chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: After my second dose I had a swollen throat; Caused me issues with swallowing; I also had a swollen lymph node; After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot; After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jul2021 at 18:30 (Lot number: unknown) at the age of 18 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: Left Arm, Administration Time:18:00), administration date: 21Jun2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: PHARYNGEAL OEDEMA (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "After my second dose I had a swollen throat"; DYSPHAGIA (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "Caused me issues with swallowing"; LYMPHADENOPATHY (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "I also had a swollen lymph node"; URTICARIA (non-serious), PRURITUS (non-serious) all with onset 16Jul2021 at 17:00, outcome "not recovered", and all described as "After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot". The events "After my second dose I had a swollen throat", "Caused me issues with swallowing", "I also had a swollen lymph node" and "After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pharyngeal oedema, dysphagia, lymphadenopathy, urticaria and pruritus. Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was also reported that, the patient had never experienced this in her life until after receiving her second dosage of Pfizer and her body had not been the same since.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Swelling of eyelid, Urticaria
Clinical narrative: Dose received: 3; I had one hive on my butt cheek. Then woke up 2 mornings after shot with small hives under my eyes. On 3rd morning there were more hives under my eyes. The hive on my butt cheek is a little lower but still there.; Woke up 2 mornings after shot, my eye lids were slightly swollen. On 3rd morning, my eyelids were also still a little swollen.; This is a spontaneous report from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 24Dec2021 at 15:15 (Lot number: 33130BA) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: LARIN 24 FE taken for Birth control. Past drug history included: Bactrim, reaction: "Drug allergy", notes: Known allergies: Bactrim and Zithromax, reaction: "Drug allergy", notes: Known allergies: Zithromax. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0170, Anatomical Location: Left arm, Administration Time: 14:00, Route of Administration: Unknown), administration date: 21Apr2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE  2, SINGLE, Lot Number: EW0185, Anatomical Location: Left arm, Administration Time: 14:00, Route of Administration: Unknown), administration date: 12May2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021 at 15:15, outcome "unknown", described as "Dose received: 3"; URTICARIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "I had one hive on my butt cheek. Then woke up 2 mornings after shot with small hives under my eyes. On 3rd morning there were more hives under my eyes. The hive on my butt cheek is a little lower but still there"; SWELLING OF EYELID (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Woke up 2 mornings after shot, my eye lids were slightly swollen. On 3rd morning, my eyelids were also still a little swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria and swelling of eyelid.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 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.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID19; COVID19;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4192024-00.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 29 years, as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) citrate free (as reported) for rheumatoid arthritis, psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "recovered" (2021) and all described as "COVID19". The action taken for adalimumab was unknown. The patient received BNT162b2 booster dose intramuscular in 2021 for COVID-19 Vaccination.  The reporter considered there was a reasonable possibility that the Covid-19 was related to bnt162b2. The reporter did not provide causality for adalimumab and event Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in this patient cannot be excluded.  Further information like specific COVID infection date needed for a full medical assessment.,Linked Report(s) : PFIZER INC-202101780508 same patient, different vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough positive COVID test after full vaccination; Breakthrough positive COVID test after full vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough positive COVID test after full vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Lymphadenopathy, Pain
Clinical narrative: The next day the lymph node under left arm felt like a lump; Dose number: 3; The dizziness was so significant could not even drive a vehicle; Was in extreme pain after booster; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 at 11:45 (batch number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Allergy NOS" (unspecified if ongoing), notes: Known allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Left arm; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Left arm; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 at 11:45, outcome "unknown", described as "Dose number: 3"; DIZZINESS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "The dizziness was so significant could not even drive a vehicle"; LYMPHADENOPATHY (non-serious) with onset 24Dec2021, outcome "recovering", described as "The next day the lymph node under left arm felt like a lump"; PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Was in extreme pain after booster". Therapeutic measures were not taken as a result of dizziness, lymphadenopathy and pain. Additional information: Some symptoms were minor. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site urticaria
Clinical narrative: "COVID arm" - welt developed at injection site within 24 hours of injection and continues to grow in size and height; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: FO7218) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing), notes: Known allergies: Iodine and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: LEVOTHYROXINE; MONTELUKAST and ALLEGRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8727; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 23Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8731; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 13Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE URTICARIA (non-serious) with onset 27Dec2021 at 12:30, outcome "not recovered", described as ""COVID arm" - welt developed at injection site within 24 hours of injection and continues to grow in size and height". Therapeutic measures were not taken as a result of vaccination site urticaria.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Haemorrhage, Illness
Clinical narrative: got an ear infection on both ears with perforation and bleeding; got an ear infection on both ears with perforation and bleeding; may have been getting sick cause of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 04Sep2021 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), EAR INFECTION (non-serious), outcome "unknown" and all described as "got an ear infection on both ears with perforation and bleeding"; ILLNESS (non-serious), outcome "unknown", described as "may have been getting sick cause of the vaccine". Reporter was a mother calling on behalf of her son who received the Pfizer BioNtech covid vaccine first dose on 04Sep2021 (Lot#FD8448). Her son is a 15 year old male with Autism. Her son may have been getting sick cause of the vaccine, he got an ear infection on both ears with perforation and bleeding after the first dose on September. Reporter wants to know if these side effects are reported with people with same condition as her son, because her main concern is the seizure and if it would happen again after receiving the booster shot. (withheld) mentioned that the caller provided the Lot# and stated that her son received the pediatric dose but cannot confirm the statement as she only has the Lot#.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: In the day after the booster shot was received, patient experienced chills and fatigue; In the day after the booster shot was received, patient experienced chills and fatigue; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 30-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Dec2021 (Lot number: 32030BD) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Route of administration: Intramuscular), administration date: 28Jan2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3247; Route of administration: Intramuscular), administration date: 18Feb2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "In the day after the booster shot was received, patient experienced chills and fatigue"; FATIGUE (non-serious) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "In the day after the booster shot was received, patient experienced chills and fatigue". Therapeutic measures were not taken as a result of chills and fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Covid-19 just the positive/ still got very badly sick with the Covid-19; Covid-19 just the positive/ still got very badly sick with the Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 just the positive/ still got very badly sick with the Covid-19". The reporter's brother took the 3rd injection and still got very badly sick with the Covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Covid-19 just the positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Covid-19 just the positive/ still got very badly sick with the Covid-19; Covid-19 just the positive/ still got very badly sick with the Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster "; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 just the positive/ still got very badly sick with the Covid-19". The reporter's sister in law took the 3rd injection and still got very badly sick with the Covid-19. The reporter's sister in law took 3rd injection and within a few weeks she was very badly sick with Covid-19 just the positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: covid-19 just the positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Immunisation
Clinical narrative: still took the 3rd injection; bleeding; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "still took the 3rd injection"; HAEMORRHAGE (medically significant) with onset 2021, outcome "not recovered", described as "bleeding". The event "bleeding" was evaluated at the physician office visit. The patient took the third vaccination, and the patient was bleeding and he was probably going to die.  There was nothing more the doctors could do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Pain in extremity
Clinical narrative: booster; left sided under arm and injection site pain; left sided under arm and injection site pain; chills; fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "left sided under arm and injection site pain"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: booster; left sided under arm and injection site pain; left sided under arm and injection site pain; chills; fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "left sided under arm and injection site pain"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation
Clinical narrative: Dose number: 3; Patient had chills for two days after receiving the 3rd dose; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 61-year-old male patient received bnt162b2 (BNT162B2), administration date 23Dec2021 (Lot number: unknown) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Patient had chills for two days after receiving the 3rd dose".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram, Fibrin D dimer
Clinical narrative: Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest; chest pain.; short of breath and difficulty taking deep breaths.; DOSE 1: 22May2021; DOSE 2: 05Aug2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Aug2021 at 12:15 (Lot number: FA6780)at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Premature menopause" (unspecified if ongoing); "Thyroid function decreased" (unspecified if ongoing), notes: low thyroid and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0187, Route of administration: Unspecified, Administration Time:10:45, Anatomical location: Left arm), administration date: 22May2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Aug2021 at 12:15, outcome "unknown", described as "DOSE 1: 22May2021; DOSE 2: 05Aug2021"; CHEST DISCOMFORT (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest"; CHEST PAIN (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "chest pain"; DYSPNOEA (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "short of breath and difficulty taking deep breaths". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Ultrasound scan, X-ray
Clinical narrative: Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest; chest pain.; short of breath and difficulty taking deep breaths.; DOSE 1: 22May2021; DOSE 2: 05Aug2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Aug2021 at 12:15 (Lot number: FA6780)at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Premature menopause" (unspecified if ongoing); "Thyroid function decreased" (unspecified if ongoing), notes: low thyroid and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0187, Route of administration: Unspecified, Administration Time:10:45, Anatomical location: Left arm), administration date: 22May2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Aug2021 at 12:15, outcome "unknown", described as "DOSE 1: 22May2021; DOSE 2: 05Aug2021"; CHEST DISCOMFORT (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest"; CHEST PAIN (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "chest pain"; DYSPNOEA (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "short of breath and difficulty taking deep breaths". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left armpit causing significant level of pain; Swollen lymph nodes in left armpit causing significant level of pain; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: FE3594) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: left arm; Lot number: EP7534; Administration time: 17:00), administration date: 23Mar2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical location: left arm; Lot number: EW0150; Administration time: 17:00), administration date: 13Apr2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 27Dec2021, outcome "recovering", and all described as "Swollen lymph nodes in left armpit causing significant level of pain". Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional information: 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 COVID-19 vaccine. Pain occurred two days after the booster shot, pain continued on day 3 somewhat reduced. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Feeling tired; Headache; Low fever (99); No appetite; Vomited 2 times; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 17:00 (Lot number: FK5618) at the age of 7 years as dose 2 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "Peanut allergy" (unspecified if ongoing), notes: Known allergies: Peanuts. Concomitant medications included: PROBIOTIC; OMEGA 3; VITAMIN D3 and FLUORIDE. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE; Lot Number: FK5618; Administration time: 18:00; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 07Dec2021, when the patient was 6 years old, for COVID-19 immunisation.  The following information was reported: FATIGUE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Feeling tired"; HEADACHE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Low fever (99)"; DECREASED APPETITE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "No appetite"; VOMITING (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Vomited 2 times". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient's mother called her pediatrician and was advised to hydrate the patient with water or Gatorade and give her food if she can tolerate it. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling tired; Headache; Low fever (99); No appetite; Vomited 2 times; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 17:00 (Lot number: FK5618) at the age of 7 years as dose 2 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "Peanut allergy" (unspecified if ongoing), notes: Known allergies: Peanuts. Concomitant medications included: PROBIOTIC; OMEGA 3; VITAMIN D3 and FLUORIDE. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE; Lot Number: FK5618; Administration time: 18:00; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 07Dec2021, when the patient was 6 years old, for COVID-19 immunisation.  The following information was reported: FATIGUE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Feeling tired"; HEADACHE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Low fever (99)"; DECREASED APPETITE (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "No appetite"; VOMITING (non-serious) with onset 29Dec2021 at 08:00, outcome "unknown", described as "Vomited 2 times". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient's mother called her pediatrician and was advised to hydrate the patient with water or Gatorade and give her food if she can tolerate it. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Somnolence, Swelling
Clinical narrative: injection site was swollen; area underneath her armpit was extremely swollen; achy; tired; headache; slept because of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "injection site was swollen"; SWELLING (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "area underneath her armpit was extremely swollen"; PAIN (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "achy"; FATIGUE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "tired"; HEADACHE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "headache"; SOMNOLENCE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "slept because of the vaccine".  Additional information: It was reported that the patient (age: 74, unit: unknown) had a fairly severe reaction after the shot. She mentioned that it lasted for 4 days (as reported), it started on 20Feb2021 and ended on 23Feb2021 or 24Feb2021. Patient was due for 2nd dose on Saturday and she heard that if a person had COVID once, they do not have to receive the 2nd dose, patient wanted to confirm if this is true.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site was swollen; area underneath her armpit was extremely swollen; achy; tired; headache; slept because of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "injection site was swollen"; SWELLING (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "area underneath her armpit was extremely swollen"; PAIN (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "achy"; FATIGUE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "tired"; HEADACHE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "headache"; SOMNOLENCE (non-serious) with onset 20Feb2021, outcome "recovered" (Feb2021), described as "slept because of the vaccine".  Additional information: It was reported that the patient (age: 74, unit: unknown) had a fairly severe reaction after the shot. She mentioned that it lasted for 4 days (as reported), it started on 20Feb2021 and ended on 23Feb2021 or 24Feb2021. Patient was due for 2nd dose on Saturday and she heard that if a person had COVID once, they do not have to receive the 2nd dose, patient wanted to confirm if this is true.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Malaise, Myalgia, Neuralgia
Clinical narrative: she went into a flare up; neurological pain; muscle pain; fatigue; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing); "neurological involvement" (unspecified if ongoing). Concomitant medications included: IMURAN [AZATHIOPRINE]; PLAQUENIL S.  The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "she went into a flare up"; NEURALGIA (non-serious), outcome "unknown", described as "neurological pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Therapeutic measures were taken as a result of condition aggravated, neuralgia, myalgia, fatigue, malaise.  Additional information: The patient got her first vaccine over a week ago (about 9 days ago) and thought she went into a flare up, her neurological pain came back, muscle pain, fatigue (still ongoing) despite having her regular treatment (usually once a week) of IV IG and 20 mg of steroid infusion last Friday. The patient asked if she should get her second dose. The patient was thinking for an extra week because she was not still feeling well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Feeling of body temperature change, Hot flush, Pain in extremity
Clinical narrative: could not touch the elbow on her right arm because it hurt; dark pink discoloration to her right elbow; Hot flashes/ she has been hot and then got kind of cold; got kind of cold/ experienced being hot more than cold; she has been hot and then got kind of cold; sore arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 27Feb2021 12:35 (Lot number: EN6205) at the age of 79 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "history of breast cancer" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing), notes: for the last 5-8 years. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Lot number: EN5318), administration date: 06Feb2021, when the patient was 79 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sore arm"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "recovering", described as "could not touch the elbow on her right arm because it hurt"; SKIN DISCOLOURATION (non-serious) with onset Mar2021, outcome "recovering", described as "dark pink discoloration to her right elbow"; HOT FLUSH (non-serious) with onset 2021, outcome "unknown", described as "hot flashes/ she has been hot and then got kind of cold"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "got kind of cold/ experienced being hot more than cold"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "she has been hot and then got kind of cold". Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient reported that after her second dose she had a sore arm, and then Thursday or Friday morning (on 04Mar2021 or 05Mar2021) she woke up and could not touch the elbow on her right arm because it hurt and she took paracetamol (TYLENOL) and ibuprofen and got some comfort, and she looked at her elbow and it looked like it had been burned with something, like an iron. She said she had a patch on her but not a rash, a dark pink shaped discoloration. The patient said that her reaction was going away, and she always has had hot flashes and stuff, she had breast cancer, but she has been hot and then gets kind of cold, but she didn't feel sick.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: could not touch the elbow on her right arm because it hurt; dark pink discoloration to her right elbow; Hot flashes/ she has been hot and then got kind of cold; got kind of cold/ experienced being hot more than cold; she has been hot and then got kind of cold; sore arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 27Feb2021 12:35 (Lot number: EN6205) at the age of 79 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "history of breast cancer" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing), notes: for the last 5-8 years. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Lot number: EN5318), administration date: 06Feb2021, when the patient was 79 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "sore arm"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "recovering", described as "could not touch the elbow on her right arm because it hurt"; SKIN DISCOLOURATION (non-serious) with onset Mar2021, outcome "recovering", described as "dark pink discoloration to her right elbow"; HOT FLUSH (non-serious) with onset 2021, outcome "unknown", described as "hot flashes/ she has been hot and then got kind of cold"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "got kind of cold/ experienced being hot more than cold"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "she has been hot and then got kind of cold". Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient reported that after her second dose she had a sore arm, and then Thursday or Friday morning (on 04Mar2021 or 05Mar2021) she woke up and could not touch the elbow on her right arm because it hurt and she took paracetamol (TYLENOL) and ibuprofen and got some comfort, and she looked at her elbow and it looked like it had been burned with something, like an iron. She said she had a patch on her but not a rash, a dark pink shaped discoloration. The patient said that her reaction was going away, and she always has had hot flashes and stuff, she had breast cancer, but she has been hot and then gets kind of cold, but she didn't feel sick.  No follow-up attempts are possible. No further information is expected.