chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 20Dec2020 at 14:30 (at the age of 52 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included asthma from an unknown date.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included progesterone (PROGESTERONE), estriol (ESTRIOL), diazepam (VALIUM) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Dec2020 at 19:00, the patient experienced she began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included steroids and benadryl. The clinical outcome of began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Tremor
Clinical narrative: I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 20Dec2020 at 14:30 (at the age of 52 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included asthma from an unknown date.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included progesterone (PROGESTERONE), estriol (ESTRIOL), diazepam (VALIUM) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Dec2020 at 19:00, the patient experienced she began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included steroids and benadryl. The clinical outcome of began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: It started with itching hands and feet and then spread over my whole body. It all turned red. I had shaking.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Tremor
Clinical narrative: It started with itching hands and feet and then spread over my whole body. It all turned red. I had shaking.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia
Clinical narrative: tachycardia (HR 150s); hypertension (BP 180/110s); This is a spontaneous report from the contactable nurse.   A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 from Sep2020. Concomitant medications were not reported. On 17Dec2020, approximately 5 min after receiving the vaccine, the patient experienced tachycardia (HR 150s) and hypertension (BP 180/110s). Therapeutic measures were taken as a result of the events and included treatment with labetolol. Outcome of the events was unknown.   Information about lot/batch number are requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, tachycardia and hypertension, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Headache and injection site pain; Headache and injection site pain; This is a spontaneous report from a contactable consumer.  An approximately 40 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 (at the age of 40 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient's concomitant medications were not reported. On an unknown date, the patient experienced injection site pain and headache. The clinical outcome of injection site pain and headache was unknown.    No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little fatigue on first two days; This is spontaneous report from a contactable consumer.   A patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown route, on 15Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant drugs were unknown. The patient reported so far there are no side effects except little fatigue on first two days from 15Dec2020. The action taken in response to the events for BNT162B2 was not applicable. The outcome of the events was recovered on 17Dec2020  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling
Clinical narrative: left ankle is very swelling, redness, it's very painful; left ankle is very swelling, redness, it's very painful; left ankle is very swelling, redness, it's very painful; This is a spontaneous report from a contactable physician (patient).   A 66-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number unknown, intramuscularly from an unspecified date (at the age of 66-years old) as a single dose (reported as I think it was 0.5 ml they gave me some card, normally it is 0.5 ml I believe, I don't know) for covid-19 immunization.  Medical history included mild hypertension for which he was on blood pressure very low dose like 50 mg from an unknown date and unknown if ongoing.  The patient is very active, four days of gym. He is not obese, not a smoker and doesn't drink. Concomitant medication included losartan.  The physician reported he worked for the hospital so was exposed to COVID-19 patients. The hospital offered the COVID-19 vaccination and he got it on Friday like 1 O clock on unspecified date and since this morning like 3am (03:00) on unspecified date, his left ankle is very swelling, redness, it's very painful. He read about the side effect its says joint swelling. "I never had problem like gout or any degenerative joint disease". He was healthy.  He doesn't know if this is related with this. He was going to call the hospital. The physician further he never have swelling like this, he doesn't know what exactly happened. He cannot say 100 percent but nothing happened, he did not take any new medicine. He doesn't have any injury. He never had gout.  He never have any degenerative joint disease. "I cannot say 100 percent but there is a possibility."  For treatment the physician stated, "no, it happened 3 am in the night since morning I am doing hot, I have put heater in front of my feet." The patient did not have lab work performed.  He was thinking to go ask hospital to rule out any gout, any arthritic pain, "I am going for arthritic". Outcome of the events left ankle is very swelling, redness, it's very painful was unknown.   The lot number/batch for the vaccine, BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, was not provided and will be requested during follow up
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Headache; Last night was throwing up; Dizziness/light headed; nausea; just like overall unwell; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient reported that she received BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medications included bupropion for anxiety. Consumer stated she thought that she was having adverse side effects. Last night (18Dec2020), she was throwing up. She got COVID-19 vaccine yesterday (18Dec2020) around 5' O clock and last night around mid-night she was throwing up and had like dizziness, she was just getting a headache now (19Dec2020), she was light headed last night, just like overall unwell. Regarding treatment, she took like calcium carbonate (TUMS) (antacids) for like nausea and ibuprofen (ADVIL). Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: sore arm; lightheaded; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced sore arm and lightheaded on 19Dec2020.  The outcome of sore arm and lightheaded was recovered in Dec2020.    No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills; Experienced mild flu like symptoms; Fever; This is a spontaneous report from a non-contactable physician (patient).  A 31 year old female patient (physician) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on19Dec2020 as a single dose for COVID-19 vaccination. Medical History was reported as none. There were no concomitant medications. On Dec2020, the patient experienced chills, mild flu like symptoms and fever. In Dec2020, she was now fully recovered. The clinical outcome of chills, mild flu like symptoms and fever was recovered Dec2020  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feeling arm soreness; This is a spontaneous report from a non-contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced feeling arm soreness in Dec2020. No other symptoms were reported.  The outcome of feeling arm soreness was recovered in Dec2020.    No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Viral titre
Clinical narrative: Headache; This is a spontaneous report from a Pfizer Sponsored Program  A non-contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2 lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a slight headache the day after getting the vaccine. Patient had no arm soreness. Patient stated that this vaccine was the best bet at getting an excellent IgG titer level without actually getting sick with Covid. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: got flu like symptoms; broke out in hives; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved  patient of unknown demographics who didn't get the flu for 30 years, took a flu shot and got flu like symptoms (Influenza like symptoms), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) 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 expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, patient didn't get the flu for 30 years, took a flu shot and got flu like symptoms (Influenza like symptoms), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: Last one in 2016 vaccine did not go into the muscle.; Had pain in the arm for 6 mos; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Digital Media through social media on 26-Nov-2020   This case involves an unknown age patient who had pain in the arm for 6 mos (vaccination site pain) and vaccine did not go into the muscle  (incorrect route of product administration), while the patient was treated with  INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date in 2016, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via Intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2016 after starting the suspect vaccine therapy, the patient it was reported that patient vaccine did not go into the muscle. (incorrect route of product administration) had pain in the arm for 6 months(vaccination site pain).  On an unknown date in November-2020,the patient again had flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome of the event vaccination site pain was resolved on an unknown date and  incorrect route of product administration was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on batch number for this case .
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Felt just as bad as when patient had the flu; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who felt just as bad as when patient had the flu (feeling abnormal), while patient was treated with influenza vaccine.  Medical history included Influenza.  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient felt just as bad as when patient had the flu (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographics who was currently 65 years old, who had been sick (illness), while patient had received INFLUENZA VACCINE.  Medical history included being sick a few times.  Information about vaccination(s), medical treatment(s), family history and concomitant medication were unknown.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after being vaccinated with INFLUENZA VACCINE, patient was sick (illness). The patient also reported that all the previous sickness were less severe in comparison to the sickness post vaccination and that the patient did not receive flu shots since high school.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment. However, the patient had reported about strengthening the immune system by consuming Vitamins and herbs.   At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patent got flu from the shots or they didn't work; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographics who got flu (influenza), while patient received influenza vaccine.  Medical history, vaccination, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of the suspect vaccine, patent got flu (influenza).  It was reported that patient was 9 years in the worked, got nine flu shots, nine times the flu shortly after. Either he got flu from the shots or they didn't work.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise, Pain in extremity
Clinical narrative: patient felt quite sick with definite flu symptoms within 2 days; sore arm; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media.  This case was linked with 2020SA353023 and 2020SA353034 (same reporter).  This case involves a female patient with an unknown age who felt quite sick with definite flu symptoms within 2 days (illness) and sore arm (Myalgia), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient felt quite sick with definite flu symptoms within 2 days (illness) and sore arm (Myalgia) (latency unknown).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Pain in extremity
Clinical narrative: Had a sore arm; got broncitus for the first and only time in my life; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.   This case involves a patient with an unknown age who had a sore arm (myalgia) and got bronchitis for the first and only time in my life (bronchitis), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of the suspect vaccine, patient had a sore arm (myalgia) and got bronchitis for the first and only time in my life (bronchitis).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient not gotten one in 22 years. Got it every year and got sick from it. stopped getting it when retired and no flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: medical assistant gave it on 18Nov2020 without reading the chart with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00377633) and transmitted to Sanofi on 01-Dec-2020.  This case involved a 6 year old male patient for whom it was reported that medical assistant gave 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on 18-Nov-2020 without reading the chart with no adverse event (expired product administered) lot number not reported, indication: prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a actual medication error  due to expired product administered.  On an unknown date, Nurse practitioner stated that she ordered the 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE for the male child with initials as BS, but she was not there that day and another medical assistant gave 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE on 18-Nov-2020 at a dose of 0.5 mL once at a standard strength without reading the chart (Lot number C55532AA Expiration date: 09-Oct-2020 via an unknown route in an unknown administration site for prophylactic vaccination) (expired product administered).  It was also reported that he was overdue for his vaccines.    At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Rash
Clinical narrative: rash on his chest; metallic taste in mouth; light headness; shortness of breath; Initial information regarding an unsolicited valid non-serious case was received from a Consumer or non-health care professional (Patient) via Medical Information (Reference number- 00394250) on 15-Dec-2020.  This case involves a 67 years old male patient who experienced metallic taste in mouth (taste disorder), light headness (dizziness), shortness of breath (dyspnoea) and rash on his chest (rash), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 24-Sep-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 24-Sep-2020, the patient developed a non-serious metallic taste in mouth (taste disorder) 10 minutes following the administration of INFLUENZA VACCINE.  On 24-Sep-2020, the patient developed a non-serious light headness (dizziness) and shortness of breath (dyspnoea) several hours following the administration of INFLUENZA VACCINE.  It was reported that, patient went for a run later that evening and he felt better.  Before went to bed symptoms stopped.  On an unknown date, the patient developed a non-serious rash on his chest (rash) unknown latency following the administration of INFLUENZA VACCINE.  Patient was feeling fine. Rash lasted less than two days.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from events.  There will be no information available on the batch number for this case.
Age: 0.58
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse mistakenly gave a 7 month old FLUBLOK with no adverse event; Initial information regarding this unsolicited valid non-serious case received from other health professional transmitted to Sanofi on 16-Dec-2020.  This case was linked to case 2020SA362408 (3.5 year old patient).  This case involved a 7 month old patient who was mistakenly received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: a high and low temperature excursion for PNEUMOVAX23 syringes; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 02-DEC-2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot number T032003 with expiration date 08-MAY-2022; route was not reported) for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was above 47 degrees Fahrenheit (60 degrees Fahrenheit) for a time frame of 85 hours. There was no previous temperature excursion. The call was because of a data logger involved. No product quality complaint was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032003; expirationdate: 08-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; MA reports a dose of ROTATEQ was given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 6-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-NOV-2020, the patient was vaccinated with an imporperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1660954, expiration date 07-MAR-2021 for prophylaxis.  The vaccine had a temperature excursion of 48.4 Farhrenheit degrees (F) and 32.7F for 15 minutes and 47 hours respectively. There were no previous temperature excursions.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: reported having a "severe reaction"; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       In November 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) route of administration reported as "injection", for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported).         In November 2018, the patient experienced a severe reaction (vaccination complication). At the time of reporting, the outcome of the event was unknown.        The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: acute demyelinating neuropathy; Inflammatory neuritis; symmetrical paralysis; Guillain Barre syndrome; Pain in neck; Pain in shoulder; Pain in arm; Weakness in legs; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   The initial information was received on 10 December 2020 via medical records (case now medically confirmed). The patient had shingle vaccination on 17 August 2020. Admission date was 29 August 2020 and discharge date was 08 September 2020. Admission diagnoses was Weakness of both legs for proximal weakness involving bilateral thigh and shoulder muscles associated with back pain and sharp thigh pain. He developed the weakness over a period of two days; it started with thighs and then involved shoulder muscles. Back pain and thigh pain preceded the weakness by about one week. Electromyography showed electrophysiologic evidence of mild acute demyelinating neuropathy. magnetic resonance imaging of spine showed mild surface enhancement along anterior conus and cauda equina most suggestive of inflammatory neuritis. Given these findings and ascending symmetrical paralysis, Guillain-Barre Syndrome most likely diagnosis. The patient was treated with Intravenous Immunoglobulin IG for 5 days. His upper extremity strength gradually improved each day and was now near baseline. During hospitalization, his lower extremity strength initially worsened over several days, then stabilized and began to slowly improve.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness, Neuritis, Pain in extremity
Clinical narrative: acute demyelinating neuropathy; Inflammatory neuritis; symmetrical paralysis; Guillain Barre syndrome; Pain in neck; Pain in shoulder; Pain in arm; Weakness in legs; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   The initial information was received on 10 December 2020 via medical records (case now medically confirmed). The patient had shingle vaccination on 17 August 2020. Admission date was 29 August 2020 and discharge date was 08 September 2020. Admission diagnoses was Weakness of both legs for proximal weakness involving bilateral thigh and shoulder muscles associated with back pain and sharp thigh pain. He developed the weakness over a period of two days; it started with thighs and then involved shoulder muscles. Back pain and thigh pain preceded the weakness by about one week. Electromyography showed electrophysiologic evidence of mild acute demyelinating neuropathy. magnetic resonance imaging of spine showed mild surface enhancement along anterior conus and cauda equina most suggestive of inflammatory neuritis. Given these findings and ascending symmetrical paralysis, Guillain-Barre Syndrome most likely diagnosis. The patient was treated with Intravenous Immunoglobulin IG for 5 days. His upper extremity strength gradually improved each day and was now near baseline. During hospitalization, his lower extremity strength initially worsened over several days, then stabilized and began to slowly improve.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site abscess, Pain in extremity, Product preparation issue
Clinical narrative: 2nd dose of Shingrix by only administering the diluent portion / diluent was not mixed with the powder; 2nd dose of Shingrix by only administering the diluent portion / diluent was not mixed with the powder; redness at the site of injection; soreness of the arm; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number CL2S5, expiry date 5th November 2022) for prophylaxis.   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that the patient received today 2nd dose of Shingrix by only administering the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.   Follow up information received from pharmacist on 25th November 2020: The patient came in for a shingles vaccine. Upon administration, the diluent was not mixed with the powder and was subsequently injected. The patient was notified later that day when the error was found. Upon follow up with the patient experienced some redness at the site of injection and soreness of the arm without any other issues to report. She was otherwise doing well. The reporter considered the injection site erythema and pain in arm to be related to Shingrix.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: shoulder pain; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 47-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number G2RX7, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. In November 2020, an unknown time after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was physician's assistant. It was reported that the patient experienced shoulder pain 5 weeks after receiving FluLaval vaccine. The reporter did not consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Dizziness, Magnetic resonance imaging normal, Malaise, Pain
Clinical narrative: sudden hearing loss in her right ear /diagnosed with moderate to severe hearing loss in her right ear; tinnitus / diagnosed / with tinnitus; Dizzy / dizziness; she started to "not feel great," / suddenly felt ill / feeling ill; achy and a sore arm; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 23rd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th July 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell and pain in arm. On 27th July 2020, the patient experienced sudden hearing loss (serious criteria GSK medically significant), tinnitus and dizziness. The patient was treated with meclozine hydrochloride (Antivert (Meclozine Hydrochloride)). On 25th July 2020, the outcome of the feeling unwell and pain in arm were recovered/resolved. On 28th July 2020, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the sudden hearing loss and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the sudden hearing loss, feeling unwell, pain in arm, tinnitus and dizziness to be related to Shingrix.  Additional details were provided as follows: Consumer states that the patient received her 2nd dose of Shingrix on left arm. She states that on 24th July 2020 started to not feel great, achy and a sore arm and these resolved on 25th July 2020. On 27th July 2020 she suddenly felt ill, dizzy, tinnitus, and sudden hearing loss in her right ear.  The patient was taken to the emergency room via ambulance at that time.  She was given an Magnetic resonance imaging (MRI) that was normal, told to take antivert, and referred to an Eye Nose Throat (ENT).  Feeling ill and dizziness had resolved with these treatments.  She was later prescribed a series of ear drum injections and treated with high dose steroids.  Steroids was not coded in due to class of drug. The patient was given a COVID test, results were negative.  She states she continues to symptoms, diagnosed with moderate to severe hearing loss in her right ear with tinnitus.  The patient was going for a consultation for a hearing aid. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Sudden hearing loss, Tinnitus
Clinical narrative: sudden hearing loss in her right ear /diagnosed with moderate to severe hearing loss in her right ear; tinnitus / diagnosed / with tinnitus; Dizzy / dizziness; she started to "not feel great," / suddenly felt ill / feeling ill; achy and a sore arm; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 23rd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th July 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell and pain in arm. On 27th July 2020, the patient experienced sudden hearing loss (serious criteria GSK medically significant), tinnitus and dizziness. The patient was treated with meclozine hydrochloride (Antivert (Meclozine Hydrochloride)). On 25th July 2020, the outcome of the feeling unwell and pain in arm were recovered/resolved. On 28th July 2020, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the sudden hearing loss and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the sudden hearing loss, feeling unwell, pain in arm, tinnitus and dizziness to be related to Shingrix.  Additional details were provided as follows: Consumer states that the patient received her 2nd dose of Shingrix on left arm. She states that on 24th July 2020 started to not feel great, achy and a sore arm and these resolved on 25th July 2020. On 27th July 2020 she suddenly felt ill, dizzy, tinnitus, and sudden hearing loss in her right ear.  The patient was taken to the emergency room via ambulance at that time.  She was given an Magnetic resonance imaging (MRI) that was normal, told to take antivert, and referred to an Eye Nose Throat (ENT).  Feeling ill and dizziness had resolved with these treatments.  She was later prescribed a series of ear drum injections and treated with high dose steroids.  Steroids was not coded in due to class of drug. The patient was given a COVID test, results were negative.  She states she continues to symptoms, diagnosed with moderate to severe hearing loss in her right ear with tinnitus.  The patient was going for a consultation for a hearing aid. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received as dose of IPOl on 10th December that expired on 7th December 2020, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years old female patient who was administered expired 0.5 ml dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot number: P1F541M and expiry date:7-Dec-2020) via intramuscular route in left arm for prophylactic vaccination on 10th December 2020 (Expired product administered).  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for prophylactic vaccination.  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Lethargy
Clinical narrative: Tired since about 10:00 AM, lethargic, pain at injection site, muscle aches, brain fog, slight headache.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Tired since about 10:00 AM, lethargic, pain at injection site, muscle aches, brain fog, slight headache.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood glucose normal, Computerised tomogram head normal, Seizure, Tongue biting
Clinical narrative: Seizure witness by wife who is a physician. Bit tongue.  No history of seizure or other neurologic disease.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure witness by wife who is a physician. Bit tongue.  No history of seizure or other neurologic disease.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Had vaccine yesterday.  Last night had body ache and fever 98.  Today only had body ache.  But when she check the temperature it was the same as yesterday.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Soreness at site, tiredness, headache, sleepiness, soreness at hand joints, lymph nodes inflammation.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Soreness at site, tiredness, headache, sleepiness, soreness at hand joints, lymph nodes inflammation.