chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Fatigue, Full blood count normal, Headache, Lymphadenopathy
Clinical narrative: patient experienced a temperature that has ranged up to 103.8 and then 100.6; enlarged lymph nodes in her neck; frontal headache; extreme tiredness; sore throat; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 70 years old female patient who experienced patient experienced a sore throat (oropharyngeal pain), temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious sore throat (oropharyngeal pain) four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 30-Aug-2020, the patient developed a non-serious patient experienced a temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue) five days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included:  On 30-Aug-2020: Body temperature: 103.8 and on an unknown date: 100.6.  On an unknown date: Full blood count: [normal]  On an unknown date: Metabolic function test: [normal]  It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of the oropharyngeal pain were not recovered.  The event outcome was unknown for body temperature increased, lymphadenopathy, headache and fatigue.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Metabolic function test normal, Oropharyngeal pain
Clinical narrative: patient experienced a temperature that has ranged up to 103.8 and then 100.6; enlarged lymph nodes in her neck; frontal headache; extreme tiredness; sore throat; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 70 years old female patient who experienced patient experienced a sore throat (oropharyngeal pain), temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious sore throat (oropharyngeal pain) four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 30-Aug-2020, the patient developed a non-serious patient experienced a temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue) five days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included:  On 30-Aug-2020: Body temperature: 103.8 and on an unknown date: 100.6.  On an unknown date: Full blood count: [normal]  On an unknown date: Metabolic function test: [normal]  It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of the oropharyngeal pain were not recovered.  The event outcome was unknown for body temperature increased, lymphadenopathy, headache and fatigue.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Oedema peripheral, Pain of skin, Sensitive skin
Clinical narrative: lymph nodes are very swollen; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix. On 3rd September 2020, less than a day after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovering/resolving.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that she got her Shingrix shot on Thursday and her lymph nodes were very swollen. It was finally went down after been extremely swollen and recovering last Thursday, 3rd September 2020 through Sunday 6th September 2020, after 3 days of vaccination. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes are very swollen; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix. On 3rd September 2020, less than a day after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovering/resolving.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that she got her Shingrix shot on Thursday and her lymph nodes were very swollen. It was finally went down after been extremely swollen and recovering last Thursday, 3rd September 2020 through Sunday 6th September 2020, after 3 days of vaccination. The reporter did not consented to follow up.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Cough, Eye haemorrhage, Pyrexia
Clinical narrative: After 6 hours, 100.8 fever, both eyes hemorrhaged, chest tightness, dry cough and weakness.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Lymph node pain, Pain, Rash erythematous, Sleep disorder
Clinical narrative: Pain, swelling, bumpy and red rash, pain moved to arm pit- lymph node- enough to keep from sleeping. Symptoms progressed over several hours. Still monitoring
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Pain, swelling, bumpy and red rash, pain moved to arm pit- lymph node- enough to keep from sleeping. Symptoms progressed over several hours. Still monitoring
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin(rHA)) (PROQUAD) dose 0.5 milliliter (strength, route of administration and anatomical location were not reported; lot number T009929 was confirmed to be valid, expiration date 16-SEP-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature from -14 degrees Celsius (C) to -10 C (maximum -9.5 C) for 38 hours and 30 minutes. The temperature excursion started on 28-JUL-2020. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient details on administration of improperly stored vaccines; This spontaneous report was received from a medical assistant and referred to a 5 year old patient of unknown gender. The patient's concurrent conditions, historical drugs and medical history were not reported. Concomitant therapies included the sterile diluent.  On 28-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (lot # S030093 and expiration date 24-MAR-2021; therapy type: recombinant Human albumin (rHA); dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error).   Additionally, it was reported that the suspect vaccines was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a time frame of 50 minutes, as recorded by the digital data logger. There was a previous temperature excursion reported as between 6 degrees F to 14 degrees F (8.47 degrees F) for a time frame of 30 minutes. No further adverse event (AE) information provided.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000976: US-009507513-2009USA001006: US-009507513-2009USA001097: US-009507513-2009USA001099: US-009507513-2009USA001114: US-009507513-2009USA001123: US-009507513-2009USA001135:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old male patient. Information about pertinent medical history or drug reactions/allergies was not provided.  On 28-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # S021620 and expiration date 09-JAN-2021) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The administered doses of the vaccines experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-13.04 degree Celsius) for 45 minutes recorded by a data logger. There was no previous temperature excursion.
Age: 36.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: pain/soreness in right upper arm; thumb numbness; weakness in the right arm; headache; This spontaneous report was received from a physician via a company representative referring to a 36-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 04-JUN-2020, 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) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis. The patient did not have any complaints after the injection. On 07-AUG-2020, 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) (lot # S020255, expiration date not reported, upon internal validation established as 09-DEC-2021).  On 14-AUG-2020 (reported as 1 week later), the patient experienced pain/soreness in right upper arm, as well as thumb numbness, weakness in the right arm and headache. The outcome of the events was unknown. It was unknown if treatment was given. The causality assessment was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 38.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired diluent that was administered with MMR II; This spontaneous report as received from a medical assistant, referring to a 38 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 22-AUG-200, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) lot # R031679, expiration date 01-NOV-2020, for prophylaxis (strength, dose, route and frequency were not reported), that was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot# S018821, expiration date 22-AUG-2020 (strength, dose, route, frequency and indication were not reported).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired diluent was administered with PROQUAD; This spontaneous report was received from a physician referring to a 4 years old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history and historical drugs were not provided.   The reporter indicated that on 24-AUG-2020, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Dosage regimen and route of administration not provided; lot # S017255 and expiration date: 01-DEC-2020, albumin status: rha) for prophylaxis, which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (lot # S018821 and expiration date 22-AUG-2020). No additional information was provided.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: MA reported an adverse event on a vaccine administered to a patient  that was later found to be stored in a freezer; vaccine was later found to be in a freezer that had insufficient data reported with data logger and a previous temperature excursion was found supported; This spontaneous report has been received from a medical assistant concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 08-SEP-2020, an adverse event was reported on the administration of an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot # T005404, expiration date 12-AUG-2020 (route of administration not reported) as prophylaxis.  It was also reported that the improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T005404 expiration date 12-AUG-2020; rHa albumin status) experienced an unknown temperature during an unspecified amount of time accompanied with another dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T013536, expiration date 17-AUG-2021, albumin status rHa) and with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S032355 with expiration date reported as 05-JUL-2022 but upon internal validation established as 14-OCT-2021). This doses were later found to be stored in a freezer that had insufficient data reported with a data logger, and had a previous temperature excursion of 6 degree Fahrenheit (°F) to 14°F (average temperature was 8.6°F) for 25 minutes. The call was due a digital data logger. The outcome of the adverse event was not reported.  The causal relationship between the adverse event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T005404 expiration date 12-AUG-2020) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reports an improperly stored PROQUAD that was administered.; No other AE reported; Information has been received from a nurse, concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T003833 and expiration date of 01-AUG-2021 (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -9 Celsius degrees to 8 Celsius degrees  (-4.12 Celsius degrees) for 30 minutes. No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: vaccine administered after temperature excursion and before temperature excursion evaluation occurred; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was not provided.     On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S006830 with an expiration date in 02-SEP-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent an initial temperature excursion of 4.8 degrees Fahrenheit, during a time frame of 60 hours, and an additional one of 5 degrees Celsius during a time frame of 12 hours. Digital data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received 2nd dose of PNEUMOVAX 23 approximately 1 year from the original dose; This spontaneous report was received from a physician assistant and a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On an unspecified date approximately in 2019, patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis. Then, the patient went to the clinic and stated the need for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23); therefore, they received, inadvertently, on 18-AUG-2020, the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, but it was approximately 1 year from the original dose. Reporter stated that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered and later was found in the record that the patient received the first administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) approximately 1 year ago.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: On 8/24/2020, the patient was administered improperly stored PROQUAD (reconstituted with properly stored Merck STERILE DILUENT).; This spontaneous report has been received from a medical assistant concerning a 4-year-old female patient of unknown ethnicity. The patient's medical history, known allergies/reactions, medical history and concomitant medications were not reported.   On 24-AUG-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot # T005406 with expiration date 12-AUG-2021; rHa albumin status; dosage regimen not reported), subcutaneously as prophylaxis (indication also reported as ''well check''). The vaccine was reconstituted with a properly stored sterile diluent. The administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) had been exposed to multiple temperature excursions between -9 degree celsius (C) to 8C (average- 6.1C) during an unknown time frame (no previous excursions). The call was performed due to a data logger.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller stated that on 8/12/2020, the patient was administered improperly stored PROQUAD (reconstituted with properly stored Merck STERILE DILUENT).; This spontaneous report was received from a medical assistant referring to a 5 years old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 19-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) lot # T001187, expiration date 11-JUL-2021 for prophylaxis (reported as well check) (reconstituted with properly stored MERCK STERILE DILUENT) (lot #, expiration date, dose, frequency and route of administration were not reported) (product storage error).  The improperly stored suspect vaccine experienced multiple temperature excursion of - 9 Celsius degrees (°C) to 8°C (average -6.1°C) for 1 hour and 15 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 12 month old male patient. Information about the patient's medical history, concurrent conditions, drug reaction or allergies was not provided.      On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S032355 with an expiration date in 14-OCT-2021), subcutaneously, for prophylaxis (strength and dose were not provided), that underwent multiples temperature excursions from -14 degrees Celsius to -10 degrees Celsius, for a time frame of 116 hours and other temperature excursion from -9 degrees Celsius to 8 degrees Celsius, for a time frame of 13 hours, for a total of 129 hours . The dose was reconstituted with properly stored sterile diluent. Digital data logger was involved.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE and no PQC; His first dose ofGARDASIL 9 was back in February 2020. 10-SEP-2020, the patient received his second dose of GARD A SIL 9; This spontaneous report was received from the patient's mother referring to her son a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   The patient's mother stated that her son received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) back in February 2020 for prophylaxis.  On 10-SEP-2020 (reported as "today"), the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and was informed he should have received the second dose 2 months after the first dose (April 2020). No other adverse event was reported.
Sex: U
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: MY KIDS GOT SICK FROM THESE ALL WINTER.; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex:    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced my kids got sick from these all winter. (preferred term: Malaise).     Action taken of Flumist was not applicable.    The outcome of the event was unknown.    The event was considered non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Gait inability
Clinical narrative: WOKE UP THE NEXT DAY AND COULDN'T  WALK.; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced woke up the next day and couldn't  walk. (preferred term: Gait inability).     The outcome of the event was unknown.    The event was considered non-serious.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation, Needle issue, No adverse event, Underdose
Clinical narrative: Needle puncture; med error; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number PK9BY, expiry date 19th March 2021) for prophylaxis.   On 14th October 2018, the patient received the 2nd dose of Shingrix .4 ml. On 14th October 2018, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: The patient received a dose of Shingrix a day before the date of reporting, but 0.1 ml of the vaccine might have been lost (and not administered to a patient) due to the needle being stuck in the patient's skin after administration, which led to accidental underdose. The reporting pharmacist stated that the intern who administered the vaccine reported to her that 0.1 ml might have lost and not administered.   Follow up information received from a pharmacist on 28th November 2018: The reporter's details were updated. The patient received the dose of Shingrix vaccine intramuscularly in an unknown arm. After administering the full dose, the needle seemed to be stuck into the patient's arm. When the intern was removing the needle. When the needle was removed, about 0.1 mg leaked back out at the injection site. The patient did not note any adverse events. He returned to the pharmacy on 17th November 2018 and received a repeat second dose. This was still within the recommended time frame of 2 to 6 months after the first dose. On an unknown date, the outcome of the needle stick/puncture and accidental underdose were unknown.  It was unknown if the reporter considered the needle stick/puncture to be related to Shingrix. The VAERS details were updated. This case was associated with a medication error without harm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Device connection issue, Exposure via skin contact, Immunisation
Clinical narrative: I don't know how much if any may have gotten in; Inadvertent exposure to vaccine; exposure via skin contact/ most of vaccine was ended up on patient's arm; Extreme body aches all over; Slight fever; Chills; Brusing; Sore arm; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date November 2020) for prophylaxis.  On 12th November 2019, the patient received the 2nd dose of Shingrix. On 12th November 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The day before reporting, the patient had 2nd dose of shingrix. When the injection went in, it sprayed out and over the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient asked, would she need another dose. This case has been linked with US2019AMR207351 and US2019206637, reported by same reporter.   Follow up information received from the nurse on 19th December 2019: The patient's demographic details were updated. The patient received the 2nd dose of Shingrix (intramuscular). Bathc number and expiry date was updated. The patient stated, the vaccine sprayed back while the pharmacist was administering it. The hub probably was not tightened and most of the vaccine was ended up on her arm and not in the muscle. The patient's arm was relaxed at the time. Then, a couple of days after this incidence, the patient received a full corrective dose of Shingrix and was correctly administered. After this dose, the patient had fairly severe side effects including body aches ll over, slight fever, chills and bruising which lasted for about a day. The patient also had sore arm and that lasted for a week. It was unknown if the reporter considered the general body pain, fever, chills, contusion and pain in arm to be related to Shingrix and Shingrix. This case was considered as medication error associated with adverse reaction. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR207351:same reporter US-GLAXOSMITHKLINE-US2019206637:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Underdose
Clinical narrative: I don't know how much if any may have gotten in; Inadvertent exposure to vaccine; exposure via skin contact/ most of vaccine was ended up on patient's arm; Extreme body aches all over; Slight fever; Chills; Brusing; Sore arm; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date November 2020) for prophylaxis.  On 12th November 2019, the patient received the 2nd dose of Shingrix. On 12th November 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The day before reporting, the patient had 2nd dose of shingrix. When the injection went in, it sprayed out and over the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient asked, would she need another dose. This case has been linked with US2019AMR207351 and US2019206637, reported by same reporter.   Follow up information received from the nurse on 19th December 2019: The patient's demographic details were updated. The patient received the 2nd dose of Shingrix (intramuscular). Bathc number and expiry date was updated. The patient stated, the vaccine sprayed back while the pharmacist was administering it. The hub probably was not tightened and most of the vaccine was ended up on her arm and not in the muscle. The patient's arm was relaxed at the time. Then, a couple of days after this incidence, the patient received a full corrective dose of Shingrix and was correctly administered. After this dose, the patient had fairly severe side effects including body aches ll over, slight fever, chills and bruising which lasted for about a day. The patient also had sore arm and that lasted for a week. It was unknown if the reporter considered the general body pain, fever, chills, contusion and pain in arm to be related to Shingrix and Shingrix. This case was considered as medication error associated with adverse reaction. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR207351:same reporter US-GLAXOSMITHKLINE-US2019206637:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Quite ill / being so sick; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. Patient's wife reported that her husband received the shingrix vaccine and ill for 36 hrs after the vaccination earlier this week. Patient's wife was asking if anything she can do to prevent being so sick after her vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation, Injection site erythema, Injection site swelling, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; Injection site redness; Injection site swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number H2HM2, expiry date 29th August 2021) and (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 11th June 2019, the patient received Shingrix. On 11th June 2019, the dose was .5 ml (.5 ml daily). On 11th June 2019, 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 reported as follows: The pharmacist stating, she was experienced at administering Shingrix vaccine.  The patient was given the second dose of the Shingrix vaccine but was initially injection only the adjuvant into the left arm, deltoid region. The pharmacist realized the error and mixed another batch of the antigen with the day of reporting and injected it also into the left arm, deltoid region intramuscularly, but about an inch lower to same day of first injection site. The batch number for Shingrix antigen (batch number H2HM2, expiry date 29th August 2021) and Adjuvant (batch number NE3TG, expiry date 10th August 2021) reported only for recovery dose (corrective action). Batch number was not reported for 1st dose of Shingrix vaccine which was incorrectly prepared.   Follow up information received from pharmacist on 22nd July 2019:  The patient had no known drug allergies. The patient returned to pharmacy 5 days later the adjuvant injection site had no visible reaction. On 11th June 2019, the patient received the 2nd dose of Shingrix 0.5 ml intramuscularly.  In June 2019, the patient experienced injection site erythema and injection site swelling.  On an unknown date, the outcome of the injection site erythema and injection site swelling was resolved with sequelae.  It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  There was light redness and swelling at Shingrix injection site. The patient stated she did not experience any systemic reactions like fever and illness. It was a medication error with adverse drug reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pruritus
Clinical narrative: redness; itching; incorrect route of drug; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix (subcutaneous). In December 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient did not know the batch number or expiration date. In mid December 2018, the patient received Shingrix. The patient who reported that the pharmacist that injected her with Shingrix was inept and his technique was hideous. The patient explained he used a subcutaneous diabetic syringe and needle to inject Shingrix into her right deltoid. She reported while he was injecting, he pinched the skin.  The patient was concerned he gave her a subcutaneous injection and was concerned about absorption and efficacy, which led to inappropriate route of vaccination. The reporter consented to follow up. The reporter declined physician information as she had not discussed with him yet.  The reporter gave her permission to contact her back if necessary.   Follow up received from consumer on 19th February 2019: There was no physician involved in vaccination with Shingrix. Consumer was a Registered nurse and she know a good injection when she seen it. And the reporter concern was whether the vaccine took. It was the second of the series and it was done in December at the pharmacy. The pharmacist who given the injection was not trained properly. She understand that this was an intramuscular injection but he used an insulin needle. He laid against my deltoid and pushed it in. Then, in the middle of the procedure, he pinched the skin. He was not very sure of himself and she think that's why he pinched the skin. Nevertheless, he did it all wrong. This was why the reporter concerned. Did she get enough of the vaccine if it was given in the fatty area of my deltoid? She did get a bad itch. She had almost no reaction the 1st time a different pharmacist. She had some edema that time. This time it caused redness and the itching continued for a number of weeks. This was my complaint. In addition, my question was did she get enough of my 2nd injection Also, who was training the pharmacists to give injections? (Hire me and the reporter would teach them the proper way to do an injection.) This case has been linked with case US2019GSK037085, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019GSK037085:same patient
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Product supply issue
Clinical narrative: inappropriate schedule of vaccine; shivering/ Chills; tired; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, tiredness and influenza-like symptoms. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown and the outcome of the shivering, tiredness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shivering, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated he had shivering, tiredness, chills, flu like symptoms with the first dose on the evening of the event that lasted about a day or two. The patient had not been able to get the second dose due to the shortage. At this time he plans to get the second dose when it was made available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: fever of 100.4 F; not feeling well (malaise); Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced fever, malaise, chills and headache. On an unknown date, the outcome of the fever, malaise, chills and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, malaise, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine at end of the day and on 9th September 2020 at morning, she woke up and not felt well (malaise) with a headache and chills. The patient had checked temperature, reading was normal, and then going back to sleep for approximately 1.5 hours. After woke up the second time patient checked temperature again and had a fever of 100.4 degree Fahrenheit. The symptoms were not resolved at the time of reporting. The reporter did not consent to health care professional's follow-up, said not necessary. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: allergy to Influenza Virus Vaccine Whole; Drug Allergies (Dronedarone and Lovastatin); Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a physician (via non-licensed Pfizer company).  This case involves a patient (age and gender not reported) who experienced allergy to influenza virus vaccine whole and drug allergies while he/she received INFLUENZA VACCINE and while treated with DRONEDARONE and LOVASTATIN.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not known.   On an unknown date, the patient started taking DRONEDARONE dosage unknown (with an unknown batch number, other dosing details not reported) and LOVASTATIN dosage unknown (with an unknown batch number, other dosing details not reported) for unknown indication. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergy to influenza virus vaccine whole (allergy to vaccine) (Unknown latency) following vaccination. On an unknown date, the patient developed a non-serious drug allergies (drug hypersensitivity) (Unknown latency) following administration of DRONEDARONE and LOVASTATIN. Other case details: It was reported that the patient had allergies to Dronedarone, Influenza Virus Vaccine Whole, Lovastatin and Sulfa (Sulfonamide antibiotics). It was also reported that the patient had a prescription of Pregabalin (Lyrica) 50 mg capsule and was taking Neurontin (not reported before or after administration of suspect products).  No relevant tests were reported.  Action taken for DRONEDARONE (DRONEDARONE) and LOVASTATIN (LOVASTATIN) was unknown.  It was not reported if the patient received a corrective treatment.  The outcome for events was unknown at the time of report.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Pain, Pain in extremity
Clinical narrative: stomach ache; body aches; arm up to shoulder was painful; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 45 years old male patient who had stomach ache (abdominal pain upper), body aches (pain) and arm up to shoulder was painful (pain in extremity), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient had not received other vaccines.   On 27-Aug-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6628AA, expiry date: 04-Apr-2022) once via intramuscular route in the left deltoid for prophylactic vaccination.  On 04-Sep-2020, the patient developed a non-serious stomach ache (abdominal pain upper), body aches (pain) and arm up to shoulder was painful (pain in extremity) 8 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided   No corrective treatment was received.  At the time of report, the outcome of events was unknown
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 9 year old male patient was given an expired Quadracel vaccination, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 year old male patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other medications or vaccinations were given at this visit.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5325BA and expiry date: 14-Nov-2019) via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.