chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Immunoglobulin therapy, Muscular weakness
Clinical narrative: Reported Symptoms: 10018767:  GUILLAIN-BARRE SYNDROME; Narrative: 52 y/o R-handed male patient essentially previously healthy who presented with subacute painless weakness and sensory deficit of BLE and distal BUE associated with gait change and stool retention. Symptom began 4-6 weeks after receiving influenza and second COVID-19 booster vaccination. Examination notable for weakness and sensory ataxia with areflexia; clinical and electrodiagnostically congruent with AIDP. Patient required IVIG treatments. Other Relevant HX: Other: GUILLIAN BARRE
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Bronchitis, COVID-19, Chest X-ray normal, Chest discomfort
Clinical narrative: Reported Symptoms: 10003025:APPETITE IMPAIRED; 10008479:CHEST PAIN; 10016256:FATIGUE; 10016558:FEVER; 10036790:PRODUCTIVE COUGH; 10040604:SHORTNESS OF BREATH; Narrative: 5/17/23 at 12:45pm - Pt presented to ED c/o worsening SOB, productive cough (started 5/16), and mid chest tightness since last night. Pt also reports poor appetite and fatigue. He states he had a subjective fever yesterday but did not check his temperature with a thermometer. Pt indicates he thought his sarcoidosis was flaring up yesterday but with worsening cough today, he presents to the ER with fever with mild tachycardia and also with a fever of 101.2. Pt tested COVID-19 positive. While patient was in the ED, he was noted to be tachycardic with HR in the low 100s to 120s, resp rate in the 30s, pox in the upper 90s and b/p 125/63. Treatment in the ER: IVF, cxr (impression - no acute pulmonary findings), ekg (sinus tachycardia), blood culture x 2, Ceftraxone 1gm IV, albuterol inhaler (6 inhalation), dexamethasone (6mg po), acetaminophen 1000mg x 1 and 2L NS) Pt admitted with respiratory distress. Primary diagnosis - COVID-19 viral syndrome. Pt admitted to hospital from 5/17/23 tp 5/19/23. Per discharge summary on 5/19: PRINCIPAL DIAGNOSIS (Reason for admission after study): 1. Acute COVID 19: 2. Pulmonary sarcodosis/OSA with Acute Bronchitis and Acute on chronic sinusitis 3. Multiple Focal Nodules are present at the right upper lobe and right lower lobe adjacent to the major fissure ADDITIONAL DIAGNOSES: OSA Pulmonary Sarcoidosis Hypertension Migraine Hyperlipidemia HOSPITAL COURSE: Acute COVID:19: with
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Electrocardiogram abnormal, Fatigue
Clinical narrative: Reported Symptoms: 10003025:APPETITE IMPAIRED; 10008479:CHEST PAIN; 10016256:FATIGUE; 10016558:FEVER; 10036790:PRODUCTIVE COUGH; 10040604:SHORTNESS OF BREATH; Narrative: 5/17/23 at 12:45pm - Pt presented to ED c/o worsening SOB, productive cough (started 5/16), and mid chest tightness since last night. Pt also reports poor appetite and fatigue. He states he had a subjective fever yesterday but did not check his temperature with a thermometer. Pt indicates he thought his sarcoidosis was flaring up yesterday but with worsening cough today, he presents to the ER with fever with mild tachycardia and also with a fever of 101.2. Pt tested COVID-19 positive. While patient was in the ED, he was noted to be tachycardic with HR in the low 100s to 120s, resp rate in the 30s, pox in the upper 90s and b/p 125/63. Treatment in the ER: IVF, cxr (impression - no acute pulmonary findings), ekg (sinus tachycardia), blood culture x 2, Ceftraxone 1gm IV, albuterol inhaler (6 inhalation), dexamethasone (6mg po), acetaminophen 1000mg x 1 and 2L NS) Pt admitted with respiratory distress. Primary diagnosis - COVID-19 viral syndrome. Pt admitted to hospital from 5/17/23 tp 5/19/23. Per discharge summary on 5/19: PRINCIPAL DIAGNOSIS (Reason for admission after study): 1. Acute COVID 19: 2. Pulmonary sarcodosis/OSA with Acute Bronchitis and Acute on chronic sinusitis 3. Multiple Focal Nodules are present at the right upper lobe and right lower lobe adjacent to the major fissure ADDITIONAL DIAGNOSES: OSA Pulmonary Sarcoidosis Hypertension Migraine Hyperlipidemia HOSPITAL COURSE: Acute COVID:19: with
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pulmonary mass, Pulmonary sarcoidosis, Pyrexia, Respiratory distress
Clinical narrative: Reported Symptoms: 10003025:APPETITE IMPAIRED; 10008479:CHEST PAIN; 10016256:FATIGUE; 10016558:FEVER; 10036790:PRODUCTIVE COUGH; 10040604:SHORTNESS OF BREATH; Narrative: 5/17/23 at 12:45pm - Pt presented to ED c/o worsening SOB, productive cough (started 5/16), and mid chest tightness since last night. Pt also reports poor appetite and fatigue. He states he had a subjective fever yesterday but did not check his temperature with a thermometer. Pt indicates he thought his sarcoidosis was flaring up yesterday but with worsening cough today, he presents to the ER with fever with mild tachycardia and also with a fever of 101.2. Pt tested COVID-19 positive. While patient was in the ED, he was noted to be tachycardic with HR in the low 100s to 120s, resp rate in the 30s, pox in the upper 90s and b/p 125/63. Treatment in the ER: IVF, cxr (impression - no acute pulmonary findings), ekg (sinus tachycardia), blood culture x 2, Ceftraxone 1gm IV, albuterol inhaler (6 inhalation), dexamethasone (6mg po), acetaminophen 1000mg x 1 and 2L NS) Pt admitted with respiratory distress. Primary diagnosis - COVID-19 viral syndrome. Pt admitted to hospital from 5/17/23 tp 5/19/23. Per discharge summary on 5/19: PRINCIPAL DIAGNOSIS (Reason for admission after study): 1. Acute COVID 19: 2. Pulmonary sarcodosis/OSA with Acute Bronchitis and Acute on chronic sinusitis 3. Multiple Focal Nodules are present at the right upper lobe and right lower lobe adjacent to the major fissure ADDITIONAL DIAGNOSES: OSA Pulmonary Sarcoidosis Hypertension Migraine Hyperlipidemia HOSPITAL COURSE: Acute COVID:19: with
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus tachycardia, Sinusitis, Tachycardia
Clinical narrative: Reported Symptoms: 10003025:APPETITE IMPAIRED; 10008479:CHEST PAIN; 10016256:FATIGUE; 10016558:FEVER; 10036790:PRODUCTIVE COUGH; 10040604:SHORTNESS OF BREATH; Narrative: 5/17/23 at 12:45pm - Pt presented to ED c/o worsening SOB, productive cough (started 5/16), and mid chest tightness since last night. Pt also reports poor appetite and fatigue. He states he had a subjective fever yesterday but did not check his temperature with a thermometer. Pt indicates he thought his sarcoidosis was flaring up yesterday but with worsening cough today, he presents to the ER with fever with mild tachycardia and also with a fever of 101.2. Pt tested COVID-19 positive. While patient was in the ED, he was noted to be tachycardic with HR in the low 100s to 120s, resp rate in the 30s, pox in the upper 90s and b/p 125/63. Treatment in the ER: IVF, cxr (impression - no acute pulmonary findings), ekg (sinus tachycardia), blood culture x 2, Ceftraxone 1gm IV, albuterol inhaler (6 inhalation), dexamethasone (6mg po), acetaminophen 1000mg x 1 and 2L NS) Pt admitted with respiratory distress. Primary diagnosis - COVID-19 viral syndrome. Pt admitted to hospital from 5/17/23 tp 5/19/23. Per discharge summary on 5/19: PRINCIPAL DIAGNOSIS (Reason for admission after study): 1. Acute COVID 19: 2. Pulmonary sarcodosis/OSA with Acute Bronchitis and Acute on chronic sinusitis 3. Multiple Focal Nodules are present at the right upper lobe and right lower lobe adjacent to the major fissure ADDITIONAL DIAGNOSES: OSA Pulmonary Sarcoidosis Hypertension Migraine Hyperlipidemia HOSPITAL COURSE: Acute COVID:19: with
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, Post-acute COVID-19 syndrome
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10038678:RESPIRATORY DEPRESSION; 10084380:COVID-19 PNEUMONIA;  Narrative: Patient has received two Pfizer COVID 19 vaccines Feb 2022. The patient presented to the ED on 15 March 2023 with shortness of breath and tachycardia.  The patient was diagnosed with COVID 19 on 4 March 2023 and was treated with molnupiravir. The patient was admitted to the hospital on 15 March 23 with respiratory failure and covid pneumonia.  The patient was treated with remdesivir, oxygen, dexamethasone, and antibiotics. The patient was discharged on 16 March 2023 with long COVID on mycophenolate. Reported per EUA.  Other Relevant HX: Other: covid pneumonia
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory depression, Respiratory failure, Tachycardia
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10038678:RESPIRATORY DEPRESSION; 10084380:COVID-19 PNEUMONIA;  Narrative: Patient has received two Pfizer COVID 19 vaccines Feb 2022. The patient presented to the ED on 15 March 2023 with shortness of breath and tachycardia.  The patient was diagnosed with COVID 19 on 4 March 2023 and was treated with molnupiravir. The patient was admitted to the hospital on 15 March 23 with respiratory failure and covid pneumonia.  The patient was treated with remdesivir, oxygen, dexamethasone, and antibiotics. The patient was discharged on 16 March 2023 with long COVID on mycophenolate. Reported per EUA.  Other Relevant HX: Other: covid pneumonia
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cardiac monitoring, Dyspnoea, Nausea, Respiratory depression
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10038678:RESPIRATORY DEPRESSION; Narrative: HISTORY OF PRESENT ILLNESS: This is a 52-year-old female as an employee and nurse in the emergency department who began having difficulty breathing and sensation of tightness in the throat about 20 minutes after receiving influenza vaccination. Patient states that the sensation continued, and she so told her her coworkers she was having difficulty breathing who than brought her to the room for further evaluation by myself. Patient denies any fevers or chills. No cough or congestion. No chest pain. Does complain of shortness of breath secondary to sensation of fullness in the throat. She states that her throat feels scratchy and full. She denies any nausea, vomiting or diarrhea. No abdominal pain. No dysuria. States that she was feeling fine prior to receiving the influenza immunization this morning. There are no other complaints today. There are no other associated symptoms or modifying factors MEDICAL DECISION MAKING: The patient was taken to the room, Hep-Lock IV established and placed on the cardiac monitor. Nurses notes reviewed. Vital signs reviewed. Patient was given 125 mg of Solu-Medrol IV. She was given 50 mg of Benadryl IV. Patient was given an albuterol breathing treatment. After few minutes of therapy the patient states that she was feeling better. Patient was monitored in the emergency department for over 2 hours. She did have some nausea for which she was given Zofran IV. On reevaluation the patient states that she feels much better. Believe the patient's
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10038678:RESPIRATORY DEPRESSION; Narrative: HISTORY OF PRESENT ILLNESS: This is a 52-year-old female as an employee and nurse in the emergency department who began having difficulty breathing and sensation of tightness in the throat about 20 minutes after receiving influenza vaccination. Patient states that the sensation continued, and she so told her her coworkers she was having difficulty breathing who than brought her to the room for further evaluation by myself. Patient denies any fevers or chills. No cough or congestion. No chest pain. Does complain of shortness of breath secondary to sensation of fullness in the throat. She states that her throat feels scratchy and full. She denies any nausea, vomiting or diarrhea. No abdominal pain. No dysuria. States that she was feeling fine prior to receiving the influenza immunization this morning. There are no other complaints today. There are no other associated symptoms or modifying factors MEDICAL DECISION MAKING: The patient was taken to the room, Hep-Lock IV established and placed on the cardiac monitor. Nurses notes reviewed. Vital signs reviewed. Patient was given 125 mg of Solu-Medrol IV. She was given 50 mg of Benadryl IV. Patient was given an albuterol breathing treatment. After few minutes of therapy the patient states that she was feeling better. Patient was monitored in the emergency department for over 2 hours. She did have some nausea for which she was given Zofran IV. On reevaluation the patient states that she feels much better. Believe the patient's
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Night sweats
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10035664:PNEUMONIA; 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; Narrative: Patient received three doses of Pfizer COVID 19 vaccine Feb/Oct 2021. The patient presented to the ED on 20 March 2023 with cough, chills, night sweats, and shortness of breath. The patient tested positive for COVID 19 on 20 March 2023 and was admitted to the hospital with sepsis and respiratory failure which led to bacterial pneumonia. The patient was treated with remdesivir, antibiotics, oxygen, inhalers, and dexamethasone. The patient was discharged on oxygen in stable condition on 1 April 2023. Reported per EUA. Other Relevant HX: Other: SEPSIS, PNEUMONIA,
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Pneumonia bacterial, Respiratory depression, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10035664:PNEUMONIA; 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; Narrative: Patient received three doses of Pfizer COVID 19 vaccine Feb/Oct 2021. The patient presented to the ED on 20 March 2023 with cough, chills, night sweats, and shortness of breath. The patient tested positive for COVID 19 on 20 March 2023 and was admitted to the hospital with sepsis and respiratory failure which led to bacterial pneumonia. The patient was treated with remdesivir, antibiotics, oxygen, inhalers, and dexamethasone. The patient was discharged on oxygen in stable condition on 1 April 2023. Reported per EUA. Other Relevant HX: Other: SEPSIS, PNEUMONIA,
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10035664:PNEUMONIA; 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; Narrative: Patient received three doses of Pfizer COVID 19 vaccine Feb/Oct 2021. The patient presented to the ED on 20 March 2023 with cough, chills, night sweats, and shortness of breath. The patient tested positive for COVID 19 on 20 March 2023 and was admitted to the hospital with sepsis and respiratory failure which led to bacterial pneumonia. The patient was treated with remdesivir, antibiotics, oxygen, inhalers, and dexamethasone. The patient was discharged on oxygen in stable condition on 1 April 2023. Reported per EUA. Other Relevant HX: Other: SEPSIS, PNEUMONIA,
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10028411:MYALGIA; 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; 10084380:COVID-19 PNEUMONIA; Narrative: Patient had two doses of Moderna COVID 19 vaccine (Feb/Mar 2021) and one dose of Pfizer COVID 19 vaccine in Aug 2022. The patient presented to the ED on 25 March 2023 with coughing wheezing, fatigue, and shortness of breath. The patient tested positive for COVID 19 on 25 March 2023 and was admitted with sepsis, covid pneumonia, and UTI. The patient was treated with antibiotics, dexamethasone, and remdesivir. The patient was discharged on 29 March 2023 in stable condition. Reported per EUA. Other Relevant HX; Other: SEPSIS, COVID PNEUMONIA
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory depression, SARS-CoV-2 test positive, Sepsis, Urinary tract infection, Wheezing
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10028411:MYALGIA; 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; 10084380:COVID-19 PNEUMONIA; Narrative: Patient had two doses of Moderna COVID 19 vaccine (Feb/Mar 2021) and one dose of Pfizer COVID 19 vaccine in Aug 2022. The patient presented to the ED on 25 March 2023 with coughing wheezing, fatigue, and shortness of breath. The patient tested positive for COVID 19 on 25 March 2023 and was admitted with sepsis, covid pneumonia, and UTI. The patient was treated with antibiotics, dexamethasone, and remdesivir. The patient was discharged on 29 March 2023 in stable condition. Reported per EUA. Other Relevant HX; Other: SEPSIS, COVID PNEUMONIA
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Hypoxia, Myalgia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10021142:HYPOXEMIA; 10028411:MYALGIA; 10038678:RESPIRATORY DEPRESSION; 10084380: COVID-19 PNEUMONIA; Narrative: Patient received two doses of Moderna COVID-19 vaccine on Jul/Aug 2021. The patient presented to the ED on 16 April 2023 with cough, shortness of breath, malaise, and fever. The patient tested positive for COVID 19 on 16 April 2023 and was admitted to the hospital with COVID pneumonia and respiratory failure. The patient was treated with antibiotics, remdesivir, and dexamethasone. The patient was discharged on 20 April 2023 in stable condition. Reported per EUA. Other Relevant HX: Other: COVID pneumonia, hypoxia
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory depression, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10021142:HYPOXEMIA; 10028411:MYALGIA; 10038678:RESPIRATORY DEPRESSION; 10084380: COVID-19 PNEUMONIA; Narrative: Patient received two doses of Moderna COVID-19 vaccine on Jul/Aug 2021. The patient presented to the ED on 16 April 2023 with cough, shortness of breath, malaise, and fever. The patient tested positive for COVID 19 on 16 April 2023 and was admitted to the hospital with COVID pneumonia and respiratory failure. The patient was treated with antibiotics, remdesivir, and dexamethasone. The patient was discharged on 20 April 2023 in stable condition. Reported per EUA. Other Relevant HX: Other: COVID pneumonia, hypoxia
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Dyspnoea, Guillain-Barre syndrome, Insomnia
Clinical narrative: SYMPTOMS OF GUILLAIN-BARRE; GETTING SEVERE SYMPTOMS QUITE OFTEN; difficulty breathing; severe dizziness; PANIC AND ANXIETY ATTACKS; insomnia; This spontaneous report received from a male patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid (2 times). The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: 1821286) dose was not reported, administered on 02-SEP-2021 for covid-19 prophylaxis. No concomitant medications were reported. The patient stated that he wanted to inquire about reimbursement for costs of fixing the adverse events after receiving the Janssen COVID 19 Vaccine. The patient also wanted to know who his lawyer need to contact for legal action. The patient stated that he went to the ER (Emergency Room) 9 times in course of a year immediately following getting the vaccine. The patient only took the vaccine because it was mandated by his work. The patient had COVID twice before getting the vaccine and never had any symptoms. After getting the vaccine, patient had symptoms of Guillain-Barre (dose series 1), severe nerve damage, difficulty breathing (dose series 1) and severe dizziness (dose series 1). The patient had panic and anxiety attacks (dose series 1), insomnia (dose series 1) and all kinds of symptoms. The patent's symptoms were too vast to name every one of them. The patient had so many symptoms that it was hard to keep track of all of them. Patient stated that it was on Janssen as they said that the vaccine was safe and effective but it was anything, but safe or effective. Patient spent thousands of dollars trying to fix his symptoms and they were still not fixed. Patient's doctor wrote him a note to exempt him from getting the booster. Patient went to different Emergency Rooms in different states, because he was getting severe symptoms quite often (dose series 1). Patient wished not to provide his address and did not have the expiration date on his vaccine card when asked by the agent. Patient did not have the address for the vaccine facility. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of guillain-barre, difficulty breathing, severe dizziness, panic and anxiety attacks, insomnia, and getting severe symptoms quite often. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Guillain-Barre syndrome. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: SYMPTOMS OF GUILLAIN-BARRE; GETTING SEVERE SYMPTOMS QUITE OFTEN; difficulty breathing; severe dizziness; PANIC AND ANXIETY ATTACKS; insomnia; This spontaneous report received from a male patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid (2 times). The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: 1821286) dose was not reported, administered on 02-SEP-2021 for covid-19 prophylaxis. No concomitant medications were reported. The patient stated that he wanted to inquire about reimbursement for costs of fixing the adverse events after receiving the Janssen COVID 19 Vaccine. The patient also wanted to know who his lawyer need to contact for legal action. The patient stated that he went to the ER (Emergency Room) 9 times in course of a year immediately following getting the vaccine. The patient only took the vaccine because it was mandated by his work. The patient had COVID twice before getting the vaccine and never had any symptoms. After getting the vaccine, patient had symptoms of Guillain-Barre (dose series 1), severe nerve damage, difficulty breathing (dose series 1) and severe dizziness (dose series 1). The patient had panic and anxiety attacks (dose series 1), insomnia (dose series 1) and all kinds of symptoms. The patent's symptoms were too vast to name every one of them. The patient had so many symptoms that it was hard to keep track of all of them. Patient stated that it was on Janssen as they said that the vaccine was safe and effective but it was anything, but safe or effective. Patient spent thousands of dollars trying to fix his symptoms and they were still not fixed. Patient's doctor wrote him a note to exempt him from getting the booster. Patient went to different Emergency Rooms in different states, because he was getting severe symptoms quite often (dose series 1). Patient wished not to provide his address and did not have the expiration date on his vaccine card when asked by the agent. Patient did not have the address for the vaccine facility. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of guillain-barre, difficulty breathing, severe dizziness, panic and anxiety attacks, insomnia, and getting severe symptoms quite often. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Guillain-Barre syndrome. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Underdose
Clinical narrative: no symptoms or side effects reported; Medical Assistant called to inquire if an expired dose of RECOMBIVAX HB was valid; a pediatric dose of RECOMBIVAX HB given to an adult; This spontaneous report was received from a medical assistant and referred to a 30-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 27-FEB-2024, the patient was vaccinated with the pediatric dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter/once, lot #U033519, expiration date: 10-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered, incorrect dose administered). Confirmed no temperature excursions on product and no symptoms or side effects reported/no additional AE (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE details; HCP called to report  that a single dose of VARIVAX was given on 2/18/2024, 1 week after the patient was given a dose of MMR on 2/11/2024 . Verified with caller that MMR was not MMR II. HCP has no additional AE details, Permission given to contact ; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-FEB-2024, the patient was administered a dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) lot # 1025567, expiration date: 14-AUG-2024 (strength, route of administration, anatomical location not provided); and on 18-FEB-2024, the patient was vaccinated with a single dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # 1039689, expiration date: 13-DEC-2024 (strength, route of administration, anatomical location not provided), both as prophylaxis (inappropriate schedule of product administration). The reporter verified that the vaccine administered was measles vaccine, mumps vaccine, rubella vaccine (MMR), not the measles, mumps and rubella (WISTAR RA 27-3) virus vaccine live (M-M-R II). No additional adverse events.   Lot number 1039689 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX). Lot number 1025567 is an invalid lot number for measles vaccine, mumps vaccine, rubella vaccine (MMR).
Age: 13.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No side effects were reported; 13-year-old female inadvertently received PROQUAD and VARIVAX instead of MMR II and VARIVAX; 13-year-old female inadvertently received PROQUAD and VARIVAX instead of MMR II and VARIVAX; 13-year-old female inadvertently received PROQUAD and VARIVAX instead of MMR II and VARIVAX; This spontaneous report was received from a registered nurse and refers to a 13-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On 03-MAR-2024, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (dose, lot #, expiration date and route were not reported) (accidental overdose, product administered to patient of inappropriate age and wrong product administered). No side effects, nor additional adverse event and no product quality complain were reported.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK received date: 01-Mar-2024 This case was reported by a patient via interactive digital media. Patient got both shots and got the shingles also. Patient was still going through them, it hit patient on left side of the face. Even the doctor had no answer. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was administered only the diluent for ACTHIB, the diluent was not reconstituted with vaccine with no reported adverse event; Initial information received on 05-Mar-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1-year-old male patient was administered only the diluent for HIB (PRP/T) VACCINE [ACT-HIB], the diluent was not reconstituted with vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Immunisation; and covid-19 vaccine for COVID-19 immunisation.  On 05-Mar-2024, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength, expiry date: unknown) (lot: UJ996AA) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and patient was administered only the diluent for acthib, the diluent was not reconstituted with vaccine with no reported adverse event (product preparation error).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 93.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Client, 93 year old lady. She got TDAP (Private) today. personnel checked system to determine eligibility to get the TDAP, and her chart did not show any history of TDAP given. The daughter who brought in the mom was also asked if the client received TDAP within the last 10 years, and she stated no. personnel proceeded to register the client on system, and the client with the daughter proceeded to the vaccinator's station (Bilingual nurse documenting and asking the questions - both mom/daughter speak another language; and another nurse vaccinating). The nurses complete their second check on system to determine eligibility for TDAP, again seeing no records of TDAP vaccination for the client. They proceeded to vaccinated and document the vaccination given. After vaccination, the mom and daughter went around the health fair, checking resources provided by the other participants/vendors at the health fair. They were at health fair for about 10-15 minutes before they left the clinic site to home.   Towards the end of the day, while doing my team lead QA, I noticed on chart that the client got a TDAP shot on 11/3/2020 already. The administering nurse also noticed this while doing her own QA. I reported the med error to my QA RN. Today (3/7/24), I called the client for a wellness check. Daughter stated the client is doing good, no issues from vaccination completed from the day prior.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Herpes zoster, Vaccination failure
Clinical narrative: break out atleast every other week/ Suspected vaccination failure; break out atleast every other week; Allergic to it now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: break out atleast every other week/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: break out atleast every other week) and allergy (Verbatim: Allergic to it now). The outcome of the vaccination failure was unknown and the outcome of the shingles and allergy were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and allergy to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2024 This case was reported by consumer via interactive digital media. The reporter was a patient. Patient got the shot and patient was allergic to it and at the reporting time reporter said that it break out at least every week. Patient advised that if allergic to a live virus shot did not get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: hospital with shingles after the vaccine/ Suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: hospital with shingles after the vaccine/ Suspected vaccination failure) (serious criteria hospitalization and GSK medically significant) and shingles (Verbatim: Shingles) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2024 This case was reported by consumer via interactive digital media. The reporter reported that the patient was 2 months in the hospital with shingles after receiving the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 01-Mar-2024 This case was reported via interactive digital media. Reporter knew several people (patients) who got shingles, after having the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: really broke out / Suspected vaccination failure; really broke out/Much worse than any of the other times; they were really painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles when was in college and in patient's 40's).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: really broke out / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: really broke out/Much worse than any of the other times) and pain (Verbatim: they were really painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient via interactive digital media. The patient had the shingle shot, and really broke out. Much worse than any of the other times and patient stated they were really painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Pain; Shingles returned/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (diagnosed with shingles in 2015) and pain. Concurrent medical conditions included post herpetic neuralgia.   In APR-2023, the patient received Shingles vaccine. In OCT-2023, between 5 and 7 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles returned/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced pain (Verbatim: Pain). The patient was treated with lidocaine. The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that could had been worse if not for vaccine. Virus attacked same nerve. The patient refused to take medications; they did not work. The patient used Lidocaine every several hours to help a little. The resulting pain was not worth skipping the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is feeling just a little sore; This non-serious 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 26-FEB-2024, the patient received Shingles vaccine. On 28-FEB-2024, 2 days after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm is feeling just a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date:29-FEB-2024 This case was reported by a patient via interactive digital media. The patient got Shingle shot Monday this is Wednesday arm was feeling just a little sore but patient would take that way before the actual Shingles. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Coeliac disease, Investigation
Clinical narrative: celiac disease; This is a spontaneous report received from an Other HCP from a sales representative.  A 22-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history (athlete/healthy). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: COELIAC DISEASE (medically significant), outcome "recovered with sequelae", described as "celiac disease". The event "celiac disease" required physician office visit. The patient underwent the following laboratory tests and procedures: investigations: celiac diagnosed. Therapeutic measures were taken as a result of coeliac disease. Clinical course: Shortly after receiving second booster, female patient developed a gluten intolerance and was diagnosed with celiac disease. No gluten issues previously according to her dad who reported this information to reporter. It was unknown if patient was pregnant or received other vaccine in four weeks or other medications in two weeks. It was unknown if patient had COVID prior vaccination or tested post vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile , and temporal association a causal relationship between the suspected drug and the reported event Celiac disease cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202400055670 same product, different patient/ event;
Age: 0.5
Sex: U
Vaccine: COVID19, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability, Product storage error, Vaccination site bruising
Clinical narrative: Some bruising on the right thigh; irritability; Patient was administered with vaccine >12 hours post puncture; expired product administered; Initial information received from country on 29-Feb-2024 regarding an unsolicited valid non-serious courtesy case received via other health professional.  This case involves a 6-month-old and unknown gender patient who had some bruising on the right thigh, irritability, expired product administered and patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine live reassort oral 5V [rotateq], pneumococcal vaccine CONJ 15V (CRM197) [Vaxneuvance], moderna covid-19 vaccine and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history included Cough on 06-MAY-2023. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VITAMIN D NOS.  On 09-Jun-2023, the patient received a dose 3 of 1 DF (dosage form) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UJ786AA) via intramuscular route in unknown administration site for for prophylactic vaccination (immunization), an unknown dose of suspect moderna covid-19 vaccine (lot: AS7185B) not produced by Sanofi Pasteur via unknown route in unknown administration site for covid-19 immunisation, dose 3 of an unknown dose of suspect vaxneuvance (lot: W039033) not produced by Sanofi Pasteur via intramuscular route in unknown administration site and dose 3 of an unknown dose of suspect rotateq (form, strength, expiry date: unknown) not produced by Sanofi Pasteur (lot: W036464) via oral route in unknown administration site for prophylactic vaccination (immunization).  On 09-Jun-2023 the patient developed a non-serious expired product administered (latency: same day)  On an unknown date the patient developed a non-serious some bruising on the right thigh (vaccination site bruising), irritability and patient was administered with vaccine >12 hours post puncture (product storage error) (unknown latency).  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Recovered / Resolved on an unknown date for the event some bruising on the right thigh and unknown for event irritability.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.