chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: is fever a side effect of this vaccine?; 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, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   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. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked if fever was a side effect of this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: could not lift up her injected arm fully; body aches; painful arm; painful arm, radiating to a pain in her back; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2020, 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, general body pain, pain in arm and back pain. On an unknown date, the outcome of the injected limb mobility decreased, general body pain, pain in arm and back pain were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, general body pain, pain in arm and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th September 2020, the patient received the 1st dose of Shingrix. The patient experienced painful arm, radiating to a pain in her back. She could not lift up her injected arm fully for 2 weeks. The patient also experienced body aches.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR219352, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219352:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick as a dog; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (gender unspecified) who got sick as a dog (illness), while received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick as a dog (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu twice; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves male patient (age unspecified) who got the flu twice (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu twice (influenza) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: made me sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient (age unspecified) who was sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00313615) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 4 years old female patient who was administered an expired dose of 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA, expiry date: 09-Oct-2020, Single dose vial) once via intramuscular route in the right arm for prophylactic vaccination on 13-Oct-2020 (expired product administered)  Medical history, 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) (given in separate arm) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was vaccinated with Fluzone Quadrivalent instead of Fluzone High Dose Quadrivalent/no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 year-old male patient who was vaccinated with 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] via intramuscular route in the left arm instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) on 28-Oct-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was also reported that patient had been admitted to the hospital prior to the vaccination.The pharmacist stated that the patient received the Fluzone Quadrivalent injection prior to the HCP recognizing that the patient could have gotten the Fluzone High Dose.   It was a case of overdose and also a actual medication error due to wrong vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Erythematous rash at injection site
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Chills, Eye pruritus, Headache, Injection site erythema
Clinical narrative: Redness, swelling and itching about 2 inches lower than injection site, itchy eyes, along with severe chills, stomach pain, muscle aches (entire body), headache
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pain
Clinical narrative: Redness, swelling and itching about 2 inches lower than injection site, itchy eyes, along with severe chills, stomach pain, muscle aches (entire body), headache
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Headache, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Technician warned possibility of flu like symptoms, take tylenol, rest, no strenuous activity.  By early evening same day started continuous headache and neckache and malaise, took tylenol, through 11/8/20.  On 11/6/20 also noticed very painful soft area above right collarbone, seems to be receding.  11/8/20 developed itchy, red, hot, rough type patch approx 4" x 5" around injection site.  Pharmacist advised draw a line around it, apply antibiotic Baci.... in case staphy infection, cortisone for anti itch.  By 11/20/20 redness & heat receding, occasional itch, did not expand.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Neck pain, Pain
Clinical narrative: Technician warned possibility of flu like symptoms, take tylenol, rest, no strenuous activity.  By early evening same day started continuous headache and neckache and malaise, took tylenol, through 11/8/20.  On 11/6/20 also noticed very painful soft area above right collarbone, seems to be receding.  11/8/20 developed itchy, red, hot, rough type patch approx 4" x 5" around injection site.  Pharmacist advised draw a line around it, apply antibiotic Baci.... in case staphy infection, cortisone for anti itch.  By 11/20/20 redness & heat receding, occasional itch, did not expand.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Patient reported persistent (weeks) pain at the injection site and difficulty moving her arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported administration of PROQUAD after product experienced temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's historical condition, concomitant drugs and allergy to drugs were not reported.   On 06-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) ( lot number was T015598, expiration dare was 02-NOV-2021, dose, strength were not reported) subcutaneously in the left vastus lateralis for prophylaxis (Product storage error). Other suspect therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(KINRIX) (lot number was PP9L5, expiration dare was 16-OCT-2021, dose, strength were not reported ).      Temperature excursion of this vaccine was 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 19 minutes without any previous temperature excursion. The digital data logger which was involved in recording excursion details (also reported no data logger was involved). The patient was fine.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: 4 lesions on chest and ear. They look like Chickenpox.; 4 lesions on chest and ear. They look like Chickenpox.; This case was reported by a consumer via interactive digital media and described the occurrence of skin lesion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced skin lesion and varicella-like rash. On an unknown date, the outcome of the skin lesion and varicella-like rash were unknown.   It was unknown if the reporter considered the skin lesion and varicella-like rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient developed 4 lesions on chest and ear. They look like chickenpox.  The patient wanted to know if he/she should get second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: felt ill / got sick; This case was reported by a consumer via call center representative and described the occurrence of illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 5th November 2020, unknown after receiving Shingrix, the patient experienced illness. On 5th November 2020, the outcome of the illness was recovered/resolved.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got sick after the first shot. The patient did not want to the 2nd dose. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who experienced flu (influenza), after receiving INFLUENZA VACCINE.  Past vaccinations included INFLUENZA VACCINE from which the patient got flu..  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Asthenia, Dizziness, Headache, Influenza
Clinical narrative: deathly sick/sick as a dog; major dizzy; almost fainted; complete flu; throwing up; weak; hurt all over bad; headache; allergic to that powerfull shot; felt off for a couple months; Initial information received on 01-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involves patient (reported that approximately 70 year) who experienced deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), while he/she received vaccine INFLUENZA VACCINE.  Medical history included Rhinorrhoea.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), within two to three hours following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Mood altered, Pain, Presyncope, Vomiting
Clinical narrative: deathly sick/sick as a dog; major dizzy; almost fainted; complete flu; throwing up; weak; hurt all over bad; headache; allergic to that powerfull shot; felt off for a couple months; Initial information received on 01-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involves patient (reported that approximately 70 year) who experienced deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), while he/she received vaccine INFLUENZA VACCINE.  Medical history included Rhinorrhoea.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), within two to three hours following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA277871, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA277871, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA277871, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA277871, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised. It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Patient developed a rash at the site of vaccination a few days after receiving the second dose of vaccine. Patient stated that the rash was improving. Advised the patient to monitor the rash, if it got worse or became painful at any point to seek medical attention. Patient understood, and replied that the rash was not bothersome, but wanted to make sure it was okay to have.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Disorientation, Hypoaesthesia, Paraesthesia, Pruritus, Skin warm
Clinical narrative: Pt reported numbness/ tingling in right arm, disorientation, after flu vaccine. Pt also reported itching on back and right leg and warmth and itching in face. HR increased to 120bpm @ approx 12:04pm. Pt did not experience any SOB/ wheezing or resp distress. Pt was administered 25mg diphenhydramine in clinic at approx 12:10pm. Pt laid supine on exam table for approx 10 mins. Hives on right forearm began to develop at 12:14pm and itching began to worsen on right arm, face itching increased as well during this time. EMS activated at 12;20pm. Hives developed on forehead at this time as well.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Pt reported numbness/ tingling in right arm, disorientation, after flu vaccine. Pt also reported itching on back and right leg and warmth and itching in face. HR increased to 120bpm @ approx 12:04pm. Pt did not experience any SOB/ wheezing or resp distress. Pt was administered 25mg diphenhydramine in clinic at approx 12:10pm. Pt laid supine on exam table for approx 10 mins. Hives on right forearm began to develop at 12:14pm and itching began to worsen on right arm, face itching increased as well during this time. EMS activated at 12;20pm. Hives developed on forehead at this time as well.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Dyspnoea
Clinical narrative: I had the flu shot at noon, we returned home and I ate a snack, then aright around the 2:00pm hour I started to have severe stomach pain, I was very short of breath, I started having chills, then sweats, then my hips hurt so bad I couldn?t get comfortable.  I took 3 advil for the pain, and about 4:00 I became with vomiting.  The chills continued, followed by sweating, then about 7:00pm I started having diarrhea and vomiting.  The pain in  my hips and chest eased about 8:30pm and I showered then went to bed, waking occasionally to drink water.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: I had the flu shot at noon, we returned home and I ate a snack, then aright around the 2:00pm hour I started to have severe stomach pain, I was very short of breath, I started having chills, then sweats, then my hips hurt so bad I couldn?t get comfortable.  I took 3 advil for the pain, and about 4:00 I became with vomiting.  The chills continued, followed by sweating, then about 7:00pm I started having diarrhea and vomiting.  The pain in  my hips and chest eased about 8:30pm and I showered then went to bed, waking occasionally to drink water.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Tinnitus
Clinical narrative: A half hour after the third series " I started getting dizzy and nauseous.  I got ringing in my ears, which I still have.  It is worse at night, but has gotten slightly better."
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: sore arm with mild swelling, feeling tired, muscle aches/pain, headache, shivering, insomnia related to sore arm and shivering
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore arm with mild swelling, feeling tired, muscle aches/pain, headache, shivering, insomnia related to sore arm and shivering
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, fatigue
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Mental impairment, Mobility decreased
Clinical narrative: after having first dose of shingrix vax. started feeling aching around 9:00 pm same night. Woke up with aches and was shivering and couldn't reach for phone or think straight. Got out of bed at 3-5am, took temp, and it was at 104 degrees. Got into a cool shower, took tylenol and went back to bed. Got up and felt exhausted, rested and by that evening, was feeling better on 08.29.20.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: after having first dose of shingrix vax. started feeling aching around 9:00 pm same night. Woke up with aches and was shivering and couldn't reach for phone or think straight. Got out of bed at 3-5am, took temp, and it was at 104 degrees. Got into a cool shower, took tylenol and went back to bed. Got up and felt exhausted, rested and by that evening, was feeling better on 08.29.20.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Mobility decreased, Myalgia
Clinical narrative: loss of power in arm, range of motion, aching pain in deltoid muscle.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Headache, Panic attack, Pyrexia
Clinical narrative: On 10/7/20 At 2:30 pm pt called & stated this was his first flu shot.  He started to have a headache & feel fatigued.  Discussed possible side effects, informed pt ot call 911 if s/s of anaphylaxis.  Informed to rest, take pain reliever. 10/8 F/U Call - pt stated he had a panic attack & breathing issues last evening.  Fever broke & no headache.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, tingling, weakness, dizziness , leg weakness
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Fatigue, Influenza like illness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Mild Flu-Like symptoms , Cough, Fatigue, Runny nose ,and Sore throat Self Supportive care  with OTC Medications cough medications and OTC throat spray, Symptoms lasted four days from onset of immunization
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: 12:30 PM Pt walked away from nurse & fell to floor- fainted.  Nurse heard a thump.  Pt came too " I just got dizzy & hit my head. " No lump was noted on her head.  Pt ate lunch & remained alert.   1:30 PM Pt playing bingo- back to class. 7:30 PM Follow up call & LM asking how she was.  No reply from parents.
Age: 52.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Full blood count normal, Lymphocyte count decreased, Neutrophil count increased, Peripheral swelling, Rash
Clinical narrative: The following day patient woke up with rash/swelling around the eyelids, maxilla face and some arms, hives present on right arm. Patient had the flu shot the previous day at the time of Shingrix, but has not had a reaction to previous flu shots. Also ate shrimp for dinner previous night, but never had a reaction to shellfish.  Patient took 1 dose of Benadryl prior to being evaluated for reaction.
Age: 52.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: The following day patient woke up with rash/swelling around the eyelids, maxilla face and some arms, hives present on right arm. Patient had the flu shot the previous day at the time of Shingrix, but has not had a reaction to previous flu shots. Also ate shrimp for dinner previous night, but never had a reaction to shellfish.  Patient took 1 dose of Benadryl prior to being evaluated for reaction.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Nerve compression, Neuritis, Sleep disorder
Clinical narrative: the day of the shot was hardly able to move my arm above my head, as the weeks continued it got worse, could lift and couldn't sleep on that arm., Saw my PCP on 10/2/20 and recommended physical therapy
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Nausea, Tremor, Vertigo
Clinical narrative: Per RN at the clinic --- Pt c/o nausea, dry mouth, legs shaky, vertigo.  BP 140/100.  Pt was taken home by fellow colleague to be with husband.  No improvement so he took her to ER.   after 4PM- Employee/Nurse went to see how she was & she had already gone home.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Patient called on 11/10 stating the site around the injection site was painful to touch, swollen, warm, and a rash was appearing on her arm and spreading around the injection site. The swelling was also spreading out from the injection site.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt became nauseated after vaccination & had small clear liquid emesis.  Parents replied " She's always like this." Nurse recommended that she get a flu shot from her MD next year.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Paraesthesia, Pruritus, Skin warm, Urticaria
Clinical narrative: Pt had 1st flu shot. C/o skin tingling & itchiness, red arm, warm to touch & minor hives.  Took benadryl. States has allergies to jalopeno, brocolli, & bees 10/21 F/U call - arm hot to touch 10/22 F/U call - welt started,  10/23 F/U call - not hot or swelling
Age: 21.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Cellulitis of left upper arm (redness, tenderness and warmth in area), low grade fever. Redness and swelling was located more where pneumococcal vaccine was given (left upper arm) as opposed to where the influenza vaccine was give (left lower arm); Clindamycin and Methylprednisolone prescribed in addition to icing are 4-6 times a day for 20 minutes at a time only, tylenol every 4 hrs as needed for discomfort/pain
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash and swelling at injection site.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope, Vomiting
Clinical narrative: Pre-syncope and non-intractable vomiting.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male 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 in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a sore arm after receiving the first dose of Shingrix vaccine This resolved within a couple of days. The reporter did not provide any additional information regarding the event. For tolerance after 2nd dose, refer case US2020AMR221923. This case has been linked with US2020221335, reported by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:2nd dose, same patient
Sex: U
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: got headache for a mont; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious social media case from a other health professional.  This case involves an unknown demographic patient who got headache for a month (headache), while the patient received INFLUENZA VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got headache for a month (headache) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient was given ActHIB injection with expired diluent / no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional on 08-Oct-2020.  This case involved a 2 years old female patient who was given injection HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent (Expired product administered),   The patient's medical history, medical treatment(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); HEPATITIS A VACCINE; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) all used for prophylactic vaccination.  On 07-Oct-2020, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) VACCINE (Powder Lot number- UJ079AA, expiration date 26-Oct-2020 and Diluent Lot number-U6402AA,Expiration Date :02-Oct-2020) (once single dose vial) via intramuscular route in the upper arm for prophylactic vaccination .  It was a case of actual medication error due to an Expired medical agent used. (latency- same time of vaccination)  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 7.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone high-dose was administered to a pediatric patient with no adverse event; Fluzone high-dose was administered to a pediatric patient with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involved a 7-years-old male patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot number- UJ450AB, expiration date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age) on 08-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   It was a case of an actual medication error case due to inappropriate age at vaccine administration and it was also a case of overdose (Latency: same day).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.