chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia, SARS-CoV-2 test
Clinical narrative: severe migraine; a week of 102 fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 15Sep2021 10:00 (age at the time of vaccination: 33-year-old) as dose 2, single for covid-19 immunization administered in pharmacy or drug store. Patient was not pregnant at time of vaccination. Patient's relevant medical history included thyroid issues and unexplained infertility from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient was tested for covid-19. Concomitant medications included included PROGESTERONE, OVIDREL, LETROZOLE, and LEVOTHYROXINE taken for unknown indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FD8448) via an unspecified route of administration, administered in arm left on 24Aug2021 16:00 (age at the time of vaccination: 33-year-old) as dose 1, single for covid-19 immunization, and experienced severe persistent migraine, that started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure, fever 102 fever and gets worse with activity, condition worsened. The patient did not take any other vaccine in four weeks. On an unknown date in Sep2021, the patient had a severe migraine that patient continue to suffer from at this time (7-8 weeks after second shot). The pain intensity of the migraine did decrease after 3-4 weeks after shot, but had not ever gone away (patient had been in pain nonstop for over 2.5 months). On an unknown date in 2021, the Patient reported that had a week of 102 fever. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 24Aug2021 and on unspecified date in 2021 (after each shot, I had a week of 102 fever) and COVID test Binoin (sars-cov-2 test) resulted as negative on 25Aug2021 (post vaccination nasal swab). The patient did not receive any treatment for the adverse events. Outcome of the event a week of 102 fever was recovered on an unspecified date in 2021 and outcome of the other event was not recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: New onset tinnitus on day 4 after 3rd booster; Administration date 06Nov2021, dose number=3; This is a spontaneous report from a contactable physician, the patient. A 57-year-old non-pregnant female patient received 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 06Nov2021 at 07:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and hypothyroid. The patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and levothyroxine sodium (LEVOTHROID); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 56-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 10Nov2021 at 08:00, the patient experienced new onset tinnitus on day 4 after 3rd booster. The event new onset tinnitus on day 4 after 3rd booster did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event new onset tinnitus on day 4 after 3rd booster. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event new onset tinnitus on day 4 after 3rd booster was not resolved at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Bad migraine since 2nd shot; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030bd) via an unspecified route of administration in the left arm on 09Nov2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 19Oct2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 09Nov2021 at 16:30, the patient experienced bad migraine since the 2nd shot. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bad migraine since the 2nd shot was not recovered at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Immunisation, Lymphadenopathy, Neck pain
Clinical narrative: Headache; Lymph node swelling; Aches in neck and left arm-pit; Aches in neck and left arm-pit; General 'grogginess'; Administration date 10Nov2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 10Nov2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to walnuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an intramuscular route of administration in the left arm on 03Mar2021 (at the age of 35-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an intramuscular route of administration in the left arm on 24Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess'. The events headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess' 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 headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess'. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess' was resolving at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Headache; Lymph node swelling; Aches in neck and left arm-pit; Aches in neck and left arm-pit; General 'grogginess'; Administration date 10Nov2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 10Nov2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to walnuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an intramuscular route of administration in the left arm on 03Mar2021 (at the age of 35-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an intramuscular route of administration in the left arm on 24Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess'. The events headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess' 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 headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess'. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, lymph node swelling, aches in neck and left arm-pit and general 'grogginess' was resolving at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain
Clinical narrative: Headache; Swollen lymph nodes; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (COMIRNATY; Lot Number: Unknown) via an unspecified route of administration on 08Nov2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced headache, swollen lymph nodes and body aches. 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 headache, swollen lymph nodes and body aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on upper right chest, rear right neck, rear left neck; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included over the counter (OTC) levocetirizine dihydrochloride (XYZAL) from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced rash on upper right chest, rear right neck, rear left neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on upper right chest, rear right neck, rear left neck was not resolved at the time of this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Within 4 minutes of receiving the dose I had tingling in my left facial cheek area, left orbital socket and towards the left ear; I can not feel it; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 08Nov2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin calcium (CRESTOR); both from an unknown date for an unknown indication and unknown if ongoing. On 08Nov2021 at 14:04, within 4 minutes of receiving the dose the patient had tingling in his left facial cheek area, left orbital socket and towards the left ear. It felt like "novacaine" was wearing off from the dentist office. He could move his face, smile frown etc. But he could not feel. 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 within 4 minutes of receiving the dose he had tingling in his left facial cheek area, left orbital socket and towards the left ear and he could not feel was resolving at the time of report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Immunisation
Clinical narrative: Chest pain on right side of chest.; Pain between shoulders.; Patient received  third dose/ Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 10Nov2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 27Mar2021 (at the age of 30-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EV10151) via an unspecified route of administration on 17Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 10Nov2021 at 16:00, on the day of vaccination, the patient experienced chest pain on right side of chest and pain between shoulders. Reportedly chest pain was present the following day but was less severe. 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 chest pain on right side of chest and pain between shoulders were resolving at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle strain, Neck pain
Clinical narrative: I have had constant back pain starting the day after my shot. The pain is across my upper back between my shoulders and up to my neck. I can't even carry my purse for more then 5 minutes without pain and strain across my back.; I can't even carry my purse for more then 5 minutes without pain and strain across my back; The pain is across my upper back between my shoulders and up to my neck. I can't even carry my purse for more then 5 minutes without pain and strain across my back.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 21Oct2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 22Oct2021 at 07:00, the day after her shot, the patient had constant back pain. The pain was across her upper back between her shoulders and up to her neck. She could not even carry her purse for more than 5 minutes without pain and strain across her back. 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 not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events constant back pain/ pain across upper back between shoulders and up to neck and could not even carry purse for more than 5 minutes without pain and strain across back were not resolved at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Inappropriate schedule of product administration, Limb discomfort, Pain, Pain in extremity
Clinical narrative: I have an excruciating pain in mi right arm; SOMETIMES I CANNOT MOVE MI ARM I TRY & LIFT IT UP ITS SUPER HEAVY; SOMETIMES I CANNOT MOVE MI ARM I TRY &LIFT IT UP ITS SUPER HEAVY THAN ITS A SHOOTING PAIN FROM MI NECK TO MI CHEST BUT MOSTLY THE ARM; SOMETIMES I CANNOT MOVE MI ARM I TRY &LIFT IT UP ITS SUPER HEAVY THAN ITS A SHOOTING PAIN FROM MI NECK TO MI CHEST BUT MOSTLY THE ARM; Second dose of BNT162B2 was administered  after 42 days of first dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Jun2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 05Aug2021 at 00:00, the patient had an excruciating pain in her right arm and sometimes she could not move her arm. When the patient tried to lift it up, it was super heavy than it was a shooting pain from her neck to her chest but mostly the arm. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excruciating pain in right arm, sometimes could not move arm, tried and lifted it up it was super heavy than its a shooting pain from neck to chest but mostly the arm 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nipple pain, Nipple swelling, SARS-CoV-2 test
Clinical narrative: My left breast/nipple have become enlarged and sore to the touch; My left breast/nipple have become enlarged and sore to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 02May2021 at 15:00(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history included Crohn's disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the  left arm on 11Apr2021 at 15:00(at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 07:00, the patient's left breast/nipple had become enlarged and sore to the touch. On 21Sep2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events left breast/nipple had become enlarged and sore to the touch were not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Disturbance in attention, Fatigue, Headache, Immunisation
Clinical narrative: mild headache; Redness at injection site; Mild sore throat; Tiredness; Inability to focus; swelling and soreness in armpit/underarm on the side of injection; swelling and soreness in armpit/underarm on the side of injection.; sore arm on side of injections; The patient was received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 09Nov2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received 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: EN5318) via an unspecified route of administration on 11Mar2021(at the age of 33-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 01Apr2021(at the age of 33-years-old), both as a single dose for COVID-19 immunisation. The concomitant medications were not reported. On 10Nov2021, the patient experienced mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections. 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 not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Swelling, Vaccination site erythema
Clinical narrative: mild headache; Redness at injection site; Mild sore throat; Tiredness; Inability to focus; swelling and soreness in armpit/underarm on the side of injection; swelling and soreness in armpit/underarm on the side of injection.; sore arm on side of injections; The patient was received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 09Nov2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received 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: EN5318) via an unspecified route of administration on 11Mar2021(at the age of 33-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 01Apr2021(at the age of 33-years-old), both as a single dose for COVID-19 immunisation. The concomitant medications were not reported. On 10Nov2021, the patient experienced mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections. 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 not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 10Jun2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 18May2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient had just sore arm. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event just sore arm was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Immunisation
Clinical narrative: lack of energy; Chills; Headache; dose received 3; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via intramuscular route of administration in the right arm on 11Nov2021 at 12:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as type 1 diabetes, latent autoimmune diabetes in adults (LADA). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included insulin aspart (NOVOLOG), metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), colecalciferol (VIT D3), iron (MANUFACTURER UNKNOWN), vitamin b complex (B COMPLEX) and unspecified multivitamins (MV); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an intramuscular route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 49-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an intramuscular route of administration in the right arm on 22Apr2021 at 15:00 (at the age of 49-year-old); both as single dose for COVID-19 immunisation. On 12Nov2021 at 02:15, the patient experienced lack of energy, chills and headache. 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 lack of energy, chills and headache was resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Hypokinesia, Immunisation
Clinical narrative: dose received 3; Pain at the injection was unable to lift arm; was unable to lift arm; Headache; Low grade fever; Chills; Cough; "feels like the flu"; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Nov2021, as a single dose for COVID-19 immunisation. It was unknown if patient had any medical history or known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, both as single dose for COVID-19 immunisation. On 10Nov2021, the patient experienced pain at the injection and was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at the injection was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vaccination site pain
Clinical narrative: dose received 3; Pain at the injection was unable to lift arm; was unable to lift arm; Headache; Low grade fever; Chills; Cough; "feels like the flu"; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Nov2021, as a single dose for COVID-19 immunisation. It was unknown if patient had any medical history or known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, both as single dose for COVID-19 immunisation. On 10Nov2021, the patient experienced pain at the injection and was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at the injection was unable to lift arm, headache, low grade fever, chills, cough, and felt like the flu was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: blood clot in the brain; This is a spontaneous report from a contactable consumer, the patient.  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 07May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunisation. The patient experienced a blood clot in the brain on an unspecified date in Aug2021. The patient was hospitalized for having blood clot in the brain for 1 day. Therapeutic measures were taken as a result of blood clot in the brain with Lovenox. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Ankles and feet are swollen; Ankles and feet are swollen; I woke up and could barely walk; calfes were sore; This is a spontaneous report from a contactable consumer, the patient. A 41-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 the left arm on 22Sep2021 at 09:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation.  The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Sep2021 at 09:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. On 10Nov2021 at 07:00, the patient's ankles and feet were swollen like he was a 300-pounds man whereas the patient weight was 150 pounds. The patient did not know what was going on but when he woke up, he could barely walk because his calves were sore like he was lifting weights as well. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Nov2021, the patient underwent COVID-19 antigen test via nasal swab and the result was negative. The clinical outcome of the events ankles and feet are swollen, could barely walk because his calves were sore was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Myositis, Pain
Clinical narrative: The day following the booster injection in my left arm, the muscles in my in my left ribcage became inflamed; acutely painful to turn, cough, hiccup, inhale, lie down, get back up, lift with my left arm, etc.; prev dose brand=Moderna/ brand=Pfizer, dose number=3; dose received = 3/ The day following the booster injection; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received third dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Nov2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included left anterior descending artery (LAD) stent. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration in the right arm on 08Nov2021 for immunisation, within 4 weeks prior to COVID vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 67-year-old) and received second dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 67-year-old); both for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 11Nov2021 at 10:00, the day following the booster injection in the left arm, patient's muscles in the left ribcage became inflamed so that it was acutely painful for the patient to turn, cough, hiccup, inhale, lie down, get back up, lift with the left arm. This continued for two days before resolving. The patient experienced no side effects from the two Moderna vaccine shots in the same arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL EXTRA STRENGTH ) and rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the muscles in left ribcage became inflamed so that it was acutely painful to turn, cough, hiccup, inhale, lie down, get back up, lift arm was resolved on 13Nov2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Pyrexia
Clinical narrative: Chills; Fever (101 deg F); Tiredness; The patient received booster/ third dose of BNT162B2; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on 11Nov2021 at 18:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was reported that patient did not know if she had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 17Mar2021 (at the age of 54-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 07Apr2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. On 12Nov2021 the patient experienced chills, fever (101 degrees Fahrenheit) and tiredness. On the same day, the patient underwent body temperature test and the result was 101 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever and tiredness was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: diarrhea; severe abdominal cramping; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A 73-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 26Feb2021 (73-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: CL9264), via an unspecified route of administration on 05Feb2021 (73-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation and flu shot with which she had a bad reaction, extreme pain in her arm. The patient had not received any vaccine within four weeks. No additional vaccines were administered on same date of the Pfizer suspect. On 01Mar2021, the patient experienced diarrhea and severe abdominal cramping. The patient received the second dose of the vaccine and she had diarrhea. The patient wanted to know if this side effect was associated with the vaccine. The patient stated that the morning she was to receive the first dose of the vaccine, she took 2 regular strength Tylenol, to prevent side effects, because in the past with the flu shot she had a bad reaction, extreme pain in her arm. People told her that it's not recommended to take Tylenol before receiving the vaccine because that will make the injection not good. The patient wanted to know if this was true. She was nervous that by doing this she may not be protected from Covid-19. The patient received the second dose Friday 26Feb2021 at about 9 or 9:30 in the morning and then early Monday morning she had very severe abdominal cramping and after wards she went to the bathroom and had diarrhea in quick succession about 4 times. After that she felt like she was pretty much cleared out for the day and did not think too much about it but she was careful of what she ate, Tuesday she was fine, but Wednesday she had some diarrhea and this morning she had some diarrhea. The patient wanted to know if this was a side effect of the vaccine. The patient had one other question, she said like they say day late and a dollar short but with the first dose no one told her, she had a severe reaction to the flu shot with her arm took so she took 2 regular strength Tylenol before the COVID vaccine, no one told her not to do that. The patient wanted to know if Tylenol negate the vaccine. The patient had diarrhea earlier in the morning. It was ongoing but it was not severe and was off and on. The adverse events did not require a visit to emergency room or physician office. The outcome of the event diarrhea was not recovered while other event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: she is in severe pain; She was feeling nauseous and throwing up; She was feeling nauseous and throwing up; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient received the Pfizer shot (Covid vaccine) on Monday and Thursday night she started having severe migraine headaches and this morning she was feeling nauseous and throwing up and she still has the migraine headaches, she is in severe pain. Reporter wanted to report it and needed some advice what to do. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is in severe pain (migraine). On 27Mar2021 she was feeling nauseous and throwing up.  Therapeutic measures were taken as a result of she is in severe pain (migraine). She takes Advil migraine, it's the strongest cut down half of migraine headache because this is a symptom for maybe the Pfizer vaccine not supposed to do anything for the symptoms. The outcome of severe pain (migraine) was not recovered. The outcome of nauseous and throwing up was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.