chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphonia, Chest discomfort, Dyspnoea, Paraesthesia oral
Clinical narrative: Patient had received her COVID-19 vaccination earlier this afternoon.  After approximately 15-20 minutes she began to develop a pruritic erythematous rash on her chest and extremities and a feeling of itchiness in her throat.  She was given Benadryl but the symptoms persisted and she began having worsening chest tightness.  She was given intramuscular epinephrine and brought to the emergency department at Medical Center.  She also had some nausea associated with this episode but believes it started following the epinephrine injection.  In the ED she was noted to have significant increased work of breathing was given a dose of intravenous epinephrine and started on an epinephrine infusion.  Patient was also given DuoNeb inhaler with good results.  Patient continues to experience some mild chest tightness and throat itchiness but denies having any pruritus or skin rash.  Patient has had anaphylactic reactions in the past with Xolair and  Dupliumab.  She recalls during those anaphylactic episodes she would feel well for a couple hours and then the symptoms of chest tightness and throat itchiness would return.  She has had a good response to continuous DuoNebs in the past and has required continues to nebs when she was admitted for her asthma exacerbations.  She denies having any sick contacts.  She has spoken with her pulmonology team at Hospital prior to receiving the COVID-19 vaccination.  Prior to this acute illness she denied having any fevers, chills, shortness of breath, new cough, abdominal pain, nausea, diarrhea, leg pain, or new leg swelling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Patient had received her COVID-19 vaccination earlier this afternoon.  After approximately 15-20 minutes she began to develop a pruritic erythematous rash on her chest and extremities and a feeling of itchiness in her throat.  She was given Benadryl but the symptoms persisted and she began having worsening chest tightness.  She was given intramuscular epinephrine and brought to the emergency department at Medical Center.  She also had some nausea associated with this episode but believes it started following the epinephrine injection.  In the ED she was noted to have significant increased work of breathing was given a dose of intravenous epinephrine and started on an epinephrine infusion.  Patient was also given DuoNeb inhaler with good results.  Patient continues to experience some mild chest tightness and throat itchiness but denies having any pruritus or skin rash.  Patient has had anaphylactic reactions in the past with Xolair and  Dupliumab.  She recalls during those anaphylactic episodes she would feel well for a couple hours and then the symptoms of chest tightness and throat itchiness would return.  She has had a good response to continuous DuoNebs in the past and has required continues to nebs when she was admitted for her asthma exacerbations.  She denies having any sick contacts.  She has spoken with her pulmonology team at Hospital prior to receiving the COVID-19 vaccination.  Prior to this acute illness she denied having any fevers, chills, shortness of breath, new cough, abdominal pain, nausea, diarrhea, leg pain, or new leg swelling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Full blood count normal, Metabolic function test normal
Clinical narrative: Patient had received her COVID-19 vaccination earlier this afternoon.  After approximately 15-20 minutes she began to develop a pruritic erythematous rash on her chest and extremities and a feeling of itchiness in her throat.  She was given Benadryl but the symptoms persisted and she began having worsening chest tightness.  She was given intramuscular epinephrine and brought to the emergency department at Medical Center.  She also had some nausea associated with this episode but believes it started following the epinephrine injection.  In the ED she was noted to have significant increased work of breathing was given a dose of intravenous epinephrine and started on an epinephrine infusion.  Patient was also given DuoNeb inhaler with good results.  Patient continues to experience some mild chest tightness and throat itchiness but denies having any pruritus or skin rash.  Patient has had anaphylactic reactions in the past with Xolair and  Dupliumab.  She recalls during those anaphylactic episodes she would feel well for a couple hours and then the symptoms of chest tightness and throat itchiness would return.  She has had a good response to continuous DuoNebs in the past and has required continues to nebs when she was admitted for her asthma exacerbations.  She denies having any sick contacts.  She has spoken with her pulmonology team at Hospital prior to receiving the COVID-19 vaccination.  Prior to this acute illness she denied having any fevers, chills, shortness of breath, new cough, abdominal pain, nausea, diarrhea, leg pain, or new leg swelling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pregnancy test negative, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient had received her COVID-19 vaccination earlier this afternoon.  After approximately 15-20 minutes she began to develop a pruritic erythematous rash on her chest and extremities and a feeling of itchiness in her throat.  She was given Benadryl but the symptoms persisted and she began having worsening chest tightness.  She was given intramuscular epinephrine and brought to the emergency department at Medical Center.  She also had some nausea associated with this episode but believes it started following the epinephrine injection.  In the ED she was noted to have significant increased work of breathing was given a dose of intravenous epinephrine and started on an epinephrine infusion.  Patient was also given DuoNeb inhaler with good results.  Patient continues to experience some mild chest tightness and throat itchiness but denies having any pruritus or skin rash.  Patient has had anaphylactic reactions in the past with Xolair and  Dupliumab.  She recalls during those anaphylactic episodes she would feel well for a couple hours and then the symptoms of chest tightness and throat itchiness would return.  She has had a good response to continuous DuoNebs in the past and has required continues to nebs when she was admitted for her asthma exacerbations.  She denies having any sick contacts.  She has spoken with her pulmonology team at Hospital prior to receiving the COVID-19 vaccination.  Prior to this acute illness she denied having any fevers, chills, shortness of breath, new cough, abdominal pain, nausea, diarrhea, leg pain, or new leg swelling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Throat irritation
Clinical narrative: Patient had received her COVID-19 vaccination earlier this afternoon.  After approximately 15-20 minutes she began to develop a pruritic erythematous rash on her chest and extremities and a feeling of itchiness in her throat.  She was given Benadryl but the symptoms persisted and she began having worsening chest tightness.  She was given intramuscular epinephrine and brought to the emergency department at Medical Center.  She also had some nausea associated with this episode but believes it started following the epinephrine injection.  In the ED she was noted to have significant increased work of breathing was given a dose of intravenous epinephrine and started on an epinephrine infusion.  Patient was also given DuoNeb inhaler with good results.  Patient continues to experience some mild chest tightness and throat itchiness but denies having any pruritus or skin rash.  Patient has had anaphylactic reactions in the past with Xolair and  Dupliumab.  She recalls during those anaphylactic episodes she would feel well for a couple hours and then the symptoms of chest tightness and throat itchiness would return.  She has had a good response to continuous DuoNebs in the past and has required continues to nebs when she was admitted for her asthma exacerbations.  She denies having any sick contacts.  She has spoken with her pulmonology team at Hospital prior to receiving the COVID-19 vaccination.  Prior to this acute illness she denied having any fevers, chills, shortness of breath, new cough, abdominal pain, nausea, diarrhea, leg pain, or new leg swelling.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Palpitations, Paraesthesia oral, Pruritus
Clinical narrative: Tingling of palate. started 5-7 min. after receiving the vaccine Difficulty breathing, tachicardia,  hypertension lasted about an hour- hour and half but hard to say until benadryl kicked in. TReated in ED with IV benadryl and pepcid . I left the hospital 5 hours later with normal vitals of heart rate in the 60's and b.p. 112/62
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypertension, Paraesthesia oral, Tachycardia
Clinical narrative: Tingling of palate. started 5-7 min. after receiving the vaccine Difficulty breathing, tachicardia,  hypertension lasted about an hour- hour and half but hard to say until benadryl kicked in. TReated in ED with IV benadryl and pepcid . I left the hospital 5 hours later with normal vitals of heart rate in the 60's and b.p. 112/62
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: Left face and arm felt numb--monitoring, but no other treatment
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left face and arm felt numb--monitoring, but no other treatment
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: SLIGHT SKIN RASH
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: SLIGHT SKIN RASH
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A week After  received the vaccine ,on Saturday 1/23/2021 I notice swelling and redness on the injection site and it was itchy. I did not take anything to treat, the next day I went to the emergency room and the gave me ibuprofen and claritin. but other then the swelling and the redness I seem to be fine no fever no other significant symptoms
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Product storage error
Clinical narrative: No adverse event; PRODUCT STORAGE ERROR; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 mL (dose, route of administration, anatomical location not provided) as prophylaxis, which reported to had been under temperature excursion (product storage error) on 18-DEC-2020 (lot # T022294, expiration date: 26-MAR-2022, and lot # T032003, expiration date: 08-MAY-2022, both stablished as valid; and lot # T02003, expiration date: 08-MAY-2022) as recorded by data logger. In addition, it was reported that the temperature and time frame for the vaccine was below 2°C (1.3C) for 0 hours 24 minutes, with previous temperature excursion below 2°C (1.6C) for 24 minutes.   Lot number T02003 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Lot number T02003 does not match any company product as confirmed by Lot verification team. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: A pharmacist reported a pediatric dose of VAQTA was administered to a 19 year old; No additional AE reported; This spontaneous report was received from a pharmacist referring to a 19-year-old patient of unknown gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number and expiration date were unknown by the reporter). It was specified that the dose administered was a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered). No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.       On 05-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133 with expiration date 15-SEP-2020; strength, dose and route were not reported) for prophylaxis (expired product administered). the product did not have any previous temperature excursion. Not supported disclaimer was provided. No additional adverse event (AE) reported. No product quality complaint (PQC).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On 20-DEC-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including but not limited to a physician assistant at a clinic, for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On 25-SEP-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including but not limited to a physician, for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: reoccurring shingles affecting his right eye; postherpetic neuralgia; diagnosed with recurrent shingles; This spontaneous report was received from a lawyer, referring to a patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 01-JAN-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving the vaccine, the patient suffered reoccurring shingles affecting his right eye and the right side of the face and head (ophthalmic herpes zoster). Plaintiff was diagnosed with recurrent shingles at various times and postherpetic neuralgia.   As a direct and proximate result the patient experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury.  The events were assessed as disabling and ophthalmic herpes zoster was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was prescribed and/or administered by a healthcare provider with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequent to the vaccination), the patient was treated by healthcare providers for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided. The reporter considered both events to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015 the patient was prescribed and/or administered by a healthcare provider with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as subsequent to the vaccination), the patient was treated by a physician for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided. The reporter considered both events to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; Caller reports the administration of expired VAQTA; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JAN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) (administration route and anatomical location were not reported) lot # S036494, expiration date on 09-JAN-2021, 1 milliliter for prophylaxis. The reporting nurse stated the administration of expired hepatitis a vaccine, inactivated(VAQTA) and inquiring information if administration of vaccine was viable. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from a physician regarding 4 month old infant of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not provided. On 18-JAN-2021, the patient was inadvertently vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (route of administration, anatomical location, vaccine scheme, lot number and expiration date were not provided) as prophylaxis; instead of the pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) vaccine. It was not noticed until 19-JAN-2021 (wrong product administered) (product name confusion). One of the billers in the physician's office noticed the mistake when she was recording the administered vaccine in the patient's medical record. The physician stated the he did not keep much Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  in his office since it was rarely administered there. He knew that he had three doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and went to check after this report, and now had only two doses left.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; 08-JUL-2020, the patient was vaccinated with an accidental 4th dose of GARDASIL 9; This spontaneous report was received from a nurse, referring to a 18 year old female patient (conflicting information, also reported as "19 year old"). The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 08-JUL-2020, the patient was vaccinated with an accidental 4th dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). The nurse stated that they just found this error looking at her records. No additional adverse event reported
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: NO OTHER AE; a temperature excursion involving GARDASIL 9 / GARDASIL 9 was administered; This spontaneous report was received from a person of physician's office, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 12-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1602284, expiration date 26-SEP-2021 for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of 31.2 Centigrade degrees (°C) during 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No other adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a other reporter, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter, by oral route as prophylaxis (concentration was not reported; lot number 1742457 and expiration date 16-FEB-2022). According to the reporter, the temperature excursion was 1.3 degrees Celsius for a time frame of 19 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Adjustment disorder, Anxiety, Blindness, Deafness, Depression
Clinical narrative: pneumonia; This spontaneous report was received from a lawyer referring to a 66-year-old female patient. Drug reactions/allergies and concomitant medication were not reported.  In June 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).        On an unknown date, 3 days after vaccination, the patient experienced pneumonia.    The outcome of pneumonia was unknown.   The reporter considered pneumonia to be a side effect of vaccination.  Upon internal review, pneumonia was considered a medically significant event.   Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, ophthalmic herpes zoster, hearing loss, severe ringing in ears, right hand tremors, panic attacks, bad eyesight, severe loss of vision, anxiety, depression and adjustment disorder (captured in MARRS 2003USA007338).; Sender's Comments:  US-009507513-2003USA007338:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Panic attack, Pneumonia, Tinnitus
Clinical narrative: pneumonia; This spontaneous report was received from a lawyer referring to a 66-year-old female patient. Drug reactions/allergies and concomitant medication were not reported.  In June 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).        On an unknown date, 3 days after vaccination, the patient experienced pneumonia.    The outcome of pneumonia was unknown.   The reporter considered pneumonia to be a side effect of vaccination.  Upon internal review, pneumonia was considered a medically significant event.   Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, ophthalmic herpes zoster, hearing loss, severe ringing in ears, right hand tremors, panic attacks, bad eyesight, severe loss of vision, anxiety, depression and adjustment disorder (captured in MARRS 2003USA007338).; Sender's Comments:  US-009507513-2003USA007338:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Visual impairment
Clinical narrative: pneumonia; This spontaneous report was received from a lawyer referring to a 66-year-old female patient. Drug reactions/allergies and concomitant medication were not reported.  In June 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).        On an unknown date, 3 days after vaccination, the patient experienced pneumonia.    The outcome of pneumonia was unknown.   The reporter considered pneumonia to be a side effect of vaccination.  Upon internal review, pneumonia was considered a medically significant event.   Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, ophthalmic herpes zoster, hearing loss, severe ringing in ears, right hand tremors, panic attacks, bad eyesight, severe loss of vision, anxiety, depression and adjustment disorder (captured in MARRS 2003USA007338).; Sender's Comments:  US-009507513-2003USA007338:
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Deafness, Herpes zoster, Pain in extremity, Skin cancer
Clinical narrative: This spontaneous report was received from a lawyer referring to a 80-year-old male patient. As concurrent conditions were reported smoker (for 20 years, 1 pack of cigarettes per day), high cholesterol, high blood pressure and chronic obstructive pulmonary disease (COPD). The patient's historical conditions included chickenpox at the age of 4-9 years old. In 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient experienced sore arm for 2 days. The outcome of sore arm was unknown. The reporter considered sore arm to be a side effect of vaccination. Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and experienced shingles, hearing loss and skin cancer (captured in MARRS 2009USA008295).; Sender's Comments: US-009507513-2009USA008295.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram, Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); UNABLE TO SLEEP DUE TO DISCOMFORT; UNABLE TO SLEEP DUE TO DISCOMFORT; This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) (batch number unknown, expiry date 31st December 2022) for rheumatoid arthritis.   Concurrent medical conditions included diverticulitis (diagnosed with diverticulitis on 15th October 2020), renal cyst and rib fracture (had 3 broken ribs). Concomitant products included minocycline hydrochloride (Minocycline), hydroxychloroquine, gabapentin and lisinopril and hydrochlorothiazide.   On 19th November 2020, the patient received Shingrix. On 20th November 2020, the patient started Xeljanz 5 mg twice daily (10 mg daily). In November 2020, less than a week after receiving Shingrix and an unknown time after starting Minocycline, the patient experienced injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort to be related to Shingrix.  Additional details were provided as follows: The CT scan results showed cyst on kidney and three broken ribs. The patient experienced symptoms of aching, redness, and swelling at the injection site (left arm). The patient was unable to sleep due to discomfort.  The patient stated that he/she would need a left knee replacement soon, physician was aware of medical conditions.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Insomnia, Sleep disorder
Clinical narrative: SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); SYMPTOMS OF ACHING, REDNESS, AND SWELLING AT THE INJECTION SITE (LEFT ARM); UNABLE TO SLEEP DUE TO DISCOMFORT; UNABLE TO SLEEP DUE TO DISCOMFORT; This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) (batch number unknown, expiry date 31st December 2022) for rheumatoid arthritis.   Concurrent medical conditions included diverticulitis (diagnosed with diverticulitis on 15th October 2020), renal cyst and rib fracture (had 3 broken ribs). Concomitant products included minocycline hydrochloride (Minocycline), hydroxychloroquine, gabapentin and lisinopril and hydrochlorothiazide.   On 19th November 2020, the patient received Shingrix. On 20th November 2020, the patient started Xeljanz 5 mg twice daily (10 mg daily). In November 2020, less than a week after receiving Shingrix and an unknown time after starting Minocycline, the patient experienced injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, sleeplessness and discomfort to be related to Shingrix.  Additional details were provided as follows: The CT scan results showed cyst on kidney and three broken ribs. The patient experienced symptoms of aching, redness, and swelling at the injection site (left arm). The patient was unable to sleep due to discomfort.  The patient stated that he/she would need a left knee replacement soon, physician was aware of medical conditions.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose / administered on 01Dec2018 and second on 30Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st December 2018).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 30th September 2020, not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received a late second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to US2020243326, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243326:same reporter
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from an approximately 63 year old male consumer with no pertinent medical history and no known drug reactions or allergies who in June 2010, was vaccinated with a dose of zoster vaccine live (Oka/Merck) (dose, route and Lot# not reported). Concomitant therapy included atorvastatin calcium (LIPITOR).  The consumer stated that "three weeks later" on approximately June 2010, he experienced herpes outbreak, then a month later on approximately July 2010, he experienced another herpes outbreak, and once more he had shingles rash and the pain that follows. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received on 19-JAN-2021, from a lawyer, regarding a case in litigation. It was confirmed that the patient was vaccinated with zoster vaccine live(ZOSTAVAX) and subsequently was treated by healthcare providers for the following injuries resulting from Plaintiff's zoster vaccine live(ZOSTAVAX) use: multiple outbreaks of herpes zoster, and postherpetic neuralgia. The outcome of post herpetic neuralgia and herpes zoster was unknown. Company Causality Assessment: Episode Profile: Medically Confirmed: N.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: High Troponin Levels; Felt dizzy; Chest felt tight; Mitral valve filling defect; Difficulty breathing; Concern of anaphylaxis; Passed out unconscious; A spontaneous report was received from a physician concerning an approximately 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect.  The patient's medical history as provided by the reporter included a history of anxiety. Concomitant medication use included sertraline, buspirone, acyclovir, propranolol, hydroxyzine and lorazepam for unknown indications.  On 04 Jan 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021) intramuscularly, in her left deltoid, for prophylaxis of COVID-19 infection.   On 04 Jan 2020, a couple of minutes after receiving the vaccine, the patient experienced dizziness, chest felt tight, difficulty breathing, and she passed out unconscious. Due to concern of anaphylaxis, while the patient was still unconscious, she was treated with epinephrine followed by intramuscular injection of cetirizine hydrochloride. In addition, ammonia salt was used. The patient woke up briefly and passed back out. Emergency medical services (EMS) arrived and almost had to intubate the patient. The patient stayed overnight in the hospital due to lab values indicating non-ST segment elevation myocardial infraction, high troponin levels, and a mitral valve filing defect. It was noted that the patient has never had an allergy to anything, including the excipients in the Moderna vaccine. In addition, the patient had no history of loss of consciousness or anaphylaxis. Relevant laboratory tests conducted included an echocardiogram which found no issues with cardiac function and noted a mitral valve filling defect.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect was unknown.; Reporter's Comments: This case concerns a 28 year old female patient with medical history anxiety who experienced Concern of anaphylaxis , high troponin levels, dizziness, chest discomfort, difficulty breathing, loss of consciousness and Mitral valve filling defect  same day after administration of the first and only dose of the mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021).  Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Mitral valve incompetence, Troponin, Troponin increased
Clinical narrative: High Troponin Levels; Felt dizzy; Chest felt tight; Mitral valve filling defect; Difficulty breathing; Concern of anaphylaxis; Passed out unconscious; A spontaneous report was received from a physician concerning an approximately 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect.  The patient's medical history as provided by the reporter included a history of anxiety. Concomitant medication use included sertraline, buspirone, acyclovir, propranolol, hydroxyzine and lorazepam for unknown indications.  On 04 Jan 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021) intramuscularly, in her left deltoid, for prophylaxis of COVID-19 infection.   On 04 Jan 2020, a couple of minutes after receiving the vaccine, the patient experienced dizziness, chest felt tight, difficulty breathing, and she passed out unconscious. Due to concern of anaphylaxis, while the patient was still unconscious, she was treated with epinephrine followed by intramuscular injection of cetirizine hydrochloride. In addition, ammonia salt was used. The patient woke up briefly and passed back out. Emergency medical services (EMS) arrived and almost had to intubate the patient. The patient stayed overnight in the hospital due to lab values indicating non-ST segment elevation myocardial infraction, high troponin levels, and a mitral valve filing defect. It was noted that the patient has never had an allergy to anything, including the excipients in the Moderna vaccine. In addition, the patient had no history of loss of consciousness or anaphylaxis. Relevant laboratory tests conducted included an echocardiogram which found no issues with cardiac function and noted a mitral valve filling defect.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, felt dizzy, chest felt tight, difficulty breathing, passed out unconscious, concern of anaphylaxis, non-ST segment elevation myocardial infraction, high troponin levels, and mitral valve filing defect was unknown.; Reporter's Comments: This case concerns a 28 year old female patient with medical history anxiety who experienced Concern of anaphylaxis , high troponin levels, dizziness, chest discomfort, difficulty breathing, loss of consciousness and Mitral valve filling defect  same day after administration of the first and only dose of the mRNA-1273 (Lot number: 011L20A, Exp. date: 03 Jul 2021).  Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.