chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Vision blurred
Clinical narrative: Constant headache for weeks; my blood pressure has been off; my eyes are blurry; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:30 as dose 2, single for covid-19 immunisation.  Medical history was reported as no. Known allergies were reported as Sulpha. The patient concomitant medications were not reported. Patient did not receive any other vaccine in four weeks.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation. The patient reported that on 02Apr2021, she experienced constant headache for weeks and after a couple days her blood pressure has been off. Sometimes very high and sometimes normal then her eyes were blurry. Never had any issues with her blood pressure in years. The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date (Sometimes very high and sometimes normal). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. The patient received treatment for adverse event as other doses of her existing blood pressure pills. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed or missed monthly cycle (menstruation) by 7+ days.; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) as dose number unknown, single via an unspecified route of administration on an unknown date (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient had delayed or missed monthly cycle (menstruation) by 7+ days, no possibility of pregnancy. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken because of this event. The patient did not receive treatment. The clinical outcome of the event delayed or missed monthly cycle (menstruation) by 7+ days was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Country added in patient tab, vaccination Facility Country added, concomitant Therapy updated.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Heart rate, Heart rate abnormal, Pyrexia
Clinical narrative: Second dose: slight red dots on her skin; Second dose: heart rate 110 beats per minute; Second dose: high fever; This is a spontaneous report from a contactable consumer (boyfriend/partner) via PPDi.  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown), via an unspecified route of administration (of unspecified age) on 06May2021 as a dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced slight red dots on her skin on 07May2021, high fever and heart rate of 110 beats per minute on unspecified date in May2021. Reporter queried for does she need to go to the doctor. At the time of the report, the outcomes of the events were unknown.  Communication: Advised caller to contact primary care doctor if needed. The caller was provided with website withheld, phone number of withheld, option 3. Caller will call at a later time. No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730 and Expiration date: Unknown) via an unspecified route, administered in Left Deltoid on 04May2021 at 09:00 (69-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19; he had the virus at one point previously in Jan2021. No family medical history, concomitant medications were reported. The patient had no history of all previous immunizations with the Pfizer vaccine. The patient was not administered with additional vaccines on same date of the Pfizer vaccine or within 4 weeks prior to vaccination. The patient had not experienced any AEs prior vaccination. The patient was not report related to a study or programme. The reporter mentioned that he got the shot and experienced some side effects. On 05May2021(Wednesday morning), he mentioned he had a fever and headaches. He also mentioned he had the virus at one point. He was calling to find out if these symptoms are normal. No investigation assessment was reported. No relevant test was reported. These adverse events did not result the patient to Emergency Room/ Physician's Office visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; body pain; This is a spontaneous report from a contactable consumer (Patients husband) reported for his wife. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06May2021 as DOSE 1, SINGLE for COVID-19 immunization in a local county vaccination center. The patient medical and concomitant medication history were reported. On May2021 the patient experienced fever, headache and body pain. Caller would like to know would it be okay for her to take over the counter Ibuprofen or Tylenol more preferred? Consent for follow up: Declined. The outcome of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Blood pressure abnormal, Blood pressure measurement, Dizziness, Dysgeusia
Clinical narrative: tachycardia; metallic taste in mouth; Dizziness; Short-term memory issues; erratic BP/HR; erratic BP/HR; difficult word finding (verbal); severe exhaustion; nausea; shakiness; autonomic dysfunction/possible dysautonomia; hyperadrenergic; exaggerated immunological response to the vaccine; felt strange/brain fog; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), administered in the right arm, on 08Jan2021 at 11:45 AM (at the age of 51-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination. Concomitant medications were reported as none. No other vaccine received in four weeks; no other medications received in two weeks. The patient previously took erythromycin and aspirin and experienced known allergies; the patient was sensitive to progesterone: tachycardia, and cipro: headaches. The patient felt strange but okay at first, on 08Jan2021. Starting two days after vaccination, on 10Jan2021, severe exhaustion, nausea, shakiness; no fever, injection site was not sore/red. 10 days later, on 20Jan2021, evolved into tachycardia, brain fog, difficult word finding (verbal), short-term memory issues, dizziness, metallic taste in mouth, erratic blood pressure (BP) and heart rate (HR). Patient could not get the second dose due to the severity of side effects. Currently, five months later, she still had not fully recuperated, although she still was (hopefully) improving. For the first time in her life, she had taken beta blockers. She had seen a variety of specialists (cardiology, neurology, hepatology, immunology...). The thought was that she had an autonomic dysfunction, hyperadrenergic, exaggerated immunological response to the vaccine started on 08Jan2021. Hopefully not permanent. She was currently not back to normal yet. Other medical history was reported as possible dysautonomia, that was diagnosed just as a result of the reaction to BNT162b2. She was otherwise healthy. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care visit. The patient had tested for COVID post vaccination and included COVID test type: nasal swab on 20Jan2021 and on 28Jan2021, both resulted negative; COVID test type: blood test on 12Mar2021 resulted negative. The events were treated with propranolol. The patient had not recovered from the events (as reported).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529184 same patient/drug, different dose/events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Epinephrine, Epinephrine increased, Fatigue, Feeling abnormal, Heart rate
Clinical narrative: tachycardia; metallic taste in mouth; Dizziness; Short-term memory issues; erratic BP/HR; erratic BP/HR; difficult word finding (verbal); severe exhaustion; nausea; shakiness; autonomic dysfunction/possible dysautonomia; hyperadrenergic; exaggerated immunological response to the vaccine; felt strange/brain fog; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), administered in the right arm, on 08Jan2021 at 11:45 AM (at the age of 51-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination. Concomitant medications were reported as none. No other vaccine received in four weeks; no other medications received in two weeks. The patient previously took erythromycin and aspirin and experienced known allergies; the patient was sensitive to progesterone: tachycardia, and cipro: headaches. The patient felt strange but okay at first, on 08Jan2021. Starting two days after vaccination, on 10Jan2021, severe exhaustion, nausea, shakiness; no fever, injection site was not sore/red. 10 days later, on 20Jan2021, evolved into tachycardia, brain fog, difficult word finding (verbal), short-term memory issues, dizziness, metallic taste in mouth, erratic blood pressure (BP) and heart rate (HR). Patient could not get the second dose due to the severity of side effects. Currently, five months later, she still had not fully recuperated, although she still was (hopefully) improving. For the first time in her life, she had taken beta blockers. She had seen a variety of specialists (cardiology, neurology, hepatology, immunology...). The thought was that she had an autonomic dysfunction, hyperadrenergic, exaggerated immunological response to the vaccine started on 08Jan2021. Hopefully not permanent. She was currently not back to normal yet. Other medical history was reported as possible dysautonomia, that was diagnosed just as a result of the reaction to BNT162b2. She was otherwise healthy. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care visit. The patient had tested for COVID post vaccination and included COVID test type: nasal swab on 20Jan2021 and on 28Jan2021, both resulted negative; COVID test type: blood test on 12Mar2021 resulted negative. The events were treated with propranolol. The patient had not recovered from the events (as reported).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529184 same patient/drug, different dose/events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Immune system disorder, Memory impairment, Mental impairment, Nausea
Clinical narrative: tachycardia; metallic taste in mouth; Dizziness; Short-term memory issues; erratic BP/HR; erratic BP/HR; difficult word finding (verbal); severe exhaustion; nausea; shakiness; autonomic dysfunction/possible dysautonomia; hyperadrenergic; exaggerated immunological response to the vaccine; felt strange/brain fog; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), administered in the right arm, on 08Jan2021 at 11:45 AM (at the age of 51-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination. Concomitant medications were reported as none. No other vaccine received in four weeks; no other medications received in two weeks. The patient previously took erythromycin and aspirin and experienced known allergies; the patient was sensitive to progesterone: tachycardia, and cipro: headaches. The patient felt strange but okay at first, on 08Jan2021. Starting two days after vaccination, on 10Jan2021, severe exhaustion, nausea, shakiness; no fever, injection site was not sore/red. 10 days later, on 20Jan2021, evolved into tachycardia, brain fog, difficult word finding (verbal), short-term memory issues, dizziness, metallic taste in mouth, erratic blood pressure (BP) and heart rate (HR). Patient could not get the second dose due to the severity of side effects. Currently, five months later, she still had not fully recuperated, although she still was (hopefully) improving. For the first time in her life, she had taken beta blockers. She had seen a variety of specialists (cardiology, neurology, hepatology, immunology...). The thought was that she had an autonomic dysfunction, hyperadrenergic, exaggerated immunological response to the vaccine started on 08Jan2021. Hopefully not permanent. She was currently not back to normal yet. Other medical history was reported as possible dysautonomia, that was diagnosed just as a result of the reaction to BNT162b2. She was otherwise healthy. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care visit. The patient had tested for COVID post vaccination and included COVID test type: nasal swab on 20Jan2021 and on 28Jan2021, both resulted negative; COVID test type: blood test on 12Mar2021 resulted negative. The events were treated with propranolol. The patient had not recovered from the events (as reported).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529184 same patient/drug, different dose/events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia, Tremor
Clinical narrative: tachycardia; metallic taste in mouth; Dizziness; Short-term memory issues; erratic BP/HR; erratic BP/HR; difficult word finding (verbal); severe exhaustion; nausea; shakiness; autonomic dysfunction/possible dysautonomia; hyperadrenergic; exaggerated immunological response to the vaccine; felt strange/brain fog; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), administered in the right arm, on 08Jan2021 at 11:45 AM (at the age of 51-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination. Concomitant medications were reported as none. No other vaccine received in four weeks; no other medications received in two weeks. The patient previously took erythromycin and aspirin and experienced known allergies; the patient was sensitive to progesterone: tachycardia, and cipro: headaches. The patient felt strange but okay at first, on 08Jan2021. Starting two days after vaccination, on 10Jan2021, severe exhaustion, nausea, shakiness; no fever, injection site was not sore/red. 10 days later, on 20Jan2021, evolved into tachycardia, brain fog, difficult word finding (verbal), short-term memory issues, dizziness, metallic taste in mouth, erratic blood pressure (BP) and heart rate (HR). Patient could not get the second dose due to the severity of side effects. Currently, five months later, she still had not fully recuperated, although she still was (hopefully) improving. For the first time in her life, she had taken beta blockers. She had seen a variety of specialists (cardiology, neurology, hepatology, immunology...). The thought was that she had an autonomic dysfunction, hyperadrenergic, exaggerated immunological response to the vaccine started on 08Jan2021. Hopefully not permanent. She was currently not back to normal yet. Other medical history was reported as possible dysautonomia, that was diagnosed just as a result of the reaction to BNT162b2. She was otherwise healthy. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care visit. The patient had tested for COVID post vaccination and included COVID test type: nasal swab on 20Jan2021 and on 28Jan2021, both resulted negative; COVID test type: blood test on 12Mar2021 resulted negative. The events were treated with propranolol. The patient had not recovered from the events (as reported).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529184 same patient/drug, different dose/events
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat irritation
Clinical narrative: trouble swallowing; Itchiness in throat; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07May2021 at 10:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included no chronic medicinal conditions, anxiety this year (as of 2021), and a hemorrhage after giving birth in 2018, blood transfusion that year 2018 and dilation and curettage (D&C) to address it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included prenatal vitamins, vitamin D, and vitamin C from unknown dates for unknown indications. The patient did not have any allergies or any reaction to vaccines. The patient previously received dose 1 of BNT162B2 on 09Apr2021 at 16:30 as a single dose in the left arm for COVID-19 immunization and experienced trouble swallowing, slightly swollen glands in throat, and "slightly thump" in throat. Seven to ten minutes after the second dose on 07May2021 at 10:30 (as reported) the patient experienced the same feeling of trouble swallowing, swallowed fine with water and itchiness in throat. The patient stayed 30 minutes at the clinic. Again because she could breathe and talk she was told to take diphenhydramine (BENADRYL). The patient went home and continued drinking water. It was easier to swallow. The patient took paracetamol (TYLENOL), slept for three hours, woke up, and had slight trouble swallowing again. She took diphenhydramine and drank water. She felt better again. The outcomes of trouble swallowing and itchiness in throat was recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiospasm, Chest pain, Electrocardiogram, Neck pain, Ultrasound scan
Clinical narrative: shooting pain in my neck on the left side; Chest pains which felt like a heart spasm or flutter; Chest pains which felt like a heart spasm or flutter; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 at 14:45 pm (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications the patient received within 2 weeks of vaccination included spironolactone, drospirenone, ethinylestradiol (SYEDA) and ibuprofen all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, three days after receiving the first dose, the patient had chest pains which felt like a heart spasm or flutter. On an unspecified date, the patient also experienced a shooting pain in her neck on the left side. These symptoms lasted off and on for about 2 weeks. She saw her doctor but they were unable to diagnose it. EKG (electrocardiogram) and carotid ultrasound were normal on an unspecified date in Apr2021. The pains subsided about 18 days after her vaccine appointment. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The device date was reported as 10May2021. The case was reported as non-serious. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Is pregnant:Yes; After shot 1: sore left arm; This is a spontaneous report from a contactable consumer, the patient.  This consumer reported in-formation for both mother and fetus/baby. This is a maternal report. A 38-years-old pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included pregnancy, anal fissure and hornet stings from an unknown date and unknown if ongoing. Concomitant medications included Prenatal MVI, Vit D3 and topical Nefedipine taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination and COVID tested post vaccination. The patient did not receive other vaccine in four weeks. The patient was exposed to vaccine while she was pregnant. Last menstrual date was 02Feb2021, her gestation period was 10 and expected delivery date was 09Nov2021. Patient experienced sore left arm after first shot on an unspecified date. The patient received no treatment. The clinical outcome of event sore left arm was recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Joint pain; Arm pain; Headache; Swelling of lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10May2021 at 15:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included low thyroid (Hypothyroidism). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and aripiprazole (ABILIFY) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 19Apr2021 at 15:15 (at the age of 28-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 11May2021 at 04:45, the patient experienced headache, swelling of lymph nodes, joint pain and arm pain. The events did not result in doctor or other Healthcare Professional office/clinic visit, and Emergency room/Department or Urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, swelling of lymph nodes, joint pain and arm pain were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy after being fully vaccinated; This is a spontaneous report from a contactable consumer. This is a maternal report. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pregnancy after being fully vaccinated (non-serious) on 07May2021. The outcome of the event was unknown. The mother reported she became pregnant while taking bnt162b2.   Information about lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Whole left side went numb, like I have paralysis; still feel it that tension on my shoulder or my left side and on my arm a little bit and it's not like same; it really took me out; I didn't have much energy on to do so much and then I have to constantly lay down; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EW0151) via an unspecified route of administration on 04Apr2021 (at the age of 65-years-old), as dose 2, single for covid-19 immunisation.   Medical history included gastrointestinal cancer metastatic from 2004 to an unknown date. Reporter stated that Gastrointestinal Cancer, that was 17 years ago, coming 17 years, in November, would be her cancer free. She reported that 2004, she came up with stage 4 cancer and its okay gastrointestinal cancer and that was 2004 and then last year, 2020. The patient's concomitant medications were not reported. It was stated that she had whole left side went numb, like she has paralysis and that lasted, she felt much better now but she could still feel it, that tension on her shoulder or her left side and on her arm a little bit and it's not like same, like she stated that had paralysis and yes it really took me out. She had to lay down, she didn't have much energy to do so much and then she had to constantly lay down but her doing much better, you know, she didn't go to doctor and didn't go to hospital because she knows the shot was in, there is nothing they could do about it and she thought, okay. She thinking positive, at least, she got two shots, you know, she stated that 14 years ago, she had stage 4 cancer and it was, she had a port put by the chest or shoulder top, that they could turn around and put the chemicals, chemo any and that was on her left side so, maybe that she whole left side was, her right side was okay and everything was functional, but her whole left side, half of her, half body was just numb. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Chronic Diarrhea; 12Mar2021, the patient received second dose and first dose; This is a spontaneous report received from a contactable consumer (Patient). A 62-year-old non-pregnant female Patient (consumer) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 12Mar2021 as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, Expiry Date: Unknown), via an unspecified route of administration, in right arm on 12Mar2021 at 11:45 as dose 1, single for covid-19 immunisation. The patient's known allergies included sulfa, Feldene, Leviquin, Ambien, and Fentanyl. Other medical history included degenerative disc disease, and hyperthyroid. The patient's concomitant medications were not reported. Not tested for Covid prior and post vaccination. No other vaccine was received in four weeks. The patient received other medications (unspecified) in two weeks. On 12Mar2021, the patient received second dose on same day with first dose (Inappropriate schedule of vaccine administered). It was reported that everything she ate went through her immediately & she had chronic diarrhoea on 10Apr2021 at 14:00. No treatment was received. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Left arm  extreme deep bone pain.; Diarrhea; vomiting; Fatigue; Exhausation; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration in Arm Left on 03Apr2021(age at vaccination: 49 Years) as DOSE,2 SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient received other medications within 2 weeks of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. Patient had allergies. Patient didn't had covid-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EN6207) via unspecified route of administration in Arm left on unspecified date (age at vaccination: 49 Years) as DOSE 1, SINGLE for covid-19 immunisation. On Apr2021 the patient experienced left arm extreme deep bone pain, diarrhoea, vomiting, fatigue, exhaustion. No Therapeutic measures were taken for the events. Patient was not tested for covid to post vaccination. The outcome of the events bone pain, diarrhoea, vomiting, fatigue was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Cardiomegaly, Chest X-ray
Clinical narrative: Chest X Ray: Slightly enlarged heart; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN8733; Expiration Date: 31Jul2021), dose 2 intramuscular, administered in Arm Left on 06Apr2021 10:00 (at the age of 82-year-old) as dose 2, single for COVID-19 immunization. Medical history included, arthritis from 2005 and ongoing, asthma from 2008 and ongoing, heart from 2018 and ongoing (Stent inserted), thyroid from 2007 and ongoing (No new suspected but not found partial removal of thyroid gland), enlarged heart (father) from an unknown date and unknown if ongoing (family history), heart attack (brother) from an unknown date and unknown if ongoing (family history). Concomitant medication(s) included sulfasalazine taken for arthritis; levothyroxine taken for thyroid; montelukast taken for asthma; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for asthma; metoprolol taken for heart; lisinopril taken for heart; prasugrel taken for heart from an unspecified start date and ongoing. The patient previously received first dose of BNT162B2 (Lot Number: EN6206; Expiry date: 30Jun2021), intramuscular administered in Left arm on 16Mar2021 10:00 (at the age of 82-year-old) for COVID-19 Immunization and experienced worst ever asthma attack. Prior vaccinations (within 4 weeks) were none reported. On 21Apr2021, patient experienced chest x ray: slightly enlarged heart. Reported, follow the 1st vaccine short, my doctor told me to immediately follow the 2nd vaccine shot with some albuterol at 4hr, inhaling for the day of the 2nd. Patient did and had no problem after the 2nd shot. The patient underwent lab tests and procedures which included stress test: everything works ok on 15Apr2021, chest x-ray: slightly enlarged heart on 21Apr2021. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: I had 104-105° temperature for 3.5 days after getting my 2nd shot; Also had a terrible headache; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; Also extremely elevated blood pressure and pulse; Also extremely elevated blood pressure and pulse; This is spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 30Apr2021 12:30 (age at the time of vaccination 35-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 30Apr2021 19:00, the patient experienced I had 104-105 degree temperature for 3.5 days after getting my 2nd shot, Also had a terrible headache, was extremely fatigued with body aches and chills, Also extremely elevated blood pressure and pulse. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: extremely elevated; Body temperature: 104-105 degree, I had 104105 degree temperature for 3.5 days after getting my 2nd shot; and Heart rate: extremely elevated. Patient received ibuprofen and Tylenol as pain and fever reducers as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hypertension, Pain
Clinical narrative: I had 104-105° temperature for 3.5 days after getting my 2nd shot; Also had a terrible headache; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; Also extremely elevated blood pressure and pulse; Also extremely elevated blood pressure and pulse; This is spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 30Apr2021 12:30 (age at the time of vaccination 35-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 30Apr2021 19:00, the patient experienced I had 104-105 degree temperature for 3.5 days after getting my 2nd shot, Also had a terrible headache, was extremely fatigued with body aches and chills, Also extremely elevated blood pressure and pulse. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: extremely elevated; Body temperature: 104-105 degree, I had 104105 degree temperature for 3.5 days after getting my 2nd shot; and Heart rate: extremely elevated. Patient received ibuprofen and Tylenol as pain and fever reducers as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: After 2nd injection, patient reported a fever; red area at the site of injection the size of an orange but never raised/ Red site, but not raised as the first one was; the patient was itchy all over about1/2 hour, which resolved without intervention.; This is a spontaneous report from a contactable pharmacist. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via Intramuscular, administered in Arm Right on 20Jan2021 (at the age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient was allergic to latex and Tdap. The patient had same reaction when received a prior tetanus containing vaccine. Exact product was unknown. Environmental allergy history, Demarol/Augmentin- listed as allergies but only due to adverse effects not true allergies. The patient taking Cardia Lisinopril prior to the event being reported. Historical vaccine included bnt162b2 in the left arm on 30Dec2020 as 1st dose for Covid-19 immunization and experienced injection site was still sore and tender and Red and itchy eyes. On an unspecified date, the patient experienced after 2nd injection, patient reported a fever, red area at the site of injection the size of an orange but never raised/ red site, but not raised as the first one was, the patient was itchy all over about1/2 hour, which resolved without intervention.  It was reported that the Pfizer product had a causal effect to the adverse event. Reaction DID not recur on re-administration of product. Vaccination Facility type was a Hospital. After 2nd injection, patient reported a fever and red area at the site of injection the size of an orange but never raised. Subsequently a few days later, the patient was itchy all over about1/2 hour, which resolved without intervention. The patient received treatment with Cephalaxin 500 PO QID x 7 d. No laboratory tests or diagnostic studies was performed. The patient received no other vaccines for any other conditions prior to the event being reported. The patient received no other vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient received no other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. None of the AEs require a visit to Emergency Room. Prior vaccinations within 4 weeks was none.  Outcome of the events fever and redness was unknown, and the outcome of the other event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, SARS-CoV-2 test
Clinical narrative: numbness in the arm; A little bit sore; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09May2021 as a single dose for covid-19 immunization. Medical history included covid-19 on an unknown date in 2021 to an unknown date. The patient's concomitant medications were not reported. The patient experienced numbness in the arm and a little bit sore on an unknown date in 2021. She was schedule for the second dose on 30May2021, however she requested for an earlier schedule because she had an important appointment to attend and originally it was in Apr2021, but it was cancelled because she was tested positive to covid-19, so she need to take rest. The vaccine facility was the one who administered her first dose however when she asked if she could take the 2nd dose earlier than the original schedule, she was advised to call Pfizer and ask for medical advice. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Heart rate abnormal
Clinical narrative: fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old male patient received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration in arm left on 13Apr2021 at 12:15 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient was not reported. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration on 23Mar2021 at 12:30 (at the age of 46-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 18Apr2021, the patient experienced fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches. The patient underwent lab tests and procedures which included nasal swab sars-cov-2 test: negative on 18Apr2021. Therapeutic measures were taken as a result of events that included aspirin. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old male patient received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration in arm left on 13Apr2021 at 12:15 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient was not reported. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration on 23Mar2021 at 12:30 (at the age of 46-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 18Apr2021, the patient experienced fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches. The patient underwent lab tests and procedures which included nasal swab sars-cov-2 test: negative on 18Apr2021. Therapeutic measures were taken as a result of events that included aspirin. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pruritus
Clinical narrative: She had a racing heart; Itchy; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. A Non-contactable female consumer (patient) reported that who received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated she had her first dose of the vaccine back in Feb2021. On an unspecified date in 2021, she had a racing heart and itchy. She wants to know if she should get the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.