chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bladder pain, Cystitis
Clinical narrative: developed a possible bladder infection; but has pain "down there", though no other symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. She was scheduled for her second injection this coming Saturday, but in the meantime has developed a possible bladder infection. She stated she was doing things around the house and possibly strained herself, but has pain "down there", though no other symptoms.  She wanted to know if she were put on a course of antibiotics if this would interfere with the efficacy of the second vaccination. Caller declined transfer to safety as she was not sure she has a bladder infection as of yet. The outcome of the events was unknown.  Information on Lot/Batch Number has been Requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: numb/numb feet/body is numb; swelling of your face and throat; swelling of your face and throat; Dizziness; weakness; neurological side effects; severe pins and needles; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in May2021 (Batch/Lot Number: EW0177; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date (prior to vaccination). The patient's concomitant medications were not reported. The patient reported that after 4 and a half months after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine, she still feels numb/body is numb. She wanted some answers when it will go away. The patient said she had swelling of face and throat, dizziness and weakness.  She noted that she experienced these symptoms for like the first 10 days. But now she had incredibly numb feet, it was bizarre, and have severe pins and needles. Patient's health care provider has sent her to an immunologist and neurologist. Patient knew that this is because of the vaccine. She was recommended to get the vaccine even after having a long hauler COVID-19.  She also noted that she never felt numb nor did have numb body before even during or after getting COVID-19. The patient had her first dose in May2021 and she is still having neurological side effects from that dose. Patient was wondering when the side effects will go away because it is now 5 months. It was an inconvenience to walk on numb feet. The reporter assessed the event numb as serious. Outcome of events numb and neurological side effects was not recovered; while rest of events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pulmonary pain
Clinical narrative: numb/numb feet/body is numb; swelling of your face and throat; swelling of your face and throat; Dizziness; weakness; neurological side effects; severe pins and needles; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in May2021 (Batch/Lot Number: EW0177; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date (prior to vaccination). The patient's concomitant medications were not reported. The patient reported that after 4 and a half months after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine, she still feels numb/body is numb. She wanted some answers when it will go away. The patient said she had swelling of face and throat, dizziness and weakness.  She noted that she experienced these symptoms for like the first 10 days. But now she had incredibly numb feet, it was bizarre, and have severe pins and needles. Patient's health care provider has sent her to an immunologist and neurologist. Patient knew that this is because of the vaccine. She was recommended to get the vaccine even after having a long hauler COVID-19.  She also noted that she never felt numb nor did have numb body before even during or after getting COVID-19. The patient had her first dose in May2021 and she is still having neurological side effects from that dose. Patient was wondering when the side effects will go away because it is now 5 months. It was an inconvenience to walk on numb feet. The reporter assessed the event numb as serious. Outcome of events numb and neurological side effects was not recovered; while rest of events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Neurological symptom, Paraesthesia
Clinical narrative: numb/numb feet/body is numb; swelling of your face and throat; swelling of your face and throat; Dizziness; weakness; neurological side effects; severe pins and needles; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in May2021 (Batch/Lot Number: EW0177; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date (prior to vaccination). The patient's concomitant medications were not reported. The patient reported that after 4 and a half months after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine, she still feels numb/body is numb. She wanted some answers when it will go away. The patient said she had swelling of face and throat, dizziness and weakness.  She noted that she experienced these symptoms for like the first 10 days. But now she had incredibly numb feet, it was bizarre, and have severe pins and needles. Patient's health care provider has sent her to an immunologist and neurologist. Patient knew that this is because of the vaccine. She was recommended to get the vaccine even after having a long hauler COVID-19.  She also noted that she never felt numb nor did have numb body before even during or after getting COVID-19. The patient had her first dose in May2021 and she is still having neurological side effects from that dose. Patient was wondering when the side effects will go away because it is now 5 months. It was an inconvenience to walk on numb feet. The reporter assessed the event numb as serious. Outcome of events numb and neurological side effects was not recovered; while rest of events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: numb/numb feet/body is numb; swelling of your face and throat; swelling of your face and throat; Dizziness; weakness; neurological side effects; severe pins and needles; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in May2021 (Batch/Lot Number: EW0177; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date (prior to vaccination). The patient's concomitant medications were not reported. The patient reported that after 4 and a half months after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine, she still feels numb/body is numb. She wanted some answers when it will go away. The patient said she had swelling of face and throat, dizziness and weakness.  She noted that she experienced these symptoms for like the first 10 days. But now she had incredibly numb feet, it was bizarre, and have severe pins and needles. Patient's health care provider has sent her to an immunologist and neurologist. Patient knew that this is because of the vaccine. She was recommended to get the vaccine even after having a long hauler COVID-19.  She also noted that she never felt numb nor did have numb body before even during or after getting COVID-19. The patient had her first dose in May2021 and she is still having neurological side effects from that dose. Patient was wondering when the side effects will go away because it is now 5 months. It was an inconvenience to walk on numb feet. The reporter assessed the event numb as serious. Outcome of events numb and neurological side effects was not recovered; while rest of events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Blood test, Dyspnoea, Dyspnoea exertional
Clinical narrative: Blood clots both lungs; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 54-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left in Aug2021 at the age of 54 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced blood clots both lungs on 07Sep2021 19:30. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for blood clots both lungs for 3 days. AE treatment was Blood thinners, pain medication. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Pulmonary thrombosis 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Pain, Pulmonary embolism, Ultrasound Doppler, Ventilation/perfusion scan
Clinical narrative: Blood clots both lungs; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 54-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left in Aug2021 at the age of 54 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced blood clots both lungs on 07Sep2021 19:30. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for blood clots both lungs for 3 days. AE treatment was Blood thinners, pain medication. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Pulmonary thrombosis 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clots both lungs; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 54-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left in Aug2021 at the age of 54 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced blood clots both lungs on 07Sep2021 19:30. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for blood clots both lungs for 3 days. AE treatment was Blood thinners, pain medication. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Pulmonary thrombosis 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: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chorioretinopathy
Clinical narrative: Central serous chorioretinopathy in my right eye; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FC3182), administered in left arm on 10Aug2021 (at the age of 35-year-old) as dose 2, single for COVID-19 immunisation. Vaccine facility type vaccine was reported as doctor's office/urgent care. The patient's medical history was not reported. The patient's concomitant medications received within two weeks were reported as none. The patient had no known allergies. The patient did not receive other vaccines within four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0179), administered in left arm on unspecified date (also reported as 10Aug2021 10:00 AM) as dose 1, single for COVID-19 immunisation. On 23Aug2021 06:00 PM patient experienced a central serous chorioretinopathy in his right eye. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to the event. The outcome of the event was resolving.  Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chorioretinopathy
Clinical narrative: Central serous chorioretinopathy in my right eye; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FC3182), administered in left arm on 10Aug2021 (at the age of 35-year-old) as dose 2, single for COVID-19 immunisation. Vaccine facility type vaccine was reported as doctor's office/urgent care. The patient's medical history was not reported. The patient's concomitant medications received within two weeks were reported as none. The patient had no known allergies. The patient did not receive other vaccines within four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0179), administered in left arm on unspecified date (also reported as 10Aug2021 10:00 AM) as dose 1, single for COVID-19 immunisation. On 23Aug2021 06:00 PM patient experienced a central serous chorioretinopathy in his right eye. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to the event. The outcome of the event was resolving.  Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Decreased appetite, Fatigue
Clinical narrative: I was a little tired (second one was a little bit worse); I had a slight fever (second one was a little bit worse); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, METFORMIN, Fibric acid and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)). At the time of the report, FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2021-301864 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Injection site swelling, Mobility decreased, Pyrexia, Vaccination site induration
Clinical narrative: I was a little tired (second one was a little bit worse); I had a slight fever (second one was a little bit worse); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, METFORMIN, Fibric acid and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)). At the time of the report, FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2021-301864 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: I was a little tired (second one was a little bit worse); I had a slight fever (second one was a little bit worse); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, METFORMIN, Fibric acid and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)). At the time of the report, FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2021-301864 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: I developed shingles for the first time in my life after receiving the first dose of the Pfizer coronavirus vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: FC3184) via an unspecified route of administration in arm left on 29Aug2021 17:00 as dose 1, single (age at vaccination: 44 years) for covid-19 immunisation. Medical history included known allergies: gallium, known allergies: latex, asthma and 15 yr survivor of cervical cancer, all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), both taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced allergies. The most recent COVID-19 vaccine was administered at pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Sep2021, it was reported that I developed shingles for the first time in my life after receiving the first dose of the Pfizer coronavirus vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received was valacyclovir HCL 1 Gram tablet and Hydroxyzine HCL. The clinical outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed shingles for the first time in my life after receiving the first dose of the Pfizer coronavirus vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: FC3184) via an unspecified route of administration in arm left on 29Aug2021 17:00 as dose 1, single (age at vaccination: 44 years) for covid-19 immunisation. Medical history included known allergies: gallium, known allergies: latex, asthma and 15 yr survivor of cervical cancer, all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), both taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced allergies. The most recent COVID-19 vaccine was administered at pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Sep2021, it was reported that I developed shingles for the first time in my life after receiving the first dose of the Pfizer coronavirus vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received was valacyclovir HCL 1 Gram tablet and Hydroxyzine HCL. The clinical outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuromuscular pain
Clinical narrative: Sharp pain in right hip; Right leg muscular pain; Irregular period; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 28May2021 at 10:00 (at the age of 32-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8036) via an unspecified route of administration in the right arm on 07May2021 at 10:00 (at the age of 32-years old) as a single dose for COVID-19 immunisation. On 04Sep2021, the patient experienced sharp pain in right hip, right leg muscular pain and irregular period. 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 not been tested for COVID-19. The clinical outcome of the events sharp pain in right hip, right leg muscular pain and irregular period was not recovered at the time of report.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Menstruation irregular, Myalgia
Clinical narrative: Sharp pain in right hip; Right leg muscular pain; Irregular period; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 28May2021 at 10:00 (at the age of 32-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8036) via an unspecified route of administration in the right arm on 07May2021 at 10:00 (at the age of 32-years old) as a single dose for COVID-19 immunisation. On 04Sep2021, the patient experienced sharp pain in right hip, right leg muscular pain and irregular period. 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 not been tested for COVID-19. The clinical outcome of the events sharp pain in right hip, right leg muscular pain and irregular period was not recovered at the time of report.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Fatigue
Clinical narrative: Feeling stomach cramps; Constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient 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 07Sep2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient 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 vaccination. The patient did not receive any concomitant medications. On 07Sep2021 at 18:00, the patient felt stomach cramps and constant diarrhea. It was reported that after 48 hours, the patient still felt stomach cramps and constant diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling stomach cramps and constant diarrhea were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Feeling stomach cramps; Constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient 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 07Sep2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient 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 vaccination. The patient did not receive any concomitant medications. On 07Sep2021 at 18:00, the patient felt stomach cramps and constant diarrhea. It was reported that after 48 hours, the patient still felt stomach cramps and constant diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling stomach cramps and constant diarrhea were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Nausea
Clinical narrative: 'I' started feeling tired; Weak; Having diarrhea; Fever of 100.9; Nausea; Just wanted to sleep but kept waking during night; Stomach cramps; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 29Aug2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 29Aug2021 at 19:00 (Sunday), after the shot, the patient started feeling tired, weak, had diarrhea, fever of 100.9 (unit unspecified), nausea and the patient just wanted to sleep but kept waking during night with stomach cramps and felt nauseated. The patient woke up in the morning on 31Aug2021 (Tuesday) feeling fine. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling tired, weak, had diarrhea, fever of 100.9, nausea, just wanted to sleep but kept waking during night and stomach cramps were recovered on 31Aug2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 'I' started feeling tired; Weak; Having diarrhea; Fever of 100.9; Nausea; Just wanted to sleep but kept waking during night; Stomach cramps; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 29Aug2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 29Aug2021 at 19:00 (Sunday), after the shot, the patient started feeling tired, weak, had diarrhea, fever of 100.9 (unit unspecified), nausea and the patient just wanted to sleep but kept waking during night with stomach cramps and felt nauseated. The patient woke up in the morning on 31Aug2021 (Tuesday) feeling fine. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling tired, weak, had diarrhea, fever of 100.9, nausea, just wanted to sleep but kept waking during night and stomach cramps were recovered on 31Aug2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Diarrhoea, Fatigue
Clinical narrative: 'I' started feeling tired; Weak; Having diarrhea; Fever of 100.9; Nausea; Just wanted to sleep but kept waking during night; Stomach cramps; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 29Aug2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 29Aug2021 at 19:00 (Sunday), after the shot, the patient started feeling tired, weak, had diarrhea, fever of 100.9 (unit unspecified), nausea and the patient just wanted to sleep but kept waking during night with stomach cramps and felt nauseated. The patient woke up in the morning on 31Aug2021 (Tuesday) feeling fine. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling tired, weak, had diarrhea, fever of 100.9, nausea, just wanted to sleep but kept waking during night and stomach cramps were recovered on 31Aug2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: 'I' started feeling tired; Weak; Having diarrhea; Fever of 100.9; Nausea; Just wanted to sleep but kept waking during night; Stomach cramps; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 29Aug2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 29Aug2021 at 19:00 (Sunday), after the shot, the patient started feeling tired, weak, had diarrhea, fever of 100.9 (unit unspecified), nausea and the patient just wanted to sleep but kept waking during night with stomach cramps and felt nauseated. The patient woke up in the morning on 31Aug2021 (Tuesday) feeling fine. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling tired, weak, had diarrhea, fever of 100.9, nausea, just wanted to sleep but kept waking during night and stomach cramps were recovered on 31Aug2021.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Heavy early period; Heavy early period; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 21Aug2021 at 19:30 (at the age of 34-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 taken within two weeks of vaccination included birth control pills (unspecified) from an unknown date for an unspecified indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 30Aug2021 at 08:00, the patient experienced heavy early period. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy early period was unknown at the time of report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy early period; Heavy early period; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 21Aug2021 at 19:30 (at the age of 34-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 taken within two weeks of vaccination included birth control pills (unspecified) from an unknown date for an unspecified indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 30Aug2021 at 08:00, the patient experienced heavy early period. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy early period was unknown at the time of report.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dysstasia, Gait disturbance, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# CW0164), at the vaccination age of 28, via an unspecified route of administration, on an unspecified date, Aug 2021, single dose, at workplace clinic, for COVID-19 immunisation. Medical history and concomitant medication not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination and post vaccination, patient was not diagnosed with COVID-19. The patient was not tested for COVID-19. On Sep 5, 2021, patient experienced hives on different areas of my body (legs, back, thighs) at various times (urticaria), loss of balance while standing and walking (balance disorder), difficulty standing in one place or walking in a straight line (dysstasia), difficulty standing in one place or walking in a straight line (gait disturbance). Patient treated with Cadista as a result of events with outcome of recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dizziness, Fatigue, Flushing
Clinical narrative: Felt lightheaded; Within 1/2 hour got very flushed; Headache; While at the dentist blood pressure was checked and it was 155/95 /checking at home on and off it stayed in the high range; This is a spontaneous report from a contactable consumer, the patient. A 42-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 on 03Sep2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, environmental allergies, allergic to chocolate, lettuce, wheat, soy, and corn. 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 medication included progesterone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 10:15, within half an hour (1/2) of vaccination, the patient got very flushed, had a headache, and felt lightheaded. This was still happening 10 days later. On an unknown date in Sep2021, while at the dentist the patient's blood pressure was checked and it was 155/95 (unspecified units). The patient's average blood pressure was 118/78 (unspecified units). When the patient checked at home the blood pressure was on and off it stayed in the high range. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events within 1/2 hour got very flushed, headache, felt lightheaded and while at the dentist blood pressure was checked and it was 155/95 /checking at home on and off it stayed in the high range was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Nausea
Clinical narrative: Felt lightheaded; Within 1/2 hour got very flushed; Headache; While at the dentist blood pressure was checked and it was 155/95 /checking at home on and off it stayed in the high range; This is a spontaneous report from a contactable consumer, the patient. A 42-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 on 03Sep2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, environmental allergies, allergic to chocolate, lettuce, wheat, soy, and corn. 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 medication included progesterone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021 at 10:15, within half an hour (1/2) of vaccination, the patient got very flushed, had a headache, and felt lightheaded. This was still happening 10 days later. On an unknown date in Sep2021, while at the dentist the patient's blood pressure was checked and it was 155/95 (unspecified units). The patient's average blood pressure was 118/78 (unspecified units). When the patient checked at home the blood pressure was on and off it stayed in the high range. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events within 1/2 hour got very flushed, headache, felt lightheaded and while at the dentist blood pressure was checked and it was 155/95 /checking at home on and off it stayed in the high range was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.