chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Lung hyperinflation, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Shortness of breath; Costochondritis/Need to take deep breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (Never smoked).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath). At the time of the report, DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that the patient never had lung/breathing problems. No concomitant medications were reported. It was reported that after two-three weeks after the first dose, the patient had noticed a little shortness of breath. It was further reported by the patient that periodically felt would need to take deep breath and determined it was costochondritis (where ribs attach to the sternum). The patient was due to get the vaccine (second booster). No treatment medications were reported for events.   This case was linked to MOD-2022-546342, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Costochondritis, Dyspnoea
Clinical narrative: little shortness of breath/felt I would need to take deep breath; Costochondritis (where ribs attach to the stern); Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills). In 2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (little shortness of breath/felt I would need to take deep breath) and COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)) outcome was unknown.     No concomitant medication were provided. Patient stated she never smoked or had lung / breathing problems. Patient was treated with Antibiotics and steroids.   This case was linked to MOD-2022-546365, MOD-2022-546342 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Costochondritis, Dyspnoea, Pyrexia
Clinical narrative: little shortness of breath/felt I would need to take deep breath; Costochondritis (where ribs attach to the stern); Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills). In 2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (little shortness of breath/felt I would need to take deep breath) and COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)) outcome was unknown.     No concomitant medication were provided. Patient stated she never smoked or had lung / breathing problems. Patient was treated with Antibiotics and steroids.   This case was linked to MOD-2022-546365, MOD-2022-546342 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: little shortness of breath/felt I would need to take deep breath; Costochondritis (where ribs attach to the stern); Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills). In 2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (little shortness of breath/felt I would need to take deep breath) and COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)) outcome was unknown.     No concomitant medication were provided. Patient stated she never smoked or had lung / breathing problems. Patient was treated with Antibiotics and steroids.   This case was linked to MOD-2022-546365, MOD-2022-546342 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Lung hyperinflation, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: little shortness of breath/felt I would need to take deep breath; Costochondritis (where ribs attach to the stern); Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (little shortness of breath/felt I would need to take deep breath), COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)), PYREXIA (Fever) and CHILLS (Chills). In 2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (little shortness of breath/felt I would need to take deep breath) and COSTOCHONDRITIS (Costochondritis (where ribs attach to the stern)) outcome was unknown.     No concomitant medication were provided. Patient stated she never smoked or had lung / breathing problems. Patient was treated with Antibiotics and steroids.   This case was linked to MOD-2022-546365, MOD-2022-546342 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: At the time of vaccination it was approx 6 to 10 days past the 30 days window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     It was unknown that the patient was ever been diagnosed positive with COVID-19. Patient had no acute illnesses at the time of vaccination and up to one month before.     On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A series of patients at a clinic received their second booster dose with a vial of Moderna that went past 30 days at 7-8 degree Celsius. At the time of administration it was approx. 6-10 days past the 30 day window. At the time of report, no patient contacted about any reactions.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vial was punctured 21 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication given. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Swelling
Clinical narrative: huge lump the size of a baseball; the lump is red.; She had a headache. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.). At the time of the report, SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022; Received a booster dose from an expired Moderna vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial) and PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022 at 10:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022 at 10:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial) and PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product was not reported.  patient received a booster dose from an expired Moderna vial.  Thaw date reported on 18-Mar-2022.  Treatment product was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: had anxiety reactions after receiving their Moderna Covid- 19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations). At the time of the report, ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-546517, MOD-2022-546518 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: 3 of her friends had anxiety reactions; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (3 of her friends had anxiety reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (3 of her friends had anxiety reactions). At the time of the report, ANXIETY (3 of her friends had anxiety reactions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Reportedly, there was no other adverse events were reported.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-546513, MOD-2022-546518 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.      Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-546515, MOD-2022-546520 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore left injection site arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 024M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (a sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (a sore left injection site arm) outcome was unknown.            No concomitant medications were reported.  Patient received the booster dose (third dose) in his left arm shoulder deltoid muscle. No treatment information was provided.   This case was linked to MOD-2022-546519, MOD-2022-546521, MOD-2022-546515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired booster dose given to a patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose given to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose given to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired booster dose given to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported  The dose was administered more than 12 hours post puncture.    The HCP also reported the patient did not have any reaction to the expired dose   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a literature report for the following literature source(s): A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "only 1 patient tested positive for COVID-19 after the first dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. The reporter considered "only 1 patient tested positive for Covid-19 after the first dose" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 02Apr2021 as dose 2, single (Lot number: EP6ASS) for Covid-19 immunisation. 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 Jan2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 02Apr2021 as dose 2, single (Lot number: EP6ASS) for Covid-19 immunisation. 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 Jan2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Severer, persistent headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: EP6ASS) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Previous dose details: Dose number: 1 (COVID 19, Pfizer), Lot number: EN6199, Vaccine location: Left arm, Prev dose brand unknown: False, Prev dose lot unknown: False), administration date: 13Mar2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "not recovered", described as "Severer, persistent headaches". The event "severer, persistent headaches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: No other vaccine in four weeks. Patient had severe, persistent headaches. Have not stopped. Never suffered headaches prior to vaccines. Patient had not been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination (Nasal Swab).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Severer, persistent headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: EP6ASS) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Previous dose details: Dose number: 1 (COVID 19, Pfizer), Lot number: EN6199, Vaccine location: Left arm, Prev dose brand unknown: False, Prev dose lot unknown: False), administration date: 13Mar2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "not recovered", described as "Severer, persistent headaches". The event "severer, persistent headaches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: No other vaccine in four weeks. Patient had severe, persistent headaches. Have not stopped. Never suffered headaches prior to vaccines. Patient had not been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination (Nasal Swab).
Sex: F
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: tongue is red and burns at the tip; swelling in gums; Gums, upper and lower lips are swollen; tongue is red and burns at the tip; difficulty biting; 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 79-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Caller received Pfizer covid vaccine 2 doses and a booster shot.), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Caller received Pfizer covid vaccine 2 doses and a booster shot.), for Covid-19 Immunization, reaction(s): "dry, cracking and pealing lips", "difficulty eating or speaking", "dry, cracking and pealing lips", "dry, cracking and pealing lips", "cuts/slits on the corner of the mouth", "cuts/slits on the corner of the mouth, it hurt", "on the back of her leg/thigh she has developed like "ringworms" round circle, red and white in the center and has a little red dots next to it". The following information was reported: TONGUE DISCOMFORT (non-serious), TONGUE ERYTHEMA (non-serious), outcome "unknown" and all described as "tongue is red and burns at the tip"; GINGIVAL SWELLING (non-serious), outcome "unknown", described as "swelling in gums"; LIP SWELLING (non-serious), outcome "unknown", described as "Gums, upper and lower lips are swollen"; EATING DISORDER (non-serious), outcome "not recovered", described as "difficulty biting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd shot (about 10 days later) on the back of her leg/thigh she has developed like ''ringworms'' round circle, red and white in the center and has a little red dots next to it; A few days later she had dry, cracking, and pealing lips, cuts/slits on the corner of the mouth, it hurt, difficulty eating or speaking, it did subside but not gone away. She saw the doctor and was prescribed cortisone cream. She stated she still has them, but they don't hurt or itch anymore. She states she has been living with this and threaten to sue Pfizer; its been about 6 month.  She stated she then received a booster dose. with the booster dose everything was in the mouth; swelling in gums, white lines in the gum, mostly on the bottom but some on the top, seem the oral doctor biopsied not cancer, doctor suggested to get a laser treatment to get rid of the white line but stated she is not going to get that. Her Gums, upper and lower lips are swollen still she has difficulty biting and now it's on both cheeks also, Her tongue was red and burns at the tip. Her HCP stated it came from the shot, she has seen 3 doctors. She stated Pfizer should provide advice on what to do, this injection is terrible the reporter wanted to know about the symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Inflammation, Rash, Rash pruritic, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "I caught Covid in January"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "I have received all 3 Pfizer vaccine shots. After every shot, I do get a rash. I caught Covid in January"; RASH (non-serious) with onset 2022, outcome "unknown", described as "After every shot, I do get a rash"; VIRAL RASH (non-serious), RASH PRURITIC (non-serious) all with onset 2022, outcome "not recovered" and all described as "I developed serious viral rashes all over my face, neck, and arms. The itchy viral rash is appearing on my face, neck and now the trunk of my body"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of suspected Covid-19, rash, viral rash, inflammation, rash pruritic. Clinical information I took prednisone just 10 days ago and it suppressed the inflammation. I stopped taking it for two days and the itchy viral rash is appearing on my face, neck and now the trunk of my body. Have you seen this before I do not know what to do. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Viral rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "I caught Covid in January"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "I have received all 3 Pfizer vaccine shots. After every shot, I do get a rash. I caught Covid in January"; RASH (non-serious) with onset 2022, outcome "unknown", described as "After every shot, I do get a rash"; VIRAL RASH (non-serious), RASH PRURITIC (non-serious) all with onset 2022, outcome "not recovered" and all described as "I developed serious viral rashes all over my face, neck, and arms. The itchy viral rash is appearing on my face, neck and now the trunk of my body"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of suspected Covid-19, rash, viral rash, inflammation, rash pruritic. Clinical information I took prednisone just 10 days ago and it suppressed the inflammation. I stopped taking it for two days and the itchy viral rash is appearing on my face, neck and now the trunk of my body. Have you seen this before I do not know what to do. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound scan, Uterine dilation and curettage
Clinical narrative: I had a healthy pregnancy before my Pfizer shot. After my Pfizer shot, I had a spontaneous miscarriage. The only different thing was this shot.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Sore shoulder area and fatigue.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Paralysis, Tremor
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. An elderly patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as ""an hour of paralysis""; CHILLS (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "flailing of arms and legs for about an hour". Reporter meet the criteria for a 2nd booster - I'm over 80, but I'm concerned about whether or not that might lead to an even more permanent result such as permanent paralysis. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. An elderly patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as ""an hour of paralysis""; CHILLS (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "flailing of arms and legs for about an hour". Reporter meet the criteria for a 2nd booster - I'm over 80, but I'm concerned about whether or not that might lead to an even more permanent result such as permanent paralysis. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Eosinophil count, Eosinophil count increased, Milk allergy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 15-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 2, single (Lot number: EP7533) at the age of 14 years for Covid-19 immunisation. The patient's relevant medical history included: "allergic to milk" (unspecified if ongoing), notes: After vaccine, appears to be allergic to, milk. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, brand: Pfizer), administration date: 21May2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: EOSINOPHIL COUNT INCREASED (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "increased eosinophil counts in the esophagus"; MILK ALLERGY (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "severe allergy to milk". The events "severe allergy to milk" and "increased eosinophil counts in the esophagus" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Eosinophil count: (Oct2021) increased, notes: in the esophagus. Therapeutic measures were taken as a result of milk allergy, eosinophil count increased. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Polymyalgia rheumatica
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 79-year-old female patient received BNT162b2 (COMIRNATY), in Mar2020 as dose 2, single (Batch/Lot number: unknown) at the age of 79 years for Covid-19 immunisation. The patient's relevant medical history included: "Heart surgery, triple bypass", start date: 2011, stop date: 2011, notes: Dressler Syndrome diagnosis took 1yr, she had it for 1yr diagnosed 1yr after heart surgery; "Dressler Syndrome" (unspecified if ongoing); "COPD", start date: 2021 (unspecified if ongoing), notes: COPD diagnosed last year; "Reactive airways disease" (unspecified if ongoing), notes: Reactive airways disease diagnosed in the early 1990s; "Sjogren's syndrome", start date: 2020, stop date: 2020, notes: Sjogren's syndrome diagnosed in 2020 maybe; "Hashimoto's disease" (unspecified if ongoing), notes: Hashimoto's disease diagnosed probably in 1980s or 1990s. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, NDC/Lot/Expiration: Unknown), administration date: Feb2020, when the patient was 79 years old, for Covid-19 immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset Apr2020, outcome "not recovered", described as "Lymphedema"; POLYMYALGIA RHEUMATICA (hospitalization, medically significant) with onset Apr2020, outcome "unknown". Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical information: The caller is a patient. She indicated that she has developed several health problems and she is asking if they could be related to the Pfizer Covid19 vaccine. She developed Polymyalgia rheumatica, lymphedema, She was not specific about when she developed these symptoms, she just mentioned that they appear after getting the 2nd dose of the vaccine. Dressler Syndrome diagnosis took a year to diagnose, she had Dressler Syndrome for a year, diagnosed a year after the heart surgery. Polymyalgia rheumatica: started when the vaccine came out. She had a flare up right after the Covid shot, around the time of the Covid shot. The massive amount of Prednisone has helped. She is in rehab, medications are at the desk. NDC/Lot/Expiration of Prednisone unknown. In the hospital she had three days of Prednisone 500mg IV, along with an IVIG infusion. NDC/Lot/Expiration Unknown for those products. She is now on 40mg Prednisone, at that time her hand opened up but her hand is now retracting again. Lymphedema: started two weeks after Polymyalgia rheumatica. Concomitant medication: normal meds, can't think of any. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202200596881 similar report from same reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in Mar2021 as dose 2, single (Lot number: EN6208) and as dose 3 (booster), single (Lot number: FH8020) for Covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got one booster dose and then he tested positive for Covid- 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Course: Receiving the primary series of the Pfizer BioNTech Covid-19 vaccine and a Pfizer-BioNTech Covid-19 booster and then getting a mild case COVID-19 disease. He was prescribed Paxlovid as treatment and is currently taking Paxlovid. He received the Pfizer Covid-19 Vaccine and he got his series and also got one booster dose and then he tested positive for Covid-19. LOT# (Paxlovid): PAA183761. Anatomical Site: Consumer stated, "Probably his left arm but he was not sure".
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: severe migraine; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "severe migraine". Therapeutic measures were taken as a result of migraine.  Additional information: Consumer would like to know how to get Paxlovid. After a month She received the two doses of the Pfizer COVID-19 vaccine she experienced severe migraine and exacerbation. She never got the booster due to that. She also mentioned that she is taking carbamazepine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Endoscopy, Intestinal resection, Laboratory test, Liver disorder, Vaccination site pain
Clinical narrative: Irregular labs indicated a liver issue; Covid vaccine issue/ Injection site pain; removed a piece of intestine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358536-00 (Agency).  A 67-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTESTINAL RESECTION (medically significant) with onset 2021, outcome "unknown", described as "removed a piece of intestine"; LIVER DISORDER (non-serious), outcome "unknown", described as "Irregular labs indicated a liver issue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Covid vaccine issue/ Injection site pain". The patient underwent the following laboratory tests and procedures: Endoscopy: (2021) No problems were found; Lab test: (unspecified date) Liver issue. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intestinal resection.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue and Covid Vaccine Issue/Injection Site Pain was not provided.Agency's opinion is that there is no reasonable possibility that the events of Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue and Covid Vaccine Issue/Injection Site Pain are related to Humira (Adalimumab). Agency's opinion is that the event of Irregular Labs Indicated a Liver issue is not assessable.  Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): Reporters causality for the events Removed a Piece of Intestine, Irregular Labs Indicated a Liver issue were not reported and for event Covid Vaccine Issue/Injection Site Pain was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.