chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Shortness of breath; heartbeat up a little bit; Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine.; Drowsiness dizziness; Headache; dizziness; Chills: Caller stated this started with the first dose of the vaccine and also with the second dose.; Sweating; could not move arm; pain at location; caller received the vaccine less than 3 weeks apart; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 intramuscular, administered in Arm Left on 19Apr2021 at 07:30 (age at vaccination 44-years-old) as dose 2, single for covid-19 immunization. The patient's medical history included fibromyalgia from an unknown. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in left arm on muscle on 05Apr2021 as dose 1, single for COVID-19 immunization which reported the events like Chills, Sweating, Pain at location, Could not move arm, Drowsiness dizziness, Headache and fatigue. In 2021, the patient received the vaccine less than 3 weeks apart. On Apr2021, had chills: patient stated that started with the first dose of the vaccine and with the second dose, had sweating and could not move arm, pain at location. On 19Apr2021, nausea: patient stated this started on the afternoon day he took the second dose of the vaccine, had drowsiness, dizziness, headache, heartbeat up a little bit. On 20Apr2021, the patient had shortness of breath. The Caller stated she has never had a doctor. She usually goes to her yearly gynecologist but her gynecologist was closing her practice and she was not working anymore. Caller stated she does not go to unwell review to see a healthcare doctor. The outcome of caller received the vaccine less than 3 weeks apart was unknown, Outcome of Chills: Caller stated this started with the first dose of the vaccine and with the second dose, Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine, Sweating and could not move arm were recovered on 21Apr2021. The outcome of heartbeat up a little bit was recovered on the same day. The outcome of Drowsiness dizziness, Headache, dizziness and pain at location was recovering, the outcome of Shortness of breath was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Mobility decreased, Nausea, Somnolence
Clinical narrative: Shortness of breath; heartbeat up a little bit; Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine.; Drowsiness dizziness; Headache; dizziness; Chills: Caller stated this started with the first dose of the vaccine and also with the second dose.; Sweating; could not move arm; pain at location; caller received the vaccine less than 3 weeks apart; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 intramuscular, administered in Arm Left on 19Apr2021 at 07:30 (age at vaccination 44-years-old) as dose 2, single for covid-19 immunization. The patient's medical history included fibromyalgia from an unknown. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in left arm on muscle on 05Apr2021 as dose 1, single for COVID-19 immunization which reported the events like Chills, Sweating, Pain at location, Could not move arm, Drowsiness dizziness, Headache and fatigue. In 2021, the patient received the vaccine less than 3 weeks apart. On Apr2021, had chills: patient stated that started with the first dose of the vaccine and with the second dose, had sweating and could not move arm, pain at location. On 19Apr2021, nausea: patient stated this started on the afternoon day he took the second dose of the vaccine, had drowsiness, dizziness, headache, heartbeat up a little bit. On 20Apr2021, the patient had shortness of breath. The Caller stated she has never had a doctor. She usually goes to her yearly gynecologist but her gynecologist was closing her practice and she was not working anymore. Caller stated she does not go to unwell review to see a healthcare doctor. The outcome of caller received the vaccine less than 3 weeks apart was unknown, Outcome of Chills: Caller stated this started with the first dose of the vaccine and with the second dose, Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine, Sweating and could not move arm were recovered on 21Apr2021. The outcome of heartbeat up a little bit was recovered on the same day. The outcome of Drowsiness dizziness, Headache, dizziness and pain at location was recovering, the outcome of Shortness of breath was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shortness of breath; heartbeat up a little bit; Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine.; Drowsiness dizziness; Headache; dizziness; Chills: Caller stated this started with the first dose of the vaccine and also with the second dose.; Sweating; could not move arm; pain at location; caller received the vaccine less than 3 weeks apart; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 intramuscular, administered in Arm Left on 19Apr2021 at 07:30 (age at vaccination 44-years-old) as dose 2, single for covid-19 immunization. The patient's medical history included fibromyalgia from an unknown. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in left arm on muscle on 05Apr2021 as dose 1, single for COVID-19 immunization which reported the events like Chills, Sweating, Pain at location, Could not move arm, Drowsiness dizziness, Headache and fatigue. In 2021, the patient received the vaccine less than 3 weeks apart. On Apr2021, had chills: patient stated that started with the first dose of the vaccine and with the second dose, had sweating and could not move arm, pain at location. On 19Apr2021, nausea: patient stated this started on the afternoon day he took the second dose of the vaccine, had drowsiness, dizziness, headache, heartbeat up a little bit. On 20Apr2021, the patient had shortness of breath. The Caller stated she has never had a doctor. She usually goes to her yearly gynecologist but her gynecologist was closing her practice and she was not working anymore. Caller stated she does not go to unwell review to see a healthcare doctor. The outcome of caller received the vaccine less than 3 weeks apart was unknown, Outcome of Chills: Caller stated this started with the first dose of the vaccine and with the second dose, Nausea: Caller stated this started on the afternoon day she took the second dose of the vaccine, Sweating and could not move arm were recovered on 21Apr2021. The outcome of heartbeat up a little bit was recovered on the same day. The outcome of Drowsiness dizziness, Headache, dizziness and pain at location was recovering, the outcome of Shortness of breath was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Grief reaction, Headache
Clinical narrative: Substantial pain at injection site; Headache; Neck pain; Lower back pain; Chills; Fever; Dizzy; 24 hours of grief; This is a spontaneous report from a non- contactable consumer (patient) or non-healthcare professional. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 30Mar2021 at 00:00 (at the age of 66-years-old) as dose 2, single and also the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Oct2021 at 00:00 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left leg on 09Mar2021 at 00:00 (at the age of 66-years-old), as dose 1, single for COVID-19 immunisation. On an unknown date in 2021, after the second dose, Patient experienced substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy and 24 hours of grief. On 06Oct2021 at 19:15, after the third dose the patient experienced the same events as that of second dose. This was significant enough to make it wonder if contacting COVID would be less impactful. 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 substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy, 24 hours of grief were resolving 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Substantial pain at injection site; Headache; Neck pain; Lower back pain; Chills; Fever; Dizzy; 24 hours of grief; This is a spontaneous report from a non- contactable consumer (patient) or non-healthcare professional. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 30Mar2021 at 00:00 (at the age of 66-years-old) as dose 2, single and also the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Oct2021 at 00:00 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left leg on 09Mar2021 at 00:00 (at the age of 66-years-old), as dose 1, single for COVID-19 immunisation. On an unknown date in 2021, after the second dose, Patient experienced substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy and 24 hours of grief. On 06Oct2021 at 19:15, after the third dose the patient experienced the same events as that of second dose. This was significant enough to make it wonder if contacting COVID would be less impactful. 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 substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy, 24 hours of grief were resolving 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nausea, Pain in extremity, Urticaria
Clinical narrative: Sore Arm; Nausea; headache; Booster dose; About 36 hours experienced pretty severe raised hives over front trunk of body up onto neck and small amount on face; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3590) via an unspecified route of administration in the right arm on 06Oct2021 at 10:15 (at the age of 68-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 67-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207) via an unspecified route of administration in the right arm on 20Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient also took previously azithromycin(Z-PAK) and experienced allergy, also took Macrobid and experienced allergy and hives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Oct2021, in first 24 hours, the patient experienced sore arm, nausea and headache. On an unknown date in Oct2021, about 36 hours the patient experienced pretty severe raised hives over front trunk of body up onto neck and small amount on face. She immediately started allegra twice daily which tamped down with 24 hrs. The patient had no problems with breathing. The patient reported that she had first time reaction to any immunization. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event pretty severe raised hives over front trunk of body up onto neck and small amount on face and included treatment with fexofenadine hydrochloride (ALLEGRA) twice daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, nausea and headache were resolved on 07Oct2021, while the clinical outcome of the event pretty severe raised hives over front trunk of body up onto neck and small amount on face was resolved on an unknown date in Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Immunisation, Off label use, Pain, Product use issue
Clinical narrative: BNT162b2 was administered on same day when Flu vaccine was administered; BNT162b2 was administered on same day when Flu vaccine was administered; dose number=3 administered; Fever; Tired; Aches; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 11Oct2021 17:00 (47-year-old at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 11Oct2021 (Batch/Lot number was not reported) to an unspecified date, at DOSE 1, SINGLE for immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 (47-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation and received second dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 (47-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation; both as a single dose for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were 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 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Oct2021, the patient experienced fever for more than 24 hours and felt tired and had aches. The clinical outcome of the events fever for more than 24 hours, tired and aches was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: BNT162b2 was administered on same day when Flu vaccine was administered; BNT162b2 was administered on same day when Flu vaccine was administered; dose number=3 administered; Fever; Tired; Aches; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 11Oct2021 17:00 (47-year-old at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 11Oct2021 (Batch/Lot number was not reported) to an unspecified date, at DOSE 1, SINGLE for immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 (47-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation and received second dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 (47-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation; both as a single dose for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were 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 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Oct2021, the patient experienced fever for more than 24 hours and felt tired and had aches. The clinical outcome of the events fever for more than 24 hours, tired and aches was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: Severe migraine; body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 32-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Er8736 and Expiration date was not reported), via an unspecified route of administration in arm left on 23Apr2021 at 15:45 (at the age of 32-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included asthma. Past drug event included morphine and experienced known allergies: morphine. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Ep7533 and Expiration date was not reported), via an unspecified route of administration in arm left on 02Apr2021 at 09:00 (at the age of 32-years-old) as a dose 1, single for COVID-19 immunization and patient experienced severe migraine, body aches, cough that got worse, slight fever, nauseated, diarrhea, just wanted to sleep and made her asthma worse using her rescue inhaler more frequently on the same date and time and the patient received gardasil vaccine (GARDASIL), via an unspecified route of administration on an unspecified date as an unspecified dose for an unspecified indication and experienced known allergies: gardasil vaccine. On an unspecified date in Apr2021, the patient experienced severe migraine, body aches both the times. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Viral upper respiratory tract infection
Clinical narrative: upper respiratory viral infection; This is a spontaneous report from a contactable pharmacist.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Reporter stated he had a patient that was supposed to receive her second shot of Pfizer covid vaccine on the day. Stated 3 days ago, on 19Oct2021 she had an upper respiratory viral infection and was currently being treated with Medrol dose pack. She was negative for covid 19 infection. Reporter wanted to know the information receiving covid shot while on medrol. Reporter also stated it was a corticosteroid and could impair the immune system and queried that were there any contraindications. Response: General Drug Interactions (v11.0) -Systemic corticosteroids administered short term (<14 days) for treatment of an acute illness had to be discontinued for at least 28 days before study intervention administration. The report was not serious. Patient underwent lab test and procedures which included on an unspecified date Covid 19 result was negative. Therapeutic measures were taken as a result of the events which included Medrol. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Joint dislocation, Joint swelling
Clinical narrative: fall and made knee swell and ankles; knee caps out of place to strengthen/ patella dislocation; fall and made knee swell and ankles; fall and made knee swell and ankles; This is a non-interventional study report from the marketing program received from a contactable consumer (patient). This is based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4074903-00).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), via intramuscular route of administration on an unspecified date as Dose 3 (Booster), Single for COVID-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number was not reported) via subcutaneous route as Dose 1 (1 in 1 once), Single, Dose 2 (1 in 1 once), Single, Dose 3 (1 in 1 once), Single from an unspecified date to an unspecified date for moderate to severe rheumatoid arthritis and psoriatic arthropathy. It was unknown date (reported as disco) if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history and concomitant medications reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported) via unspecified route of administration on an unspecified date as Dose 1, Single and via unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. On an unspecified date, patient experienced knee caps out of place to strengthen/ patella dislocation, slipped on ice/fall and made knee swell and ankles/ knee swelling and elbow swelling. Action taken with adalimumab (HUMIRA) was unknown. The outcome of the events was knee caps out of place to strengthen/ patella dislocation and joint swelling was not recovered, and the outcome of other events was recovered on an unknown date.  The reporter's causality for the event(s) of knee caps out of place to strengthen, slipped on ice and made knee swell and ankles and elbow swelling with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's causality for the event(s) of knee caps out of place to strengthen, slipped on ice and made knee swell and ankles and elbow swelling with BNT162B2 was possible.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further inform expected.; Sender's Comments: The evens of fall, patella dislocation, knee swelling and ankle swelling are unrelated to the suspect product BNT162B2 since fall is accidental due to slipping on ice and patella dislocation, knee swelling and ankle swelling are consequential to fall.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test
Clinical narrative: soreness in arm; received the J and J vaccine on 08Mar2021.  Pfizer vaccine was administered as a booster dose; received the J and J vaccine on 08Mar2021.  Pfizer vaccine was administered as a booster dose; This is a spontaneous report from a contactable consumer. This consumer reported for a 62-year-old female patient that: A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: 32030BD), dose 2 intramuscular, administered left arm on 22Oct2021 (at the age of 62-year-old) as DOSE 2 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had previously received first of COVID-19 VACCINE NRVV AD26 (JNJ 78436735), (Batch/lot number: unknown), via an unspecified route of administration on 08Mar2021. On 22Oct2021 the patient received the J and J vaccine on 08mar2021. Pfizer vaccine was administered as a booster dose. On 23Oct2021 the patient experienced the only side effect was soreness in arm the next day after vaccination. It was currently subsiding. The patient underwent lab tests and procedures which included COVID-19 test unknown results (Nasal Swab) on an unspecified date in 2021. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not received any treatment. The outcome of soreness in arm was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Feeling hot, Immunisation, Rash, Swelling
Clinical narrative: rash to red breast; rash to red breast; tenderness; swollen; heat and rash to red breast; Covid booster; Off-label use; This is a spontaneous report from a contactable physician received via a sales representative. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for Covid-19 immunization and influenza vaccine (FLU VACCINE VII, Lot number and expiry date: Not reported), via an unspecified route of administration from an unspecified date as Unknown dose, single for an unspecified indication. The patient's medical history included Type 1 diabetic, high blood pressure and a breast cancer survivor since 2020. The patient's concomitant medications were not reported. The patient previously received the past drugs BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown, Age at vaccination:49-year-old at vaccination) via an unspecified route of administration on an unspecified date as Dose 1, Single and Dose 2, Single for COVID-19 immunization. On an unspecified date, the patient experienced with tenderness, swollen, heat and rash to red breast. It was reported that she received both flu vaccine and Pfizer COVID-19 booster on the same day 12 prior to her symptoms. Event took place after use of product. It was suspected that it could be an inflammatory response to the 4th vaccine but wasn't certain, to be held reported seeing that on a rare occasion on other vaccinated individuals. The patient was prescribed and received treatment with 500 mg of Cephalexin capsules once a day for 7 days. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Tenderness
Clinical narrative: rash to red breast; rash to red breast; tenderness; swollen; heat and rash to red breast; Covid booster; Off-label use; This is a spontaneous report from a contactable physician received via a sales representative. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for Covid-19 immunization and influenza vaccine (FLU VACCINE VII, Lot number and expiry date: Not reported), via an unspecified route of administration from an unspecified date as Unknown dose, single for an unspecified indication. The patient's medical history included Type 1 diabetic, high blood pressure and a breast cancer survivor since 2020. The patient's concomitant medications were not reported. The patient previously received the past drugs BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown, Age at vaccination:49-year-old at vaccination) via an unspecified route of administration on an unspecified date as Dose 1, Single and Dose 2, Single for COVID-19 immunization. On an unspecified date, the patient experienced with tenderness, swollen, heat and rash to red breast. It was reported that she received both flu vaccine and Pfizer COVID-19 booster on the same day 12 prior to her symptoms. Event took place after use of product. It was suspected that it could be an inflammatory response to the 4th vaccine but wasn't certain, to be held reported seeing that on a rare occasion on other vaccinated individuals. The patient was prescribed and received treatment with 500 mg of Cephalexin capsules once a day for 7 days. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: I had a rash and about the rash was on buttock.; I started with shingles/It look like shingles that hurt.; This is a spontaneous report from a contactable consumer or other non hcp.   A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: 30155BA), dose 3 via an unspecified route of administration, administered in Arm Left on 18Oct2021 (at the age of 68 years) as dose 3 (booster), single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included denosumab (PROLIA). The patient previously took bnt162b2 for covid-19 immunization as dose 1, bnt162b2 for covid-19 immunization as dose 2, shingrix, omeprazole for neoplasm malignant. On 18Oct2021 the patient experienced a rash on buttock and started with shingles/it look like shingles that hurt. Patient went to the doctor yesterday and they said patient started with shingles that patient got the Pfizer the 3rd booster, that got it on Monday and on that evening she had this rash so she didn't know whether the rash was from the vaccine because she had read somewhere where you can get a rash from it or what was that number now I have 3 of the vaccine for shingles before (Further not clarified) and so anyway are they see nurse practitioner says that it look like shingles that hurt so I just (Sentence Incomplete). Patient have put some Polysporin on the rash and it was going to get better and you know what made it feels like sick in that and everything and then doctor gave me. It was a pill Val acyclovir and all its Valacyclovir 1 mg tablet, one tablet every eight hours for seven days and then they ordered me something to put on the rash when she went out there after several hours its done already they have to call the doctor and then doctor had to call them back. Probably 2 weeks before she had an injection in the left arm she had Prolia injection in her side arm so she give me some medicines an omeprazole to take and that is supposed to treat me from having the cancer again hopefully. Clinical outcome of the events was reported as unknown.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthritis, Back pain, Condition aggravated, Fatigue
Clinical narrative: Current-Hair loss; Skin rash; intermittent left lower sharp back pain; swollen lymph node; headaches; arthritis pain worse; arthritis pain worse; tired; hair shedding; flue like Symptoms; Other vaccine same date vaccine date 09Sep2021; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0185 MUSC), via an unspecified route of administration, administered in Arm Left on 09Sep2021 (age at vaccination 62-Years-old) as dose 3 (booster), single for COVID-19 immunization; SHINGRIX, via an unspecified route of administration from 09Sep2021 (Batch/Lot number was not reported) to 09Sep2021, at unspecified dose for an unspecified indication . Medical history included arthritis from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , blood iron decreased from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); chorionic gonadotrophin (HTROP); colecalciferol (VIT D [COLECALCIFEROL]); calcium (CALCIUM) and fish/flack seed all taken for an unspecified indication, start and stop date were not reported. The patient previously took, niacin and experienced drug hypersensitivity, statins and experienced drug hypersensitivity. Patient previously received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (age at vaccination 61-Years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL3249 MUSC), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (age at vaccination 61-Years-old) as dose 2, single for COVID-19 immunization. on an unspecified date patient experienced current-Hair loss, Skin rash, intermittent left lower sharp back pain after vac- swollen lymph node, headaches, arthritis pain worse, tired, hair shedding, flue like Symptoms. HAIR LOSS is my biggest concern and 09Sep2021, other vaccine same date vaccine date 09sep2021, dose number=3. Patient did not received any treatment. The outcome events other vaccine same date vaccine date 09sep2021, dose number=3 was unknown and rest all was not received.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hair disorder, Headache, Immunisation, Influenza like illness, Lymphadenopathy
Clinical narrative: Current-Hair loss; Skin rash; intermittent left lower sharp back pain; swollen lymph node; headaches; arthritis pain worse; arthritis pain worse; tired; hair shedding; flue like Symptoms; Other vaccine same date vaccine date 09Sep2021; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0185 MUSC), via an unspecified route of administration, administered in Arm Left on 09Sep2021 (age at vaccination 62-Years-old) as dose 3 (booster), single for COVID-19 immunization; SHINGRIX, via an unspecified route of administration from 09Sep2021 (Batch/Lot number was not reported) to 09Sep2021, at unspecified dose for an unspecified indication . Medical history included arthritis from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , blood iron decreased from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); chorionic gonadotrophin (HTROP); colecalciferol (VIT D [COLECALCIFEROL]); calcium (CALCIUM) and fish/flack seed all taken for an unspecified indication, start and stop date were not reported. The patient previously took, niacin and experienced drug hypersensitivity, statins and experienced drug hypersensitivity. Patient previously received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (age at vaccination 61-Years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL3249 MUSC), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (age at vaccination 61-Years-old) as dose 2, single for COVID-19 immunization. on an unspecified date patient experienced current-Hair loss, Skin rash, intermittent left lower sharp back pain after vac- swollen lymph node, headaches, arthritis pain worse, tired, hair shedding, flue like Symptoms. HAIR LOSS is my biggest concern and 09Sep2021, other vaccine same date vaccine date 09sep2021, dose number=3. Patient did not received any treatment. The outcome events other vaccine same date vaccine date 09sep2021, dose number=3 was unknown and rest all was not received.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: Current-Hair loss; Skin rash; intermittent left lower sharp back pain; swollen lymph node; headaches; arthritis pain worse; arthritis pain worse; tired; hair shedding; flue like Symptoms; Other vaccine same date vaccine date 09Sep2021; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0185 MUSC), via an unspecified route of administration, administered in Arm Left on 09Sep2021 (age at vaccination 62-Years-old) as dose 3 (booster), single for COVID-19 immunization; SHINGRIX, via an unspecified route of administration from 09Sep2021 (Batch/Lot number was not reported) to 09Sep2021, at unspecified dose for an unspecified indication . Medical history included arthritis from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , blood iron decreased from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); chorionic gonadotrophin (HTROP); colecalciferol (VIT D [COLECALCIFEROL]); calcium (CALCIUM) and fish/flack seed all taken for an unspecified indication, start and stop date were not reported. The patient previously took, niacin and experienced drug hypersensitivity, statins and experienced drug hypersensitivity. Patient previously received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (age at vaccination 61-Years-old) as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL3249 MUSC), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (age at vaccination 61-Years-old) as dose 2, single for COVID-19 immunization. on an unspecified date patient experienced current-Hair loss, Skin rash, intermittent left lower sharp back pain after vac- swollen lymph node, headaches, arthritis pain worse, tired, hair shedding, flue like Symptoms. HAIR LOSS is my biggest concern and 09Sep2021, other vaccine same date vaccine date 09sep2021, dose number=3. Patient did not received any treatment. The outcome events other vaccine same date vaccine date 09sep2021, dose number=3 was unknown and rest all was not received.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Herpes zoster, Inappropriate schedule of product administration, Ocular hyperaemia
Clinical narrative: My right eye became red and tender; My right eye became red and tender; Diagnosed with herpes zoster infection from an inflammatoryresponse from the COVID vaccine.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FD8448), via an unspecified route of administration, administered in arm left on 28Sep2021 at 17:00 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 03130BA), via an unspecified route of administration, administered in arm right on 24Sep2021 at 20:30 as dose 1, single for COVID-19 immunization. The facility type vaccine was reported as pharmacy or drug store. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The patient had no known allergies. On 09Oct2021 at 05:30, patient experienced her right eye became red and tender. Diagnosed with herpes zoster infection from an inflammatory response from the COVID vaccine. On 28Sep2021 at 17:00, experienced inappropriate schedule of vaccine administered. Therapeutic measures were taken as a result of adverse event which included Valaciclvir, Erythromycin eye drops and ointment. Adverse events resulted in physician office visit. The clinical outcome for the event my right eye became red and tender, diagnosed with herpes zoster infection from an inflammatory response from the covid vaccine was reported as recovering while for the event inappropriate schedule of vaccine administered was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Facial spasm, Migraine, Muscle spasms, Photophobia
Clinical narrative: extreme sensitivity to light; severe migraines; facial muscle spasms; facial muscle spasms; Extreme stomach pain in upper stomach; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FF8814) via an unspecified route of administration, administered in Arm Left on 22Oct2021 16:00 (age 37-years at the time of vaccination), as single dose for COVID-19 immunization. Medical history included colitis ulcerative, generalised anxiety disorder, panic attack, bipolar hypertension retaining of fluid at times insomnia, patient previously took iodine and experienced drug hypersensitivity, allergy to chemicals, rubber sensitivity. Concomitant medication included sertraline hydrochloride (ZOLOFT), lithium, amitriptyline, quetiapine fumarate (SEROQUEL), metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior to vaccination. On 23Oct2021 20:30 the patient experienced extreme stomach pain in upper stomach, extreme sensitivity to light, severe migraines, and facial muscle spasms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Apr2020 Nasal Swab, sars-cov-2 test: negative on 16Nov2020 Nasal Swab, sars-cov-2 test: negative on 29Aug2021 Nasal Swab, sars-cov-2 test: negative on 24Sep2021 Blood test done. The outcome of all the events was not recovered.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.