginning to have the similar problem. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menopause, Oligomenorrhoea, Ovarian failure
Clinical narrative: I had an abnormally long menses; I was confirmed to be post menopausal; I have autoimmune ovarian failure; This is a spontaneous report from a contactable nurse (patient). A 38-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EJ-1686, Expiry date: not reported), via an unspecified route of administration, administrated in left arm on 29Dec2020 16:00 (at age of 38-years-old) as dose 1, single for COVID-19 immunization in workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Jan2021, the patient experienced I had an abnormally long menses, I was confirmed to be post-menopausal, and I have autoimmune ovarian failure. On 06Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative, Nasal Swab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The reporter stated that after first dose, she had an abnormally long menses, then never had one again. In July, the patient was confirmed to be post menopausal at age 38. The patient was referred to a specialist who said that she had autoimmune ovarian failure. No therapeutic measures were taken in response to the events. The outcome of the events was unknown.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Dizziness, Fatigue
Clinical narrative: Chronic cough has worsened; Chronic cough has worsened; Extreme dizziness 4 hours after shot; nausea; vomiting; body aches and pains; headache; fatigue/I tire easily; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received third dose (BOOSTER, SINGLE), of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via intramuscularly, administered in Arm Left on 28Sep2021 at 12:00 (age at vaccination: 74-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included nausea, pain, hyperlipidaemia and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included prochlorperazine edisylate (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) taken for nausea from 28Sep2021 to 02Oct2021, via oral route of administration, ibuprofen taken for pain from 28Sep2021 to 02Oct2021, via oral route of administration and atorvastatin taken for hyperlipidaemia, blood cholesterol from 2018 to an unspecified stop date. The patient was not diagnosed with covid prior to covid-19 vaccine. The patient was not tested for covid-19 post vaccination. The patient was not allergic to any medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date: Jun2021), via intramuscularly in left arm, on 03Feb2021 at 13:00 (age at vaccination: 73-years-old), as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: 30Jun2021), via intramuscularly in left arm, on 22Feb2021 at 12:00 (age at vaccination: 73-years-old), as DOSE 2, SINGLE for COVID-19 immunization. It was reported that, approximately 4 hours after 3rd dose was received, I experienced sudden onset of severe Dizziness, Followed by Nausea and Vomitting those sysmptoms persisted for nearly 7 days, then lessened. 10 days later, I am still experiencing Dizziness, but am able to walk and drive. I tired easily and my chronic cough has worsened. On 28Sep2021 at 17:00 PM, the extreme dizziness, nausea, vomiting, body aches and pains, headache, fatigue/I tired easily and chills. 10 days later, he was still experiencing dizziness, but he was able to walk and drive. On an unspecified date, his chronic cough had worsened. The patient did not receive any treatment for the events. Outcome of the event nausea and vomiting was recovered on an unspecified date in 2021, outcome of the events, dizziness, body aches and pains, headache, fatigue/I tired easily, chills was recovering and outcome of the other events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Chronic cough has worsened; Chronic cough has worsened; Extreme dizziness 4 hours after shot; nausea; vomiting; body aches and pains; headache; fatigue/I tire easily; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received third dose (BOOSTER, SINGLE), of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via intramuscularly, administered in Arm Left on 28Sep2021 at 12:00 (age at vaccination: 74-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included nausea, pain, hyperlipidaemia and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included prochlorperazine edisylate (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) taken for nausea from 28Sep2021 to 02Oct2021, via oral route of administration, ibuprofen taken for pain from 28Sep2021 to 02Oct2021, via oral route of administration and atorvastatin taken for hyperlipidaemia, blood cholesterol from 2018 to an unspecified stop date. The patient was not diagnosed with covid prior to covid-19 vaccine. The patient was not tested for covid-19 post vaccination. The patient was not allergic to any medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date: Jun2021), via intramuscularly in left arm, on 03Feb2021 at 13:00 (age at vaccination: 73-years-old), as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: 30Jun2021), via intramuscularly in left arm, on 22Feb2021 at 12:00 (age at vaccination: 73-years-old), as DOSE 2, SINGLE for COVID-19 immunization. It was reported that, approximately 4 hours after 3rd dose was received, I experienced sudden onset of severe Dizziness, Followed by Nausea and Vomitting those sysmptoms persisted for nearly 7 days, then lessened. 10 days later, I am still experiencing Dizziness, but am able to walk and drive. I tired easily and my chronic cough has worsened. On 28Sep2021 at 17:00 PM, the extreme dizziness, nausea, vomiting, body aches and pains, headache, fatigue/I tired easily and chills. 10 days later, he was still experiencing dizziness, but he was able to walk and drive. On an unspecified date, his chronic cough had worsened. The patient did not receive any treatment for the events. Outcome of the event nausea and vomiting was recovered on an unspecified date in 2021, outcome of the events, dizziness, body aches and pains, headache, fatigue/I tired easily, chills was recovering and outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness progressing to needing a walker to ambulate; Tingling and numbness progressing to needing a walker to ambulate; Tingling and numbness progressing to needing a walker to ambulate; This is a spontaneous report from a contactable other healthcare professional (hcp). This report was received via a sales representative. A 5-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced tingling and numbness progressing to needing a walker to ambulate. This started 3 weeks after a dose of the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Paraesthesia, hypoaesthesia, gait disturbance and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before; This is a spontaneous report from a contactable pharmacist.  An elderly patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included anaemia. The patient concomitant medication was not reported. The patient previously took BNT162B2, dose 1 for COVID-19 immunisation.  The patient received a blood transfusion within the past 24 to 48 hours. Patient was scheduled for a booster dose of the Pfizer BioNTech Covid-19 Vaccine on 11Oct2021. The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event( Anaemia aggravated) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Loss of personal independence in daily activities, Urinary incontinence
Clinical narrative: couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder; can't seem to get back on her feet; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Sep2021 (at the age of 64-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) diagnosed in 2010 or 2011, cancer, severely immunocompromised, severely allergic to latex; patient also had surgery for cancer and chemo which is finally over. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No flu prior to vaccination. In Sep2021, the patient couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder and had to have disposal underwear just to handle things, and can't seem to get back on her feet. Every time she thinks she's getting better, she has a bad air quality day and sets her back, it doesn't put her back in bed per se but it puts her where she's not able to function like she normally does and that really affects her COPD (for clarification). She confirmed all symptoms were disabling, she couldn't even get out of bed. She wanted to know how long the symptoms would last from the Pfizer Covid 19 Vaccine. Outcome of the events was unknown.  Relatedness of drug to all reactions/events: Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Heart rate, Heart rate increased
Clinical narrative: boil, hurts and big; Rapid heart beat that night; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 29Sep2021 12:00 (Batch/Lot Number: FF2588) at the age of 52 years old, as dose 2, single for covid-19 immunisation. Medical history included known allergies: latex. Concomitant medication(s) included iron taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: FF2587) administered in arm left on 08Sep2021 12:00. No other vaccine in four weeks. No COVID prior vaccination; not COVID tested post vaccination. Events started on 07Oct2021 12:00. The patient experienced rapid heartbeat that night (as reported). Unknown treatment for adverse event. Later (as reported), the patient started feeling a burning sensation on her middle back to later be a boil. She doesn't get boils and it hurts and was big. She was prescribed amoxicillin Events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events were recovering.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Extrasystoles, Heart rate irregular
Clinical narrative: this all hit him really hard/had premature beats; heart rate skip a beat every other beat; had premature beats; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included feelings of premature beats around the end of May2021 or first part of Jun2021. It might have started earlier, but he didn't know for sure. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 10Jul2021 as dose 1, single for COVID-19 immunization. It was reported the patient ended up in the hospital and had premature beats (also reported as heart rate skip a beat every other beat). On 13Aug2021, all these events hit him really hard and ended up in the hospital for overnight on 14Aug2021 (presumed). As of 22Sep2021, the premature beats and heart rate skip a beat every other beat were ongoing. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Vaccination Failure (28/Sep/2021, covid test result, Positive); covid test result, Positive; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable Consumer. This 52-year-old male Consumer reported for himself that:  A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810) via unspecified route of administration in left arm on 02Sep2021 (at the age of 52-year-old) as dose 2, single for COVID-19 immunization. The patient other medical history: one. Patient don't have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. Concomitant medication was not reported. The patient received other medications within 2 weeks of vaccination: Blood pressure (Other medications in two weeks: Blood pressure). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El1283) via unspecified route of administration in left arm on 20Jan2021 as dose 1, single for COVID-19 immunization. On 28Sep2021 the patient experienced Drug ineffective, covid test result, positive and inappropriate schedule of vaccine administered. Patient reported on 01Mar2021 we are not sure, but all tests were negative triggering Lichen Planus triggering the loss of all my hand finger nails and feet fingernails. And all these were in Mar2021.Patient received treatment of steroid shots and outcome was not recovered. Patient underwent lab tests and procedures which included sars-cov-2 (Nasal Swab) test negative on 11May2021, sars-cov-2 (Nasal Swab) test positive on 28Sep2021. Patient received treatment for events. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dyspnoea, Glossodynia, Heart rate increased, Hypersensitivity, Oropharyngeal pain
Clinical narrative: severe allergic reaction; face was swollen; tongue hurts; sore throat; difficulty breathing; swelling of face/throat; fast heart beat; rash all over body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as single dose for immunization.  The patient medical history and concomitant medications were not reported. She received the third shot of the Pfizer Covid 19 vaccine last Wednesday, 06Oct2021, the first dose, and she also had her flu shot; however, she experienced a severe allergic reaction. She wanted to know what needs to be done after experiencing this. It was still happening at the time of report. She stated she had been to the emergency room twice; she has spent about 4 hours there last night. She spent about 8 hours there and they have already told her there is nothing she can do. She noted she has been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. Her face was swollen, tongue hurts, sore throat. She stated that she was experiencing almost every side effect on the list she is reading including severe ones. She experienced difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. The patient has not recovered from the events.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pharyngeal swelling, Rash, Swelling face
Clinical narrative: severe allergic reaction; face was swollen; tongue hurts; sore throat; difficulty breathing; swelling of face/throat; fast heart beat; rash all over body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as single dose for immunization.  The patient medical history and concomitant medications were not reported. She received the third shot of the Pfizer Covid 19 vaccine last Wednesday, 06Oct2021, the first dose, and she also had her flu shot; however, she experienced a severe allergic reaction. She wanted to know what needs to be done after experiencing this. It was still happening at the time of report. She stated she had been to the emergency room twice; she has spent about 4 hours there last night. She spent about 8 hours there and they have already told her there is nothing she can do. She noted she has been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. Her face was swollen, tongue hurts, sore throat. She stated that she was experiencing almost every side effect on the list she is reading including severe ones. She experienced difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. The patient has not recovered from the events.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Dyspnoea, Fatigue, Heart rate
Clinical narrative: Atrial Fibrillation; short of breath; chest pain when I tried to breathe; heart rate went to 158; very tired; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 27Sep2021 08:30 (Lot Number: fe3592), at the age of 75-years-old, as dose 3 (booster), single for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, back disorder from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of bnt162b2, administered Arm Left, on 15Jan2021 04:30 PM (Batch/Lot No: ek4176), at the age of 75-years-old, for COVID-19 immunization and second dose of bnt162b2 administered Arm Left on 05Feb2021 08:30 AM (Batch/Lot No: ek4176), at the age of 75-years-old for COVID-19 immunization. The patient experienced atrial fibrillation on 05Oct2021 08:00; very tired on 28Sep2021; short of breath and chest pain when he tried to breathe on 02Oct2021; heart rate went to 158 in Oct2021. The clinical course was reported as follows: The day after 3 dose became, patient was very tired. He started to get short of breath about 4 days after dose. Then started having chest pain when he tried to breathe. On Tuesday a week and a day after 3 dose, her heart rate went to 158, he went to ER and was told he has Atrial Fibrillation and went home with prescribed medication. He works out on a regular basis. His heart rate is usually around 45 to 49, hardly ever over 60, two days after ER visit he felt much better and seemed to be back to normal. Not sure if related but was told by his doctor he might need to do something about his slow heartbeat, before this occurred. The events resulted in emergency room/department or urgent care. Treatment received for the adverse events which included an unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: 45 to 49 (heart rate is usually around 45 to 49, hardly ever over 60) on an unknown date and 158 in Oct2021. Therapeutic measures were taken as a result of atrial fibrillation, very tired, short of breath, chest pain when he tried to breathe and heart rate went to 158. The outcome of the events was recovered in Oct2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Atrial Fibrillation; short of breath; chest pain when I tried to breathe; heart rate went to 158; very tired; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 27Sep2021 08:30 (Lot Number: fe3592), at the age of 75-years-old, as dose 3 (booster), single for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, back disorder from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of bnt162b2, administered Arm Left, on 15Jan2021 04:30 PM (Batch/Lot No: ek4176), at the age of 75-years-old, for COVID-19 immunization and second dose of bnt162b2 administered Arm Left on 05Feb2021 08:30 AM (Batch/Lot No: ek4176), at the age of 75-years-old for COVID-19 immunization. The patient experienced atrial fibrillation on 05Oct2021 08:00; very tired on 28Sep2021; short of breath and chest pain when he tried to breathe on 02Oct2021; heart rate went to 158 in Oct2021. The clinical course was reported as follows: The day after 3 dose became, patient was very tired. He started to get short of breath about 4 days after dose. Then started having chest pain when he tried to breathe. On Tuesday a week and a day after 3 dose, her heart rate went to 158, he went to ER and was told he has Atrial Fibrillation and went home with prescribed medication. He works out on a regular basis. His heart rate is usually around 45 to 49, hardly ever over 60, two days after ER visit he felt much better and seemed to be back to normal. Not sure if related but was told by his doctor he might need to do something about his slow heartbeat, before this occurred. The events resulted in emergency room/department or urgent care. Treatment received for the adverse events which included an unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: 45 to 49 (heart rate is usually around 45 to 49, hardly ever over 60) on an unknown date and 158 in Oct2021. Therapeutic measures were taken as a result of atrial fibrillation, very tired, short of breath, chest pain when he tried to breathe and heart rate went to 158. The outcome of the events was recovered in Oct2021.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Inappropriate schedule of product administration
Clinical narrative: blind; got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it; The initial case was missing the following minimum criteria: medical information only. Upon receipt of follow-up information on 08Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on 15Jul2021 (Lot Number: FD8448; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunization.  Medical history included ongoing lupus from an unknown date. The patient's concomitant medications were not reported. The patient got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it. The patient then applied for a job and she is supposed to get both shots, she wanted to know if she should just go to the same place that she got her first one, or what should she do. During the call the patient was reading information from the card and stated that she needs a flashlight because she is blind. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure abnormal, Blood pressure measurement, Condition aggravated, Dizziness
Clinical narrative: Sjogren's reacted; Sjogren's reacted, asthma kicked in; headache; rash; nodule; dizziness; blood pressure erratic (jumped up and down); asthma; nausea; had trouble with the left eye/very blurred; had trouble with the left eye/very painful; This is a spontaneous report from a contactable consumer (patient) reported for self. A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included bilateral hearing loss, having a little bit of trouble hearing, autoimmune disorder, 5 autoimmune diseases, asthma, heart, sjogren's disease all from an unknown date and unknown if ongoing. Concomitant medications included rheumatology drugs. Historical vaccine included NT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and MMR Immunization and has no immunity. The patient experienced Sjogren's reacted, and asthma kicked in, difficulty hearing, headache, rash, nodule, dizziness, blood pressure erratic (jumped up and down), asthma, had trouble with the left eye/very blurred, had trouble with the left eye/very painful and nausea all on an unspecified date. The seriousness of the events was not reported. It was reported that patient has sjogren's disease and after the vaccine she had trouble with the left eye: very painful and got very blurred after vaccine 2 blurriness lasted for over 7 days. Sjogren's reacted" because of her underlying conditions she needs to get a booster dose because they do not know how long her immunity may last or how much immunity she has due to her condition. The outcome of the events had trouble with the left eye/very painful/very blurred were recovered on an unknown date in 2021 and it was unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea, Nodule, Rash
Clinical narrative: Sjogren's reacted; Sjogren's reacted, asthma kicked in; headache; rash; nodule; dizziness; blood pressure erratic (jumped up and down); asthma; nausea; had trouble with the left eye/very blurred; had trouble with the left eye/very painful; This is a spontaneous report from a contactable consumer (patient) reported for self. A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included bilateral hearing loss, having a little bit of trouble hearing, autoimmune disorder, 5 autoimmune diseases, asthma, heart, sjogren's disease all from an unknown date and unknown if ongoing. Concomitant medications included rheumatology drugs. Historical vaccine included NT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and MMR Immunization and has no immunity. The patient experienced Sjogren's reacted, and asthma kicked in, difficulty hearing, headache, rash, nodule, dizziness, blood pressure erratic (jumped up and down), asthma, had trouble with the left eye/very blurred, had trouble with the left eye/very painful and nausea all on an unspecified date. The seriousness of the events was not reported. It was reported that patient has sjogren's disease and after the vaccine she had trouble with the left eye: very painful and got very blurred after vaccine 2 blurriness lasted for over 7 days. Sjogren's reacted" because of her underlying conditions she needs to get a booster dose because they do not know how long her immunity may last or how much immunity she has due to her condition. The outcome of the events had trouble with the left eye/very painful/very blurred were recovered on an unknown date in 2021 and it was unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Sjogren's syndrome, Vision blurred
Clinical narrative: Sjogren's reacted; Sjogren's reacted, asthma kicked in; headache; rash; nodule; dizziness; blood pressure erratic (jumped up and down); asthma; nausea; had trouble with the left eye/very blurred; had trouble with the left eye/very painful; This is a spontaneous report from a contactable consumer (patient) reported for self. A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included bilateral hearing loss, having a little bit of trouble hearing, autoimmune disorder, 5 autoimmune diseases, asthma, heart, sjogren's disease all from an unknown date and unknown if ongoing. Concomitant medications included rheumatology drugs. Historical vaccine included NT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and MMR Immunization and has no immunity. The patient experienced Sjogren's reacted, and asthma kicked in, difficulty hearing, headache, rash, nodule, dizziness, blood pressure erratic (jumped up and down), asthma, had trouble with the left eye/very blurred, had trouble with the left eye/very painful and nausea all on an unspecified date. The seriousness of the events was not reported. It was reported that patient has sjogren's disease and after the vaccine she had trouble with the left eye: very painful and got very blurred after vaccine 2 blurriness lasted for over 7 days. Sjogren's reacted" because of her underlying conditions she needs to get a booster dose because they do not know how long her immunity may last or how much immunity she has due to her condition. The outcome of the events had trouble with the left eye/very painful/very blurred were recovered on an unknown date in 2021 and it was unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; This is a spontaneous report from a contactable physician from a Pfizer sponsored Program. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Batch/Lot number was not reported) on an unspecified date as dose 1, single and on an unspecified date as dose 2, single both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporting physician wants to know if it was unusual for a patient having two vaccines to get COVID. The physician wants to know how common it is for a person who has two vaccines to get a COVID infection. The physician reported that they have a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Headache, Influenza like illness, Pain
Clinical narrative: heart aches; flu like symptoms; fever; aches; headaches; back aches; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 2nd dose (lot number: EN6200) on 24Feb2021 at age of 76 years old, at the 3rd dose (lot number: FF2588) on 05Oct2021 at 02: 30 AM at age of 77 years old; both via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. Medical history included heart issues. Concomitant medications were unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously receive the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 03Feb2021 via an unspecified route of administration in the left arm at age of 76 years old as single dose for COVID-19 immunization. The patient had flu like symptoms, fever, aches, headaches after both the second and third injections, also heart aches and back aches too, on 05Oct2021. No treatment was received for the events. No hospitalization prolonged. Outcome of the events was recovered on Oct2021. This report was reported as non-serious.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: heart aches; flu like symptoms; fever; aches; headaches; back aches; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 2nd dose (lot number: EN6200) on 24Feb2021 at age of 76 years old, at the 3rd dose (lot number: FF2588) on 05Oct2021 at 02: 30 AM at age of 77 years old; both via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. Medical history included heart issues. Concomitant medications were unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously receive the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 03Feb2021 via an unspecified route of administration in the left arm at age of 76 years old as single dose for COVID-19 immunization. The patient had flu like symptoms, fever, aches, headaches after both the second and third injections, also heart aches and back aches too, on 05Oct2021. No treatment was received for the events. No hospitalization prolonged. Outcome of the events was recovered on Oct2021. This report was reported as non-serious.   Follow-up attempts are completed. No further information is expected.