chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: Patient received Menactra instead of Menveo and patient administered it without considering if the two vaccines were interchangeable/No AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 27 years old female patient who on 19-Jun-2020, received 0.5 mL first dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6560BA and expiry date 02-Apr-2021) via intramuscular route at an unknown administration site for prophylactic vaccination instead of second dose of suspect MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO] not produced by Sanofi Pasteur (lot number and expiry date not reported) and patient administered it without considering if the two vaccines were interchangeable (wrong product administered)  The patient's past vaccination(s) included MENVEO (first dose about 6 months ago). The patient's medical history, past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing myasthenia gravis and immunodeficiency (due to myasthenia gravis).    Case details: The reporter stated that the pharmacist reports that a patient presented in order to take meningitis immunization and patient had received Menveo about six months ago, but her HCP wanted her to receive two immunization series for immunocompromised status due to myasthenia gravis. Pharmacist states that their pharmacy did not use Menveo, they use Menactra, and she administered it without considering if the second vaccines were interchangeable. Then the patient's physician's office called her and said they were not interchangeable. Pharmacist contacted the local board of health, and was told that the two vaccines are interchangeable.  Details of laboratory data was not reported.  It was an actual medication error case due to wrong product administered.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the Pentacel vaccine without mixing the powder so the patient only was given the liquid portion, No AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA165285 (same reporter).  This case involves a seven month old male patient who received a 0.5 ml third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot Diluent: U6615AA, Powder: UJ196AB, expiry date: 02-Mar-2021) once via an intramuscular route in the left thigh for prophylactic vaccination on 16-Jun-2020, without mixing the powder so the patient only was given the liquid portion.  The patient's past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2-month old receiving an expired dose of Pentacel/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a two months old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was expired before nine days (Box: Lot: UJ066ABA, Exp: 13-Jun-2020, ActHIB: Lot: UJ066AB, Exp: 13-Jun-2020 and Dtap-IPV: Lot: UJ100AA, Exp: 13-Jun-2020) on 22-Jun-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  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: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received the pentacel injection but only received the liquid portion, no AE; Initial information was received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 month old male patient who received first 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U65408A and expiry date 06-Apr-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 22-Jun-2020, but received only the liquid portion (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: MNQ
Symptoms: Product container issue, Product package associated injury, Skin laceration
Clinical narrative: Did not realize it was broken and then the top cracked off and fell off and cut her; The glass was shattered and no vaccine inside of the vial, the box was all soggy; Vial was broken at the bottom; No vaccine inside of the vial, there is no solution left in the vial; Initial information was received on 25-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse (reporting for self).  This case involves female nurse who stated that, while opening the suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ( lot U6484AC and expiry date 10-Jan-2021) she did not realize it was broken and then the top cracked off and fell off and cut her (product package associated injury), and mentioned that the glass was shattered and no vaccine inside of the vial, the box was all soggy (product packaging issue), vial was broken at the bottom (product physical issue) and no vaccine inside of the vial, there is no solution left in the vial (product quality issue).  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of product packaging issue, product physical issue and product quality issue.  Details of laboratory data were not reported.  Final diagnosis was product package associated injury.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of product package associated injury and was not applicable for product packaging issue, product physical issue and product quality issue.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: 101.7 F fever, shivering, headache, nausea
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pruritus, Rash erythematous
Clinical narrative: Developed pain during the administration, later experienced body aches and a mild headache that started a couple of hours later.  A red rash appeared from the beginning and progressed to a deeper red circle, warm to the touch. Body aches and low grade headache lasted a couple of days. Still with persistent red raised rash, was very itchy, relieved with triamcinolone ointment with zyrtec. Took tylenol for her body aches and headache.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Skin warm
Clinical narrative: Developed pain during the administration, later experienced body aches and a mild headache that started a couple of hours later.  A red rash appeared from the beginning and progressed to a deeper red circle, warm to the touch. Body aches and low grade headache lasted a couple of days. Still with persistent red raised rash, was very itchy, relieved with triamcinolone ointment with zyrtec. Took tylenol for her body aches and headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pruritus, Eye swelling, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm, head-aches, flu-like symptoms, eye swelling, cheek selling, sever ear lobe itching
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Sore arm, head-aches, flu-like symptoms, eye swelling, cheek selling, sever ear lobe itching
Age: 1.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given QUADRACEL instead of Daptacel. No adverse effects noted at the time of the administration.  Parents were informed, pediatrician was informed. Sanofi-Pasteur Medical Team consulted. No need for any follow-up. Doses count as valid doses of both DTAP and IPV that are included in the Quadracel.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Erythema of eyelid, Eyelid pain, Swelling of eyelid
Clinical narrative: Shortly after end of visit returned to clinic with swollen red painful left eye(lids); not itchy; no rash; no shortness of breath; no swelling of lips, tongue, or extremities.   L/S CTAB.   Benadryl 50mg PO x1 administered in clinic.  Swelling began to improve within 1/2 hour.  Added cetirizine the following day due to incomplete resolution of sx.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DUE TO THE FINDING ON 6/26/2020 WHEN REVIEWING THE PATIENTS CHART FOR UPCOMING VISIT I NOTICED THE  VACCINE ZOSTAVAX WAS GIVEN BACK ON 12/04/2018 VERSES A VARICELLA VACCINE FORTHE PATIENT.  AT THE TIME THERE WAS NO REPORT BY THE PARENTS AFTER THE INJECTION THAT THE CHILD HAD ANY REACTION.  IN THE PAST YEAR AND A HALF WE HAVE SEEN THE CHILD TWICE  AND THERE NO REPORTED COMPLAINT BY THE PARENTS THAT THEY NOTICED ANYTHING DIFFERENT WITH THE CHILD.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: The morning following administration of vaccines, patient woke up with rash scattered throughout entire body with fever. Fever resolved with Tylenol/ibuprofen. Benadryl for itching.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood culture negative, Chills, Culture urine negative, Exposure during pregnancy
Clinical narrative: Pt's third pregnancy where dose of TDaP has been given with each pregnancy within a span of 5 years. All normal weight kids. At the last (third) pregnancy, the dose is given at 4pm and patient started experience muscle weakness, pain later that evening around 11 pm. Overnight and the next morning, patient had continued weakness, chills, fevers and unable to move easily.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: Pt's third pregnancy where dose of TDaP has been given with each pregnancy within a span of 5 years. All normal weight kids. At the last (third) pregnancy, the dose is given at 4pm and patient started experience muscle weakness, pain later that evening around 11 pm. Overnight and the next morning, patient had continued weakness, chills, fevers and unable to move easily.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported.; Medical assistant called reporting an improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 17-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S031705, expiration date 06-APR-2021, strength, dose and route were not reported) for prophylaxis.    Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was stored at -11.5 degree Celsius for 37 minutes. There was no previous temperature excursion reported. The digital data logger was involved. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 11-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: he developed a painful erythematous rash distal to the injection site; he developed a painful erythematous rash distal to the injection site; This spontaneous report as received from a pharmacist refers to a 67-year-old male patient. The patient's concurrent condition included hypertension. The patient had drug allergy to guafenesin and loratadine (reported as loratidine).      On 22-JUN-2020, the patient was vaccinated with 0.5 ml dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021, intramuscularly for vaccination. Concomitant therapies included azelastine hydrochloride (ASTELIN), cetirizine hydrochloride (ZYRTEC), lisinopril (manufacturer unknown), pravastatin and beclomethasone dipropionate(QNASL).     On 23-JUN-2020 (reported also as the following day), the patient developed a painful erythematous rash distal to the injection site. The patient was going to be seen by the physician later that day for possible unknown treatment. No treatment was given for the event at the reporting time. None lab diagnostics/studies were performed. The outcome of  the event was reported as not recovered.  The causality assessment between the event and the vaccination with  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-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
Age: 1.08
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects to the patient; 13 month old was given ZOSTAVAX on 12/04/2018; This spontaneous report was received from a nurse, referring to a 13 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies were not provided.  On 04-DEC-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot # N026815, expiration date 25-DEC-2018; strength, dose, frequency, route) for prophylaxis (inappropriate schedule of product administration). Nurse reported that the office was doing an audit and discovered the error. Nurse reported no adverse effects to the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness in the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received Shingrix and experienced only soreness in the injection site. This case has been linked with case US2020AMR108489, reported by same reporter for the 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR108489:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: tiredness; headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were unknown.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not had side effects with the first shot. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had tiredness and headache. The reporter asked was it normal to have tiredness and headache after Shingrix booster shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills 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 was selected as adult as per vaccine indication. The patient received Shingrix and on day 3 presented with fever and chills.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; flare ups of shingles; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the patient experienced shingles after vaccination with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: lessen the resulting site pain; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site pain 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, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site 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 an adult as per the vaccine indication. The patient received Shingrix and had injection site pain. The reporter asked if apply ice right after shot could lessen the resulting site pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Chills, Eye pain, Injection site erythema
Clinical narrative: had to sleep because she couldn't move; she couldn't move; arm was aching; pain in her joints; erythema around her injection site; pain in her eye socket /  pain behind her eye ball; shaky; chills; intense muscle pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of pain (In past, the patient experienced mild achy feeling in her arm after receiving the vaccine).   On 19th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced tremor, chills and myalgia. On 19th June 2020, the patient experienced pain in arm, joint pain, injection site erythema and eye pain. On 20th June 2020, the patient experienced bedridden and mobility decreased. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: By 9:00 am, the patient received Shingrix in left arm. The patient experienced arm was aching and within 2 hours she had pain in her joints. The patient received Tylenol 200 mg. for pain and it barely touched. The patient experienced pain in her eye socket and erythema around her injection site.  On 20th June 2020, 1 day after vaccination the patient had to sleep because she could not move. Her side effects have all resolved today. The patient mentioned that she had had the Zostavax previously and other flu shots and she experienced a mild achy feeling in her arm, however, it was nothing similar to what she experienced with the Shingrix vaccine. The patient described her Shingrix side effects as the most intense muscle pain with shaky chills and pain behind her eye ball.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107111:same reporter US-GLAXOSMITHKLINE-US2020AMR107678:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Tremor
Clinical narrative: had to sleep because she couldn't move; she couldn't move; arm was aching; pain in her joints; erythema around her injection site; pain in her eye socket /  pain behind her eye ball; shaky; chills; intense muscle pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of pain (In past, the patient experienced mild achy feeling in her arm after receiving the vaccine).   On 19th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced tremor, chills and myalgia. On 19th June 2020, the patient experienced pain in arm, joint pain, injection site erythema and eye pain. On 20th June 2020, the patient experienced bedridden and mobility decreased. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: By 9:00 am, the patient received Shingrix in left arm. The patient experienced arm was aching and within 2 hours she had pain in her joints. The patient received Tylenol 200 mg. for pain and it barely touched. The patient experienced pain in her eye socket and erythema around her injection site.  On 20th June 2020, 1 day after vaccination the patient had to sleep because she could not move. Her side effects have all resolved today. The patient mentioned that she had had the Zostavax previously and other flu shots and she experienced a mild achy feeling in her arm, however, it was nothing similar to what she experienced with the Shingrix vaccine. The patient described her Shingrix side effects as the most intense muscle pain with shaky chills and pain behind her eye ball.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107111:same reporter US-GLAXOSMITHKLINE-US2020AMR107678:same reporter
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Insomnia, Peripheral swelling
Clinical narrative: Swollen arm, upset stomach, headache, fatigue, insomnia. Occurring after injection and lasting 1 day later, mostly resolved by 7/1/2020 (2nd day after). Recommended Tylenol to help mitigate symptoms when she receives second injection.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: HPI: Patient is a 58-year-old female is here today for evaluation of right shoulder pain.  She states that this pain started after having a shingles vaccination.  She denies any injury or trauma but continues note quite a bit of pain in the right shoulder.  She likes to exercise regularly to include lifting weights in the gym and states that she is unable to do so because of the pain.  She has not had any prior problems with the right shoulder.  There is been no bruising.  She has tried some treatments to include cupping.  Hx provided by: patient Right shoulder films: Films demonstrate very minimal degenerative changes at the AC joint Treatment of her shoulder to include cortisone 3/13/2020. If no relief will have MRI.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain, X-ray limb abnormal
Clinical narrative: HPI: Patient is a 58-year-old female is here today for evaluation of right shoulder pain.  She states that this pain started after having a shingles vaccination.  She denies any injury or trauma but continues note quite a bit of pain in the right shoulder.  She likes to exercise regularly to include lifting weights in the gym and states that she is unable to do so because of the pain.  She has not had any prior problems with the right shoulder.  There is been no bruising.  She has tried some treatments to include cupping.  Hx provided by: patient Right shoulder films: Films demonstrate very minimal degenerative changes at the AC joint Treatment of her shoulder to include cortisone 3/13/2020. If no relief will have MRI.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arrhythmia, Cardiac monitoring, Dyspnoea, Fatigue
Clinical narrative: PATIENT REPORTED TODAY  (7/1/2020) THAT HE STARTED HAVING ARRHYTHMIA AND DIFFICULTY BREATHING LATER IN THE EVENING AFTER THE VACCINE AROUND 7PM, AND HAD EXTREME FATIGUE THAT CONTINUED ON THE NEXT DAY AS WELL
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Menveo powder was mixed with sterile water diluent instead of provided diluent by healthcare worker in the facility.  No adverse reaction or response occurred while patient in the office.  We called GlaxoSmithKline and notified of error.  Representative that took information states that no adverse reaction should occur and replacement Menveo needs to be given.  This can be given at anytime and is not time sensitive based on dose given today.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Asthenia, Eye movement disorder, Pallor
Clinical narrative: Received call from the patient's mother who refers that on the afternoon of 06/24/2020 the boy had a bowel movement, was pale, and eyes turn back and also had some weakness. Was instructed to call the patient's pediatrician for evaluation or take to an emergency room. Mother states she has called the pediatrician with no luck. Patient's mother was oriented to take him to the hospital but she stated she doesn't want to go to the hospital because she is concerned of COVID19. We recommended to call the tele consult line to explain to them his symptoms after vaccination. She was once again reminded of possible side effects after vaccination and reiterate to have the child seen by a clinician to get his vital signs and his current health condition be evaluated. I let the mother know to get back to me after the child has been evaluated by the clinician. Next day on 06/26/2020 at 2:56pm I take time to call the patient's mother to check how the patient is doing since the mother did not call back to let us know about the clinical evaluation. The mother said she did not take the child to get evaluated because after the first incident it had not reoccurred nor anything else had happened. The child has been well, with lots of energy, playing as normal. She says she tried to communicate with Dr by phone without success. The mother was grateful I had follow up with her but that the child had being doing well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: mother called on 06/26/2020 at 10:37 am to advise the patient had been vomiting and had a fever of 103.0 at 4:00 am. Mother called back on 06/26/2020 at 2:35 pm and states that patient had held some water and a half of a sandwich down. Fever is now at 99.0 to 100.0 mother stated that she will continue to monitor and push fluids to the patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: On 6/30/20 patient developed an erythematous papular rash starting at 9am over left & right clavicle, shoulder area and chest. 15-20 lesions total. Began itching around 3pm on 6/30/20. Evaluated via telehealth. Advised to use calamine lotion and keep covered.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Lymph node pain, Lymphadenopathy, Magnetic resonance imaging abnormal, Soft tissue swelling, Ultrasound scan abnormal
Clinical narrative: swelling and tenderness lymph nodes supraclavicular and axillary right side.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema Hives, face, arms, legs, neck, trunk
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Angioedema Hives, face, arms, legs, neck, trunk
Age: 23.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Chest pain, Dizziness, Painful respiration
Clinical narrative: Patient reported  dizziness and chest pain following administration of vaccinations. Patient reported experiencing chest pain prior to administration of vaccines earlier in the day. Chest pain was midsternal, worse with inhalation. Patient did not experience syncope.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Epigastric discomfort, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Headache; Stomach irritation; Tiredness; Achy; preventing them from sleeping; being so uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 22nd June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd June 2020, 1 hr after receiving Shingrix, the patient experienced influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort. On an unknown date, the outcome of the influenza-like symptoms, headache, gastric irritation and tiredness were not recovered/not resolved and the outcome of the pain, difficulty sleeping and discomfort were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu-like symptoms and a headache. The caller stated that on the day of vaccination (less than a day after vaccination), the patient felt tired and achy going into the night and preventing them from sleeping due to being so uncomfortable.  The caller confirmed that all symptoms on day 2 after the injection are better but not fully gone.  No lot or expiry provided due to receiving at a pharmacy. The healthcare professional information was not obtained.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain
Clinical narrative: Flu-like symptoms; Headache; Stomach irritation; Tiredness; Achy; preventing them from sleeping; being so uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 22nd June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd June 2020, 1 hr after receiving Shingrix, the patient experienced influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort. On an unknown date, the outcome of the influenza-like symptoms, headache, gastric irritation and tiredness were not recovered/not resolved and the outcome of the pain, difficulty sleeping and discomfort were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu-like symptoms and a headache. The caller stated that on the day of vaccination (less than a day after vaccination), the patient felt tired and achy going into the night and preventing them from sleeping due to being so uncomfortable.  The caller confirmed that all symptoms on day 2 after the injection are better but not fully gone.  No lot or expiry provided due to receiving at a pharmacy. The healthcare professional information was not obtained.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Swelling; This is a spontaneous report from a contactable pharmacist.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced swelling. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Sex: M
Vaccine: FLUX
Symptoms: Adverse reaction, Feeling abnormal, Malaise
Clinical narrative: sickest he's ever been; felt he was "on his deathbed"/had bad reaction; Initial information received on 16-Jun-2020 and additional information recieved on 18-Jun-2020 respectively regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves a 73 years old male patient who was sickest ever been (malaise) and had bad reaction, felt he was "on his deathbed" (unevaluable event), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date in 1978, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1978, the patient was sickest ever been (malaise) and had bad reaction, felt he was "on his deathbed" (unevaluable event) (Unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events for multiple days in 1978.  Laboratory details were not reported.  Final diagnosis was malaise and unevaluable event.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported.  Information on batch number was requested.; Sender's Comments: A 73 year old male patient experienced malaise and unevaluable reaction (described as felt like being on deathbed) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Medical history, concomitant medication and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based on the reported information role of vaccine cannot be assessed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm, followed by fever, chills, nausea, body aches, lethargic for over 24 hours
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm, followed by fever, chills, nausea, body aches, lethargic for over 24 hours
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site mass, Injection site rash, Pain, Pruritus, Rash vesicular
Clinical narrative: about 2 weeks after the shot he developed a lump and small bumps around the injection site. sore and itchy. a few other chicken pox like bumps on his body appeared in the following 3 days. since traveling we didn't see the doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 18-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Malaise, Vomiting
Clinical narrative: diarrhea; vomiting; sweats; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingles vaccine. On 23rd June 2020, less than a day after receiving Shingles vaccine, the patient experienced diarrhea, vomiting and sweating. On an unknown date, the outcome of the diarrhea, vomiting and sweating were unknown.   It was unknown if the reporter considered the diarrhea, vomiting and sweating to be related to Shingles vaccine.  Additional case details were reported as follows: At 11am, the patient received shingles vaccination. The patient was very ill during the night with diarrhea, vomiting and sweats.  The patient did not recover until approximately noon today. The patient asked was it advisable not to get the 2nd shot in this case.
Sex: F
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The health care professional stated that patient had reported experiencing myalgia which persisted for about a week The reporter consent to follow up.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Syringe issue, Underdose
Clinical narrative: Imovax Rabies having a delay in dose due to the vaccine not going into the skin, no AE; leak occurred while injecting into the right deltoid; that a new needle was placed on the end of the syringe, no AE; Initial information received on 25-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse via other health care professional and additional information received on 29-Jun-2020 from quality department.  This case involves a 25 year old female patient having a delay in dose RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 24-Jun-2020, the patient received a 0.5 ml dose of suspect RABIES (HDC) VACCINE (lot P1E22M and expiry date: 30-Oct-2020; Injection, liquid solution) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of product administration.  It was also the case of needle issue.  It was reported that nurse reporting on behalf of a consumer on Imovax Rabies having a delay in dose due to the vaccine not going into the skin but the vaccine leaking from the luer lok connection. The nurse reported that the leak occurred while injecting into the right deltoid; and that the consumer was administered another Imovax Rabies dose that was successful.  Number: 100049631 Issue Status: In Process Sample Status: Requested and Awaited  Batch number: P1E522M Expiry date: 30-Oct-2020  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.