chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: child received a Dtap instead of a Tdap/no AE; Initial information received on 22-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional(office staff).  This case involves a 11 years old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL](batch number and expiry date not reported) instead DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID[TDAP] via unknown route in unknown administration site on an unknown date for prophylactic vaccination(wrong product administered). It was reported that now patient age is 18 years old and she received vaccine when she was 11 years old and realized this because of her immunization record.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  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 batch number for this case.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Seven year old patient was received Quadracel/No AE; Initial information was received on 29-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 year old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided. It was reported that patient was not vaccinated since he was one year old.  Patient received concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE (MMRV).  On 19-Jun-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   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.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of Act-HIB/No AE; Initial information received on 29-Jun-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 15 months old male patient (also reported as 13 months old) was vaccinated with a 0.5ml dose of HIB (PRP/T) VACCINE [ACT-HIB] which was already expired (lot UJ112AAC and expiry date: 21-JUN-2020) via unknown route in left arm on 29-Jun-2020 for prophylactic vaccination (expired product administered).  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 (DTAP) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV).  It was an actual medication error case due to expired vaccine used.  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.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given to the patient and afterwards they discovered that vial was expired / No AE; Initial information was received on 29-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 48 years old female patient who received 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date not reported) via intramuscular route in the right deltoid for prophylactic vaccination on 18-Jun-2020.  The patient's past medical history included Splenectomy. The patient's medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for immunisation.  Case details: Vaccine specialist states that the patient was going to restart dosage of Menactra and Menveo. Vaccine was given last week and afterwards they discovered that vial was expired and patient was reluctant to get another dose. Patient had previously had a splenectomy and was not sure if she had received her childhood Menactra vaccines, so the HCP gave her a Menactra vaccine at age 48, however the vaccine was expired. The patient declined to come in and have another vaccine. The physician asks if there are titers that can be drawn for Menactra  It was an actual medication error case due to expired vaccine used.   At a time of reporting 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 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.  There will be no information available on the batch number for this case
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Gait disturbance, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: On 7/2/20 presented to Clinic with left thigh with 14x10 cm slightly raised, erythematous circular lesion.  There is mild induration in the center without palpable fluctuance.  Mild tenderness to palpation.  Compartments are soft without pain or compression.  No purulent drainage.  Slight limp with ambulation.  Prescribed Clindamycin (208.5 mg) by mouth 3 times a day for 5 days.  Seen on 7/3/20 at Hospital and prescribed diphenhydramine prn.  At time of this visit patient had cough/fever and CoVid19 testing was performed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: On 7/2/20 presented to Clinic with left thigh with 14x10 cm slightly raised, erythematous circular lesion.  There is mild induration in the center without palpable fluctuance.  Mild tenderness to palpation.  Compartments are soft without pain or compression.  No purulent drainage.  Slight limp with ambulation.  Prescribed Clindamycin (208.5 mg) by mouth 3 times a day for 5 days.  Seen on 7/3/20 at Hospital and prescribed diphenhydramine prn.  At time of this visit patient had cough/fever and CoVid19 testing was performed.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Inflammation, Mass, Pain
Clinical narrative: pt developed low grade fever  99 for 2 days along with inflamation size of palm of ones hand.    c/o hard lump at center of inflamation. and continues to be sore.  pt states inflamation {reddness decreased but still sore  }
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: pt developed low grade fever  99 for 2 days along with inflamation size of palm of ones hand.    c/o hard lump at center of inflamation. and continues to be sore.  pt states inflamation {reddness decreased but still sore  }
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a licensed nurse practitioner and refers to a 18-month-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002505 (lot number was verified to be valid for formulation vial), expiration date 04-APR-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or additional adverse effects reported; inadvertently received first dose in VARIVAX immunization series that was expired; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant medications, drug reactions or allergies were not reported. Concomitant therapy included sterile diluent (manufacturer unknown).   On 25-JUN-2020, the patient was inadvertently vaccinated with an expired first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R017768 and expiration date: 21-JUN-2020; strength, dose, route, and anatomical site of injection were not reported) for prophylaxis (expired product administered). No symptoms or additional adverse effects was reported (no adverse event).
Sex: F
Vaccine: MMR, MMRV
Symptoms: Antibody test negative, Wrong product administered
Clinical narrative: the patient was accidentaly administered a dose of proquad instead of a dose of MMR II; the patient was accidentaly administered a dose of proquad instead of a dose of MMR II; On an unspecified date in June 2020 the patient was found to have a negative titer; This spontaneous report was received from a nurse referring to a 21-year-old female patient.  The patient did not have any pertinent medical history. The patient's drugs reactions/allergies were unknown. The patient's concomitant medications included unspecified birth control medications.  On an unknown dates, the patient was vaccinated with series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, anatomical location, route, lot # and expiration date were unknown) for prophylaxis (reported as "prevention of measles, mumps and rubella"). On an unknown date in June 2020, the patient was found to have a negative titer (antibody test negative). On 23-JUN-2020, the patient came into office for administration of a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) booster dose. On same day, the patient was accidentally administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, anatomical location, route, lot # and expiration date were unknown) for prophylaxis, instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (interchange of vaccine products, wrong product administered). It was reported that the administration of the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not related to product confusion caused by the packaging. No product quality complaint (PQC) involved. The outcome of antibody test negative was unknown. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt a lot more; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced achiness and hurt a lot more than dose two. HCP could not provide lot number and expiration date for dose one because it was given at another pharmacy. No start date or outcome for achiness provided. No additional information was provided. Consented to follow up. This case has been linked with case US2020113038, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020113038:for 2nd dose
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Muscle fatigue, Pain in extremity
Clinical narrative: sore arm; tired muscle; upset stomach; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2020 17:00, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, muscle fatigue, upset stomach and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, muscle fatigue, upset stomach and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle fatigue, upset stomach and headache to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experinced tired muscles, upset stomach, sore arm and headache. The reporter wanted to know how long these likely to last. The patient took Ibuprofen which does seem to help.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: pain in arm; received beyond 6 month dosing window; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female 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 pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced pain in arm. The patient received 2nd dose beyond 6 month which led to lengthening of vaccination schedule. This was a medication error with harm.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: knee pain; This case was reported by a consumer and described the occurrence of knee pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee pain 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 adult as per the vaccine indication. The patient was not sure if she kad knee pain before her first Shingrix dose. The patient thought the knee pain was from aerobics, she states the pain started in left knee and at time of reporting both knees hurt.  The patient states her knees were hurting before the second shingrix dose which she received two weeks ago form the date of reporting. The patient need to take a methylprednisolone dose pack for knee pain. Was that safe to take the prednisone without causing problems with the vaccination that patient received, would it diminish the vaccine This case has been linked with case US2020AMR114277, reported by same patient for 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This case was reported by a other health professional via interactive digital media and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced dizziness and vertigo. On an unknown date, the outcome of the dizziness and vertigo were unknown.   It was unknown if the reporter considered the dizziness and vertigo to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient experienced dizziness, vertigo after vaccination.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Syncope
Clinical narrative: Continuous fainting; due to continuous fainting spells had to give up martial arts afterwards; Could not move; This case was reported by a consumer via interactive digital media and described the occurrence of fainting in a 12-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant), mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the fainting and activities of daily living impaired were unknown and the outcome of the mobility decreased was recovered/resolved.   The reporter considered the fainting, mobility decreased and activities of daily living impaired to be related to Bexsero.  Additional details were reported as follows: The reeporter reported that the patient received vaccine shot and had severe reaction to the shot. The patient was active in martial arts and had to give up because he started to having fainting speels afte the shot. Also the patient could not move for 24 hours and did not even lift himself up. No other information was reported. Since the product was unknown and case reported under MenBMi the suspect was conservativetly captured as Bexsero vaccine (Men B NVS).
Age: 0.33
Sex: F
Vaccine: MENB
Symptoms: Autism spectrum disorder, Laboratory test abnormal, Meningitis
Clinical narrative: ended up meningitis scariest; autism type 2; This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a infant female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, couple of days after receiving Bexsero, the patient experienced meningitis (serious criteria GSK medically significant) and autism (serious criteria GSK medically significant). On an unknown date, the outcome of the meningitis and autism were unknown.   The reporter considered the meningitis and autism to be related to Bexsero.  Additional information was provided as follows: The patient had the shot and a few day later ended up with meningitis scariest thing ever had to go though. The patient was a healthy child and was developing normal like her twin brother. The mother of patient noticed after patient got better that something was different about her. The patient was tested and found out she was type 2 autism. The mother of the patient wander if it was due to the shot. The situation of patient was hard as parent to see, she believed that it was a side effect to the vaccination which triggered her to get meningitis from the shot and she believed that meningitis was the huge link to autism.
Sex: M
Vaccine: MEN
Symptoms: Epilepsy
Clinical narrative: epilepsy; This case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the epilepsy was unknown.   It was unknown if the reporter considered the epilepsy to be related to Meningococcal B vaccine.  Additional case details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient developed epilepsy after getting the vaccination for college. The follow up was not required.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: sore arm / couldn't lift it; very sore arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 62 or 63 year. Exactly 2 months back from 6th June 2020, the patient received the 1st dose of shingrix. The patient experienced very sore arm, It was so sore she couldn't lift it. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR113970, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR113970:Same patient, 1st dose
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Pain, Pain in extremity
Clinical narrative: HEADACHE; body aches; FATIGUE; SORE ARM; This case was reported by a physician via sales rep and described the occurrence of headache in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of influenza like illness (received flu vaccine on 27th August 2019).   On 17th June 2020, the patient received the 1st dose of Shingrix. On 17th June 2020, 8 hrs after receiving Shingrix, the patient experienced headache, general body pain, fatigue and pain in arm. On an unknown date, the outcome of the headache, general body pain, fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the headache, general body pain, fatigue and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient experienced symptoms on evening of the day of vaccination.  Approximately 8 hours following administration. The patient slept the entire day following the vaccination. No fever was reported.  Symptoms resolved after the second day. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case. This case has been linked with US2019158430, reported by same reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever as high as 102F; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 2737P, expiry date 22nd January 2022) for prophylaxis.   On 25th June 2020, the patient received the 1st dose of Shingrix. On 26th June 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The patient experienced fever one day after receiving the first dose of Shingrix. The body temperature was reported as 102F. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Restlessness
Clinical narrative: some itching too; All of those areas are red and slightly raised; Red patch on back; Spots of rash on her belly; rash has presented in various areas; flu-like symptoms; Feverish / feeling hot; was uncomfortable; tossed / redness also presented that evening with a knot / areas are red; Injection site knot; was restless; turned throughout the night; arm is still sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in January 2020, on left ear, left side of neck and over collarbone).   On 24th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th June 2020, the patient experienced influenza-like symptoms, feeling hot, discomfort, injection site erythema, injection site mass, restlessness and sleeplessness. On 26th June 2020, the patient experienced rash, itchy rash, raised rash, skin red and spot-like rash. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema and restlessness were recovering/resolving and the outcome of the feeling hot, discomfort, injection site mass, sleeplessness, raised rash, skin red and spot-like rash were unknown and the outcome of the rash, pain in arm and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling hot, discomfort, injection site erythema, injection site mass, restlessness, sleeplessness, rash, pain in arm, itchy rash, raised rash, skin red and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The reporter stated that, after vaccination, the patient felt feverish but did not had fever. In the evening after vaccination, the patient was uncomfortable, felt hot  restless and tossed and turned throughout the night. The patient also had redness at injection site and injection site knot in the evening after vaccination. The reporter stated that, the area started out the size of a quarter. On 26th June 2020, it was 5 inches across arm and flu like symptoms were better. The reporter stated that, the arm was still sore and had rash presented in various areas. Less than a week, the patient had pain in arm. 2 days after vaccination, the patient had rash, pruritus, swelling, skin red and spot-like rash. The rash was along the line of her chest where the bottom of a sports bra would be. The reporter stated that the rash on chin below lip in the area that the man might had a gotee and also had on fore head between eye brows. The patient had spoty rash on belly and 3 red patches on back. all of those area were red and slightly raised with some itching too. The reporter stated that, the patient was on intermittent fasting and was in 20 hours of fasting currently. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Delirium, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: Delirious; Hands hurt / hands they were so painful; barely get to my bed / ould not even get to the phone; fever shot up so high; Shivering; shaking for hours; This case was reported by a consumer via call center representative and described the occurrence of delirium in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced delirium (serious criteria GSK medically significant), pain in hand, activities of daily living impaired, fever, shivering and tremor. On an unknown date, the outcome of the delirium, pain in hand, activities of daily living impaired, fever, shivering and tremor were not recovered/not resolved.   It was unknown if the reporter considered the delirium, pain in hand, activities of daily living impaired, fever, shivering and tremor to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for herself. after vaccination the patient could barely get to her bed, her hands hurt so bad. Her fever shot up so high and she was shivering and shaking for hours , her hands they were so painful. The patient thought they were gonna come off and patient was so delirious. The patient could not even get to the phone. The permission to follow up denied.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Delirious; Hands hurt / hands they were so painful; barely get to my bed / ould not even get to the phone; fever shot up so high; Shivering; shaking for hours; This case was reported by a consumer via call center representative and described the occurrence of delirium in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced delirium (serious criteria GSK medically significant), pain in hand, activities of daily living impaired, fever, shivering and tremor. On an unknown date, the outcome of the delirium, pain in hand, activities of daily living impaired, fever, shivering and tremor were not recovered/not resolved.   It was unknown if the reporter considered the delirium, pain in hand, activities of daily living impaired, fever, shivering and tremor to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for herself. after vaccination the patient could barely get to her bed, her hands hurt so bad. Her fever shot up so high and she was shivering and shaking for hours , her hands they were so painful. The patient thought they were gonna come off and patient was so delirious. The patient could not even get to the phone. The permission to follow up denied.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head, Facial paralysis
Clinical narrative: Facial paralysis, left sided, diagnosed with Bell's Palsy in the Emergency Department
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed slight swelling, redness and pain at the injection site the following day.  Pain, redness and warmth remained until 07.02.2020 at which time it was improving.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: 2 minutes after administering the vaccines the patient briefly passed out.  She was placed in a supine position and given some water.  Vital signs were taken, BP and Pulse remained normal.  Eventually patient was able to sit up and felt better.  Patient remained in the office for 25 minutes after the event, was released home with mom, instructed to avoid strenuous activities and swimming today.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: Patient had a rash on arm, tenderness at injection site, redness and itching.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Swelling
Clinical narrative: erythema about 8" surrounding injection site.  Given claritin and iced on 7/5/20 by parent.  7/6/20 less red and swelling less. Still icing and will give claritin again today.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Since the new excursion, one dose of improperly stored ROTATEQ was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-FEB-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and on 20-APR-2020, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), both therapies administered orally as prophylaxis (doses, anatomical locations, lot numbers and expiration dates were not reported). These vaccines did not experience temperature excursions. On 22-JUN-2020, the patient was vaccinated with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), which experienced a temperature excursion (anatomical injection site and dose were not reported; lot number S028771, which has been verified to be valid, expiration date reported and validated as 09-APR-2021), administered orally as prophylaxis (product storage error).  On an unknown date, the vaccine experienced a temperature excursion below 36 degrees Fahrenheit (F) (30.3F) for 15 minutes, as recorded by data logger. There was a previous temperature excursion above 47 F (54.6F) for 1 hour.; Sender's Comments:  US-009507513-2006USA009138: US-009507513-2006USA009121:
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: tested the patient for HPV, which was positive; Patient received a dose in March 2012 and February 2013; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On an unknown date in March 2012, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), injection, 0.5 milliliter, intramuscularly (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On an unknown date in February 2013, the patient received another dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, 0.5 milliliter, intramuscularly (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis(inappropriate schedule of vaccine administered).    On an unknown date (reported as recent), the patient underwent human papillomavirus (HPV) test, which was positive for an unknown strain or strains of the virus. The patient's mother sought medical attention and called health department. The patient did not receive any treatment. The outcome of the event was reported as not recovered.   The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms; improperly stored dose of Gardasil 9 (lot R028656, expiration 7/27/2021) was administered; This spontaneous report as received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R028656, expiration date 27-JUL-2021, intramuscularly (strength and dose was not reported), for prophylaxis. Temperature and time frame of storage was reported as 27 degrees Fahrenheit for 3 hours. There was no previous temperature excursion. Digital data logger was involved.T he patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MEN
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This case was reported by a consumer via interactive digital media and described the occurrence of cellulitis in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Meningococcal B vaccine.  Additional information was provided as follows: The age at vaccination was not reported. It was cellulitis what occuring to the patient after receiving vaccine. The case was linked with case US2020AMR118262, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR118262:Same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Pain, Vaccine positive rechallenge
Clinical narrative: Accidental Skin Exposure; Achiness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020AMR114059).   On 25th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain. On 25th June 2020, the patient experienced exposure via skin contact. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and exposure via skin contact were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: The patient described achiness as dose one hurt a lot more than dose two. The health care professional noted the patient experienced what was described as a significant amount of liquid that ran down her arm during vaccination with dose two of Shingrix, which led to exposure via skin contact. No additional information provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR114059:for 2nd dose
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful to the touch injection area.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a child received a dose of MMR II at age 1 on an unknown date from an unknown provider, and again at age 3; No additional adverse effects were reported in the patient.; This spontaneous report was received from a physician, referring to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date, the patient received a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, Live (M-M-R II) at the age of 1-year-old, however, on an unknown date, a second dose of that vaccine was administered, when the patients was 3-year-old (doses, routes of administration, vaccination schemes and anatomical sites of injection were not reported; lot numbers and expiration dates were unknown by the reporter) (inappropriate schedule of product administration); both vaccines were administered as prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) 0.5 milliliter (ml). No additional adverse effects were reported in the patient.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was "inadvertently administered an expired dose of VAQTA today, 06/30/2020."; This spontaneous report has been received from a pharmacist referring to a 74 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 30-JUN-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: S001832, expiration date: 12-MAY-2020; route and dose details were unknown) for prophylaxis (expired product administered). No adverse symptoms reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report as received from a lawyer and the patient (pt) refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported.  On or about 29-AUG-2011, the pt was vaccinated by the physician with a dose of zoster vaccine live(ZOSTAVAX), (Dose, route, lot number and expiration date were not provided) for for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the pt was treated by a a physician in the medical Office for shingles. As a direct and proximate result ofvaccination with zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report as received from a lawyer and the patient (pt) refers to a female patient of unknown age. Medical history, concurrent conditions and concomitant medication were not reported.  On or about 04-AUG-2014, the pt was vaccinated by a health care professional with a dose of zoster vaccine live(ZOSTAVAX), (Dose, route, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by physician for shingles resulting from the use of zoster vaccine live(ZOSTAVAX). The outcome of herpes zoster was unknown.
Sex: U
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DTaP was administered instead of Tdap on a teenager patient/no AE; Initial information received on 27-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a teenager patient(exact age and gender not known) who was vaccinated with DTAP [ DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE] instead of TDAP[ DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE](batch number, dosing details and expiry date not reported)  via unknown route in unknown administration site on an unknown date for prophylactic vaccination(Wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave an expired Adacel to a patient today, no AE; patient was administered with 0.05 ml dose of vaccine, No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 year old female patient who was vaccinated with an expired 0.05 mL once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5980DA, expiry date: 22-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination on 30-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation and Meuzieo .  It was an actual medication error case due to expired vaccine used and vaccine under dose. It was reported that the nurse gave 0.05 ml expired Adacel vaccine to a patient today.  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 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.