chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dermatitis atopic, Eczema, Rash
Clinical narrative: Rash; breakout of eczema on his thighs, and he noticed for about 5 days he broke out with some eczema spots on his legs; atopic dermatitis; This is a solicited report based on information received by Pfizer. (manufacturer control 2021SA092686), from a non-Pfizer sponsored program (marketing program not available). A contactable consumer (patient) reported that a 74-year-old male patient received BNT162B2, via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation; dupilumab (DUPIXENT, Batch/Lot number was not reported), subcutaneous on 01Jan2018 at 600 mg (Ioading dose), followed by (on an unspecified date) maintenance dose of 300 mg every 2 weeks for intrinsic eczema and attention deficit hyperactivity disorder. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 in 2021. On Mar2021, the patient experienced rash; breakout of eczema on his thighs, and he noticed for about 5 days he broke out with some eczema spots on his legs; and atopic dermatitis. He was only been giving his injection on the right and left side of his abdomen - dupilumab used for attention deficit hyperactivity disorder. The nurse encouraged the injection on his thighs so that maybe better coverage or rotate the sites at least. He was going to his doctor's office on an appointment in 2 weeks. He would speak with them then and possibly switch over to pen that time. His last dose was on 05Mar2021. The patient had rash (medically significant) after COVID booster in Mar2021. He said it lasted for 3 weeks and was different than atopic dermatitis (AD), was transitory. At the time of the report, it was unknown if dupilumab was continued or discontinued. Physical assessment of 'PTC' was done. The action taken in response to the event(s) for dupilumab was unknown. Outcome of rash was recovered, while other events were unknown.   Company causality: not reportable for all events for dupilumab; related for rash for tozinameran [Pfizer biontech covid-19 vaccine]; not reportable for rest of the events for tozinameran [Pfizer biontech covid-19 vaccine].   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Productive cough
Clinical narrative: I had shortness of breath for almost a month afterwards; I had a lot of phlegm; I had a lot of redness; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:00 (at the age of 34-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma. There were no concomitant medications. Patient did not receive any other vaccine in four weeks or other medication in two weeks. Patient had no known allergies. It was unknown if patient was pregnant at the time of vaccination. Patient reported that on 17Jun2021 at 01:00, I had shortness of breath for almost a month afterwards. I had a lot of phlegm. when I put a magnet against my arm it fights against the magnet, I had a lot of redness. The AE resulted in emergency room/department or urgent care. Patient received treatment of Inhaler and mucinex dm, and antibiotics. Patient did not had covid prior vaccination and not covid tested post vaccination. The outcome of the event was recovered with sequel on an unspecified date on 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report based on the information received by Pfizer. (Manufacturer Report Number: 847098). A contactable consumer reported that a 48-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 2021 (Lot number and expiry date not reported) as dose number unknown, single for covid-19 prophylaxis; and liraglutide (SAXENDA, strength 6mg/ml), subcutaneous in 2021 (Lot Number: LZFR670, Expiry date: Apr2023) at 6 mg/ml (as reported) unspecified frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. Patient had COVID-19 pneumonia beginning on 03Jul2021. The patient was hospitalized on 03Jul2021 and was in the intensive care unit (ICU) on a ventilator. The patient was discharged on 17Jul2021 after 14 days in the hospital. The patient felt the COVID-19 Pneumonia was caused by the Pfizer COVID-19 vaccine.  The action taken in response to the event for bnt162b2 was not applicable, and for liraglutide temporarily withdrawn on an unknown date in 2021 (reported as may have stopped Saxenda for a couple of weeks). The outcome for the event COVID-19 pneumonia was not recovered.   Company Comment: COVID-19 pneumonia is assessed as unlisted according to the company core data sheet (CCDS) for Saxenda. Limited Information as related to age, weight, BMI. medical history Concomitant medications, family/social history, and laboratory/diagnostic evaluation limits medical assessment. The single case report is not considered to change the current knowledge of the safety profile of the product  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Oedema, Sinus disorder
Clinical narrative: edema in major joints & especially lower legs; severe sinus swelling; my major joints swelled up; extremely painful to move; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 05Feb2021 (Lot Number: EC9269) at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included a history of allergies and take have taken allergy shots for years. Known allergy was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included tamsulosin hcl, testosterone (ANDROGEL), sildenafil, simvastatin and overran. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 15Jan2021 (Batch/Lot Number: EC1284) at the age of 78-year-old as single dose for COVID-19 immunization. On 07Feb2021 at 12:00, the patient experienced edema in major joints, especially lower legs and severe sinus swelling. 2 days after 2nd dose the patient was feeling OK, so he went for a walk (first exercise since vac). About 1/4 mile out his major joints swelled up and began extremely painful to move. Edema slowly reduced, he tried compression socks which helped some. About 3 months later, he saw internist who sent him to a vein specialist. He thinks the patient will have a permanent problem with edema. The patient was scheduled for an echocardiogram and vein ultrasound. He think that this is too much of a coincidence to be another cause. The patient was concerned about getting a booster because he may sustain further permanent damage to he vascular system. In addition to edema, the patient's sinuses swelled up and required a month of heavy-duty medication (Chance) to return to their normal swelling. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Hospitalization Prolonged was none. Treatment was received. The outcome of events was recovered with sequel.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Immunisation, Off label use
Clinical narrative: weak; loss of appetite; covid test result=Positive; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer. An unspecified age male patient received the third dose of BNT162B2 (COVID19 Vaccine) via an unspecified route of administration in Oct2021 as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medication included influenza vaccine. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. In Oct2021, the patient experienced individual weak and loss of appetite. In Oct2021, the patient performed covid test (type was unknown) and result was positive. The events of weakness and appetite lost resulted in emergency room/department or urgent care. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: weak; loss of appetite; covid test result=Positive; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer. An unspecified age male patient received the third dose of BNT162B2 (COVID19 Vaccine) via an unspecified route of administration in Oct2021 as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medication included influenza vaccine. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. In Oct2021, the patient experienced individual weak and loss of appetite. In Oct2021, the patient performed covid test (type was unknown) and result was positive. The events of weakness and appetite lost resulted in emergency room/department or urgent care. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated several months ago her husband (patient) developed blood clots that he thought might be related to his Pfizer vaccine. He went to the hospital and was told that his condition was not related to his vaccination. The event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Two Rheumatoid arthritis flare up; This is a solicited report from a contactable consumer via a company. (MFR Control No. 21K-163-4101491-00). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 26Aug2021 (at the age of 60 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, the first dose intramuscular on 31Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to 29Jul2021, at unspecified dose, oral from 2021 (Batch/Lot number was not reported) to 25Aug2021, at unspecified dose for Moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. In 2021, the patient experienced two rheumatoid arthritis flare-up while he was paused from taking his RINVOQ in order to get his COVID-19 vaccines. On 30Jul2021 and 25Aug2021, the patient experienced stop taking the RINVOQ when patient had COVID-19 vaccines (Intentional misuse in dosing frequency). The action taken in response to the events for upadacitinib was unknown. The outcome of the event was recovering at the time of report.   Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of stop taking the rinvoq when patient had COVID-19 vaccines onset 30Jul2021 and 25Aug2021 was not provided. The reporters causality for the event(s) of two rheumatoid arthritis flare-up with RINVOQ (upadacitinib) was no reasonable possibility. Causuality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): Intentional misuse in dosing frequency - Intentional product misuse. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A. Causuality:  Rheumatoid arthritis flare up - Rheumatoid arthritis. Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the causal association between the event rheumatoid arthritis flare up and the suspect drug BNT162B2  is assessed unrelated.  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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Incorrect route of product administration, SARS-CoV-2 test
Clinical narrative: Received 1st and 2nd dose of COVID-19 vaccine subcutaneous; COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) via a non-Pfizer-sponsored program, FACILITATED COLLECT, based on information received by Pfizer from  (Manufacturer Control Number: 21K-163-4116265-00).   Solicited report from the USA by a consumer of a 44-year-old female with events of non-serious COVID-19 and entire family caught COVID-19 with Humira (Adalimumab). There was no reported medical history. On unknown dates (2021), the patient experienced COVID-19 and entire family caught COVID-19. In 2021, the COVID-19 and entire family caught COVID-19 resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Feb2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech (subcutaneous). On 01Mar2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech (subcutaneous). Primary reporter contact for lot number information was not available. Relevant laboratory and other diagnostic tests included blood work: blood count came back up in Jan2021; and COVID-19 test: COVID-19 (positive) in 2021. The patient recovered from COVID-19 in 2021.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID-19 and entire family caught COVID-19 with Humira (Adalimumab) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; 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 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) at dose 1, single and dose 2, single (lot number, expiry date not reported); both via an unspecified route of administration, on an unspecified date, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got both of his doses of the Covid vaccine and then experienced Covid, he also had some symptoms with Covid such as fever, coughing, little weak and lost the sense of smell on an unspecified date. The patient stated that he could still taste, and he never got short of breath. Therapeutic measures included Nyquil for a couple of weeks. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Immunisation, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Third covid booster; Third covid booster; COVID-19; COVID-19; Vaccination site swelling; Vaccination site induration; Vaccination site pruritus; This is a solicited report from a contactable consumer (patient), via the non Pfizer-sponsored program, and based on the information received by Pfizer. (MFR. Control no. 21K-163-4076974-00).  Solicited report from a consumer of a 62-year-old male with events of non-serious COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster with adalimumab (HUMIRA). There was no reported medical history. In 2021, the patient experienced patient had swelling, hardness and itchiness around injection site after third COVID booster. In Aug2021, the patient experienced COVID. In 2021, the COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster resolved. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Dec2020, patient received first dose COVID-19 vaccine manufactured by Pfizer. On 19Jan2021, patient received second dose COVID-19 vaccine manufactured by Pfizer.  Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of COVID with adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event(s) of patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021, patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 and patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 was not provided.  Change History: On 11Oct2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "patient had swelling, hardness and itchiness around injection site after third covid booster" was added.  The reporter's assessment of the causal relationship of the reported events with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - COVID-19, vaccination failure, vaccination site swelling, vaccination site induration, vaccination site induration, immunization, off label use and the suspect drug "BNT162B2" cannot be completely excluded.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Third covid booster; Third covid booster; COVID-19; COVID-19; Vaccination site swelling; Vaccination site induration; Vaccination site pruritus; This is a solicited report from a contactable consumer (patient), via the non Pfizer-sponsored program, and based on the information received by Pfizer. (MFR. Control no. 21K-163-4076974-00).  Solicited report from a consumer of a 62-year-old male with events of non-serious COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster with adalimumab (HUMIRA). There was no reported medical history. In 2021, the patient experienced patient had swelling, hardness and itchiness around injection site after third COVID booster. In Aug2021, the patient experienced COVID. In 2021, the COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster resolved. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Dec2020, patient received first dose COVID-19 vaccine manufactured by Pfizer. On 19Jan2021, patient received second dose COVID-19 vaccine manufactured by Pfizer.  Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of COVID with adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event(s) of patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021, patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 and patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 was not provided.  Change History: On 11Oct2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "patient had swelling, hardness and itchiness around injection site after third covid booster" was added.  The reporter's assessment of the causal relationship of the reported events with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - COVID-19, vaccination failure, vaccination site swelling, vaccination site induration, vaccination site induration, immunization, off label use and the suspect drug "BNT162B2" cannot be completely excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer.  A 60-year-old adult male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), dose 2 via an unspecified route of administration, on 19Feb2021 (age at vaccination: 59 years), as DOSE 2, SINGLE and dose 1 via an unspecified route of administration, on 29Jan2021 (Lot number: EN5318) (age at vaccination: 59 years), as a DOSE 1, SINGLE both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not had other vaccine in four weeks. The patient did not have Covid prior to the vaccination and tested for the COVID post vaccination. On 19Oct2021, the patient experienced COVID-19 confirmed by positive COVID-19 test (vaccination failure). On 18Oct2021 the patient underwent lab test procedure which includes Nasal swab test resulted positive on 19Oct2021. Outcome of the event COVID-19 was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: left arm, where she got shot was numb and had some redness; left arm, where she got shot was numb and had some redness; fatigue; 102F fever/her temperature was up to 102; chills; joint pain that lasted over 6 hours; severe headaches; felt like she was hit by truck; Patient received booster dose of BNT162B2.; Patient received booster dose of BNT162B2.; she was sick.; generalized body aches; This is a spontaneous report from a contactable nurse (patient) reported for self. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration administered in left arm on 18Oct2021 at 16:00PM as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as DOSE 1 and DOSE 2, SINGLE for COVID-19 immunization and patient stated that with the last two there was no problems. The patient felt like she was hit by truck, severe headaches on 18Oct2021 21:00 PM, she was sick on 18Oct2021, generalized body aches on Oct2021, 102f fever/her temperature was up to 102 on 19Oct2021 16:00PM, chills, joint pain that lasted over 6 hours on 19Oct2021, left arm, where she got shot was numb and had some redness on 20Oct2021, fatigue on 20Oct2021, patient received booster dose of BNT162B2 on 18Oct2021. Patient was asking what other side effect she will be expecting in the next week. Patient stated as she got the booster shot of the Pfizer-BioNTech COVID-19 Vaccine on Monday and she felt like she was hit by truck. She never had COVID. She had the first and second dose and had no reaction but now she was sick, she has layed out of work for 2-3 days and She was saying that that was not normal and was asking what was going on. She also noted that she was never getting another vaccine again. she has not left her house and was very sick. Stated that she wanted to know what is going on. Is for the Pfizer booster. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 19Oct2021 and 99.8 and 95 fahrenheit on an unknown date in Oct2021. Therapeutic measures were taken as a result of events Mortin for events headaches, body aches and Tylenol 500mg for fever, chills, joint pain. The outcome of the event felt like she was hit by truck, she was sick, chills was recovered on 190ct20219, 102F fever/her temperature was up to 102, fatigue was not recovered, 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: Headache, Illness, Immunisation, Off label use, Pain
Clinical narrative: left arm, where she got shot was numb and had some redness; left arm, where she got shot was numb and had some redness; fatigue; 102F fever/her temperature was up to 102; chills; joint pain that lasted over 6 hours; severe headaches; felt like she was hit by truck; Patient received booster dose of BNT162B2.; Patient received booster dose of BNT162B2.; she was sick.; generalized body aches; This is a spontaneous report from a contactable nurse (patient) reported for self. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration administered in left arm on 18Oct2021 at 16:00PM as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as DOSE 1 and DOSE 2, SINGLE for COVID-19 immunization and patient stated that with the last two there was no problems. The patient felt like she was hit by truck, severe headaches on 18Oct2021 21:00 PM, she was sick on 18Oct2021, generalized body aches on Oct2021, 102f fever/her temperature was up to 102 on 19Oct2021 16:00PM, chills, joint pain that lasted over 6 hours on 19Oct2021, left arm, where she got shot was numb and had some redness on 20Oct2021, fatigue on 20Oct2021, patient received booster dose of BNT162B2 on 18Oct2021. Patient was asking what other side effect she will be expecting in the next week. Patient stated as she got the booster shot of the Pfizer-BioNTech COVID-19 Vaccine on Monday and she felt like she was hit by truck. She never had COVID. She had the first and second dose and had no reaction but now she was sick, she has layed out of work for 2-3 days and She was saying that that was not normal and was asking what was going on. She also noted that she was never getting another vaccine again. she has not left her house and was very sick. Stated that she wanted to know what is going on. Is for the Pfizer booster. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 19Oct2021 and 99.8 and 95 fahrenheit on an unknown date in Oct2021. Therapeutic measures were taken as a result of events Mortin for events headaches, body aches and Tylenol 500mg for fever, chills, joint pain. The outcome of the event felt like she was hit by truck, she was sick, chills was recovered on 190ct20219, 102F fever/her temperature was up to 102, fatigue was not recovered, 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: Pyrexia, Vaccination site erythema, Vaccination site hypoaesthesia
Clinical narrative: left arm, where she got shot was numb and had some redness; left arm, where she got shot was numb and had some redness; fatigue; 102F fever/her temperature was up to 102; chills; joint pain that lasted over 6 hours; severe headaches; felt like she was hit by truck; Patient received booster dose of BNT162B2.; Patient received booster dose of BNT162B2.; she was sick.; generalized body aches; This is a spontaneous report from a contactable nurse (patient) reported for self. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration administered in left arm on 18Oct2021 at 16:00PM as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as DOSE 1 and DOSE 2, SINGLE for COVID-19 immunization and patient stated that with the last two there was no problems. The patient felt like she was hit by truck, severe headaches on 18Oct2021 21:00 PM, she was sick on 18Oct2021, generalized body aches on Oct2021, 102f fever/her temperature was up to 102 on 19Oct2021 16:00PM, chills, joint pain that lasted over 6 hours on 19Oct2021, left arm, where she got shot was numb and had some redness on 20Oct2021, fatigue on 20Oct2021, patient received booster dose of BNT162B2 on 18Oct2021. Patient was asking what other side effect she will be expecting in the next week. Patient stated as she got the booster shot of the Pfizer-BioNTech COVID-19 Vaccine on Monday and she felt like she was hit by truck. She never had COVID. She had the first and second dose and had no reaction but now she was sick, she has layed out of work for 2-3 days and She was saying that that was not normal and was asking what was going on. She also noted that she was never getting another vaccine again. she has not left her house and was very sick. Stated that she wanted to know what is going on. Is for the Pfizer booster. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 19Oct2021 and 99.8 and 95 fahrenheit on an unknown date in Oct2021. Therapeutic measures were taken as a result of events Mortin for events headaches, body aches and Tylenol 500mg for fever, chills, joint pain. The outcome of the event felt like she was hit by truck, she was sick, chills was recovered on 190ct20219, 102F fever/her temperature was up to 102, fatigue was not recovered, 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: Drug ineffective, Multiple sclerosis, Suspected COVID-19
Clinical narrative: SARS 2; SARS 2; MS; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient's friend reported: "Saw my doctor on the 19th and showed him the lesions on my lower, left, abdomen, and he said nothing as to why the lesions appeared after the first Pfizer injection, which was about one or two days. As those of us who do research the FDA did not follow their rules in approving any drug for wide consumption. So, these new vaccines never were tested for years, and they cannot save older citizens with underlying heath conditions. I also lost a friend (the patient). She had MS and in ten days she was called home, or died of SARS 2." The outcome of MS was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. The cause of death was SARS 2.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: SARS 2; SARS 2
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Coma, Confusional state, Death
Clinical narrative: became worse, she could not speak, the right part of the limbs did not move/diagnosed a stroke; coma; evening of the same day she was gone; low blood pressure; ill; confused in conversation; This is a spontaneous report from a contactable consumer. A 97-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021 the patient was vaccinated. After 2 hours, when they were returning home, the patient became ill (she began to react unusually to events, confused in conversation, slowed down her speech). After 10 we arrived home, the situation did not change, being scared, the reporter immediately called an ambulance. The doctor said that this was a normal phenomenon after vaccination, and because of low blood pressure, he gave an injection that increases blood pressure, recommended sleeping and resting. The reporter did not calm down on this and called the doctor who did the vaccination, she repeated the same thing that everything would pass in 2-3 days, and that this condition fully complies with the recommendations. The doctor and reporter called several times during 22Aug2021 and 23Aug2021, she assured they that she had called the COVID center, and they said the same thing - a normal reaction of the body. At about 8.30 am on 24Aug2021, the patient became worse, she could not speak, the right part of the limbs did not move, an ambulance was immediately called, the doctor diagnosed a stroke, then took her to the specialized hospital. As a result, she was in a coma (24Aug2021) until 31Aug2021, and in the evening of the same day she was gone. The patient died on 31Aug2021. It was not reported if an autopsy was performed. The outcome of events was not reported.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: evening of the same day she was gone
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Illness
Clinical narrative: became worse, she could not speak, the right part of the limbs did not move/diagnosed a stroke; coma; evening of the same day she was gone; low blood pressure; ill; confused in conversation; This is a spontaneous report from a contactable consumer. A 97-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021 the patient was vaccinated. After 2 hours, when they were returning home, the patient became ill (she began to react unusually to events, confused in conversation, slowed down her speech). After 10 we arrived home, the situation did not change, being scared, the reporter immediately called an ambulance. The doctor said that this was a normal phenomenon after vaccination, and because of low blood pressure, he gave an injection that increases blood pressure, recommended sleeping and resting. The reporter did not calm down on this and called the doctor who did the vaccination, she repeated the same thing that everything would pass in 2-3 days, and that this condition fully complies with the recommendations. The doctor and reporter called several times during 22Aug2021 and 23Aug2021, she assured they that she had called the COVID center, and they said the same thing - a normal reaction of the body. At about 8.30 am on 24Aug2021, the patient became worse, she could not speak, the right part of the limbs did not move, an ambulance was immediately called, the doctor diagnosed a stroke, then took her to the specialized hospital. As a result, she was in a coma (24Aug2021) until 31Aug2021, and in the evening of the same day she was gone. The patient died on 31Aug2021. It was not reported if an autopsy was performed. The outcome of events was not reported.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: evening of the same day she was gone
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable other HCP. A 66-year-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318), via intramuscular route on 04Mar2021 (age at vaccination: 65 years) as DOSE 1, SINGLE; via intramuscular route on 25Mar2021 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was administered vaccine in a workplace clinic. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Oct2021, the patient experienced tested positive on 0october after being exposed to his granddaughter who also tested positive. On 19Oct2021, the patient underwent sars-cov-2 test (nasal swab) which was positive. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The outcome of the events was recovering. The device date was 21Oct2021. No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the reported information, a causal relationship between the events Covid-19 and Vaccination failure and suspected drug cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Injection site burning; This is a Spontaneous report based on the information received by Pfizer. (MFR Control No. # 21K-163-4120930-00).   A 56-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), intramuscular on 10Mar2021 (At the age of 56 years) as DOSE 1, SINGLE, patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) intramuscular on 31Mar2021 (At the age of 56 years old) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from Jun2020 (Batch/Lot number was not reported) to May2021, at 40 mg,1 in 1 wk, subcutaneous from 03Oct2021 (Batch/Lot number was not reported) and ongoing, at 40 mg,1 in 1 wk for rheumatoid arthritis; etanercept (ENBREL), via an unspecified route of administration from 02May2021 (Batch/Lot number was not reported) to an unspecified date, at UNK, single for an unspecified indication. Medical history included Formaldehyde allergy manifested by inflammation, Nickel/Cobalt allergy manifested by rash from an unknown date and unknown if ongoing, alcohol use from 1983 to an unknown date, one drink a week of margarita or wine and was a non smoker. Concomitant medications included methotrexate and folic acid were taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine sodium taken for hypothyroidism, start and stop date were not reported. The patient experienced rheumatoid arthritis flare up and vaccination site burning on Mar2021. Patient also had device issue and it was difficult to use on 10Oct2021. At the time of reporting the outcome of the event was recovered for rheumatoid arthritis and was unknown for vaccination site burning.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (COMIRNATY Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 as dose 2, single for COVID-19 immunisation. Medical history included connective tissue disorder (Genetic connective tissue) and` congenital anomaly (Birth defects) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. After 2nd dose of vaccine the patient experienced anaphylactic reaction, felt like something was stuck in her throat, tongue became swollen and red on an unspecified date in 2021 which later ended up to visit emergency room. The patient wanted to know if ok to get a 3rd dose of pfizer covid vaccine given her anaphylactic experience after the 2nd. Reporter clarified that although she has hx of genetic connective tissue and birth defects, she did not consider herself immunosuppressed. Reporter clarified that it is the booster and not the 3rd dose that she is wanting to get. Patient said, she started taking ramipril 1.5 weeks ago and developed arm pain; described as muscle and joint pain from shoulders to her fingers. asking will it go away and if so then when? Also, as per agent, reporter had 2nd dose of pfizer covid vaccine on Jan 27th and experienced an anaphalytic reaction. She felt like something was stuck in her throat and tongue became swollen and red. She was given epipen and benadryl and sent to Emergency Dept and treated with additional medications and then released 9 hrs later. She was asking for recommendations for other types of covid 19 vaccines should/could she get if she should not get pfizer covid vaccine. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away in the sleep; This is a spontaneous report received from a non-contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 02Oct2021 05:00PM (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation at a pharmacy or drug store. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included insulin taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date in Feb2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 2, single and on an unspecified date in Jan2021 (at the age of 66-years-old; Batch/lot number and expiration date were not reported) as dose 1, single, both via an unspecified route of administration in the right arm and for COVID-19 immunisation. No other vaccine in was administered in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 07Oct2021 09:00AM, 4 days later after the booster shot, the patient passed away in the sleep. It was unknown if treatment was received for the event. The outcome of the event was fatal. The patient died on 07Oct2021.  An autopsy was not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Passed away in the sleep
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Neoplasm malignant, SARS-CoV-2 test
Clinical narrative: died of confirmed covid-19 after the Pfizer vaccination, he was confirmed cancer; died of confirmed covid-19 after the Pfizer vaccination albeit he was confirmed cancer; died of confirmed covid-19 after the Pfizer vaccination albeit he was confirmed cancer; This is a spontaneous report from a contactable other healthcare professional.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient died of confirmed covid-19 after the Pfizer vaccination albeit he was confirmed cancer.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Covid-19,Drug ineffective,Neoplasm malignant  and the suspect drug BNT162B2 cannot be excluded totally. case will be reassess 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died of confirmed covid-19 after the Pfizer vaccination