chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Immunisation, Oral mucosal blistering, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Back ache; Headache; Sore throat; Mouth blisters; Fatigue; Runny nose; Cough; Elevated pulse rate (+20bpm); Loss of appetite; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3189) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) taken for immunization on 28Sep2021. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Oct2021, the patient experienced back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 04Oct2021, the patient underwent pulse rate test and the result was +20 beats per minute (bpm). Since the vaccination, the patient had been tested for COVID-19. On 01Oct2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR); other) and the result was negative. The clinical outcome of the events back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Back ache; Headache; Sore throat; Mouth blisters; Fatigue; Runny nose; Cough; Elevated pulse rate (+20bpm); Loss of appetite; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3189) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) taken for immunization on 28Sep2021. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Oct2021, the patient experienced back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 04Oct2021, the patient underwent pulse rate test and the result was +20 beats per minute (bpm). Since the vaccination, the patient had been tested for COVID-19. On 01Oct2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR); other) and the result was negative. The clinical outcome of the events back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Peripheral swelling, Swelling
Clinical narrative: Right arm swollen and red; Right arm swollen and red; Right armpit is swollen and painful; Right armpit is swollen and painful; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the right upper arm on 07Oct2021 at 17:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had known allergies to fragrances. 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 lisinopril (MANUFACTURER UNKNOWN) from unknown date for an unspecified indication and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 09Oct2021 at 10:00, the patient had her right arm swollen and red, right armpit was swollen and painful. 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 right arm swollen and red and right armpit was swollen and painful was not resolved at the time of this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus
Clinical narrative: Terrible itching with no rash from top of head to tip of toes; Dose 3 administration: 29Sep2021 at 15:00; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 29Sep2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 10:00 (at the age of 72-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 19Feb2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 30Sep2021 at 20:00, the patient had terrible itching with no rash from top of head to tip of toes. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event terrible itching with no rash from top of head to tip of toes which included treatment with unspecified steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event terrible itching with no rash from top of head to tip of toes was not resolved at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Immunisation, Malaise
Clinical narrative: Slight chills; General malaise; Skin was extremely hot to touch; Dose 3/booster dose administration on 07Oct2021; This is a spontaneous report from a contactable nurse, the patient. A 67-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Oct2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) 40 mg one tablet daily for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9267) via an unspecified route of administration in the right arm on 04Feb2021 as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 26Feb2021 as a single dose for COVID-19 immunisation. On 08Oct2021 at 06:00, within 24 hours after vaccination, the patient experienced slight chills, general malaise and her skin was extremely hot to touch. 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 slight chills, general malaise and skin was extremely hot to touch was resolved on 09Oct2021 at 10:00.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Immunisation, Neck pain, Pain in extremity
Clinical narrative: Upper arm pain; Neck and back pain; Neck and back pain/Shoulder pain; General joint pain; Administration date 08Oct2021 at 13:45, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 08Oct2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included spondyloarthropathy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and adalimumab (MANUFACTURER UNKNOWN); both taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received 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 03Mar2021 (at the age of 41-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 15:45, the patient had "administration date 08Oct2021 at 15:45, dose number=3". On 09Oc2021, the patient experienced upper arm/shoulder pain, neck and back pain and general joint pain. 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 the events upper arm/shoulder pain, neck, back pain and general joint pain and included self treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upper arm/shoulder pain, neck and back pain, and general joint pain was not recovered at the time of this report. The clinical outcome of the event "administration date 08Oct2021 at 15:45, dose number=3" was unknown at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash, Urticaria
Clinical narrative: Severe rash of hives on arms, legs, and buttocks; Severe rash of hives on arms, legs, and buttocks; Booster dose administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3589) via an unspecified route of administration in the left arm on 08Oct2021 at 12:15 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to alpha gal-meat. 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 ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 27Jan2020 at 16:30 (at the age of 66-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 17Feb2021 at 12:30 (at the age of 66-years-old); both as a single dose for COVID-19 immunisation. On 09Oct2021 at 00:30, the patient experienced severe rash of hives on arms, legs, and buttocks. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe rash of hives on arms, legs, and buttocks was resolved on 09Oct2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Off label use, Pyrexia
Clinical narrative: Chills; Fever of 99.6; Dose 3 administration: 06Oct2021 at 14:15; The patient received third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 06Oct2021 at 14:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, previous stroke and blue spruce allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), iron (MANUFACTURER UNKNOWN) 65mg and lisinopril (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6299) via an unspecified route of administration in the left arm on 21Feb2021 at 14:00 (at the age of 72-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 14Mar2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received alendronate sodium (FOSAMAX) for unknown indication and experienced drug allergy. On 07Oct2021 at 14:45 (day after), the patient experienced chills and fever of 99.6 (unspecified units). On the same day, the patient underwent body temperature test and the result was 99.6 (unspecified units). 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 the event which included treatment with ibuprofen (reported as IBU) (MANUFACTURER UNKNOWN), napped and felt better that evening (at the time of this report). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and fever of 99.6 (unspecified units) was resolved on an unknown date in Oct2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: I Woke up with a small marble sized knot in my left arm, two in left from my injection site; Redness/the redness has spread about 3cm from original marker.; I circled it and marked the time on my arm to watch the growth rate of redness and swelling.; feeling tired/weak.; feeling tired/weak.; This is a spontaneous report from a contactable consumer, the patient. A 30-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 08Oct2021 at 14:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was 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 17Sep2021 at 14:30 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. On 09Oct2021 at 08:00, the patient experienced tired/weak. On same day at 08:25, the patient woke up with a small marble sized knot in the left arm, two in the left from her injection site, the patient circled it and marked the time on the arm and watched the growth rate of redness and swelling. On the same day at 17:00, the redness had spread about 3cm from original marker. The patient had marked it again and just kept an eye on it. 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 small marble sized knot in the left arm, two in the left from her injection site, redness and swelling, feeling tired/weak 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Noninfective sialoadenitis, Parotid gland enlargement
Clinical narrative: Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild swelling and tenderness in lymph node on right at my mandibular angle.; Mild swelling and tenderness in lymph node on right at my mandibular angle.; 3rd booster dose; This is a spontaneous report from a contactable physician, the patient. A 72-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 27Aug2021 at 19:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), ubidecarenone (COQ10), cyanocobalamin (VITAMIN B-12), vitamin d nos (MANUFACTURER UNKNOWN), levoglutamide (GLUTAMINE), ascorbic acid (VITAMIN C) and fish oil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 13Dec2020 at 14:00 (at the age of 71-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EKS730) via an unspecified route of administration in the right arm on 13Jan2021 at 14:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, about 2 weeks after booster dose, the patient experienced mild inflammation with minimal swelling and tenderness in his right parotid gland and mild swelling and tenderness in lymph node on right at his mandibular angle. It has slowly improved over the next 2-3 weeks. On 04Oct2021, the patient underwent rapid antigen test via nasal swab and the result was negative. 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 been tested for COVID-19. The clinical outcome of the events mild inflammation with minimal swelling and tenderness in his right parotid gland and mild swelling and tenderness in lymph node on right at his mandibular angle was resolving at the time of this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Salivary gland pain
Clinical narrative: Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild inflammation with minimal swelling and tenderness in my right parotid gland; Mild swelling and tenderness in lymph node on right at my mandibular angle.; Mild swelling and tenderness in lymph node on right at my mandibular angle.; 3rd booster dose; This is a spontaneous report from a contactable physician, the patient. A 72-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 27Aug2021 at 19:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), ubidecarenone (COQ10), cyanocobalamin (VITAMIN B-12), vitamin d nos (MANUFACTURER UNKNOWN), levoglutamide (GLUTAMINE), ascorbic acid (VITAMIN C) and fish oil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 13Dec2020 at 14:00 (at the age of 71-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EKS730) via an unspecified route of administration in the right arm on 13Jan2021 at 14:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, about 2 weeks after booster dose, the patient experienced mild inflammation with minimal swelling and tenderness in his right parotid gland and mild swelling and tenderness in lymph node on right at his mandibular angle. It has slowly improved over the next 2-3 weeks. On 04Oct2021, the patient underwent rapid antigen test via nasal swab and the result was negative. 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 been tested for COVID-19. The clinical outcome of the events mild inflammation with minimal swelling and tenderness in his right parotid gland and mild swelling and tenderness in lymph node on right at his mandibular angle was resolving at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Immunisation, Nausea, Pain
Clinical narrative: Nausea; Diarrhea; Headache; Body aches; Administration date 07Oct2021 at 11:00, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 07Oct2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 valsartan (MANUFACTURER UNKNOWN) from an unknown date for 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 on an unknown date as a single dose and also 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 as a single dose for COVID-19 immunisation. The patient previously received alprazolam (XANAX) and experienced drug allergy.  On 07Oct2021 at 11:00, the patient had "administration date 07Oct2021 at 11:00, dose number=3." On 07Oct2021 at 15:00, the patient experienced nausea, diarrhea, headache 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 reported events nausea, diarrhea, headache and body aches. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, diarrhea, headache and body aches was resolved with sequelae on an unknown date in Oct2021. The clinical outcome of the event  "administration date 07Oct2021 at 11:00, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Off label use; A third (booster) dose of BNT162b2 was administered; Injection site swelling; Injection site redness; Injection site itchiness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 06Oct2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included heart surgery, knee replacement and cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), dexlansoprazole (DEXILANT), eicosapentaenoic acid ethyl ester (VASCEPA) and ezetimibe/bempedoic acid (NEXLIZET); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 11Mar2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 01Apr2021 at 18:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Oct2021, the patient experienced injection site swelling, injection site redness and injection site itchiness. The patient reported that four days post shot, the patient still had all of these. 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 injection site swelling, injection site redness and injection site itchiness were not resolved at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Immunisation, Swelling
Clinical narrative: Major swelling under left underarm and left breast; Major swelling under left underarm and left breast; Booster; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received third booster dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 08Oct2021 at 18:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and sulfa antibiotics. 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: ENG6202) via an unspecified route of administration in the left arm on 03Mar2021 at 12:30 (at the age of 30-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 12:30 (at the age of 30-year-old), both as a single dose for COVID-19 immunisation. On 09Oct2021 at 06:00, the patient experienced major swelling under left underarm and left breast. The event 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 event major swelling under left underarm and left breast was not resolved at the time of this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Myalgia
Clinical narrative: Fever (100.3); Chills; Muscle aches; Nausea; Exhaustion; Administration date 09Oct2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the right arm on 09Oct2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and kidney stones. The patient was sensitive to peanuts, nuts, milk and gluten, but was not an allergic. 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 other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the right arm on 28Feb2021 at 13:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 09Oct2021 at 10:00, the patient had "administration date 09Oct2021, dose number=3". On 10Oct2021 at 09:00, the patient experienced fever (100.3), chills, muscle aches, nausea and exhaustion. 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 of the events fever (100.3), chills, muscle aches, nausea and exhaustion. On 10Oct2021 at 09:00, the patient underwent body temperature test and the result was 100.3 (units were unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (100.3), chills, muscle aches, nausea and exhaustion was not resolved. The clinical outcome of the event "administration date 09Oct2021, dose number=3" was unknown at the time of this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever (100.3); Chills; Muscle aches; Nausea; Exhaustion; Administration date 09Oct2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the right arm on 09Oct2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and kidney stones. The patient was sensitive to peanuts, nuts, milk and gluten, but was not an allergic. 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 other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the right arm on 28Feb2021 at 13:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 21Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 09Oct2021 at 10:00, the patient had "administration date 09Oct2021, dose number=3". On 10Oct2021 at 09:00, the patient experienced fever (100.3), chills, muscle aches, nausea and exhaustion. 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 of the events fever (100.3), chills, muscle aches, nausea and exhaustion. On 10Oct2021 at 09:00, the patient underwent body temperature test and the result was 100.3 (units were unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (100.3), chills, muscle aches, nausea and exhaustion was not resolved. The clinical outcome of the event "administration date 09Oct2021, dose number=3" was unknown at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: 1 day after second dose: Swollen left armpit; 1 day after second dose: Dizziness and Light headedness; 1 day after second dose: Nausea; 1 day after second dose: Weakness; 1 day after second dose: Fatigue; Dose 1: 28Aug2021; Dose 2: 06Oct2021; This is a spontaneous report from a contactable consumer, the patient. A 32-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 06Oct2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma allergies. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), cetirizine hydrochloride (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and unspecified prenatal vitamins for unknown indication from an unknown date 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 24Aug2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 07Oct2021, 1 day after the second dose, the patient experienced swollen left armpit, dizziness, light headedness, nausea, weakness and fatigue. The adverse 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 swollen left armpit, dizziness, light headedness, nausea weakness and fatigue was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 1 day after second dose: Swollen left armpit; 1 day after second dose: Dizziness and Light headedness; 1 day after second dose: Nausea; 1 day after second dose: Weakness; 1 day after second dose: Fatigue; Dose 1: 28Aug2021; Dose 2: 06Oct2021; This is a spontaneous report from a contactable consumer, the patient. A 32-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 06Oct2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma allergies. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), cetirizine hydrochloride (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and unspecified prenatal vitamins for unknown indication from an unknown date 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 24Aug2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 07Oct2021, 1 day after the second dose, the patient experienced swollen left armpit, dizziness, light headedness, nausea, weakness and fatigue. The adverse 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 swollen left armpit, dizziness, light headedness, nausea weakness and fatigue was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Off label use, Pain
Clinical narrative: Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site; Left underarm swollen; Severe headache; Jaw pain; Body aches; Chills; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant 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 received unspecified antibiotic (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received 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 14Jan2021 at 13:00 (at the age of 57-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 04Feb2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 23:45, the patient experienced severe headache, jaw pain, body aches and chills, till the half of 09Oct2021. On 09Oct2021, the patient noticed rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots and left underarm swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 08Sep2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through nasal swab and the result was negative. The clinical outcome of the events severe headache, jaw pain, body aches and chills were resolved on 09Oct2021 while rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots, left underarm swollen was resolving at the time of this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Rash erythematous, Rash papular, SARS-CoV-2 test, Skin warm
Clinical narrative: Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site; Left underarm swollen; Severe headache; Jaw pain; Body aches; Chills; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant 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 received unspecified antibiotic (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received 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 14Jan2021 at 13:00 (at the age of 57-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 04Feb2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 23:45, the patient experienced severe headache, jaw pain, body aches and chills, till the half of 09Oct2021. On 09Oct2021, the patient noticed rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots and left underarm swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 08Sep2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through nasal swab and the result was negative. The clinical outcome of the events severe headache, jaw pain, body aches and chills were resolved on 09Oct2021 while rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots, left underarm swollen was resolving at the time of this report.