chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Rash vesicular, SARS-CoV-2 test, Secretion discharge
Clinical narrative: Instant effect of chest tightness; Palpitations; Increased HR; Dizziness; Blister like rash; excessive phlegm/mucus; excessive phlegm/mucus; Nausea; Vomitting; Diarrohea; body/joint pain; joint pain; Headache; High temperature; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0177), via an unspecified route of administration, in arm left on 27Jul2021 at 08:45 (age at vaccination 53 year) as dose 1, single for covid-19 immunisation. Medical history included non-seasonal allergies, anxiety, overweight and arthritis in multiple joints. The patient had Covid prior vaccination. No other vaccines were received in four weeks. Concomitant medications included sertraline; clonazepam (KLONOPIN); acorus calamus, bacopa monnieri, celastrus paniculatus, centella asiatica, evolvulus alsinoides, foeniculum vulgare, glycyrrhiza glabra, myristica fragrans, terminalia arjuna, withania somnifera (COGNIUM); cetirizine since an unknown date. The patient was allergic to Dilaud and Albuterol. On 27Jul2021, the patient experienced instant effect of chest tightness, palpitations, increased hr, dizziness, and several hours later blister like rash, high temperature nausea, vomiting, diarrhea, body/joint pain, severe headache and excessive phlegm/mucus. The patient underwent lab tests which included body temperature as high on 27Jul2021. The patient was tested for Covid tested post vaccination via Nasal Swab on 28Jul2021 with result as Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with Z PAC. FLUTICAZONE. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Instant effect of chest tightness; Palpitations; Increased HR; Dizziness; Blister like rash; excessive phlegm/mucus; excessive phlegm/mucus; Nausea; Vomitting; Diarrohea; body/joint pain; joint pain; Headache; High temperature; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0177), via an unspecified route of administration, in arm left on 27Jul2021 at 08:45 (age at vaccination 53 year) as dose 1, single for covid-19 immunisation. Medical history included non-seasonal allergies, anxiety, overweight and arthritis in multiple joints. The patient had Covid prior vaccination. No other vaccines were received in four weeks. Concomitant medications included sertraline; clonazepam (KLONOPIN); acorus calamus, bacopa monnieri, celastrus paniculatus, centella asiatica, evolvulus alsinoides, foeniculum vulgare, glycyrrhiza glabra, myristica fragrans, terminalia arjuna, withania somnifera (COGNIUM); cetirizine since an unknown date. The patient was allergic to Dilaud and Albuterol. On 27Jul2021, the patient experienced instant effect of chest tightness, palpitations, increased hr, dizziness, and several hours later blister like rash, high temperature nausea, vomiting, diarrhea, body/joint pain, severe headache and excessive phlegm/mucus. The patient underwent lab tests which included body temperature as high on 27Jul2021. The patient was tested for Covid tested post vaccination via Nasal Swab on 28Jul2021 with result as Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with Z PAC. FLUTICAZONE. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Rhinorrhoea, Swollen tongue, Tongue erythema
Clinical narrative: has a numb area on her tongue and there is a red patch on the area where it is numb; has a numb area on her tongue and there is a red patch on the area where it is numb; tongue is swollen; she is having a lot of mucus ever since the COVID vaccine; This is a spontaneous report received from a contactable consumer (patient's husband) via Pfizer sponsored program.  A 39-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FA7485, Expiration date and NDC number was unknown), via an unspecified route of administration, administered on 26Jul2021 as dose 1, single (at the age of 39-year-old) for COVID-19 immunization. The patient had no medical history and did not receive concomitant medications. On 26Jul2021, patient's husband was unsure if this was relevant, but patient was having a lot of mucus ever since the COVID vaccine. On 27Jul2021, patient had a numb area on her tongue and there was a red patch on the area where it was numb, tongue was swollen, it had become slightly swollen. There were spots going around her tongue, all the way around it and it goes around the outside rim of her tongue and there was one spot on top of her tongue. The spot got bigger on the tongue. It was reported that numb area on her tongue and there was a red patch on the area where it was numb was worsened. They were worried about if it was going to be safe to get the second dose. Patient still has it now. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain in her armpit/7 days after experiencing pain under her arm pit; pain under her arm pit, tender and burning; its tender/tender pain.; It is the pain in the same arm, left arm on injection side.; fever; pain; pain in the same arm; This is a spontaneous report from a contactable consumer or other Non-Healthcare professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Left on 11Jun2021 (At the age of 47-Years), as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date, as dose 1, single (at the age of 47 years) for covid-19 immunization. On 18Jun2021, after the 7 days of vaccination, the patient experienced pain in her armpit/7 days after experiencing pain under her arm pit, pain under her arm pit, tender and burning, its tender/tender pain and on an unspecified date in Jun2021, the patient experienced the pain in the same arm, left arm on injection side, fever, pain and pain in the same arm. Caller mentioned she had both shots of Pfizer COVID vaccine, the second dose on 11Jun2021. 7 days after experiencing pain under her arm pit, tender and burning. Until now almost one month later she still had that pain. It was the pain in the same arm, left arm on injection side.  She had fever and pain and after 7 days began experiencing under her arm, it's not visible, she didn't know if it was a lymph node. Her doctor told her that it was related to the vaccine, a strong response. After 7 days the caller started experiencing this type of pain, its tender. It was burning and tender pain. The clinical outcome of the event fever was unknown at the time of this report. However, the clinical outcome of rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: pain in her armpit/7 days after experiencing pain under her arm pit; pain under her arm pit, tender and burning; its tender/tender pain.; It is the pain in the same arm, left arm on injection side.; fever; pain; pain in the same arm; This is a spontaneous report from a contactable consumer or other Non-Healthcare professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Left on 11Jun2021 (At the age of 47-Years), as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date, as dose 1, single (at the age of 47 years) for covid-19 immunization. On 18Jun2021, after the 7 days of vaccination, the patient experienced pain in her armpit/7 days after experiencing pain under her arm pit, pain under her arm pit, tender and burning, its tender/tender pain and on an unspecified date in Jun2021, the patient experienced the pain in the same arm, left arm on injection side, fever, pain and pain in the same arm. Caller mentioned she had both shots of Pfizer COVID vaccine, the second dose on 11Jun2021. 7 days after experiencing pain under her arm pit, tender and burning. Until now almost one month later she still had that pain. It was the pain in the same arm, left arm on injection side.  She had fever and pain and after 7 days began experiencing under her arm, it's not visible, she didn't know if it was a lymph node. Her doctor told her that it was related to the vaccine, a strong response. After 7 days the caller started experiencing this type of pain, its tender. It was burning and tender pain. The clinical outcome of the event fever was unknown at the time of this report. However, the clinical outcome of rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right arm, right foot, and left foot; This is a spontaneous report from a contactable consumer (patient) via regulatory authority support.  A female patient of unspecified age (age: 49, units: unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8734) via intramuscular route, administered in Right arm on 19Apr2021 (age at vaccination 49-year-old) as Dose 2, Single for Covid-19 immunization. The patient was related to a study or programme The patient's had no medical history and concomitant medications. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: Not reported) via an unspecified route of administered in Left arm on 29Mar2021 (age at vaccination 49-year-old) as Dose 1, Single for Covid-19 immunization and no events reported. On an unknown date in May2021 (months after second dose), the patient experienced rash on right arm, right foot, and left foot. Rash comes and goes. These AE(s) were worsened. She confirmed that rash was not on her face, fingers, or on her legs. She doesn't know if it's from the shot. No investigation assessment was reported. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Hot flush, Hypoaesthesia, Paraesthesia
Clinical narrative: facial numbness & tingling/ my right fingertips went numb; facial numbness & tingling; my face & lips felt like they had been shot full of novocaine.; my hot flashes came back; loss of taste in the right side of my mouth.; The numbness in my fingers went away; This is a spontaneous report from a contactable consumer. A 60 year old female patient received second dose of bnt162b2 (COMIRNATY solution for injection, Batch/Lot Number: GN6204) via an unspecified route of administration, administered in Arm Left on 8Mar2021 04:00 PM as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing and allergic reaction to sulpha drugs from an unknown date and was unknown if ongoing. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ)  taken for an unspecified indication, start and stop date were not reported. The patient experienced right fingertips went numb, the lower, right quadrant of face & lips felt like they had been shot full of novocaine, hot flashes came back (but only to face) with a vengeance, the numbness in fingers went away, facial numbness & tingling and loss of taste in the right side of mouth on 10Mar2021. Patient did not receive treatment for these events. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient reported that 2 days after 2nd dose of the vaccine, patients' right fingertips went numb. The lower, right quadrant of her face & lips felt like they had been shot full of novocaine. And, after 2 years, her hot flashes came back (but only to her face) with a vengance. The numbness in her fingers went away, but the patient is still plagued by the facial numbness & tingling and loss of taste in the right side of mouth. And, the severity of the hot flashes has increased. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The most recent COVID-19 vaccine was administered at Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of the event numbness in fingers was recovered and of other events was not recovered.  No follow-up attempts are possible; No further information is expected  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever; Sore arm; tired; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 14-year-old female patient in response to Non-HCP letter sent in cross referenced case that included:  A 14-years-old female patient received bnt162b2 (BNT162B2 Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 16:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in Arm Left on 14May2021 at 4pm as dose 1 single for covid-19 immunisation, the patient experienced chills, fever and sore arm. The patient experienced, the same fever but it tasted 2 days. Overall tolerance of second dose was not better. Sore arm, tired, fever for 2days, on an unspecified date in 2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pyrexia
Clinical narrative: She was having high fever.; she is  having like stuffiness.; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FA7484 and expiration date: unknown), via an unspecified route of administration on 29Jul2021 as dose 2, single (at the age of 12-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021, the patient experienced high fever and she is having like stuffiness. On an unspecified date, the patient underwent lab tests and procedures which included body temperature is high. Therapeutic measures were taken as a result of event fever with Tylenol and Motrin and therapeutic measures were not taken for event stuffiness. The outcome of event fever was recovered on an unspecified date in 2021 and stuffiness was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever of 101.2; Headache; This is a spontaneous report from a contactable consumer(parent). A 15-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration on 29Jul2021 14:30 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient (reporter's daughter) got her first Pfizer yesterday afternoon around 2:30 and on 30Jul2021 she had fever of 101.2 and she got a headache. The patient underwent lab tests and procedures which included body temperature: 101.2 on 30Jul2021. She did not have prior vaccination within four weeks. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Rash erythematous, Skin discolouration, Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration, administered in Arm Left on 28Jul2021 12:00 (at the age of 69-year-old) as dose 2, single for COVID-19 immunization at Pharmacy. The patient medical history and concomitant medications were not reported. Relevant past drug history was none. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration, administered in Arm Left on 07Jul2021 at 11:00 am (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Jul2021 at 22:00, the patient experienced large red swollen rash on arm where it was administered and on 29Jul2021, patient had covid arm, large hard swollen lump-ned, that hurt to touch, skin has a small amount of discoloration left, have a mild burning sensation where the lump was. Seriousness criteria was reported as not Serious. Patient had not received any treatment. It was reported that, Swelling was almost all gone. Patient still had a mild burning sensation where the lump was, but it seems to be getting better. Patient did not have any other side effects. Clinical outcome of the events large red swollen rash on arm where it was administered was not recovered and recovering for rest events.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration, administered in Arm Left on 28Jul2021 12:00 (at the age of 69-year-old) as dose 2, single for COVID-19 immunization at Pharmacy. The patient medical history and concomitant medications were not reported. Relevant past drug history was none. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration, administered in Arm Left on 07Jul2021 at 11:00 am (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Jul2021 at 22:00, the patient experienced large red swollen rash on arm where it was administered and on 29Jul2021, patient had covid arm, large hard swollen lump-ned, that hurt to touch, skin has a small amount of discoloration left, have a mild burning sensation where the lump was. Seriousness criteria was reported as not Serious. Patient had not received any treatment. It was reported that, Swelling was almost all gone. Patient still had a mild burning sensation where the lump was, but it seems to be getting better. Patient did not have any other side effects. Clinical outcome of the events large red swollen rash on arm where it was administered was not recovered and recovering for rest events.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Movement disorder, Musculoskeletal stiffness, Neck pain
Clinical narrative: movement very limited; very stiff; First Dose: Apr 1 2021/Second dose: 13 Apr 2021; pain that starts at the injection site and goes into the shoulder and neck; pain that starts at the injection site and goes into the shoulder and neck; pain that starts at the injection site and goes into the shoulder and neck; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Age at Vaccination 62-years-old) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. Medical history included glaucoma, since age 19, corrective lens user. States she is going to need her glasses because of the teensy writing on the bottle. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for radiation thyroiditis; bimatoprost (LUMIGAN) taken for glaucoma; hyaluronate sodium, macrogol 400, propylene glycol (SYSTANE HYDRATION) taken for dry eye. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Age at Vaccination 62-years-old) as DOSE 1 SINGLE for COVID-19 immunization and experienced Pain that starts at the injection site and goes into the shoulder and neck. On 13Apr2021, the patient had First Dose: Apr 1, 2021/Second dose: 13 Apr 2021, pain that starts at the injection site and goes into the shoulder and neck, on an unknown date experienced movement very limited, very stiff. It was reported that she received her first dose on 01Apr2021/second dose on 13Apr2021 seemed like it was the right thing to do. Whenever she had trouble, she had taken Ibuprofen both times during first and second dose for only maybe a day and half so, did not visited emergency room or physician's office. The outcome for the event was unknown.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: movement very limited; very stiff; First Dose: Apr 1 2021/Second dose: 13 Apr 2021; pain that starts at the injection site and goes into the shoulder and neck; pain that starts at the injection site and goes into the shoulder and neck; pain that starts at the injection site and goes into the shoulder and neck; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Age at Vaccination 62-years-old) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. Medical history included glaucoma, since age 19, corrective lens user. States she is going to need her glasses because of the teensy writing on the bottle. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for radiation thyroiditis; bimatoprost (LUMIGAN) taken for glaucoma; hyaluronate sodium, macrogol 400, propylene glycol (SYSTANE HYDRATION) taken for dry eye. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Age at Vaccination 62-years-old) as DOSE 1 SINGLE for COVID-19 immunization and experienced Pain that starts at the injection site and goes into the shoulder and neck. On 13Apr2021, the patient had First Dose: Apr 1, 2021/Second dose: 13 Apr 2021, pain that starts at the injection site and goes into the shoulder and neck, on an unknown date experienced movement very limited, very stiff. It was reported that she received her first dose on 01Apr2021/second dose on 13Apr2021 seemed like it was the right thing to do. Whenever she had trouble, she had taken Ibuprofen both times during first and second dose for only maybe a day and half so, did not visited emergency room or physician's office. The outcome for the event was unknown.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: the rash occurred after the second vaccine, started two days sooner; This is a spontaneous report from a contactable consumer (patient). A 22 years old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as Dose 2, Single for covid-19 immunization at Health Clinic. The patient's medical history included known allergies to sulfa drugs, ceclor, amoxicillin. The patient's concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with covid prior vaccination. Since the vaccination, the patient had been tested for COVID-19 with negative result. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 22-year-old) as Dose 1, Single for Covid-19 immunization and experienced rash on thighs, calves, buttocks, the rash occurred after the second vaccine, started two days sooner. The rash recurrence after the second vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 18Apr2021 (post vaccination). The patient received treatment for resulted event. The outcome of event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Photophobia, Rash
Clinical narrative: headache; pain in my eyes; sensitivity to light; Chills; rash is huge; injection site started to itch/rash is huge; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ew0171), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 12:45 (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sometimes seasonal allergies, WPW syndrome (wolff-parkinson-white syndrome) and SVT heart problem. Concomitant medications included BENADRYL taken for seasonal allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Er8737), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 07:00 (at the age of 46-years-old) as DOSE1, SINGLE for covid-19 immunisation and experienced pain in extremity. Patient did not receive any other vaccine in four weeks. The patient reported that second dose had at 1 pm got home and was ok on 28Apr2021, until 7 pm, after a headache started than pain in my eyes sensitivity to light so I went to bed did not take a pain killer, had pain all night, body aches, chills but no high fever at all next day excruciating pain so at 2 pm like 25 hours, after the injection patient took ibuprofen 600 mg and it helped a lot gradually, injection site started to itch, patient took Benadryl on the 29Apr2021 at night and today the rash was huge but not itchy. Patient was not tested Covid post vaccination. Therapeutic measures was taken due to the events and patient was treated with ibuprofen 600 mg were taken as a result of headache, pain in my eyes, chills, and Benadryl was taken for injection site started to itch and rash (over the counter medications). The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: headache; pain in my eyes; sensitivity to light; Chills; rash is huge; injection site started to itch/rash is huge; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ew0171), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 12:45 (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sometimes seasonal allergies, WPW syndrome (wolff-parkinson-white syndrome) and SVT heart problem. Concomitant medications included BENADRYL taken for seasonal allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Er8737), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 07:00 (at the age of 46-years-old) as DOSE1, SINGLE for covid-19 immunisation and experienced pain in extremity. Patient did not receive any other vaccine in four weeks. The patient reported that second dose had at 1 pm got home and was ok on 28Apr2021, until 7 pm, after a headache started than pain in my eyes sensitivity to light so I went to bed did not take a pain killer, had pain all night, body aches, chills but no high fever at all next day excruciating pain so at 2 pm like 25 hours, after the injection patient took ibuprofen 600 mg and it helped a lot gradually, injection site started to itch, patient took Benadryl on the 29Apr2021 at night and today the rash was huge but not itchy. Patient was not tested Covid post vaccination. Therapeutic measures was taken due to the events and patient was treated with ibuprofen 600 mg were taken as a result of headache, pain in my eyes, chills, and Benadryl was taken for injection site started to itch and rash (over the counter medications). The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: with receipt of 3rd (booster) covid vaccination; This case is considered invalid as there are no indication that patient experienced an event under the suspect drug (bnt162b2).  This is a spontaneous report from a contactable Nurse. A 58-year-old non-pregnant female patient 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 (at the age of 58-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient experienced receipt of 3rd (booster) covid vaccination on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up on 22Oct2021 this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.  This follow-up report is being submitted to amend previously reported information reassessed the case as invalid.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Somnolence
Clinical narrative: her son has been sleeping 14-16 hours a day; her son wasn't eligible to receive the vaccine yet; This is a spontaneous report from a contactable consumer or other non hcp.   A 10-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID19 MRNA SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Consumer said her 10-year-old son received both doses of the Pfizer-BioNTech Covid-19 Vaccine. However, it wasn't until after his 2nd dose that she realized her son wasn't eligible to receive the vaccine yet. She is seeking for recommendations on what to do. She said it has already been 5 days, and her son has been sleeping 14-16 hours a day the patient experienced her son wasn't eligible to receive the vaccine yet, her son has been sleeping 14-16 hours a day on an unspecified date with outcome of unknown.   Follow up (22Sep2021): This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported information included.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Amendment: This follow up report is being submitted to amend previously reported information: Recoded event "Off label use in unapproved age group" to "Inappropriate age at vaccine administration".
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose decreased, Blood pressure decreased, Blood pressure measurement
Clinical narrative: tachycardia; hands and nail bed turned blue; blood sugar and blood pressure dropped; blood sugar and blood pressure dropped; weakness; dizziness; very pale; hands were icy cold; labyrinthitis; This is a spontaneous report from a contactable nurse (reporting herself). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Aug2021 (at the age of 37-years-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, supraventricular tachycardia (does carry an EpiPen and said heart is not functioning great) and allergy. The patient's concomitant medications were not reported. On 20Aug2021, the patient received her first dose of the vaccine, about 10 minutes after administration, patient experienced tachycardia, forty-five minutes to one hour after administration her hands and nail bed turned blue, blood sugar and blood pressure dropped, she experienced weakness, dizziness, hands were icy cold, labyrinthitis and was reportedly very pale. It was reported that not even 45 minutes to maybe an hour after receiving the first dose Pfizer BioNTech Vaccine, the caller hands and nailbeds turned blue, hands were icy cold, blood sugar dropped, blood pressure dropped, everything dropped. The caller was transported to the emergency room from the caller department she works in, the caller coworkers called the paramedics. In the emergency department where she was told she had labyrinthitis and severe dizziness and was prescribed steroids. The patient was out of work for two weeks. On 20Aug2021, the patient underwent lab tests and procedures which included blood glucose was dropped, blood pressure measurement was dropped. The patient outcome of the events was unknown at the time of this report.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dizziness, Labyrinthitis, Pallor, Peripheral coldness
Clinical narrative: tachycardia; hands and nail bed turned blue; blood sugar and blood pressure dropped; blood sugar and blood pressure dropped; weakness; dizziness; very pale; hands were icy cold; labyrinthitis; This is a spontaneous report from a contactable nurse (reporting herself). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Aug2021 (at the age of 37-years-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, supraventricular tachycardia (does carry an EpiPen and said heart is not functioning great) and allergy. The patient's concomitant medications were not reported. On 20Aug2021, the patient received her first dose of the vaccine, about 10 minutes after administration, patient experienced tachycardia, forty-five minutes to one hour after administration her hands and nail bed turned blue, blood sugar and blood pressure dropped, she experienced weakness, dizziness, hands were icy cold, labyrinthitis and was reportedly very pale. It was reported that not even 45 minutes to maybe an hour after receiving the first dose Pfizer BioNTech Vaccine, the caller hands and nailbeds turned blue, hands were icy cold, blood sugar dropped, blood pressure dropped, everything dropped. The caller was transported to the emergency room from the caller department she works in, the caller coworkers called the paramedics. In the emergency department where she was told she had labyrinthitis and severe dizziness and was prescribed steroids. The patient was out of work for two weeks. On 20Aug2021, the patient underwent lab tests and procedures which included blood glucose was dropped, blood pressure measurement was dropped. The patient outcome of the events was unknown at the time of this report.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; hands and nail bed turned blue; blood sugar and blood pressure dropped; blood sugar and blood pressure dropped; weakness; dizziness; very pale; hands were icy cold; labyrinthitis; This is a spontaneous report from a contactable nurse (reporting herself). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Aug2021 (at the age of 37-years-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, supraventricular tachycardia (does carry an EpiPen and said heart is not functioning great) and allergy. The patient's concomitant medications were not reported. On 20Aug2021, the patient received her first dose of the vaccine, about 10 minutes after administration, patient experienced tachycardia, forty-five minutes to one hour after administration her hands and nail bed turned blue, blood sugar and blood pressure dropped, she experienced weakness, dizziness, hands were icy cold, labyrinthitis and was reportedly very pale. It was reported that not even 45 minutes to maybe an hour after receiving the first dose Pfizer BioNTech Vaccine, the caller hands and nailbeds turned blue, hands were icy cold, blood sugar dropped, blood pressure dropped, everything dropped. The caller was transported to the emergency room from the caller department she works in, the caller coworkers called the paramedics. In the emergency department where she was told she had labyrinthitis and severe dizziness and was prescribed steroids. The patient was out of work for two weeks. On 20Aug2021, the patient underwent lab tests and procedures which included blood glucose was dropped, blood pressure measurement was dropped. The patient outcome of the events was unknown at the time of this report.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Immunisation, Lethargy, Migraine
Clinical narrative: weak; coughing; lethargic; migrane; Patient received DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 77-years-old female (wife) patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Sep2021 as DOSE 3 (BOOSTER), SINGLE (age at vaccination 77 years old) for covid-19 immunization. Patient's medical history included asthma, migraine both were from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received previously first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as dose 2, single for covid-19 immunization and experienced lethargic, weak, went down after Dose 1 and Dose 2. The patient taken third dose of BNT162B2 on 29Sep2021 (Booster dose). On 29Sep2021, patient experienced weak, coughing, lethargic, and migraine. It was reported that 3 hours after the booster on 29Sep2021 patient experienced coughing (noting that the coughing was bad enough at 10 PM), patient experienced weak, lethargic, and woke up with a migraine. Patient received treatment with Tessalon Perles, Nyquil at 4 or 5 AM for coughing. Both of these medications helped. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: 24 hours following injection, experienced chills; 24 hours following injection, experienced some fatigue.; Booster / Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 50125BA) via an unspecified route of administration in the left arm on 30Sep2021 at 02:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes (II) and known allergy to penicillin.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to COVID vaccine. Concomitant medication included influenza vaccine inact sag 3v (FLUAD) for an unknown indication in the left arm on 23Sep2021. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 14:00, 24 hours following injection, the patient experienced chills and some fatigue. This persisted for about 4 hours. 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. The clinical outcome of the events 24 hours following injection, chills and some fatigue was resolved on 01Oct2021 at 18:00.  Amendment: This follow-up report is being submitted to amend previously reported information: to update vaccination facility information and adverse event off label use was removed since the booster dose was administered after 22-Sep-2021 and off label use checkbox was unchecked in product notes accordingly.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Nasal congestion, Nasopharyngitis, Oral herpes
Clinical narrative: Multiple fever blisters persist on lips; Head cold symptoms; Dizziness; Sneezing; Congestion worsening; Booster, dose received: 3; This is a spontaneous report from a contactable consumer (patient) reported for herself. This is the first of two reports. A 69-years-old female patient (patient was not pregnant at the time of vaccination) received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Sep2021 at 13:00 pm (age at vaccination was 69 years) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included breast cancer and known allergy to shellfish. Concomitant medication included letrozole taken for an unspecified indication. The patient previously took macrobid [nitrofurantoin] and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 04Mar2021 at 13:00 pm (age at vaccination was 68 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 22Mar2021 at 00:00 am (age at vaccination was 68 years) as dose 2, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Sep2021, the patient experienced multiple fever blisters persist on lips and head cold symptoms- dizziness, sneezing, congestion worsening. The events did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of the events multiple fever blisters persist on lips and head cold symptoms- dizziness, sneezing, congestion worsening was not resolved at the time of this report.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.