chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Fibrin D dimer, Inflammatory marker increased, International normalised ratio normal
Clinical narrative: Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1392542) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Shellfish allergy, Allergic reaction to antibiotics (Clindamycin), Penicillin allergy, Drug allergy (Codeine) and Hypertension. Concomitant products included LISINOPRIL, CALCIUM, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), FISH OIL, IBUPROFEN and LORATADINE for an unknown indication.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient was treated with COLCHICINE at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, C-reactive protein: 64.5 (High) Increased. On 27-Apr-2021, Fibrin D dimer: 0.32 (Inconclusive) 0.32. On 27-Apr-2021, Inflammatory marker test: increased (High) Increased. On 27-Apr-2021, International normalised ratio: 1.09 normal (normal) normal. On 27-Apr-2021, Red blood cell sedimentation rate: 56 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate increased
Clinical narrative: Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1392542) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Shellfish allergy, Allergic reaction to antibiotics (Clindamycin), Penicillin allergy, Drug allergy (Codeine) and Hypertension. Concomitant products included LISINOPRIL, CALCIUM, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), FISH OIL, IBUPROFEN and LORATADINE for an unknown indication.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient was treated with COLCHICINE at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, C-reactive protein: 64.5 (High) Increased. On 27-Apr-2021, Fibrin D dimer: 0.32 (Inconclusive) 0.32. On 27-Apr-2021, Inflammatory marker test: increased (High) Increased. On 27-Apr-2021, International normalised ratio: 1.09 normal (normal) normal. On 27-Apr-2021, Red blood cell sedimentation rate: 56 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Fibrin D dimer, Inflammatory marker test, International normalised ratio
Clinical narrative: Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1392542) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Shellfish allergy, Allergic reaction to antibiotics (Clindamycin), Penicillin allergy, Drug allergy (Codeine) and Hypertension. Concomitant products included LISINOPRIL, CALCIUM, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), FISH OIL, IBUPROFEN and LORATADINE for an unknown indication.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient was treated with COLCHICINE at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, C-reactive protein: 64.5 (High) Increased. On 27-Apr-2021, Fibrin D dimer: 0.32 (Inconclusive) 0.32. On 27-Apr-2021, Inflammatory marker test: increased (High) Increased. On 27-Apr-2021, International normalised ratio: 1.09 normal (normal) normal. On 27-Apr-2021, Red blood cell sedimentation rate: 56 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate
Clinical narrative: Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1392542) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Shellfish allergy, Allergic reaction to antibiotics (Clindamycin), Penicillin allergy, Drug allergy (Codeine) and Hypertension. Concomitant products included LISINOPRIL, CALCIUM, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), FISH OIL, IBUPROFEN and LORATADINE for an unknown indication.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient was treated with COLCHICINE at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, C-reactive protein: 64.5 (High) Increased. On 27-Apr-2021, Fibrin D dimer: 0.32 (Inconclusive) 0.32. On 27-Apr-2021, Inflammatory marker test: increased (High) Increased. On 27-Apr-2021, International normalised ratio: 1.09 normal (normal) normal. On 27-Apr-2021, Red blood cell sedimentation rate: 56 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: LUMP AT INJECTION SITE ON LEFT ARM; HOT FLASHES; FEVER; FATIGUE/FEELING DRAINED; HEADACHE; This spontaneous report received from a patient concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced fatigue/feeling drained. On 03-APR-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced lump at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and fatigue/feeling drained on 05-APR-2021, and fever, and headache on 04-APR-2021, and had not recovered from lump at injection site on left arm. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hot flush, Injection site mass, Pyrexia
Clinical narrative: LUMP AT INJECTION SITE ON LEFT ARM; HOT FLASHES; FEVER; FATIGUE/FEELING DRAINED; HEADACHE; This spontaneous report received from a patient concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced fatigue/feeling drained. On 03-APR-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced lump at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and fatigue/feeling drained on 05-APR-2021, and fever, and headache on 04-APR-2021, and had not recovered from lump at injection site on left arm. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration
Clinical narrative: two days post first vaccine onset of early, heavy bleeding.; Anatomical Location: Leg Left; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 13:00 (age at vaccination 37 year) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medications included ibupropion taken for an unspecified indication, start and stop date were not reported. It was reported that adverse event Despite having little to no period with IUD, two days post first vaccine onset of early, heavy bleeding (medically significant) on 01May2021 08:00. Stopped after 7 days. Two days after second vaccine, extreme bleeding for 3 full weeks so heavy that my body expelled my IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and she still taking them 6 weeks after vaccine. Patient received treatment as Progesterone; scheduled uterine ablation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event Anatomical Location was Leg Left was unknown. Outcome of the other event was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Product administered at inappropriate site
Clinical narrative: two days post first vaccine onset of early, heavy bleeding.; Anatomical Location: Leg Left; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 13:00 (age at vaccination 37 year) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medications included ibupropion taken for an unspecified indication, start and stop date were not reported. It was reported that adverse event Despite having little to no period with IUD, two days post first vaccine onset of early, heavy bleeding (medically significant) on 01May2021 08:00. Stopped after 7 days. Two days after second vaccine, extreme bleeding for 3 full weeks so heavy that my body expelled my IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and she still taking them 6 weeks after vaccine. Patient received treatment as Progesterone; scheduled uterine ablation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event Anatomical Location was Leg Left was unknown. Outcome of the other event was recovering.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Malaise
Clinical narrative: Day after injection (Shot was # 2 of pfizer covid series), patinent found to have generalized tonic clonic seizures which lasted 30 minutes, T- 103.5.  EMS called and brought child to Hospital.  ER fluids administered due to tachycardia/hypotension.  Extra dose of depakote 750 mg given in ED.  Chest xray and labs done.  Patient found to have elevated troponins, which when repeated were higher.  ER doctor discussed case with Hospital, and transfer was arranged for admission for overnight monitoring.  Echocardiogram done that evening.  Troponins followed overnight and into next morning.  Troponins peaked at midnight and then trended down. Patient discharged home the following day.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Chest X-ray, Condition aggravated, Echocardiogram, Electrocardiogram
Clinical narrative: Day after injection (Shot was # 2 of pfizer covid series), patinent found to have generalized tonic clonic seizures which lasted 30 minutes, T- 103.5.  EMS called and brought child to Hospital.  ER fluids administered due to tachycardia/hypotension.  Extra dose of depakote 750 mg given in ED.  Chest xray and labs done.  Patient found to have elevated troponins, which when repeated were higher.  ER doctor discussed case with Hospital, and transfer was arranged for admission for overnight monitoring.  Echocardiogram done that evening.  Troponins followed overnight and into next morning.  Troponins peaked at midnight and then trended down. Patient discharged home the following day.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure, Hypotension, Laboratory test, Tachycardia, Troponin increased
Clinical narrative: Day after injection (Shot was # 2 of pfizer covid series), patinent found to have generalized tonic clonic seizures which lasted 30 minutes, T- 103.5.  EMS called and brought child to Hospital.  ER fluids administered due to tachycardia/hypotension.  Extra dose of depakote 750 mg given in ED.  Chest xray and labs done.  Patient found to have elevated troponins, which when repeated were higher.  ER doctor discussed case with Hospital, and transfer was arranged for admission for overnight monitoring.  Echocardiogram done that evening.  Troponins followed overnight and into next morning.  Troponins peaked at midnight and then trended down. Patient discharged home the following day.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Echocardiogram, Hypotension, Myocarditis, Pyrexia
Clinical narrative: Day after injection (Shot was # 2 of pfizer covid series), patinent found to have generalized tonic clonic seizures which lasted 30 minutes, T- 103.5.  EMS called and brought child to Hospital.  ER fluids administered due to tachycardia/hypotension.  Extra dose of depakote 750 mg given in ED.  Chest xray and labs done.  Patient found to have elevated troponins, which when repeated were higher.  ER doctor discussed case with Hospital, and transfer was arranged for admission for overnight monitoring.  Echocardiogram done that evening.  Troponins followed overnight and into next morning.  Troponins peaked at midnight and then trended down. Patient discharged home the following day.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Tachycardia, Troponin, Troponin increased, Vomiting
Clinical narrative: Day after injection (Shot was # 2 of pfizer covid series), patinent found to have generalized tonic clonic seizures which lasted 30 minutes, T- 103.5.  EMS called and brought child to Hospital.  ER fluids administered due to tachycardia/hypotension.  Extra dose of depakote 750 mg given in ED.  Chest xray and labs done.  Patient found to have elevated troponins, which when repeated were higher.  ER doctor discussed case with Hospital, and transfer was arranged for admission for overnight monitoring.  Echocardiogram done that evening.  Troponins followed overnight and into next morning.  Troponins peaked at midnight and then trended down. Patient discharged home the following day.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dark circles under eyes, Dysphonia, Dyspnoea
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear congestion, Fatigue, Flushing, Laboratory test, Migraine
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Periorbital swelling, Pruritus, Sinus congestion
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Crying, Dysphonia, Dyspnoea, Ear congestion
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fluid retention, Headache, Migraine, Nasal congestion, Periorbital swelling
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Immunoglobulin therapy, Myocarditis, Troponin increased
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable physician. A 13-year-old male patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0185, Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on 18Jun2021 (at the age of 13-year-old), as single dose for COVID-19 immunisation. Medical history reported as none. The patient had no known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0185, Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on 27May2021 (at the age of 13-year-old), as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient was tested for COVID-19 with PCR with nasal swab: negative on 20Jun2021. On 20Jun2021, the patient experienced myocarditis. The patient was hospitalized for 3 days and hospitalization was prolonged as a result of the event. The patient underwent lab tests and procedures which included PCR with nasal swab: negative on 20Jun2021. Patient received treatment for event with IVIG and pulse of corticosteroids. The outcome of event was resolved on an unspecified date in Jun2021.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event Myocarditis and the suspect drug 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: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable physician. A 13-year-old male patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0185, Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on 18Jun2021 (at the age of 13-year-old), as single dose for COVID-19 immunisation. Medical history reported as none. The patient had no known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0185, Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on 27May2021 (at the age of 13-year-old), as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient was tested for COVID-19 with PCR with nasal swab: negative on 20Jun2021. On 20Jun2021, the patient experienced myocarditis. The patient was hospitalized for 3 days and hospitalization was prolonged as a result of the event. The patient underwent lab tests and procedures which included PCR with nasal swab: negative on 20Jun2021. Patient received treatment for event with IVIG and pulse of corticosteroids. The outcome of event was resolved on an unspecified date in Jun2021.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event Myocarditis and the suspect drug 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: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Intensive care
Clinical narrative: PATIENT'S SYMPTOMS STARTED 6/15/2021 AS GENERALIZED WEAKNESS AND BODY ACHES.  PATIENT HAD 2 SUBSEQUENT ER VISITS ON 6/20/2021 AND 6/22/2021. PATIENT ARRIVED TO HOSPITAL ON 6/24/2021 WITH COMPLAINTS OF CHEST TIGHTNESS, THROAT TIGHTNESS, LOWER EXTREMITY SWELLING, SOB, BACK PAIN, AND WHOLE BODY NUMBNESS.  PATIENT ADMITTED HOSPITAL 6/25/2021 AND SUBSEQUENTLY DIAGNOSED WITH GUILLAIN-BARRE SYNDROME BY NEUROLOGIST POST LUMBAR PUNCTURE AND EXAM.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: PATIENT'S SYMPTOMS STARTED 6/15/2021 AS GENERALIZED WEAKNESS AND BODY ACHES.  PATIENT HAD 2 SUBSEQUENT ER VISITS ON 6/20/2021 AND 6/22/2021. PATIENT ARRIVED TO HOSPITAL ON 6/24/2021 WITH COMPLAINTS OF CHEST TIGHTNESS, THROAT TIGHTNESS, LOWER EXTREMITY SWELLING, SOB, BACK PAIN, AND WHOLE BODY NUMBNESS.  PATIENT ADMITTED HOSPITAL 6/25/2021 AND SUBSEQUENTLY DIAGNOSED WITH GUILLAIN-BARRE SYNDROME BY NEUROLOGIST POST LUMBAR PUNCTURE AND EXAM.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lumbar puncture abnormal, Pain, Peripheral swelling, Throat tightness
Clinical narrative: PATIENT'S SYMPTOMS STARTED 6/15/2021 AS GENERALIZED WEAKNESS AND BODY ACHES.  PATIENT HAD 2 SUBSEQUENT ER VISITS ON 6/20/2021 AND 6/22/2021. PATIENT ARRIVED TO HOSPITAL ON 6/24/2021 WITH COMPLAINTS OF CHEST TIGHTNESS, THROAT TIGHTNESS, LOWER EXTREMITY SWELLING, SOB, BACK PAIN, AND WHOLE BODY NUMBNESS.  PATIENT ADMITTED HOSPITAL 6/25/2021 AND SUBSEQUENTLY DIAGNOSED WITH GUILLAIN-BARRE SYNDROME BY NEUROLOGIST POST LUMBAR PUNCTURE AND EXAM.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Contusion, Injection site haemorrhage, Laboratory test, Pain in extremity
Clinical narrative: The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg.  The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000.  He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000.  He was diagnosed with immune thrombocytopenic purpura.  No treatment was given, observation only.  Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19.  He was ANA negative.  His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased, Rash
Clinical narrative: The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg.  The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000.  He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000.  He was diagnosed with immune thrombocytopenic purpura.  No treatment was given, observation only.  Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19.  He was ANA negative.  His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Bleeding time prolonged, Contusion, Full blood count abnormal, Immune thrombocytopenia
Clinical narrative: The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg.  The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000.  He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000.  He was diagnosed with immune thrombocytopenic purpura.  No treatment was given, observation only.  Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19.  He was ANA negative.  His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive, Thrombocytopenia
Clinical narrative: The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg.  The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000.  He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000.  He was diagnosed with immune thrombocytopenic purpura.  No treatment was given, observation only.  Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19.  He was ANA negative.  His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.