chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After pt received the 2nd dose of Shingrix, she had a new outbreak of shingles; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced new outbreak of shingles in the same place after receiving 2nd dose of Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case was linked with US2020AMR012069, reported by same reporter.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Demyelinating polyneuropathy, Guillain-Barre syndrome, Subacute inflammatory demyelinating polyneuropathy
Clinical narrative: Guillain-Barre; inflammatory demyelinating polyneuropathy; This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 53-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3DE4L, expiry date 30th June 2020) for prophylaxis.   Concurrent medical conditions included pulmonary embolism (admitted to hospital in December 2019 for treatment).   On 10th December 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 22nd December 2019, 12 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and demyelinating polyneuropathy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and demyelinating polyneuropathy were unknown.   It was unknown if the reporter considered the guillain barre syndrome and demyelinating polyneuropathy to be related to Fluarix Quadrivalent 2019-2020 season.   Additional case details were reported as follows: The patient was administered with Fluarix via intramuscular route while in hospital for pulmonary embolism treatment. On 22nd December 2019, the patient was readmitted due to symptoms of inflammatory demyelinating polyneuropathy and was diagnosed with Guillain-Barre syndrome.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was vaccinated with adacel which was not viable due to delayed transit, no AE; patient was vaccinated with adacel which was not viable due to delayed transit, no AE; Initial and additional information was received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (office staff).  This case involves a 37 years old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot: U6602AA, expiry date: 25-Feb-2022) via intramuscular route at right deltoid on 28-Dec-2019, which was not viable due to delayed transit.   Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) on 28-Dec-2019 for Immunisation.  It was an actual medication error due to incorrect product storage and product shipment delay.  At the time of reporting, the patient did not experienced 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 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain, Oropharyngeal pain, Urticaria, Vomiting
Clinical narrative: 4 years patient received vaccine in his left thigh; throat pain; abdominal pain; vomiting; hives on back and abdomen; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 4 years old male patient who experienced abdominal pain (abdominal pain), vomiting (vomiting), throat pain (oropharyngeal pain) and hives on back and abdomen (urticaria), while he received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Concomitant vaccination included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD]. The patient received this vaccine in same visit and had no adverse reactions.  On 06-Jan-2020, the patient received a dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-AUG-2021] via unknown route in the left thigh.  On 06-Jan-2020, the patient developed a non-serious abdominal pain (abdominal pain), vomiting (vomiting), throat pain (oropharyngeal pain) and hives on back and abdomen (urticaria), 5 minutes following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was also the case of actual medication error due to vaccine administered at inappropriate site. Patient received vaccine in his left thigh (product administered at inappropriate site).  Details of laboratory data not reported.  Final diagnosis was urticaria, oropharyngeal pain, vomiting and abdominal pain. All events were reported as severe reaction.  It was not reported if the patient received a corrective treatment.  Outcome of the all reported events was unknown.  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: 41.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one of their patients who is 41 years old, was administered a Fluzone HD vaccination/no AE; one of their patients who is 41 years old, was administered a Fluzone HD vaccination; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 41 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jan-2020, the patient received a dose of suspect 0.5 mg INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AB and expiry date: 29-Jun-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting there was 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: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 month old child was inadvertently given a Typhim vaccine / no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 months old female patient who received 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (lot number-RZA301M and Expiry date- 31-May-2021) via unknown route in right vastus lateralis on 07-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE (YELLOW FEVER VACCINE),INFLUENZA VACCINE (INFLUENZA VACCINE), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error case due to inappropriate age at vaccine administration.   At a 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.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel that was given to the wrong age group/no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] that was given to the wrong age group/no ae (Product administered to patient of inappropriate age)  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 09-Jan-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA via intramuscular route in the right thigh.  On 09-Jan-2020, the patient received non-serious Quadracel that was given to the wrong age group/no AE (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  This is a case of actual medication error due to product administered to patient of inappropriate age.  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: FLU4, HEP
Symptoms: Injection site swelling, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: swelling in the thigh area; Fluzone Quadrivalent being administered to newborn child; Fluzone Quadrivalent being administered to newborn child, Supposed to give Hep B when this occurred; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Fetus male patient (DOB 09-Jan-2020) who developed swelling in the thigh area (swelling) and fluzone quadrivalent being administered to newborn child, (product administered to patient of inappropriate age), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of HEPATITIS B VACCINE[HEPATITIS B VACCINE] .  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date not reported) via intramuscular route in the left thigh.   On an unknown date, the patient developed a non-serious swelling in the thigh area (swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was also an actual medication error case due product administered to patient of inappropriate age and Wrong product administered. It was reported as Fluzone Quadrivalent was administered to newborn child. Supposed to give Hep B when this occurred.  No laboratory data reported.  Final diagnosis was swelling.  No corrective treatment was received.  The outcome was unknown for the event swelling.  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.  Information on batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A college student was accidentally given two Fluzone Quadrivalent doses within one flu season/No AE; Initial information was received on 17-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 19 year old female patient who accidentally received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  The patient received first and second 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6657NA and UJ305AB, expiry date-30-Jun-2020) via an unknown route in the left deltoid on date 16-Oct-2019 and 15-Jan-2020 respectively.  It was a case of an actual medication error due to extra dose administered.  At the time of report, no adverse event was reported.  The patient thought that she was being asked about a calendar year rather than a flu season year. The clinic's system did not flag the patient as having already received the flu shot for this season, so another dose of Fluzone Quadrivalent was given.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was administered without mixing the ActHIB component/ no adverse event; Initial information received on 20-Jan-2020 regarding an unsolicited valid non-serious case received from a physician assistant.  This case involves a 2 month old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the ActHIB component (Product preparation issue).  Patient's medical history, treatments, family history not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE)  and HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) for Immunisation  On 20-Jan-2020, the patient received a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 ml (lot U6629AA, Expiration date: 20-May-2021) via intramuscular route at an unknown side of leg (right or left).  It was a case of actual medication error due to Product preparation issue.  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHib reconstituted with Sterile water instead of the 0.4% saline diluent and administered to the patient/no AE; Initial information received on 20-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the 0.4% saline diluent (lot number, expiry date, route and site of administration were not reported) on an unknown date.  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a actual medication error due to wrong solution used in drug reconstitution.  At the time of this 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 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.  Information on the batch number was requested.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Neck pain
Clinical narrative: injection site was painful and swollen; injection site was painful; injection site was swollen; irritation of the nerve; radiated pain up her neck; nausea; vomiting; headache; swelling of the deltoid; Initial information received on 22-Jan-2020 regarding an unsolicited valid serious case received from a physician.  This case involves an adult female patient of unknown age who presented injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain), while she received vaccine INFLUENZA VACCINE.  The patient medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain) few hours following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events on 01-Jan-2020.  No lab test reported.  Final diagnosis was vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain, vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  The information of the batch number was requested.; Sender's Comments: Patient experienced vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain few hours after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Pain, Peripheral swelling, Radiculopathy, Vaccination site inflammation, Vomiting
Clinical narrative: injection site was painful and swollen; injection site was painful; injection site was swollen; irritation of the nerve; radiated pain up her neck; nausea; vomiting; headache; swelling of the deltoid; Initial information received on 22-Jan-2020 regarding an unsolicited valid serious case received from a physician.  This case involves an adult female patient of unknown age who presented injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain), while she received vaccine INFLUENZA VACCINE.  The patient medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious injection site was painful and swollen (vaccination site inflammation), irritation of the nerve (radiculopathy), radiated pain up her neck (pain), nausea (nausea), vomiting (vomiting), headache (headache), swelling of the deltoid (swelling), injection site was painful (vaccination site pain), injection site was painful (vaccination site pain) few hours following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events on 01-Jan-2020.  No lab test reported.  Final diagnosis was vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain, vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  The information of the batch number was requested.; Sender's Comments: Patient experienced vaccination site inflammation, radiculopathy, pain, nausea, vomiting, swelling, vaccination site pain few hours after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Approximatly 5 minutes after vaccine administration, patient stated that she felt light headed and thought she may pass out.  Patient  was given water and Gatorade and monitored for 30 minutes.  She requested to lie down.  She did not lose consciousness and after 30 minutes states she was feeling better and went home.  Pharmacist followed up with the patient about 1 hour later by phone and she reported feeling totally fine.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Dtap.  She was supposed to get Tdap.   She had no adverse reactions.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Myalgia
Clinical narrative: flu-like muscular ache - 2 days, diarrhea 1 day
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dizziness postural, Malaise, Myalgia
Clinical narrative: Sore arm, early morning hours malaise, muscle aches, pronounced shivering, dizziness upon standing and felt faint although didn't pass out.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm, early morning hours malaise, muscle aches, pronounced shivering, dizziness upon standing and felt faint although didn't pass out.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Information has been received from a lawyer regarding a case in litigation concerning a 62-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On 25-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis in a pharmacy. On or about 25-FEB-2018, as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer a stroke, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of stroke was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Drug hypersensitivity, Headache, Myalgia
Clinical narrative: Allergic reaction; continuous headache; nausea; lack of appetite; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; rash developed around the injection site; it covered my whole forearm, a solid-red rash; area was hot; Area was sore; This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain. On an unknown date, the outcome of the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain were recovered/resolved.   It was unknown if the reporter considered the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was reported. The age group was selected as adult as per vaccine indication. The patient had prolonged and possibly allergic reaction to it, so the patient was hesitant about getting the second dose. The patient had the non-life-threatening reactions.  The patent experienced continuous headache and nausea or lack of appetite, and it was as if all of to the joints, muscles, and nerve endings of the body were painful. A rash developed around the injection site, and it grew and covered whole forearm, a solid-red rash, not hives, and the area was hot and very sore. These effects lasted for about 5 days, the rash lasted for 6 days. The patent thought that the patient might be allergic and should not get the second shot because of strong reactivity, particularly the spread of the rash, which was over the 100mm mentioned somewhere in documentation.  The patient was concerned because the patient Hashimoto's Thyroiditis, that could be contraindicated.  The patient asked if GSK was doing a specific study for specific disorders, including thyroid.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Neuralgia, Pain, Rash, Rash erythematous
Clinical narrative: Allergic reaction; continuous headache; nausea; lack of appetite; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; rash developed around the injection site; it covered my whole forearm, a solid-red rash; area was hot; Area was sore; This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain. On an unknown date, the outcome of the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain were recovered/resolved.   It was unknown if the reporter considered the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was reported. The age group was selected as adult as per vaccine indication. The patient had prolonged and possibly allergic reaction to it, so the patient was hesitant about getting the second dose. The patient had the non-life-threatening reactions.  The patent experienced continuous headache and nausea or lack of appetite, and it was as if all of to the joints, muscles, and nerve endings of the body were painful. A rash developed around the injection site, and it grew and covered whole forearm, a solid-red rash, not hives, and the area was hot and very sore. These effects lasted for about 5 days, the rash lasted for 6 days. The patent thought that the patient might be allergic and should not get the second shot because of strong reactivity, particularly the spread of the rash, which was over the 100mm mentioned somewhere in documentation.  The patient was concerned because the patient Hashimoto's Thyroiditis, that could be contraindicated.  The patient asked if GSK was doing a specific study for specific disorders, including thyroid.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Allergic reaction; continuous headache; nausea; lack of appetite; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; rash developed around the injection site; it covered my whole forearm, a solid-red rash; area was hot; Area was sore; This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain. On an unknown date, the outcome of the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain were recovered/resolved.   It was unknown if the reporter considered the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was reported. The age group was selected as adult as per vaccine indication. The patient had prolonged and possibly allergic reaction to it, so the patient was hesitant about getting the second dose. The patient had the non-life-threatening reactions.  The patent experienced continuous headache and nausea or lack of appetite, and it was as if all of to the joints, muscles, and nerve endings of the body were painful. A rash developed around the injection site, and it grew and covered whole forearm, a solid-red rash, not hives, and the area was hot and very sore. These effects lasted for about 5 days, the rash lasted for 6 days. The patent thought that the patient might be allergic and should not get the second shot because of strong reactivity, particularly the spread of the rash, which was over the 100mm mentioned somewhere in documentation.  The patient was concerned because the patient Hashimoto's Thyroiditis, that could be contraindicated.  The patient asked if GSK was doing a specific study for specific disorders, including thyroid.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Mental disorder
Clinical narrative: Mental Blur; This case was reported by a consumer via call center representative and described the occurrence of mental disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mental disorder. On an unknown date, the outcome of the mental disorder was unknown.   It was unknown if the reporter considered the mental disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced mental blur after receiving Shingrix. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Electromyogram, Magnetic resonance imaging, Muscular weakness, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Sever pain in left arm after 3-4 days of vaccination. Pain subsided and left pointer finger and thumb left with extreme weakness.  Condition diagnosed by a hand specialist to be Parsonage Turner Syndrome. There is no treatment for this.  This has left me with a permanent disability.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperthyroidism, Rash, Scan thyroid gland, Swelling, Thyroid cyst
Clinical narrative: Swelling and rash to the wrist and swelling of neckline the following morning (10/19/19). Swelling eventually reduced but still remains slightly.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroiditis subacute
Clinical narrative: Swelling and rash to the wrist and swelling of neckline the following morning (10/19/19). Swelling eventually reduced but still remains slightly.
Sex: U
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient experienced no symptoms; patient was administered a dose of PNEUMOVAX 23 5 months after he was admonistered a dose of PREVENAR 13; This spontaneous report as received from a pharmacist refers to a 65-year-old patient of unknown gender. The patient was immunocompetent. No information on patient's other pertinent medical history, drug reactions or allergies and concomitant medications was provided.   On 16-JAN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S013490, expiration date 06-MAR-2021, dose and anatomical location were not reported) intramuscularly for prophylaxis, 5 months after he was administered a dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (dose, route of administration and anatomical location were not reported).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; The vaccine coordinator is reporting the patient was administered a dose of VARIVAX on 1/8/2020 , that had been improperly stored.; This spontaneous report was received from the office manager and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 08-jan-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) that had been improperly stored, lot # S021926 with expiration date of 15-JUL-2012, for prophylaxis (route of administration and frequency were not reported). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (DILUENT MRK). No additional adverse events reported.      It was stated that the vaccines underwent a temperature excursion of 1.2°FC (degrees Celsius) for 3 hours 9 minutes. No previous temperature excursion was done. The call was because of a "data logger".
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Muscular weakness
Clinical narrative: suffered slurred speech and right arm weakness / diagnosed with an acute stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-FEB-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as recommended for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, lot #, expiration date were not provided). On an unknown date, reported as shortly after receiving suspected vaccine the patient suffered slurred speech and right arm weakness. Subsequently, she was diagnosed with an acute stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not presented prior to using suspected vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. Causality assessment between the event and the suspect vaccine was considered related, by the reporter.   Upon internal review, the event of stroke was considered to be medically significant. Acute stroke was considered to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; Expired vaccine used; This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. The patient's medical history, current condition and drug reactions/allergies  were not reported. Concomitant therapies included sterile diluent.     On 22-JAN-2020 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) after its labeled expiration date (lot # R001659, expiry date: 17-JAN-2020) therapy type was recombinant therapy type (RHA) for prophylaxis (expired product administered). No additional adverse effects were reported. No product quality complaint (PQC) was reported. The outcome of expired product administered and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Lichen planus, Rash, Type IV hypersensitivity reaction
Clinical narrative: bilateral foot rash, the rash eventually spread to her upper and lower legs/ankles / pt diagnosed with lichen planus; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 14-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a bilateral foot rash. The rash eventually spread to her upper and lower legs and ankles. The patient was referred to a dermatologist and diagnosed with lichen planus, a T-cell mediated auto-immune reaction, following a punch biopsy on 15-MAR-2018. Since her diagnosis, the patient continued to suffer from the effects of her skin condition and received triamcinolone acetonide (KENALOG) injections when her lichen planus flared. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved.  The event was considered related to zoster vaccine live (ZOSTAVAX).  The event of lichen planus was considered to be disabling.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient did not experience any symptoms; a patient, who is 12 months old was inadvertently administered one dose of GARDASIL 9; This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. No information regarding the patent's medical history, concurrent conditions and concomitant medications was provided.   On 23-JAN-2020, the 12- month- old patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R032768, expiration date: 31-AUG-2021, 1 dosage form, intramuscularly for prophylaxis. The patient did not experience any symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: severe urticaria; This case was reported by a physician via sales rep and described the occurrence of urticaria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient experienced severe urticaria after a dose of Shingrix. Further information was not reported.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site pain, Lethargy
Clinical narrative: Pain; Discomfort at the injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date unknown) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site discomfort and lethargy. On an unknown date, the outcome of the injection site pain, injection site discomfort and lethargy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site discomfort and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving 1st dose, the patient experienced pain around the injection site, discomfort at the injection site and lethargy which dissipated after two days. For tolerence of 2nd dose, refer case US2020011363.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: red, swollen, raised 2 inch by 1.5 inch area below the injection site; swollen, raised 2 inch by 1.5 inch area below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose on an unknown date).   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced erythema and local swelling. On an unknown date, the outcome of the erythema and local swelling were unknown.   It was unknown if the reporter considered the erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed an extremely red, swollen, raised 2 inch by 1.5 inch area below the injection site. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis
Clinical narrative: encephalitis; This case was reported by a consumer via call center representative and described the occurrence of encephalitis in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was recovered/resolved.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 77 or 78 years. The patient took over a year to recover from  encephalitis. The reporter did not consent to follow up. The reporter declined to answer any additional questions.