chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a re frozen dose of the vaccine; Patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.; Sender's Comments: This case concerns a 75 year old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after the third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a re refrozen dose of the vaccine; Patient received a re refrozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.  No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender,  with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender,  with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received a refrozen dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received a refrozen dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.; Sender's Comments: This is a case of Expired Product Administered concerning an elderly patient of unknown gender with no relevant medical history, who experienced no other associated adverse events. The events occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial flutter
Clinical narrative: atrial flutter; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FLUTTER (atrial flutter) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (it has been controlled for the past two years with antiarrhythmic medications.).    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced ATRIAL FLUTTER (atrial flutter) (seriousness criterion medically significant). At the time of the report, ATRIAL FLUTTER (atrial flutter) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included antiarrymic medications.   No treatment medications were provided by the reporter.  Patient stated that the resistance could not resolved with pharmacologic therapy.  Company comment: This case concerns a 66-year-old patient with previous relevant medical history of atrial fibrillation, who experienced the unexpected serious AESI event of atrial flutter. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The medical history of atrial fibrillation remains as a confounding factor. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old patient with previous relevant medical history of atrial fibrillation, who experienced the unexpected serious AESI event of atrial flutter. The event occurred 2 days after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The medical history of atrial fibrillation remains as a confounding factor. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Loss of consciousness, Vaccination site pain
Clinical narrative: collapsed on the floor / laid on the floor; cold sweats but he was hot/cold and clammy; he was hot; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 038A21A and 013A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed on the floor / laid on the floor), COLD SWEAT (cold sweats but he was hot/cold and clammy), FEELING HOT (he was hot) and VACCINATION SITE PAIN (pain in the arm) outcome was unknown.       Treatment product was not provided by the reporter  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.  This is a Spontaneous case concerning a 66-year-old, male patient with medical history of taking lisinopril and metformin as concomitant medication,  who experienced the unexpected non serious events of loss of consciousness. The event occurred approximately 1 day after the third dose of the Moderna COVID 19 vaccine..  The rechallenge is not applicable. The drugs metformin and lisinopril are co suspects for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 66-year-old, male patient with medical history of taking lisinopril and metformin as concomitant medication,  who experienced the unexpected non serious events of loss of consciousness. The event occurred approximately 1 day after the third dose of the Moderna COVID 19 vaccine..  The rechallenge is not applicable. The drugs metformin and lisinopril are co suspects for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain
Clinical narrative: The patient received the third/booster dose of BNT162b2; Intermittent extreme fatigue after all COVID-19vaccines for at least one week; Achiness after all COVID-19 vaccines for at least one week; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 (at the age of 45-years-old), received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 45-years-old) and also received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the right arm on 25Oct2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on 26Sep2021 for immunisation. On an unknown date in 2021, the patient felt  intermittent extreme fatigue and achiness after all COVID-19 vaccines for at least one week. For dose two, those symptoms continued for 2 full weeks. On 26Oct2021, after third dose the patient continued to have these symptoms now (at the time of this report). Therapeutic measures were not taken as a result of the events felt intermittent extreme fatigue and achiness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt intermittent extreme fatigue and achiness was not resolved at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Back pain, Breast pain, Feeling cold
Clinical narrative: Pain in my lower right back; Bloated stomach; Having gas; Warmth in upper body; Feeling cold; Pain in right hip; I also experienced a funny tingling feeling under my left arm pit; Sore left arm; Nauseated; Pain on the right side of breast; Pain in my pelvis area; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis, pre-diabetic and known allergies to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. On 05May2021 at 10:50, 20 minutes after getting the Pfizer vaccine injection, the patient began to have pain in her pelvis area that felt like menstrual cramps or labor pain. The pain came every 15 minutes and lasted all day and evening. The patient took naproxen sodium (ALEVE) at night to relieve the pain. The next day, she did not feel the pain in the pelvis area. On 05May2021 at 11:00, the patient continued to have pain in her lower right back and in right hip for a whole month. The patient also experienced a funny tingling feeling under her left arm pit and continued to do so; it was a strange feeling that comes and go away quickly. The patient experienced the tingling feeling every day. The other symptoms disappeared within four days; such as pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event pain in her pelvic area which included treatment with naproxen sodium (ALEVE) from an unknown date to unknown date. The clinical outcome of the events pain in her pelvis area was resolved with sequelae on an unknown date in 2021, pain in her lower right back, pain in right hip was resolved with sequelae on an unknown date in Jun2021, funny tingling feeling under her left arm pit was not resolved, whereas the clinical outcome of the events pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach were resolved on an unknown date in May2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flatulence, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Pain in my lower right back; Bloated stomach; Having gas; Warmth in upper body; Feeling cold; Pain in right hip; I also experienced a funny tingling feeling under my left arm pit; Sore left arm; Nauseated; Pain on the right side of breast; Pain in my pelvis area; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis, pre-diabetic and known allergies to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. On 05May2021 at 10:50, 20 minutes after getting the Pfizer vaccine injection, the patient began to have pain in her pelvis area that felt like menstrual cramps or labor pain. The pain came every 15 minutes and lasted all day and evening. The patient took naproxen sodium (ALEVE) at night to relieve the pain. The next day, she did not feel the pain in the pelvis area. On 05May2021 at 11:00, the patient continued to have pain in her lower right back and in right hip for a whole month. The patient also experienced a funny tingling feeling under her left arm pit and continued to do so; it was a strange feeling that comes and go away quickly. The patient experienced the tingling feeling every day. The other symptoms disappeared within four days; such as pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event pain in her pelvic area which included treatment with naproxen sodium (ALEVE) from an unknown date to unknown date. The clinical outcome of the events pain in her pelvis area was resolved with sequelae on an unknown date in 2021, pain in her lower right back, pain in right hip was resolved with sequelae on an unknown date in Jun2021, funny tingling feeling under her left arm pit was not resolved, whereas the clinical outcome of the events pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach were resolved on an unknown date in May2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain
Clinical narrative: Pain in my lower right back; Bloated stomach; Having gas; Warmth in upper body; Feeling cold; Pain in right hip; I also experienced a funny tingling feeling under my left arm pit; Sore left arm; Nauseated; Pain on the right side of breast; Pain in my pelvis area; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis, pre-diabetic and known allergies to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. On 05May2021 at 10:50, 20 minutes after getting the Pfizer vaccine injection, the patient began to have pain in her pelvis area that felt like menstrual cramps or labor pain. The pain came every 15 minutes and lasted all day and evening. The patient took naproxen sodium (ALEVE) at night to relieve the pain. The next day, she did not feel the pain in the pelvis area. On 05May2021 at 11:00, the patient continued to have pain in her lower right back and in right hip for a whole month. The patient also experienced a funny tingling feeling under her left arm pit and continued to do so; it was a strange feeling that comes and go away quickly. The patient experienced the tingling feeling every day. The other symptoms disappeared within four days; such as pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event pain in her pelvic area which included treatment with naproxen sodium (ALEVE) from an unknown date to unknown date. The clinical outcome of the events pain in her pelvis area was resolved with sequelae on an unknown date in 2021, pain in her lower right back, pain in right hip was resolved with sequelae on an unknown date in Jun2021, funny tingling feeling under her left arm pit was not resolved, whereas the clinical outcome of the events pain on the right side of breast, sore left arm, warmth in upper body, feeling cold, nauseated, had gas and bloated stomach were resolved on an unknown date in May2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Have not had a period since receiving the last shot; DOSE 1 on 12Jan2021 and DOSE 2 on 06Aug2021; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via intramuscular route of administration on 06Aug2021 at 14:30 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1284), via intramuscular route of administration on 12Jan2021 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. On 19Aug2021, the patient had not had a period since receiving the last shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event not had a period since receiving the last shot was not resolved at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash macular, Urticaria
Clinical narrative: Hives turned into large itchy blotches of pink the next day; Splotchy hives on injection arm up to neck; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Nov2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and triamterene (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 44-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 07Nov2021 at 20:00, the patient experienced splotchy hives on injection arm up to neck after 55 hours of administration. Hives turned into large itchy blotches of pink the next day. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event splotchy hives on injection arm up to neck, hives turned into large itchy blotches of pink the next day was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Pharyngeal swelling
Clinical narrative: Shortness of breath/difficulty breathing; Throat swelling; Arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm (also reported as left deltoid) on 08Nov2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included bupropion (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sertraline hydrochloride (ZOLOFT) and experienced drug allergy. On 08Nov2021 at 17:30, the patient experienced shortness of breath, difficulty breathing, throat swelling and arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with cetirizine hydrochloride (ZYRTEC) and then diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath/difficulty breathing, throat swelling and arm soreness were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac discomfort, Chest pain, Hypoaesthesia, Myocardial infarction
Clinical narrative: like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; I was having Heart pressure and my heart and my jaw and my throat was numb.; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm (left upper arm) on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events like having a heart attack, and It was extreme like after the reflex like pain in my chest was unknown. The outcome of the events my throat was numb, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; I was having Heart pressure and my heart and my jaw and my throat was numb.; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm (left upper arm) on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events like having a heart attack, and It was extreme like after the reflex like pain in my chest was unknown. The outcome of the events my throat was numb, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer, Mammogram
Clinical narrative: breast cancer; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Mar2021 (Batch/Lot Number: EN6204) as dose 2, single (at the age of 68 years-old) for COVID-19 immunisation; varenicline tartrate (CHANTIX), via an unspecified route of administration from May2020 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, then via an unspecified route of administration from Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, then via an unspecified route of administration from an unspecified date (Batch/Lot Number: EM4807; Expiration Date: Jun2023) to an unspecified date, at 1 mg (1 mg for 4 weeks, 56 tablets) for smoking cessation therapy.  Medical history was unknown. There were no concomitant medications.  The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the left arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single (at the age of 68 years-old) for COVID-19 immunisation. The patient experienced breast cancer on an unknown date in 2021.  The clinical course is as follows: the patient went to get her annual mammogram, they asked if she had a COVID vaccine and she said yes, she has had both doses of the Pfizer COVID vaccine in her left arm. She had another mammogram and a biopsy and it was cancer, the patient had to have a lumpectomy. The patient stated she thought that what was odd is that she got her shots in her left arm and it is her left breast where the cancer shows. The patient stated the cancer was in the very beginning stages, and the patient will be undergoing radiation. The patient reported that no one in her family has had breast cancer and they don't know why she got it. Therapeutic measure were taken as a result of the event and included lumpectomy, surgery and radiation. The patient underwent lab tests and procedures on an unknown date in 2021 which included biopsy: it was cancer, mammogram: unknown results, and additional mammogram: it was cancer. The action taken in response to the event for varenicline tartrate was unknown. The clinical outcome of the event breast cancer was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site pain
Clinical narrative: soreness in arm where they shot him; chest pain; This is a spontaneous report from a contactable reporter (patient) via the Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm on 28Feb2021, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included congestive heart failure and chest pain.  The patient's concomitant medications were not reported.  On 28Feb2021, the patient experienced soreness in arm where they shot him and chest pain.  After encouraging caller to speak with his HCP about chest pain, patient stated chest pain is not new for him, he has congestive heart failure and has chest pain before the vaccine.  The patient is asking if it is safe to take Ibuprofen for treatment of symptoms. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes below the left armpit; pain in the left arm; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm, on 25Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient did not experience any side effects after receiving the first dose. On an unspecified date in 2021 after the second BNT162B2 dose, the patient experienced swollen lymph nodes below the left armpit and pain in the left arm. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm sorenes; headache; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously received ibuprofen (MOTRIN) for muscle pain after yard work.  The patient reported she was told that she can take a paracetamol (TYLENOL) but not to take ibuprofen after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She reported arm soreness and headache on an unspecified date in 2021, stated that she took two pills of paracetamol yesterday. She was asking when she can take a ibuprofen again. She stated that she always took ibuprofen for muscle pain after yard work. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: unusual abdomen pain; This is a spontaneous report from a non-contactable consumer (patient's daughter).  A female patient of an unspecified age (reported as 88, no units) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dementia Alzheimer's from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient had her vaccine on Friday (unspecified date) and she has started having some unusual abdomen pain. She does have Alzheimer's and her description of things are a little different because of this. She was walking around with a basin even though she says she does not feel nauseated. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: could hardly walk; dizzy; arm hurt; felt weak; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 27Feb2021 11:00 (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history included disability and pain in his knee both from unknown dates and ongoing. Concomitant medications were not reported. The patient previously took tramadol for 5 years because he has pain in his knee and experienced withdrawals. The patient went off tramadol because he read to not take pain killers while taking the vaccine. On an unspecified date, the patient's arm hurt and felt weak but these went away the next day. On 28Feb2021, the patient could hardly walk and was dizzy. On 01Mar2021, the patient had no symptoms, only pain in his knee due to his condition. The patient recovered from arm hurt and felt weak on an unspecified date; and from could hardly walk and dizzy on 01Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, 14 days after vaccination, the patient experienced vertigo specially in the morning. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Hyperhidrosis, Pain in jaw
Clinical narrative: metallic taste in his mouth; his jaw began to hurt; sweating profusely; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age (reported as 40, unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got his first Pfizer vaccine dose and "he immediately had metallic taste in his mouth, then his jaw began to hurt 30 min later and now he was sweating profusely." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: Flu like symptoms; My back started burning and it's been burning all day all night, I can't do anything; it was like fire; Sore throat; pain; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the Pfizer shot 2 days ago and started getting flu like symptoms maybe 10 hours later. Then about maybe 24 hours after that, the back started burning and it's been burning all day all night and can't do anything. Patient took couple of muscle relaxers (Treatment). It was just like fire (Intent: burning sensation). Patient also had a sore throat and headache. Patient doesn't know if this was common or not. Patient reported to be in so much pain. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Chills; did vomit a little bit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she got her vaccine on Monday and by Wednesday (Feb2021), she woke up and she had bad chills and that she did vomit a little bit. Patient said that she had no fever. She will get the next shot on the 15Mar2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The reporter stated her doctor said his second dose of the vaccine gave him body aches. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain and soreness in arm (upper left arm-same side as vaccination); This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 22Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced pain and soreness in arm (upper left arm-same side as vaccination) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EN6201) at the age of 70-years-old as dose 1, single for covid-19 immunisation.  The patient has no medical history and concomitant medication. On an unspecified date in Feb2021, the patient experienced swollen lymph nodes. The patient did not receive treatment for the event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: moderate sore arm; moderate nausea; exhaustion; This is a spontaneous report from a contactable consumer received via Regulatory Authority. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 14:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced moderate sore arm, moderate nausea, exhaustion on 03Mar2021. The patient received no treatment for the events. The patient was recovering for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.