chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Pain, Pyrexia
Clinical narrative: Fever 99.3; Body aches; Fatigues; Dose received: 3; 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 right, administration date 07Jan2022 at 15:00 (Lot number: 33036BD) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN; "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Postmenopause" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: CHLORTHALIDONE, COREG, ALLEGRA, POTAS and unspecified multivitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EK5730; Route of administration: unspecified), administration date: 23Dec2020, when the patient was 55 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EK4176; Route of administration: unspecified), administration date: 13Jan2021, when the patient was 55 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 15:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 08Jan2022, outcome "recovering", described as "Fever 99.3"; PAIN (non-serious) with onset 08Jan2022, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 08Jan2022, outcome "recovering", described as "Fatigues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain and fatigue.  Additional information: 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. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Migraine; Stiff neck pain; Low grade fever; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 11:00 (Lot number: unknown) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: AMLODIPINE; OLMESARTAN and ZOLPIDEM.  The following information was reported: MIGRAINE (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Migraine"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Stiff neck pain"; PYREXIA (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, musculoskeletal stiffness and pyrexia.  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 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, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 5-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Jan2022 at 11:00 (Lot number: FK5618) at the age of 5 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Zucchini. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FK5618, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 11:00), administration date: 19Dec2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: VOMITING (non-serious) with onset 10Jan2022 at 02:30, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional Information: 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. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site scab
Clinical narrative: Site where was injected developed a large 1 inch (very soft) scab, that came off revealing raw pink skin / Felt something like a bug and rubbed shoulder, but there was no bug it was the skin which came off with a booger like consistency; 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 06Jan2022 at 13:30 (Lot number: FJ8762) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Administration Location: Left Arm; Route of administration: Unspecified), administration date: 25Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0172; Administration Location: Left Arm; Route of administration: Unspecified), administration date: 22Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 13:30, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE SCAB (non-serious) with onset 09Jan2022 at 22:30, outcome "unknown", described as "Site where was injected developed a large 1 inch (very soft) scab, that came off revealing raw pink skin / Felt something like a bug and rubbed shoulder, but there was no bug it was the skin which came off with a booger like consistency". Therapeutic measures were not taken as a result of vaccination site scab.  Additional information: The patient did not scratch the injection site. The patient reported the events as they were happening. 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 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Immunisation, Nausea, Pain
Clinical narrative: Very sore arm; Fever; Chills; Body aches; Sore joints; Nausea; Dose number: 3; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 09:45 (Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing), notes: MVP; "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS; "MTHFR deficiency" (unspecified if ongoing), notes: MTHFR and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 08Jan2022 at 09:45, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Very sore arm"; PYREXIA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Body aches"; ARTHRALGIA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Sore joints"; NAUSEA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Nausea". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, pain, arthralgia and nausea.  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 doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Very sore arm; Fever; Chills; Body aches; Sore joints; Nausea; Dose number: 3; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 09:45 (Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing), notes: MVP; "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "polycystic ovarian syndrome" (unspecified if ongoing), notes: PCOS; "MTHFR deficiency" (unspecified if ongoing), notes: MTHFR and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 08Jan2022 at 09:45, outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Very sore arm"; PYREXIA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Body aches"; ARTHRALGIA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Sore joints"; NAUSEA (non-serious) with onset 08Jan2022 at 10:00, outcome "unknown", described as "Nausea". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, pain, arthralgia and nausea.  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 doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Immunisation, Interchange of vaccine products, Painful respiration, SARS-CoV-2 test
Clinical narrative: Chest pain about 24 hours after receiving booster dosage; Slight pain when breathing in; Primary immunisation: Moderna; Booster: BNT162b2; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FJ1611) at the age of 19 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: Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot Number: 021B21A; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 13Apr2021, when the patient was 18 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot Number: 036B21A; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 11May2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 07Jan2022, outcome "unknown", described as "Primary immunisation: Moderna; Booster: BNT162b2"; IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "Dose number: 3"; CHEST PAIN (non-serious) with onset 08Jan2022, outcome "recovered with sequelae", described as "Chest pain about 24 hours after receiving booster dosage"; PAINFUL RESPIRATION (non-serious) with onset 09Jan2022, outcome "recovered with sequelae", described as "Slight pain when breathing in". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain and painful respiration.  Additional information: It was reported that chest pain was throbbing, dull pain that later intensified has later died down and reduced the morning after when pain reliever taken Therapeutic measures included pain-relieving medications (unspecified). The event had improved but was still present albeit at a lower pain intensity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had 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: U
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Inflammation, Magnetic resonance imaging, Mental impairment
Clinical narrative: vision disturbances; inflammation on the brain; my brain just did not want to function at all; having problems with inflammation that has gotten worse; having problems with inflammation that has gotten worse; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization. The following information was reported: NONINFECTIVE ENCEPHALITIS (medically significant) with onset 2021, outcome "unknown", described as "inflammation on the brain"; MENTAL IMPAIRMENT (medically significant) with onset 2021, outcome "unknown", described as "my brain just did not want to function at all"; INFLAMMATION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "unknown" and all described as "having problems with inflammation that has gotten worse"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "unknown", described as "vision disturbances". The events "inflammation on the brain", "my brain just did not want to function at all", "having problems with inflammation that has gotten worse", "having problems with inflammation that has gotten worse" and "vision disturbances" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated, notes: I had was showing elevated information; magnetic resonance imaging: unknown results. clinical course:Consumer stated, "I am in curious over if there has been any reporting of inflammation from the Pfizer vaccine itself? I started having problems with inflammation that has gotten worse and it started like a week or so after I had the second shot. So I was wondering if there is any report that has been reported about inflammation and last week I was told I have, probably they are going to be doing a biopsy but they think there is inflammation on the brain." While paraphrasing the concern: Consumer stated, "Yes well it is shortly after about, I have to look at, it is probably was about 2 weeks, maybe a week after second shot, I have some symptoms. When I had the second shot, the day of it, where my brain just did not want to function at all and I just went and rested. About a week, week and a half, like two weeks later, I started noticing vision disturbances and they have stayed. That was in March so I have these vision disturbances from quite a long time that. Since second shot and then it is been progressing. because of the eye symptoms, they thought maybe the brain has inflammation."
Sex: U
Vaccine: COVID19
Symptoms: Noninfective encephalitis, Visual impairment
Clinical narrative: vision disturbances; inflammation on the brain; my brain just did not want to function at all; having problems with inflammation that has gotten worse; having problems with inflammation that has gotten worse; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization. The following information was reported: NONINFECTIVE ENCEPHALITIS (medically significant) with onset 2021, outcome "unknown", described as "inflammation on the brain"; MENTAL IMPAIRMENT (medically significant) with onset 2021, outcome "unknown", described as "my brain just did not want to function at all"; INFLAMMATION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "unknown" and all described as "having problems with inflammation that has gotten worse"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "unknown", described as "vision disturbances". The events "inflammation on the brain", "my brain just did not want to function at all", "having problems with inflammation that has gotten worse", "having problems with inflammation that has gotten worse" and "vision disturbances" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated, notes: I had was showing elevated information; magnetic resonance imaging: unknown results. clinical course:Consumer stated, "I am in curious over if there has been any reporting of inflammation from the Pfizer vaccine itself? I started having problems with inflammation that has gotten worse and it started like a week or so after I had the second shot. So I was wondering if there is any report that has been reported about inflammation and last week I was told I have, probably they are going to be doing a biopsy but they think there is inflammation on the brain." While paraphrasing the concern: Consumer stated, "Yes well it is shortly after about, I have to look at, it is probably was about 2 weeks, maybe a week after second shot, I have some symptoms. When I had the second shot, the day of it, where my brain just did not want to function at all and I just went and rested. About a week, week and a half, like two weeks later, I started noticing vision disturbances and they have stayed. That was in March so I have these vision disturbances from quite a long time that. Since second shot and then it is been progressing. because of the eye symptoms, they thought maybe the brain has inflammation."
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Memory impairment, SARS-CoV-2 test
Clinical narrative: For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15 minute spells; For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15 minute spells; I had a couple incidents when I did not recall something I had done at work; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6203) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: High gluten and "Dairy intolerance" (unspecified if ongoing), notes: Known allergies: Dairy sensitivity. Concomitant medications included: VITAMIN B; PROBIOTIC and CALCIUM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EM9809; Route of administration: unspecified), administration date: 09Feb2021, when the patient was 61 years old, for COVID-19 immunisation.  The following information was reported: FEELING ABNORMAL (non-serious), DIZZINESS (non-serious) all with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), and all described as "For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15-minute spells"; MEMORY IMPAIRMENT (non-serious) with onset an unknown date in 2021, outcome "recovered", described as "I had a couple incidents when I did not recall something I had done at work". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness and memory impairment.  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. The incident that worried her from getting a booster was a Sunday afternoon she had a 15-minute dizzy spell and had to lay down. She signed out 2 tax documents and a check - her husband called her later the next morning saying that she had put 3 different dates - they should had been the same date. 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 been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Immunisation, Urinary tract infection
Clinical narrative: "I" had an adverse reaction to the booster vaccine. "I" had a stye and a UTI, no symptoms prior to thevaccine.; "I" had an adverse reaction to the booster vaccine. "I" had a stye and a UTI, no symptoms prior to thevaccine.; Dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Jan2022 at 11:00 (Lot number: FJ1611)at the age of 33 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Soy allergy" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: Almonds and "Nickel sensitivity" (unspecified if ongoing), notes: Known allergies: Nickel. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical Location: Right arm, Route of Administration: Unspecified, Time of Administration: 00:00), administration date: 21Mar2021, when the patient was 32 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8729 , Anatomical Location: Right arm, Route of Administration: Unspecified, Time of Administration: 00:00.), administration date: 11Apr2021, when the patient was 32 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 11:00, outcome "unknown", described as "dose number=3"; HORDEOLUM (non-serious), URINARY TRACT INFECTION (non-serious) all with onset 06Jan2022 at 19:00, outcome "recovering", and all described as ""I" had an adverse reaction to the booster vaccine. "I" had a stye and a UTI, no symptoms prior to the vaccine". Therapeutic measures were taken as a result of hordeolum and urinary tract infection.  Additional Information: 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 received AZO for UTI and warm compress for eye as the treatment. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Road traffic accident, Syncope
Clinical narrative: booster; fainted; crashed the vehicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570; 159558).  A 25-year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunization in a pharmacy. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First Dose, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown"; SYNCOPE (medically significant) with onset 14Dec2021, outcome "recovered" (Dec2021); ROAD TRAFFIC ACCIDENT (non-serious) with onset 14Dec2021, outcome "unknown". The events were described as follows. The patient received her Pfizer covid-19 vaccine booster on 14Dec2021 and got in her car and drove off and fainted while in the car and crashed the vehicle. After she got the booster, nobody informed her about staying around for the 15 minutes like they had had on the previous vaccinations, therefore she left. She was driving home and within 10 minutes of getting the vaccine, she fainted and crashed her vehicle. She didn't have any serious injuries but does have some car damages and things like that. She had no serious injuries. She has recovered completely from the fainting.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Hypoaesthesia, Immunisation, Pain
Clinical narrative: Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness; Also had odd pain shooting down to my elbow; Also had odd pain shooting down to my elbow; Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit.; It feels like there is a ball there but when I go to feel there isn't anything.; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 08Jan2022 at 13:00 (Lot number: unknown) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 27Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 13:00, outcome "unknown", described as "Dose number 3"; HYPOAESTHESIA (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness"; PAIN (non-serious), ARTHRALGIA (non-serious), all with onset 09Jan2022 at 06:30, outcome "not recovered", and all described as "Also had odd pain shooting down to my elbow"; AXILLARY PAIN (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit"; SWELLING (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "It feels like there is a ball there but when I go to feel there isn't anything". Therapeutic measures were not taken as a result of hypoaesthesia, pain, arthralgia, axillary pain and swelling.  Additional Information: The patient did not receive any other vaccines within four weeks prior to 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness; Also had odd pain shooting down to my elbow; Also had odd pain shooting down to my elbow; Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit.; It feels like there is a ball there but when I go to feel there isn't anything.; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 08Jan2022 at 13:00 (Lot number: unknown) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 27Mar2021, when the patient was 29 years old, for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2; MANUFACTURER UNKNOWN; Lot Number: Unknown; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 13:00, outcome "unknown", described as "Dose number 3"; HYPOAESTHESIA (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Numbness on left hand the next day, if it wasn't my entire hand being numb, it was in between my pinky and ring finger/ Today I woke up with the same numbness"; PAIN (non-serious), ARTHRALGIA (non-serious), all with onset 09Jan2022 at 06:30, outcome "not recovered", and all described as "Also had odd pain shooting down to my elbow"; AXILLARY PAIN (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "Today I woke up with the same numbness and a very uncomfortable but painful pain in my armpit"; SWELLING (non-serious) with onset 09Jan2022 at 06:30, outcome "not recovered", described as "It feels like there is a ball there but when I go to feel there isn't anything". Therapeutic measures were not taken as a result of hypoaesthesia, pain, arthralgia, axillary pain and swelling.  Additional Information: The patient did not receive any other vaccines within four weeks prior to 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 lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: one eyelid got swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CORTISONE. The following information was reported: SWELLING OF EYELID (non-serious) with onset 01Jan2022, outcome "not recovered", described as "one eyelid got swollen". The event "one eyelid got swollen" was evaluated at the physician office visit. Additional information The patient had cortisone injection to  knee every 3 months (ZILRETTA) cortisone injection,  the patient received the first dose of the Pfizer COVID-19 vaccine on 22Dec2021 and 10 days later, she had one eyelid swell up. She clarified it was only one eyelid. The eyelid was still a little swollen. Her doctor prescribed her 20mg of Prednisone for 3 days. she had not taken the Prednisone yet.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Muscular weakness, Myalgia, Pain assessment
Clinical narrative: arm pain; joint and muscle pain; joint and muscle pain; there was some blue/blackish discoloration; loss of strength in the arm that got the injection; booster dose; 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 80 year-old male patient received BNT162b2 (BNT162B2), administered in arm, 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: Bnt162b2 (Dose 1 (Anatomical Location: Arm)), administration date: Mar2021, for covid-19 immunisation, reaction(s): "pain in arm"; Bnt162b2 (Dose 2 (Anatomical Location: Arm)), administration date: 2021, for Covid-19 immunisation, reaction(s): "pain in arm". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "joint and muscle pain"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "there was some blue/blackish discoloration"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "loss of strength in the arm that got the injection". The events "arm pain", "joint and muscle pain", "joint and muscle pain", "there was some blue/blackish discoloration" and "loss of strength in the arm that got the injection" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient received booster dose about a month and a half ago. The patient had to wear a sling and the patient stated that the arm hurt worse out of the sling.  The blue/blackish discoloration and loss of strength happened in the arm that got the injection, but that it was on the lower bicep, not in the upper shoulder where he got the shot. He also mentioned that his HCP has said other people have had similar side effects.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, X-ray
Clinical narrative: arm pain; joint and muscle pain; joint and muscle pain; there was some blue/blackish discoloration; loss of strength in the arm that got the injection; booster dose; 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 80 year-old male patient received BNT162b2 (BNT162B2), administered in arm, 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: Bnt162b2 (Dose 1 (Anatomical Location: Arm)), administration date: Mar2021, for covid-19 immunisation, reaction(s): "pain in arm"; Bnt162b2 (Dose 2 (Anatomical Location: Arm)), administration date: 2021, for Covid-19 immunisation, reaction(s): "pain in arm". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "joint and muscle pain"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "there was some blue/blackish discoloration"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "loss of strength in the arm that got the injection". The events "arm pain", "joint and muscle pain", "joint and muscle pain", "there was some blue/blackish discoloration" and "loss of strength in the arm that got the injection" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient received booster dose about a month and a half ago. The patient had to wear a sling and the patient stated that the arm hurt worse out of the sling.  The blue/blackish discoloration and loss of strength happened in the arm that got the injection, but that it was on the lower bicep, not in the upper shoulder where he got the shot. He also mentioned that his HCP has said other people have had similar side effects.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: "I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again.; "I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again.; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 11Mar2021 (Lot number: unknown) at the age of 36 year(s) as dose 1, single for COVID-19 immunisation and bnt162b2 (COMIRNATY), administration date 01Apr2021 (Lot number: unknown) at the age of 36 year(s) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Mar2021, outcome "recovered" (an unknown date), MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in Apr2021, outcome "recovered" (an unknown date) and all described as ""I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again". The event "I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding and menstruation irregular.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergies; This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (005570).  A 74 year-old female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergies: Adhesive Bandage" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergies: codeine, reaction(s): "Drug allergy". Vaccination history included: Pneumococcal vaccines, for Immunization, reaction(s): "Allergies to vaccine". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergies". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Breakthrough Infection- Positive antigen test 03Jan2021; Breakthrough Infection- Positive antigen test 03Jan2021; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Dec2021 14:00 (Lot number: FE3594) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administered in arm right, administration date 29Apr2021 13:00 (Lot number: 003C21A) as dose 2, single and intramuscular, administered in arm right, administration date 02Apr2021 14:00 (Lot number: 031B12A) 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: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Dec2021 14:00, outcome "unknown" and all described as "Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" and all described as "Breakthrough Infection- Positive antigen test 03Jan2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab; (03Jan2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient was not diagnosed with covid-19 prior to vaccination. The patient did not have other vaccines in the last four weeks. The patient has no known allergies.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Breakthrough Infection- Positive antigen test 03Jan2021; Breakthrough Infection- Positive antigen test 03Jan2021; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Dec2021 14:00 (Lot number: FE3594) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administered in arm right, administration date 29Apr2021 13:00 (Lot number: 003C21A) as dose 2, single and intramuscular, administered in arm right, administration date 02Apr2021 14:00 (Lot number: 031B12A) 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: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Dec2021 14:00, outcome "unknown" and all described as "Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" and all described as "Breakthrough Infection- Positive antigen test 03Jan2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab; (03Jan2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient was not diagnosed with covid-19 prior to vaccination. The patient did not have other vaccines in the last four weeks. The patient has no known allergies.