chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for vaccines; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 03-AUG-2020, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, route of administration and anatomical site of vaccination were not reported; lot number S038698, which has been verified to valid, expiration date reported and validated as 01-DEC-2021) as prophylaxis. The administered dose of vaccine experienced the temperature excursion of -10.2 degrees Celsius (multiple) for 1 hour and 53 minutes (product storage error), as recorded by data logger. No previous temperature excursion was reported. The outcome of product storage error is unknown.; Sender's Comments:  US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA01425: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA014950: US-009507513-2008USA014936: US-009507513-2009USA000112: US-009507513-2008USA014871:
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects for patient; administration of expired VAQTA; This spontaneous report has been received from a medical assistant, regarding to 73-year-old male patient. The patient's pertinent medical history included: hypertension, hyperlipidemia, hyperthyroidism, anemia, benign prostatic hyperplasia, hepatic steatosis, gout, melanoma, hepatic cyst, prostatic nodule and tortuous aorta. His drug reactions included lisinopril cough (capture in MARRS number: 2009USA002555). Concomitant therapies included atorvastatin, calcium (unspecified), fish oil, febuxostat, levothyroxine sodium, vitamins (unspecified), ascorbic acid and vitamin D (unspecified).  On 04-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection of 1 milliliter (mL), administered intramuscularly (IM) (vaccination scheme and anatomical location were not provided; lot number S021449 has been verified to be a valid lot number, expiration was on 23-AUG-2020), as prophylaxis. Additionally, no adverse effects were reported for the patient and the vaccine had no excursions. The patient did not sought medical attention.; Sender's Comments:  US-009507513-2009USA002555:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: warmth; local stiffness; nausea; temperature at that time was 98.6F; Headache; fatigue; they treated it as cellulitis in her arm; extreme soreness, swelling, redness and warmth from shoulder to elbow; swelling; rednes from shoulder to elbow; This spontaneous report was received from a Registered Nurse and refers to a 77 year old female patient of unknown age. Information about the patient's medical history, concurrent conditions or concomitant medications was not provided. The patient had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 in 2006.  On 24-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramusculary, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administatrion was not reported) for the prevention of pneumococcal disease.   On 25-AUG-2020, the patient complained of "extreme soreness, swelling, redness and warmth from shoulder to elbow". Then, on 26-AUG-2020, the "swelling and warmth had extended to her hand", reported "local stiffiless, but no tingling", "nausea, no vomitting", "felt like I was running a temperature" (caller reported temperature at that time was 98.6F). Nurse reported that the patient had called the pharmacy and the health care profressifonal stated that "they treated it as cellulitis in her arm"; The patient was prescribed "linezolid 600 mg BID for 10 days".  At the time of this report the "area remained red, mildly swollen, forearm to wrist" and that she was experiencing "headache and severe fatigue". However, the patient was recovering from pain, fatigue, headache, cellulitis, pyrexia, nausea, musculoskeletal stiffness and joint warmth.  The reporter did not provide teh causality between the events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, cellulitis was considered to be medically significant.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002460:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Joint warmth, Musculoskeletal stiffness, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: warmth; local stiffness; nausea; temperature at that time was 98.6F; Headache; fatigue; they treated it as cellulitis in her arm; extreme soreness, swelling, redness and warmth from shoulder to elbow; swelling; rednes from shoulder to elbow; This spontaneous report was received from a Registered Nurse and refers to a 77 year old female patient of unknown age. Information about the patient's medical history, concurrent conditions or concomitant medications was not provided. The patient had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 in 2006.  On 24-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramusculary, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administatrion was not reported) for the prevention of pneumococcal disease.   On 25-AUG-2020, the patient complained of "extreme soreness, swelling, redness and warmth from shoulder to elbow". Then, on 26-AUG-2020, the "swelling and warmth had extended to her hand", reported "local stiffiless, but no tingling", "nausea, no vomitting", "felt like I was running a temperature" (caller reported temperature at that time was 98.6F). Nurse reported that the patient had called the pharmacy and the health care profressifonal stated that "they treated it as cellulitis in her arm"; The patient was prescribed "linezolid 600 mg BID for 10 days".  At the time of this report the "area remained red, mildly swollen, forearm to wrist" and that she was experiencing "headache and severe fatigue". However, the patient was recovering from pain, fatigue, headache, cellulitis, pyrexia, nausea, musculoskeletal stiffness and joint warmth.  The reporter did not provide teh causality between the events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, cellulitis was considered to be medically significant.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002460:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: warmth; local stiffness; nausea; temperature at that time was 98.6F; Headache; fatigue; they treated it as cellulitis in her arm; extreme soreness, swelling, redness and warmth from shoulder to elbow; swelling; rednes from shoulder to elbow; This spontaneous report was received from a Registered Nurse and refers to a 77 year old female patient of unknown age. Information about the patient's medical history, concurrent conditions or concomitant medications was not provided. The patient had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 in 2006.  On 24-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramusculary, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administatrion was not reported) for the prevention of pneumococcal disease.   On 25-AUG-2020, the patient complained of "extreme soreness, swelling, redness and warmth from shoulder to elbow". Then, on 26-AUG-2020, the "swelling and warmth had extended to her hand", reported "local stiffiless, but no tingling", "nausea, no vomitting", "felt like I was running a temperature" (caller reported temperature at that time was 98.6F). Nurse reported that the patient had called the pharmacy and the health care profressifonal stated that "they treated it as cellulitis in her arm"; The patient was prescribed "linezolid 600 mg BID for 10 days".  At the time of this report the "area remained red, mildly swollen, forearm to wrist" and that she was experiencing "headache and severe fatigue". However, the patient was recovering from pain, fatigue, headache, cellulitis, pyrexia, nausea, musculoskeletal stiffness and joint warmth.  The reporter did not provide teh causality between the events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, cellulitis was considered to be medically significant.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002460:
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Pain, X-ray limb
Clinical narrative: the patient thought the needle was still in his arm; the patient thought the needle was still in his arm; a hard mass at the injection site; pain from the neck down; This spontaneous report was received from a registered pharmacist and refers to a 58-year-old male patient. The patient's pertinent medical history included hypertension, high cholesterol and hydrocephalus. The patient had no drug reactions or allergies. His concomitant medications included cyanocobalamin, acetazolamide, anastrozole, hydrochlorothiazide (+) lisinopril and rosuvastatin.  On 22-MAR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one time dose, intramuscularly, lot # R031961, expiration date 09-JUN-2020, for prophylaxis.   On 22-MAR-2019, the patient experienced pain from the neck down and a hard mass at the injection site. The patient though the needle was still in his arm. Therefore, on an unknown date, he saw his health care professional. He was exanimated and got an x-ray (results not provided). At the reporting time, the patient did not recover from the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  The pharmacist reported that the events caused significant disability or incapacity. It was unknown whether the patient was hospitalized due to the events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R031961; expirationdate: 09-JUN-2020; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Custumer reporting AE administration of improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 03-SEP-2020, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 1 injection (route of administration was not provided) lot # reported as T012422 expiration date 19-SEP-2022, for prophylaxis.   The improperly stored dose experienced temperature excursion of 14.4 Fahrenheit (F) degrees for 30 min. There was no previous temperature excursions. The call was because a digital data logger. No additional adverse event was reported.; Sender's Comments:  US-009507513-2009USA002498:
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Lymph node pain, Pain in extremity, Skin burning sensation, Skin irritation
Clinical narrative: Armpit redness; Armpit burning irritation; Armpit burning irritation; Arm was sore; Tenderness in lymph gland; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received Shingrix. On 31st August 2020, less than a day after receiving Shingrix, the patient experienced lymph node tenderness. On 1st September 2020, the patient experienced localized erythema, skin irritation and burning sensation skin. In September 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the lymph node tenderness, localized erythema, skin irritation and burning sensation skin were unknown.   It was unknown if the reporter considered the pain in arm, lymph node tenderness, localized erythema, skin irritation and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and arm was sore. No redness at injection site. The patient started to feel tenderness in lymph gland under left arm, redness and burning irritation in left armpit.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administrated an expired dose of Menactra, No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves an 11-years-old male patient who was vaccinated with a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6208AB and expiration date 08-Jul-2020) via an intramuscular route in the right arm for prophylactic vaccination on 05-Aug-2020.  The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient concomitantly vaccinated with a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient missed her second dose of IMOVAX RABIES, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 46-years-old female patient who received first dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date not reported) via an unknown route and administration site on 04-Aug-2020 she missed her second dose in the series for post exposure immunization and received it on 11-Aug-2020 dose: 1 mL (batch number: R1C711M, expiry date: 30-Apr-2021) via an intramuscular route in the left deltoid for post exposure immunization.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. No concomitant medication were given.   It was an actual medication error due to missed dose.  At the time of reporting, no adverse event were 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 the batch number for this case.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a 0.05 ml invalid dose of Adacel, No AE; Adacel were administered to patient after being exposed to 30 Farenhiet, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health professional.  The case is linked to the cases 2020SA209621 and 2020SA210303 (same reporter).  This case involves a 30 years old male patient who received the 0.05 ml invalid dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiration date not reported), after being exposed to 30 Fahrenheit via unknown route in the left deltoid as prophylactic vaccination on 09-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient received 0.05 mL dose of FLUZONE Quadrivalent, No AE; patient administered with a dose of Fluzone QIV that was exposed to 30 Fahrenheit, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 22 years old female patient who received a 0.05 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in the right deltoid for prophylactic vaccination on 09-Aug-2020 which was exposed to 30 Fahrenheit.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product storage error temperature too low and it was a case of vaccine underdose.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a 0.05 ml invalid Adacel and Fluzone Quadrivalent, no AE; Adacel and Fluzone Quadrivalent were administered after being exposed to 30 Farenheit, no AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from other health care professional.  The case is linked to the cases 2020SA209550 and 2020SA210303 (same reporter).  This case involves a 62 years old female patient who received 0.05 ml invalid dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiration date were not reported for both the vaccines), after being exposed to 30 Fahrenheit via unknown route in the right deltoid (however was not specified that which vaccine was given at this site) as prophylactic vaccination on 08-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 year old patient given a dose of Adacel, no AE; 4 year old patient given a dose of Adacel and not the ordered Pentacel, no AE; Initial information was received on 25-Aug-2020 and additional information on 26-Aug-2020 regarding an unsolicited valid non-serious case from the physician via phone.  This case involves a four years old female patient who was vaccinated DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Wrong product administered and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) for prophylactic vaccination on 22-Aug-2020.  On 22-Aug-2020, the patient received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6612AA, expiry date not reported) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.   Laboratory data: not applicable. As corrective measurement: physician planning to administer the Pentacel to the patient in 14 days. Outcome: not applicable.  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
Symptoms: Dyskinesia, Eye movement disorder, Neurological symptom, Tic
Clinical narrative: neurological reactions with jerking of his head; eyes rolling back; weird ticking habit; shrugging movements and opening mouth; Initial information was received on 31-Aug-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves a 5-year-old male patient who had neurological reactions with jerking of his head (dyskinesia), eyes rolling back (eye movement disorder), weird ticking habit (tic), shrugging movements and opening mouth (movement disorder) while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient had not received any concomitant vaccination that day.  On an unknown date in Dec-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6695LA, expiry date 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a neurological reactions with jerking of his head (dyskinesia), eyes were rolling back (eye movement disorder) and had a weird ticking habit (tic) within a few days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Dyskinesia was assessed as medically significant and rest events were assessed as non-serious.  On an unknown date, the patient had more shrugging movements and opening mouth (movement disorder) (unknown latency) (non-serious event) following the administration of INFLUENZA QUADRIVAL A-B VACCINE The patient was seen by a pediatrician as his mother thought he had an allergic reaction. He did not have any reactions like rash.  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 dyskinesia, eye movement disorder and movement disorder was unknown while the patient was recovering from tic by the end of Apr-2020.; Sender's Comments: This case concerns a 5 year old male patient who had dyskinesia, eye movement disorder and movement disorder within few days after vaccination with INFLUENZA INFLUENZA QUADRIVAL A-B VACCINE. He had tic (unknown latency) after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. The time to onset is compatible for events dyskinesia, eye movement disorder and movement disorder. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweating, chills, headache, tired
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash, Rash erythematous, Urticaria
Clinical narrative: Mother reported and showed pictures of diffuse intense, erythematous, urticarial  rash over baby's body. The rash started at the injection site about 1 day after the vaccination then spread to cover her body (sparing the face) over the next 2-3 days. Mom provided supportive care and did not seek medical consultation as the baby did not appear uncomfortable.  She presented for routine follow up at a clinic separate from the vaccinating clinic and asked for advice on future vaccines.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Facial rash
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster, Pruritus, Rash, Rash pruritic, Skin discolouration
Clinical narrative: Awoke morning of 9 Sep with intense itching.  The same occurred on the 10th.  Awoke at 0100 on 11Sep to find that the back of my thighs have broken out in hives (no hives in previous 67 years) and a very dark rash w/itch at my waistline.  It appears that I have a mild case of shingles.  No new foods or activity that could be the cause.  In addition to the medications taken at the time of the injection, that same day I started taking amlodipine, Flowmax, and sulfamethoxazole.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Awoke morning of 9 Sep with intense itching.  The same occurred on the 10th.  Awoke at 0100 on 11Sep to find that the back of my thighs have broken out in hives (no hives in previous 67 years) and a very dark rash w/itch at my waistline.  It appears that I have a mild case of shingles.  No new foods or activity that could be the cause.  In addition to the medications taken at the time of the injection, that same day I started taking amlodipine, Flowmax, and sulfamethoxazole.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Injection site: very sore, swollen, big red circular rash. Symptoms even after 43 hours post injection. Muscular aches over whole body -shoulders, legs, arms, fingers, brushing hair. A little better after 43 hours. Headache - symptoms still after 43 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Injection site: very sore, swollen, big red circular rash. Symptoms even after 43 hours post injection. Muscular aches over whole body -shoulders, legs, arms, fingers, brushing hair. A little better after 43 hours. Headache - symptoms still after 43 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: soreness around injection site; redness around injection site; Skin being hot around the injection site; feeling weird; tired; feet and lower legs feeling cold; headache; dizziness; lips tingling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2020, couple of hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips. On 31st August 2020, the outcome of the weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm.  After receiving Shingrix, the patient felt weird, tired, feet and lower legs were cold, headache, dizziness and tingling in lips.  The patient also experienced soreness around the injection site, redness around the injection site that looked like a circle and skin had been hot around the injection site. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Paraesthesia oral, Peripheral coldness
Clinical narrative: soreness around injection site; redness around injection site; Skin being hot around the injection site; feeling weird; tired; feet and lower legs feeling cold; headache; dizziness; lips tingling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2020, couple of hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips. On 31st August 2020, the outcome of the weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, weird feeling, tiredness, coldness of lower extremities, headache, dizziness and tingling lips to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm.  After receiving Shingrix, the patient felt weird, tired, feet and lower legs were cold, headache, dizziness and tingling in lips.  The patient also experienced soreness around the injection site, redness around the injection site that looked like a circle and skin had been hot around the injection site. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: induration at injection site; dizziness; episode of "all over" itching; redness at site of injection; swelling at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On 1st September 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced injection site induration, dizziness and generalized pruritus. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site induration, dizziness and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, dizziness and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and swelling at site of injection. The HCP also reported that the patient experienced induration at injection site, dizziness and an episode of all over itching.  None of the effects lasted for very long. The reporter consented to follow up and no batch number and expiration date was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: fever; muscle ache; headache; felt awful for 4-5 days; This case was reported by a physician via call center representative 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, muscle pain, headache and feels awful. On an unknown date, the outcome of the fever, muscle pain and headache were unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain, headache and feels awful 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 an adult per the vaccine indication. The patient felt awful for 4 to 5 days with fever, muscle ache, headache. No further details were provided.  The reporter consent to follow up. This case has been linked with case US2020178097, US2020AMR178687 and US2020178096 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020AMR178687:Original Case : US2020178099 (same reporter)
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: gastrointestinal (GI) distress; patient presented with fever of almost 102; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from non-health care professional (Pharmacy-other).  This case involves female patient of unknown age who experienced GI (gastrointestinal) distress (abdominal discomfort) and presented with fever of almost 102 (pyrexia), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 02-Sep-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA VACCINE (lot number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious GI (gastrointestinal) distress (abdominal discomfort) and presented with fever of almost 102 (pyrexia) on an unknown latency following the administration of INFLUENZA VACCINE. Patient had reported to hospital following receiving vaccination yesterday.  No other relevant laboratory test results reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  There will be no information available on the batch number.; Sender's Comments: This case involves female patient (unknown age) who experienced serious abdominal discomfort and pyrexia on an unknown exact latency (approximately one-two days) following vaccination with INFLUENZA QUADRIVAL A-B HIGH DOSE VACCINE. The time to onset was compatible. However, detailed additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data were not reported. Based upon the reported information, the role of the vaccine cannot be assessed. Missing data needed for further assessment of the case.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error, Underdose
Clinical narrative: patient received a 0.05 ml invalid dose of Adacel ,No AE; Adacel was administered after being exposed to 30 Farenheit, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  The case is linked to the cases 2020SA209621 and 2020SA210303 (same reporter).  This case involves a 33 years old female patient who received a 0.05 mL invalid dose of  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiration date were not reported), after being exposed to 30 Fahrenheit via unknown route in the right deltoid as prophylactic vaccination on 09-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 24 year female patient administered expired dose of Adacel, no AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional .  This case involves a 24 year old female patient who received 0.5 ml first expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6021AA and expiry date: 27-Jul-2020) via intramuscular route in the right deltoid on 31-Aug-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of actual medication error 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: 59.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Nausea, Skin warm, Vomiting
Clinical narrative: The vaccination was given at noon on 9/9/2020. At 4:30 PM that evening, I noticed a slight nausea and weakness. I ate normally, and by bedtime at 8 PM my skin was very hot, and this continued for at least 24 hours. By 6 AM the next morning, I felt too weak to lift more than a glass of water, but my temperature (taken orally) was normal.   During the course of the day 9/10/2020, I did not eat or drink, laid in bad all day, but vomited twice. Today (9/11/2020) I feel 50%, and have started to eat and drink.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: fever 100, body aches, muscle pains, fatigue
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Blood pressure increased, Chills, Feeling cold, Feeling hot, Heart rate increased
Clinical narrative: Awoke feeling cold, shivering uncontrollably.  Low grade fever (99.7) despite taking 2 ibuprofen 2 hours earlier at bedtime due to arm soreness.  Chills and shaking continued for 30 minutes until falling back asleep.  Awoke 2 hours later feeling warm, 101.4 fever.  Blood pressure (138/84) and heart rate (106) elevated.  Similar experience to fall 1976 reaction to the Swine Flu Vaccine administered .
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Awoke feeling cold, shivering uncontrollably.  Low grade fever (99.7) despite taking 2 ibuprofen 2 hours earlier at bedtime due to arm soreness.  Chills and shaking continued for 30 minutes until falling back asleep.  Awoke 2 hours later feeling warm, 101.4 fever.  Blood pressure (138/84) and heart rate (106) elevated.  Similar experience to fall 1976 reaction to the Swine Flu Vaccine administered .
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Large hive, like a welt, developed at the site of the flu shot.  He woke up with it, so it happened over night.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: PTS MOTHER CALLED ON 9/8/2020 STATING THAT PT WAS COMPLAINING OF A STIFF NECK AND THAT HE WOULD NOT TURN HIS HEAD TO THE LEFT.  TREATMENT RECOMMENDED WAS OTC TYLENOL OR MOTRIN AS NEEDED, GENTLE STRETCHING EXERCISE, AND OTC BENGAY TYPE OF CREAMS
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Myalgia
Clinical narrative: Bruising at site of injection; headache; overall muscle pain
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: PTS MOTHER CALLED ON 9/8/2020 STATING THAT PT WAS COMPLAINING OF A STIFF NECK AND THAT HE WOULD NOT TURN HIS HEAD TO THE LEFT.  TREATMENT RECOMMENDED WAS OTC TYLENOL OR MOTRIN AS NEEDED, GENTLE STRETCHING EXERCISE, AND OTC BENGAY TYPE OF CREAMS
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red itchy hives on arms bilaterally reported by patient's daughter.  Denied  SOB, for difficulty breathing, Angioedema.    Patient ordered to take claritin 10mg and daugher stated she applied benadryl cream to arms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Myalgia
Clinical narrative: Sore arm, muscle pain, headache, shivering, tiredness, fast heart beat.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm, muscle pain, headache, shivering, tiredness, fast heart beat.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Cluster of vesicles near injection site
Age: 66.0
Sex: M
Vaccine: FLUA4, FLUA3
Symptoms: Chills, Lethargy, Muscular weakness, Myalgia, Pain
Clinical narrative: Day 1 - muscle soreness within 2 to 3 hours after injection; pain became bad enough at night to impact my sleep Day 2 - significant muscle soreness and weakness remains, plus having chills, lethargy Day 3 - chills and lethargy gone, but significant muscle soreness and weakness remain Day 4 - significant muscle soreness and weakness remain - I've never had this continue for so long after a flu shot. Is this considered adverse? How much longer should this pain and weakness continue? Even typing  or driving a car hurts like crazy.