chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: Loss of range of motion in left shoulder accompanied by severe pain with movement; Loss of range of motion in left shoulder accompanied by severe pain with movement; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 24Oct2021 08:00 (Lot number: FE3592) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "PCN allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 10Jan2021, when the patient was 30 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM, Route of Administration: Intramuscular), administration date: 22Dec2020, when the patient was 30 years old, for COVID-19 immunization. The patient has no history of COVID-19 prior to vaccination. The patient was not COVID tested post vaccination. The following information was reported: ARTHRALGIA (disability), JOINT RANGE OF MOTION DECREASED (disability) all with onset 24Oct2021 16:00, outcome "not recovered" and all described as "Loss of range of motion in left shoulder accompanied by severe pain with movement". Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events arthralgia and joint range of motion decreased which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Loss of range of motion in left shoulder accompanied by severe pain with movement; Loss of range of motion in left shoulder accompanied by severe pain with movement; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 24Oct2021 08:00 (Lot number: FE3592) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "PCN allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 10Jan2021, when the patient was 30 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM, Route of Administration: Intramuscular), administration date: 22Dec2020, when the patient was 30 years old, for COVID-19 immunization. The patient has no history of COVID-19 prior to vaccination. The patient was not COVID tested post vaccination. The following information was reported: ARTHRALGIA (disability), JOINT RANGE OF MOTION DECREASED (disability) all with onset 24Oct2021 16:00, outcome "not recovered" and all described as "Loss of range of motion in left shoulder accompanied by severe pain with movement". Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events arthralgia and joint range of motion decreased which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Muscle spasms
Clinical narrative: Autoimmune Antibody Titer Became Elevated; I developed muscle spasms; documented sensory and motor neuropathy; documented sensory and motor neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 29Mar2021 16:00 (Lot number: EN6200) at the age of 62 years as dose 1, single for covid-19 immunization at a pharmacy. Relevant medical history included: "AMD" (unspecified if ongoing); "Allergy: Mangoes" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL]; OMEGA-3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]; ALPRAZOLAM; AREDS. Other concomitant medication includes statins. The following information was reported: MUSCLE SPASMS (disability) with onset 14Apr2021, outcome "recovering", described as "I developed muscle spasms"; PERIPHERAL SENSORY NEUROPATHY (disability), PERIPHERAL MOTOR NEUROPATHY (disability) all with onset 14Apr2021, outcome "recovering" and all described as "documented sensory and motor neuropathy"; ANTIBODY TEST ABNORMAL (disability), outcome "unknown", described as "Autoimmune Antibody Titer Became Elevated". The events "i developed muscle spasms", "documented sensory and motor neuropathy", "documented sensory and motor neuropathy" and "autoimmune antibody titer became elevated" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test (Antibody Titer): became elevated. Therapeutic measures were taken as a result of muscle spasms, peripheral sensory neuropathy, peripheral motor neuropathy which includes treatment with Gabapentin, Lyrica, Clonazepam. Additional information: No COVID prior to vaccination. Not tested for COVID post vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Antibody test abnormal, Muscle spasms, Peripheral motor neuropathy, Peripheral sensory neuropathy
Clinical narrative: Autoimmune Antibody Titer Became Elevated; I developed muscle spasms; documented sensory and motor neuropathy; documented sensory and motor neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 29Mar2021 16:00 (Lot number: EN6200) at the age of 62 years as dose 1, single for covid-19 immunization at a pharmacy. Relevant medical history included: "AMD" (unspecified if ongoing); "Allergy: Mangoes" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL]; OMEGA-3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]; ALPRAZOLAM; AREDS. Other concomitant medication includes statins. The following information was reported: MUSCLE SPASMS (disability) with onset 14Apr2021, outcome "recovering", described as "I developed muscle spasms"; PERIPHERAL SENSORY NEUROPATHY (disability), PERIPHERAL MOTOR NEUROPATHY (disability) all with onset 14Apr2021, outcome "recovering" and all described as "documented sensory and motor neuropathy"; ANTIBODY TEST ABNORMAL (disability), outcome "unknown", described as "Autoimmune Antibody Titer Became Elevated". The events "i developed muscle spasms", "documented sensory and motor neuropathy", "documented sensory and motor neuropathy" and "autoimmune antibody titer became elevated" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test (Antibody Titer): became elevated. Therapeutic measures were taken as a result of muscle spasms, peripheral sensory neuropathy, peripheral motor neuropathy which includes treatment with Gabapentin, Lyrica, Clonazepam. Additional information: No COVID prior to vaccination. Not tested for COVID post vaccination.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Inflammation, Myalgia, Pain in extremity
Clinical narrative: Diagnose with  inflammation on the left side of the chest; Pain on the left chest and shoulder; Problems of unstable blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure), INFLAMMATION (Diagnose with  inflammation on the left side of the chest) and ARTHRALGIA (Pain on the left chest and shoulder) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Before vaccination) in 2020. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series) on 27-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Pollen allergy.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and ARTHRALGIA (Pain on the left chest and shoulder). On an unknown date, the patient experienced INFLAMMATION (Diagnose with  inflammation on the left side of the chest). In March 2022, ARTHRALGIA (Pain on the left chest and shoulder) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and INFLAMMATION (Diagnose with  inflammation on the left side of the chest) outcome was unknown.            Patient was not given other vaccines within 1 month prior to Moderna COVID-19 Vaccine.  Patient reported that ever since receiving Moderna booster dose patient was having problems of unstable blood pressure and until a couple of weeks ago, had pain on the left chest and shoulder and patient was taking a muscle relaxers for this. Patient was diagnosed with inflammation on the left side of the chest and patient went to see doctors and to the hospital several times. Patient did not experienced any similar events in the past. Treatment medication included medication for high blood pressure.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Diagnose with  inflammation on the left side of the chest; Pain on the left chest and shoulder; Problems of unstable blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure), INFLAMMATION (Diagnose with  inflammation on the left side of the chest) and ARTHRALGIA (Pain on the left chest and shoulder) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Before vaccination) in 2020. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series) on 27-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Pollen allergy.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and ARTHRALGIA (Pain on the left chest and shoulder). On an unknown date, the patient experienced INFLAMMATION (Diagnose with  inflammation on the left side of the chest). In March 2022, ARTHRALGIA (Pain on the left chest and shoulder) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and INFLAMMATION (Diagnose with  inflammation on the left side of the chest) outcome was unknown.            Patient was not given other vaccines within 1 month prior to Moderna COVID-19 Vaccine.  Patient reported that ever since receiving Moderna booster dose patient was having problems of unstable blood pressure and until a couple of weeks ago, had pain on the left chest and shoulder and patient was taking a muscle relaxers for this. Patient was diagnosed with inflammation on the left side of the chest and patient went to see doctors and to the hospital several times. Patient did not experienced any similar events in the past. Treatment medication included medication for high blood pressure.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Inflammation
Clinical narrative: Diagnose with  inflammation on the left side of the chest; Pain on the left chest and shoulder; Problems of unstable blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure), INFLAMMATION (Diagnose with  inflammation on the left side of the chest) and ARTHRALGIA (Pain on the left chest and shoulder) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Before vaccination) in 2020. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series) on 27-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Pollen allergy.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and ARTHRALGIA (Pain on the left chest and shoulder). On an unknown date, the patient experienced INFLAMMATION (Diagnose with  inflammation on the left side of the chest). In March 2022, ARTHRALGIA (Pain on the left chest and shoulder) had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Problems of unstable blood pressure) and INFLAMMATION (Diagnose with  inflammation on the left side of the chest) outcome was unknown.            Patient was not given other vaccines within 1 month prior to Moderna COVID-19 Vaccine.  Patient reported that ever since receiving Moderna booster dose patient was having problems of unstable blood pressure and until a couple of weeks ago, had pain on the left chest and shoulder and patient was taking a muscle relaxers for this. Patient was diagnosed with inflammation on the left side of the chest and patient went to see doctors and to the hospital several times. Patient did not experienced any similar events in the past. Treatment medication included medication for high blood pressure.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: First dose: Had a sore arm/ Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First dose: Had a sore arm/ Second dose: Had a sore arm".  Additional Information:First dose: Had a sore arm/ Second dose: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine.Other Conditions: No. Investigations: No. Other Products: No.consumer who would like to report an adverse effect of a family member after receiving the Adult Pfizer Covid Vaccine Booster dose. height/weight: unknown.HCP:Caller does not have name, address, telephone number or email to provide. All the caller knows is the patient received the booster dose Adult Pfizer Covid Vaccine on 28Dec2021. The patient did not feel well after receiving the booster dose Adult Pfizer Covid Vaccine. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism. Caller is not sure if the autopsy details are available.Patient was a school teacher so was given whenever first rounds given. NDC/lot/expiration: Unknown, Caller could get this information but does not have it available to provide at this time.Route of administration: Arm, unknown if left or right arm.The patient was back to work and working and active until receiving third dose Adult Pfizer Covid Vaccine. The caller is not completely sure but guessing all doses were received in the afternoon. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: The caller does not believe so. Additional Information Did any AE(s) require a visit to: Emergency Room: Physician Office: No, the patient just did not feel well after the booster dose Adult Pfizer Covid Vaccine and the caller was told this by the patient's son who lived with the patient at the time. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): no.Patient's Medical History (including any illness at time of vaccination): none.Relevant Tests: none.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474084 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: First dose: Had a sore arm/ Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First dose: Had a sore arm/ Second dose: Had a sore arm".  Additional Information:First dose: Had a sore arm/ Second dose: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine.Other Conditions: No. Investigations: No. Other Products: No.consumer who would like to report an adverse effect of a family member after receiving the Adult Pfizer Covid Vaccine Booster dose. height/weight: unknown.HCP:Caller does not have name, address, telephone number or email to provide. All the caller knows is the patient received the booster dose Adult Pfizer Covid Vaccine on 28Dec2021. The patient did not feel well after receiving the booster dose Adult Pfizer Covid Vaccine. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism. Caller is not sure if the autopsy details are available.Patient was a school teacher so was given whenever first rounds given. NDC/lot/expiration: Unknown, Caller could get this information but does not have it available to provide at this time.Route of administration: Arm, unknown if left or right arm.The patient was back to work and working and active until receiving third dose Adult Pfizer Covid Vaccine. The caller is not completely sure but guessing all doses were received in the afternoon. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: The caller does not believe so. Additional Information Did any AE(s) require a visit to: Emergency Room: Physician Office: No, the patient just did not feel well after the booster dose Adult Pfizer Covid Vaccine and the caller was told this by the patient's son who lived with the patient at the time. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): no.Patient's Medical History (including any illness at time of vaccination): none.Relevant Tests: none.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474084 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism
Clinical narrative: First dose: Had a sore arm/ Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First dose: Had a sore arm/ Second dose: Had a sore arm".  Additional Information:First dose: Had a sore arm/ Second dose: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine.Other Conditions: No. Investigations: No. Other Products: No.consumer who would like to report an adverse effect of a family member after receiving the Adult Pfizer Covid Vaccine Booster dose. height/weight: unknown.HCP:Caller does not have name, address, telephone number or email to provide. All the caller knows is the patient received the booster dose Adult Pfizer Covid Vaccine on 28Dec2021. The patient did not feel well after receiving the booster dose Adult Pfizer Covid Vaccine. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism. Caller is not sure if the autopsy details are available.Patient was a school teacher so was given whenever first rounds given. NDC/lot/expiration: Unknown, Caller could get this information but does not have it available to provide at this time.Route of administration: Arm, unknown if left or right arm.The patient was back to work and working and active until receiving third dose Adult Pfizer Covid Vaccine. The caller is not completely sure but guessing all doses were received in the afternoon. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: The caller does not believe so. Additional Information Did any AE(s) require a visit to: Emergency Room: Physician Office: No, the patient just did not feel well after the booster dose Adult Pfizer Covid Vaccine and the caller was told this by the patient's son who lived with the patient at the time. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): no.Patient's Medical History (including any illness at time of vaccination): none.Relevant Tests: none.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474084 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: Had a sore arm/ Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First dose: Had a sore arm/ Second dose: Had a sore arm".  Additional Information:First dose: Had a sore arm/ Second dose: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine.Other Conditions: No. Investigations: No. Other Products: No.consumer who would like to report an adverse effect of a family member after receiving the Adult Pfizer Covid Vaccine Booster dose. height/weight: unknown.HCP:Caller does not have name, address, telephone number or email to provide. All the caller knows is the patient received the booster dose Adult Pfizer Covid Vaccine on 28Dec2021. The patient did not feel well after receiving the booster dose Adult Pfizer Covid Vaccine. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism. Caller is not sure if the autopsy details are available.Patient was a school teacher so was given whenever first rounds given. NDC/lot/expiration: Unknown, Caller could get this information but does not have it available to provide at this time.Route of administration: Arm, unknown if left or right arm.The patient was back to work and working and active until receiving third dose Adult Pfizer Covid Vaccine. The caller is not completely sure but guessing all doses were received in the afternoon. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: The caller does not believe so. Additional Information Did any AE(s) require a visit to: Emergency Room: Physician Office: No, the patient just did not feel well after the booster dose Adult Pfizer Covid Vaccine and the caller was told this by the patient's son who lived with the patient at the time. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): no.Patient's Medical History (including any illness at time of vaccination): none.Relevant Tests: none.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474084 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hip arthroplasty, Pain in extremity, SARS-CoV-2 test
Clinical narrative: First dose: Had a sore arm/ Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First dose: Had a sore arm/ Second dose: Had a sore arm".  Additional Information:First dose: Had a sore arm/ Second dose: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine.Other Conditions: No. Investigations: No. Other Products: No.consumer who would like to report an adverse effect of a family member after receiving the Adult Pfizer Covid Vaccine Booster dose. height/weight: unknown.HCP:Caller does not have name, address, telephone number or email to provide. All the caller knows is the patient received the booster dose Adult Pfizer Covid Vaccine on 28Dec2021. The patient did not feel well after receiving the booster dose Adult Pfizer Covid Vaccine. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism. Caller is not sure if the autopsy details are available.Patient was a school teacher so was given whenever first rounds given. NDC/lot/expiration: Unknown, Caller could get this information but does not have it available to provide at this time.Route of administration: Arm, unknown if left or right arm.The patient was back to work and working and active until receiving third dose Adult Pfizer Covid Vaccine. The caller is not completely sure but guessing all doses were received in the afternoon. List all vaccines administered on same date with the Pfizer vaccine considered as suspect: The caller does not believe so. Additional Information Did any AE(s) require a visit to: Emergency Room: Physician Office: No, the patient just did not feel well after the booster dose Adult Pfizer Covid Vaccine and the caller was told this by the patient's son who lived with the patient at the time. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): no.Patient's Medical History (including any illness at time of vaccination): none.Relevant Tests: none.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474084 similar report from same reporter
Sex: U
Vaccine: PNC20, PNC, PPV
Symptoms: Injection site pain
Clinical narrative: Patient felt that Prevnar 20 was more painful than receiving Pneumovax; This spontaneous report was received from a pharmacist reporting on themselves. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On an unknown date, the patient was vaccinated with Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided) and Pneumococcal vaccine conj 7v (crm197) (PREVNAR 20) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided); both for prophylaxis.  On an unknown date, the patient felt that Pneumococcal vaccine conj 7v (crm197) (PREVNAR 20) was more painful than receiving of Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Action taken and outcome of the event was not provided.  The relatedness between suspect therapies and the event was not provided.
Sex: U
Vaccine: PNC20, PNC, PPV
Symptoms: Pain
Clinical narrative: Patient felt that Prevnar 20 was more painful than receiving Pneumovax; This spontaneous report was received from a pharmacist reporting on themselves. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On an unknown date, the patient was vaccinated with Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided) and Pneumococcal vaccine conj 7v (crm197) (PREVNAR 20) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided); both for prophylaxis.  On an unknown date, the patient felt that Pneumococcal vaccine conj 7v (crm197) (PREVNAR 20) was more painful than receiving of Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Action taken and outcome of the event was not provided.  The relatedness between suspect therapies and the event was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Muscular weakness, Tremor
Clinical narrative: adverse effects happened about 20 minutes after the vaccine. patient experienced severe dizziness (described having squared visions), tremor on all extremities, muscle weakness (caused him to collapse), headache (back of the head)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: adverse effects happened about 20 minutes after the vaccine. patient experienced severe dizziness (described having squared visions), tremor on all extremities, muscle weakness (caused him to collapse), headache (back of the head)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine expired two days before (3/25/22) administration.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: After a week past the booster my left elbow joint started aching. Then my right pinky joint. A week later my right thumb joint aches.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine expired two days before (3/25/22) administration.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Blood test normal, Constipation, Diarrhoea
Clinical narrative: 5 days after being vaccinated I had terrible abdominal cramping and pain, so much so that I had to stay in bed. Since then I started noticing symptoms of bloating, gas, and cramping. Later this turned into constipation and loose bowels. My menses have also become irregular. They were very predictable before and now I have spotting days before, my periods are sometimes long, sometimes short. They are completely unpredictable, varying between 14-28 days between them. Shortly after having been vaccinated I also had issues with dry eye and was having frequent eye flare-ups. Not sure if any of it is related, but I never had these kinds of issues before this year.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Flatulence, Immunisation reaction, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: 5 days after being vaccinated I had terrible abdominal cramping and pain, so much so that I had to stay in bed. Since then I started noticing symptoms of bloating, gas, and cramping. Later this turned into constipation and loose bowels. My menses have also become irregular. They were very predictable before and now I have spotting days before, my periods are sometimes long, sometimes short. They are completely unpredictable, varying between 14-28 days between them. Shortly after having been vaccinated I also had issues with dry eye and was having frequent eye flare-ups. Not sure if any of it is related, but I never had these kinds of issues before this year.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Ultrasound scan normal
Clinical narrative: 5 days after being vaccinated I had terrible abdominal cramping and pain, so much so that I had to stay in bed. Since then I started noticing symptoms of bloating, gas, and cramping. Later this turned into constipation and loose bowels. My menses have also become irregular. They were very predictable before and now I have spotting days before, my periods are sometimes long, sometimes short. They are completely unpredictable, varying between 14-28 days between them. Shortly after having been vaccinated I also had issues with dry eye and was having frequent eye flare-ups. Not sure if any of it is related, but I never had these kinds of issues before this year.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired two days before (3/25/22) administration.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody positive, Condition aggravated, Hypothyroidism, Lymph node pain
Clinical narrative: My lymph nodes were swollen and the side of my throat and hurt from my ear down to my whole neck. I waited to get it looked at until I was going to a routine visit with my doctor. When I went, she did a Thyroid Antibody Testing and levels were very high. My PCP raised my dosage of thyroid medicine levothyroxine. I'm doing better since my medication was increased and I've been avoiding foods that trigger my immune system.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph nodes were swollen and the side of my throat and hurt from my ear down to my whole neck. I waited to get it looked at until I was going to a routine visit with my doctor. When I went, she did a Thyroid Antibody Testing and levels were very high. My PCP raised my dosage of thyroid medicine levothyroxine. I'm doing better since my medication was increased and I've been avoiding foods that trigger my immune system.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Chronic tinnitus which seems to correlate with diet/supplements. Can be partially managed by avoiding some trigger foods, taking enough iron and B vitamins, avoiding excess dietary manganese, D3, methyl B12, methylfolate. I thought it was purely related to dietary changes at first so I didn't even want to think that it could be vaccine-related, so I never even reported it through V-safe. Now I feel like I should report it. The tinnitus persists to this day. A Moderna booster, lot 046c21a, diminished it for a week. Damage may possibly be permanent, but too soon to tell so I'm not checking that now below.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Culture, Genital herpes, Headache, Herpes simplex test negative
Clinical narrative: After getting the vaccine the next day I woke up with chills, vomit, headache, and fever. A week later from getting the vaccine (10 days) I woke up with my vagina feeling sore and then when I checked down there I had 2 white spots which I had never ever had before. They were hurting a little and felt sore so I went to get it checked at the urgent care,  I was told it was herpes. Which I had never had before and have never even had a cold sore before. The doctor said what she saw was minimal. She submitted a culture and said it was herpes, I can not believe it was herpes if before the vaccine I had no symptoms of herpes or of a ?first flare up?. I have not had partners w herpes as well, the only connection I can have is that it is that they are two small vaginal ulcers that came as a side effect of the virus injected into me (Covid vaccine).  One spot has already disappeared w out herpes medication so I believe it is not herpes but an ulcer from the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex test positive, Pyrexia, Vaginal ulceration, Vomiting, Vulvovaginal pain
Clinical narrative: After getting the vaccine the next day I woke up with chills, vomit, headache, and fever. A week later from getting the vaccine (10 days) I woke up with my vagina feeling sore and then when I checked down there I had 2 white spots which I had never ever had before. They were hurting a little and felt sore so I went to get it checked at the urgent care,  I was told it was herpes. Which I had never had before and have never even had a cold sore before. The doctor said what she saw was minimal. She submitted a culture and said it was herpes, I can not believe it was herpes if before the vaccine I had no symptoms of herpes or of a ?first flare up?. I have not had partners w herpes as well, the only connection I can have is that it is that they are two small vaginal ulcers that came as a side effect of the virus injected into me (Covid vaccine).  One spot has already disappeared w out herpes medication so I believe it is not herpes but an ulcer from the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Genital herpes, Heavy menstrual bleeding, Sexually transmitted disease test, Vulvovaginal pain
Clinical narrative: After getting the vaccine the next day I woke up with chills, vomit, headache, and fever. A week later from getting the vaccine (10 days) I woke up with my vagina feeling sore and then when I checked down there I had 2 white spots which I had never ever had before. They were hurting a little and felt sore so I went to get it checked at the urgent care,  I was told it was herpes. Which I had never had before and have never even had a cold sore before. The doctor said what she saw was minimal. She submitted a culture and said it was herpes, I can not believe it was herpes if before the vaccine I had no symptoms of herpes or of a ?first flare up?. I have not had partners w herpes as well, the only connection I can have is that it is that they are two small vaginal ulcers that came as a side effect of the virus injected into me (Covid vaccine).  One spot has already disappeared w out herpes medication so I believe it is not herpes but an ulcer from the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Illness, Incorrect dose administered
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (losing a lot of hair/I brush it and lot of hair comes out), ILLNESS (Got sick for 2 days with booster) and INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dosage instead of the dosage of 3rd dose, Received the booster, but only 0.25 ml instead of full dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399OA, 029A21A and 028A21A) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder, Diabetes and Immunocompromised. Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (JARDIANCE MET), SACUBITRIL, VALSARTAN (ENTRESTO), CARVEDILOL and TRAZODONE HYDROCHLORIDE (TRAZODONE) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced ALOPECIA (losing a lot of hair/I brush it and lot of hair comes out). On an unknown date, the patient experienced ILLNESS (Got sick for 2 days with booster) and INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dosage instead of the dosage of 3rd dose, Received the booster, but only 0.25 ml instead of full dose). At the time of the report, ALOPECIA (losing a lot of hair/I brush it and lot of hair comes out) had not resolved, ILLNESS (Got sick for 2 days with booster) had resolved and INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dosage instead of the dosage of 3rd dose, Received the booster, but only 0.25 ml instead of full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported by the patient that hair loss started by 2nd week of February 2022. It was reported by patient that she had heart problem, diabetes and was taking this medication with no side effect but taking their shot gave her hair loss. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Albumin urine present, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Blood creatinine increased
Clinical narrative: ANCA- associated vasculitis limited to kidneys with renal failure; not diagnosed until 7/15/21 but after continued decline with progressive fatigue and new onset of flank pain in the interim.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea increased, Blood urine present, Decreased appetite, Fatigue, Flank pain
Clinical narrative: ANCA- associated vasculitis limited to kidneys with renal failure; not diagnosed until 7/15/21 but after continued decline with progressive fatigue and new onset of flank pain in the interim.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glomerulonephritis rapidly progressive, Headache, Lethargy, Malaise, Micturition urgency
Clinical narrative: ANCA- associated vasculitis limited to kidneys with renal failure; not diagnosed until 7/15/21 but after continued decline with progressive fatigue and new onset of flank pain in the interim.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Necrosis, Pollakiuria, Red blood cells urine positive, Renal failure, Urine analysis abnormal
Clinical narrative: ANCA- associated vasculitis limited to kidneys with renal failure; not diagnosed until 7/15/21 but after continued decline with progressive fatigue and new onset of flank pain in the interim.