chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: needle was removed from arm, blood streamed down her arm about 5-6 inches; This is a spontaneous report from a contactable consumer (husband reporting for wife). This 68-year-old female patient female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6201, unspecified route in arm on 09Feb2021 as single dose (at the age of 68 years) for Covid-19 Immunization.  No medical history reported, and no concomitant medication reported.  Historical vaccine included BNT162B2 for Covid-19 Immunization.  The patients husband reported when the needle was removed from his wife's arm, blood streamed down her arm about 5-6 inches on 09Feb2021.  The doctor who removed the needle immediately put a round bandage on the injection site and then the stream stopped but before there was a steady stream of blood running down her arm.  Patient's husband is wondering if she could have lost any of the vaccine when this happened. The caller would like to know if there is any possibility the vaccine might have come out in the blood.  Patient's husband heard the first dose given in (name of city) had leaking from the syringe prior to injection and was an invalid dose.  Patients husband reported "the doctor who did the vaccine did put the needle all the way in and pushed the plunger all the way in." Patient's husband is wondering about how much vaccine is remaining for his protection and the potential need for revaccination.  Outcome of event needle was removed from arm, blood streamed down her arm about 5-6 inches was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first single dose of BNT162B2 (Pfizer, solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Feb2021 10:30 to 11Feb2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light headed and dizzy, mild; lasted day of injection on 11Feb2021 16:00. The event was considered as non-serious by the reporter. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from the event on an unspecified date in Feb2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Muscle tightness, Throat tightness
Clinical narrative: anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; This is a spontaneous report from a contactable consumer (the patient).  A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on 05Feb2021 at 11:10 AM  (at the age of 75 years), as a single dose for COVID-19 immunization. Medical history included kidney transplant. Concomitant medication included tacrolimus, mycophenolate mofetil (MYCOPHENOLATE), prednisone. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), on 14Jan2021 for COVID-19 immunization). On 05Feb2021 at around 18:00 PM, the patient had what he believed was an anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest (he clarified that upper chest as where the neck meets the chest. It may have been a little lower, but not that far down that he would have worried. It was the upper chest where the neck meets the chest. Not in the chest to the left or right). It lasted intermittently for 4 days. He reported that it was not continuous, it would come for 2-3 hours dissipate and then come again. It wasn't all day and all night. He reported "I'm better now". The clinical outcome of anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest  was recovered on 10Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 03Feb2021 (12:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included vulvodynia; back issues; sulfa allergy; penicillin (PCN) allergy; and allergy to "mycins". Concomitant medication included estrogens conjugated (PREMARIN) and propranolol. The patient previously took morphine sulfate, and had drug allergy; lansoprazole (ZOLANAS), and had drug allergy; and tetanus vaccine, and had allergy to the vaccine. The patient was not pregnant at the time of vaccination. On 11Feb2021 (16:30), the patient had induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it. The reported events resulted into physician's office visit. The patient did not receive any treatment for the reported events. The outcome of the events, 'induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Glaucoma, Hypoaesthesia, Hypoaesthesia eye, Pruritus
Clinical narrative: severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer.  A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received.  The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Visual field defect
Clinical narrative: severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer.  A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received.  The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: seizure; unresponsive for 20 minutes; This is a spontaneous report from a contactable physician reporting for himself. A 93-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 93 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included dementia from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 (at the age of 93 years old) as a single dose in the deltoid right for COVID-19 IMMUNIZATION. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin and levothyroxine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 13:30, the patient experienced a seizure and was unresponsive for 20 minutes. Treatment for the events included careful observation and airway protection. The outcome of the events seizure and unresponsive was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Unresponsive to stimuli cannot be excluded.  The case will be reassessed if additional information becomes available.  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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in left arm on 27Jan2021 11:00 (at age 43-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure. The patient did not have  COVID prior vaccination. No known allergies. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC), sildenafil citrate (VIAGRA), and amfetamine sulfate (AMPHETAMINE SALTS). The patient tested positive for SARS-CoV-2 on 12Feb2021, patient was symptomatic (cough, diarrhea, headache) since 06Feb2021. Covid test post vaccination via Nasal Swab, (NAAT Aptima SARS-CoV-2 assay) on 12Feb2021 with covid test result Positive. Treatment received included Aspirin. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Haemorrhage, Pyrexia
Clinical narrative: passed some blood when he went to the bathroom; fever of 100 degrees; This is a spontaneous report from a contactable consumer, the patient.  A male patient of an unknown age (reported as 73 with no units provided) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 13Feb2021, the patient passed some blood when he went to the bathroom and had a fever of 100 degrees Fahrenheit. The clinical outcomes of the passed some blood when he went to the bathroom and fever were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Malaise, Nausea
Clinical narrative: Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the point I almost went to the emergency room/terribly unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EN5318, via an unspecified route of administration on 02Feb2021 15:45 (at the age of 72 years old) for COVID-19 vaccination, Unspecified other vaccine (Pfizer) on 02Feb2021, dose number in the left arm for an unspecified indication.Medical history included asthma from an unknown date and unknown if ongoing (asthma under control), pancreatitis chronic from an unknown date and unknown if ongoing (Occasional chronic pancreatitis), Blood pressure from an unknown date and unknown if ongoing, drug allergies from an unknown date and unknown if ongoing.  Concomitant medication included Blood pressure medication. The patient previously took morphine and experienced allergies morphine and sulfa and experienced allergies sulfa. The patient received the vaccination at the hospital. On 02Feb2021, the patient felt as if she was having a heart attack. On 02Feb2021, the patient had trouble breathing, nausea, and severe headache. On 02Feb2021, the patient was felling generally unwell to the point she almost went to the emergency room. The excruciating headache and terribly unwell feeling has lasted well over 10 days. No treatment was received for the events. Outcome of the events was recovering. The patient did not have covid prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear pain
Clinical narrative: loss of hearing; ear pains; This is a spontaneous report from a contactable consumer, the patient. This female patient of unknown age  (reported as (age: 80 unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 25Jan2021 for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported.  On an unknown date in 2021, the patient had ear pain and loss of hearing. The events were reported as non-serious. The clinical outcome of ear pain and loss of hearing was unknown. The reporter was unsure if the events were related.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Glassy eyes, Headache, Pain
Clinical narrative: eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient.  A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization.  Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants.  Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins.  The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy.  On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy.  On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events.   The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, SARS-CoV-2 test, Swelling of eyelid
Clinical narrative: eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient.  A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization.  Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants.  Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins.  The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy.  On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy.  On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events.   The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (the patient).  A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EM9810), via an unspecified route of administration, in the right arm (at the age of 67 years) on 09Feb2021 at 10:30 AM at single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included lisinopril (LISINOPRIL ACTAVIS), rosuvastatin, acetylsalicylic acid (ASPIRIN 81). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and experienced rash,  Sulphamide and experienced nose bleed. On 10Feb2021 at 08:30 AM, the patient experienced Bell's Palsy.  The patient visited the emergency room Therapeutic measures were taken as a result of Bell's Palsy and included tape left eye closed and use wetting gel. The clinical outcome of the bells palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation episode; This is a spontaneous report from a contactable consumer, the patient, from the Pfizer-sponsored program.  A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included heart problem and tachycardia. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) for heart problem and tachycardia from an unknown date and unknown if ongoing.  On an unknown date, 6 days after the first dose, the patient experienced atrial fibrillation episode which required hospitalization for a few days. The patient mentioned her medication was going to be changed to sotalol (MANUFACTURER UNKNOWN) due to the event (unspecified if treatment started). The clinical outcome of the atrial fibrillation episode was unknown. The patient also mentioned that nobody thought her experience was related to the Pfizer vaccine.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event atrial fibrillation episodes is attributed to an underlying medical condition and assessed unrelate to BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after the first dose; Tested positive after the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received 1st dose of BNT162B2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after the first dose on an unspecified date. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of event was unknown.  Information about batch/lot number requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid virus after first dose vaccine; tested positive for covid virus after first dose vaccine; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received 1st dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid virus after first dose vaccine. The patient underwent lab tests and procedures which included covid virus test: positive on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure decreased, Blood pressure measurement, Chest pain, Dizziness
Clinical narrative: whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809), via an unspecified route of administration on 13Feb2021 10:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None medical history. Concomitant medication included omeprazole, fexofenadine hydrochloride (ALLEGRA). The patient experienced achy right arm (site of injection) about 12 hours after injection on 13Feb2021 21:30; achy muscles all over body about 16 hours after injection on 13Feb2021. Pain was relieved by taking two naproxen tablets. The outcome of events was recovered in Feb2021. The events were reported as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization.  Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal.  Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg  for allergies, vitamin D at 1000 iU  daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing.  The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021.  The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pneumonia, Pyrexia
Clinical narrative: touch of pneumonia; running a fever/temperature; running a fever/temperature; This is a spontaneous report from a contactable consumer (child of patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. Medical history included Alzheimer's. The patient's concomitant medications were not reported. The patient experienced running a fever/temperature and a touch of pneumonia on 11Feb2021. The clinical course was reported as follows: The day the patient was to go for her second dose, she was running a fever and was not able to go. The patient was diagnosed and had a touch of pneumonia. The patient was put on unspecified steroids and two unspecified antibiotics. The patient was running a temperature on an unspecified date but was better on 12Feb2021. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of running a fever and a touch of pneumonia was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large lymph node swelling on left side of neck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced large lymph node swelling on left side of neck after use of product. Shot was in the left. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI  and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: she had symptoms of a stroke; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) first dose, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Initially, it was reported that the patient experienced symptoms of Bell's palsy before getting the second dose. It was further reported that the patient stated it was not true that she experienced Bell's palsy. She mentioned she had symptoms of a stroke on an unspecified date. She wanted to confirm that her appointment for next 20Feb2021 has not been cancelled. Consumer refused to continue with the survey. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Limb discomfort, Painful respiration
Clinical narrative: Increased blood pressure; Pain breathing; felt some discomfort in her hand; This is a spontaneous report from a contactable Physician.     A 82-years-old female patient received the first dose of  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on  08Feb2021 at 0.3 mL, single for Covid-19 immunisation .  Medical history included ongoing cardiac disorder (she has had five bypasses ten years ago) , ongoing lung disorder,  ongoing osteoporosis  , she has had three operations on her spinal cord. She has a neurologic compression fracture from ages ago , seasonal allergy,  nitrate compound therapy, hypertension, anticoagulant therapy, electrolyte imbalance.  Concomitant medication included ranolazine (RANEXA), isosorbide (ISOSORBIDE), gliclazide (DIAZIDE [GLICLAZIDE]), apixaban (ELIQUIS), magnesium (MAGNESIUM) , ubidecarenone (Q-10 CO-ENZYME).  The patient experienced increased blood pressure  on 09Feb2021 with outcome of not recovered , pain breathing  on 09Feb2021 with outcome of not recovered , felt some discomfort in her hand  on 09Feb2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: increased   on 09Feb2021 166/100 and pulse 65. The 100 was alarming to her. The patient would notice the increase in blood pressure and pain breathing when walking longer distances  Information on the lot/ batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Loss of consciousness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer.  A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported.  Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: chills; slight fever; flu like symptoms; minor headache; slight aching limbs; mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el3247), via an unspecified route of administration on 15Feb2021 11:45 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food or other products. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously received first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization (lot number: el3247, administration time: 11:00 AM, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 15Feb2021 23:00, the patient experienced chills, slight fever, slight aching limbs, minor headache (would describe as flu like symptoms) occurred 10 hours post injection with mild fatigue during course of following day. The events were reported as non-serious. No treatment was received for the adverse events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; slight fever; flu like symptoms; minor headache; slight aching limbs; mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el3247), via an unspecified route of administration on 15Feb2021 11:45 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food or other products. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously received first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization (lot number: el3247, administration time: 11:00 AM, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 15Feb2021 23:00, the patient experienced chills, slight fever, slight aching limbs, minor headache (would describe as flu like symptoms) occurred 10 hours post injection with mild fatigue during course of following day. The events were reported as non-serious. No treatment was received for the adverse events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: arm soreness; more discomfort than I usually have for vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 73; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date at an unknown dose and frequency as blood thinner. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first dose of BNT162B2 and experience arm soreness on the second day, more discomfort than she usually have for vaccine. By the third day, the patient was fine, and reported that "it went away". The patient stated that "they have to give me a 2nd shot, right? since I'm on a blood thinner". The outcome of the events was recovered on an unspecified date. The action taken in response to the events for apixaban was unknown.  Information about lot/batch number has been requested.