chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: was given Fluzone High Dose at the age of 64 years ago on 26Sep2019 with no AE; was given Fluzone High Dose at the age of 64 years ago on 26Sep2019 with no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 64 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that was given Fluzone High Dose at the age of 64 years ago on 26-Sep-2019 with no AE (product administered to patient of inappropriate age) and (overdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA and expiry date: 06-May-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Influenza like illness, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Similar to the first shot, 12 hours after vaccine body aches and fever began.  This second time was actually worse than the first.  Like the first time, I have had to miss a day of work because of the intense flu-like symptoms.  This time, I had bit of rapid heartbeat as well, not sure if that was related to the fever, but I definitely noticed it.  I am still not 100% as of today, but can feel myself getting back to normal.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: PT RECEIVED VACCINE IN STORE 10/19. (THURSDAY). STARTING THE NEXT DAY THE PT STARTED TO EXPERIENCE TINGLING/NUMBNESS DOWN LEFT ARM. HER LAST 2 FINGERS WERE FEELING NUMB, PINKY AND RING FINGER.  PT CALLED PHARMACY AND SPOKE TO STAFF PHARMACIST. SHE WAS GIVEN ADVICE TO TAKE IBUPROFEN AND AND ICE THE AREA OF THE INJECTION. ALSO ADVISED THAT THIS SENSATION COULD LAST UP TO 7-10 DAYS.  I WAS INFORMED OFF THE CALL MY FOLLOWING SHIFT ATTEMPTED TO CALL THE PT ON 10/30 WITH NO CONTACT/ANSWER.  PT CALLED BACK 11/2, STILL HAVING TINGLING IN THE TWO FINGERS OFF HER LEFT ARM.  I ADVISED TO CONTINUE WITH IBUPROFEN FOR COMFORT, IF SYMPTOMS DID NOT IMPROVE THEN SHE SHOULD FOLLOW UP WITH HER PCP.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Fatigue, Headache, Pyrexia
Clinical narrative: Increased anxiety, headache, low-grade fever, fatigue
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Was administered a dose of VARIVAX by intramuscular injection instead of subcutaneous; No adverse effects reported; This spontaneous report was received from a pharmacy student and refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003448, 1 dosage form, by intramuscular injection instead of subcutaneous injection, for prophylaxis. No adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose of PEDVAX; This spontaneous report was received from a medical assistant referring to an 8 weeks old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 03-OCT-2019, the patient received an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177, expiration date was 08-OCT-2021) (exact dose and route of administration were not reported) for prophylaxis(product storage error). The administered dose was stored under the temperature of 46.5 degree Fahrenheit for 5 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006584: US-009507513-1910USA006414: US-009507513-1910USA006576:
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etlects reported; patient received an improperly stored dose of PED VAX; This spontaneous report was received from a medical assistant referring to a 5 months old female patient. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.       On 03-OCT-2019, the patient was vaccinated with improperly stored dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177, expiration date 08-OCT-2021, route of administration was not provided) for prophylaxis. Administered doses of vaccine experienced temperature excursion of 46.5 degrees Fahrenheit (F) for 5 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1910USA006584: US-009507513-1910USA006415: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006268:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.      On 10-OCT-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012246 and expiration date 10-FEB-2019) (strength, dose and route of administration were not provided) as prophylaxis (product storage error). The vaccine was exposed to temperature of 68 degrees Fahrenheit for 8 hours. Previous  temperature excursion was reported as 57 degrees Fahrenheit for 2 hours. The data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: the plunger of the pre-filled syringe broke and cut the nurse's finger; the plunger of the pre-filled syringe broke and cut the nurse's finger; This spontaneous report was received from a medical assistant regarding an unidentified nurse of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 10-OCT-2019, the nurse at the pediatric center administered Hepatitis A Vaccine, Inactivated (VAQTA), lot# S021092 with expiry date of 18-MAY-2020 and the plunger of the prefilled syringe broke and cut the nurse's finger (Wound, Accidental exposure to product, Occupational exposure to product and Exposure via skin contact). It was reported that the plunger rod was pulled back fully, then the barrel broke while administering the vaccine and the defect was noted while administering the vaccine (Product quality issue). The broken Hepatitis A Vaccine, Inactivated (VAQTA) syringe could not be retrieved from the pediatric centre because it was discarded. Outcome and causality of the events were not reported.  This is a non-valid report due to lack of patient identifiers.  Follow-up information has been received from the office administrator on 21-OCT-2019. According with the reporter, the body of the syringe did not break, it was only the finger flange where the nurse placed her thumb what broke. Besides, it was stated that the patient did not miss the dose of the medication, because the nurse used a different syringe for the administration of the medication, the broken syringe was not used on the patient.  As there were no contact between the medication and the nurse the events accidental exposure to product, occupational exposure to product and exposure via skin contact were deleted.  This case was previously considered non-valid but per current process it was determined to be valid as the patient is a female
Age: 47.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Measles antibody positive, Mumps antibody test negative, Pyrexia, Rash, Rubella antibody positive
Clinical narrative: has Fever/Rash on 10/16/2019; has Fever/Rash on 10/16/2019 / full body rash; Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low( less than 13.5); had developed chicken pox after receiving the MMR II vaccine; This spontaneous report was received from an office manager referring to a 47 years old male patient. The patient's medical history included insomnia and negative for Immunocompromised condition. The patient's historical drug included neomycin, gelatin and gelatin containing products. The patient's historical vaccine included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R). The patient had no allergies/no previous reaction to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), neomycin, gelatin or gelatin containing products. The patient had not immune suppressed. The patient not received an antibody-containing blood product in previous 11 months and had no history of thrombocytopenia or thrombocytopenic purpura. Concomitant therapies included lorazepam (ATIVAN).   On 03-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (single dose, 0.5 milliliter formula) subcutaneously in the left arm for prophylaxis (reported as titers were done and measles antibodies IgG came back low).  Reconstitute with sterile diluent (lot# S016863; expiration date: 02-APR-2022; dose, strength unknown). All the suspects were stored in correct temperature storage range.   On an unknown date in October 2019, the patient developed chickenpox after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  On 16-OCT-2019, the patient experienced fever and rash.  On 17-OCT-2019, the patient experienced full body rash. Antibody test showed Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low (less than 13.5). The patient went to the emergency room for medical attention and treatment was provided for the adverse event. The outcome of all the events was reported as recovering. Causality assessment was not provided.
Age: 47.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Varicella
Clinical narrative: has Fever/Rash on 10/16/2019; has Fever/Rash on 10/16/2019 / full body rash; Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low( less than 13.5); had developed chicken pox after receiving the MMR II vaccine; This spontaneous report was received from an office manager referring to a 47 years old male patient. The patient's medical history included insomnia and negative for Immunocompromised condition. The patient's historical drug included neomycin, gelatin and gelatin containing products. The patient's historical vaccine included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R). The patient had no allergies/no previous reaction to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), neomycin, gelatin or gelatin containing products. The patient had not immune suppressed. The patient not received an antibody-containing blood product in previous 11 months and had no history of thrombocytopenia or thrombocytopenic purpura. Concomitant therapies included lorazepam (ATIVAN).   On 03-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (single dose, 0.5 milliliter formula) subcutaneously in the left arm for prophylaxis (reported as titers were done and measles antibodies IgG came back low).  Reconstitute with sterile diluent (lot# S016863; expiration date: 02-APR-2022; dose, strength unknown). All the suspects were stored in correct temperature storage range.   On an unknown date in October 2019, the patient developed chickenpox after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  On 16-OCT-2019, the patient experienced fever and rash.  On 17-OCT-2019, the patient experienced full body rash. Antibody test showed Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low (less than 13.5). The patient went to the emergency room for medical attention and treatment was provided for the adverse event. The outcome of all the events was reported as recovering. Causality assessment was not provided.
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; a 2 month old child was vaccinated with Proquad; Information has been received from a medical assistant concerning a 2-month-old patient (gender not provided). The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.  On 25-OCT-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), lot # S005879, expiration date on 25-AUG-2010 (dosage, route and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration).  No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: The patient received improperly stored vaccine; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.  On 30-SEP-2019, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot number S007770; expiration date 24-JUL-2020; 1 dose; route unknown) for prophylaxis (Product storage error).   Temperature was 1.4 Celsius. Time frame was 20 minutes. Previous temperature excursion was 10.5 Celsius for 56 minutes. The call was because of a data logger.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 30-SEP-2019, the patient received 1 dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004251 and expiration date 22-SEP-2020; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The vaccine underwent temperature of 1.4 Celsius for a duration of 20 minutes. The previous temperature excursion of 10.5 Celsius for a duration of 56 minutes. The call was because of data logger.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site pain, Mobility decreased, Product use in unapproved indication, Pyrexia
Clinical narrative: unable to move his limb; warmth; The patient experienced injection site pain, unable to move his limb, fever, warmth after getting the PNEUMOVAX 23; fever; Indication: For Pneumonia; Information has been received from a 51 years old male consumer, referring to himself. The patient's pertinent historical conditions included bronchitis, pneumonia and chronic sinus infection. Concomitant medication included rosuvastatin. The patient was allergic to levofloxacin (LEVAQUIN).  On 19-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (one shot, strength, dose detail, lot# and expiration date were unknown) through left biceps for pneumonia (product use in unapproved indication).  On the same date after vaccination, the patient experienced injection site pain, unable to move his limb, fever and warmth. Blood work was performed without results provided. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: unable to move his limb; warmth; The patient experienced injection site pain, unable to move his limb, fever, warmth after getting the PNEUMOVAX 23; fever; Indication: For Pneumonia; Information has been received from a 51 years old male consumer, referring to himself. The patient's pertinent historical conditions included bronchitis, pneumonia and chronic sinus infection. Concomitant medication included rosuvastatin. The patient was allergic to levofloxacin (LEVAQUIN).  On 19-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (one shot, strength, dose detail, lot# and expiration date were unknown) through left biceps for pneumonia (product use in unapproved indication).  On the same date after vaccination, the patient experienced injection site pain, unable to move his limb, fever and warmth. Blood work was performed without results provided. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported for the patient; one dose of an improperly stored vaccine vaccine, PEDV AXHJB, was administered to one patient; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.      On 06-SEP-2019, the patient was vaccinated with one dose of an improperly stored (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route of administration were not reported; lot number R021075 has been verified to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); expiration date 10-JUN-2021) as prophylaxis. No adverse effects reported for the patient.        The vaccine experienced the following temperature excursion: 54 degrees Fahrenheit (°F) for 3 hours and 30 minutes. Reportedly, there had been previous temperature excursions of 56 °F for 45 minutes. The digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: an unknown patient received her second dose of GARDASIL9 2 years after her first dose; No adverse effects; This spontaneous report was received from medical assistance, concerning a female patient of unknown age. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug allergies or reactions were not reported.   On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Subsequently (reported as "2 years after the first dose"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (strengths, routes of administrations, anatomical sites of injections, lot numbers,  and expiration dates were not reporter) both for prophylaxis (inappropriate schedule of product administration). No adverse effects reported nor quality complain involved.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse ffects reported; one dose of improperly stored MMRII was inadvertently administered to the patient; This spontaneous report was received from a Medical Assistant, concerning a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and drug allergies or reactions were not reported.   On 03-OCT-2019, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (product storage error), lot number R028003 with an expiration date on 01-OCT-2020 (strength, route of administration, and anatomical site of injection were not reported) for prophylaxis. The vaccine was administrated concomitantly with the sterile diluent which was stored properly. No adverse effects reporter nor product quality complain involved.  The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) experienced a temperature above 47 degrees Fahrenheit (52 degrees Fahrenheit) for 10 hours. It was not a previous temperature excursion. The temperature was recorded by the data logger.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient passed out; Information has been received from a physician via a company representative referring to a 11 years old female patient.  Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and meningococcal acyw conj vaccine (carrier unspecified) (MENACWY). The patient's pertinent medical history and drug reactions/ allergies were unknown by the reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis.      The patient passed out after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and the patient was not not injured. The patient was observed and monitored for 30 minutes in doctor's office and then went home.   No product quality complaint (PQC) was involved. No treatment was given for the adverse event. Information about lab diagnostics/studies performed was unknown by the reporter. The outcome of event passed out was reported as recovered. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event passed out was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Leukaemia
Clinical narrative: patient developed leukemia after vaccination wilh GARDASIL-9; This spontaneous report was received from a pharmacist via a company representative through an article referring to a female patient of unknown age. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown.   On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis.  On an unknown date (reported as recently, not specified further), the patient developed leukemia after vaccination wilh hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of leukaemia was unknown.  It was unknown if patient sought medical attention or not and if any treatment or laboratory tests were performed for the event.  Causality assessment was not provided.  Upon internal review, leukemia was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported; Patient was administered an improperly stored PROQUAD; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's past relevant drugs, medical history, or concurrent conditions was not provided. Concomitant therapies included sterile diluent.   On 30-OCT-2019, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: S012472 which was verified to be a valid lot number; expiration date: 20-OCT-2020) as prophylaxis (dose, dose number, route of administration, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion between 15 to 46 degrees Fahrenheit (F) (36 degrees F) for 336 hours. There was no previous temperature excursion. No adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Neuralgia, Tenderness
Clinical narrative: Neuropathic pain (peripheral) in the left arm above the elbow; Sensitive to touch; painful to have clothing rub against it or to roll over in bed; This case was reported by a nurse via sales rep and described the occurrence of peripheral neuropathic pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced peripheral neuropathic pain, touch sensitivity increased and tenderness. On an unknown date, the outcome of the peripheral neuropathic pain and touch sensitivity increased were unknown and the outcome of the tenderness was not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathic pain, touch sensitivity increased and tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 65 years or 66 years. About 1 month after receiving Shingrix, the patient experienced neuropathic pain (peripheral) in the left arm above the elbow (injection arm). It was sensitive to touch and painful to had clothing rub against it or to roll over in bed.  The pain was ongoing. The reporter gave consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low fever; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she knew running a fever after this vaccine was a side effect and asked if this fever make a person contagious. The patient stated that she was not sick so she would assume she was not contagious.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Erythema, Injection site pruritus, Malaise
Clinical narrative: Injection site redness; Injection site itching; Difficulty taking a deep breath; Arm swollen; Arm warm to the touch; not doing well; Dizziness; This case was reported by a physician and described the occurrence of dizziness in a 28-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date June 2020) for prophylaxis.   On 24th October 2019 13:00, the patient received FluLaval Tetra 2019-2020 season. On 24th October 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced dizziness, difficulty breathing, swelling arm, skin warm and unwell. On 24th October 2019 13:50, the patient experienced erythema of extremities and injection site itching. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell were unknown.   It was unknown if the reporter considered the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Flu vaccine in the right arm. The patient received 50mg Benadryl intramuscularly in her right arm. The patient experienced redness and itching at the site of injection. No other complaints were noted. The patient had no difficulty in breathing or swelling anywhere. The patient was given ice and was told to monitor because all other systems were intact. The patient was told to follow up if the events get wore. At 14:00, the staff person from the front office called and told that the patient was not doing well. The physician went to the office with all the emergency supplies. The patient was sitting down and reported that she experienced difficulty taking a deep breath and felt dizzy. The patient's right arm looked more red, slightly swollen and warm to touch. At 14:21, EMS was called and it came at 14:25. The vital signs were the blood pressure was 124/91 mm hg and the heart rate was 94. At the time of reporting, the patient was fully cognitive and was aware of the situation. The patient's husband was notified about the events. The patient was then transferred to the hospital for follow-up with the ambulance at 14:35. The patient remained calm during the process. The case has been linked with case US2019AMR196157 reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Injection site redness; Injection site itching; Difficulty taking a deep breath; Arm swollen; Arm warm to the touch; not doing well; Dizziness; This case was reported by a physician and described the occurrence of dizziness in a 28-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date June 2020) for prophylaxis.   On 24th October 2019 13:00, the patient received FluLaval Tetra 2019-2020 season. On 24th October 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced dizziness, difficulty breathing, swelling arm, skin warm and unwell. On 24th October 2019 13:50, the patient experienced erythema of extremities and injection site itching. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell were unknown.   It was unknown if the reporter considered the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Flu vaccine in the right arm. The patient received 50mg Benadryl intramuscularly in her right arm. The patient experienced redness and itching at the site of injection. No other complaints were noted. The patient had no difficulty in breathing or swelling anywhere. The patient was given ice and was told to monitor because all other systems were intact. The patient was told to follow up if the events get wore. At 14:00, the staff person from the front office called and told that the patient was not doing well. The physician went to the office with all the emergency supplies. The patient was sitting down and reported that she experienced difficulty taking a deep breath and felt dizzy. The patient's right arm looked more red, slightly swollen and warm to touch. At 14:21, EMS was called and it came at 14:25. The vital signs were the blood pressure was 124/91 mm hg and the heart rate was 94. At the time of reporting, the patient was fully cognitive and was aware of the situation. The patient's husband was notified about the events. The patient was then transferred to the hospital for follow-up with the ambulance at 14:35. The patient remained calm during the process. The case has been linked with case US2019AMR196157 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pain at the injection site; Redness, rash and itching at the injection site; Rash at injection site; Itching at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chicken pox vaccine (received in 2012).   On 19th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site rash and injection site itching. On 19th October 2019, the patient experienced injection site pain. On 22nd October 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 51 years or 52 years. The patient never had chicken. The caller reported pain at the injection site within a few hours following vaccination that lasted approximately 3 days. On 20th October 2019, within 24 hours of vaccination, the patient had redness, rash and itching at the injection site that was still unresolved at the reporting date. The reporter did not consent to follow-up. The caller provided very limited information and only wanted to share side effect information for safety report.  The caller declined to provide pharmacy information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2020) for prophylaxis.   Concomitant products included prednisone and azathioprine.   On 22nd October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th October 2019, 3 days after receiving Shingrix, the patient experienced shingles and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The reported batch number K9M59 was updated to K9M5N as per sales data sheet. On tuesday, the patient received Shingrix on left arm. On the reporting date, the patient experienced shingles and pain. On the reporting date, the patient went to the doctor today and was confirmed with shingles. The patient was prescribed valtrex for shingles.  No further details were provided.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Occupational exposure to product, Product complaint, Skin laceration
Clinical narrative: Cut; Product Complaint; exposure via skin contact; Pharmaceutical product complaint; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) and (batch number AH992, expiry date 18th March 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Shingrix.  Additional details were provided as follows: The reporter was an experienced user of the product.He pulled out an adjuvant suspension from the carton to prepare a dose to administer to a consumer.When he pulled out the vial, he went to remove the label and was cut on his left middle finger by what he discovered to be a damaged adjuvant suspension vial filed related adverse event, which led to laceration of finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint.  The base of the vial was missing a piece of glass and the rest of the base had branching cracks.The product was not administered to a consumer. No damage was noted to the package or carton at the time it was received but the carton was not opened until the user needed to obtain a dose. The box was not inspected at the time the shipment was received.No evidence of leakage in the package carton.There are glass pieces still in the carton.No product is left in the vial.The reporter would email a picture of the suspect vial to GlaxoSmithKline. The reporter would return the suspect adjuvant suspension vial and the corresponding lyophilized powder vial to GlaxoSmithKline.Please provide credit for one dose of the Shingrix vaccine. The reporter consented to follow up. The reporter was a pharmacist and gave permission for his physician to be contacted.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, couple of weeks after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the heard a conversation in a pharmacy while waiting to receive flu shot where a patient stated they became sick a couple weeks after receiving a flu vaccine in the past. The reporter declined to provide further information for safety report. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: Fever, body aches, very sore at injection site, headache, difficulty sleeping
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea
Clinical narrative: AFTER THE ADMINISTRATION OF THE VACCINE HPV GARDASIL 9 TO THE PATIENT; SHE BEGINS HAVING  NAUSEAS, WANT O VOMIT AND VERBALIZE OF HAVING A LITTLE HEADACHE. I RECOMMEND TO THE MOTHER TO KEEP WATCHING HER DAUGHTER DURING THE DAY AND IF IT PERSIST VISIT AN EMERGENCY ROOM AS SOON AS POSSIBLE.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills
Clinical narrative: Body chills from 8-11 pm on the evening of vaccination.  Took Tylenol to alleviate symptoms.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin reaction
Clinical narrative: left arm was red and itchy. patient is using benedrly started 3-4 hours after immunization and is still currently red and itchy on 11-4-19
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Influenza IIV4 (fluarix 6Mo+) 0.5 ml was given im in Left deltoid. Pt developed itching and redness to upper extremities shortly after receiving vaccine. Benadryl 50 mg im stat given, relief noted (less itching + redness) vital signs T 97.8 P 86 R 25 B/P 136/83 O2 sat 98%. Pt stable, no apparent distress.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Influenza IIV4 (fluarix 6Mo+) 0.5 ml was given im in Left deltoid. Pt developed itching and redness to upper extremities shortly after receiving vaccine. Benadryl 50 mg im stat given, relief noted (less itching + redness) vital signs T 97.8 P 86 R 25 B/P 136/83 O2 sat 98%. Pt stable, no apparent distress.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy; redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 36-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number ID2TM ?, expiry date unknown) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Tetra 2019-2020 season. On 22nd October 2019, immediately after receiving Fluarix Tetra 2019-2020 season, the patient experienced injection site itching and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Fluarix Tetra 2019-2020 season.  Additional details were received as follows: The reporter stated that, the patient experienced a Left deltoid Injection site reaction that was itchy and red after receiving vaccine. The reporter stated that the patient developed the symptom shortly after receiving the vaccine. The reporter consented to follow up.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Itchy; redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 36-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number ID2TM ?, expiry date unknown) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Tetra 2019-2020 season. On 22nd October 2019, immediately after receiving Fluarix Tetra 2019-2020 season, the patient experienced injection site itching and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Fluarix Tetra 2019-2020 season.  Additional details were received as follows: The reporter stated that, the patient experienced a Left deltoid Injection site reaction that was itchy and red after receiving vaccine. The reporter stated that the patient developed the symptom shortly after receiving the vaccine. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Urticaria
Clinical narrative: Hives on bilateral feet - joint pain hands + feet.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT STATES SHE HAD PAIN IN ARM OF INJECTION START ON 11/03/2019( 4 DAYS AFTER THE INJECTION)  AND CONTINUING ON 11/04/2019 SHE IS TAKING OTC PAIN MEDICATION TO CONTROL THE PAIN AND IS SEEING DR ABOUT THIS ISSUE LATER TODAY.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle rigidity, Muscle spasms, Musculoskeletal disorder, Myositis
Clinical narrative: THE INJECTION WAS INTO MY LEFT UPPER ARM. WITHIN A FEW HOURS, I FELT PAIN WHCH GRADUALLY BECAME EXTREMELY INTENSE.   MY LEFT UPPER ARM WAS TOTALLY RIGID & NON-FUNCTIONAL.  A VIST TO THE DOCTOR AFTER 10 DAYS, REVEALED A SEVERELY INFLAMED DELTOID MUSCLE.  IT STILL HAS NOT ABATED TOTALLY.  IT GOES INTO SPASM IF I TRY TO MOVE IT AND  IT HAS SPREAD TO MY SHOULDER. DR. PRESCRIBED AN ANTI-INFLAMMATORY CREAM, VOLTARIN.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: THE INJECTION WAS INTO MY LEFT UPPER ARM. WITHIN A FEW HOURS, I FELT PAIN WHCH GRADUALLY BECAME EXTREMELY INTENSE.   MY LEFT UPPER ARM WAS TOTALLY RIGID & NON-FUNCTIONAL.  A VIST TO THE DOCTOR AFTER 10 DAYS, REVEALED A SEVERELY INFLAMED DELTOID MUSCLE.  IT STILL HAS NOT ABATED TOTALLY.  IT GOES INTO SPASM IF I TRY TO MOVE IT AND  IT HAS SPREAD TO MY SHOULDER. DR. PRESCRIBED AN ANTI-INFLAMMATORY CREAM, VOLTARIN.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body Aches , Fatigue, Head Aches, Fever 101.7 until 11/3/2019 AM
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Throughout the day on Sunday, November 4th, I experienced the following: 1. chills 2. entire body, joint and neck soreness including stomach soreness (not stomache) but soreness that one would feel as if they had vomitted many times. 3. headache 4.  muscle pain 5. extreme lethargy and tiredness
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Neck pain, Pain
Clinical narrative: Throughout the day on Sunday, November 4th, I experienced the following: 1. chills 2. entire body, joint and neck soreness including stomach soreness (not stomache) but soreness that one would feel as if they had vomitted many times. 3. headache 4.  muscle pain 5. extreme lethargy and tiredness
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Rash started on 11-3-19 on pt's thighs, back and buttocks. on 11-4-19 rash spread to arms, hands and palms. Rash is also very itchy. Pt has not tried anything for the rash, we recommended Benadryl OTC
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: 1. Extreme weakness and tiredness 2. Muscle and joint soreness 3. Mental Fogginess 4. Headache
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 1. Extreme weakness and tiredness 2. Muscle and joint soreness 3. Mental Fogginess 4. Headache
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Inflammation, Rash, Rash pruritic, Varicella post vaccine
Clinical narrative: Rash on abdomen, head, face, neck, back, perineum, arm, foot, hand, leg.  Rash was inflamed and itchy.  Rash developed on 10/30/2019, one day after vaccine.  Rash started on wrists, spread to chest and eventually to most of his body area.  DNP diagnosed rash as varicella virus.  Diphenhydramine 12.5mg/5mL oral liquid prescribed to be taken every 4-6 hours as needed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Patient has "itching so bad that it hurts" on left arm above elbow and extending to left side of back and chest. Patient said that these symptoms did not start until 1 month after vaccination.