chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Headache, Mydriasis, Nausea, Vision blurred
Clinical narrative: Experienced cranial nerve 3 palsy of the right eye; headache; double vision; nausea; Double vision, right eye fixed and turned outward; dilated pupil; droop of eyelid; inability to move eye past a certain position, difficulty focusing on close-up objects; inability to move eye past a certain position, difficulty focusing on close-up objects; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 06Aug2021 (Lot number: FC3180) at the age of 49 years 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: CRANIAL NERVE PALSIES MULTIPLE (medically significant) with onset 2021, outcome "unknown", described as "Experienced cranial nerve 3 palsy of the right eye"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown", described as "double vision"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Double vision, right eye fixed and turned outward"; MYDRIASIS (non-serious) with onset 2021, outcome "unknown", described as "dilated pupil"; EYELID PTOSIS (non-serious) with onset 2021, outcome "unknown", described as "drop of eyelid"; EYE MOVEMENT DISORDER (non-serious), VISION BLURRED (non-serious) all with onset 2021, outcome "unknown" and all described as "inability to move eye past a certain position, difficulty focusing on close-up objects"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". It was reported that Description of Event:  Age 49. Experienced cranial nerve 3 palsy of the right eye. Symptoms included: initial onset came on with a headache, double vision and nausea. Double vision, right eye fixed and turned outward, dilated pupil, drop of eyelid, inability to move eye past a certain position, difficulty focusing on close-up objects, dizziness, nausea. She told me about this yesterday and said her eye doctor told her it was caused by the vaccine, so I am reporting it. Name of Product: COVID Vaccine Lot #FC3180 Pharmacy/Store 06Aug2021 Awareness Date: 06Dec2021 Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Loss of consciousness, Thrombosis
Clinical narrative: booster; large blood clots in her pulmonary artery. Clots were also found by her knee.; passed out twice one morning; difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unspecified dose.), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "large blood clots in her pulmonary artery. Clots were also found by her knee."; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "passed out twice one morning"; IMMUNISATION (hospitalization, medically significant) with onset 08Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "difficulty breathing". Therapeutic measures were taken as a result of thrombosis, loss of consciousness, dyspnea.  Clinical course: After receiving her booster shot on 08Nov, she started to experience difficulty breathing. Around 4 weeks later, she passed out twice one morning. She went to the hospital where they performed emergency surgery to remove large blood clots in her pulmonary artery. Clots were also found by her knee. Now needs lovenox injections and still being monitored.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Immense chronic fatigue; Brain fog; Shortness of breath; Felt that I would faint; Chronic migraines that lasted for six months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: ER8730) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Carrots, Celery and Peas" (unspecified if ongoing), notes: Verbatim: known allergies: Carrots, Celery and Peas; "Known allergies: Peaches and Cantaloupe" (unspecified if ongoing), notes: Verbatim: Known allergies: Peaches and Cantaloupe. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: Apr2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (disability) with onset 27Apr2021, outcome "recovering", described as "Chronic migraines that lasted for six months"; FATIGUE (disability) with onset May2021, outcome "recovering", described as "Immense chronic fatigue"; FEELING ABNORMAL (disability) with onset May2021, outcome "recovering", described as "Brain fog"; DYSPNOEA (disability) with onset May2021, outcome "recovering", described as "Shortness of breath"; DIZZINESS (disability) with onset May2021, outcome "recovering", described as "Felt that I would faint". The events "chronic migraines that lasted for six months", "immense chronic fatigue", "brain fog", "shortness of breath" and "felt that i would faint" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results, notes: Blood workup; magnetic resonance imaging: (2021) unknown results, notes: MRI scans. Therapeutic measures were not taken as a result of migraine, fatigue, feeling abnormal, dyspnoea, dizziness. Clinical course: Within a week of the second dose, I started having. A month after the second dose, I began experiencing. I was essentially disabled and could not live my life as I did before. I went to several doctor and they could not diagnose anything. I have never tested positive for COVID. These effects only began to go away six months after the second dose. Patient did not take any other vaccine in four weeks. Patient did not have Covid -19 prior to vaccination and did not taken Covid-19 test after vaccination.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine
Clinical narrative: Immense chronic fatigue; Brain fog; Shortness of breath; Felt that I would faint; Chronic migraines that lasted for six months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: ER8730) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Carrots, Celery and Peas" (unspecified if ongoing), notes: Verbatim: known allergies: Carrots, Celery and Peas; "Known allergies: Peaches and Cantaloupe" (unspecified if ongoing), notes: Verbatim: Known allergies: Peaches and Cantaloupe. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: Apr2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (disability) with onset 27Apr2021, outcome "recovering", described as "Chronic migraines that lasted for six months"; FATIGUE (disability) with onset May2021, outcome "recovering", described as "Immense chronic fatigue"; FEELING ABNORMAL (disability) with onset May2021, outcome "recovering", described as "Brain fog"; DYSPNOEA (disability) with onset May2021, outcome "recovering", described as "Shortness of breath"; DIZZINESS (disability) with onset May2021, outcome "recovering", described as "Felt that I would faint". The events "chronic migraines that lasted for six months", "immense chronic fatigue", "brain fog", "shortness of breath" and "felt that i would faint" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results, notes: Blood workup; magnetic resonance imaging: (2021) unknown results, notes: MRI scans. Therapeutic measures were not taken as a result of migraine, fatigue, feeling abnormal, dyspnoea, dizziness. Clinical course: Within a week of the second dose, I started having. A month after the second dose, I began experiencing. I was essentially disabled and could not live my life as I did before. I went to several doctor and they could not diagnose anything. I have never tested positive for COVID. These effects only began to go away six months after the second dose. Patient did not take any other vaccine in four weeks. Patient did not have Covid -19 prior to vaccination and did not taken Covid-19 test after vaccination.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had the virus this past July; I had the virus this past July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jul2021, outcome "unknown" and all described as "I had the virus this past July".  Additional information: Reporter queried for to get more information on your trial, and possibly participate in it. Reporter stated that she had the virus this past July and she passed it on to her husband as well. Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101743024 same reporter/AE/SD, different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Inflammatory marker increased, Inflammatory marker test, Pain in extremity, Vaccination site pain
Clinical narrative: Crohn's disease aggravated; sore arm after pfizer vaccines; Vaccination site pain; Inflammatory marker increased; 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): 21K-163-4184013-00 (AbbVie).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Jul2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single and intramuscular, administration date 23Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "not recovered", described as "Crohn's disease aggravated"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm after pfizer vaccines"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Inflammatory marker increased". The patient underwent the following laboratory tests and procedures: inflammatory marker test: elevated. The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced Inflammation Level Elevated And Crohn's Disease Flare Up. In 2021, the patient experienced Had Sore Arm After Pfizer Vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of had sore arm after Pfizer vaccines with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of inflammation level elevated was not provided. The reporter's causality for the event(s) of Crohn's Disease Flare Up with Humira (Adalimumab) was a reasonable possibility.  Causality for BNT162B2 Vaccination site pain was not reported, Inflammatory marker increased was not reported, Crohn's disease aggravated 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 information in the case  a possible causal association between the reported  events  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) diagnosed with covid, notes: diagnosed with Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Fatigue, Pain, Therapeutic response shortened
Clinical narrative: Spondylitis ankylosing aggravated; Wearing off effect; Tiredness; Ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4182773-00.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Jan2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single and intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk(cf (1 in 2 wk)) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "Wearing off effect"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Tiredness"; PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Ache". The action taken for adalimumab was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN)  Reporter's causality for events not reported for adalimumab and BNT162B2. The case would be managed based on company assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Ankylosing spondylitis, Therapeutic response shortened, Fatigue, and Pain and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Breakthrough positive covid case 7 weeks after booster; Breakthrough positive covid case 7 weeks after booster; booster; is_pregnant: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An adult female patient (pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0196) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "not recovered" and all described as "Breakthrough positive covid case 7 weeks after booster"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 2021, outcome "unknown", described as "is_pregnant: Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: if covid tested post vaccination: Yes. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Immunisation, Limb discomfort, Rash, Rash erythematous
Clinical narrative: Stomach and legs worse; Broke out with a red rash over most of my body.; Stomach and legs worse; Broke out with a red rash over most of my body.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 15:45 (Batch/Lot number: unknown) at the age of 68 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Not known , Location of injection: Arm Left), for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), for Covid-19 Immunisation. The following information was reported: LIMB DISCOMFORT (medically significant), ABDOMINAL DISCOMFORT (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "Stomach and legs worse"; RASH ERYTHEMATOUS (medically significant), RASH (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "Broke out with a red rash over most of my body."; IMMUNISATION (medically significant) with onset 03Dec2021 15:45, outcome "unknown", described as "booster". The events "stomach and legs worse", "broke out with a red rash over most of my body.", "stomach and legs worse" and "broke out with a red rash over most of my body." were evaluated at the physician office visit. Therapeutic measures were taken as a result of limb discomfort, rash erythematous, abdominal discomfort, rash.  Clinical Course: Lot and batch was unknown as patient was unable to locate or read the details. Prior vaccinations within 4 weeks was unknown. Steroid and Benadryl was received for adverse event treatment. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. other medical history: Non major, Events started about 2 days after the booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Immunodeficiency, Off label use
Clinical narrative: she got the booster in Aug2021; she got the booster in Aug2021; 4 months since her booster and she is immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: IMMUNODEFICIENCY (medically significant) with onset 2021, outcome "unknown", described as "4 months since her booster and she is immunocompromised"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Aug2021, outcome "unknown" and all described as "she got the booster in Aug2021".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Immunisation, Productive cough, Pyrexia
Clinical narrative: he has received the booster dose yesterday; He got fever; Experienced some chills; Had some Phlegm in throat and nose; I was in bed for three hours; 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 70 year-old male patient received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: FD0809) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: he had covid 2 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 2021, when the patient was 70 years old, for COVID-19 Immunization; Bnt162b2 (2nd Dose), administration date: 2021, when the patient was 70 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "he has received the booster dose yesterday"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "He got fever"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "Experienced some chills"; PRODUCTIVE COUGH (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Had some Phlegm in throat and nose"; BEDRIDDEN (non-serious) with onset Dec2021, outcome "unknown", described as "I was in bed for three hours". Therapeutic measures were taken as a result of pyrexia, chills, productive cough. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Muscular weakness, Paraesthesia
Clinical narrative: 3 months ago after receiving his covid booster he started experiencing tingling; numbness in left hand, then left arm, left leg and left eye; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ), since 20Jan2020 (Batch/Lot number: unknown) at 5 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "3 months ago after receiving his covid booster he started experiencing tingling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in left hand, then left arm, left leg and left eye"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was unknown.  Additional information included: Patient reports that 3 months ago after receiving his covid booster he started experiencing tingling/numbness in left hand, then left arm, left leg and left eye, and muscle weakness; happens almost every day no med changes and no UC flareups. Md did an MRI that was clear, he is following up with his physician next week.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Pain, Rheumatoid arthritis, Swelling
Clinical narrative: Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high.; Caller added that she cannot walk and she is always in pain.; Caller said she already have arthritis but she noticed that it got worse after her second shot.; Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high.; Caller added that she cannot walk and she is always in pain.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), SWELLING (non-serious), outcome "unknown" and all described as "Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high."; GAIT DISTURBANCE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Caller added that she cannot walk and she is always in pain."; ARTHRITIS (non-serious), outcome "unknown", described as "Caller said she already have arthritis but she noticed that it got worse after her second shot.". Clinical course: she already had arthritis but she noticed that it got worse after her second shot. Caller stated she had now rheumatoid arthritis and her swelling was high as well as the numbers were very high. Caller added that she cannot walk and she was always in pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction to vaccine". It was unknown if therapeutic measures were taken as a result of anaphylactic reaction. Clinical course included patient reported an AE from the Pfizer vaccine, but the patient didn't specify which vaccine. Reporter clarified that the patient took another medication that this pharmacy dispensed, and the patient reported the AE during a call regarding that other medication.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus; Tested positive for Covid virus; 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 61-year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and administered in arm, administration date 06Apr2021 (Lot number: EW0176) at the age of 60 years as dose 1, single for covid-19 immunisation. Vaccination Facility Type of first vaccine was pharmacy and of second vaccine was vaccination clinic in a stadium. The patient had no relevant medical history. There were no concomitant medications. No other vaccines were administered on Same Dates or within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "recovering" and all described as "Tested positive for Covid virus". The event "tested positive for covid virus" was evaluated at the physician office visit (Telemedicine appointment). The event didn't require a visit to Emergency Room.. Caller states she is calling about the Pfizer adult Covid vaccine. She received both vaccines in Apr2021, and she contracted the Covid virus last week. She was still in quarantine. Caller states that Pfizer advertised that a person was 80 percent protected from getting Covid after both vaccines. Her doctor told her to take vitamins. Caller does not provide names or product information. Caller asks if a person should get the booster shot if they have natural infection? Caller asks if there have been breakthrough infections with the Pfizer Covid vaccine, as compared to the other Covid vaccines? The patient underwent the following laboratory tests and procedures: sars-cov-2 test (rapid test): (03Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Thrombosis
Clinical narrative: Painful menstruation with large blood clots; Painful menstruation with large blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cystic fibrosis" (unspecified if ongoing). No Covid prior vaccination. Concomitant medication(s) included: ZENPEP. No other vaccine in four weeks. The following information was reported: THROMBOSIS (medically significant), DYSMENORRHOEA (non-serious) all with onset 04Dec2021 12:00, outcome "recovering" and all described as "Painful menstruation with large blood clots". The event "painful menstruation with large blood clots" and "painful menstruation with large blood clots" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of thrombosis, dysmenorrhoea. Clinical course: No covid tested post vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 33 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0196, Expiration Date: Dec2021) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cirrhosis" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose:1, single), for COVID-19 Immunization, reaction(s): "break through Covid infection"; Bnt162b2 (Dose:2, single), for COVID-19 Immunization, reaction(s): "break through Covid infection". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "I have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: break through covid infection. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: COVID-19 infection, confirmed by PCR test.; COVID-19 infection, confirmed by PCR test.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL3247) at the age of 43 years as dose 2, single and administered in arm left, administration date 01Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "COVID-19 infection, confirmed by PCR test.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (07Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions that lasted two to three days; Dose received: 3/ Dose number=3,; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 24Nov2021 at 15:00 (Lot number: FJ1620) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical site: Left arm, Administration time: 15:00), administration date: 20Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0182, Anatomical site: Left arm, Administration time: 14:00), administration date: 12May2021, when the patient was 32 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 at 15:00, outcome "unknown", described as "Dose received: 3/ Dose number=3,"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 01Dec2021 at 13:00, outcome "recovered" (an unknown date in Dec2021), described as "Premature ventricular contractions that lasted two to three days". Therapeutic measures were not taken as a result of ventricular extrasystoles.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. 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 and emergency room/department or urgent care.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain in extremity, Swelling, Vaccination site swelling
Clinical narrative: Swelling at injection site; Swollen and pain in armpit in days following vaccine; Swollen and pain in armpit in days following vaccine; Pain down arm and stops atelbow; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or non HCP). The reporter is the patient.   A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 16:45 (Lot number: FD7218) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications was prescribed but not taken. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EP6955; Administration Time: 16:45; vaccine location: Left Arm), administration date: 18Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8729; Administration Time: 16:45; vaccine location: Left Arm), administration date: 08Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 16:45, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE SWELLING (non-serious) with onset 10Dec2021 at 00:00, outcome was "not recovered", described as "Swelling at injection site"; AXILLARY PAIN (non-serious), SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) both with onset 10Dec2021 at 00:00, outcome "not recovered", and both described as "Swollen and pain in armpit in days following vaccine". Therapeutic measures were not taken as a result of vaccination site swelling, axillary pain, swelling and pain in extremity.  Additional information:  The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. It was reported that injection itself was painless with no bleeding afterwards. 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 and emergency room/department or urgent care.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Immunisation
Clinical narrative: Fever; Chills; Sore muscles; Sore injection area; Sore arm pit lymph node; Headache; Nauseous; Tired; Cough; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 10Dec2021 at 11:00 (Lot number: FJ8757) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa medication. The patient had received unspecified concomitant medications. Past drug history included: Ampicillin, reaction: "Drug allergy", notes: Known allergies: ampicillin. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0158, Anatomical location: Right arm, Administration time: 10:00), administration date: 14May2021, when the patient was 56 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm, Administration time: 10:30), administration date: 09Apr2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 at 11:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore muscles"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore injection area"; LYMPH NODE PAIN (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore arm pit lymph node"; HEADACHE (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Nauseous"; FATIGUE (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Tired"; COUGH (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Cough". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, lymph node pain, headache, nausea, fatigue and cough. Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Sore muscles; Sore injection area; Sore arm pit lymph node; Headache; Nauseous; Tired; Cough; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 10Dec2021 at 11:00 (Lot number: FJ8757) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa medication. The patient had received unspecified concomitant medications. Past drug history included: Ampicillin, reaction: "Drug allergy", notes: Known allergies: ampicillin. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0158, Anatomical location: Right arm, Administration time: 10:00), administration date: 14May2021, when the patient was 56 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm, Administration time: 10:30), administration date: 09Apr2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 at 11:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore muscles"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore injection area"; LYMPH NODE PAIN (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Sore arm pit lymph node"; HEADACHE (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Nauseous"; FATIGUE (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Tired"; COUGH (non-serious) with onset 10Dec2021 at 17:00, outcome "not recovered", described as "Cough". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, lymph node pain, headache, nausea, fatigue and cough. Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.