chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Vomiting
Clinical narrative: headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse.  A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation.  Medical history included osteoarthritis, and migraines.  The patient's concomitant medications were not reported.  The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination.  The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood test abnormal, COVID-19, Cough, Fatigue
Clinical narrative: positive Covid result; positive Covid result; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 11:00 (Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included hyperlipidemia, essential hypertension, subarachnoid hemorrhage. No known allergies. Patient had no Covid prior vaccination. Concomitant medications included fenofibrate; losartan potassium (LOSARTIN). No other vaccine in four weeks. The patient started having flu-like symptoms 10 days after vaccine (10Apr2021), including low grade fever, body aches, exhaustion, difficulty breathing, cough, sore throat, upset stomach and bad headache. Blood tests on 14Apr2021 showed infection, inflammation and ultimately positive Covid result (Nasal Swab) on 15Apr2021. No treatment received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: positive Covid result; positive Covid result; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 11:00 (Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included hyperlipidemia, essential hypertension, subarachnoid hemorrhage. No known allergies. Patient had no Covid prior vaccination. Concomitant medications included fenofibrate; losartan potassium (LOSARTIN). No other vaccine in four weeks. The patient started having flu-like symptoms 10 days after vaccine (10Apr2021), including low grade fever, body aches, exhaustion, difficulty breathing, cough, sore throat, upset stomach and bad headache. Blood tests on 14Apr2021 showed infection, inflammation and ultimately positive Covid result (Nasal Swab) on 15Apr2021. No treatment received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive Covid result; positive Covid result; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 11:00 (Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included hyperlipidemia, essential hypertension, subarachnoid hemorrhage. No known allergies. Patient had no Covid prior vaccination. Concomitant medications included fenofibrate; losartan potassium (LOSARTIN). No other vaccine in four weeks. The patient started having flu-like symptoms 10 days after vaccine (10Apr2021), including low grade fever, body aches, exhaustion, difficulty breathing, cough, sore throat, upset stomach and bad headache. Blood tests on 14Apr2021 showed infection, inflammation and ultimately positive Covid result (Nasal Swab) on 15Apr2021. No treatment received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive Covid result; positive Covid result; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 11:00 (Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included hyperlipidemia, essential hypertension, subarachnoid hemorrhage. No known allergies. Patient had no Covid prior vaccination. Concomitant medications included fenofibrate; losartan potassium (LOSARTIN). No other vaccine in four weeks. The patient started having flu-like symptoms 10 days after vaccine (10Apr2021), including low grade fever, body aches, exhaustion, difficulty breathing, cough, sore throat, upset stomach and bad headache. Blood tests on 14Apr2021 showed infection, inflammation and ultimately positive Covid result (Nasal Swab) on 15Apr2021. No treatment received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Dyspnoea, Peripheral swelling
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Feeling cold, Influenza like illness
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle contracture, Nasal disorder, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Productive cough, Respiratory tract congestion, Rhinorrhoea, Skin discolouration
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Influenza, Skin discolouration
Clinical narrative: BREATHING DIFFICULTY; FELT LIKE REALLY BAD FLU; ASTHMA ATTACK; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, fever, and very sick with covid symptoms, and concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced turned purple in the face. On 17-MAR-2021, the subject experienced asthma attack. On an unspecified date, the subject experienced breathing difficulty, and felt like really bad flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulty, felt like really bad flu, turned purple in the face and asthma attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210442027.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Ear pain, Facial paralysis, Hypoaesthesia oral
Clinical narrative: Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 26Mar2021 at 08:15 (Batch/Lot number was not reported) as a single dose (at the age of 43 years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included high blood pressure from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included lisinopril, metoprolol, hydrochlorothiazide, and clarithromycin; all from unknown dates for unknown indications. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 05Mar2021 at 10:15 (Batch/Lot number was not reported) (at the age of 43 Years-old) for COVID-19 immunisation.  On 11Apr2021 at 14:00 the patient experienced bells palsey (Bell's palsy).  The event resulted in emergency room visit.  Therapeutic measures were taken as a result of Bell's palsy and included prednisone and valacyclovir. The clinical outcome of the event Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain
Clinical narrative: Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 26Mar2021 at 08:15 (Batch/Lot number was not reported) as a single dose (at the age of 43 years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included high blood pressure from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included lisinopril, metoprolol, hydrochlorothiazide, and clarithromycin; all from unknown dates for unknown indications. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 05Mar2021 at 10:15 (Batch/Lot number was not reported) (at the age of 43 Years-old) for COVID-19 immunisation.  On 11Apr2021 at 14:00 the patient experienced bells palsey (Bell's palsy).  The event resulted in emergency room visit.  Therapeutic measures were taken as a result of Bell's palsy and included prednisone and valacyclovir. The clinical outcome of the event Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 26Mar2021 at 08:15 (Batch/Lot number was not reported) as a single dose (at the age of 43 years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included high blood pressure from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included lisinopril, metoprolol, hydrochlorothiazide, and clarithromycin; all from unknown dates for unknown indications. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 05Mar2021 at 10:15 (Batch/Lot number was not reported) (at the age of 43 Years-old) for COVID-19 immunisation.  On 11Apr2021 at 14:00 the patient experienced bells palsey (Bell's palsy).  The event resulted in emergency room visit.  Therapeutic measures were taken as a result of Bell's palsy and included prednisone and valacyclovir. The clinical outcome of the event Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Heart rate increased, Laboratory test, Magnetic resonance imaging head
Clinical narrative: 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Ew0158) via an unspecified route of administration, administered on the right arm on 10Apr2021 09:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. 72 hours after receiving the shot he had debilitating vertigo and nausea on 14Apr2021 10:00 AM which still persists at the 5th and 6th day. The events resulted in Emergency room/department or urgent care visit, Hospitalization for 2 days. Therapeutic measures were taken as a result of the events which included Meclizine 25mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test post vaccination: Nasal Swab on 14Apr2021: Negative. Outcome of the events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vertigo, X-ray
Clinical narrative: 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Ew0158) via an unspecified route of administration, administered on the right arm on 10Apr2021 09:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. 72 hours after receiving the shot he had debilitating vertigo and nausea on 14Apr2021 10:00 AM which still persists at the 5th and 6th day. The events resulted in Emergency room/department or urgent care visit, Hospitalization for 2 days. Therapeutic measures were taken as a result of the events which included Meclizine 25mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test post vaccination: Nasal Swab on 14Apr2021: Negative. Outcome of the events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Ew0158) via an unspecified route of administration, administered on the right arm on 10Apr2021 09:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. 72 hours after receiving the shot he had debilitating vertigo and nausea on 14Apr2021 10:00 AM which still persists at the 5th and 6th day. The events resulted in Emergency room/department or urgent care visit, Hospitalization for 2 days. Therapeutic measures were taken as a result of the events which included Meclizine 25mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test post vaccination: Nasal Swab on 14Apr2021: Negative. Outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Muscle spasms, Ultrasound scan abnormal, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abortion, Haemorrhage, Pregnancy test, Ultrasound abdomen
Clinical narrative: I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.  The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation.   On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered.  Information about the Lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Glossodynia, Hypoaesthesia, Paraesthesia, Speech disorder
Clinical narrative: arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15  (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dysphagia, Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15  (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Swollen tongue
Clinical narrative: arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15  (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Feeling of relaxation
Clinical narrative: she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; feeling drugged; felt really dizzy/got dizzy when she got up and started moving around doing stuff; the left side of her body went numb; her arm, left side of her body, leg and face felt dead, numb and weird; she "went out" for the night; lightheaded; weakness in the left arm; still feeling weak; chills at night; This is a spontaneous report from a Pfizer Sponsored Patient Support Program COVAX US Support via a contactable consumer (patient). Follow-up received on 20Apr2021 was processed together along with initial information.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), intramuscular, administered in arm left on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, immediately after the vaccine she felt really dizzy and the left side of her body went numb, also she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe and described it as feeling drugged. On an unspecified in Apr2021, the patient experienced chills at night, nothing closed or was swollen however her husband had to help her up the stairs because her arm, left side of her body, leg and face felt dead, numb, and weird. On an unspecified in Apr2021, she "went out" for the night. On an unspecified in Apr2021 (on Saturday), she was dizzy and lightheaded and left side of her body was still weird, numb and on Sunday she felt totally normal and got dizzy when she got up and started moving around doing stuff. She was getting better, but her left arm was still weak and had to think about moving it and she was still feeling dizzy when moving around and still having weakness in the left arm. The patient was wondering how long this was going to last, if the second shot was going to be worse and as she had a side effect after the first dose of the vaccine, should she get the second dose though she didn't have any severe reaction to the COVID-19 vaccine first dose. However, she had pretty bad reaction like lightheaded (on an unspecified date in Apr2021), arm and face numbness and chills after the first dose had been given and until about 10 days and now, she was still feeling weak and numb. She was wondering if she still needed to get her second dose of the vaccine given the side effects. She was advised to consult her health care professional on taking the second dose. The outcome was recovered on an unspecified date in Apr2021 for lightheaded and chills at night, unknown for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; feeling drugged; felt really dizzy/got dizzy when she got up and started moving around doing stuff; the left side of her body went numb; her arm, left side of her body, leg and face felt dead, numb and weird; she "went out" for the night; lightheaded; weakness in the left arm; still feeling weak; chills at night; This is a spontaneous report from a Pfizer Sponsored Patient Support Program COVAX US Support via a contactable consumer (patient). Follow-up received on 20Apr2021 was processed together along with initial information.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), intramuscular, administered in arm left on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, immediately after the vaccine she felt really dizzy and the left side of her body went numb, also she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe and described it as feeling drugged. On an unspecified in Apr2021, the patient experienced chills at night, nothing closed or was swollen however her husband had to help her up the stairs because her arm, left side of her body, leg and face felt dead, numb, and weird. On an unspecified in Apr2021, she "went out" for the night. On an unspecified in Apr2021 (on Saturday), she was dizzy and lightheaded and left side of her body was still weird, numb and on Sunday she felt totally normal and got dizzy when she got up and started moving around doing stuff. She was getting better, but her left arm was still weak and had to think about moving it and she was still feeling dizzy when moving around and still having weakness in the left arm. The patient was wondering how long this was going to last, if the second shot was going to be worse and as she had a side effect after the first dose of the vaccine, should she get the second dose though she didn't have any severe reaction to the COVID-19 vaccine first dose. However, she had pretty bad reaction like lightheaded (on an unspecified date in Apr2021), arm and face numbness and chills after the first dose had been given and until about 10 days and now, she was still feeling weak and numb. She was wondering if she still needed to get her second dose of the vaccine given the side effects. She was advised to consult her health care professional on taking the second dose. The outcome was recovered on an unspecified date in Apr2021 for lightheaded and chills at night, unknown for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Dizziness postural, Feeling abnormal
Clinical narrative: she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; feeling drugged; felt really dizzy/got dizzy when she got up and started moving around doing stuff; the left side of her body went numb; her arm, left side of her body, leg and face felt dead, numb and weird; she "went out" for the night; lightheaded; weakness in the left arm; still feeling weak; chills at night; This is a spontaneous report from a Pfizer Sponsored Patient Support Program COVAX US Support via a contactable consumer (patient). Follow-up received on 20Apr2021 was processed together along with initial information.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), intramuscular, administered in arm left on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, immediately after the vaccine she felt really dizzy and the left side of her body went numb, also she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe and described it as feeling drugged. On an unspecified in Apr2021, the patient experienced chills at night, nothing closed or was swollen however her husband had to help her up the stairs because her arm, left side of her body, leg and face felt dead, numb, and weird. On an unspecified in Apr2021, she "went out" for the night. On an unspecified in Apr2021 (on Saturday), she was dizzy and lightheaded and left side of her body was still weird, numb and on Sunday she felt totally normal and got dizzy when she got up and started moving around doing stuff. She was getting better, but her left arm was still weak and had to think about moving it and she was still feeling dizzy when moving around and still having weakness in the left arm. The patient was wondering how long this was going to last, if the second shot was going to be worse and as she had a side effect after the first dose of the vaccine, should she get the second dose though she didn't have any severe reaction to the COVID-19 vaccine first dose. However, she had pretty bad reaction like lightheaded (on an unspecified date in Apr2021), arm and face numbness and chills after the first dose had been given and until about 10 days and now, she was still feeling weak and numb. She was wondering if she still needed to get her second dose of the vaccine given the side effects. She was advised to consult her health care professional on taking the second dose. The outcome was recovered on an unspecified date in Apr2021 for lightheaded and chills at night, unknown for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling of relaxation, Hypoaesthesia, Limb discomfort, Muscular weakness, Respiration abnormal
Clinical narrative: she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; feeling drugged; felt really dizzy/got dizzy when she got up and started moving around doing stuff; the left side of her body went numb; her arm, left side of her body, leg and face felt dead, numb and weird; she "went out" for the night; lightheaded; weakness in the left arm; still feeling weak; chills at night; This is a spontaneous report from a Pfizer Sponsored Patient Support Program COVAX US Support via a contactable consumer (patient). Follow-up received on 20Apr2021 was processed together along with initial information.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), intramuscular, administered in arm left on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, immediately after the vaccine she felt really dizzy and the left side of her body went numb, also she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe and described it as feeling drugged. On an unspecified in Apr2021, the patient experienced chills at night, nothing closed or was swollen however her husband had to help her up the stairs because her arm, left side of her body, leg and face felt dead, numb, and weird. On an unspecified in Apr2021, she "went out" for the night. On an unspecified in Apr2021 (on Saturday), she was dizzy and lightheaded and left side of her body was still weird, numb and on Sunday she felt totally normal and got dizzy when she got up and started moving around doing stuff. She was getting better, but her left arm was still weak and had to think about moving it and she was still feeling dizzy when moving around and still having weakness in the left arm. The patient was wondering how long this was going to last, if the second shot was going to be worse and as she had a side effect after the first dose of the vaccine, should she get the second dose though she didn't have any severe reaction to the COVID-19 vaccine first dose. However, she had pretty bad reaction like lightheaded (on an unspecified date in Apr2021), arm and face numbness and chills after the first dose had been given and until about 10 days and now, she was still feeling weak and numb. She was wondering if she still needed to get her second dose of the vaccine given the side effects. She was advised to consult her health care professional on taking the second dose. The outcome was recovered on an unspecified date in Apr2021 for lightheaded and chills at night, unknown for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.