chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Inflammation, SARS-CoV-2 test, Thrombosis
Clinical narrative: Extreme inflammatory response.  In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in Obtuse Marginal; This is a spontaneous report from a contactable consumer (patient).  A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Lot Number: EN6207), age at vaccination of 54-years-old, as single dose for covid-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing, connective tissue disorder from an unknown date and unknown if ongoing. Patient was not pregnant. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported; isosorbide mononitrate (IMDUR) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity.   The patient experienced extreme inflammatory reaction on 24Mar2021 at 04:00 AM and clot blood on 24Mar2021; events were serious as resulted in Emergency room/department or urgent care, hospitalization (for 5 days), life threatening illness (immediate risk of death from the event). The patient had extreme inflammatory response; in ER/hospitalized 5 days post vaccine. Angiogram was performed and clot in obtuse marginal was found; unable to remove clot, surgeon was able to break it apart and balloon the vessel open. It was unknown if patient had COVID prior vaccination. Patient had no other vaccine in four weeks. Sars-cov-2 test was negative on 15Apr2021. The patient was considered to be recovering from the events.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anaphylactic reaction, Hypertension
Clinical narrative: Anaphylaxis; Initial information received on 17-Mar-2021 regarding an unsolicited valid serious courtesy case received from an other health care professional via consumer in the United States.  This case involves a 68 years old female patient (166 cm and 81.65 kg) who experienced anaphylaxis (anaphylactic reaction), while she received MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  At the time of the event, the patient had ongoing hypertension.   On 27-Oct-2009, the patient received a dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE (batch number: UP006AA, expiry date: 15-MAR-2011) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in Oct-2009, the patient experienced a serious anaphylaxis (anaphylactic reaction) after few days following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. This event was assessed as medically significant  The event (Anaphylaxis) qualified for Adverse Event of Special Interest.  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratories data/ results available.  It was not reported if the patient received a corrective treatment for the event (Anaphylaxis).  At time of reporting, the outcome of event anaphylaxis was unknown.; Sender's Comments: This case concerns a 68 years old female patient who experienced anaphylaxis few days after vaccination with MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The time to onset is compatible. The patient's medical condition at the time of vaccination was hypertension. However, lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Illness
Clinical narrative: bedridden for 4 days; Very ill; Initial information was received on 12-Apr-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).  This case involves adult female patient who experienced bedridden for 4 days (bedridden) and very ill (illness), while receiving vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bedridden for 4 days (bedridden) and very ill (illness), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Laboratory data was not reported.  It was unknown if the patient experienced any additional symptoms/events, concomitant disease or risk factor.  It was not reported if the patient received a corrective treatment or not.  The outcome was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns an adult female patient who experienced illness and was bedridden, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. The patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Flushing, Rash
Clinical narrative: flushy rash; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from a physician via Information (reference number :00541842).  This case involves patient of unknown demography who experienced flushy rash (rash) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   In 2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot U3579AA and expiration date :Jun-2011) via unknown route in an unknown administration site for prophylactic vaccination.  In 2010, the patient developed a non-serious flushy rash (rash), 2 hours after the administration of vaccine. Caller stated patient reported the reaction at time of event. Caller was with the questions on accessing previous years package insert  for FLUZONE from 2010 so he can compare products to a Covid (coronavirus disease) vaccine, due to the patient being apprehensive about receiving the Covid vaccine.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: a child received a Pentacel vaccine, but the DTaP/ IPV liquid was not mixed with the HIB component, with no reported AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four-month-old (unknown gender) patient who received a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine, but the DTAP/ IPV liquid was not mixed with the HIB component (product preparation issue).  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 ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 25-Mar-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ406AA, 09-Oct-2021) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported that, the child will be brought back in for an Act-HIB vaccine as a corrective.  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: 66.0
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00542982) and transmitted to Sanofi on 31-Mar-2021.  This case involves a 66 years old patient (age unspecified) who had an allergic reaction (hypersensitivity) when received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot ZUH201AA, expiry date: 30-Jun-2011) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The caller (pharmacist) was requesting a product composition list for Fluzone Quadrivalent from year 2010. The patient reported that she had an allergic reaction after receiving the Fluzone vaccine. The caller has a patient who is interested in getting the coronavirus disease (COVID 19) vaccine. The caller would like to compare the list of ingredients from 2010 Fluzone Quadrivalent to the COVID 19.   No laboratory data was provided  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome of event was unknown.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired dose of Ipol/ no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 31-Mar-2021 from a nurse via Agency (Reference number- 00543194) and transmitted to Sanofi on 31-Mar-2021.  This case involves a 5 year-old male patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (batch number P1F541M and expiry date 07-Mar-2021) via an intramuscular route at the left deltoid on 08-Mar-2021 for prophylactic vaccination (expired product administered).   The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient received expired dose of Act-Hib/no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-APR-2021 from a health care professional via Global Medical Information (Reference number- 00544865) and transmitted to Sanofi on 01-APR-2021.  This case is linked to case 2021SA108007(same reporter).  This case involves a 18 month-old female patient who was vaccinated with 0.5 mL(total) expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch number UJ143AAA; expiry date 22-Mar-2021; frequency: once; strength: standard) via an intramuscular route at the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vacciantion.  Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-HIB and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, Still using product: No.  At the time of reporting, no adverse event was reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Ipol was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00544923) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 5-year-old female patient who administered expired dose of IPV (VERO) [IPOL] (Expired product administered).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.   On 31-Mar-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1B251N, expiry date: 13-Mar-2021] via an intramuscular route at a left arm for prophylactic vaccination.  It was a case actual medication error due expired product administered. [Latency: at the same time of vaccination].  It was reported that, a clinic was want guidance after an expired dose of Ipol was administered.  Product used : Used Still using product : No.  At the time of report, no adverse event was reported.  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 on the batch number for this case.
Sex: F
Vaccine: HIBV
Symptoms: Dermatitis diaper, Rash
Clinical narrative: body rash; Diaper rash; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional via Global Medical Information (GMI) (Reference number- 00546075) and transmitted to Sanofi on 02-Apr-2021.  This case involves an 18-month-old female patient who had body rash (rash) and diaper rash (dermatitis diaper) after receiving HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 16-Dec-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE Injection (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious body rash (rash) and diaper rash (dermatitis diaper) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The details of laboratory data were not reported.  The patient was treated with CALAMINE, ZINC OXIDE (CALADRYL) nd cool bath.  At time of reporting, the outcome was unknown for the events.   There will be no information available on the batch number for this case.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Physician has a patient that didn't have her Menactra at 11 years of age but got it at 12 years of age with no adverse event; Initial information was received on 02-Apr-2021 regarding an unsolicited valid non-serious case from a physician (Inquiry number: 00546483).  It was reported that vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) was administered to a female patient of 12 year old by a physician instead of 11 year old on an unknown date for prophylactic vaccination (inappropriate age at vaccine administration).  It was a case of actual medication error due to product administered to patient of inappropriate age.  The female patient came back in for a visit at 16 years old but was 25 days shy of her 16th birthday, physician states that the school is telling the mother that the child is not adequately vaccinated  At the time of report, no adverse event reported.  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 on batch number for this case.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Skin warm, Urticaria
Clinical narrative: Big red hive on arm. Hot to touch and itches. And is firm to the touch.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Headache, Pain
Clinical narrative: Had Covid symptoms fever chills, body aches and headache for a day and a half after the vaccination. I?m two weeks post vaccination and my joints are painful it even hurts to walk
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had Covid symptoms fever chills, body aches and headache for a day and a half after the vaccination. I?m two weeks post vaccination and my joints are painful it even hurts to walk
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: 8 days after the 2nd dose, I started to experience heart PVCs on a frequent basis (approximately 4 per minute)
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting 16 hours after injection. Mild fatigue, injection site soreness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Skin swollen, hard, painful to the touch in a 2 in radius around the injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Arm pain: started about 4 hours after shot, got worse despite early ice and movement Insomnia: went to sleep around 9:30pm, woke up at 11:30pm and an hour and a half later, still unable to go back to sleep, despite meditation, reading, music, etc. Wide awake.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Lethargy, Pain
Clinical narrative: Lethargy, achy, chills, all subsiding after 24 hours. Itching at injection site 2 days after 2nd dose injection. No symptoms with first dose.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Full body rash -- itchy and slightly burning
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue, exhaustion
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Paraesthesia, Pyrexia
Clinical narrative: 7 DAYS AFTER THE SHOT (APRIL 12TH 2021, THERE ARE HOT TINGLY AND PRICKLY SENSATION ALL OVER (AND STILL HAS THIS SIDE EFFECT ON APRIL 21ST 2021)  2ND AND 3RD DAY, HAD FEVER AND FATIGUE BUT WENT AWAY ON THE 4TH DAY
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hypoxia
Clinical narrative: At 1400, nausea and yea he started.   By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness.  VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor.   Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021.   Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Tachycardia
Clinical narrative: At 1400, nausea and yea he started.   By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness.  VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor.   Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021.   Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, fever, body aches over  a week.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Pain, Resuscitation, Unresponsive to stimuli
Clinical narrative: My father complained of soreness and body aches from the shot Sunday night to my mom and Monday morning to his boss at work. My sister found  him that afternoon in my parent's home unresponsive and call proceeded to call 911 and start CPR. But it was to late and he was already gone.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Blood magnesium normal, Full blood count normal, Haematocrit increased, Metabolic function test
Clinical narrative: The patient had 2 emergency department visits for this problem.  The first visit the patient presented with urticaria.  The patient was treated with antihistamines (H1 and H2 blockers) and corticosteroids.  He was discharged home on prednisone twice daily and over-the-counter Benadryl.  He represented to the emergency department with worsening of symptoms.  The urticaria were much more diffuse and the patient also had angioedema of the lips.  There was no angioedema of the tongue or throat.  The patient had no wheezing or shortness of breath.  He was treated with H1 and H2 blockers again, IV corticosteroids and IM epinephrine.  The symptoms improved and the patient was discharged on fexofenadine twice daily, famotidine twice daily, the prednisone was increased to daily and hydroxyzine  as needed for breakthrough pruritus or rash.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count increased, Urticaria
Clinical narrative: The patient had 2 emergency department visits for this problem.  The first visit the patient presented with urticaria.  The patient was treated with antihistamines (H1 and H2 blockers) and corticosteroids.  He was discharged home on prednisone twice daily and over-the-counter Benadryl.  He represented to the emergency department with worsening of symptoms.  The urticaria were much more diffuse and the patient also had angioedema of the lips.  There was no angioedema of the tongue or throat.  The patient had no wheezing or shortness of breath.  He was treated with H1 and H2 blockers again, IV corticosteroids and IM epinephrine.  The symptoms improved and the patient was discharged on fexofenadine twice daily, famotidine twice daily, the prednisone was increased to daily and hydroxyzine  as needed for breakthrough pruritus or rash.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore at injection site a week after vaccine administered
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Fat lip
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he only got 2 doses and not 3; This spontaneous report was received from a consumer concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with dose 1 (when 25 years old) and 2 for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (dose, route of administration, lot # and expiration date were not reported). It was reported that he only got 2 doses and not 3 (inappropriate schedule of product administration). The reporter was unsure of the missed dose but will check the vaccination records with the health care professional.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No product quality complaints or additional adverse events were reported in this case; Patient received first dose of GARDASIL-9 at age 13. Received 2nd dose at 16 years of age; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date, at the age of 13-year-old the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, concentration, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), on 24-FEB-2019, at the age of 16-year-old the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis, at a dose of 0.5 milliliters (ml) (formulation, concentration, route of administration and anatomical site of vaccination were not provided, lot number R025155, which has been verified to be valid, expiration date reported and validated as 23-MAY-2021) (inappropriate schedule of product administration). No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025155; expirationdate: 23-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PNC13, PPV
Symptoms: Adverse reaction
Clinical narrative: Had vaccine in 2008 and had reaction.; This spontaneous report was received from an other reporter type via Pfizer, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   The patient reported that, she could not remember if on an unknown date in 2008 she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), administered as prophylaxis or if she received pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (formulations, concentrations, doses, vaccination scheme frequencies, anatomical sites of vaccination, lot numbers and expiration dates were not reported), but she had a reaction (adverse reaction). The outcome of adverse reaction was not provided. The causality assessment between both suspect vaccines was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Paralysis, Vaccination complication
Clinical narrative: She was paralyzed; had bad reactions to it; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's medical history included poliomyelitis, previous drug reactions or allergies and concomitant medications were not reported.     In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).         On an unknown date, the patient had bad reactions to vaccine (vaccination complication) and she was paralyzed (paralysis).   The outcome of paralysis and vaccination complication was not reported. The causality assessment between Zoster Vaccine Live (ZOSTAVAX) and vaccination complication was considered related, and for paralysis was not reported.       Upon internal review, paralysis was considered disable and medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever with Shingrix?; This case was reported by a consumer via interactive digital media (Shingrix GSK ) and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported however it was captured as adult as per vaccine indication. The patient posted as question fever with Shingrix?' No further information could be obtained.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix around 19Dec2019 / is late for the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Twinrix (received Twinrix about 6-8 years ago, refer case US2021086439) and Shingrix (1st dose received on 19th December 2020).   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 case was reported by pharmacist on behalf of patient. The patient received 1st dose of Shingrix and was late for 2nd dose. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. No symptoms were reported.  The reporter consented to follow up. The case was linked with case US2021086439 for same patient and reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086439:same patient (Twinrix case)
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given their second shots 2 WEEKS after their first; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient was reporter's sister. The age at vaccination was not reported. The patient received second shot two weeks after first shot, which led to shortening of vaccination schedule. The reporter was worried that the patient was not properly immunized and asked advice if the patient should received second shot again. No further information was provided. This case has been linked with case US2021AMR087444, reported by the same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087444:same reporter (Male PT case)
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: My left side was tingling; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of tingling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had received dose of shingrix and 2 weeks later experienced tingling on left side. The patient was asking about to take the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: inquiring if a patient can receive/second dose of shingrix/First dose was on oct 1st 2018.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st October 2018).   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 reported 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 reporter inquired if the patient could received the delayed 2nd dose of Shingrix or if the series should be restarted. The reporter did not consent to follow up.  Notes:The patient's date of birth was reported as 28th November, which is later than 1st onset date (October 2018), hence date of birth is not captured in system raised for the same.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 7th September 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 was reported as follows: The age at vaccination was not applicable to this report. The patient received 1st dose of Shingrix more than 1 year ago. Till the reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Batch number and Expiration date were not reported during conversation but mentioned they have them available just not able to find them. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR090769:same reporter
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Temp excursion  went below freezing (20 F for 20 minutes / Pediarix was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of product storage error in a 7-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On 14th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error 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 reporter was a medical assistant. The reporter mentioned the temperature excursion went below freezing (20 degree F for 20 minutes) for across vaccines that happened on 12th April 2021 which was not known till the time of reporting. On 14th April 2021, the patient received Pediarix dose, which was kept below temperature 20 degree F, which led to product storage error. The reporter consented to follow up
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; patient that requested a second dose / First dose was given on 12Sep2019; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number X9GM4, expiry date 15th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for the 1st suspect vaccine. The age at vaccination was not applicable for 2nd suspect vaccine. The patient experienced shingles at some point between 1st dose and the day of reporting. The patient requested a second dose of Shingirx, till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The reported batch number for 1st dose was X96M4, however it was updated to X9GM4 as per sales datasheet. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 / August 2019 / 1 year and a half later / patient is back to receive dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 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 reported as follows: The age at vaccination was not applicable. The patient received 1st dose of shingrix in August 2019 and 1 and half year later at the time of reporting patient was back to receive the 2nd dose. Till the time of reporting patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination. All patient identifiers were reported. No further clarification made. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER; CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (had few beers today). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. Batch number for covid-19 vaccine ad26.cov2.s cannot be requested as reporter unable to follow up. No concomitant medications were reported.  On an unspecified date, the subject experienced fever and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: SORE THOAT; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm (deltoid) for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced sore thoat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore thoat, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Headache, Insomnia, Pain
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; BODY ACHES; RIGHT ARM PAIN; DIFFICULTY IN SLEEPING; HEADACHE; FEVER AROUND 100F; This spontaneous report received from a consumer concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, and expiry: UNKNWON) dose was not reported, administered on 22-MAR-2021 16:00 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches, right arm pain, difficulty in sleeping, headache and fever around 100 F. On 05-APR-2021, the patient had an antibody test and no antibodies were shown in the test which suspected immunological vaccine failure. Laboratory data included: Body temperature (NR: not provided) around 100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever around 100F, body aches, and right arm pain, and the outcome of difficulty in sleeping and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 06-Apr-2021: The following information was updated and incorporated into the case narrative: AER at units, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: personnel units present, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome. 20210344672-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: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; BODY ACHES; RIGHT ARM PAIN; DIFFICULTY IN SLEEPING; HEADACHE; FEVER AROUND 100F; This spontaneous report received from a consumer concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, and expiry: UNKNWON) dose was not reported, administered on 22-MAR-2021 16:00 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches, right arm pain, difficulty in sleeping, headache and fever around 100 F. On 05-APR-2021, the patient had an antibody test and no antibodies were shown in the test which suspected immunological vaccine failure. Laboratory data included: Body temperature (NR: not provided) around 100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever around 100F, body aches, and right arm pain, and the outcome of difficulty in sleeping and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 06-Apr-2021: The following information was updated and incorporated into the case narrative: AER at units, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: personnel units present, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome. 20210344672-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