chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Overdose, Rash, Vaccination site erythema
Clinical narrative: Opposed to the Booster Formulation of Covid Vaccine (50ug); A rash developed on the bulk of her arm.; Inflammation; Injection site exhibited significant redness; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (A rash developed on the bulk of her arm.), INFLAMMATION (Inflammation), VACCINATION SITE ERYTHEMA (Injection site exhibited significant redness) and OVERDOSE (Opposed to the Booster Formulation of Covid Vaccine (50ug)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 10-Dec-2021, the patient experienced OVERDOSE (Opposed to the Booster Formulation of Covid Vaccine (50ug)). In December 2021, the patient experienced RASH (A rash developed on the bulk of her arm.), INFLAMMATION (Inflammation) and VACCINATION SITE ERYTHEMA (Injection site exhibited significant redness). On 10-Dec-2021, OVERDOSE (Opposed to the Booster Formulation of Covid Vaccine (50ug)) had resolved. At the time of the report, RASH (A rash developed on the bulk of her arm.) outcome was unknown and INFLAMMATION (Inflammation) and VACCINATION SITE ERYTHEMA (Injection site exhibited significant redness) was resolving.            No Concomitant medications were reported.  No Treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine was given 6 days post expiry date.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: His doctor prescribe antibiotics for his allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies). At the time of the report, HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient took Moderna COVID 19 vaccine 5 days ago and his doctor prescribe antibiotics for his allergies. No concomitant medication information was provided
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Gluteus instead of the deltoid; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Gluteus instead of the deltoid) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Gluteus instead of the deltoid). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Gluteus instead of the deltoid) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse further stated that they administered a 1st dose of the Moderna vaccine to one of their patients 24 hours after vial was pierced.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: During the shot it felt like she stuck into to far in my arm. It felt like it hit a bone. I felt the shot being administered. My two doses before this was painless and uneventful. I felt nothing and suffered no side effects including no pain at the injection site. But my booster shot was completely different. Starting the administration, the immediate pain at the injection site, and the continue pain the following day and stiffness in my upper left arm.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Injection site became warm to the touch, sore, a little swollen, red and itchy. It looks like a rash. I took Tylenol for some of the discomfort with pain and used a cold compress.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site became warm to the touch, sore, a little swollen, red and itchy. It looks like a rash. I took Tylenol for some of the discomfort with pain and used a cold compress.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, Asymptomatic COVID-19, Blood magnesium normal, Blood potassium decreased, COVID-19
Clinical narrative: Patient discharged after (4) day inpatient admission.  Patient is a 55M  with PMHx significant for alcohol abuse who presents  from dextox center for acute alcohol withdrawal. He was hallucinating, reporting the walls are melting and he sees an old woman and a ship captain standing at the door.      In ED, admission labs significant for mag 1.3, potassium 3.0, pancytopenia with WBC 3.86, RBC 3.58, platelet 69. He was treated with IVF bolus, 20mEq of IV potassium, started on etoh withdrawal protocols and covid19 swab was found to be positive. Lipase was elevated but he denies abdominal pain. He  was treated with IV fluids and electrolyte replacement. He was seen by Psychiatry  and was placed on prn Ativan for acute withdrawals, thiamine and folic acid.    His electrolytes were monitored and replaced accordingly. His diet was advanced. Per patient and family request, he was re evaluated by psychiatry for anxiety. He agreed to start Cymbalta 30 mg daily   For his COVID 19, he is fully vaccinated and asymptomatic. He did not require treatment   PT/OT initially recommended acute rehab. PM and R recommended home with outpatient therapy and balance center   He also wanted to continue intensive outpatient therapy for his ETOH abuse. He was discharged to home in stable condition on 12/15/21
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Lipase increased, Pancytopenia, Platelet count decreased, Red blood cell count decreased
Clinical narrative: Patient discharged after (4) day inpatient admission.  Patient is a 55M  with PMHx significant for alcohol abuse who presents  from dextox center for acute alcohol withdrawal. He was hallucinating, reporting the walls are melting and he sees an old woman and a ship captain standing at the door.      In ED, admission labs significant for mag 1.3, potassium 3.0, pancytopenia with WBC 3.86, RBC 3.58, platelet 69. He was treated with IVF bolus, 20mEq of IV potassium, started on etoh withdrawal protocols and covid19 swab was found to be positive. Lipase was elevated but he denies abdominal pain. He  was treated with IV fluids and electrolyte replacement. He was seen by Psychiatry  and was placed on prn Ativan for acute withdrawals, thiamine and folic acid.    His electrolytes were monitored and replaced accordingly. His diet was advanced. Per patient and family request, he was re evaluated by psychiatry for anxiety. He agreed to start Cymbalta 30 mg daily   For his COVID 19, he is fully vaccinated and asymptomatic. He did not require treatment   PT/OT initially recommended acute rehab. PM and R recommended home with outpatient therapy and balance center   He also wanted to continue intensive outpatient therapy for his ETOH abuse. He was discharged to home in stable condition on 12/15/21
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, White blood cell count decreased
Clinical narrative: Patient discharged after (4) day inpatient admission.  Patient is a 55M  with PMHx significant for alcohol abuse who presents  from dextox center for acute alcohol withdrawal. He was hallucinating, reporting the walls are melting and he sees an old woman and a ship captain standing at the door.      In ED, admission labs significant for mag 1.3, potassium 3.0, pancytopenia with WBC 3.86, RBC 3.58, platelet 69. He was treated with IVF bolus, 20mEq of IV potassium, started on etoh withdrawal protocols and covid19 swab was found to be positive. Lipase was elevated but he denies abdominal pain. He  was treated with IV fluids and electrolyte replacement. He was seen by Psychiatry  and was placed on prn Ativan for acute withdrawals, thiamine and folic acid.    His electrolytes were monitored and replaced accordingly. His diet was advanced. Per patient and family request, he was re evaluated by psychiatry for anxiety. He agreed to start Cymbalta 30 mg daily   For his COVID 19, he is fully vaccinated and asymptomatic. He did not require treatment   PT/OT initially recommended acute rehab. PM and R recommended home with outpatient therapy and balance center   He also wanted to continue intensive outpatient therapy for his ETOH abuse. He was discharged to home in stable condition on 12/15/21
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Myalgia, Pyrexia
Clinical narrative: Fatigue, chills, fever, muscle aches, migraine
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood albumin decreased, Blood calcium decreased, Blood glucose normal, COVID-19
Clinical narrative: Patient discharged after (3) day inpatient admission. Patient is a 53 y.o. male with pmhx relevant for Obesity (BMI 43.46), OSA (non-adherent with home CPAP), Depression, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. He is vaccinated x2 with Pfizer. Symptoms started 12/7. Tested positive 12/13. Received dexamethasone from 12/13, Remdesivir from 12/13. Is discharged on home oxygen none at rest 4L with exertion. Due to continued supplemental oxygen requirements I have prescribed dexamethasone 3 more days to complete 7 day course. Patient is advised of quarantine guidelines and understands that earliest clearance date is 12/18. He was also informed of new diagnosis of prediabetes (HbA1c 6.0) and advised on lifestyle modifications, follow-up. He is enrolled with COVID at home monitoring program at discharge and wife is a nurse as well.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiomegaly, Chest X-ray abnormal, Condition aggravated, Glucose tolerance impaired
Clinical narrative: Patient discharged after (3) day inpatient admission. Patient is a 53 y.o. male with pmhx relevant for Obesity (BMI 43.46), OSA (non-adherent with home CPAP), Depression, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. He is vaccinated x2 with Pfizer. Symptoms started 12/7. Tested positive 12/13. Received dexamethasone from 12/13, Remdesivir from 12/13. Is discharged on home oxygen none at rest 4L with exertion. Due to continued supplemental oxygen requirements I have prescribed dexamethasone 3 more days to complete 7 day course. Patient is advised of quarantine guidelines and understands that earliest clearance date is 12/18. He was also informed of new diagnosis of prediabetes (HbA1c 6.0) and advised on lifestyle modifications, follow-up. He is enrolled with COVID at home monitoring program at discharge and wife is a nurse as well.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lung opacity
Clinical narrative: Patient discharged after (3) day inpatient admission. Patient is a 53 y.o. male with pmhx relevant for Obesity (BMI 43.46), OSA (non-adherent with home CPAP), Depression, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. He is vaccinated x2 with Pfizer. Symptoms started 12/7. Tested positive 12/13. Received dexamethasone from 12/13, Remdesivir from 12/13. Is discharged on home oxygen none at rest 4L with exertion. Due to continued supplemental oxygen requirements I have prescribed dexamethasone 3 more days to complete 7 day course. Patient is advised of quarantine guidelines and understands that earliest clearance date is 12/18. He was also informed of new diagnosis of prediabetes (HbA1c 6.0) and advised on lifestyle modifications, follow-up. He is enrolled with COVID at home monitoring program at discharge and wife is a nurse as well.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive
Clinical narrative: Patient discharged after (3) day inpatient admission. Patient is a 53 y.o. male with pmhx relevant for Obesity (BMI 43.46), OSA (non-adherent with home CPAP), Depression, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. He is vaccinated x2 with Pfizer. Symptoms started 12/7. Tested positive 12/13. Received dexamethasone from 12/13, Remdesivir from 12/13. Is discharged on home oxygen none at rest 4L with exertion. Due to continued supplemental oxygen requirements I have prescribed dexamethasone 3 more days to complete 7 day course. Patient is advised of quarantine guidelines and understands that earliest clearance date is 12/18. He was also informed of new diagnosis of prediabetes (HbA1c 6.0) and advised on lifestyle modifications, follow-up. He is enrolled with COVID at home monitoring program at discharge and wife is a nurse as well.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 26th November 2021) for prophylaxis.   On 7th December 2021, the patient received Shingrix. On 7th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of expired Shingrix, which led to expired vaccine used. The reporter consented to follow up. This case has been linked to US2021252024 and US2021AMR252432, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252024:same reporter US-GLAXOSMITHKLINE-US2021AMR252432:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: 2 vaccine shots and now I have them again/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self reported by th patient. The age at vaccination was not reported. The patient had 2 vaccine shots and had shingles again.  The reporter stated that, it was no fun. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the Pediarix vaccine was partially administered to the patient because the vaccine leaked out the syringe because the syringe was cracked, which led to incomplete dose administered. The reporter was inquiring whether the vaccine should be administered again and if so, when since patient did not receive the entire recommended dose. The syringe was cracked before administering the vaccine, but not noticed until it was actually administered. As per report, it was something the vaccine administrator did that caused the syringe to crack. No product quality complaint raised. The reporter did not provide any additional details. The reporter consented to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head discomfort, Headache, Pyrexia
Clinical narrative: fatigued; Feverish; Headache; stuffy head/Head Congestion; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 97x9j, expiry date 30th April 2023) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 5th December 2021, 2 days after receiving Shingrix, the patient experienced fatigue, fever, headache and head discomfort. On an unknown date, the outcome of the fatigue, fever, headache and head discomfort were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, headache and head discomfort to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her 1st dose of Shingrix on Friday, in her left deltoid. She reported on Sunday she felt fatigued, and feverish. She also stated she had a headache and stuffy head (congestion). These symptoms lasted for 4 days and they were now resolved. The reporter consented to follow up. The reporter would not provide her mailing address for documentation of the call. She gave consent to contact her, but not her health care professional.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest discomfort, Delirium, Dizziness
Clinical narrative: This spontaneous report received from a patient concerned a 58-year-old Not Hispanic/Latino and white female. The patient's height, and weight were not reported. The patient's concurrent conditions included: enterocytes cystitis (captured: cystitis), bad bladder (captured: bladder disorder), bees sting allergy, wasp sting allergy, and sulfa allergy. The patient previously received covid-19 vaccine vaccination (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine. On 05-DEC-2021, the patient received covid-19 vaccine (suspension for injection, route of admin not reported, lot number: 1855191, expiry: Unknown) dose was not reported,1 total administered to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 06-DEC-2021 (reported as Monday), the patient woke up on morning really sick and complained of delirium (serious event), dizziness, chest feeling heavy, felt like the worst flu, feeling weak, fever, body aches, headache, "so sick this time", and Fever 102 (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 102 F. On 09-DEC-2021, the patient experienced sores in mouth (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 99.5- 99.8 F (reported as "normally 97.9F). The patient also stated no fever for 3 days as of now and asked for advice on what to do regarding AE (adverse event). The action taken with covid-19 vaccine was not applicable. The outcome of fever 102 was recovered (also reported as not recovered but stated to be recovered by the patient). The outcomes of the following events were not reported/unknown: headache, delirium, weakness, dizziness, body aches, feels like the worst flu, so sick this time, and chest feeling heavy. The outcome of sores in mouth was not recovered. The patient had not recovered from delirium, dizziness, sores in mouth, and feels like the worst flu, and the outcome of sick and chest feeling heavy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211222712-COVID-19 VACCINE Delirium. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 58-year-old Not Hispanic/Latino and white female. The patient's height, and weight were not reported. The patient's concurrent conditions included: enterocytes cystitis (captured: cystitis), bad bladder (captured: bladder disorder), bees sting allergy, wasp sting allergy, and sulfa allergy. The patient previously received covid-19 vaccine vaccination (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine. On 05-DEC-2021, the patient received covid-19 vaccine (suspension for injection, route of admin not reported, lot number: 1855191, expiry: Unknown) dose was not reported,1 total administered to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 06-DEC-2021 (reported as Monday), the patient woke up on morning really sick and complained of delirium (serious event), dizziness, chest feeling heavy, felt like the worst flu, feeling weak, fever, body aches, headache, "so sick this time", and Fever 102 (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 102 F. On 09-DEC-2021, the patient experienced sores in mouth (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 99.5- 99.8 F (reported as "normally 97.9F). The patient also stated no fever for 3 days as of now and asked for advice on what to do regarding AE (adverse event). The action taken with covid-19 vaccine was not applicable. The outcome of fever 102 was recovered (also reported as not recovered but stated to be recovered by the patient). The outcomes of the following events were not reported/unknown: headache, delirium, weakness, dizziness, body aches, feels like the worst flu, so sick this time, and chest feeling heavy. The outcome of sores in mouth was not recovered. The patient had not recovered from delirium, dizziness, sores in mouth, and feels like the worst flu, and the outcome of sick and chest feeling heavy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211222712-COVID-19 VACCINE Delirium. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: This spontaneous report received from a patient concerned a 58-year-old Not Hispanic/Latino and white female. The patient's height, and weight were not reported. The patient's concurrent conditions included: enterocytes cystitis (captured: cystitis), bad bladder (captured: bladder disorder), bees sting allergy, wasp sting allergy, and sulfa allergy. The patient previously received covid-19 vaccine vaccination (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine. On 05-DEC-2021, the patient received covid-19 vaccine (suspension for injection, route of admin not reported, lot number: 1855191, expiry: Unknown) dose was not reported,1 total administered to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 06-DEC-2021 (reported as Monday), the patient woke up on morning really sick and complained of delirium (serious event), dizziness, chest feeling heavy, felt like the worst flu, feeling weak, fever, body aches, headache, "so sick this time", and Fever 102 (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 102 F. On 09-DEC-2021, the patient experienced sores in mouth (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 99.5- 99.8 F (reported as "normally 97.9F). The patient also stated no fever for 3 days as of now and asked for advice on what to do regarding AE (adverse event). The action taken with covid-19 vaccine was not applicable. The outcome of fever 102 was recovered (also reported as not recovered but stated to be recovered by the patient). The outcomes of the following events were not reported/unknown: headache, delirium, weakness, dizziness, body aches, feels like the worst flu, so sick this time, and chest feeling heavy. The outcome of sores in mouth was not recovered. The patient had not recovered from delirium, dizziness, sores in mouth, and feels like the worst flu, and the outcome of sick and chest feeling heavy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211222712-COVID-19 VACCINE Delirium. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION( BREAKTHROUGH INFECTION); BRAIN FOG ASSOCIATED WITH BREAKTHROUGH INFECTION; COULDN'T DO NORMAL ACTIVITIES; FATIGUE; This spontaneous report received from a patient concerned a 68 year old Not Hispanic or Latino and white female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 07-APR-2021, the patient experienced fatigue and couldn't do normal activities and on 15-NOV-2021 patient started not feeling well. On 19-NOV-2021, the patient experienced confirmed clinical vaccination failure and confirmed covid-19 infection (breakthrough infection). On NOV-2021, the patient experienced brain fog associated with breakthrough infection. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Diagnosed with COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on APR-2021, and couldn't do normal activities, had not recovered from brain fog associated with breakthrough infection, and the outcome of confirmed covid-19 infection( breakthrough infection) and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.  .; Sender's Comments: V0:20211229772-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION( BREAKTHROUGH INFECTION); BRAIN FOG ASSOCIATED WITH BREAKTHROUGH INFECTION; COULDN'T DO NORMAL ACTIVITIES; FATIGUE; This spontaneous report received from a patient concerned a 68 year old Not Hispanic or Latino and white female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 07-APR-2021, the patient experienced fatigue and couldn't do normal activities and on 15-NOV-2021 patient started not feeling well. On 19-NOV-2021, the patient experienced confirmed clinical vaccination failure and confirmed covid-19 infection (breakthrough infection). On NOV-2021, the patient experienced brain fog associated with breakthrough infection. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Diagnosed with COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on APR-2021, and couldn't do normal activities, had not recovered from brain fog associated with breakthrough infection, and the outcome of confirmed covid-19 infection( breakthrough infection) and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.  .; Sender's Comments: V0:20211229772-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FZ1A, 041L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause (for four years.), Heartburn, Nausea and Rheumatoid arthritis. Concomitant products included OMEPRAZOLE for Nausea and Heartburn, PREDNISONE for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID), ACETAZOLAMIDE, GABAPENTIN, BENZONATATE, CLONAZEPAM, FOLIC ACID, LEFLUNOMIDE, FAMOTIDINE (PEPCID AC), MILNACIPRAN HYDROCHLORIDE (SAVELLA), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), ZINC and RITUXIMAB (RITUXAN) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-406624 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: developed a urinary tract infection after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose). At the time of the report, URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose) had resolved.            The patient received their primary series with the Moderna COVID-19 vaccine and developed a urinary tract infection after their 2nd dose, which delayed the receipt of their booster shot. The patient's doctor had advised the patient to hold off on getting the booster shot due to the illness. The patient was prone to get UTIs and their doctor said that it was unrelated to the vaccination event as their 2nd dose was in March and the UTI was in Nov-2021. The patient had since received some antibiotics and was recovered to receive their booster shot.  No medical history was provided by the reporter.  Treatment medication included some Antibiotics.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
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 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-May-2021.    On 24-Nov-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021 at 12:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, SARS-CoV-2 test: positive (Positive) Positive, Rapid test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. It was reported that expired moderna vaccine given to 7 patients and moderna vial was moved from freezer to refrigerator on 24 Nov 2021 the same day the dose was administered.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Limb discomfort
Clinical narrative: she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal; she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal; she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal), LIMB DISCOMFORT (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal) and DIARRHOEA (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced ABDOMINAL PAIN (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal), LIMB DISCOMFORT (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal) and DIARRHOEA (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal). At the time of the report, ABDOMINAL PAIN (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal), LIMB DISCOMFORT (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal) and DIARRHOEA (she had terrible abdominal pain an diarrhea, also some discomfort in the arm that was no big deal) outcome was unknown.            Patient stopped taking lupus and Ra medication before vaccination as recommended by her doctor. No treatment details were reported. Patient's DOB was reported as 10-Jul-2021.