chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product dose omission issue, Product preparation issue
Clinical narrative: received just the HIB portion powder vial and was reconstituted with sterile water, did not receive the DTAP IPV portion/no AE; Initial information was received on 14-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15-month-old male patient who received just the HIB portion powder vial and was reconstituted with sterile water, did not receive the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 09-Apr-2021, the patient received a dose of 0. 5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ217AC, expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination (product preparation issue).  It was a case of actual medication error due to Inappropriate reconstitution technique (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and 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 exclusively to ensure the 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: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00561558).  This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included NA (sodium).  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, 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 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional   This case involves a patient (unknown demographics) who received an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6585AA and expiry date: 11-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  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.; Sender's Comments:  00561594:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: A patient received an expired diluent of ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves a patient (unknown demographics) who received an expired diluent HIB (PRP/T) VACCINE [ACT-HIB] (lot U6567AA and expiry date: 01-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The caller reported that the diluent was expired and the powder portion still within date, that the medication sent to the hospital floor from the pharmacy in a plastic bag out of the box and the patient had already been discharged from the hospital. Powder Portion: LOT: UJI66AA and  expiry date: 31-May-2021  This was a case of actual medication error due to expired product administered (latency same day).  At the time of reporting, 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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL vaccine was administered to a patient with no reported adverse event; Initial information received on 14-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown demographic patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported, expiry date-04-Apr-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 14-Apr-2021 (expired product administered) .  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported that, something like this happened before and there was a 30 day window after expiration that product could be used; the reporter had a query about, does PENTACEL have a window like that or should we tell the patient what happened. As the agent unable to clarify which product reporter was referring to that has a 30-day window after expiration that product could be used.  At time of reporting, 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 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 available on the lot number for this case.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Patient accidentally received the Daptacel vaccine instead of the Adacel vaccine with no adverse event.; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00561685).  This case involves an 11 years old female patient who accidentally received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5743AA and expiration date: 06-Jun-2022) via unknown route at an unknown administration site (wrong product administered) for prophylactic vaccination on 09-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter states that when she went to get the Adacel vaccine, the Adacel and Daptacel boxes were next to each other and the boxes were the same size. Because of this, she accidentally grabbed the wrong box.   At the time of reporting, the patient experienced no specific 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. 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: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional  This case involves a patient (unknown demographics) who received an expired dose of suspect IPV (VERO) [IPOL] (batch number and expiry date not reported, about a month ago) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Office manager reported that an expired IPOL was administered to a patient. She asked what to expect after that, and if there are any side effects or not.  This was a case of actual medication error due to extra dose administered (latency same day).  At the time of reporting, 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 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.  There will be no information available on the batch number for this case.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: 6 year old male patient was given expired Ipol, with no adverse event; Initial information received on 19-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 year old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 07-Apr-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot R1B25 and expiry date: 13-Mar-2021) (Strength  standard) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  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 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: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient was given expired Ipol vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via Global Medical Information (GMI) (Reference number- 00567199) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old female patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021) (expired product administered) on 13-Apr-2021.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX for prophylactic vaccination on 13-Apr-2021.  No other vaccine received by patient.  Caller wanted to know what to do if 8 patients got expired IPOL vaccine.   It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, 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.; Sender's Comments:  00567142 (original case):
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient was given expired IPOL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00567201) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old male patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021 via an intramuscular route in right thigh) (expired product administered) on 06-Apr-2021.  The patient's medical history, past medical treatment and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX prophylactic vaccination. No other vaccines were received by patient.  Caller wanted to know what to do if 8 patients got expired IPOL vaccine.   It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, 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.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired Menactra , with no adverse event; Initial information received on 19-Apr-2021 regarding an unsolicited valid  non-serious case from a other health professionals   This case involves a 22 years old female patient who received an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (0.5 ml, lot U6346AA and expiration date: 30-Aug-2020, frequency: once) via intramuscular route in the right deltoid for prophylactic vaccination on 19-Apr-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitants were administered to the patient.  It was an actual medication error due to expired vaccine used (latency: same day).  Reported that caller asked what to do if an expired Menactra was given to a patient.  At the time of reporting, it was unknown whether the patient had any 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Facial paralysis, Lacrimation increased
Clinical narrative: a 58 yr old female who presents with Facial Droop (since Covid shot Moderna first dose done on 4/22/21, Eyes watery, face drop mostly left side, ), Blood Pressure (would like to increase her Losartan to 2x a day), Health Maintenance (declines all HM dues for now) She reports that she had her first Moderna COVID-19 vaccine 4 days ago. The following day she developed some drooping and the left side of her face and some watery eye. By her report the symptoms are staying about the same without any improvement noted. She has not had any fever
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Tonsillar hypertrophy
Clinical narrative: Pt presented to ER approx. 15min after onset of symptoms. Presented with visibly swollen tonsils, reported difficulty breathing, and hoarseness of voice. Was treated with 50mg Benadryl and discharged with improved symptoms.
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death
Clinical narrative: He died the same day he received the shot
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Severe muscle pain radiating down my arm to my hand. Swelling of entire arm. After 24hrs: Muscle aches all over body, general weakness and malaise.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Severe muscle pain radiating down my arm to my hand. Swelling of entire arm. After 24hrs: Muscle aches all over body, general weakness and malaise.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Heart rate
Clinical narrative: Side effects that started with pain in arm where injected, then achiness in whole body, chills  was sleepless that night.  The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache.  Fever up to 101.6F.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Insomnia, Malaise, Pain
Clinical narrative: Side effects that started with pain in arm where injected, then achiness in whole body, chills  was sleepless that night.  The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache.  Fever up to 101.6F.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Side effects that started with pain in arm where injected, then achiness in whole body, chills  was sleepless that night.  The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache.  Fever up to 101.6F.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: excruciating back pain, 10/10,  Pt went to ER for treatment and got ketorolac.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Rash red itchy
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, chills, fatigue, muscle aches, headache, a little sore at injection point on arm.   No medication taken.  Took approximately 36 hours for adverse effects to subside.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, fatigue, muscle aches, headache, a little sore at injection point on arm.   No medication taken.  Took approximately 36 hours for adverse effects to subside.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling
Clinical narrative: SWOLLEN EYES AND LIPS
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Pulmonary thrombosis
Clinical narrative: Death after experiencing blood clot to the lung
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate steadily above 115. Has gotten as high as 167.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Hypercoagulation, Mechanical ventilation, Myocardial infarction, Resuscitation
Clinical narrative: Blood clots,  heart attack,  died, cpr 5 times  survived  Blood is very thick  blood thinners unable to thin
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Transcutaneous pacing
Clinical narrative: Blood clots,  heart attack,  died, cpr 5 times  survived  Blood is very thick  blood thinners unable to thin
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciatica in both legs for 3 days now.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Musculoskeletal stiffness, Night sweats, Pyrexia
Clinical narrative: Stiff arm, headache, fever, reaction at injection site(raised welts) tiredness, night sweats.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Stiff arm, headache, fever, reaction at injection site(raised welts) tiredness, night sweats.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: One hour severe chill 16.5 hrs after injecton without fever.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Extreme body aches and chill started around 4:00 and continued throughout the day. Took tylenol but it did not help.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inflammation, Injection site pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: inflammation; 1.2cm fluid collection; complaint of pain in arm since 2/20/2021; tenderness at injection site; This spontaneous report was received from a physician referring to a 33 (unit not provided) female patient. The patient's concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS). The patient has no known drug allergies (NKDA) and no pertinent medical history. The patient's concurrent condition was not reported.  On 08-OCT-2020, 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) (strength, dose, batch/lot# and expiration date were unknown) intramuscularly (IM) for vaccination. On 17-FEB-2021, 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) (strength, dose, batch/lot# and expiration date were unknown, IM) for vaccination.  On 11-MAR-2021, the patient was seen again with complaint of pain in arm since 20-FEB-2021 with tenderness at injection site but no erythema or signs of infection. On 12-MAR-2021, the patient had sonogram that was negative. On 21-MAR-2021, the patient had magnetic resonance imaging (MRI) which showed inflammation and 1.2cm fluid collection. Medical attention was sought. Symptoms were treated with ibuprofen (ADVIL) and warm soaks. The outcome of the events was not recovered. The causality assessment was not provided.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Bursitis, Magnetic resonance imaging normal, Pain in extremity, Periarthritis, Ultrasound scan
Clinical narrative: inflammation; 1.2cm fluid collection; complaint of pain in arm since 2/20/2021; tenderness at injection site; This spontaneous report was received from a physician referring to a 33 (unit not provided) female patient. The patient's concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS). The patient has no known drug allergies (NKDA) and no pertinent medical history. The patient's concurrent condition was not reported.  On 08-OCT-2020, 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) (strength, dose, batch/lot# and expiration date were unknown) intramuscularly (IM) for vaccination. On 17-FEB-2021, 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) (strength, dose, batch/lot# and expiration date were unknown, IM) for vaccination.  On 11-MAR-2021, the patient was seen again with complaint of pain in arm since 20-FEB-2021 with tenderness at injection site but no erythema or signs of infection. On 12-MAR-2021, the patient had sonogram that was negative. On 21-MAR-2021, the patient had magnetic resonance imaging (MRI) which showed inflammation and 1.2cm fluid collection. Medical attention was sought. Symptoms were treated with ibuprofen (ADVIL) and warm soaks. The outcome of the events was not recovered. The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Vaccine has also had a prior temperature excursion; Expired product administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.  On 12-APR-2021, the patient was administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot# S037574 with expire date 10-APR-2021; strength and route were unknown) for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) had also had a prior temperature excursion, above 9 Celsius degree (10.7 Celsius degree) for 40 hours and 48 minutes. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S037574; expirationdate: 10-APR-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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: The patient was treated for shingles, postherpetic neuralgia and other zozter-related conditions; The patient was treated for shingles, postherpetic neuralgia and other zozter-related conditions; The patient was treated for shingles, postherpetic neuralgia and other zozter-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt.) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-SEP-2014, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions as prescribed and/or administered by a pharmacist. On an unspecified date, the pt. experienced shingles, post herpetic neuralgia and other zoster-related conditions (ill-defined disorder). On an unspecified date, the pt. was treated by a health care provider (HCP) for the aforementioned events and was hospitalized due to the events. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: a large area of redness, itching, and swelling at the injection site; a large area of redness, itching, and swelling at the injection site; a large area of redness, itching, and swelling at the injection site; This spontaneous report was received from a nurse, referring to a 21 years old female patient. The patient's concomitant vaccine included tetanus toxoid. The patient had no pertinent medical history. The patient had no known drug allergies prior to this adverse event. Information about the patient's concurrent conditions was not reported.  On 13-APR-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T017179, expiration date 26-OCT-2021; route was reported as injection) in the right arm for hepatitis A prophylaxis.  On the same date, the patient experienced a large area of redness, itching, and swelling at the injection site. The patient was treated with cetirizine hydrochloride (ZYRTEC) 10 mg, diphenhydramine hydrochloride (BENADRYL) as needed (prn) and hydrocortisone prn, topically. There was no lab diagnostics/studies performed. On 13-APR-2021, 19-APR-2021, the patient had sought medical attention. The patient was better each day post-injection. In April 2021, the patient recovered. The causality assessment between hepatitis a vaccine, inactivated (VAQTA) and all events was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T017179; expirationdate: 26-OCT-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: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was inadvertently administered Expired PNEUMOVAX 23 by Nurse.; This spontaneous report was received from a nurse and a physician assistant, referring to an 84 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 21-APR-2021, the patient was inadvertently administered expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S018405, expiration date 28-MAR-2021; dose and route were unknown) for prophylaxis by nurse (expired product administered). There was no additional adverse event. There was no temperature excursion reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S018405; expirationdate: 28-MAR-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
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm sore; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (2101USA009217), referring to an elderly male patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 15-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced arm sore. The outcome of the event was unknown. The causality assessment was related.  This case was split from a legal case regarding the same patient.
Age: 65.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: arm sore; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (2101USA009217), referring to an elderly male patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 15-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced arm sore. The outcome of the event was unknown. The causality assessment was related.  This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2101USA009217: US-009507513-2104USA006940:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: patient took the Shingles shot & ended up with severe cases of the Shingles/ suspected vaccination failure; 2 friends who took the Shingles shot & both ended up with severe cases of the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received the shingles shot and ended up with severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR091437, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091437:same reporter (patient 2 of 2)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the Shingles shot and ended up with Shingles, suspected vaccination failure; 2 friends who took the Shingles shot & both ended up with severe cases of the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received the shingles shot and ended up with severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR091431, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091431:same reporter (patient 1 of 2)
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed second shot / I took my fist shot in July  / July 2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 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 age at vaccination was not applicable to this report. The age group was not reported but was selected as adult as per vaccine indication. Till the time of reporting patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. No additional Information provided.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number ER2613, expiry date unknown) for prophylaxis, estradiol vaginal for drug use for unknown indication and estradiol + norethisterone acetate (Combipatch) for drug use for unapproved indication.   The patient's past medical history included esophageal acid reflux and shingles (experienced one severe case and one mild case of shingles 10 years ago before the date of reporting, when patient was at her mid 50's). Previously administered products included Zostavax (received on 9th January 2015). Concurrent medical conditions included food allergy (Raw shrimp allergy), allergy to antibiotic (Sulfamethoxazole TMP DS 800-160 mg Tablet), drug allergy (vioxx) and fruit allergy (fresh pineapple).   On 1st December 2018, the patient received the 2nd dose of Shingrix. On 2nd July 2018, the patient received the 1st dose of Shingrix. On 16th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. On an unknown date, the patient started estradiol vaginal at an unknown dose and frequency and Combipatch .05 mg at an unknown frequency. On 16th April 2021, 867 days after receiving Shingrix and 1019 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with estradiol vaginal was unknown. The action taken with Combipatch was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The ethnicity information and race information was available but not provide. The patient received the two doses of Shingrix,one dose of Covid-19 vaccine on left arm and within 2 weeks of Vaccination patient received estradiol (Vaginal Tabs 10 mcg,) and combipatch (0.05-0.14mg) and later patient experienced mild Shingles symptoms on left side of abdomen and left side of back. The patient had no Shingles side effects until 8 hours after her first Covid vaccine The patient did not received any treatment. The patient was not tested or diagnosed with COVID-19. It was unknown if the reporter considered the shingles to be related to Cocid-19 vaccine, estradiol vaginal tablet and combipatch. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster
Clinical narrative: Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number ER2613, expiry date unknown) for prophylaxis, estradiol vaginal for drug use for unknown indication and estradiol + norethisterone acetate (Combipatch) for drug use for unapproved indication.   The patient's past medical history included esophageal acid reflux and shingles (experienced one severe case and one mild case of shingles 10 years ago before the date of reporting, when patient was at her mid 50's). Previously administered products included Zostavax (received on 9th January 2015). Concurrent medical conditions included food allergy (Raw shrimp allergy), allergy to antibiotic (Sulfamethoxazole TMP DS 800-160 mg Tablet), drug allergy (vioxx) and fruit allergy (fresh pineapple).   On 1st December 2018, the patient received the 2nd dose of Shingrix. On 2nd July 2018, the patient received the 1st dose of Shingrix. On 16th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. On an unknown date, the patient started estradiol vaginal at an unknown dose and frequency and Combipatch .05 mg at an unknown frequency. On 16th April 2021, 867 days after receiving Shingrix and 1019 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with estradiol vaginal was unknown. The action taken with Combipatch was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The ethnicity information and race information was available but not provide. The patient received the two doses of Shingrix,one dose of Covid-19 vaccine on left arm and within 2 weeks of Vaccination patient received estradiol (Vaginal Tabs 10 mcg,) and combipatch (0.05-0.14mg) and later patient experienced mild Shingles symptoms on left side of abdomen and left side of back. The patient had no Shingles side effects until 8 hours after her first Covid vaccine The patient did not received any treatment. The patient was not tested or diagnosed with COVID-19. It was unknown if the reporter considered the shingles to be related to Cocid-19 vaccine, estradiol vaginal tablet and combipatch. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose of Shingrix / second dose 18 months later after the first dose; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follow: The patient received second dose of Shingrix 18 months later after the first dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: the site is still hot and swollen; the site is still hot; This case was reported by a consumer via (Shingrix GSK and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2021, the patient received Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site warmth to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingrix and the site was still hot and swollen. The patient inquired was this normal. The follow-up would not possible as no contact details were available.