chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death, Exposure via breast milk
Clinical narrative: baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.; baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via transmammary on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter wanted to know the data for the risks, adverse reactions, and side effects associated with the Pfizer-BioNTech Covid-19 Vaccine. She wanted to know the exact percentage of each. She also wants to know information about blood clots, and deaths associated with the vaccine. She said there was a baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine. The reporter said she has rheumatoid arthritis, and was on Embrel, and Methotrexate. She wants to know the possible interaction and risks of her medications and condition with the Pfizer-BioNTech Covid-19 Vaccine. The reporter wanted the complete list, and the breakdown of the ingredients for the approved Comirnaty, and the approved Pfizer-BioNTech Covid-19 Vaccine. The baby died on 09Sep2021. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: baby yesterday that died because its breastfeeding mother got the vaccine and its been linked back to the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: Dizziness; Chills; Exhaustion; Feeling unwell; Tightness in chest; Fast heartbeat; Shortness of breath/ trouble breathing; Headache; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Sep2021 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) for immunisation on 26Aug2021. The patient received other medications (unspecified) within two weeks of COVID-19 vaccine. The patient received other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021, the patient experienced dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache, and stomach pain. The events resulted in emergency room/department visit or urgent care. It was unknown whether any therapeutic measures were 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 dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache and stomach pain were resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Palpitations
Clinical narrative: Dizziness; Chills; Exhaustion; Feeling unwell; Tightness in chest; Fast heartbeat; Shortness of breath/ trouble breathing; Headache; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Sep2021 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) for immunisation on 26Aug2021. The patient received other medications (unspecified) within two weeks of COVID-19 vaccine. The patient received other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021, the patient experienced dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache, and stomach pain. The events resulted in emergency room/department visit or urgent care. It was unknown whether any therapeutic measures were 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 dizziness, chills, exhaustion, feeling unwell, tightness in chest, fast heartbeat, shortness of breath/ trouble breathing, headache and stomach pain were resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Swollen supraclavicular lymph node (right); Fever; Muscle aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the right arm on 11Sep2021 at 12:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was unknown. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 20Aug2021 at 09:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Sep2021 at 01:15, the patient experienced swollen supraclavicular lymph node (right), fever, muscle aches, headache, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen supraclavicular lymph node (right), fever, muscle aches, headache, and fatigue were not resolved at the time of this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urine analysis, Vaccination site pain
Clinical narrative: I am still having pain; This is a spontaneous report from a contactable consumer. This 50-year-old consumer (patient) reported for self. A 50-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks and No, nothing within last couple of years. It was reported that the patient had vaccine a month ago on my right arm. On 13Aug2021, the patient experienced still having pain. The patient underwent lab tests and procedures which included blood test: unknown results. "If I go to my doctor and he did blood work and or I get a urine specimen yesterday I have nothing to do with this. Its irrelevant and nothing to do with my arm from a month ago". The patient receive treatment with Aspirin 81 mg. Outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: I am still having pain; This is a spontaneous report from a contactable consumer. This 50-year-old consumer (patient) reported for self. A 50-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks and No, nothing within last couple of years. It was reported that the patient had vaccine a month ago on my right arm. On 13Aug2021, the patient experienced still having pain. The patient underwent lab tests and procedures which included blood test: unknown results. "If I go to my doctor and he did blood work and or I get a urine specimen yesterday I have nothing to do with this. Its irrelevant and nothing to do with my arm from a month ago". The patient receive treatment with Aspirin 81 mg. Outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Limb discomfort, Vertigo
Clinical narrative: Vertigo; Dizzy; My ear hurt a little bit; sore arm; This is a Spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient of unspecified age and gender 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 on 24Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19, fever, headache, event verbatim : when I had the COVID I didn't even have the sore arm, no dizziness and nothing like that. The only thing I had was the fever and the headache. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced vertigo, dizzy, my ear hurt a little bit, sore arm. The clinical outcome of events were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Arm is hurting across.; Headache; Right side of my chest really hurts.; Hard to breathe.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 10Sep2021 (Age at vaccination was 51 years) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient did not have any other medical condition. There were no concomitant medications. The patient did not receive any other vaccine. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, on 20Aug2021 as dose 1, single for COVID-19 immunization. On 11Sep2021 patient was stated that he gets his second shot last night. Today, patient woke up, his arm was hurting across and headache, but his right side of his chest really hurts. It's kind of, hard to breathe and his chest hurts really bad on that side, Not his heart side. The right side where, he got the shot. Patient went to the pharmacist and she doesn't know. Patient got a little worse, since this morning but not much but he can tell it's still strong. So, If it doesn't go away then quick here he will go to the hospital cause there's something wrong. The patient did not perform any lab test. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Scar
Clinical narrative: scars on my face; Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3182; Expiration Date: 31Oct2021 via an unspecified route of administration in Arm Left on 28Aug2021 (age at vaccination: 58-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't receive other medications. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA6789) via unspecified route of administration on 07Aug2021 in Arm Left (age at vaccination:58-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced shingles on 30Aug2021 with outcome of unknown, scars on my face on an unspecified. Therapeutic measures were taken as a result of shingles, scars on my face was Valacyclovir (Dose: 1000mg, 3 times a day, Tablet), pain meds, Gabapentin, one time a day or as needed, 300mg.The outcome of the events herpes zoster, scar was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: She also has an allergy that could lead to an anaphylactic shock.; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was asking for the ingredients used in the Pfizer Biontech COVID19 vaccine since she also has an allergy that could lead to an anaphylactic shock on unknown date. Caller was asking for the ingredients because she has seen around 6 patients with severe reactions from the vaccine and the worst one was ended up with intubation. Caller also added that everyone was scared in receiving the vaccine after witnessing that. Caller also worked in triage and mentioned that she was a traveller and has seen 5 or 6 people that had issues. She stated that one diabetic patient that came in with her sugar always controlled but skyrocketed to 600 and will not get down no matter what they give her. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Productive cough, SARS-CoV-2 test
Clinical narrative: Sore throat; Congestion; Cough with some phlegm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 07Sep2021 at 19:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Sep2021, the patient experienced sore throat, congestion and cough with some phlegm. The patient was tested negative for COVID in two different methods of testing over three times. The events resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent antigen test and nucleic acid amplification test (NAAT)/molecular test via nasal swab and the results were negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, congestion and cough with some phlegm were resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Lymphadenopathy, Malaise
Clinical narrative: Muscle pain; Joint pain; Feeling dizzy/dizzness; Unwell; Swollen lymph nodes; Swelling of throat; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 05Sep2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications from an unknown date for an unknown indication and unknown if ongoing. On 06Sep2021, the patient experienced muscle pain, joint pain, feeling dizzy and unwell, swollen lymph nodes, swelling of throat, dizziness and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, joint pain, feeling dizzy/dizzness, unwell, swollen lymph nodes, swelling of throat and weakness was not resolved at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling
Clinical narrative: Muscle pain; Joint pain; Feeling dizzy/dizzness; Unwell; Swollen lymph nodes; Swelling of throat; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 05Sep2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications from an unknown date for an unknown indication and unknown if ongoing. On 06Sep2021, the patient experienced muscle pain, joint pain, feeling dizzy and unwell, swollen lymph nodes, swelling of throat, dizziness and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, joint pain, feeling dizzy/dizzness, unwell, swollen lymph nodes, swelling of throat and weakness was not resolved at the time of report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste within minutes of injection; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358a) via an unspecified route of administration in the left arm on 11Sep2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 11Sep2021 at 11:45, within minutes of injection, the patient experienced metallic taste. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste within minutes of injection was resolving at the time of this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Nervousness
Clinical narrative: Just not feeling well; Nausea; fluttering in stomach (butterflies instomach feeling); This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 07Sep2021 at 18:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included colecalciferol (VITAMIN D3), acetylsalicylic acid (ASPIRIN), curcuma longa rhizome (TURMERIC) and unspecified multivitamin; all from an unknown date for an unknown indication and unknown if ongoing. On 07Sep2021 at 18:45, the patient was not feeling well, nausea and fluttering in stomach (butterflies in stomach feeling). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events just not feeling well, nausea and fluttering in stomach (butterflies in stomach feeling) was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Swelling
Clinical narrative: Swelling under the armpit on the left side where the injection was taken on the upper part of the arm; Under arm felt really weird like irritated; Under arm felt really weird like irritated and painful from movement; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Sep2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive concomitant medications. On 10Sep2021 at 23:00, the night of the vaccination, the patient's under arm felt really weird like irritated and painful from movement. On 11Sep2021, the patient experienced swelling under the armpit on the left side where the injection was taken on the upper part of the arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events underarm felt really weird like irritated and painful from movement and swelling under the armpit was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitations since receiving the 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 14May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and verapamil (MANUFACTURER UNKNOWN); both for an unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, since receiving second dose, the patient experienced heart palpitations. The heart palpitations resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 06Sep2021, the patient underwent Nasal Swab SARS CoV-2 test and the result was unknown. Therapeutic measures were not taken as a result of heart palpitations. The clinical outcome of the event heart palpitations was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Somnolence, Swelling, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 09Sep2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included bad disk in back. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 16Aug2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 10Sep2021 at 07:00, the patient had swelling in left armpit. The patient woke up with a migraine and vomiting. On 11Sep2021, whole next day, the patient felt exhausted and slept. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in left armpit, migraine, vomiting, exhausted and slept the whole next day were resolving at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: under the arm where I got the vaccine which is my right arm, is swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported) via an unspecified route of administration at right arm on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced under the arm where I got the vaccine which was my right arm, was swollen. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Having heart issues; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection and Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced having heart issues on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Electroencephalogram abnormal, Fall, Ketoacidosis
Clinical narrative: couldn't get up; seizures/Multiple seizure episode at home; ketoacidosis; started falling; EEG on 09Feb2021: Facio Brachial Dystonia; This is a spontaneous report from a contactable consumer or other non hcp.     A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 06Feb2021 14:30 (at age of 73 years)(Lot Number: EN9581) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included Diabetes type-2, High blood pressure, High cholesterol, all from 01Jan2005 and ongoing and Seizure episode affecting left side from 27Jan2021 to an unknown date (1 episode lasting 30-45 sec, MRI with/without contrast (Negative result)). Historical Vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1, intramuscular, administered in Arm left at single dose on 16Jan2021 02:30 pm(at age of 73 years),( lot number: EL3248) for Covid-19 immunization and experienced seizure episodes Multiple.  Prior vaccinations within 4 weeks was None.  Concomitant medication(s) included amlodipine besilate, benazepril hydrochloride (LOTREL) orally for Blood pressure, atorvastatin calcium (LIPITOR) orally for Cholesterol, empagliflozin orally for Diabetes type-2, insulin glargine (LANTUS) for Diabetes type-2, metformin oral for Diabetes type-2, all from an unspecified start date and ongoing.    The patient experienced ketoacidosis on 06Mar2021 with outcome of unknown , seizures/multiple seizure episode at home on 04Mar2021 with outcome of not recovered , required visit to Emergency room, solumedrol and Dexamethasone received as treatment, Seriousness criteria: Life threatening, Hospitalization, Persistent/significant disability/ Incapacity; couldn't get up transported to hospital by ambulance on 24Aug2021 with outcome of unknown , started falling on 08Mar2021 with outcome of unknown , spinal tap-liquid clear on 27Apr2021 with outcome of unknown.  The patient was hospitalized for ketoacidosis from 06Mar2021 to 16Mar2021.  The patient was hospitalized for seizures/multiple seizure episode at home from 08Feb2021 to 22Feb2021.  The patient was hospitalized for couldn't get up from 25Aug2021 to 28Aug2021.  The patient underwent lab tests and procedures which included: MRI on 04Feb2021, 16Aug2021 with Result as Negative (Comments: Did tests MRIs);  Cat scan on 04Feb2021 (negative);  EEG on 09Feb2021: Facio Brachial Dystonia;   Pet scan Between 03Jun2021 and 12Jun2021(unknown date), Result: Negative;  Spinal tap on 27Apr2021 (Result: Clear).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging, Positron emission tomogram, Seizure
Clinical narrative: couldn't get up; seizures/Multiple seizure episode at home; ketoacidosis; started falling; EEG on 09Feb2021: Facio Brachial Dystonia; This is a spontaneous report from a contactable consumer or other non hcp.     A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 06Feb2021 14:30 (at age of 73 years)(Lot Number: EN9581) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included Diabetes type-2, High blood pressure, High cholesterol, all from 01Jan2005 and ongoing and Seizure episode affecting left side from 27Jan2021 to an unknown date (1 episode lasting 30-45 sec, MRI with/without contrast (Negative result)). Historical Vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1, intramuscular, administered in Arm left at single dose on 16Jan2021 02:30 pm(at age of 73 years),( lot number: EL3248) for Covid-19 immunization and experienced seizure episodes Multiple.  Prior vaccinations within 4 weeks was None.  Concomitant medication(s) included amlodipine besilate, benazepril hydrochloride (LOTREL) orally for Blood pressure, atorvastatin calcium (LIPITOR) orally for Cholesterol, empagliflozin orally for Diabetes type-2, insulin glargine (LANTUS) for Diabetes type-2, metformin oral for Diabetes type-2, all from an unspecified start date and ongoing.    The patient experienced ketoacidosis on 06Mar2021 with outcome of unknown , seizures/multiple seizure episode at home on 04Mar2021 with outcome of not recovered , required visit to Emergency room, solumedrol and Dexamethasone received as treatment, Seriousness criteria: Life threatening, Hospitalization, Persistent/significant disability/ Incapacity; couldn't get up transported to hospital by ambulance on 24Aug2021 with outcome of unknown , started falling on 08Mar2021 with outcome of unknown , spinal tap-liquid clear on 27Apr2021 with outcome of unknown.  The patient was hospitalized for ketoacidosis from 06Mar2021 to 16Mar2021.  The patient was hospitalized for seizures/multiple seizure episode at home from 08Feb2021 to 22Feb2021.  The patient was hospitalized for couldn't get up from 25Aug2021 to 28Aug2021.  The patient underwent lab tests and procedures which included: MRI on 04Feb2021, 16Aug2021 with Result as Negative (Comments: Did tests MRIs);  Cat scan on 04Feb2021 (negative);  EEG on 09Feb2021: Facio Brachial Dystonia;   Pet scan Between 03Jun2021 and 12Jun2021(unknown date), Result: Negative;  Spinal tap on 27Apr2021 (Result: Clear).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Nasal congestion, Night sweats
Clinical narrative: Over sleeping; Congestion; Severe lethargy; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Aug2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine/dexamfetamine (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Aug2021 at 07:00, the patient experienced severe lethargy, over sleeping, night sweats, and congestion. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe lethargy, over sleeping, night sweats, congestion was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Sep2021, the patient experienced severe diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient was not tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event severe diarrhea was not resolved at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: another doctor who recently treated a female patient with the same symptoms who was test for Shingles and tested positive; this person also received the Pfizer COVID 19 vaccine in the same time frame; This is a spontaneous report from a contactable consumer or other non hcp.    A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 23Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: unknown), via an unspecified route of administration on 02Apr2021 12:00 administered in left arm as single dose for COVID-19 immunisation. The patient experienced another doctor who recently treated a female patient with the same symptoms who was test for shingles and tested positive; this person also received the pfizer covid 19 vaccine in the same time frame on 2021.  The patient underwent lab tests and procedures which included herpes zoster: positive on 2021. The outcome of event was unknown.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dental paraesthesia, Dizziness, Fatigue
Clinical narrative: Fatigue; Tingling of teeth; Heaviness in chest; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Sep2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 09Sep2021, 24 hours after the vaccination, the patient experienced fatigue, tingling of teeth, heaviness in chest and dizzy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, tingling of teeth, heaviness in chest and dizzy was resolved on an unknown date in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number- Unknown) via an unspecified route of administration, administered on unknown date as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number- not reported) via an unspecified route of administration, administered on unknown date as Dose 1, single. Patient had has low immune system. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experiencing chills, headache and fever. The outcome of event was not unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Inappropriate schedule of product administration, Ocular discomfort, Somnolence
Clinical narrative: Patient administered first dose of Pfizer-BioNTech Covid-19 Vaccine on 05Sep2021 and second dose on 07Sep2021; sleeping a lot; has not been opening his eyes; has not been much responsive; This is a spontaneous report from a contactable consumer or other non-health care professional. A 68-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD0809, NDC and UPC number: unknown) dose 1 via an unspecified route of administration on 05Sep2021 (at the age of 68 years old) as dose 1, single and dose 2 via an unspecified route of administration on 07Sep2021 (Lot Number: FF2589) as dose 2, single for COVID-19 immunization at hospital. Vaccine was not administered at military facility. Medical history included urinary tract infection but prior to these events the patient was admitted to the hospital on 01Sep2021 for a urinary tract infection and was discharged home on 08Sep2021. Concomitant medication(s) included atorvastatin calcium; docusate; ferrous sulphate; midodrine; milk of magnesia; pantoprazole; quetiapine; dutasteride accord; fludrocortisone acetate; levetiracetam; venlafaxine; spiriva handihaler (tiotropium bromide monohydrate); cholecalciferol; acetaminophen; montelukast sodium; senna glycosides; amoxicillin taken from 08Sep2021 and. Investigation assessment was reported as unknown. He has other unspecified medications that are prescribed only as needed and have not been taken in the 2 weeks prior to onset of events. On an unspecified date the patient experienced patient administered first dose of pfizer-BioNTech covid-19 vaccine on 05sep2021 and second dose on 07sep2021. On 08Sep2021 sleeping a lot, has not been opening his eyes, has not been much responsive. Reporter stated that these doses were administered while the patient was hospitalized for unrelated reason. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Computerised tomogram, Dizziness, Extra dose administered
Clinical narrative: muscle discomfort on my left arm and leg; rapid heartbeat 106-120 sporadically; nausea; lightheadedness & tightness; lightheadedness & tightness; random dizzy episodes; intermittent muscle pains in my left arm & left leg; BP is high then low; fatigue; Sleeping is irregular; pressure headache/pressure pounding headaches; my booster 19Aug2021; my booster 19Aug2021; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (patient) reported that:  A 48-year-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in arm left on 19Aug2021 as dose 3, (age at the time of vaccination 48-years-old), single for covid-19 immunization. The patient previously took first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 22Jan2021 12:00 PM as dose 1, and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration, administered in arm left on 12Feb2021 (age at the time of vaccination 47-years-old), single for covid-19 immunization. The patient medical history included Thyroid. Patient was known allergies to PCN and Tramadol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks RX by my doctor. I have been having symptoms since my booster 19Aug2021. I was able to manage the first few days after my shot because I knew/researched what is expected. On 20Aug2021 07:00AM, the patient stated my pressure pounding headaches are continuous, rapid heartbeat 106-120 sporadically with nausea, lightheadedness and tightness, random dizzy episodes, and intermittent muscle pains in my left arm & left leg-same side as my shot, my BP is high then low. Sleeping is irregular/fatigue. This symptoms come in different phases and not all at once. As combination of shot 1 and 2, but this time its weeks not 48 hours. I had a CT scan just to check, it is normal. I am not worried because it is better then getting COVID. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the events were recovered with sequel. At the time of reporting, the events muscle discomfort on my left arm and leg and pressure headache/pressure pounding headaches was not recovered and event my booster 19Aug2021 was unknown.