chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Blood test abnormal, Cardiac stress test, Electrocardiogram abnormal, Supraventricular tachycardia
Clinical narrative: heart rate was at 192 for several hours even during sleep; Graves' disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2021 at 12:00 as dose 2, single (Lot number: FA6780) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRBESARTAN; CALCIUM (Other medications in two week), Ibesartan 300 mg one a day women 50+ 600 mg calcium. Vaccination history included: BNT162b2 (Prev Dose Lot number: Ew0187, Prev Dose lot unknown: False, administration time: 12:00, Prev dose dose number: 1, Prev dose Vaccine location=Left arm), administration date: 29Jun2021, when the patient was 52-year-old, for COVID-19 immunisation. There was no covid prior vaccination and no known allergies. There was no other vaccine in four weeks. The following information was reported: BASEDOW'S DISEASE (disability, medically significant) with onset 05Aug2021 at 14:00, outcome "recovered with sequelae", described as "Graves' disease"; HEART RATE INCREASED (disability) with onset 05Aug2021 at 14:00, outcome "recovered with sequelae", described as "heart rate was at 192 for several hours even during sleep". The events "heart rate was at 192 for several hours even during sleep" and "graves' disease" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Graves' disease, notes: my blood work indicated Graves' disease that I've never had prior to my vaccinations; Heart rate: 192, notes: heart rate was at 192 for several hours even during sleep. Therapeutic measures were taken as a result of heart rate increased, basedow's disease. Clinical course: Patients heart rate was at 192 for several hours even during sleep and the emergency room Drs were able to give her something to bring it down but said her blood work indicated Graves' disease that she had never had prior to her vaccinations. She had cardiac and endocrinologist appts and was still currently taking thyroid medicine that they were trying to ween her off of now. Still taking medicine for Graves' disease not sure  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Blood test, Heart rate, Heart rate increased
Clinical narrative: heart rate was at 192 for several hours even during sleep; Graves' disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2021 at 12:00 as dose 2, single (Lot number: FA6780) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRBESARTAN; CALCIUM (Other medications in two week), Ibesartan 300 mg one a day women 50+ 600 mg calcium. Vaccination history included: BNT162b2 (Prev Dose Lot number: Ew0187, Prev Dose lot unknown: False, administration time: 12:00, Prev dose dose number: 1, Prev dose Vaccine location=Left arm), administration date: 29Jun2021, when the patient was 52-year-old, for COVID-19 immunisation. There was no covid prior vaccination and no known allergies. There was no other vaccine in four weeks. The following information was reported: BASEDOW'S DISEASE (disability, medically significant) with onset 05Aug2021 at 14:00, outcome "recovered with sequelae", described as "Graves' disease"; HEART RATE INCREASED (disability) with onset 05Aug2021 at 14:00, outcome "recovered with sequelae", described as "heart rate was at 192 for several hours even during sleep". The events "heart rate was at 192 for several hours even during sleep" and "graves' disease" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Graves' disease, notes: my blood work indicated Graves' disease that I've never had prior to my vaccinations; Heart rate: 192, notes: heart rate was at 192 for several hours even during sleep. Therapeutic measures were taken as a result of heart rate increased, basedow's disease. Clinical course: Patients heart rate was at 192 for several hours even during sleep and the emergency room Drs were able to give her something to bring it down but said her blood work indicated Graves' disease that she had never had prior to her vaccinations. She had cardiac and endocrinologist appts and was still currently taking thyroid medicine that they were trying to ween her off of now. Still taking medicine for Graves' disease not sure  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lichen planus
Clinical narrative: After the booster had vulvar lichen planus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 14Jan2021 at 08:00 as dose 2, single (Lot number: EL6142) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Left shoulder injury", start date: Aug2020 (ongoing); "H/O allergy/Allergy" (unspecified if ongoing); "allergy/seasonal" (unspecified if ongoing); "H/O skin lichen planus", start date: 2017 (unspecified if ongoing), notes: recovered completely in 2 months. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for hypersensitivity, seasonal allergy. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EJ1685, Anatomical location: Left arm, Time: 08:00 AM, Expiry date: Mar2021, Route of administration: Intramuscular), administration date: 24Dec2020, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (disability, medically significant) with onset 2021, outcome "not recovered", described as "After the booster had vulvar lichen planus". The event "after the booster had vulvar lichen planus" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy vulva: (2021) lichen planus, notes: lichenoid inflammation with vacuolar degeneration consistent with lichen planus (gynecology Dr. (name withheld)). Therapeutic measures were taken as a result of lichen planus. The patient had not received any other vaccines within 4 weeks. The patient had no family medical history relevant to adverse event. The patient had a H/O skin lichen planus in 2017 which was recovered completely in 2 months. The patient did not take any medications for it. The patient took COVID vaccine in 24Dec2020 (Initial dose). Then vaccines booster on 14Jan2021. After the booster, the patient had vulvar lichen planus in Jan-Feb 2021 and had biopsy with gynaecology. (Illegible) The patient received treated presently for lesions with topical and oral steroids, tacrolimus topical including clobetasol topical, steroids (STEROID) taper pills, estradiol topical, tacrolimus ointment. It was debilitating condition with scaling and pain.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Lichen planus cannot be completely ruled out. 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.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Biopsy vulva, Lichen planus
Clinical narrative: After the booster had vulvar lichen planus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 14Jan2021 at 08:00 as dose 2, single (Lot number: EL6142) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Left shoulder injury", start date: Aug2020 (ongoing); "H/O allergy/Allergy" (unspecified if ongoing); "allergy/seasonal" (unspecified if ongoing); "H/O skin lichen planus", start date: 2017 (unspecified if ongoing), notes: recovered completely in 2 months. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for hypersensitivity, seasonal allergy. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EJ1685, Anatomical location: Left arm, Time: 08:00 AM, Expiry date: Mar2021, Route of administration: Intramuscular), administration date: 24Dec2020, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (disability, medically significant) with onset 2021, outcome "not recovered", described as "After the booster had vulvar lichen planus". The event "after the booster had vulvar lichen planus" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy vulva: (2021) lichen planus, notes: lichenoid inflammation with vacuolar degeneration consistent with lichen planus (gynecology Dr. (name withheld)). Therapeutic measures were taken as a result of lichen planus. The patient had not received any other vaccines within 4 weeks. The patient had no family medical history relevant to adverse event. The patient had a H/O skin lichen planus in 2017 which was recovered completely in 2 months. The patient did not take any medications for it. The patient took COVID vaccine in 24Dec2020 (Initial dose). Then vaccines booster on 14Jan2021. After the booster, the patient had vulvar lichen planus in Jan-Feb 2021 and had biopsy with gynaecology. (Illegible) The patient received treated presently for lesions with topical and oral steroids, tacrolimus topical including clobetasol topical, steroids (STEROID) taper pills, estradiol topical, tacrolimus ointment. It was debilitating condition with scaling and pain.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Lichen planus cannot be completely ruled out. 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.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities, Seizure
Clinical narrative: This spontaneous report received from a patient concerned a 34 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient previously received with Covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s.(dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported and batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, 1 total administered on 27-MAY-2022 at 10:00 to left arm for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported. On 27-MAY-2022, at about 17:00 in the evening patient's legs felt restless and started to felt sick, she was laying down and had seizure (dose number in series 2). Then for a week she had a 5-10 seizures per day. She lost her speech and could not talk or had a slurred speech (dose number in series 2). On 27-MAY-2022, she was hospitalized after seizure for 3 days and was discharged on 29-MAY-2022. On 03-JUN-2022, the patient experienced anxiety, ringing in ears, headache and fatigue (dose number in series 2). Patient visited the emergency room (seizures, slurred speech, lost speech) and physician office (anxiety, ringing in ears, headache, fatigue) and currently seeing doctors and neurologists and getting testing done. Her speech came back within a week (duration were 7 days). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures, and slurred speech on 03-JUN-2022, and restless legs, and had not recovered from anxiety, ringing in ears, headache, and fatigue. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220624963-Covid-19 vaccine ad26.cov2.s- seizures, slurred speech, Restless legs. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dysarthria, Fatigue, Headache, Restless legs syndrome
Clinical narrative: This spontaneous report received from a patient concerned a 34 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient previously received with Covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s.(dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported and batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, 1 total administered on 27-MAY-2022 at 10:00 to left arm for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported. On 27-MAY-2022, at about 17:00 in the evening patient's legs felt restless and started to felt sick, she was laying down and had seizure (dose number in series 2). Then for a week she had a 5-10 seizures per day. She lost her speech and could not talk or had a slurred speech (dose number in series 2). On 27-MAY-2022, she was hospitalized after seizure for 3 days and was discharged on 29-MAY-2022. On 03-JUN-2022, the patient experienced anxiety, ringing in ears, headache and fatigue (dose number in series 2). Patient visited the emergency room (seizures, slurred speech, lost speech) and physician office (anxiety, ringing in ears, headache, fatigue) and currently seeing doctors and neurologists and getting testing done. Her speech came back within a week (duration were 7 days). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures, and slurred speech on 03-JUN-2022, and restless legs, and had not recovered from anxiety, ringing in ears, headache, and fatigue. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220624963-Covid-19 vaccine ad26.cov2.s- seizures, slurred speech, Restless legs. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Tinnitus
Clinical narrative: This spontaneous report received from a patient concerned a 34 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient previously received with Covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. Age at time of vaccination 32 years old. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s.(dose number in series 1). The patient received booster dose of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported and batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, 1 total administered on 27-MAY-2022 at 10:00 to left arm for prophylactic vaccination. Age at time of vaccination 34 years old. No concomitant medications were reported. On 27-MAY-2022, at about 17:00 in the evening patient's legs felt restless and started to felt sick, she was laying down and had seizure (dose number in series 2). Then for a week she had a 5-10 seizures per day. She lost her speech and could not talk or had a slurred speech (dose number in series 2). On 27-MAY-2022, she was hospitalized after seizure for 3 days and was discharged on 29-MAY-2022. On 03-JUN-2022, the patient experienced anxiety, ringing in ears, headache and fatigue (dose number in series 2). Patient visited the emergency room (seizures, slurred speech, lost speech) and physician office (anxiety, ringing in ears, headache, fatigue) and currently seeing doctors and neurologists and getting testing done. Her speech came back within a week (duration were 7 days). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizures, and slurred speech on 03-JUN-2022, and restless legs, and had not recovered from anxiety, ringing in ears, headache, and fatigue. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220624963-Covid-19 vaccine ad26.cov2.s- seizures, slurred speech, Restless legs. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 26-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.            No concomitant drug was reported.  It was reported that patient took second booster dose on 26-May-2022 (Expiry date: 20-May-2022)  No Treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Biopsy skin, Blood test, Colonoscopy, Computerised tomogram
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Discomfort, Gastrointestinal disorder, Laboratory test, Mammogram
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Oesophagogastroduodenoscopy, Pain, Positron emission tomogram, Skin discolouration
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Discomfort, Mammogram
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oesophagogastroduodenoscopy, Positron emission tomogram, Rash papular, Skin discolouration, Spirometry
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Have had discomfort from my neck down to my groin; Discoloration of my skin and they are saying possible Lichen; Discoloration of my skin and they are saying possible Lichen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 at 18:00 as dose number unknown (booster), single (Lot number: FF2590) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 Immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), RASH PAPULAR (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Discoloration of my skin and they are saying possible Lichen"; DISCOMFORT (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Have had discomfort from my neck down to my groin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of discomfort, skin discolouration, rash papular.  Additional information: The patient did not have other medical symptoms and was not taking any concomitant medications. The patient did not receive any vaccination 4 weeks prior of getting the COVID-19 Vaccine. The patient reported a possible side effect for the Vaccine booster (Pfizer COVID-19 Vaccine). The patient had discomfort from neck down to groin, along with a discoloration of skin and they are saying possible Lichen. Prior to the booster, the patient was a very healthy active person, but this started 4 weeks after booster shot. The patient was still experiencing, and they are worsening. The patient was going to specialist, but no medication yet.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Hepatitis, Laboratory test, Pyrexia, Ultrasound scan
Clinical narrative: hepatitis of no known; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (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; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEPATITIS (hospitalization), outcome "unknown", described as "hepatitis of no known". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown result; tested for viruses and other potential sources: Unknown result; Ultrasound scan: Unknown result. The patient was hospitalized at Hospital name Withheld, and diagnosed with "hepatitis of no known cause" six days after receiving her second booster (from Name Withheld). She received the booster May 18, and I was hospitalized May 24. She is a 58 year old woman with no related preexisting issues. They tested for viruses and other potential sources The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Hepatitis, Investigation, Ultrasound scan
Clinical narrative: hepatitis of no known; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (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; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEPATITIS (hospitalization), outcome "unknown", described as "hepatitis of no known". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown result; tested for viruses and other potential sources: Unknown result; Ultrasound scan: Unknown result. The patient was hospitalized at Hospital name Withheld, and diagnosed with "hepatitis of no known cause" six days after receiving her second booster (from Name Withheld). She received the booster May 18, and I was hospitalized May 24. She is a 58 year old woman with no related preexisting issues. They tested for viruses and other potential sources The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Incorrect dose administered, Overdose
Clinical narrative: Error: Incorrect Reconstitution.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product preparation error, Somnolence
Clinical narrative: Error: Incorrect Reconstitution.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Incorrect dose administered, Pain in extremity, Product preparation issue, Somnolence
Clinical narrative: Error: Incorrect Reconstitution-
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Diarrhoea, Headache
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 14:30 as dose 3 (booster), single (Lot number: Fm7553), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 73 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: autoimmune disease oral lichen planus stomach problems acid reflux had operation I March made worse; "oral lichen planus" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "operation" (unspecified if ongoing), notes: had operation I March made worse; "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "known allergy: Tylenol"; Vicodin, reaction(s): "known allergy: Vicodin". Vaccination history included: Pfizer (Dose Number: 2, single, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 04Oct2021, for COVID-19 Immunization; Pfizer (Dose Number: 1, single , Batch/Lot No: Ep7534, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "fever 101-104"; HEADACHE (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Jun2022 at 02:00, outcome "not recovered" and all described as "muscle and joint pain"; LIMB DISCOMFORT (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, diarrhea, limb discomfort, myalgia, arthralgia. Additional information: patient reported that, on 10Jun2022 at 2:00 AM, patient had very high fever 101-104, very bad headache, stomach pains, very bad diarrhea, sore arm, muscle and joint pain. Patient had the flu but this much worse only happened with last 2 boosters. No other vaccine received in four weeks. No Covid prior vaccination and tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Limb discomfort, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 14:30 as dose 3 (booster), single (Lot number: Fm7553), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 73 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: autoimmune disease oral lichen planus stomach problems acid reflux had operation I March made worse; "oral lichen planus" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "operation" (unspecified if ongoing), notes: had operation I March made worse; "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "known allergy: Tylenol"; Vicodin, reaction(s): "known allergy: Vicodin". Vaccination history included: Pfizer (Dose Number: 2, single, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 04Oct2021, for COVID-19 Immunization; Pfizer (Dose Number: 1, single , Batch/Lot No: Ep7534, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "fever 101-104"; HEADACHE (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Jun2022 at 02:00, outcome "not recovered" and all described as "muscle and joint pain"; LIMB DISCOMFORT (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, diarrhea, limb discomfort, myalgia, arthralgia. Additional information: patient reported that, on 10Jun2022 at 2:00 AM, patient had very high fever 101-104, very bad headache, stomach pains, very bad diarrhea, sore arm, muscle and joint pain. Patient had the flu but this much worse only happened with last 2 boosters. No other vaccine received in four weeks. No Covid prior vaccination and tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Headache, Limb discomfort
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 14:30 as dose 3 (booster), single (Lot number: Fm7553), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 73 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: autoimmune disease oral lichen planus stomach problems acid reflux had operation I March made worse; "oral lichen planus" (unspecified if ongoing); "stomach problems" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "operation" (unspecified if ongoing), notes: had operation I March made worse; "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "known allergy: Tylenol"; Vicodin, reaction(s): "known allergy: Vicodin". Vaccination history included: Pfizer (Dose Number: 2, single, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 04Oct2021, for COVID-19 Immunization; Pfizer (Dose Number: 1, single , Batch/Lot No: Ep7534, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "fever 101-104"; HEADACHE (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Jun2022 at 02:00, outcome "not recovered" and all described as "muscle and joint pain"; LIMB DISCOMFORT (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Jun2022 at 02:00, outcome "not recovered", described as "stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, diarrhea, limb discomfort, myalgia, arthralgia. Additional information: patient reported that, on 10Jun2022 at 2:00 AM, patient had very high fever 101-104, very bad headache, stomach pains, very bad diarrhea, sore arm, muscle and joint pain. Patient had the flu but this much worse only happened with last 2 boosters. No other vaccine received in four weeks. No Covid prior vaccination and tested for Covid post vaccination. No follow-up attempts are possible. No further information is expected.