chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Coordination abnormal, Disturbance in attention, Investigation
Clinical narrative: loss of concentration; lost 25 pounds; While driving his car he pushed the gas pedal instead of break, mental confusion; Something had screwed up in his brain, he has loss of coordination; motor skills have been affected; Memory loss; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination) and MOTOR DYSFUNCTION (motor skills have been affected) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination), MOTOR DYSFUNCTION (motor skills have been affected) and AMNESIA (Memory loss). At the time of the report, DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination), MOTOR DYSFUNCTION (motor skills have been affected) and AMNESIA (Memory loss) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: no signs of stroke (normal) No signs of stroke.         The symptoms started after the second dose, within 5 days to a week of it. Patient experienced 25 pound weight loss, loss of motor skills, loss of concentration, coordination and confusion during daily activities.  The patient received medical exams and they showed no signs of stroke. The symptoms are gradually resolving.  No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Weight decreased
Clinical narrative: loss of concentration; lost 25 pounds; While driving his car he pushed the gas pedal instead of break, mental confusion; Something had screwed up in his brain, he has loss of coordination; motor skills have been affected; Memory loss; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination) and MOTOR DYSFUNCTION (motor skills have been affected) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination), MOTOR DYSFUNCTION (motor skills have been affected) and AMNESIA (Memory loss). At the time of the report, DISTURBANCE IN ATTENTION (loss of concentration), WEIGHT DECREASED (lost 25 pounds), CONFUSIONAL STATE (While driving his car he pushed the gas pedal instead of break, mental confusion), COORDINATION ABNORMAL (Something had screwed up in his brain, he has loss of coordination), MOTOR DYSFUNCTION (motor skills have been affected) and AMNESIA (Memory loss) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: no signs of stroke (normal) No signs of stroke.         The symptoms started after the second dose, within 5 days to a week of it. Patient experienced 25 pound weight loss, loss of motor skills, loss of concentration, coordination and confusion during daily activities.  The patient received medical exams and they showed no signs of stroke. The symptoms are gradually resolving.  No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Collapsible left arm pain/ he would raise his arm it would just drop because it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt). At the time of the report, PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. It was reported that Without any HCP's suggestion, the patient had used over-the-counter Tylenol and ibuprofen for the symptoms.   This case was linked to MOD-2021-064148 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: still not feeling well/doesn't feel well; feels miserable from it; little lightheaded; got a little clammy; throwing up/throwing up for 8-10 hours; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy) and VOMITING (throwing up/throwing up for 8-10 hours) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E22A and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever). At the time of the report, MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to MOD-2021-346807 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: still not feeling well/doesn't feel well; feels miserable from it; little lightheaded; got a little clammy; throwing up/throwing up for 8-10 hours; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy) and VOMITING (throwing up/throwing up for 8-10 hours) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E22A and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever). At the time of the report, MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to MOD-2021-346807 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administration past beyond use date/Exp 10/03/21 (03Oct2021); administration past beyond use date/Exp 10/03/21 (03Oct2021); This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)). At the time of the report, PRODUCT STORAGE ERROR (administration past beyond use date/Exp 10/03/21 (03Oct2021)) and EXPIRED PRODUCT ADMINISTERED (administration past beyond use date/Exp 10/03/21 (03Oct2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site arm that was even more painful; fever that lasted for 8 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site arm that was even more painful) and PYREXIA (fever that lasted for 8 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm that was even more painful) and PYREXIA (fever that lasted for 8 hours). At the time of the report, VACCINATION SITE PAIN (injection site arm that was even more painful) outcome was unknown and PYREXIA (fever that lasted for 8 hours) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-347445 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Multiple bilateral segmental and sub-segmental pulmonary embolisms.; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Multiple bilateral segmental and sub-segmental pulmonary embolisms.) in a 55-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Multiple bilateral segmental and sub-segmental pulmonary embolisms.) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Multiple bilateral segmental and sub-segmental pulmonary embolisms.) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive and negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY EMBOLISM (Multiple bilateral segmental and sub-segmental pulmonary embolisms.) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Twenty-four hours prior to onset of symptoms, the two-vaccine series of Moderna was completed.There was no evidence of deep vein thrombosis. In addition, his hypercoagulable work-up was negative.  The patient was both COVID-19 PCR negative and COVID-19 IgG antibody negative, but positive for COVID-19 IgM antibody.  Company Comment: This case concerns a 55 year-old male patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism (AESI). The event occurred within 24 hours after the second dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter's assessment. Hypercoagulable workup was reported to be negative and there was no evidence of deep vein thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received 13-Oct-2021 and does not contain any new information.; Sender's Comments: This case concerns a 55 year-old male patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism (AESI). The event occurred within 24 hours after the second dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter's assessment. Hypercoagulable workup was reported to be negative and there was no evidence of deep vein thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient who received the vaccine beyond the use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Somnolence
Clinical narrative: Groggy; shortness of breath; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Groggy), DYSPNOEA (shortness of breath) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Weight gain (Due to COVID-19).    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Groggy), DYSPNOEA (shortness of breath) and FATIGUE (tired). At the time of the report, SOMNOLENCE (Groggy), DYSPNOEA (shortness of breath) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-329621 (Patient Link).
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site and surface of a few square centimeters swollen and warm.; Itching at the injection site; injection site and surface of a few square centimeters swollen and warm.; pain in the armpit (ganglion) of the arm on the side of the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.). On 01-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.). At the time of the report, VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.) outcome was unknown and AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No treatment information was provided.  No treatment information was provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 939901 and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  On 10-sep-2021 vials were stored in refrigerator. Reporter states Date of administration of vaccine on 4Oct, 5Oct, 6Oct with same batch number 939901 .   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: non significant follow up appended
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Diarrhoea, Flushing, Headache, Pain
Clinical narrative: Fever; pain; flushing; conjunctivitis; headache; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on 01Aug2021 16:45 (at the age of 53-years) as dose 2, single for COVID-19 immunization. The patient's medical history included ehlers danlos syndrome. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on 09Jul2021 10:00 (at the age of 53 years) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks nor any other medications in two weeks. The patient did not have COVID prior vaccination nor tested for COVID post vaccination. On 02Aug2021, at 15:00 the patient experienced fever, pain, flushing, conjunctivitis, headache and diarrhea. Treatment received for adverse events was unknown. The outcome of all the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; pain; flushing; conjunctivitis; headache; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on 01Aug2021 16:45 (at the age of 53-years) as dose 2, single for COVID-19 immunization. The patient's medical history included ehlers danlos syndrome. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on 09Jul2021 10:00 (at the age of 53 years) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks nor any other medications in two weeks. The patient did not have COVID prior vaccination nor tested for COVID post vaccination. On 02Aug2021, at 15:00 the patient experienced fever, pain, flushing, conjunctivitis, headache and diarrhea. Treatment received for adverse events was unknown. The outcome of all the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Biopsy, Colonoscopy, Diarrhoea
Clinical narrative: Diarrhea/loose stool; abdominal cramping; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FA6780, expiry date not reported) via an unspecified route of administration, administered in left arm on 21Jul2021 11:00 (at the age of 48 years old) as dose 1, single for covid-19 immunisation. Medical history included allergies, deficiency (Vitamin D), supplement, and pain. The patient had no covid prior vaccination and was not tested for covid post vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included loratadine (CLARITIN) taken for allergies from an unspecified start date and ongoing, orally at 10mg, unknown frequency; vitamin d [vitamin d nos] taken for deficiency (Vitamin D) from an unspecified start date and ongoing, orally at 5000 iU, unknown frequency; multivitamins [vitamins nos] taken as supplement orally from an unspecified start date and ongoing; and oral ibuprofen taken for pain at 400 mg, unknown frequency from an unspecified start date and ongoing. The patient had no other vaccine in four weeks. On 24Jul2021 at 09:00 AM, patient experienced diarrhea/loose stool and abdominal cramping. On 31Jul2021, it was reported that diarrhea had a seriousness criterion of persistent/significant disability/incapacity. Patient had colonoscopy on 17Sep2021, and patient was still waiting for biopsy results. Treatment was received in response to the event diarrhea while no treatment was received for abdominal cramping. The outcome of the events was not recovered. Patient had dose 2 of BNT162B2 (Batch/Lot number: FC8486) on 11Aug2021, at 16:00, administered in the left arm.   No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Got SIRVA(Shoulder Injury Related to Vaccine); This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced got SIRVA (shoulder injury related to vaccine on 27Feb2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (24Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller reports arm soreness after both doses of the vaccine; The initial case was missing the following minimum criteria no adverse effect. Upon receipt of 25Aug2021 case contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on Mar2021 (batch or lot number was not reported) as dose 2, single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on Feb2021 (batch or lot number was not reported) as dose 1, single dose for covid-19 immunisation and experienced her arm was little bit sore. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced arm soreness after both doses (arm was little bit sore after each dose) of the vaccine. Patient did not had any side effects. She had her arm was a little sore and also she stated any time she get a shot it like that. Patient inquired regarding does that present any health problems, having it that close together regards to the booster or 3rd dose of the Pfizer COVID vaccination. Patient would like to know efficacy data that we may have on the vaccine. Patient received both doses of the Pfizer covid 19 vaccinations. First dose in Feb2021 and the second dose was had in Mar2021. Patient inquired regarding the booster dose. She would like to know when she can get the booster doses and questions 6 to 8 months after the 2nd dose and also stated booster shot for Pfizer and that was in Feb and Mar and she asked how long did she have to wait and they told her to get one within a month after the last shot and also stated called earlier just to see when she can get and she think it was on 18th that she called. After that patient stated that she can get a booster one month after the last shot, after the last vaccine so, that answered her question then she got a letter saying that her question was unclear so, did they give her wrong answer or that's the right answer. That's bother if they gave her the wrong answer. Caller didn't know she did mention that her arm was little bit sore after each dose but that is not why she called but she got her first dose in Feb2021 and her second dose is in Mar2021 but she did not have the specific dates. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left hand, left and right legs/feet, right lower arm
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Already are a tinnitus sufferer but about 6 weeks after the vaccine it got worse and the ringing much louder; This is a spontaneous report from a contactable consumer(patient). A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly of administration in Arm Right on 30Apr2021 15:45, at 62-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  The patient was not pregnant at the time of vaccine. Medical history included tinnitus sufferer and allergy to neosporin, non-organic eggs, and gabapentin. Concomitant medications included naproxen sodium, sumatriptan succinate (TREXIMET), bupropion hydrochloride (WELLBUTRIN) and topiramate. All concomitant drugs were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly of administration in Arm Right on 06Apr2021 03:00 pm, at 62-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  No other vaccine in four weeks. The patient had not got Covid prior vaccination and had not Covid tested post vaccination. The patient reported she already were a tinnitus sufferer but about 6 weeks (as reported) after the vaccine it got worse and the ringing much louder on 31May2021. The patient got no treatment and was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Insomnia, Limb mass, Malaise
Clinical narrative: Really bad ball in the hand; really sharp pain in left hand; vaccine was administered in left hand; whole day was not feeling good; stomach hurt; does not want to eat; can't get good sleep; This is a spontaneous report from a contactable consumer (patient's wife). A 39-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left hand on 18Aug2021 08:30 (Batch/Lot number was not reported, Caller did not have the patient's vaccine card and does not have this information to provide) as dose 1, single at the age of 39-year-old for COVID-19 immunisation. Medical history included COVID-19 in May2020. There were no concomitant medications. The patient experienced really sharp pain in left hand from night of 18Aug2021 and ongoing, really sharp pain in left hand was reported as worsened; really bad ball in the hand from night of 19Aug2021 and ongoing; stomach hurt, did not want to eat, can't get good sleep in 2021; whole day was not feeling good in Aug2021. He got the vaccine in the morning. At night, he started complaining that he got a sharp pain. The whole day he was not feeling good. Last night, when taking off his shirt, he got like a really bad ball in the hand. His stomach hurt and he did not want to eat. He can't really get any good sleep. The big problem was the sharp pain, lots of sharp pain. It was last night. She called right now to the pharmacy to see what was going on, if they would give some medicines or something. They gave her a paper with this number. Sharp pain in left hand: Stated he was not experiencing the pain now. He was working as a waiter. He was working in the day and at night when he came back to the house, it was really bad, at night. She thought it is coming worse. Really bad ball in the hand: It was not too big, like it covers the hand. It was the same this morning. Events did not require a visit to emergency room or physician office. No treatment received. She went to the pharmacy and asked for the vaccine. She did the paperwork and he did not tell her exactly. It got worse or something like that. It was nothing like that. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. No family medical history relevant to events. No relevant tests. The outcome of really sharp pain in left hand and really bad ball in the hand was not recovered. The outcome of other events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Really bad ball in the hand; really sharp pain in left hand; vaccine was administered in left hand; whole day was not feeling good; stomach hurt; does not want to eat; can't get good sleep; This is a spontaneous report from a contactable consumer (patient's wife). A 39-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left hand on 18Aug2021 08:30 (Batch/Lot number was not reported, Caller did not have the patient's vaccine card and does not have this information to provide) as dose 1, single at the age of 39-year-old for COVID-19 immunisation. Medical history included COVID-19 in May2020. There were no concomitant medications. The patient experienced really sharp pain in left hand from night of 18Aug2021 and ongoing, really sharp pain in left hand was reported as worsened; really bad ball in the hand from night of 19Aug2021 and ongoing; stomach hurt, did not want to eat, can't get good sleep in 2021; whole day was not feeling good in Aug2021. He got the vaccine in the morning. At night, he started complaining that he got a sharp pain. The whole day he was not feeling good. Last night, when taking off his shirt, he got like a really bad ball in the hand. His stomach hurt and he did not want to eat. He can't really get any good sleep. The big problem was the sharp pain, lots of sharp pain. It was last night. She called right now to the pharmacy to see what was going on, if they would give some medicines or something. They gave her a paper with this number. Sharp pain in left hand: Stated he was not experiencing the pain now. He was working as a waiter. He was working in the day and at night when he came back to the house, it was really bad, at night. She thought it is coming worse. Really bad ball in the hand: It was not too big, like it covers the hand. It was the same this morning. Events did not require a visit to emergency room or physician office. No treatment received. She went to the pharmacy and asked for the vaccine. She did the paperwork and he did not tell her exactly. It got worse or something like that. It was nothing like that. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. No family medical history relevant to events. No relevant tests. The outcome of really sharp pain in left hand and really bad ball in the hand was not recovered. The outcome of other events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hyperhidrosis
Clinical narrative: Chest pain in middle of night with sweats; Chest pain in middle of night with sweats; This is a spontaneous report from a contactable other hcp (patient).    A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Aug2021 16:00 (Batch/Lot number was not reported) as single dose (at the age of 42 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Medical history none. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jul2021 (at the age of 42 years old) in the left arm for COVID-19 immunisation. On 19Aug2021 01:00, the patient experienced chest pain in middle of night with sweats with outcome of recovering. No treatment was required. The case was assessed as non-serious.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, SARS-CoV-2 test
Clinical narrative: Severe Diarrhea (>20 times a day) and fatigue lasting 2 weeks; Severe Diarrhea (>20 times a day) and fatigue lasting 2 weeks; This is a spontaneous report from a contactable other hcp (patient). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248 and expiry date: unknown), dose 2 via an unspecified route of administration on 11Jan2021 at 14:45 as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination: 20-years-old). Medical history included irritable bowel syndrome, IgA Deficiency, depression, anxiety, attention deficit hyperactivity disorder. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and buspirone (BUSPIRONE). The patient historical vaccine includes received bnt162b2, on 21DEC2020 as dose 1 (Batch/Lot Number: EH9899) for covid-19 immunisation (age at vaccination: 20-years-old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced severe diarrhea (>20 times a day) and fatigue lasting 2 weeks on 15Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date (Tested 5 times after 2nd shot, don't remember dates but they were all negative), sars-cov-2 test: negative on an unknown date (Tested 5 times after 2nd shot, don't remember dates but they were all), sars-cov-2 test: negative on an unknown date (Tested 5 times after 2nd shot, don't remember dates but they were all), sars-cov-2 test: negative on an unknown date (Tested 5 times after 2nd shot, don't remember dates but they were all), sars-cov-2 test: negative on an unknown date (Tested 5 times after 2nd shot, don't remember dates but they were all). The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Outcome of both the events was recovered on an unknown date.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Proteinuria
Clinical narrative: Proteinuria; This is a spontaneous report from contactable consumer. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patient.  A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID- 19 Immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she knew another person who got the shot and now had too much protein in their blood work on an unspecified date. It's called proteinuria. Reporter clarified that she was an insurance agent and Someone else (not her husband) just got declined health insurance because there was too much protein in his blood although he was perfectly healthy. She knew there was positives but to have someone have to too protein and their protein spike. That sent a red flag in her opinion. Patient underwent lab test and procedures on an unspecified date which included blood work: too much protein. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lichen planus, Rash
Clinical narrative: After getting vaccine in the last week of May I developed rash all over my body.; Dermatologist diagnosed it as Lichen planus with blisters; Dermatologist diagnosed it as Lichen planus with blisters; This is a spontaneous report from a contactable consumer (Patient). A 33-year-old-female non pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 09MAY2021 at 14:00 (at the age of 33 years old) as a single dose for COVID-19 immunisation. Patient's medical history none reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No concomitant medications were reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021 at 13:00 the patient experienced rash all over body after getting vaccine in the last week of May and dermatologist diagnosed it as Lichen planus with blisters. The patient received treatment for the events. The patient visited physician office due to events. The outcome of the events was not recovered.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, SARS-CoV-2 test, Vaccination site inflammation, Vaccination site mass
Clinical narrative: The day of the booster shot I started coughing and ten days later I am still coughing.; Also I have a very large inflammation sore spot about 3 inches wide and long on my bicep between the shoulder and my elbow; Also I have a very large inflammation sore spot about 3 inches wide and long on my bicep between the shoulder an my elbow; It is very sore and shows no sign of leaving; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  An 89-years-old female (non-pregnant) patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: /Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 17Aug2021 14:00 (Age at vaccination 89 years) as dose number unknown, single for covid-19 immunization. Medical history included arrhythmia from an unknown date and unknown if ongoing. Concomitant medications included other medications taken within two weeks were amlodipine (AMLODIPINE); pregabalin (PREGABALIN); levetiracetam (LEVETIRACETAM); losartan (LOSARTAN); apixaban (ELIQUIS), all were taken for an unspecified indication, with unknown start and stop date. No known allergies were reported. The patient did not receive any other vaccines within 4 weeks. Patient had not tested for Covid prior to vaccination and tested for Covid post vaccination. It was reported that on 17Aug2021, the patient started coughing from the day of the booster shot. Also, she had a very large inflammation sore spot about 3 inches wide and long on her bicep between the shoulder and her elbow, thing happened was about halfway between her shoulder where they put in the injection. It was very sore and shows no sign of leaving. Ten days later she was still coughing, and she did have a Covid test to make sure it was not covid and test came out negative. Consumer was told about the role of Pfizer Drug Safety and Pfizer Medical Information Department. The patient underwent lab tests and procedures which included Nasal swab test and Rapid test for sars-cov-2 test results negative for both tests on 24Aug2021. The patient did not receive any treatment for the events caused. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, Vaginal haemorrhage
Clinical narrative: I began to experience spotting that eventually turned into menstruation.; I began to experience spotting that eventually turned into menstruation.; Its now day 12 and it has not stopped.; Its now day 12 and it has not stopped.; This is a spontaneous report from a contactable other hcp (Patient). A 38-years-old non pregnant female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: Ew0168) via an unspecified route of administration, administered in Arm Left on 17Aug2021 14:15 pm (At the age of 38 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  She had no known allergies. She did not receive any other vaccines in four weeks. Prior to vaccination, she was not tested for covid. She was not tested to covid post vaccination. On 18Aug2021, after 24 hours post injection the patient experienced "i began to experience spotting that eventually turned into menstruation" "Its now day 12 and it has not stopped". She did not receive treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.