chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Palpitations, Tinnitus
Clinical narrative: Extreme ringing in my ears and head.; Heart palpitations (beating hard, not rapid) I could hear my heartbeat in my ears.; Dose number 3; This is a spontaneous report received from a contactable consumer. The reporter is the patient.   A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 19:00 (Lot number: 3313088) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing), notes: I have a hx of Tinnitus; "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Avocado and "Allergy to plants" (unspecified if ongoing), notes: Known allergies: Dill. Concomitant medication included: IRBESARTAN/HCTZ. Past drug history included: Bactrim, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number- EW0162, Route of Administration: Unspecified, Anatomical site: Left arm), administration date: 22May2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number- EW0217, Route of Administration: Unspecified, Anatomical site: Left arm), administration date: 12Jun2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022 at 19:00, outcome "unknown", described as "Dose number 3"; TINNITUS (non-serious) with onset 03Jan2022 at 22:00, outcome "not recovered", described as "Extreme ringing in my ears and head"; PALPITATIONS (non-serious) with onset 03Jan2022 at 22:00, outcome "not recovered", described as "Heart palpitations (beating hard, not rapid) I could hear my heartbeat in my ears". Therapeutic measures were not taken as a result of tinnitus and palpitations.  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, emergency room/department or urgent care.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid-19 infection; Breakthrough Covid-19 infection; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Nov2021 (Lot number: PAA173696) at the age of 27 years as dose 3 (booster), single, administration date 04Apr2021 (Lot number: ER8729) as dose 2, single and administration date 06Mar2021 (Lot number: EN6205) 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) with onset 15Nov2021, outcome "unknown", described as "booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Breakthrough Covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Ear pain, Fatigue, Headache
Clinical narrative: Periodic headaches; Extreme neck pain; Back pain; Thigh pain. Moderate pain in right arm: injection location.; Mild pain inside ears.; Mild sore throat; Moderate fatigue.; Mild tightening of chest.; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 at 14:00 (Lot number: unknown) as dose 1, 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 medication(s) included: SHINGRIX taken for Immunisation, start date: 06Dec2021, stop date: 06Dec2021; TDAP taken for Immunisation, start date: 06Dec2021, stop date: 06Dec2021; PHENTERMINE; FLONASE and CLONAZEPAM.  The following information was reported: HEADACHE (non-serious) with onset 03Jan2022 at 18:00, outcome "recovering", described as "Began about 6:00pm: Approximately 3 hours after injection. Periodic headaches"; NECK PAIN (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), EAR PAIN (non-serious), OROPHARYNGEAL PAIN (non-serious), FATIGUE (non-serious), CHEST DISCOMFORT (non-serious) all with onset 03Jan2022 at 18:00, outcome "recovering", and all described as "Extreme neck, back, thigh pain". Therapeutic measures were not taken as a result of headache, neck pain, back pain, pain in extremity, ear pain, oropharyngeal pain, fatigue and chest discomfort.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine. 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.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: Periodic headaches; Extreme neck pain; Back pain; Thigh pain. Moderate pain in right arm: injection location.; Mild pain inside ears.; Mild sore throat; Moderate fatigue.; Mild tightening of chest.; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 at 14:00 (Lot number: unknown) as dose 1, 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 medication(s) included: SHINGRIX taken for Immunisation, start date: 06Dec2021, stop date: 06Dec2021; TDAP taken for Immunisation, start date: 06Dec2021, stop date: 06Dec2021; PHENTERMINE; FLONASE and CLONAZEPAM.  The following information was reported: HEADACHE (non-serious) with onset 03Jan2022 at 18:00, outcome "recovering", described as "Began about 6:00pm: Approximately 3 hours after injection. Periodic headaches"; NECK PAIN (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), EAR PAIN (non-serious), OROPHARYNGEAL PAIN (non-serious), FATIGUE (non-serious), CHEST DISCOMFORT (non-serious) all with onset 03Jan2022 at 18:00, outcome "recovering", and all described as "Extreme neck, back, thigh pain". Therapeutic measures were not taken as a result of headache, neck pain, back pain, pain in extremity, ear pain, oropharyngeal pain, fatigue and chest discomfort.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine. 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.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Breast mass, Breast pain, Immunisation
Clinical narrative: My under arm and arm pit along with my breast have been sore. They ache on and off.; My under arm and arm pit along with my breast have been sore. They ache on and off.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 17:30 (Lot number: RJ8762) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). Concomitant medications included unspecified VITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0168, Anatomical location: Left arm, Administration time: 16:30, Route of administration: Unspecified), administration date: 14May2021, when the patient was 39 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0217, Anatomical location: Left arm, Administration time: 17:30, Route of administration: Unspecified), administration date: 11Jun2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 17:30, outcome "unknown", described as "Dose number:3"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious), AXILLARY MASS (non-serious), BREAST MASS (non-serious) all with onset 24Dec2021 at 07:30, outcome "not recovered", and all described as "My under arm and arm pit along with my breast have been sore. They ache on and off". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, breast pain, axillary mass and breast mass.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported that it almost felt as if there was a lump in her armpit or breast. Both on left side where she had the shot. 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 and result was negative.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: My under arm and arm pit along with my breast have been sore. They ache on and off.; My under arm and arm pit along with my breast have been sore. They ache on and off.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 17:30 (Lot number: RJ8762) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). Concomitant medications included unspecified VITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0168, Anatomical location: Left arm, Administration time: 16:30, Route of administration: Unspecified), administration date: 14May2021, when the patient was 39 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0217, Anatomical location: Left arm, Administration time: 17:30, Route of administration: Unspecified), administration date: 11Jun2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 17:30, outcome "unknown", described as "Dose number:3"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious), AXILLARY MASS (non-serious), BREAST MASS (non-serious) all with onset 24Dec2021 at 07:30, outcome "not recovered", and all described as "My under arm and arm pit along with my breast have been sore. They ache on and off". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, breast pain, axillary mass and breast mass.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported that it almost felt as if there was a lump in her armpit or breast. Both on left side where she had the shot. 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 and result was negative.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Immunisation, Swelling
Clinical narrative: I woke up with a very tender and swollen armpit on the arm where I got my vaccine: and it's been very uncomfortable; I woke up with a very tender and swollen armpit on the arm where I got my vaccine: and it's been very uncomfortable; I woke up with a very tender and swollen armpit on the arm where I got my vaccine: and it's been very uncomfortable; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 02Jan2022 at 15:30 (Lot number: unknown) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure increased" (unspecified if ongoing), notes: Mildly elevated blood pressure and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication included: VITAMIN D. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Anatomical location: Left Arm), administration date: 13Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: UNKNOWN; Anatomical location: Left Arm), administration date: 04May2021, when the patient was 32 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 at 15:30, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), SWELLING (non-serious), DISCOMFORT (non-serious) all with onset 03Jan2022, outcome "not recovered", and all described as "I woke up with a very tender and swollen armpit on the arm where I got my vaccine: and it's been very uncomfortable". Therapeutic measures were not taken as a result of axillary pain, swelling and discomfort.  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 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Frequent headaches/ severe headaches; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date an unknown date in Oct2021 at 11:00 (Lot number: unknown) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A; Known allergies: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: left arm; Administration time: 14:30), administration date: 27Aug2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset an unknown date in Oct2021, outcome "not recovered", described as "Frequent headaches/ severe headaches". Therapeutic measures were not taken as a result of headache.  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. Within a day or two of receiving the COVID vaccine, the patient had experienced frequent headaches. She did not have a history of getting headaches. Prior to getting the COVID vaccine getting a headache was extremely rare. Since the vaccine, she had been getting frequent (almost every day) and sometimes severe headaches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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, FLUX
Symptoms: Asthma, COVID-19, Drug ineffective, Immunisation
Clinical narrative: I had three Pfizer Covid vaccinations; currently fighting Covid; currently fighting Covid; severe asthma; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  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; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single for 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 "I had three Pfizer Covid vaccinations"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "currently fighting Covid"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma". The events "currently fighting covid" and "severe asthma" were evaluated at the physician office visit.  Clinical course: Patient had received three Pfizer Covid vaccinations and the flu one as well and currently fighting with Covid and severe asthma. Her doctor recommended Paxlovid (nirmatrelvir and ritonavir tablets), but there were no pharmacies in her area carrying this antiviral drug.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Jun2021 (Lot number: EW0179) at the age of 48 years as dose 2, single and intramuscular, administration date 14May2021 (Lot number: EW0173) as dose1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow up information has been requested
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2590) at the age of 50 years as dose 3 (booster), single, administration date 01Mar2021 (Lot number: EL3247) as dose 2, single and administration date 08Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovered" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: covid test type post vaccination: Other,. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: The patient had no known allergies.The patient had no other vaccination in the past 4 weeks. The patient did not have Covid prior to vaccination and tested positive to Covid after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Contracted Covid-19. Fever and flu like symptoms for 6 days.; Contracted Covid-19. Fever and flu like symptoms for 6 days.; This is a spontaneous report received 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), intramuscular, administered in arm left, administration date 01Apr2021 (Lot number: EN6199) at the age of 46 years as dose 2, single and intramuscular, administered in arm left, administration date 11Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient did not receive any other vaccine in four weeks. There were no concomitant medications (did not receive other medications in two weeks).The patient had no Covid prior vaccination and tested covid post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "Contracted Covid-19. Fever and flu like symptoms for 6 days.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 24.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for COVID-19; Patient tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 09:00 (Lot number: EW0217) at the age of 24 years as dose 3(booster), single, administered in arm left, administration date 04May2021 09:00 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 13Apr2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (Batch/Lot number: unknown). Relevant medical history included: "chronic Urticaria" (unspecified if ongoing), notes: other medical history: Chronic urticaria; "known allergies: Penicilin" (unspecified if ongoing), notes: known allergies: Penicilin. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Dec2021 18:00, outcome "recovered" and all described as "Patient tested positive for COVID-19". The event "patient tested positive for covid-19" and "patient tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive, notes: Nasal Swab; (15Dec2021) positive, notes: Nasal Swab. The action taken for cetirizine hydrochloride was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included symptom management using OTC medications.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives; Rashes; Itching started 2 or 3 months after vaccine; This is a spontaneous report received 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 left arm, administration date 26May2021 (Lot number: EW0183) at the age of 19 years as dose 2, 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 and "Allergy" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0183, Route of administration: Unspecified, Anatomical site: left arm), administration date: 05May2021, when the patient was 19 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Hives"; RASH (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Rashes"; PRURITUS (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Itching started 2 or 3 months after vaccine". The events "Hives", "Rashes" and "Itching started 2 or 3 months after vaccine" 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 urticaria, rash and pruritus.  Additional Information: 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 been tested for COVID-19. Treatment included Benadryl and Xyzal for urticaria, rash and pruritus.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive/symptoms: cough, congestion and "more" body aches, lost taste and fever for a day; Covid positive/symptoms: cough, congestion and "more" body aches, lost taste and fever for a day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Apr2021 (Lot number: EP7533) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "skipping heart beats" (unspecified if ongoing), notes: ("fibulations"). Family history included: "GI cancer" (unspecified if ongoing), notes: paternal; "high blood pressure" (unspecified if ongoing), notes: paternal; "Cancer" (unspecified if ongoing), notes: father died of Cancer and mother was living and currently has no medical conditions. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "recovered" (Dec2021) and all described as "Covid positive/symptoms: cough, congestion and "more" body aches, lost taste and fever for a day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient was diagnosed with Covid positive on 23Dec2021, but the symptoms started around 21Dec2021, soon after his son. The symptoms included cough, congestion and "more" body aches, lost taste, and fever for a day; the patient took Tylenol. The patient acquired Covid through his son, who lives together with daughter and wife. The symptoms resolved near 29Dec2021 or on 30Dec2021. The patient did not receive the booster and the last dose of Comirnaty was administered on 11Apr2021. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for the COVID-19 (omicron); I tested positive for the COVID-19 (omicron); Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 (Lot number: FF8841) at the age of 55 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6199) as dose 2, single and intramuscular, administered in arm left, administration date 24Feb2021 11:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Patient did not have Relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "recovering" and all described as "I tested positive for the COVID-19 (omicron)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive for omicron, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not received any other vaccine in four weeks. Patient did not had Covid prior vaccination. Facility type Vaccine: Workplace clinic.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: feeling cold/now, feeling extremely cold even through being fully dressed; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; Pfizer vaccine as a booster; 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). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcer" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "lower back issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, single), administration date: 18May2021, for Covid-19 Immunization, reaction(s): "Have a reaction which lasted almost 2 months". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Dec2021, outcome "unknown" and all described as "I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021"; IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Pfizer vaccine as a booster"; FEELING COLD (non-serious) with onset 28Dec2021, outcome "not recovered", described as "feeling cold/now, feeling extremely cold even through being fully dressed".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Feeling cold
Clinical narrative: feeling cold/now, feeling extremely cold even through being fully dressed; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; Pfizer vaccine as a booster; 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). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcer" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "lower back issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, single), administration date: 18May2021, for Covid-19 Immunization, reaction(s): "Have a reaction which lasted almost 2 months". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Dec2021, outcome "unknown" and all described as "I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021"; IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Pfizer vaccine as a booster"; FEELING COLD (non-serious) with onset 28Dec2021, outcome "not recovered", described as "feeling cold/now, feeling extremely cold even through being fully dressed".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive, Vaccination failure
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a program, other case identifier(s) 21K-163-4214623-00.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; HUMIRA, subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 antibody test positive (20Dec2021) positive.  Causality for HUMIRA. The reporter causality for the event(s) of TESTED POSITIVE FOR COVID-19 was not provided. Daily dose of Humira Citrate free, COVID-19 virus test positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Drug ineffective; COVID-19 virus test positive; 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-163-4214623-00.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Dec2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 20Dec2021, outcome "not recovered", described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. The action taken for adalimumab was dosage permanently withdrawn.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality: COVID-19 virus test positive (SARS-CoV-2 test positive) Causality as per reporter (Drug/Vaccine): Possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Photopsia, Vitreous floaters
Clinical narrative: Light flashes; Eye floaters; This is a spontaneous report from a contactable reporter (consumer or non-HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 at 11:45 (Lot number: FE3593) at the age of 71 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ASPIRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FC3181; Anatomical site: Left arm; Administration time: 10:30), administration date: 26Aug2021, when the patient was 71 years old, for COVID-19 immunisation.  The following information was reported: PHOTOPSIA (non-serious) with onset 20Sep2021 at 08:00, outcome "recovering", described as "Light flashes"; VITREOUS FLOATERS (non-serious) with onset 20Sep2021 at 08:00, outcome "not recovered", described as "Eye floaters". The events "Light flashes" and "Eye floaters" were 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 photopsia and vitreous floaters.  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. Four days after second shot, the patient got eye floaters, and light flashes. Saw optometrist, eyes checked ok. Flashes had subsided, but had 3 floaters in each eye. He never had floaters before in 71 years. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Breakthrough symptomatic COVID infection; Breakthrough symptomatic COVID infection; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Oct2021 (Lot number: FN8027) at the age of 49 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EP6955) as dose 2, single and administration date 03Mar2021 (Lot number: EL3247) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough symptomatic COVID infection"; IMMUNISATION (medically significant) with onset 17Oct2021, outcome "unknown", described as "Booster". The clinical course was reported as follows: Breakthrough symptomatic COVID infection after 2 doses plus booster. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; She tested positive for covid and experiencing very mild stuffy nose and sore throat; She tested positive for covid and experiencing very mild stuffy nose and sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old 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 "She tested positive for covid and experiencing very mild stuffy nose and sore throat". 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Left leg calf, ankle, and for pain started two weeks after 2nd dose; Left leg calf, ankle, and for pain started two weeks after 2nd dose; 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 arm right, administration date 27Aug2021 at 16:00 (Lot number: FC3180) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FA7485; Anatomical location: Right arm; Administration time: 16:00), administration date: 06Aug2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 17Sep2021, outcome "not recovered", and all described as "Left leg calf, ankle, and for pain started two weeks after 2nd dose". The event "Left leg calf, ankle, and for pain started two weeks after 2nd dose" was evaluated at the emergency room visit and the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events pain in extremity and arthralgia.  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 vaccine. She was still in pain (at the time of this report). Since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Recurring hives on torso and limbs since 3 days after 3rd shot; Hives appear every day in different places,are sometimes itchy, and then recede; 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 left arm, administration date 07Dec2021 at 12:00 (Lot number: unknown)at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: 15May2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 12:00, outcome "unknown", described as "Dose number 3"; URTICARIA (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Recurring hives on torso and limbs since 3 days after 3rd shot"; PRURITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Hives appear every day in different places, are sometimes itchy, and then recede". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria and pruritus.  Additional Information: The patient had no known allergies. 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. The events did not result in doctor 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted COVID-19 and tested positive with severe symptoms; contracted COVID-19 and tested positive with severe symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2) (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 was not reported. There were no concomitant medications. The patient did not receive any other vaccinations within 4 weeks prior to the first administration date of the Pfizer vaccine. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reactions: "burning eyes", "headache/severe headache", "minor muscle pain/severe muscle pain", "severe runny nose"; "chills", "migraine", "internal burning sensation", "insomnia", "sore throat", "coughing", "fatigue". On Oct2021, the patient contracted COVID-19 and tested positive with severe symptoms. The patient has not sought medical treatment due to the doctor saying there was not treatment unless the patient required hospitalization. The outcome of the events was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101675599 same patient and reporter, different dose and event