chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Vaccination site pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272124-00.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of some pain in arm after wards covid vaccinated and Flu shoot and rheumatoid arthritis flare up with adalimumab was not provided. The reporter's causality for the event(s) of vaccination site pain and Rheumatoid arthritis flare up with bnt162b2 was possible. The reporter's causality for the event(s) of vaccination site pain and Rheumatoid arthritis flare up with influenza vaccine was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events . There is limited information provided in this report. This case will be reassessed once additional information is available.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Fatigue, Impaired healing
Clinical narrative: Felt tired; C diff/took a year to heal; C diff/took a year to heal; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272984-00 (Agency).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Aug2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriasis; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant), IMPAIRED HEALING (non-serious) all with onset 2020, outcome "recovered" (2020) and all described as "C diff/took a year to heal"; FATIGUE (non-serious), outcome "recovered", described as "Felt tired". The action taken for adalimumab and risankizumab was unknown.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of C DIFF/TOOK A YEAR TO HEAL onset in 2020, C DIFF/TOOK A YEAR TO HEAL onset in 2020 and FELT TIRED with HUMIRA(ADALIMUMAB) was a reasonable possibility. Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of C DIFF/TOOK A YEAR TO HEAL onset in 2020, C DIFF/TOOK A YEAR TO HEAL onset in 2020 and FELT TIRED was not provided. Drug: PFIZER BIONTECH COVID-19 Causality as per reporter (Drug/Vaccine): Not Related  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective
Clinical narrative: It could be related to episode of covid; It could be related to episode of covid; Diabetes; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4268250-00 (Agency).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for psoriasis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "It could be related to episode of covid"; DIABETES MELLITUS (medically significant) with onset 2022, outcome "unknown", described as "Diabetes". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimubab) and BNT162B2: The reporter's causality for the event(s) of diabetes/it could be related to episode of COVID onset in 2022 and diabetes/it could be related to episode of COVID unknown onset was not provided. The reporter assessed the causality of all the events with Humira as not reported while assessed the causality of all the events with BNT162B2 as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective(LOE) cannot be ruled out. As there is limited information in the case provided, the causal association between the event Diabetes and the suspect drug BNT162B2 assessed possibly unrelated The case will be reassessed once new information is 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID; Contracted COVID; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269730-00 (Company).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Contracted COVID". The action taken for adalimumab was unknown.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of CONTRACTED COVID was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event CONTRACTED COVID-19 (COVID-19), Causality as per reporter (Drug/Vaccine): Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient has sore arm from being vaccinated on 2/11/22; The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed; The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed; This is a spontaneous report from a contactable reporter (Pharmacist).  A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: None reported; Known allergies: None reported. Concomitant medication was reported as none. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: 29May2021, when the patient was 14 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), administration date: 19Jun2021, when the patient was 14 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 11Feb2022, outcome "unknown" and all described as "The vaccine vial used to vaccinate was at room temperature for about 31 hours. It still falls in the 36 hour range allowed"; PAIN IN EXTREMITY (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Patient has sore arm from being vaccinated on 2/11/22". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Poor quality product administered, Product temperature excursion issue, Vaccination site pain
Clinical narrative: Patient reported arm soreness at injection site; Feeling weak and tired; Feeling weak and tired; The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported; The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported; This is a spontaneous report from a contactable reporter (pharmacist).   A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 at 16:45 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Neurological disorder NOS" (unspecified if ongoing), notes: Neurological disorder. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8734; Anatomical location: Left arm; Route of administration: Intramuscular), administration date: 01Jun2021, when the patient was 14 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Anatomical location: Left arm; Route of administration: Intramuscular), administration date: 22Jun2021, when the patient was 14 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 12Feb2022, outcome "unknown", described as "The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), with onset 12Feb2022, outcome "unknown", described as "The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported"; VACCINATION SITE PAIN (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Patient reported arm soreness at injection site"; ASTHENIA (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Feeling weak and tired". FATIGUE (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Feeling weak and tired". Therapeutic measures were taken as a result of vaccination site pain, asthenia and fatigue.  Additional information: Therapeutic measures included treatment with TYLENOL to help with the symptoms. It was reported that the vial was still within recommended 36 hour window. The patient had no known allergies. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Sudden onset of never ending tinnitus/ The occasional tinnitus I experienced before this booster was ringing in the ears. This still occasionally occurs. The other is constant and never ending.; Some times it's worse than others, but it has definitely affected my ability to hear clearly; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 11:45 (Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: yes and "Tinnitus" (unspecified if ongoing), notes: Occasional tinnitus she experienced before this booster was ringing in the ears. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Sudden onset of never ending tinnitus/ The occasional tinnitus I experienced before this booster was ringing in the ears. This still occasionally occurs. The other is constant and never ending"; HYPOACUSIS (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Some times it's worse than others, but it has definitely affected my ability to hear clearly". Therapeutic measures were not taken as a result of tinnitus and hypoacusis.  Additional information: The patient had unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was also reported, tinnitus sounded like a forest of insects (at twilight) in her head non-stop. Sometimes it was worse than others. Tinnitus still occasionally occurred. The other was constant and never ending. It was reported that the patient had not yet sought for professional help, she will see in the near future and she was also waiting if this was temporary. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got Covid/Acute COVID-19; Got Covid/Acute COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: D0809, Expiration Date: 28Jan2022) as dose 3 (booster), 0.3 ml single, administration date 01May2021 (Lot number: EW0164, Expiration Date: Aug2021) as dose 2, 0.3 ml single and administration date 10Apr2021 (Lot number: EW0153, Expiration Date: Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Got Covid/Acute COVID-19".
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab Test, Result Positive; Nasal Swab Test, Result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:45 (Lot number: 33026BD) at the age of 37 years as dose 2, single and administered in arm left, administration date 21Aug2021 16:00 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR HFA; ALBUTEROL SULFATE; OXYCODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Nasal Swab Test, Result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab (done at urgent care); (07Jan2022) positive, notes: Nasal Swab (done at pharmacy).  Clinical course: No other vaccine taken in four weeks. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Nasal Swab Test, Result Positive; Nasal Swab Test, Result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:45 (Lot number: 33026BD) at the age of 37 years as dose 2, single and administered in arm left, administration date 21Aug2021 16:00 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR HFA; ALBUTEROL SULFATE; OXYCODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Nasal Swab Test, Result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab (done at urgent care); (07Jan2022) positive, notes: Nasal Swab (done at pharmacy).  Clinical course: No other vaccine taken in four weeks. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Nasal Swab Test, Result Positive; Nasal Swab Test, Result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:45 (Lot number: 33026BD) at the age of 37 years as dose 2, single and administered in arm left, administration date 21Aug2021 16:00 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR HFA; ALBUTEROL SULFATE; OXYCODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Nasal Swab Test, Result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab (done at urgent care); (07Jan2022) positive, notes: Nasal Swab (done at pharmacy).  Clinical course: No other vaccine taken in four weeks. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Idiopathic Thrombocytopenia; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Idiopathic Thrombocytopenia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a causal association between the reported event idiopathic thrombocytopenia and 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 RAs, Ethics Committees, and investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Breakthrough menstrual bleeding; Heavy menstruation; Irregular menstrual cycles; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 32 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "Breakthrough menstrual bleeding"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "Heavy menstruation"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "Irregular menstrual cycles". The events "Breakthrough menstrual bleeding", "Heavy menstruation" and "Irregular menstrual cycles" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of intermenstrual bleeding, heavy menstrual bleeding and menstruation irregular.  Additional Information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included unspecified treatment for the events intermenstrual bleeding, heavy menstrual bleeding and menstruation irregular. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4265408-00 (Abbvie).  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155128) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for upadacitinib was unknown.  Clinical Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was provided as possible at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Computerised tomogram, Fatigue, Headache
Clinical narrative: headache; fatigue; chills; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 12:00 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 62 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Seasonal allergies" (ongoing), notes: Onset date: Ongoing (+35 yrs); "Pneumonia", start date: Feb2020, stop date: Mar2020; "Bronchitis", start date: Oct2019, stop date: Nov2019. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot Number: EN6202, Expires 30Jun2021, Anatomical Site of Injection: Left Arm, Time:12:00 PM), administration date: 24Feb2021, when the patient was 62 years old, for covid-19 immunization, reaction: "Headache"; Allergy serum (Anatomical Site of injection: Both Arms (2- L arm, 1- other) 3 shots total), administration date: 10Feb2021; Allergy serum (Anatomical Site of injection: Both Arms (2- L arm, 1- other) 3 shots total), administration date: 03Mar2021. The following information was reported: HEADACHE (non-serious) with onset 17Mar2021 21:00, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 17Mar2021 21:00, outcome "recovered" (2021), described as "fatigue"; CHILLS (non-serious) with onset 17Mar2021 21:00, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, fatigue and chills.  Additional information: Treatment received were Tylenol and rest.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: On Wed, Feb 9th, three day after the 3rd dose, the patient felt a lump under the left arm (the same arm of vaccination).; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2022 (Lot number: FK9729) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0169), administration date: 15Apr2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0183), administration date: 09May2021, when the patient was 62 years old, for COVID-19 immunisation.  The following information was reported: AXILLARY MASS (non-serious) with onset 09Feb2022, outcome "not recovered", described as "On Wed, Feb 9th, three day after the 3rd dose, the patient felt a lump under the left arm (the same arm of vaccination)". Therapeutic measures were not taken as a result of axillary mass.  Additional information: It was reported that the lump under the left arm of the patient was about the size of an egg, the next day. The patient still had the lump when this was discussed on 12Feb2022 (as reported). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Muscle disorder, Myalgia, Pain
Clinical narrative: terrible headache; body aches; muscle aches; she couldn't get up; muscles gave up; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious), outcome "recovered", described as "she couldn't get up"; MUSCLE DISORDER (non-serious), outcome "recovered", described as "muscles gave up"; HEADACHE (non-serious), outcome "recovered", described as "terrible headache"; PAIN (non-serious), outcome "not recovered", described as "body aches"; MYALGIA (non-serious), outcome "not recovered", described as "muscle aches". Additional information: Reporter is the patient's sister. Patient couldn't get up after she got the vaccine. Her muscles gave up. That happened for a day. She had a terrible headache that lasted 3 or 4 days. Her body aches are still there. It's been over a month since she got the vaccine. Until now, she still has muscle aches, body aches.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411277 Same reporter/drug, different patient, similar events
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Productive cough, Syncope
Clinical narrative: episode of fainting; dizziness; pounding headache; muscle aching; excess phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 13Feb2022, outcome "unknown", described as "episode of fainting"; MYALGIA (non-serious) with onset 12Feb2022, outcome "unknown", described as "muscle aching"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset 12Feb2022, outcome "unknown", described as "pounding headache"; PRODUCTIVE COUGH (non-serious) with onset Feb2022, outcome "unknown", described as "excess phlegm". Clinical course: Reporter received her first dose of Pfizer covid vaccine on 10Feb and her symptoms associated with the vaccine began on Saturday. Reports muscle aching (began on Saturday) ; episode of fainting (Sunday)  and dizziness (Sunday) ; pounding headache (Saturday), excess phlegm (unsure when) .asking how long should she expect the side effects to last and wanting recommendations on what OTC medication is best.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: we're really tired; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "we're really tired".  Additional information: Call shared how both her and husband got vaccine and her husband was tired the next day too. They were both laying around like really tired.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I started to experience chest pain two weeks after receiving booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Dec2021 (Lot number: 33036BD) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). The patient did not take concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7533, Route of administration: Unspecified, Anatomical site: Left arm), administration date: 17Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0162, Route of administration: Unspecified, Anatomical site: Right arm), administration date: 08May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: CHEST PAIN (non-serious) with onset an unknown date in Jan2022, outcome "recovering", described as "I started to experience chest pain two weeks after receiving booster shot". Therapeutic measures were not taken as a result of chest pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Depression, Vaginal haemorrhage
Clinical narrative: has not stopped bleeding or passing clots; anemic; weak; depressed; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A registered nurse patient received bnt162b2 (COMIRNATY), administration date 09Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient reported that since the vaccination has not stopped bleeding or passing clots. She had 2 surgeries and has been prescribed different medications to stop the bleeding. However, nothing has worked and she was still bleeding. As a result of this, the patient was anemic, weak and depressed. The reason is bringing this to the attention is because no one knows what's in the vaccine that triggered the body to start bleed. The outcome of the events was not recovered.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 12:30 (Lot number: EL9267) as dose 2, single and intramuscular, administered in arm left, administration date 23Jan2021 02:30 (Lot number: EL8982) as dose 1 (single) for covid-19 immunisation. Relevant medical history included: "Sciatica", start date: 14Jan2021 (ongoing), notes: Hip replacement for AVN 13Apr2021; "Hip Pain", start date: 14Jan2021 (ongoing), notes: hip replacement for AVN 13Apr2021; "Hip Replacement", start date: 13Apr2021 (unspecified if ongoing), notes: hip replacement for AVN 13Apr2021; "AVN" (unspecified if ongoing), notes: hip replacement for AVN 13Apr2021. Concomitant medication(s) included: DIAZEPAM taken for pain in extremity; ALLEGRA (ongoing); FLONASE ALLERGY RELIEF (ongoing); PRAVASTATIN (ongoing). Prior vaccinations were none. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Mar2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 27Mar2021, outcome "unknown", described as "COVID-19". The patient had to undergo hip replacement for AVN on 13Apr2021. Pre surgical Covid test on 27Mar2021 was positive. No symptoms and barely left house for 3 weeks prior. The patient was retested for Covid on 30Mar2021and the test was negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157379 same patient/different drug/event/dose
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Eczema, Thyroid disorder
Clinical narrative: developed thyroid whereby his Tsh levels shot up; developed thyroid whereby his Tsh levels shot up; eczema deteriorated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Pfizer sponsored program. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots), for COVID-19 immunization, reaction(s): "Tsh levels shot up", "eczema deteriorated", "thyroid". The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), THYROID DISORDER (non-serious), outcome "unknown" and all described as "developed thyroid whereby his Tsh levels shot up"; ECZEMA (non-serious), outcome "unknown", described as "eczema deteriorated". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: My son, 14 years old, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots. Have you received similar feedback from other parents whose children's have taken these shots.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Fatigue, Feeling abnormal, Headache
Clinical narrative: it hurt her arm; it was swollen for a while; Very dry mouth; nauseated; can't taste the food; really bad headache; really exhausted; diarrhea; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; brain fog (needs to double check everything she does); not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "it hurt her arm"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "it was swollen for a while"; DRY MOUTH (non-serious) with onset 2022, outcome "unknown", described as "Very dry mouth"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseated"; TASTE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "can't taste the food"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "really bad headache"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "really exhausted"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 2022, outcome "unknown" and all described as "everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "brain fog (needs to double check everything she does)"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "not feeling well".  Additional Information: Patient reported that she had her Pfizer Covid19 Booster shot at pharmacy 2 weeks ago, and it hurt her arm, it was swollen for a while, and right after the shot she had symptoms. She stated that up until now she was still not feeling well. She never had these problems with the first 2 shots of the Pfizer-BioNTech Covid19 Vaccine. She wanted to know what's wrong with her and when this will go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: it hurt her arm; it was swollen for a while; Very dry mouth; nauseated; can't taste the food; really bad headache; really exhausted; diarrhea; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; brain fog (needs to double check everything she does); not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "it hurt her arm"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "it was swollen for a while"; DRY MOUTH (non-serious) with onset 2022, outcome "unknown", described as "Very dry mouth"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseated"; TASTE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "can't taste the food"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "really bad headache"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "really exhausted"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 2022, outcome "unknown" and all described as "everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "brain fog (needs to double check everything she does)"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "not feeling well".  Additional Information: Patient reported that she had her Pfizer Covid19 Booster shot at pharmacy 2 weeks ago, and it hurt her arm, it was swollen for a while, and right after the shot she had symptoms. She stated that up until now she was still not feeling well. She never had these problems with the first 2 shots of the Pfizer-BioNTech Covid19 Vaccine. She wanted to know what's wrong with her and when this will go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.