chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Additional information received and Patient demographics were updated
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Additional Information received and Patient Demographics were updated.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient  received Moderna vaccine which had been frozen,refrozen and rethawed.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.). At the time of the report, PRODUCT STORAGE ERROR (patient  received Moderna vaccine which had been frozen,refrozen and rethawed.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported   This case was linked to MOD-2021-381132 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 948548) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns a patient, with no details on age, gender, or medical history, who experienced the unexpected fatal event of death. The date of death was not reported, neither vaccination date. The event occurred after receiving an unknown dose number of mRNA-1273 Moderna vaccine. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, with no details on age, gender, or medical history, who experienced the unexpected fatal event of death. The date of death was not reported, neither vaccination date. The event occurred after receiving an unknown dose number of mRNA-1273 Moderna vaccine. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 032L20A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up document contains no new information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer
Clinical narrative: Bladder diverticulum cancer; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER CANCER (Bladder diverticulum cancer) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced BLADDER CANCER (Bladder diverticulum cancer) (seriousness criterion medically significant). At the time of the report, BLADDER CANCER (Bladder diverticulum cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: abnormal (abnormal) Diagnosis of bladder diverticulum cancer..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.  Company comment: This case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected event of Bladder Cancer. The event the same month after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-378125 (Patient Link).; Sender's Comments: This case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected event of Bladder Cancer. The event the same month after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune hepatitis
Clinical narrative: acute severe autoimmune hepatitis; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) in a 47-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 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) to be possibly related.    Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis.  This is case concerns a 47-year-old male patient with no relevant medical history reported, who experienced serious, AESI, unexpected event of Autoimmune hepatitis. The event occurred unknown days after the second dose of mRNA-1273 vaccine. Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis. Very limited information is avaliable at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380217 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is case concerns a 47-year-old male patient with no relevant medical history reported, who experienced serious, AESI, unexpected event of Autoimmune hepatitis. The event occurred unknown days after the second dose of mRNA-1273 vaccine. Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis. Very limited information is avaliable at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Paraesthesia, Rash, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Cellulitis; Pink tinge on her arm; Hot/raved/spreading; Like a rash/it got worse; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 0018(B)21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACYCLOVIR [ACICLOVIR] and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PARAESTHESIA (Pink tinge on her arm), VACCINATION SITE WARMTH (Hot/raved/spreading), RASH (Like a rash/it got worse) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at an unspecified dose and frequency. At the time of the report, CELLULITIS (Cellulitis), PARAESTHESIA (Pink tinge on her arm), VACCINATION SITE WARMTH (Hot/raved/spreading), RASH (Like a rash/it got worse) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient mentioned that she experienced a pink tinge on her arm, like a rash and it got worse: red and hot and raved and spreading. The rash was 2-3 inches below the injection site. Patient was on supplements.  Company comment -This case concerns a 73 year-old female patient with no reported medical history who experienced the unexpected serious event of cellulitis. The event occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378110 (Patient Link).; Sender's Comments: This case concerns a 73 year-old female patient with no reported medical history who experienced the unexpected serious event of cellulitis. The event occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized; Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) and PAIN (Pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) (seriousness criterion hospitalization) and PAIN (Pain) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.  Company Comment: This case concerns a male subject of unknown age, with no relevant medical history, who experienced the serious unexpected events of Herpes zoster and Pain. The events, which resulted in hospitalization, occurred unknown number of days after the administration of the second dose of mRNA-1273 vaccine. At the time of the report, the outcome of the events was Unknown. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up report contains No new information (NNI).; Sender's Comments: This case concerns a male subject of unknown age, with no relevant medical history, who experienced the serious unexpected events of Herpes zoster and Pain. The events, which resulted in hospitalization, occurred unknown number of days after the administration of the second dose of mRNA-1273 vaccine. At the time of the report, the outcome of the events was Unknown. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Mild sore shoulder; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: EP7534), via an unspecified route of administration, administered in right arm on 09Apr2021 at 10:15, as dose 1, single for COVID-19 immunization at Hospital. The patient medical and concomitant medications reported as none. The patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. List of any other medications the patient received within 2 weeks of vaccination reported as none. The patient had not received any other vaccinations within 4 weeks prior to the COVID vaccine. The patient received other vaccine same date vaccine date (09Apr2021). On an unspecified date in Apr2021 the patient experienced Mild sore shoulder. Since vaccination patient not tested for covid-19. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: EP7533), via an unspecified route of administration, administered in right arm on 14Apr2021 at 11:15 (at the age of 56 years old) as dose 2, single for COVID-19 immunization at Hospital and experienced the events Tinnitus, mild sore shoulder, fatigue and dizziness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481505 Same patient, same product in different dose, partial same event
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Investigation, Palpitations, Pulmonary pain
Clinical narrative: Pain in lungs; Palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient reported for herself). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208), via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:15 (01:15 PM) (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient did not receive any other vaccine 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 not been tested for COVID-19. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 10Mar2021 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization and experienced palpitations, shortness of breath. The patient past drug included Bactrim and experienced allergy. On an unspecified date in Mar2021, the patient experienced palpitations and shortness of breath. On 02May2021, the patient experienced pain in lungs. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Reported Event: I have been having palpitations and shortness of breath since I have been vaccinated. 02May2021, I started having pain in my lungs. I have been to cardiologist and primary care physician and so far, all test and blood work have been normal. More tests are scheduled. I had no symptoms or issues until after I received the COVID 19 vaccination. The patient underwent lab tests and procedures which included test and blood work have been normal on an unspecified date in May2021. It was unknown whether the patient was received treatment. The outcome of all the events was not recovered at the time of the report. Device date was 03May2021.  No follow-up attempts were needed. No further information was expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Joint swelling, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: I experienced swelling in my hands/Swelling calves; Swelling face; Swelling ankles; the next day I started feeling a slight burning sensation; Feeling itching that continued for the next 2 1/2+ weeks; Approximately 4-5 hrs after injection I started feeling pins & needles throughout my entire body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old non pregnant female non pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 23Jul2021 09:30 (at the age of: 61-years-old) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, asthma, Sulfa drugs allergy and shellfish allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), senna acutifolia (SENNA ACUTIFOLIA), vitamin d3 (VITAMIN D3), probiotics (PROBIOTICS) and multi vitamin received 2 weeks prior to the vaccination. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was reported that approximately 4-5 hrs after injection she started feeling pins & needles throughout her entire body, the next day she started feeling a slight burning sensation as well as itching that continued for the next 2 1/2 plus weeks. Also, she experienced swelling in her hands/face in the a.m. & calves/ankles in the p.m. about 1 week after the shot. The patient did not received treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was recovered/resolved with Sequel.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I experienced swelling in my hands/Swelling calves; Swelling face; Swelling ankles; the next day I started feeling a slight burning sensation; Feeling itching that continued for the next 2 1/2+ weeks; Approximately 4-5 hrs after injection I started feeling pins & needles throughout my entire body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old non pregnant female non pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 23Jul2021 09:30 (at the age of: 61-years-old) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, asthma, Sulfa drugs allergy and shellfish allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), senna acutifolia (SENNA ACUTIFOLIA), vitamin d3 (VITAMIN D3), probiotics (PROBIOTICS) and multi vitamin received 2 weeks prior to the vaccination. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was reported that approximately 4-5 hrs after injection she started feeling pins & needles throughout her entire body, the next day she started feeling a slight burning sensation as well as itching that continued for the next 2 1/2 plus weeks. Also, she experienced swelling in her hands/face in the a.m. & calves/ankles in the p.m. about 1 week after the shot. The patient did not received treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was recovered/resolved with Sequel.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Nail discolouration, Pain in extremity
Clinical narrative: severe pain in the left foot, especially on the left big toe; toenail is bluish in color; severe pain and numbness in toe, feet and chest; severe pain and numbness in toe, feet and chest; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Left on 11Aug2021 15:15 (at the age of 42 years old) as dose 2, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not 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. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: FH6780 OR FN6780) on 21Jul2021 at 13:30 for covid-19 immunisation. The patient experienced severe pain in the left foot, especially on the left big toe, toenail is bluish in colour, severe pain and numbness in toe, feet and chest, on 12Aug2021. Caller mentioned that "this morning, he woke up with severe pain in the left foot, especially on the left big toe, his toenail is bluish in colour. Caller mentioned that he experienced numbness, "very numb" big toe after experiencing pain on it. when he walks or stands, he has pain on the left foot going to the calf. Agent states the patient got second dose yesterday, 11Aug2021, states he is having severe pain on his feet and toe, also on the chest. toenail is bluish in colour, also not having much feeling on his feet, a reduced sense of feeling. Wants to know if this is a normal side effect or if he needs to go to the doctor. Caller clarifies he got the Pfizer Covid vaccines, clarifies it is his left foot that is affected, states he had the injection in left shoulder, states the pain is especially in his big left toe, states he noticing the nail is looking like a bluish colour, states there is a lot of numbness in the big toe toward the tip of the toe and when walking or standing it causes pain from toe into foot and up into the left calf. Severe pain and numbness in toe, feet and chest and toenail is a bluish color were reported as worsened. AE(s) does not require a visit to Emergency Room or Physician Office. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Herpes simplex test
Clinical narrative: herpes outbreak; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0169) via an unspecified route of administration, administered in right arm on 08Jul2021 between 1-2pm (age at vaccination: 21-Year-old) as DOSE 1, SINGLE for Covid-19 immunization from Vaccination Clinic through the hospital. Medical history included herpes simplex from an unknown date and unknown if ongoing (when she was younger, she had herpes simplex virus. She has not had an outbreak since she was 15 or 16). There were no concomitant medications. Patient had no adverse event following prior vaccinations. She had received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 17Aug2021 (Lot Number: FC3181) as Dose 2, Single for Covid-19 immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On unspecific date in Jul2021, after first dose the patient experienced herpes outbreak. On an unspecific date the patient underwent lab tests and procedures which included herpes simplex test: positive for herpes via vaginal swab. The event resulted in Physician office visit not in emergency. Therapeutic measures were taken as a result of herpes outbreak. The outcome of the event was resolved on an unspecified date in Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Swelling
Clinical narrative: Left armpit swollen; Left armpit sore; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 27-year-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), ethinylestradiol, norethisterone (NORTREL 777) and escitalopram (MANUFACTURER UNKNOWN) 10 mg; all for unknown indication on an unknown date. Patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 10Apr2021 at 09:00, the patient experienced left armpit swollen and sore, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left armpit swollen and sore, fatigue and headache were recovered on an unknown date in Apr2021 at the time of this report.  No follow-up attempts are needed, information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: rash on my mid thighs to top of my knees; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other healthcare care professional (Nurse, Patient reported for herself that).  A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158), via unspecified route of administration in right arm on 24Apr2021 (at the age of 56-years-old) as DOSE 2, SINGLE for COVID-19 immunization. patient was not pregnant at the time of vaccination. Medical history included High blood pressure. Patient concomitant medications included losartan and metoprolol for an unspecified indication and therapy dates were also not reported. The patient previously received BNT162b2 (COMIRNATY, Batch/Lot Number: EW0151) via an unspecified route of administration in right arm 06Apr2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced outbreak of HSV1 on 10Apr2021.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received Losartan and Metoprolol within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, Patient developed a rash on her mid thighs to top of her knees (4 days after vaccination) and received inappropriate schedule of vaccine administration. Patient did not receive any treatment. The outcome of the event rash was recovering.  No follow-up attempts are required. No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Oral herpes
Clinical narrative: herpes outbreak on her lip; herpes outbreak on her lip; This is a spontaneous report from a contactable consumer (patient).  A 61-yaers-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6206)  via an unspecified route of administration, administered in left arm on 12Mar2021 (at the age of 60-years-old) as dose 2, single for covid-19 immunization. The patient medical history included history of herpes outbreaks and ongoing osteoarthritis diagnosed years ago (maybe 8-10 years ago). The patient history also included that Kidneys were not functioning the best. She had this since she was little. She had an infection that came from her teeth and caused them to shut down a little more. They were not running like they should have been. The patient concomitant medications was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9266 ) via an unspecified route of administration on 19Feb2021 as dose 1, single for covid-19 immunization. On 23Sep2021, the patient stated that she had experienced herpes outbreak on her lip (herpes simplex aggravated). She was taking medication for the herpes and wanted to get the Pfizer Booster. She did have both doses of the vaccine already. The herpes showed up after her doses. The patient queried whether she should wait to get the booster. The patient also stated that the medication helped her before. Therapeutic measures were taken as a result of herpes outbreak on her lip and included oral medication (unspecified). The patient did not require hospitalization for the events. The patient was still experiencing the events at the time of report. The outcome of the events was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She was not feeling well at first; felt sick day after injection; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date as single and dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single for covid-19 immunization. Medical history included endocarditis from an unknown date and unknown if ongoing endocarditis 8 years ago, diagnosed of Endocarditis specifically mitral valve prolapse, miscarriage from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was allergic to these antibiotic medications (Gentamycin and Vancomycin). She added that Amoxicillin did not help with her condition and diagnosed of Endocarditis specifically mitral valve prolapse. On an unspecified date, the patient was not feeling well at first and felt sick day after injection. The patient was not feeling well at first but was able to do normal activities and she was not feeling well at first. She mentioned that it's not that debilitating. She received the first and second dose of the vaccine and will be scheduled on 04Oct2021 to receive the third dose .Patient asking if the third dose (booster) is the same as the first and second dose of the Pfizer BioNTech (Comirnaty) vaccine. Clinical outcome of the event was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I was really sick; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number and Expiration Date were not reported) via an unspecified route of administration, on an unspecified date (age at vaccination: 57 years), as dose 2, single for COVID-19 immunization. The patient's medical history included thyroid cancer (2 stage thyroid cancer). The patient's concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (T3) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number and Expiration Date were not reported) via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date, the patient stated that she was very sick.It was reported that I thought I may have some bones out that was my limb nodes to be backed up (Further Clarifications unknown). I took medicine for pain, used my inhaler, I used my heart medicine because the raising heart, I was getting very lightheaded. Possibly took Tylenol for headache, lorazepam, apparently heart medicine and then I take loprazolam. For the other medication I called to my cardiologist and she got me a heart manager to try catch what's going on. At that time I was not sure that it was related to a vaccine cause I do have heart conditions (Further Clarifications Unknown). consumer stated, "No, I have client to work # company and in another state, it is important. I just wanted to make sure you had it and now I understand what's going on so its getting better over time. I just wanted to make sure you have the data I truly appropriate the opportunity to got the vaccine, I regret what's so ever. 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain, Pruritus, Rash
Clinical narrative: itchy; hurting/warm and tender to touch; broke out in a big rash on her arm and the pink area is expanding; expanding pink area, is very itchy; Off label use; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced itchy, hurting/warm, and tender to touch, broke out in a big rash on her arm and the pink area is expanding and expanding pink area, is very itchy. The patient stated that she got her booster on Thursday and has been itchy and hurting but today broke out in a big rash on her arm and the pink area was expanding. She asked if she could take something like Benadryl. The patient stated that she had the booster on Thursday and was okay on Friday and Saturday she started to itch. She stated she woke up with a huge rash, expanding pink area, is very itchy, warm, and tender to touch. She asked what she could do and if she could take Benadryl. She stated it was the Pfizer 3rd dose of the Covid. Investigation Assessment was not Provided. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: itchy; hurting/warm and tender to touch; broke out in a big rash on her arm and the pink area is expanding; expanding pink area, is very itchy; Off label use; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced itchy, hurting/warm, and tender to touch, broke out in a big rash on her arm and the pink area is expanding and expanding pink area, is very itchy. The patient stated that she got her booster on Thursday and has been itchy and hurting but today broke out in a big rash on her arm and the pink area was expanding. She asked if she could take something like Benadryl. The patient stated that she had the booster on Thursday and was okay on Friday and Saturday she started to itch. She stated she woke up with a huge rash, expanding pink area, is very itchy, warm, and tender to touch. She asked what she could do and if she could take Benadryl. She stated it was the Pfizer 3rd dose of the Covid. Investigation Assessment was not Provided. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Off label use
Clinical narrative: he should have waited longer than the 6 months to receive his booster dose after the second dose.; he should have waited longer than the 6 months to receive his booster dose after the second dose.; Feels awful; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first and second doses of BNT162B2 for COVID-19 immunization. It was reported that on an unspecified date the patient was feeling awful today. He was feeling awful and was not going to be working that day. He should have waited more than six months. He was assuming that the patient meant that he should have waited longer than six months to receive his booster dose after the second dose. The caller was assuming this event started today but he was not sure. It was unknown if additional Vaccines administered on Same Date of the Pfizer . The outcome for the 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Immunisation, Swelling, Vaccination site discomfort
Clinical narrative: I started having swelling and discomfort in my right arm pit area; Discomfort in right arm pit area; Discomfort at the injection site; Booster; This is a spontaneous report from a non-contactable nurse regarding a patient. A 45-year-old non-pregnant female patient booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0180, Expiry date: unknown) (age at the time of vaccination was 45 years, patient was non-pregnant at the time of vaccination), via intramuscular administered in Arm Right on 01Oct2021 at 10:30 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure abnormal treated with unspecified blood pressure medication, penicillin allergy. The patient's concomitant medication included unspecified medication for blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EH9899), via intramuscular administered in Arm Right on 07Jan2021 at 08:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3302), via intramuscular administered in Arm Right on 29Jan2021 at 08:00 as dose 2, single for COVID-19 immunization. On 02Oct2021 at 13:00, the patient started having swelling and discomfort in her right arm pit area. The patient had the usually discomfort at injection site but the swelling and discomfort in her right arm pit was a side effect that she didn't experience with her first or second dose. The patient had notified her employee health department as well. The events didn't result in physician or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling and discomfort in right arm pit area, discomfort at the injection site was resolving at the time of this report.   No follow-up attempts were possible. No further information was expected.