chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Peptic ulcer, Vomiting
Clinical narrative: Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, I cant walk anymore; the pain is in my legs, in my feet, in my arms/fingers hurt; I had diarrhea and I had to throw up; I had diarrhea and I had to throw up; back hurts; all my bones are hurting; This is a spontaneous report from a contactable consumer (patient). This 86-year-old female patient received 1st dose of BNT162B2 (lot# ER8732) at the age of 86 years old, on 26Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Ulcer pain since got the shot. Cant walk anymore, the pain is in her legs, in her feet, in her arms (if take a pain killer it do not work). She cannot drive car nor go no places. Also Diarrhea, Had to throw up. Since I got this shot the first day I got, for 4 days I had diarrhea and I had to throw up, well I have never seen this in my life because when I throw it up it was (not clear), it was like two. Now I got this shot on 03/26 and now I am in ulcer pain, I cant walk, all my bones are hurting, I cant drive my car anymore, I cant go no place. I am 86 years old and all by myself. I dont know what to do I am in pain. My leg hurts I hardly can walk, my back hurts, my arms hurt, my fingers hurt. I dont know what I have to do. I am 86 years old and I live by myself and I dont know what to do. The first shot I got was on (03/36) and I had no problem with this one, but the second one I got is killing me (refer to AER#2021630678)." Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer. An adult male patient received COVID vaccine (unspecified trade name), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2020 14:30(as reported, pending clarify) (Lot Number: AIN09876R4) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Facility type vaccine was Doctor office/urgent care. Medical history included hypertension, diabetes and food contains nuts allergy. Patient had covid prior vaccination. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication. The patient experienced diarrhea from 09Aug2020 08:10(as reported) with outcome of recovered.  The patient was hospitalized for diarrhea for 2 days.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP77534) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced cold. Patient stated that she scheduled this morning at 10:20 to receive her second dose. However, she had a cold. So, she wanted to know what happens next. She need number to reschedule her 2nd dose. Outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: body aches (pain); Initial information received on 29-May-2021 regarding an unsolicited valid non-serious case from a consumer from a patient support program via Regulatory Authority, (Manufacturer Report Number- UNT-2021-009583).  This case involves a 44 years old female patient (68 kg) who experienced body aches (pain), after receiving INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN].  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included SILDENAFIL CITRATE.  On 26-Apr-2021, the patient started taking REMODULIN (TREPROSTINIL SODIUM, 2.5 mg/ml, batch number and expiration date not reported) via subcutaneous for Pulmonary arterial hypertension. The current dose was reported as 0.00125 Î¼g/kg, continuous via subcutaneous (SQ) route.  On 22-May-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  In May-2021, the patient developed a non-serious body aches (pain), within few days following the dose intake of TREPROSTINIL SODIUM and in the same month following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  Action taken with SQ (subcutaneous) Remodulin was not reported for the event of pain.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the event pain.  The reporter did not provide causality for the event of pain.  There will no information on the batch number for this case.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event; Initial information received on 27-May-2021 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 35-year old male patient who got DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event (product use issue) [lot number: UH949AA and expiration date: 18-Nov-2022] via intramuscular route in the left deltoid unknown route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to product use issue (latency: unknown).  It was reported that he said that a needle was attached to the syringe and that they placed the syringe with the needle attached in the refrigerator.  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: 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 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.  There will be no information available regarding batch number in this case.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine Adacel (Tdap) was administered to an infant, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00630973) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 6 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6900AA and expiry date was not reported) via unknown route at an unknown administration site (product administered to patient of inappropriate age) for prophylactic vaccination on 04-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  The reporter needed to know what she needs to do from here? She states that she administered the wrong vaccine (adacel) to an infant on Friday. what do we need to do? Is there anything to watch out for?"  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received first dose at 10 years & 8 months and the second dose at 14 years & 3 months with no AE.; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00631041) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 16 years old female patient who received first dose at 10 years and 8 months and the second dose at 14 years and 3 months of  suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination (inappropriate schedule of product administration) on an unknown date.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter stated that patient is currently 16 years old and asked does patient need a booster?  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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.  There will be no information on the batch number for this case.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: A patient received a partial dose with no AE; entire hub of the syringe came off/ there was a leakage with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (nurse) via Agency (Reference number- 00631232) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 28 years old female patient who received an one mL dose (partial received) of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (lot T1B492M and expiry date: 07-Dec-2021) via intramuscular route in right deltoid (underdose) for prophylactic vaccination on 07-Jun-2021, as entire hub of the syringe came off and there was a leakage while administrating (syringe issue).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  The nurse reports confirmed the product was not mishandled. The nurse added that they are not comfortable billing the consumer with the vaccine and was asking about how to process a reimbursement request.  It was an actual medication error case due vaccine underdose (latency: same day).  It was also a case of syringe leak as when reporter was mixing the medication, when she flipped the vial, the entire hub of the syringe came off. They were able to put it back in and administered the vaccine but there was a leakage. The consumer is estimated to have received half the dose.  At the time of reporting, the patient experienced no adverse event.   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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Immediate strong soreness at injection site; sore enough that I spoke to the nurse doing the 15-minute watch. She told me to monitor it and that soreness was a common result. My arm was sore but I also have some tingling and numbness in my left arm and hands. It is uncomfortable and worrying but does not seem to affect my activities at this point. That being said it has worsened over the period between now and the injection.   My only side effect from the first injection was soreness the day after the injection, which subsided within two days with no lasting effects.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Depression, Electrocardiogram, Feeling abnormal
Clinical narrative: Last May 6, 2021, I recieved my 1st dose of MODERNA vaccine. For the last 5 days I don't feel any side effects on my body. But on the 6th day after my vaccination, I started to feel anxiety, insomnia, brain fog followed by  depression, panic attack and rapid heart palpitation and it lasted for 3 weeks. Until now, there are times that I can still feel the rapid heart palpitation.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Laboratory test, Palpitations, Panic attack
Clinical narrative: Last May 6, 2021, I recieved my 1st dose of MODERNA vaccine. For the last 5 days I don't feel any side effects on my body. But on the 6th day after my vaccination, I started to feel anxiety, insomnia, brain fog followed by  depression, panic attack and rapid heart palpitation and it lasted for 3 weeks. Until now, there are times that I can still feel the rapid heart palpitation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Echocardiogram normal
Clinical narrative: May 22nd felt like I was going to have a heart attack.  Pain started in chest more throughout the next few days. May 26 went to health clinic. Was told to go to hospital. Had ekgs. One abnormal...was sent home with no treatment.  Was called but hospital nurse to come back in the next day to check for heart inflammation as she had recently read about the reverse effects with moderna. Had more ekgs done and never had a test for inflammation and got sent home. May 30th had headaches, muscle aches, sore throat at night and cough. Still having chest pain. Started getting a rash on my left side of my face.  May 31st, vomited and felt sick most of the day.  June 1st noon. Took a bath and got extremely dizzy and fatigued so I layed down. Didn't wake up till 7pm. June 2nd, had an appt with regular dr. Asked for a test to check for inflammation. Was told to take aleve 2 times a day.. Found out I'm allergic to it.. Had an echo done next morning. Was told test results were normal.  May 11th till present day, June 16th, I am struggling with breathing and still have chest pain. Given no treatment.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: May 22nd felt like I was going to have a heart attack.  Pain started in chest more throughout the next few days. May 26 went to health clinic. Was told to go to hospital. Had ekgs. One abnormal...was sent home with no treatment.  Was called but hospital nurse to come back in the next day to check for heart inflammation as she had recently read about the reverse effects with moderna. Had more ekgs done and never had a test for inflammation and got sent home. May 30th had headaches, muscle aches, sore throat at night and cough. Still having chest pain. Started getting a rash on my left side of my face.  May 31st, vomited and felt sick most of the day.  June 1st noon. Took a bath and got extremely dizzy and fatigued so I layed down. Didn't wake up till 7pm. June 2nd, had an appt with regular dr. Asked for a test to check for inflammation. Was told to take aleve 2 times a day.. Found out I'm allergic to it.. Had an echo done next morning. Was told test results were normal.  May 11th till present day, June 16th, I am struggling with breathing and still have chest pain. Given no treatment.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rash, Vomiting
Clinical narrative: May 22nd felt like I was going to have a heart attack.  Pain started in chest more throughout the next few days. May 26 went to health clinic. Was told to go to hospital. Had ekgs. One abnormal...was sent home with no treatment.  Was called but hospital nurse to come back in the next day to check for heart inflammation as she had recently read about the reverse effects with moderna. Had more ekgs done and never had a test for inflammation and got sent home. May 30th had headaches, muscle aches, sore throat at night and cough. Still having chest pain. Started getting a rash on my left side of my face.  May 31st, vomited and felt sick most of the day.  June 1st noon. Took a bath and got extremely dizzy and fatigued so I layed down. Didn't wake up till 7pm. June 2nd, had an appt with regular dr. Asked for a test to check for inflammation. Was told to take aleve 2 times a day.. Found out I'm allergic to it.. Had an echo done next morning. Was told test results were normal.  May 11th till present day, June 16th, I am struggling with breathing and still have chest pain. Given no treatment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chemotherapy, Chest X-ray abnormal, Computerised tomogram abnormal, Death
Clinical narrative: Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks.  She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath.  They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dyspnoea, Fatigue, Feeding disorder, Gait disturbance
Clinical narrative: Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks.  She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath.  They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pneumonia, Rash, Renal failure, Sepsis
Clinical narrative: Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks.  She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath.  They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Small cell lung cancer
Clinical narrative: Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks.  She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath.  They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Dyspnoea, Troponin
Clinical narrative: PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myocarditis, SARS-CoV-2 test negative, Troponin I increased
Clinical narrative: PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 101 fever Body aches Tiredness
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Asthenia, Basophil count, C-reactive protein, Chills
Clinical narrative: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Eosinophil count, Haematocrit, Haemoglobin, Headache, Lymphocyte count
Clinical narrative: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count
Clinical narrative: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neutrophil count, Pain, Platelet count, Pyrexia
Clinical narrative: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count, Streptococcus test, Viral test negative, White blood cell count
Clinical narrative: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.
Sex: U
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: No further information is available; a patient inadvertently received the second dose of PNEUMOVAX23; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 26-JUN-2018, the patient was given the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.  On 17-MAY-2021, the patient inadvertently received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose, lot # T033369 and expiration date 26-MAY-2022; strength and route were unknown) for prophylaxis (inappropriate schedule of product administration). No pqc. No further information was available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; an expired dose of VAQTA was administered today; This spontaneous report was received from a temp stability agent (medical assistant) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 19-MAY-2021 (reported as today), an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T014590 and expiration date 15-APR-2021; strength and route were unknown) was administered for prophylaxis (expired product administered). The reporter reported that product was properly stored up through administration. The reporter did not report any signs/symptoms. No further information provided. No additional adverse events reported. No product quality complaint. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got a severe case of the shingles!; This case was reported by a consumer via media and described the occurrence of suspected 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, 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 details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient developed severe case of shingles after receiving Shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient cousin had a shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. The reporter stated that, the patient had them just as bad as reporter did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Felt a little sick for a couple of days; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he/she received vaccine and felt a little sick for a couple of days. No other information was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired pediatric dose of Engerix-B / expired on 06/3/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th June 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 11th June 2021, patient received Engerix B pediatric which was expired on 3rd June 2021. The reporter asked if the vaccine should be repeated or not.  The Healthcare professional was not confortable giving any detail. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Two patient / late for the second dose / first dose / on December 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose of Shingrix received in December 2019).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient's identifiers, LOT number and expiration date was not provided for the first dose. The reporter did not consented to follow up. This is 1 of the 2 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR129763: reporter. Patient #2 of 2.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: receive an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA260A, expiry date 31st March 2021) for prophylaxis.   On 2nd June 2021, the patient received Menveo (intramuscular). On 2nd June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient inadvertently received an expired dose of Menveo in the left deltoid. As per sales data sheet reported batch number was changed from AMAA260A to AMVA260A. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MILD PAIN IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) 1 total dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient did 2 antibodies tests and they were negative. On 28-MAY-2021 his result came out negative. The second test was done on 04-JUN-2021 and test came out negative(confirmed immunological vaccine failure). He took the vaccine, he did not have any side effects. He only had mild pain in the site of injection went away the same day after 4 hours. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. On 04-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild pain in site of injection on 01-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210616495-covid-19 vaccine ad26.cov2. s -confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product administration error, Product label issue
Clinical narrative: OVERDOSE; PRODUCT ADMINISTRATION ERROR; NOT OBVIOUS LABELING ON VIAL; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced overdose, product administration error, and not obvious labeling on vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose, product administration error and not obvious labeling on vial was not reported. This report was non-serious. This report was associated with product quality complaint 90000182226. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR OF A VACCINE DOSE FROM A PUNCTURED VIAL THAT WAS LEFT 3 HOURS AT ROOM TEMPERATURE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature. On 09-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature and out of specification product use was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dysgeusia, Myalgia, Swelling
Clinical narrative: DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause. This report was serious (Death).; Sender's Comments: V0; 20210626664- COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 69-year-old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no information on medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 02-JUN-2021, the patient had a negative antibody test (coded as suspected immunological vaccine failure). Laboratory data included: SARS-CoV-2 ELISA test (NR: not provided) as negative. The test was an IgG Elisa-Spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626695 -Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Seizure, Urinary incontinence
Clinical narrative: SEIZING; PASSED OUT; LIGHTHEADED; URINATED; VOMITED; NAUSEATED; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021, around 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, after vaccination, patient waited around 30 minutes in store before heading home in a car driven by his father. After ten minutes, in the car, patient's father noticed that patient had slumped over after saying he felt lightheaded and passed out. Patient started seizing for about 30 seconds, urinated on himself and finally came to asking where he was. Then within five minutes, patient got nauseated and vomited. Once patient vomited, he started feeling better. He was able to shower with assistance once home and is now lying down feeling lightheaded and nauseated. Patient's parents continued monitor him for the next several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizing, passed out, urinated, and vomited, and had not recovered from lightheaded, and nauseated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627035-COVID-19 VACCINE AD26.COV2.S- seizing, passed out. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SEIZING; PASSED OUT; LIGHTHEADED; URINATED; VOMITED; NAUSEATED; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021, around 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, after vaccination, patient waited around 30 minutes in store before heading home in a car driven by his father. After ten minutes, in the car, patient's father noticed that patient had slumped over after saying he felt lightheaded and passed out. Patient started seizing for about 30 seconds, urinated on himself and finally came to asking where he was. Then within five minutes, patient got nauseated and vomited. Once patient vomited, he started feeling better. He was able to shower with assistance once home and is now lying down feeling lightheaded and nauseated. Patient's parents continued monitor him for the next several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizing, passed out, urinated, and vomited, and had not recovered from lightheaded, and nauseated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627035-COVID-19 VACCINE AD26.COV2.S- seizing, passed out. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.