chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Headache; Diarrhea; bodyaches; chills; fatigue; Sinus pressure; This is a spontaneous report from a contactable consumer reported for herself. A 45-years-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in right arm on 28Jan2021 at 04:15 PM (at the age of 45-years-old), as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. On 29Jan2021 at 04:00 PM, the patient experienced headache, diarrhea, body aches, chills, fatigue, and sinus pressure. Patient was not diagnosed with COVID Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient was not recovered from the events at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Headache; Diarrhea; bodyaches; chills; fatigue; Sinus pressure; This is a spontaneous report from a contactable consumer reported for herself. A 45-years-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in right arm on 28Jan2021 at 04:15 PM (at the age of 45-years-old), as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. On 29Jan2021 at 04:00 PM, the patient experienced headache, diarrhea, body aches, chills, fatigue, and sinus pressure. Patient was not diagnosed with COVID Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient was not recovered from the events at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Fatigue, Pain, Pyrexia
Clinical narrative: Fever 99 degrees; Fatigue feel asleep without provocation; mild injection site irritation; body aches; bone ache; This is spontaneous report from a contactable 69-year-old female consumer (patient).  A 69-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration in right arm on 03Feb2021 at 14:15 (at the age of 69-year-old) as a 2nd dose, single for COVID-19 immunization. Medical history included hypothyroidism, hashimotos, allergies to medications, food, or other products was none. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm right on 12Jan2021 14:15 PM at a 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 04Feb2021 at 16:00, the patient experienced fever 99 degrees, fatigue feel asleep without provocation, mild injection site irritation, body aches / bone ache. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature was fever 99 degrees on 04Feb2021. The events were reported as non-serious. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: Fever 99 degrees; Fatigue feel asleep without provocation; mild injection site irritation; body aches; bone ache; This is spontaneous report from a contactable 69-year-old female consumer (patient).  A 69-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration in right arm on 03Feb2021 at 14:15 (at the age of 69-year-old) as a 2nd dose, single for COVID-19 immunization. Medical history included hypothyroidism, hashimotos, allergies to medications, food, or other products was none. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm right on 12Jan2021 14:15 PM at a 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 04Feb2021 at 16:00, the patient experienced fever 99 degrees, fatigue feel asleep without provocation, mild injection site irritation, body aches / bone ache. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature was fever 99 degrees on 04Feb2021. The events were reported as non-serious. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: 100F fever; chills; muscle aches; This is a spontaneous report from a non-contactable consumer or other non hcp.  An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of product-COVID 19 (lot-unknown-False), Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient experienced 100 fahrenheit fever, chills, muscle aches on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on an unspecified date. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the list of any other medications the patient received within 2 weeks of vaccination. It was unknown whether the patient received any treatment for the adverse event. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient had been tested for COVID-19 since the vaccination. Outcome of the events was resolved on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: Severe headache; Fever; Muscle and joint pain; Muscle and joint pain; Lethargy; This is a spontaneous report from a contactable consumer (patient) reported.   An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via unspecified route of administration, administrated in left arm on 03Feb2021 at 15:00 as 2nd dose single for COVID-19 immunization. The patient medical history included fibromyalgia, arthritis. Allergies to medications, food, or other products: amoxicillin. Patient received first dose (BNT162B2, Batch/Lot no: EL0140) via an unspecified route of administration, administrated in right arm on 01Jan2021 at 10:00 for COVID-19 immunization. the patient concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in hospital. On 04Feb2021 at 03:00am, patient experienced severe headache, muscle and joint pain, fever, lethargy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Head banging, Headache
Clinical narrative: However, on the second day, she had a headache and still has a headache today that continues to get wors; She still has this banging in her head; This is a spontaneous report from a contactable consumer.   A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient reported that first day after the second dose, she had no reaction, however, on the second day, she had a headache and still has a headache that continues to get worse. Patient received treatment medication ibuprofen once in a day for event headache and it was getting worse and it was not unbearable, but she still has this banging in her head. In a caller response the patient states that after the first shot, her headache went away after 2 days, however, after the second dose, she's still having the headache after the 6th day. Patient is asking what she should do. Outcome of the event headache was not recovered, head banging was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130300 similar report from same reporter
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Intractable headache; Lowgrade fever; Chills; Fatigue; Malaise; This is a spontaneous report from a contactable Other HCP (patient). A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route on 04Feb2021 at 12:30 (at the age of 34-years) as 2nd dose, single in left arm for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccine in four weeks of vaccination. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN). The patient previously received first dose of BNT162B2 (Lot number: EL0142), via an unspecified route on 14Jan2021 at 12:30 (at the age of 34-years) as 1st dose, single in left arm for COVID-19 immunisation. Patient was not diagnosed with COVID prior vaccination. The patient was not pregnant at the time of vaccination. On 05Feb2021 at 12:00, the patient experienced intractable headache, chills, low grade fever, fatigue and malaise. Post vaccination the patient was not tested for COVID. Treatment was not received for the reported events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Polymerase chain reaction, Pyrexia
Clinical narrative: severed headache; chills; fever of 102; This is a spontaneous report received from a contactable Nurse (patient herself). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 28Jan2021 08:15 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunization. Medical history included drug hypersensitivity (penicillin) from an unknown date and unknown if ongoing, patient had no other medical history. Concomitant medication(s) included calcium, vitamin d nos and paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 15:00 the patient experienced severe headache, chills and fever of 102. Patient was not diagnosed with COVID-19 Prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 02Feb2021 Fever, polymerase chain reaction: negative on 04Feb2021, sars-cov-2 test: negative on 04Feb2021. The reporter assessed all the events as non-serious. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severed headache; chills; fever of 102; This is a spontaneous report received from a contactable Nurse (patient herself). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 28Jan2021 08:15 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunization. Medical history included drug hypersensitivity (penicillin) from an unknown date and unknown if ongoing, patient had no other medical history. Concomitant medication(s) included calcium, vitamin d nos and paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 15:00 the patient experienced severe headache, chills and fever of 102. Patient was not diagnosed with COVID-19 Prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 02Feb2021 Fever, polymerase chain reaction: negative on 04Feb2021, sars-cov-2 test: negative on 04Feb2021. The reporter assessed all the events as non-serious. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever now 102.4°F; This is a spontaneous report received from a contactable consumer (patient's wife) via a Pfizer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unknown date as 2nd dose, single for covid-19 immunization. On an unknown date (this happened after the second dose of vaccine), the patient was experienced high fever now 102.4 degree F and already taken paracetamol (TYLENOL) for fever. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Headache, Heart rate, Heart rate increased
Clinical narrative: Severe headache; increased heart rate avg. 103 bpm; very dry throat; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration in Right Arm on 06Feb2021 at 03:45 PM as 2nd dose single and first dose via an unspecified route of administration on 16Jan2021 at 11:00 PM as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine in 4 weeks and 2 weeks prior vaccination. The patient did not tested covid prior and post vaccination. Patient was having no allergies. On 07Feb2021 at 09:00PM, the patient experienced severe headache, increased heart rate avg. 103 bpm and very dry throat. The patient did not receive any treatment. The patient underwent lab tests and procedures which included heart rate: increased heart rate avg. 103 bpm on 07Feb2021. The clinical outcome of the events was not recovered.   Information about Lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Dizziness, Headache
Clinical narrative: Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: Headache; muscle aches; joint pain; fever over 101; chills; fatigue; swelling of injection site; injection site pain; slight nausea; stomach cramping; This is a spontaneous report from a non-contactable other HCP.   A 39-year-old non pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, (Lot Number: EL1484 expiry date unknown), via unspecified route of administration in left arm on 05Feb2021, 03:15 PM (at the age of 39-year-old) as a single dose for covid-19 immunization. The patient medical history included sulfa antibiotics allergy. The patient's concomitant medications were not reported. The patient did not have any other vaccination prior to 4 weeks of COVID vaccine. Patient did not diagnose with COVID prior to vaccine and not tested for COVID-19 after vaccination. On 05-Feb-2021: 18:30 the patient experienced headache, muscle aches, joint pain, fever over 101, chills, fatigue, swelling of injection site, injection site pain, slight nausea, stomach cramping. No treatment received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Headache; muscle aches; joint pain; fever over 101; chills; fatigue; swelling of injection site; injection site pain; slight nausea; stomach cramping; This is a spontaneous report from a non-contactable other HCP.   A 39-year-old non pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, (Lot Number: EL1484 expiry date unknown), via unspecified route of administration in left arm on 05Feb2021, 03:15 PM (at the age of 39-year-old) as a single dose for covid-19 immunization. The patient medical history included sulfa antibiotics allergy. The patient's concomitant medications were not reported. The patient did not have any other vaccination prior to 4 weeks of COVID vaccine. Patient did not diagnose with COVID prior to vaccine and not tested for COVID-19 after vaccination. On 05-Feb-2021: 18:30 the patient experienced headache, muscle aches, joint pain, fever over 101, chills, fatigue, swelling of injection site, injection site pain, slight nausea, stomach cramping. No treatment received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Headache; muscle aches; joint pain; fever over 101; chills; fatigue; swelling of injection site; injection site pain; slight nausea; stomach cramping; This is a spontaneous report from a non-contactable other HCP.   A 39-year-old non pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, (Lot Number: EL1484 expiry date unknown), via unspecified route of administration in left arm on 05Feb2021, 03:15 PM (at the age of 39-year-old) as a single dose for covid-19 immunization. The patient medical history included sulfa antibiotics allergy. The patient's concomitant medications were not reported. The patient did not have any other vaccination prior to 4 weeks of COVID vaccine. Patient did not diagnose with COVID prior to vaccine and not tested for COVID-19 after vaccination. On 05-Feb-2021: 18:30 the patient experienced headache, muscle aches, joint pain, fever over 101, chills, fatigue, swelling of injection site, injection site pain, slight nausea, stomach cramping. No treatment received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain
Clinical narrative: After the first shot, her headache went away after 2 days; After the first shot, her headache went away after 2 days; dull pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose, single for covid-19 immunization. The patient past medical history and concomitant medication was not reported. the patient reported that she received the second dose of the COVID vaccine 6 days ago. The first day after the second dose, she had no reaction, however, on the second day, she had a headache and still has a headache today that continues to get worse on an Unspecified date. She was not taking Ibuprofen every 4 hours and only took 2 tablets about 3 or 4 hours ago. She had dull pain that doesn't go away. The outcome of event was not recovered.  Information about lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected. .; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122285 similar report from same reporter
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 as a 1st dose, single for COVID-19 immunisation. Co-suspect medication included Aimovig (ERENUMAB AOOE) for migraine. The patient's medical history included migraines for 67 years. The patient's concomitant medications were not reported. Stated that she took the first dose of covid vaccine on the 05Feb2021 and she did not have any side effects aside a mild headache (patient said that she always gets a headache since she had migraine for 67 years). Patient stated that she takes an injection of Aimovig (for Migraine) every 10th of every month and she would like to know whether if it interferes with the covid vaccine and she should skip/take it later. The patient stated that she usually take 2 Tylenol for a headache and she was good to go. On an unspecified date in Feb2021, the patient experienced headache. Treatment medication included Tylenol. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Headache; discomfort; nausea; diarrhea; This is a spontaneous report from a non-contactable consumer (patient herself). A 30-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 03Feb2021 16:00 (at the age of 30-years-old) as single dose for COVID-19 immunisation. The patient medical history included Known allergies: Bacitracin. Concomitant medication included vitamins nos taken for an unspecified indication, received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 05Feb2021, the patient experienced, Headache, discomfort, nausea, diarrhea and received no treatment for adverse events. The patient underwent lab tests and procedures which included Nasal Swab: PCR (sars-cov-2 test): negative on 04Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/Batch number could not be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: Severe body aches; Headache; Nausea; Diarrhea; Tiredness; Feeling of unwell; Lung and chest pain; Lung and chest pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Feb2021 18:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included arthritis, inflammation, covid prior vaccination on 10Mar2020. The patient was no known allergies. There were no concomitant medications. On 04Feb2021 at 09:00, patient experienced severe body aches, headache, nausea, diarrhea, tiredness, feeling of unwell, lung and chest pain. There was no treatment. The patient was not pregnant. There was no covid tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pulmonary pain
Clinical narrative: Severe body aches; Headache; Nausea; Diarrhea; Tiredness; Feeling of unwell; Lung and chest pain; Lung and chest pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Feb2021 18:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included arthritis, inflammation, covid prior vaccination on 10Mar2020. The patient was no known allergies. There were no concomitant medications. On 04Feb2021 at 09:00, patient experienced severe body aches, headache, nausea, diarrhea, tiredness, feeling of unwell, lung and chest pain. There was no treatment. The patient was not pregnant. There was no covid tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK9231, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 10:30am (at the age of 37-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2, lot number: EH9899) via an unspecified route of administration, administered in left arm on 12Jan2021 10:30am for COVID-19 Immunization. Patient did not take other vaccine in four weeks. On 02Feb2021 the patient experienced, about 14 hours after 2nd dose, developed a fever of 101.5 and a headache. This lasted about 24 hours but improved, especially with over the counter dose of acetaminophen. Lower fever (100.5) persisted for another 24 hours. All symptoms resolved within 48 hours. Patient did not receive any treatment for AE. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient underwent lab tests and procedures which included body temperature: lower fever (100.5) on an unspecified date (Lower fever persisted for another 24 hours), body temperature is 101.5 on 02Feb2021. The outcome of the events was reported as recovered on 04Feb2021.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: headache; Soreness in left arm; nausea; swollen face on left side; dizziness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 in the right arm on 15Jan2021 (Lot number: unknown) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. On 05Feb2021, the patient experienced soreness in left arm, nausea, dizziness, swollen face on left side and headache. No treatment received for AE. On 07Feb2021, the patient tested COVID post vaccination. The patient tested Nasal Swab and the result was negative. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: headache; Soreness in left arm; nausea; swollen face on left side; dizziness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 in the right arm on 15Jan2021 (Lot number: unknown) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. On 05Feb2021, the patient experienced soreness in left arm, nausea, dizziness, swollen face on left side and headache. No treatment received for AE. On 07Feb2021, the patient tested COVID post vaccination. The patient tested Nasal Swab and the result was negative. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; This is a spontaneous report from a contactable 68-year-old male consumer reported for himself that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:30 (Batch/Lot number was not reported) as, SINGLE for covid-19 immunization. The patient's medical history included allergic to penicillin, erythromycin and lactose intolerant from an unknown date and unknown if ongoing. Concomitant medications included simvastatin, lisinopril and primidone; all used for unknown indication start and stop date was not provided. On 29Jan2021 at 07:00 AM, the patient experienced frequent headaches with tingling in fingers on left hand. Patient was not received any treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of both events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Headaches; dizziness; weakness; joint pain; tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262; Expiration Date: unknown) dose 1 via unspecified route of administered in Arm Left on 03Feb2021 11:45 AM as 1st DOSE SINGLE for covid-19 immunisation.  The patient medical history was essential thrombocytopenia. Concomitant medications included baby aspirin, lisinopril, pravastatin and tramadol. On 06Feb2021: 07:00 AM the patient experienced headaches dizziness weakness joint pain and tired. Outcome of the events was recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Today I have a headache/she has a slight headache; This is a spontaneous report from a contactable consumer (patient). A female of unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: EL9265, Expiry Date: Unknown), via an unspecified route of administration on 07Feb2021 as a, single dose for covid-19 immunization. The patient's medical History included seasonal allergies and sinuses form an unspecified date. Patient's concomitant medications were not reported. In Feb2021 on unspecified date. The patient reported that, she got the vaccine yesterday and she has a slight headache. She wants to know if can take Tylenol. she is not sure if the headache is from the vaccine or her sinuses; she has sinus issues from time to time. Patient also reported that, she has seasonal allergies which may be causing the headache. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, hyperlipidemia and iodine allergy. The patient received other medications in two weeks. The patient did not had COVID-19 prior to vaccination and did not tested for COVID post vaccination. The patient experienced low grade headache and slight soreness at the injection site on 18Jan2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021. Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Headache; Chills; tiredness; Sore; Felt not well; injection site is painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported for a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318) at 59-year-old as single dose for COVID-19 immunisation. Medical history included ongoing diabetes. Concomitant medication included metformin taken for diabetes. The patient got the first dose on 02Feb2201 and on 03Feb2021 been experiencing headache, chills, tiredness and injection site was painful. Consumer stated, "she got the shot on 02Feb2021 and on 03Feb2021 patient just at all days then she having headache and chills. I noticed "possibility" (not clarified) sore but her question was can patient take like Ibuprofen or something to deal with the headache". Consumer stated, "on 02Feb2021 she got (received vaccine) and this morning (03Feb2021) during the class time. She just felt not well. She calling to see if I can take Advil or ibuprofen for the headache down." When probed still having the problems, consumer stated, "(Yes)." Consumer added, "she just need to know she can take ibuprofen for this headache to "cool down" (not clarified). Outcome of the event headache was not recovered and all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Chills; tiredness; Sore; Felt not well; injection site is painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported for a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318) at 59-year-old as single dose for COVID-19 immunisation. Medical history included ongoing diabetes. Concomitant medication included metformin taken for diabetes. The patient got the first dose on 02Feb2201 and on 03Feb2021 been experiencing headache, chills, tiredness and injection site was painful. Consumer stated, "she got the shot on 02Feb2021 and on 03Feb2021 patient just at all days then she having headache and chills. I noticed "possibility" (not clarified) sore but her question was can patient take like Ibuprofen or something to deal with the headache". Consumer stated, "on 02Feb2021 she got (received vaccine) and this morning (03Feb2021) during the class time. She just felt not well. She calling to see if I can take Advil or ibuprofen for the headache down." When probed still having the problems, consumer stated, "(Yes)." Consumer added, "she just need to know she can take ibuprofen for this headache to "cool down" (not clarified). Outcome of the event headache was not recovered and all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache
Clinical narrative: Headache; chills; abdominal cramps; This is a spontaneous report from a non-contactable consumer [patient]. A 73-year-old non-pregnant female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration in left arm on 07Feb2021 at 12:45 (at the age of 73-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history included hip pain (meloxicam). Several past surgeries. No chronic health conditions. Concomitant medication included meloxicam for hip pain and super c vitamin (ascorbic acid). No allergies reported. No vaccinations in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 08Feb2021 at 13:15, the patient experienced headache, chills, abdominal cramps. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: patient that had a headache took a muscle relaxant, should have taken the second shot today.; This is a spontaneous report from a Pfizer-Sponsored Program by a contactable consumer. A Male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number was unknown), via an unspecified route of administration on an unknown date as single for COVID-19 immunisation. The patient's medical history, concomitant medications were not reported. The reporter stated that the patient that had a headache took a muscle relaxant, should have taken the second shot today. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected; Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: fever; runny nose; headache; nausea; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old non-regnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) first dose  via an unspecified route of administration on 26Jan2021 12:00  as SINGLE DOSE for Covid-19 immunisation.Medical history included and concomitant medications were not reported. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient was not administered any other vaccines for 2 weeks and patient had no allergies. On 26Jan2021 the patient experienced fever, runny nose, headache, nausea, body aches. The outcome of the events were recovered.  Batch/Lot number was not reported at the time of report completion for an unknown reason.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever for 15 hours >99.8 to max 102.5; Chills intermittently for 1 day; Headache throbbing 1 day; This is a spontaneous report from a contactable other health care professional (patient herself).  A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via unspecified route of administration, on 08Jan2021, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL3246), via unspecified route of administration, on 28Jan2021 (in left arm); both doses given at single dose, for Covid-19 immunization. The patient did not have covid prior to vaccination and had no allergies. The patient's medical history included oral contraceptive. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) at dose of 5 mg and piroxicam (PAXIL [PIROXICAM]) taken as oral contraceptive at dose of 30 mg OCP (oral contraceptive). On 29Jan2021 03:00 AM, the patient experienced fever for 15 hours >99.8 to max 102.5, chills intermittently for 1 day, and headache throbbing for 1 day. The patient did not receive any treatment for the events. The outcome of the event was considered as resolving.  Follow-up attempts are completed. No further information is expected.