chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: "she was in office yesterday for 5yr wcc this morning leg was itching.  Looked at it and where she got shot was raised, warm and big hasn't given her any medication for it"
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Abdominal X-ray, Crying, Irritability, Lethargy, Neurological examination normal
Clinical narrative: 24 hours after administration, infant became inconsolable for over 12 hours. Evaluation in ED showed no other reason for irritability. Workup included a normal abdominal xray, non focal exam and normal corneal staining exam. The following day infant was still slightly lethargic but not crying inconsolably. On day 4 after immunization, infant returned to baseline.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Vital dye staining cornea absent, X-ray normal
Clinical narrative: 24 hours after administration, infant became inconsolable for over 12 hours. Evaluation in ED showed no other reason for irritability. Workup included a normal abdominal xray, non focal exam and normal corneal staining exam. The following day infant was still slightly lethargic but not crying inconsolably. On day 4 after immunization, infant returned to baseline.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt has a golf ball sized lump on right thigh area is red and warm to the touch. Pt's mother was advised by staff to give pt Benadryl and apply a cold compress to area. Advised to call this clinic if symptoms increase.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Myalgia, Pain in extremity, Rash erythematous
Clinical narrative: Red rash covering entire bicep area on arm (outside and inside of arm).  This is below the injection site.  Rash spreading on upper arm. Bicep painful to touch.  Pain in armpit down to elbow.   Difficulty extending arm due to upper arm pain. Taking 500 mg acetaminophen (2 per day).  On day 4 and still have these symptoms. No information on GSK website or CDC regarding rashes (not at injection site) or armpit pain!!  Pharmaceutical company should be more responsible and held accountable for lack of symptom information.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: reconstituted with expired STERILE DILUENT; This spontaneous report was received from a study coordinator and refers to a patient of unknown age and gender, who was enrolled in an unspecified clinical study, which was not a Merck sponsored or Merck investigator initiated study. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-APR-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023504, expiration date 16-APR-2020 (exact dose, frequency, route of administration were not reported) for prophylaxis, which was reconstituted with an expired dose of sterile diluent lot# N028746, expiration date 17-MAR-2020 (exact dose, frequency, route of administration were not reported).
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Prescriptions of Shingrix for patients younger than 50 years old; Prescriptions of Shingrix for patients younger than 50 years old; This case was reported by a pharmacist via call center representative and described the occurrence of product prescribing error in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error and inappropriate age at vaccine administration. On an unknown date, the outcome of the product prescribing error and inappropriate age at vaccine administration were unknown.  Additional information was provided as follows: The age at vaccination was not reported but could be lesser than 50 years old. The pharmacist reported having received prescription of Shingrix for patients younger than 50 years old, which led to product prescribing error and inappropriate age at vaccine administration. The reporter did not consent to follow up. No further information was provided. This case had been linked with US2020083387, reported by same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Forgot to reconstitute the vaccine; Administered just the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   On 15th May 2020, the patient received Shingrix. On 15th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The Pharmacist reported that she accidentally administered just the adjuvant for Shingrix, forgot to reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with US2020083390, reported by same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ActHIB diluent was used to administer ActHIB to 2 patients, no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients of unknown demography, who were vaccinated with a dose of (PRP/T) VACCINE [ACT-HIB] (lot number: UJ055AA, expiry date of the vaccine is 17-Nov-2020 and expiry date of the diluent is 22-Apr-2020) via an unknown route at an unknown administration site for prophylactic vaccination on an un unknown date, which was reconstituted with expired diluent.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to expired product administered. It was reported that the nurse called and inquires expired Act-HIB diluent was used to administer Act-HIB vaccine to 2 patients and if would it be valid.  At the time of this report, the 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 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: 0.58
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 7 month-old child received only DTaP/ IPV portion of vaccine/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7-month-old patient who received only DTaP/ IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient had received DTaP (Diphtheria, Tetanus, Ac Pertussis), Hep B (hepatitis B), IPV (inactivated polio vaccine) and Act HIB in past. Past medical history, medical treatment and family history were not provided.  Patient received HEPATITIS B and PNEUMO as concomitant medication.   On 20-Mar-2020, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [DTaP/IPV: lot UJ315AA, expiry date: 04-Apr-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that, Patient did not receive the Act HIB [lot UJ258AA, expiry date: 04-Apr-2021] portion of vaccine.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired 0.5 ml dose of Daptacel vaccine/No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a one year old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The caller stated that 0.5 ml of Daptacel was given IM to a patient and it was allready expired.  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 was no information available on the lot number.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Ipol was inadvertently administered to a patient/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case involves a four-month-old female patient who received expired dose of IPV (VERO) [IPOL].  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), HIB VACCINE CONJ (TET TOX) (ACTHIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and oral ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination on 05-May-2020.  On 05-May-2020, the patient received a second 0.5 mL dose of suspect IPV (VERO) lot P1A461M, expiry date 03-May-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  An expired dose of IPOL was inadvertently administered to a patient.  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: 18.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Menactra vaccine instead of indicated meningococcal B vaccines, no adverse event; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from the nurse.  This case is linked to case 2020SA129700(same reporter).  This case involves an 18 year old male patient who  was vaccinated with the 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6455CA and expiration date was not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 15-May-2020 instead of MENINGOCOCCAL VACCINE B.  The patient had received the two doses of Menactra in past. The patient did not receive any concomitant vaccine.  This was an actual medication error case due to wrong vaccine administered.  At the time of reporting, adverse event was not 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: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel vaccine was givent to a 4 month old, no adverse event; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA126031 (same reporter).  This case involves a four month old patient who was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (inappropriate age at vaccine administration).  Medical history, concomitant medication, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 11-May-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via intramuscular route in left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age.  The patient received Quadracel in fourth month. No other vaccines were given on that day. This was the third DTaP and first Ipol.  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 lot number for this case.
Age: 21.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Menactra vaccine instead of the Meningococcal B, No AE; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA129645 (same reporter).  This case involves a 21 year old male patient who was vaccinated with a 0.5ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6576AA and expiry date: 15-Nov-2020) via intramuscular route in the left deltoid on 15-May-2020 instead of the vaccines MENINGOCOCCAL VACCINE B (lot number and expiry date not reported) for prophylactic vaccination.   The patient's past vaccination(s) included MENACTRA two doses.  The patient's medical history, concomitant medication, medical treatment(s) and family history were not provided.   It was a actual medication error due to wrong vaccine administered.   At the time of report adverse event 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 2 month old received both Pentacel and Acthib, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 months old male patient who received first 0.5 ml doses of  both DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (suspension for injection, lot UJ016AAA) and HIB (PRP/T) VACCINE [ACT-HIB] (Powder and solvent for solution for injection, lot UJ077AAB) via intramuscular route in the left thigh as prophylactic vaccination on 14-May-2020.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered (justification: pentacel also has act-hib component in it).   No adverse event reported at the time of reporting.  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.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 week old patient recived a dose of an expired dose of Act-Hib vaccine, no adverse event; a 2 week old patient was administered a dose of Acthib, no advesre event; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (practice manager/office staff).  This case involves a one week and four day old (also reported as 2 weeks) male patient who was vaccinated with the 0.5 ml first dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ183AA and expiration date 12-Feb-2012) via an intramuscular route in the right thigh on 15-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any other vaccine.  It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.  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: 3.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adacel that was administered to 3 year old instead of another vaccine daptacel, no AE; Adacel that was administered to 3 year old instead of another vaccine daptacel, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 3 year old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) instead of another vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via unknown route in the right thigh as prophylactic vaccination on 18-May-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration(for Adacel).   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 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 on the batch number for this case.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Heart rate increased, Injection site pain
Clinical narrative: fever, chills, body aches, rapid heartbeat, weakness, fatigue, arm pain at site of injection
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever, chills, body aches, rapid heartbeat, weakness, fatigue, arm pain at site of injection
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I gave meningococcal menactra instead of meningococcal bexsero. There was no adverse reaction from the patient. I called and verified with the patients mom and she stated there was no reactions patient was experiencing. Patient will be following up in the office to get the correct vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diarrhoea, Haemorrhage, Headache, Herpes simplex
Clinical narrative: Outbreaks of Herpes 2, similar in severity and frequency to initial outbreak 40 years ago (fever, malaise, headache, diarrhea, severe blistering with bleeding lasting 4 - 5 days).  Gradual reduction in frequency and intensity of outbreaks over the following 6 months.  During the intervening 40 year period, outbreaks had been very rare, occurring less than once in every 7 - 10 years.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Outbreaks of Herpes 2, similar in severity and frequency to initial outbreak 40 years ago (fever, malaise, headache, diarrhea, severe blistering with bleeding lasting 4 - 5 days).  Gradual reduction in frequency and intensity of outbreaks over the following 6 months.  During the intervening 40 year period, outbreaks had been very rare, occurring less than once in every 7 - 10 years.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received one dose of improperly stored varivax; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were provided. On 17-APR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, schedule and dose # were unspecified) lot#S022756 expiration date reported as 22-JUL-2021 and lot#R020654 expiration date reported as 18-JUL-2020 via subcutaneous route for prophylaxis (product storage error). It was reported that, the sterile diluent used to reconstitute the vaccine was properly stored. No additional adverse effects reported. The temperature was reported as 5.7 Fahrenheit, previous temperature excursions were reported as -13.3 Celsius for 18 minutes and -13.2 Celsius for 18 minutes. The total time frame was reported as 18 minutes. There was an involvement of digital data logger. No product quality complaint involved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hot flush, Incomplete course of vaccination, Injection site pain
Clinical narrative: Hot flashes; Injection site pain; fever; nausea; chills; tiredness; This case was reported by a other health professional and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago from the date of reporting ).   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 received as follows: The age at vaccination was not applicable for this report.   The patient need second shot of Shingrix. It has been one year. This led to incomplete course of vaccination. The reporter asked where he could get the vaccine.   Follow up information received from other health professional on 11th May 2020: The patient stated she has reported an adverse event to GlaxoSmithKline previously. On 27th April 2020 05:00, the patient received the 2nd dose of Shingrix.  In April 2020, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever, nausea, chills, tiredness and hot flashes.  On an unknown date, the outcome of the injection site pain, fever, nausea, chills and tiredness were recovered and the outcome of the hot flashes was unknown. This case US2020AMR040764 is a duplicate of US2020AMR079364. All future correspondence will be submitted to US2020AMR040764.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Hot flashes; Injection site pain; fever; nausea; chills; tiredness; This case was reported by a other health professional and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago from the date of reporting ).   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 received as follows: The age at vaccination was not applicable for this report.   The patient need second shot of Shingrix. It has been one year. This led to incomplete course of vaccination. The reporter asked where he could get the vaccine.   Follow up information received from other health professional on 11th May 2020: The patient stated she has reported an adverse event to GlaxoSmithKline previously. On 27th April 2020 05:00, the patient received the 2nd dose of Shingrix.  In April 2020, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever, nausea, chills, tiredness and hot flashes.  On an unknown date, the outcome of the injection site pain, fever, nausea, chills and tiredness were recovered and the outcome of the hot flashes was unknown. This case US2020AMR040764 is a duplicate of US2020AMR079364. All future correspondence will be submitted to US2020AMR040764.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus
Clinical narrative: diagnosed her with shingles; itching; red patch on the dorsal lateral top of her right foot; blistering; This case was reported by a physician via sales rep and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 1st May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 12 days after receiving Shingrix, the patient experienced shingles, pruritus, skin red and blister. On an unknown date, the outcome of the shingles, pruritus, skin red and blister were unknown.   It was unknown if the reporter considered the shingles, pruritus, skin red and blister to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient felt fine until 12th May 2020 evening. On 13th May 2020, the patient noticed an itching, blistering red patch on the dorsal lateral top of her right foot. Up until that point, she had no other symptoms after she received the vaccine.  The reported stated that, since this patient actually works for the reporter as phlebotomist, he/she looked at her right foot in morning of the date of reporting and diagnosed her with shingles.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles on the side of her head; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 13th August 2019, the patient received the 2nd dose of Shingrix. On 7th May 2020, 384 days after receiving Shingrix and 268 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   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: After receiving 2nd dose of Shingrix, the patient was started experiencing the symptoms of shingles on the side of her head on 07th May 2020. The reporter was consented to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Dry throat, Erythema, Rhinorrhoea, Sneezing
Clinical narrative: Dad left office after checking out approximately 5 minutes after vaccines were given.  States that patient started sneezing,runny nose, face red, with c/o throat being dry.  Dad returned to office immediately. Benadryl was administered at approximately 2:20 p.m.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vomiting which lasted 2 days from date of receiving vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood magnesium normal, Diarrhoea, Full blood count normal, Joint swelling
Clinical narrative: 4 days after vaccine administration developed nausea and diarrhea, followed by joint pains/swelling and macular rash
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Nausea, Rash macular
Clinical narrative: 4 days after vaccine administration developed nausea and diarrhea, followed by joint pains/swelling and macular rash
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Patient had sudden onset of sweats and lightheadedness while at work.  She was sent home, proceeded to have 1 episode of vomiting and then rested.  Feeling completely fine after resting.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site urticaria, Injection site warmth, Muscular weakness
Clinical narrative: Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Cystitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site ulcer
Clinical narrative: Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: red local reaction at the shot site on the right thigh.  return tomorrow for a follow up appointment
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms: body aches, fever, chills, shivering, headache, general malaise
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms: body aches, fever, chills, shivering, headache, general malaise
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness around injection site and in the arm of injection. Started 2 days after injection.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Moving hives all over the body starting on face then traveling to the rest of the body,
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: tiredness, fatigue, headache
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Nausea, Pain, Peripheral swelling
Clinical narrative: Pt developed chills, nausea, body aches, itchy arm hours after receiving vaccine. The next day the arm was swollen, red and itchy and warm to touch..
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: Pt developed chills, nausea, body aches, itchy arm hours after receiving vaccine. The next day the arm was swollen, red and itchy and warm to touch..
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Injection site erythema
Clinical narrative: Pt developed chills, nausea, body aches, itchy arm hours after receiving vaccine. The next day the arm was swollen, red and itchy and warm to touch..
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Vomiting
Clinical narrative: Pt developed chills, nausea, body aches, itchy arm hours after receiving vaccine. The next day the arm was swollen, red and itchy and warm to touch..
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Mastoiditis, Pain, Pyrexia
Clinical narrative: MASTODitis & Shingles Every 3 to 4 weeks Severe pain/Fever/Fatigue I have Had Shingles since 1990. 1 outbreak 1 to 2 times a year. Same place same size I have Dates and pictures. Since Shinrix I have them every 3 to 4 weeks - continuously since shot. Confirmed/Pictured. Time and dates!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Joint swelling, Nausea, Peripheral swelling, Rash
Clinical narrative: 5/18/20- NAUSEA + DIARRHEA. MOSTLY DIARRHEA ALL DAY 5/19/20- SWELLING OF HANDS, ANKLES, WRIST GENERALIZED RASH - ARMS, & FROM WAIST TO KNEES. NON-PRURITIC. TREATED AT HOSPITAL WITH IV BENADRYL & NOW ON OTC Benadryl.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Irritability, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administration error - 2 month vaccines given at 1 month of age - child doing well, 0 concerns *No adverse reaction* Medical Assistant administered vaccines too early to a child. Dr. spoke with family hours after administration, patents told him child was fussy, no fever, eating well, no concerns.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Lethargy, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Soreness around area where shot was given (Day 1) soreness of right arm; severe lethargy and rash developed in mid-section on both sides as well as left-hand wrist (Day 2) Continued soreness of right arm; severe lethargy and rash grew from mid-section up part of back (Day 3) Continued soreness of right arm; severe lethargy and rash continued to grow up back and increase to go below waist (Day 4) - contacted medical unit to report as symptoms were not subsiding. Med Unit doctor referred me to see a dermatologist on day 5 Soreness in right arm and lethargy continued; rash continued to give off heat and itch.  Visited dermatologist who examined rash and determined it was a reaction to the flu shot.  Prescribed a steroid shot, antihistamine, and cream for the rash  (Day 5) Lethargy subsided and rash stopped expanding up back and below waist (Day 6) Rash started going away and lethargy subsided (Day 7) Rash was gone (Day 8)
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Soreness around area where shot was given (Day 1) soreness of right arm; severe lethargy and rash developed in mid-section on both sides as well as left-hand wrist (Day 2) Continued soreness of right arm; severe lethargy and rash grew from mid-section up part of back (Day 3) Continued soreness of right arm; severe lethargy and rash continued to grow up back and increase to go below waist (Day 4) - contacted medical unit to report as symptoms were not subsiding. Med Unit doctor referred me to see a dermatologist on day 5 Soreness in right arm and lethargy continued; rash continued to give off heat and itch.  Visited dermatologist who examined rash and determined it was a reaction to the flu shot.  Prescribed a steroid shot, antihistamine, and cream for the rash  (Day 5) Lethargy subsided and rash stopped expanding up back and below waist (Day 6) Rash started going away and lethargy subsided (Day 7) Rash was gone (Day 8)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Hunger, Injection site erythema, Malaise
Clinical narrative: Extreme fatigue, fever of 101.3 (on and off for two days,) mild diarrhea, huge  red bullseye at injection site (4in. diameter) malaise, overly hungry.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, fever of 101.3 (on and off for two days,) mild diarrhea, huge  red bullseye at injection site (4in. diameter) malaise, overly hungry.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. In 2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) at a family heath center for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to vaccination), the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live(ZOSTAVAX) vaccine, pt has and will 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 will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Keratitis, Photopsia, Vitreous degeneration, Vitreous opacities
Clinical narrative: vitreous degeneration / vision loss with flashing lights in the left eye; keratoconjunctivitis; branchlike vitreous opacity; Information has been received regarding a case in litigation from a lawyer and the pt on 14-MAY-2020, referring to a 74 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The pt that was vaccinated by a pharmacist on 09-DEC-2016 with zoster vaccine live (ZOSTAVAX) (lot# and route unknown)  for the long-term prevention of shingles and zoster related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: vision loss along with flashing lights in the left eye. The pt was diagnosed with keratoconjuntivitis, branchlike vitreous opacities and vitreous degeneration. The outcome of keratoconjuntivitis, branchlike vitreous opacities and vitreous degeneration was unknown. The causality assessment between keratoconjuntivitis, branchlike vitreous opacities and vitreous degeneration with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, vitreous degeneration was determined to be a medically significant event.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: cerebrovascular accident; Information has been received regarding a case in litigation from a lawyer and the pt on 14-MAY-2020, referring to a 62 year old male pt. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-OCT-2015, the pt was vaccinated by a medical provider with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: cerebrovascular accident diagnosed on 20-JAN-2016. The outcome of cerebrovascular accident was unknown. The causality assessment between cerebrovascular accident with zoster vaccine live (ZOSTAVAX) was reported as related. Upon internal review, cerebrovascular accident was determined to be a medically significant event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Swelling in my armpit and discolored
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: I was fine for the hours after the shot and then later in the day when I looked at phone messages I had such a brain fog that I did not know who the people were that I had been in contact with regarding a specific issue.  Basically people I had been working with for months on a situation did not register at that moment and I could not recall their names or faces.  For the rest of the night I would look at a piece of paper with their names on and I could not recall them.  It scared me and my wife so much for the rest of the night.  I woke up the next morning and had total recall so I did not report it to my dr.