chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter
Clinical narrative: Atrial fibrillation; Flutter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; ATRIAL FLUTTER (non-serious), outcome "unknown", described as "Flutter".  Clinical course: Customer verbatim: Pfizer BioNTech Covid Vaccine and Atrial fibrillation/flutter - a phase IV clinical study of CDC and FDA data Summary: Atrial fibrillation/flutter is found among people who get Pfizer BioNTech Covid Vaccine, especially for people who are male, 60plus old. Reporters husband developed this and they reported it but have not heard from them. Requested to be contacted to discuss this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Feeding disorder, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Manager, spoke with wife 12/14/2021 who indicated that spouse is hospitalized and unable to walk, eat, or do many motions on his own. Suspected Guillain-Barre syndrome. She indicated that the Health Department is requesting the medical record as they are wanting the information on which vaccine was given. Medical records request from patient's spouse was received by our facility on 12/21/2021 and all requested records were sent on this date. Reportedly, there was a VAERS report submitted by the facility where patient received treatment.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: not known
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: not known
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19, Chest X-ray abnormal, Chronic respiratory disease
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Endotracheal intubation, General physical health deterioration, Malaise
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Polyuria, Pulmonary embolism, Renal impairment, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sepsis, Systemic inflammatory response syndrome
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Death, Dizziness, Dyspnoea, Endotracheal intubation
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extubation, Fall, Headache, Intensive care, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Septic shock, Urinary tract infection
Clinical narrative: pt brought to ED via EMS after falling out of bed; c/o SOB, generalized weakness, dizziness, headache, chills; O2 supplementation, ABX, dexamethasone given; positive for COVID; COVID pneumonia; sepsis with shock; O2 demand increased; transferred to ICU; required intubation; worsening acute hypoxic respiratory distress; acute PE and UTI; AKI; code status was intubation only; transitioned to comfort measures; extubated and pt passed away
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Developed a pulmonary embolus
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: Developed a pulmonary embolus
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Culture, Dyspnoea, Echocardiogram, Hypoxia
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Body temperature increased, Chest pain, Dyspnoea, Laboratory test
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung disorder, Nasopharyngitis, Oxygen saturation decreased, Productive cough, Pulmonary hypertension
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test negative, Sputum discoloured
Clinical narrative: Continuing respiratory distress from 1st VAERS - On 4-20-2022, I woke up with cold symptoms. On 4-24-2022, I started noticing decreased 02 sats and it was getting harder to breath. My temp was going up to 101.6 and I was coughing up brown stuff. I was on a maximum of 3L oxygen. I did two COVID-19 home tests and both were negative. I went to the hospital/ER later that day and I was put on 6L of oxygen. They admitted me that day and tested me for COVID-19 and it was negative. I was eventually put on hi flow 02. I woke up the following day on 15L 02. I was then put on 12L non rebreather along with the 15L of 02. I was on this for 4 days. On Friday, they were able to start lowering my oxygen. They started me on high dose steroids 40mg iv every 8 hours. I have had a few episodes of chest pain and my blood pressure went up. I am now on 2L oxygen. Very little reserve. Questionable diagnosis of Right Pulmonary Hypertension. They are unsure if it is due to the lung disease. I am still in the hospital. I hope to be discharged tomorrow or the next day on home 02.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Eructation, Laboratory test
Clinical narrative: 06/2021 2 months after second dose of COVID-19 Vaccine, I began to notice a burning feeling in my stomach. I was belching a lot more as well. It was continuing to get worse and so I consulted my doctor, who then gave me prescriptions. There is a lot of pain and burning, and I have a really hard time eating as well. Endoscopy showed small hernia and that I had a lot of bile in my stomach. Gastro surgeon did another endoscopy and showed no hernia however a lot of inflammation. They checked my esophagus and multiple areas in my abdomen and only found inflammation. I am scheduled to see my neurologist next for further workup. I am on prescriptions that are helping me function, Diprovate, Pantoprazole, are doing great however, there is still the pain as well as discomfort with the prescriptions in use.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Duodenogastric reflux, Dyspepsia, Eating disorder, Endoscopy abnormal
Clinical narrative: 06/2021 2 months after second dose of COVID-19 Vaccine, I began to notice a burning feeling in my stomach. I was belching a lot more as well. It was continuing to get worse and so I consulted my doctor, who then gave me prescriptions. There is a lot of pain and burning, and I have a really hard time eating as well. Endoscopy showed small hernia and that I had a lot of bile in my stomach. Gastro surgeon did another endoscopy and showed no hernia however a lot of inflammation. They checked my esophagus and multiple areas in my abdomen and only found inflammation. I am scheduled to see my neurologist next for further workup. I am on prescriptions that are helping me function, Diprovate, Pantoprazole, are doing great however, there is still the pain as well as discomfort with the prescriptions in use.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eructation, Hernia, Inflammation, Pain
Clinical narrative: 06/2021 2 months after second dose of COVID-19 Vaccine, I began to notice a burning feeling in my stomach. I was belching a lot more as well. It was continuing to get worse and so I consulted my doctor, who then gave me prescriptions. There is a lot of pain and burning, and I have a really hard time eating as well. Endoscopy showed small hernia and that I had a lot of bile in my stomach. Gastro surgeon did another endoscopy and showed no hernia however a lot of inflammation. They checked my esophagus and multiple areas in my abdomen and only found inflammation. I am scheduled to see my neurologist next for further workup. I am on prescriptions that are helping me function, Diprovate, Pantoprazole, are doing great however, there is still the pain as well as discomfort with the prescriptions in use.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Spouse claims that the patient passed away two days after receiving Pfizer booster dose.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Muscular weakness
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030L20A) for COVID-19 vaccination.     Patient did not ever have COVID positive test or diagnosis. The patient did not have any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to chemicals (Conray 400 dye), Diabetes (No changes in status such as improvement or worsening) since 1993 and Kidney disorder (No changes in status such as improvement or worsening). Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN DETEMIR (LEVEMIR), GLIPIZIDE, METOPROLOL, LOSARTAN, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and ROSUVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). In March 2021, HEADACHE (Headache) had resolved.            After 2nd shot patient had experienced headache for 24 hours. Treatment medications were not reported.   This case was linked to MOD-2022-552505, MOD-2022-552512 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030L20A) for COVID-19 vaccination.     Patient did not ever have COVID positive test or diagnosis. The patient did not have any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to chemicals (Conray 400 dye), Diabetes (No changes in status such as improvement or worsening) since 1993 and Kidney disorder (No changes in status such as improvement or worsening). Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN DETEMIR (LEVEMIR), GLIPIZIDE, METOPROLOL, LOSARTAN, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and ROSUVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). In March 2021, HEADACHE (Headache) had resolved.            After 2nd shot patient had experienced headache for 24 hours. Treatment medications were not reported.   This case was linked to MOD-2022-552505, MOD-2022-552512 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, Balance test, Blood test, Dizziness
Clinical narrative: Developed intermittent lightheadedness and forgetfulness/memory loss.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory normal, Magnetic resonance imaging head normal, Memory impairment, Prostatic specific antigen normal, Scan myocardial perfusion normal
Clinical narrative: Developed intermittent lightheadedness and forgetfulness/memory loss.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Full blood count normal, Headache, Laboratory test, Nausea
Clinical narrative: Severe, pounding headache that started while driving. Accompanied by severe photophobia and nausea. Vertigo started one day later, along with the headache. Headache increased in intensity over 5 days, unrelenting. Headache resolved 7 days after it started.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vertigo
Clinical narrative: Severe, pounding headache that started while driving. Accompanied by severe photophobia and nausea. Vertigo started one day later, along with the headache. Headache increased in intensity over 5 days, unrelenting. Headache resolved 7 days after it started.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I was vaccinated in March and April of 2021 and was positive covid in Dec21 for 4 or 5 days. I had a cough,chills and sore throat
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vomiting
Clinical narrative: Chills- body aches/soreness/headache and threw up once
Age: 66.0
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: the patient did not experience any adverse events; systemic 9-valent human papillomavirus vaccine for recalcitrant common cutaneous warts in preparation for renal transplant in 66-year-old woman; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 66-year-old female patient. Her concurrent conditions included chronic renal failure, type 2 diabetes, hypertension and thyroid cancer. The patient's historical conditions was not reported.   The patient presented with 10 recalcitrant cutaneous warts on both hands that had been present for 10 years (started in approximately 2008). On an unknown date, she was treated with liquid nitrogen (reported as countless treatments) but despite the treatment, the warts never improved.   In 2018, after informed consent, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, intramuscularly (dose, anatomical location, lot# and expiration date were not provided) for recalcitrant cutaneous warts (off label use). The warts began to improve after the first dose of the vaccine. On an unspecified dates, she received second and third intramuscular vaccine injections with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, lot# and expiration date were not provided) at 2, and 6 months. The warts were completely resolved after the third dose.  The period of observation was from 2018-2021. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was well tolerated, the patient did not experience any adverse events (no adverse event), and she successfully underwent renal transplantation in 2019, in less than 3 months after the last injection. She did not experience post-transplant recurrence of the warts.    A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product storage error). On an unknown date, before the administration, vaccine underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported (No adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2204USA001816:
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events.; Caller is nurse reporting administration of expired dose of PROQUAD.; This spontaneous report has been received from a nurse regarding a 4 years-old female patient. The patient's concurrent condition, concomitant therapies, historical condition, drug allergies and reaction were not reported.   On 05-APR-2022,  the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA), lot # T031825, expiration date reported as 16-MAR-2022, subcutaneous (dose and frequency were not reported) in the right deltoid for prophylaxis.No temperature excursions reported. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any adverse effects or symptoms after receiving the ROTATEQ; a dose of ROTATEQ was given after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 11-APR-2022, the patient received a dose of rotavirus vaccine, live, oral, pentavalent therapy (ROTATEQ) 2 milliliter once, orally as prophylaxis (lot # 1707502 with expiry date 31-MAR-2022) after its expiration date (Expired product administered). The patient did not have any adverse effects or symptoms after receiving the rotavirus vaccine, live, oral, pentavalent therapy (ROTATEQ) (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; PROQUAD was inadvertently administered 1 day after its expiration date; This spontaneous report as received from an office manager and refers to a 5 year old male patient. On 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T034826 exp date 11-APR-2022) (dose 1 subcutaneously in the right thigh at a private clinic. Concomitant therapies included sterile diluent. It was reported that the vaccine was removed from storage and no adverse response was noted in the patient.; Sender's Comments:  US-009507513-2203USA003273:
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No abnormal signs or symptoms have been reported for this patient; She reports this was a vaccine selection error as the provider intended to administer MMR vaccine instead of Proquad; She reports this was a vaccine selection error as the provider intended to administer MMR vaccine instead of Proquad; patient received 0.5 ml of Varivax and 0.5 ml of Proquad due to vaccine selection error; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 12-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) dose of 0.5 ml, subcutaneously in the left thigh, lot # U027947, expiration date was reported as 12-APR-2023 but upon internal validation process it was established as 08-SEP-2023 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) dose of 0.5 ml, subcutaneously in the right thigh, lot # U029324, expiration date 19-MAR-2023, albumin status has been verified as recombinant human albumin (rHA). Both vaccines were administered for prophylaxis. This was a vaccine selection error as the provider intended to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Administration error was discovered on the evening of 12-APR-2022 (also reported as on 13-APR-2023, discrepant information) after the patient was discharged to home with her parents. No abnormal signs or symptoms have been reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired PROQUAD; This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.  On 19-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # T034826 was found to be valid, expiration date 11-APR-2022 (expired product administered) (dose, route of administration and injection site were not reported) for prophylaxis. No additional adverse events were reported. The reporter confirmed, that it was no temperature reported for the affected vaccine.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP reported that VARIVAX with an expiration date of 4/10/2022 was administered to a patient today (4/21/2022). HCP requested information on re-vaccination of VARIVAX; This spontaneous report was received from a nurse and concerns 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) in dose of 0.5 ml, lot number T012551, expiration date 10-APR-2022 (formulation was not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: Issues with some PNEUMOVAX23 having a broken flange; no adverse event; This spontaneous report was received from an office manager. The reporter stated there were issues with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number U026796, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 28-JAN-2023). The flange was broken (syringe issue). No adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA008646: US-009507513-2111USA009249: US-009507513-2204USA007667: US-009507513-2204USA007829:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired MMR II was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  On 25-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # T013727, expiration date: 21-APR-2022; strength and route were not reported) 0.5 mL for prophylaxis (expired product administered). The vaccine did not have a temperature excursion. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Pain in jaw, Trigeminal neuralgia
Clinical narrative: Pain on face, severe, area of trigeminal nerve; Pain on face, severe, area of trigeminal nerve; Pain on face, severe, area of trigeminal nerve from his ear to lower jaw; Pain on face, severe, area of trigeminal nerve from his ear to lower jaw; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, 1 day after receiving Shingrix, the patient experienced facial pain, trigeminal neuralgia, ear pain and jaw pain. On an unknown date, the outcome of the facial pain, trigeminal neuralgia, ear pain and jaw pain were not recovered/not resolved.   It was unknown if the reporter considered the facial pain, trigeminal neuralgia, ear pain and jaw pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by patient's wife. The patient received Shingrix 2 days ago and the day after he started experiencing pain on the right side of his face.  At the time of reporting, it was more severe and follows the area of the trigeminal nerve from his ear to lower jaw on the right. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Pain
Clinical narrative: Got my shot w/my covid vaccines. It hurt.; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional Information:  Receipt Date: 23-APR-2022 Reporter's Comments: This case was reported via (Shingrix page) interactive. The patient received his/ her shot with covid vaccines, it hurt but did not make sick.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms terrible; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingrix vaccine 3 days before the day of the reporting and felt the same way flu like symptoms which was terrible. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: I had the vaccine it was rough; This case was reported by a consumer via interactive digital media and described the occurrence of pain during injection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain during injection. On an unknown date, the outcome of the pain during injection was unknown.   It was unknown if the reporter considered the pain during injection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine and he/she felt vaccine was rough but so much better than shingles.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Periarthritis
Clinical narrative: Frozen shoulder; mostly pain free; This case was reported by a consumer via interactive digital media and described the occurrence of frozen shoulder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced frozen shoulder and pain. On an unknown date, the outcome of the frozen shoulder and pain were recovering/resolving.   It was unknown if the reporter considered the frozen shoulder and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient got the shingles vaccine and ended up with frozen shoulder from it, 7 and 1/2 months of agony. The patient was finally pain free mostly. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: taken shingles vaccine, got the shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient got Shingle vaccine and still had shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: sick all day; did it knock me on my butt; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingles vaccine. On 23rd April 2022, less than a month after receiving Shingles vaccine, the patient experienced sickness and malaise. On an unknown date, the outcome of the sickness and malaise were unknown.   It was unknown if the reporter considered the sickness and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just received the second shot and did it knock on patients butt patient was sick all day the day prior to the reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn't know it should have a 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine few years ago. The patient did not know it should have a second dose. The patient asked did he/she need to repeat dose or just a second dose. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 18Sep2019, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th September 2019,(batch number BP578, expiration date 20th December 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The patient received first dose of Shingrix series and had not yet received second dose. The Reporter gave permission for follow-up via phone, declined to provide email address. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked with case US2022AMR070604, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070604:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pts outside the 6 month window, HCP gave the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown 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 Information: GSK Receipt Date: 25-APR-2022 Reporter's comment: The pharmacist reported that when this happened before, the patients were late for their second dose of Shingrix and it was outside the 6-month interval, when she gave the second dose. No further details regarding patient or product available but registered pharmacist agreeable to follow-up. The registered pharmacist did not know how many patients this occurred with either. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.  This case has been linked to the US2022AMR070596 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070596:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: kicking my ass; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   The reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022  Reporter's Comments: This case was received from the consumer via interactive digital media. The patient reported that Shingle vaccine was kicking his/her ass. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: didn't have any side effects with either one other than a sore arm.; hurt a lot than covid shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR071660   Additional Information: GSK Receipt Date: 27-APR-2022  Reporter's comment: This case was reported by a patient via Interactive Digital Media. The patient did not have any side effects with either one other than a sore arm.  The shingles shot hurt a lot more than the Covid shot. Additional supportive information:  For tolerance of 2nd dose refer case US2022AMR071660. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071660:same reporter