chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Musculoskeletal stiffness, Palpitations
Clinical narrative: the reaction started with a rush like I was going to faint.; feel a surge or flush of heat followed by my heart racing/each day I'd be woken by the surge/flush and all symptoms repeating; feel a surge or flush of heat followed by my heart racing/Palpitations; anxiety; inability to eat; my insides felt like they were being squeezed; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER 8733 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 11:30 AM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included colitis ulcerative. The patient previously took Tramadol, Pseudoephedrine, Dextromethorphan, and Keflex which had known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 12:45 PM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medication included mesalamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Apr2021 at 12:15 PM, (2 weeks to the day after her 2nd shot), the reaction started with a rush like I was going to faint. For 11 days following her body would feel a surge or flush of heat followed by her heart racing, palpitations, anxiety, inability to eat, her insides felt like they were being squeezed. This lasted for the most part, the entire day. When it subsided, she felt normal, but each day she would be woken by the surge/flush and all symptoms repeating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment clonazepam to control the palpitations. Outcome of the event the reaction started with a rush like I was going to faint was recovered on an unspecified date and for all other events, it was recovered on 30Apr2021 at 12:15.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Feeding disorder, Feeling abnormal, Hot flush, Palpitations
Clinical narrative: the reaction started with a rush like I was going to faint.; feel a surge or flush of heat followed by my heart racing/each day I'd be woken by the surge/flush and all symptoms repeating; feel a surge or flush of heat followed by my heart racing/Palpitations; anxiety; inability to eat; my insides felt like they were being squeezed; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER 8733 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 11:30 AM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included colitis ulcerative. The patient previously took Tramadol, Pseudoephedrine, Dextromethorphan, and Keflex which had known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 12:45 PM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medication included mesalamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Apr2021 at 12:15 PM, (2 weeks to the day after her 2nd shot), the reaction started with a rush like I was going to faint. For 11 days following her body would feel a surge or flush of heat followed by her heart racing, palpitations, anxiety, inability to eat, her insides felt like they were being squeezed. This lasted for the most part, the entire day. When it subsided, she felt normal, but each day she would be woken by the surge/flush and all symptoms repeating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment clonazepam to control the palpitations. Outcome of the event the reaction started with a rush like I was going to faint was recovered on an unspecified date and for all other events, it was recovered on 30Apr2021 at 12:15.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: the reaction started with a rush like I was going to faint.; feel a surge or flush of heat followed by my heart racing/each day I'd be woken by the surge/flush and all symptoms repeating; feel a surge or flush of heat followed by my heart racing/Palpitations; anxiety; inability to eat; my insides felt like they were being squeezed; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER 8733 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 11:30 AM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included colitis ulcerative. The patient previously took Tramadol, Pseudoephedrine, Dextromethorphan, and Keflex which had known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 12:45 PM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medication included mesalamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Apr2021 at 12:15 PM, (2 weeks to the day after her 2nd shot), the reaction started with a rush like I was going to faint. For 11 days following her body would feel a surge or flush of heat followed by her heart racing, palpitations, anxiety, inability to eat, her insides felt like they were being squeezed. This lasted for the most part, the entire day. When it subsided, she felt normal, but each day she would be woken by the surge/flush and all symptoms repeating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment clonazepam to control the palpitations. Outcome of the event the reaction started with a rush like I was going to faint was recovered on an unspecified date and for all other events, it was recovered on 30Apr2021 at 12:15.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Covid vaccine doesn't work when taking Mayzent; Covid vaccine doesn't work when taking Mayzent; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at 63-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included siponimod fumarate (MAYZENT). The patient stated covid vaccine didn't work when taking Mayzent. The outcome of events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid vaccine doesn't work when taking Mayzent; Covid vaccine doesn't work when taking Mayzent; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at 63-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included siponimod fumarate (MAYZENT). The patient stated covid vaccine didn't work when taking Mayzent. The outcome of events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Tinnitus
Clinical narrative: Repetitive pulsing sound in left ear; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bananas, watermelon, cantaloupe, honeydew (fruit allergy). 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 01Jul2021 at 20:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. 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. On 24Jul2021 at 07:00, the patient experienced repetitive pulsing sound in left ear. Therapeutic measures were not taken for the events. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event repetitive pulsing sound in left ear was not resolved at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Repetitive pulsing sound in left ear; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bananas, watermelon, cantaloupe, honeydew (fruit allergy). 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 01Jul2021 at 20:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. 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. On 24Jul2021 at 07:00, the patient experienced repetitive pulsing sound in left ear. Therapeutic measures were not taken for the events. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event repetitive pulsing sound in left ear was not resolved at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Furuncle, Injection site rash, Rash
Clinical narrative: Horrible headache pain; chest feels heavy; very tired; Rash under left arm and Rash on right armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 01Aug2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neck pain. The patient had no known allergies to medications, food or other products. Concomitant medications included lorazepam (ATIVAN), naproxen (MANUFACTURER UNKNOWN) and hydrocodone bitartrate, paracetamol (VICODIN). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 01Aug2021 at 12:30, 30 minutes after vaccination, the patient experienced rash under left arm which was of size 5x3 inches, chest felt heavy and the patient was very tired. On 02Aug2021, next morning after the vaccination, the patient experienced horrible headache with pain rate of 10 which lasted for 2 days and rash on right arm pit that was same as the left arm. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event horrible headache pain was resolved on 04Aug2021, events rash under left arm, rash on right armpit, chest felt heavy and very tired were not resolved at the time of report.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Rash, SARS-CoV-2 test
Clinical narrative: Horrible headache pain; chest feels heavy; very tired; Rash under left arm and Rash on right armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 01Aug2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neck pain. The patient had no known allergies to medications, food or other products. Concomitant medications included lorazepam (ATIVAN), naproxen (MANUFACTURER UNKNOWN) and hydrocodone bitartrate, paracetamol (VICODIN). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 01Aug2021 at 12:30, 30 minutes after vaccination, the patient experienced rash under left arm which was of size 5x3 inches, chest felt heavy and the patient was very tired. On 02Aug2021, next morning after the vaccination, the patient experienced horrible headache with pain rate of 10 which lasted for 2 days and rash on right arm pit that was same as the left arm. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event horrible headache pain was resolved on 04Aug2021, events rash under left arm, rash on right armpit, chest felt heavy and very tired were not resolved at the time of report.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood 25-hydroxycholecalciferol, Chest X-ray, Diplopia, Hypoaesthesia
Clinical narrative: numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist/weakness in jaw/weakness in neck; blurry vision in left eye with double vision when tired; ringing in ears; blurry vision in left eye with double vision when tired; Fatigue; This is a spontaneous report from a contactable consumer (patient), the patient's grandmother and by the patient's grandfather. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunization; and BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration on 21Apr2021 (at the age of 22 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included gene mutation (prothrombin gene mutation) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced numbness, tingling and weakness in the left foot and ankle and progressed to the left arm with weakness in the wrist, weakness in the jaw and neck, blurry vision in the left eye with double vision when tired, ringing in ears and fatigue. The events were experienced after the patient received the first vaccine dose and continued. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included electromyogram on thoracic spine, neck and brain(Unknown date): unknown; lumbar puncture (Unknown date): unknown; magnetic resonance imaging (Unknown date): no lesions on his brain so he does not have Multiple Sclerosis; and sars-cov-2 test (18May2021): negative. Clinical outcome of the events numbness, tingling and weakness in left foot and ankle and progressed to the left arm with weakness in wrist (hypoaesthesia), weakness in the jaw and neck, blurry vision in the left eye with double vision when tired and ringing in ears was not resolved. Clinical outcome of the event fatigue was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Tinnitus, Vision blurred
Clinical narrative: numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist/weakness in jaw/weakness in neck; blurry vision in left eye with double vision when tired; ringing in ears; blurry vision in left eye with double vision when tired; Fatigue; This is a spontaneous report from a contactable consumer (patient), the patient's grandmother and by the patient's grandfather. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunization; and BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration on 21Apr2021 (at the age of 22 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included gene mutation (prothrombin gene mutation) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced numbness, tingling and weakness in the left foot and ankle and progressed to the left arm with weakness in the wrist, weakness in the jaw and neck, blurry vision in the left eye with double vision when tired, ringing in ears and fatigue. The events were experienced after the patient received the first vaccine dose and continued. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included electromyogram on thoracic spine, neck and brain(Unknown date): unknown; lumbar puncture (Unknown date): unknown; magnetic resonance imaging (Unknown date): no lesions on his brain so he does not have Multiple Sclerosis; and sars-cov-2 test (18May2021): negative. Clinical outcome of the events numbness, tingling and weakness in left foot and ankle and progressed to the left arm with weakness in wrist (hypoaesthesia), weakness in the jaw and neck, blurry vision in the left eye with double vision when tired and ringing in ears was not resolved. Clinical outcome of the event fatigue was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diplopia, Electromyogram, Fatigue, Hypoaesthesia
Clinical narrative: numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist/weakness in jaw/weakness in neck; blurry vision in left eye with double vision when tired; ringing in ears; blurry vision in left eye with double vision when tired; Fatigue; This is a spontaneous report from a contactable consumer (patient), the patient's grandmother and by the patient's grandfather. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunization; and BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration on 21Apr2021 (at the age of 22 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included gene mutation (prothrombin gene mutation) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced numbness, tingling and weakness in the left foot and ankle and progressed to the left arm with weakness in the wrist, weakness in the jaw and neck, blurry vision in the left eye with double vision when tired, ringing in ears and fatigue. The events were experienced after the patient received the first vaccine dose and continued. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included electromyogram on thoracic spine, neck and brain(Unknown date): unknown; lumbar puncture (Unknown date): unknown; magnetic resonance imaging (Unknown date): no lesions on his brain so he does not have Multiple Sclerosis; and sars-cov-2 test (18May2021): negative. Clinical outcome of the events numbness, tingling and weakness in left foot and ankle and progressed to the left arm with weakness in wrist (hypoaesthesia), weakness in the jaw and neck, blurry vision in the left eye with double vision when tired and ringing in ears was not resolved. Clinical outcome of the event fatigue was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist/weakness in jaw/weakness in neck; blurry vision in left eye with double vision when tired; ringing in ears; blurry vision in left eye with double vision when tired; Fatigue; This is a spontaneous report from a contactable consumer (patient), the patient's grandmother and by the patient's grandfather. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunization; and BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration on 21Apr2021 (at the age of 22 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included gene mutation (prothrombin gene mutation) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced numbness, tingling and weakness in the left foot and ankle and progressed to the left arm with weakness in the wrist, weakness in the jaw and neck, blurry vision in the left eye with double vision when tired, ringing in ears and fatigue. The events were experienced after the patient received the first vaccine dose and continued. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included electromyogram on thoracic spine, neck and brain(Unknown date): unknown; lumbar puncture (Unknown date): unknown; magnetic resonance imaging (Unknown date): no lesions on his brain so he does not have Multiple Sclerosis; and sars-cov-2 test (18May2021): negative. Clinical outcome of the events numbness, tingling and weakness in left foot and ankle and progressed to the left arm with weakness in wrist (hypoaesthesia), weakness in the jaw and neck, blurry vision in the left eye with double vision when tired and ringing in ears was not resolved. Clinical outcome of the event fatigue was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist; numbness,tingling and weakness in left foot and ankle/numbness tingling and weakness in left arm with weakness in wrist/weakness in jaw/weakness in neck; blurry vision in left eye with double vision when tired; ringing in ears; blurry vision in left eye with double vision when tired; Fatigue; This is a spontaneous report from a contactable consumer (patient), the patient's grandmother and by the patient's grandfather. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunization; and BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration on 21Apr2021 (at the age of 22 years old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included gene mutation (prothrombin gene mutation) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced numbness, tingling and weakness in the left foot and ankle and progressed to the left arm with weakness in the wrist, weakness in the jaw and neck, blurry vision in the left eye with double vision when tired, ringing in ears and fatigue. The events were experienced after the patient received the first vaccine dose and continued. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included electromyogram on thoracic spine, neck and brain(Unknown date): unknown; lumbar puncture (Unknown date): unknown; magnetic resonance imaging (Unknown date): no lesions on his brain so he does not have Multiple Sclerosis; and sars-cov-2 test (18May2021): negative. Clinical outcome of the events numbness, tingling and weakness in left foot and ankle and progressed to the left arm with weakness in wrist (hypoaesthesia), weakness in the jaw and neck, blurry vision in the left eye with double vision when tired and ringing in ears was not resolved. Clinical outcome of the event fatigue was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Guillan-Barre like symptoms; Ascending numbness; paresthesias of legs and arms; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 11Jun2021 15:30 (Lot number was not reported) as single dose (Age at Vaccination: 40-year-old) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included melatonin (MELATONIN). On 25Jul2021 08:00 patient experienced guillan-barre like symptoms, ascending numbness and paresthesias of legs and arms. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if patient was treated for the events. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination with PCT, Nasal Swab result was negative on 21Jul2021. Patient had not recovered from the events, at the time of the report.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Guillan-Barre like symptoms; Ascending numbness; paresthesias of legs and arms; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 11Jun2021 15:30 (Lot number was not reported) as single dose (Age at Vaccination: 40-year-old) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included melatonin (MELATONIN). On 25Jul2021 08:00 patient experienced guillan-barre like symptoms, ascending numbness and paresthesias of legs and arms. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if patient was treated for the events. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination with PCT, Nasal Swab result was negative on 21Jul2021. Patient had not recovered from the events, at the time of the report.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Tingling; Numbness; I am suffering from bad headache ever since, like migraines and like pressure headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0199, Expiration date: unknown), dose 1 intramuscular, administered in Deltoid Right on 13May2021 15:28 (at the age of 31-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included vitamins nos taken for an unspecified indication, start and stop date were not reported. Patient reported a side effect from the Pfizer vaccine (confirmed as Pfizer COVID vaccine). So, since she had the vaccine, was in May, a few days after the vaccine, she cannot remember it might had been three days, she did get like tingling, numbness and headache (May2021). She was suffered from bad headache ever since, like migraines and like pressure headache (May2021). Patient stated concomitant medications was "Just vitamins." Patient stated, she guessed just a follow up (further clarification unknown), just as an event like it continued and it never goes away, she was really hoping that eventually the headache goes away. Patient stated condition was still happening. Patient received Advil liquid gel or Aleve as treatment for events. Therapeutic measures were taken as a result of tingling, numbness, i am suffering from bad headache ever since, like migraines and like pressure headache. There was no investigation assessment. The clinical outcome of event I am suffering from bad headache ever since, like migraines and like pressure headache was not recovered and unknown for another events.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Paraesthesia
Clinical narrative: Tingling; Numbness; I am suffering from bad headache ever since, like migraines and like pressure headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0199, Expiration date: unknown), dose 1 intramuscular, administered in Deltoid Right on 13May2021 15:28 (at the age of 31-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included vitamins nos taken for an unspecified indication, start and stop date were not reported. Patient reported a side effect from the Pfizer vaccine (confirmed as Pfizer COVID vaccine). So, since she had the vaccine, was in May, a few days after the vaccine, she cannot remember it might had been three days, she did get like tingling, numbness and headache (May2021). She was suffered from bad headache ever since, like migraines and like pressure headache (May2021). Patient stated concomitant medications was "Just vitamins." Patient stated, she guessed just a follow up (further clarification unknown), just as an event like it continued and it never goes away, she was really hoping that eventually the headache goes away. Patient stated condition was still happening. Patient received Advil liquid gel or Aleve as treatment for events. Therapeutic measures were taken as a result of tingling, numbness, i am suffering from bad headache ever since, like migraines and like pressure headache. There was no investigation assessment. The clinical outcome of event I am suffering from bad headache ever since, like migraines and like pressure headache was not recovered and unknown for another events.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness; I am suffering from bad headache ever since, like migraines and like pressure headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0199, Expiration date: unknown), dose 1 intramuscular, administered in Deltoid Right on 13May2021 15:28 (at the age of 31-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included vitamins nos taken for an unspecified indication, start and stop date were not reported. Patient reported a side effect from the Pfizer vaccine (confirmed as Pfizer COVID vaccine). So, since she had the vaccine, was in May, a few days after the vaccine, she cannot remember it might had been three days, she did get like tingling, numbness and headache (May2021). She was suffered from bad headache ever since, like migraines and like pressure headache (May2021). Patient stated concomitant medications was "Just vitamins." Patient stated, she guessed just a follow up (further clarification unknown), just as an event like it continued and it never goes away, she was really hoping that eventually the headache goes away. Patient stated condition was still happening. Patient received Advil liquid gel or Aleve as treatment for events. Therapeutic measures were taken as a result of tingling, numbness, i am suffering from bad headache ever since, like migraines and like pressure headache. There was no investigation assessment. The clinical outcome of event I am suffering from bad headache ever since, like migraines and like pressure headache was not recovered and unknown for another events.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema of mouth 12 hours after injection. Angioedema of scrotum 108 hrs/4.5 days; This is a spontaneous report from a contactable consumer reported for himself  A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 11:00 (Batch/Lot Number: Ew0185) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine: Hospital. Medical history included hypersensitivity, covid-19. The patient's concomitant medications were not reported. The patient experienced angioedema of mouth 12 hours after injection angioedema of scrotum 108 hrs/4.5 days (medically significant) on 04Aug2021 20:00 with outcome of not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypoaesthesia eye, Pharyngeal paraesthesia, Rash, Throat irritation
Clinical narrative: Drooping of the face; Rash around forehead and eyes; swollen eyes; numb face spreading quickly; Alligator like skin and blotches drooping of the face; Alligator like skin and blotches drooping of the face; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection, Lot Number: Fa7484), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 16:00 (age at Vaccination 18 years) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history and concurrent conditions was none. Patient did not have any relevant past drug history. Patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash around forehead and eyes, swollen eyes, numb face spreading quickly, alligator like skin and blotches, drooping of the face on 05Aug2021 at 12:00 AM. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that events caused emergency room/department or urgent care visit. Since the vaccination patient was not tested for COVID-19. There was no hospitalization. Patient took treatment for the events. The treatment medication included Prednisone and antihistamine. The case was reported as non-serious. The outcome of the events was reported as not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Facial paralysis, Hypoaesthesia, Rash, Rash macular
Clinical narrative: Drooping of the face; Rash around forehead and eyes; swollen eyes; numb face spreading quickly; Alligator like skin and blotches drooping of the face; Alligator like skin and blotches drooping of the face; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection, Lot Number: Fa7484), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 16:00 (age at Vaccination 18 years) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history and concurrent conditions was none. Patient did not have any relevant past drug history. Patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash around forehead and eyes, swollen eyes, numb face spreading quickly, alligator like skin and blotches, drooping of the face on 05Aug2021 at 12:00 AM. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that events caused emergency room/department or urgent care visit. Since the vaccination patient was not tested for COVID-19. There was no hospitalization. Patient took treatment for the events. The treatment medication included Prednisone and antihistamine. The case was reported as non-serious. The outcome of the events was reported as not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin disorder
Clinical narrative: Drooping of the face; Rash around forehead and eyes; swollen eyes; numb face spreading quickly; Alligator like skin and blotches drooping of the face; Alligator like skin and blotches drooping of the face; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection, Lot Number: Fa7484), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 16:00 (age at Vaccination 18 years) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history and concurrent conditions was none. Patient did not have any relevant past drug history. Patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash around forehead and eyes, swollen eyes, numb face spreading quickly, alligator like skin and blotches, drooping of the face on 05Aug2021 at 12:00 AM. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that events caused emergency room/department or urgent care visit. Since the vaccination patient was not tested for COVID-19. There was no hospitalization. Patient took treatment for the events. The treatment medication included Prednisone and antihistamine. The case was reported as non-serious. The outcome of the events was reported as not recovered.
Age: 48.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Pulmonary embolism, Scan with contrast abnormal
Clinical narrative: Bilateral pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-Aug-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.