chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I received two vaccines at the same time - one for the flu and the other for shingles. They were both administered very quickly. Within a couple of hours I was feeling nauseous, dry mouth, headache and swelling and  pain in my shoulder where I received the shingles vaccine. As the evening went on symptoms became worse with chills, weakness, loss of appetite fever, extreme tiredness, unable to sleep.  The next day I was unable to get out of bed except for about 5 minutes at a time.  Continued chills, headache pain, weakness, etc. Extreme tiredness. Injection sight is very hot, hard  and swollen on Sunday evening, two days later. Other symptoms have subsided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: I received two vaccines at the same time - one for the flu and the other for shingles. They were both administered very quickly. Within a couple of hours I was feeling nauseous, dry mouth, headache and swelling and  pain in my shoulder where I received the shingles vaccine. As the evening went on symptoms became worse with chills, weakness, loss of appetite fever, extreme tiredness, unable to sleep.  The next day I was unable to get out of bed except for about 5 minutes at a time.  Continued chills, headache pain, weakness, etc. Extreme tiredness. Injection sight is very hot, hard  and swollen on Sunday evening, two days later. Other symptoms have subsided.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given combo Pediavax with Hep B and also an individual Hep B vaccine. There were no adverse events. The patient was observed closely and notified immediately at time of event. We have separated vaccine fridge and implemented second check to avoid this error in the future.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Incorrect product storage; This spontaneous report was received from a registered nurse who referred to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.  Since 28-JUL-2020, the temperature excursion was intermittent and on an unknown, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # S032357 had been verified to be a valid number; expiration date 14-OCT-2021) (T002843 had been verified to be a valid number; expiration date 23-JAN-2022); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHa) (dose not reported) (lot number T009929 and S031882  have been verified to be valid lot numbers; expiration dates: 16-SEP-2021 and 07-APR-2021, respectively); both vaccines for prophylaxis (strengths, frequencies, routes of administration, and anatomical locations were not reported). The  temperature  excursion was at -14 degrees Celsius (C) to -10 degrees C (max -9.5 degree C) , for a time frame of 38 hours and 30 minutes, and no had previous temperature excursion. It was reported that the call was due to data logger.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered
Clinical narrative: a GARDASIL 9 was administered twice at the same time/ there were two nurses when the incident happened and they both grabbed the GARDASIL 9 and gave it at the same time; one dose was meant for the patient's sibling; Therapy Start Date: May 20th 2019/ was at office to receive second dose of the series/ AE Onset Date: 08-SEP-2020; This spontaneous report was received from a registered nurse, referring to a 16-year-old male patient. The patient's pertinent medical history or current conditions were not reported. He had no concomitant medications and his previous drug reactions/allergies were amoxicillin and penicillin.  On 20-MAY-2019, 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) (formulation, strength, dose, route of administration, lot number or expiration date were not reported) as prophylaxis.  On 08-SEP-2020, the patient was at the nurse's office to receive the second dose of the 3 series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The nurses were giving multiple vaccines, and two nurses grabbed one vaccine each, and the patient was vaccinated twice at the same time with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml), intramuscular (strength and anatomical site of vaccination were not reported; lot number S026371, expiration date reported and validated as 01-APR-2022) as prevention of human papillomavirus (HPV) (prophylaxis) (incorrect dose administered). The nurse reported that there were two doses of the vaccine in the room at that time, and one dose was meant for the patient's sibling (wrong patient received product). It was reported that the patient did not receive any treatment for the events, and no laboratories diagnostics/ studies were performed. The patient was stable at the time of the report and he did not seek medical attention. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S026371; expirationdate: 01-APR-2022; 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 meet the criteria for Reportability.
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; This spontaneous report was received from a nurse and refers to a currently 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # T003833 has been verified to be a valid lot number, expiration date as 01-AUG-2021) (dose number, route and anatomical location of administration were not provided) for prophylaxis.         The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) ) was exposed to a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.84 degrees Celsius) for 45 minutes and -9 degrees Celsius to 9 degrees Celsius (-4.12 degrees Celsius) for 30 minutes (product storage error), which were detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints were reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician, concerning a 12-year-old patient of unknown gender.  Information on concurrent conditions, medical history and concomitant medications were not reported.   On 19-OCT-2016, the patient received the first dose of same patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient received the second dose on 21-DEC-2016, and was in the office on 09-SEP-2020, and would be receiving a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse symptoms reported.
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; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella virus vaccine live (PROQUAD) for prophylaxis (lot # S023651 has been verified to be a valid lot number measles, mumps, rubella and varicella virus vaccine live, expiration date reported and establish as 26-JAN-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were from -14° Celsius (C) to -10°C for 45 minutes, and from -9°C to 8°C for 30 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion.   No adverse effect was reported.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; one dose of PEDVAX HB was administered to patient after temperature excursion; This spontaneous report was received from a physician and refers to a 2-months-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On an unspecified date, improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (Lot No. S031500 has been verified to be a valid lot number expiration date reported as 20-APR-2022, but upon internal validation established as 21-APR-2022), experienced an intermittent temperature excursion of 1.3 degree Celsius (C) for a period of 4 hours and 30 minutes with a previous temperature excursion of 1.13 degree Celsius (C) for a period of 3 hours. The excursion was called by a digital data logger.  On 09-SEP-2020, the patient was vaccinated with an improperly stored dose of of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency and route of administration not provided) (Lot No. S031500 has been verified to be a valid lot number expiration date reported as 20-APR-2022, but upon internal validation established as 21-APR-2022), as prophylaxis. The patient did not experience any adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; given third dose PROQUAD 09/09/2020 in error; This spontaneous report has been received from a a physician (administrator) referring to a patient of an unknown age and gender. Information concerning the patient's concurrent conditions, pertinent medical history, concomitant medications, and previous drug allergies or reactions were not provided.  On 24-AUG-2020, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen, route of administration, lot number and expiration date were not provided) as prophylaxis.   On 09-SEP-2020, a third dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) lot # T009930, expiration date 16-SEP-2021 (dosage regimen and route of administration were not reported) was given in error as prophylaxis. No additional adverse event (AE) was reported.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: TERRIBLY SICK; A spontaneous report has been received from a consumer. The report concerns a female patient  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 terribly sick (preferred term: Malaise).     The outcome of the event  terribly sick was unknown.    The event  terribly sick  was considered non-serious.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Muscular weakness
Clinical narrative: MILD WEAKNESS BEGINNING LATE AT NIGHT, 24 HOURS FOLLOWING IMMUNIZATIONS. PROGRESSED THROUGHOUT THE NEXT SEVERAL DAYS, BUT MOSTLY IN THE LEGS. SEVERE WEAKNESS IN LEGS.  PATIENT REPORTS ON 9/14/2020 THAT SYMPTOMS HAVE IMPROVED SLIGHTLY, ENOUGH TO ALLOW RETURN TO WORK . PRIMARY CARE PRESCRIBER HAS BEEN NOTIFIED.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient came into office for a CPE. Her MICR stated she was due for a Men B vaccine. Provider ordered a Men B vaccine. Staff prepared and administered a Men Conjugate (menvo). This vaccine was verified by Staff to be menvo but was not verified to the patient need. Staff realized this error when documenting the vaccine in the EMR.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient came in with his mother on 9/10 to receive his vaccines. I gave all the need paperwork to his mother on the vaccines he was given and then gave him his shot. When I went to put the information into our EMR that's when I seen the err that I made. I told my office manger what I did which was. I made a mistake in gave patient the  Dtap  vaccine but he was do to get the Tdap.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion
Clinical narrative: Pt was the last patient of the day for the provider and the error was noticed the next day. The provider and patients mother were made aware by employee. The agency was contacted by clinic employee and spoke to agency employee. They stated the patient would be fine and the doses would count. Upon discussion with employee, she stated she did not know the Kinrix was for 4 years and up. After this I looked at the box but it does not state that it is for 4 and up. We wrote on the box 4 and up and then posted a note on the fridge with a breakdown of the combo vaccines and information on the ages for them. A coaching and mentoring was done for the employee.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Injection site pain, Injection site swelling, Mucosal hypertrophy
Clinical narrative: Site pain swelling. Extreme shivering for 3 hours. Thick mucous. Chest heavy from nipple line up
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: father called next day child with pain, erythema , small erythematous areas and tender to touch.  Patient was already on Clindamycin for inspect bites diagnosed with  cellulites. Patient returned to clinic  two days later with left should pain, swelling and mild edema ; site was warm with rash blanching.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain, Pallor
Clinical narrative: father called next day child with pain, erythema , small erythematous areas and tender to touch.  Patient was already on Clindamycin for inspect bites diagnosed with  cellulites. Patient returned to clinic  two days later with left should pain, swelling and mild edema ; site was warm with rash blanching.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: father called next day child with pain, erythema , small erythematous areas and tender to touch.  Patient was already on Clindamycin for inspect bites diagnosed with  cellulites. Patient returned to clinic  two days later with left should pain, swelling and mild edema ; site was warm with rash blanching.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal
Clinical narrative: Joint pain
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red, flat, itchy rash on face, arms, chest, back, genitalla and legs erupted on 9/8/2020.  Mom applied Over the counter hydrocortisone cream.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: significant left arm swelling
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm red and swollen--doesn't hurt and doesn't itch no fever
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Injection site muscle pain - moderate:  onset within 10 minutes of injection and lasting 3 days Low-grade fever of 100.4:  onset next day and lasting one day
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Patient received her flu shot in the pharmacy on 9/8/20 and went home without event. Two days later, on 9/10/20, patient broke out in hives, which covered her entire body. She did not have trouble breathing, fortunately.  She went to urgent care, where she was prescribed methylprednisolone 4 mg dose pack, levocetirizine 5 mg, and an epinephrine 0.3mg auto-injector for the future. She is reportedly still itching and in a lot of discomfort.  She spoke to me, the pharmacist on 9/13/20 and suspects that she had an allergic reaction to the flu shot.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea, Feeling hot, Heart rate increased, Hyperhidrosis, Lip swelling
Clinical narrative: Severe diarrhea, Lips tingling and swelling, rapid heart rate, sweaty, feeling hot (pt didn't check for fever).
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia oral
Clinical narrative: Severe diarrhea, Lips tingling and swelling, rapid heart rate, sweaty, feeling hot (pt didn't check for fever).
Sex: F
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: anxiety issues; This spontaneous report was received from a consumer via a company representative referring to her daughter of unknown age. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On an unknown date, the patient was vaccinated with the first shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis.         On an unknown date (reported as after the administration), the patient experienced anxiety issues. The outcome of the event was unknown. The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of PNEUMOVAX 23; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 08-SEP-2020, the patient received an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot number T010779, expiration date on 30-JAN-2022, for prophylaxis (dose, dose number, route of administration and anatomical location were not provided).  It was reported that the vaccine was exposed to a temperature of 70 Fahrenheit degrees for 5 hours. There was no previous temperature excursion. The call was not placed because of a Digital Data logger report. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-2022; 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 meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9, PPV
Symptoms: Product storage error
Clinical narrative: unspecified number of patients were administered improperly stored doses of GARDASIL 9 or PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On unknown dates, patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R036913, expiration date on 23-SEP-2021 and lot #1602283, expiration date reported as 16-AUG-2021, but internally validated as 18-AUG-2021, for prophylaxis or with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #S026366, expiration date on 17-SEP-2020. Vaccines were improperly stored at a temperature of 30.5°F during a time frame of 2 hours and 45 minutes. There was no previous temperature excursions and the call was not because of a data logger.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Hypersomnia, Pyrexia
Clinical narrative: In the middle of night all bones acheing.  Very weak.  Fever of 101.7 From Friday late night early Saturday, Slept all day until Sunday morning at 6am  Treatment Tylenol Extra Strength, Hot Bath, slept, fluids only (ginger ale)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Temp of 101.8, severe body aches, chills, fatigue, headache for 36 hours body aches, headache, fatigue and temp below 100.8 for 8 hours.  Injection site swelling, redness and pain for 72 hours
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Temp of 101.8, severe body aches, chills, fatigue, headache for 36 hours body aches, headache, fatigue and temp below 100.8 for 8 hours.  Injection site swelling, redness and pain for 72 hours
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Approx 2 days (9/11) after Tdap patient experienced swelling in her right leg that continued to get worse into evening of 9/11. Patient states that she iced her leg and the swelling went down somewhat but came back the next day and the day after thru today 9/14 where she is still experiencing swelling but to a lesser degree.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: M
Vaccine: VARZOS
Symptoms: Concomitant disease aggravated, Condition aggravated, Haematospermia, Herpes simplex
Clinical narrative: This spontaneous report was received from a regulatory authority (AU-TGA-0000470983) and refers to a 70-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On an unknown date the patient was vaccinated with Zoster vaccine live (ZOSTAVAX) (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for immunisation. On an unknown date the patient experienced concomitant disease aggravated. The consumer stated, that previously, quiescent Herpes Simplex infection became quite active over a 9 to 12 month period. Rather than skin eruptions appeared to effect the bladder/urinary tract system. Comments were made to General Practitioner (GP). After more than 30 years, wife was finally infected (without the patient's skin lesions appearing). The patient was referred to urologist without results (or interest) due to blood in seminal fluid. The outcome of concomitant disease aggravated was reported as recovered/resolved. on an unknown date.  The causality assessment between the event and Zoster Vaccine Live (ZOSTAVAX) was reported as possible.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 4 years with 2 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 6 years with 11 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 16 months old female patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis; she also received fist dose of hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, anatomical location and indication were not reported) lot # 7595K with expiration date on 30-DEC-2021, administered intramuscularly (IM); both at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccines which were used according to the instruction leaflet; however, they underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccines were okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Age: 1.33
Sex: M
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 6 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis; he also received fist dose of hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, anatomical location and indication were not reported) lot # 7595K with expiration date on 30-DEC-2021, administered intramuscularly (IM); both at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccines which were used according to the instruction leaflet; however, they underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccines were okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: at least one case where the child was given the Hep B series early; This spontaneous report was received from a nurse prescriber referring to a child of unknown age (reported as at least one case). There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On unknown dates, the patient was early given the hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, dose, route, frequency, lot number and expiration date were not reported) series for prophylaxis (inappropriate schedule of product administration).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA002297:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: administered PNEUMOVAX23 which expired on 06/13/2020; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 02-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R010724, expiration date 13-JUN-2020, once; dose was not reported) via intramuscular for prophylaxis. The vaccine was expired. Per the memo, there was only a month window after expiry supported with this vaccine (expired product administered). There was no PQC or additional AE associated with either case.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting AE of improperly stored vaccine administered to patient; This spontaneous report was received from a nurse referring to a 23 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S008151, expiration date: 20-NOV-2021; 0.5 milliliter; route was not reported) for prophylaxis (product storage error).    The administered dose of the vaccine experienced a temperature excursion -48.39 Fahrenheit (F) for 1 hour and 45 minutes time frame. There was no previous temperature excursion. The digital data logger was involved.  No additional adverse effect details available. Device was not available for evaluation (obtain was reported as false). 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report was received from a physician referring to a 58 years old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.     Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at temperature of 48.39 Fahrenheit (F) for 1 hour and 45 minutes. The was no previous temperature excursion.   On 24-AUG-2020, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, lot # T009744, expiration date 28-JAN-2022) via unknown route for prophylaxis (Improper storage of product in use). This call was because a data logger. No product quality complaint (PQC) was reported. The outcome of the event was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller stated that on 8/19/2020, the patient was administered improperly stored VARlVAX; This spontaneous report was received from a registered nurse, referring a female patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 19-AUG-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error). As concomitant therapy, a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number S008566, which has been verified to be valid, expiration date reported and validated as 16-NOV-2021) was used to reconstitute the vaccine (medication dilution). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) to -10C (-12.1C) for a time frame of 3 hours, and from -9C to 8C (-7.5C) for 8 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014014:
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: so far, the child had not experience any of those effects or other effects.; GARDASIL 9 injection was given to 4 year old child; This spontaneous report was received from a nurse, referring to a 4 years old patient of unknown gender. Information about historical conditions, concurrent conditions and concomitant medications were unknown.  On 08-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were unknown) for prophylaxis (product administered to patient of inappropriate age). The nurse stated this was unintentional. The office had called Poison Control but was not provided with any guidance on what to look for in children younger than 9 years old. Nurse said the parent of the child had been advised of the side effects listed in the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) product information (PI) and that so far, the child had not experience any of those effects or other effects. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; 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 meet the criteria for Reportability.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Erythema, Injection site pain, Pain in extremity
Clinical narrative: the shot was really bad; This case was reported by a consumer via other manufacturer and described the occurrence of adverse event in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypothyroidism. Concomitant products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided This case has been linked with case US2020AMR177651, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177651:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: soreness around the injection site; tiredness; aching in body; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On 11th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain, tiredness, pain and injection site erythema. On an unknown date, the outcome of the injection site pain, tiredness, pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm intramuscularly. The patient reported after receiving the first dose of Shingrix had redness around the injection site, soreness around the injection site, tiredness, and aching in body and these all resolved within 24 hours.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178047:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: It's been 10 months since my 1st shot. I forgot the 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 10 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: covered head to toe in hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had covered head to toe in hives.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: developed a rash in trunk area; tenderness at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash and injection site tenderness. On an unknown date, the outcome of the rash and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the rash and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed rash in trunk area and tenderness at the injection site the following day that received the first dose of Shingrix. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pain of skin, Pruritus, Rash macular
Clinical narrative: allergic reaction / continues to worsen; red; itchy; blotches on his skin; painful blotches on his skin; blisters on his legs and feet; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash. On an unknown date, the outcome of the allergic reaction, erythema and pruritus were not recovered/not resolved and the outcome of the itchy rash, skin pain and blistery rash were unknown.   It was unknown if the reporter considered the allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated he has what seems to be an allergic reaction and it continues to worsen.  He reported red itchy painful blotches on his skin. He also reported blisters on his legs and feet.  He has seen a dermatologist and is taking a steroid cream. He reported that he was allergic to a lot of things" so he was unsure if this is related to the Shingrix or not. He declined to provide any information beyond that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178479:same patient