chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Ataxia, Vestibular neuronitis
Clinical narrative: Vestibular neuritis; Ataxia; This case was reported by a physician via sales rep and described the occurrence of vestibular neuronitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced vestibular neuronitis and ataxia. On an unknown date, the outcome of the vestibular neuronitis and ataxia were unknown.   It was unknown if the reporter considered the vestibular neuronitis and ataxia to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Lot number, expiration or vaccination date was unknown at the time of reporting. The patient experienced vestibular neuritis and it got worse with time until the patient experienced ataxia. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: Red arm; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, fever and chills. On an unknown date, the outcome of the erythema of extremities, fever and chills were unknown.   It was unknown if the reporter considered the erythema of extremities, fever and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced red arm. The reporter declined to provide information for safety reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Mobility decreased
Clinical narrative: Extreme bad reaction in the lower arm; Difficulty to lift the arm; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 60-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, unknown after receiving Shingrix, the patient experienced adverse reaction and mobility decreased. On an unknown date, the outcome of the adverse reaction and mobility decreased were unknown.   It was unknown if the reporter considered the adverse reaction and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced an extreme bad reaction on her lower arm and difficulty to lift the arm (not sure if it was on the injection site). It was reported that the patient did not report this to her doctor, but who reported this adverse event recommended to do so.  No further information regarding Shingrix vaccine was reported or any details from the patient experience.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: joint pain in both the left and right hand and both the knees/ aching in knee; muscle pain in both the left and right hand and both the knees; aching in her arms; This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a 52-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   On 9th December 2019, the patient received Boostrix (intramuscular). On 11th December 2019, the patient received the 1st dose of Twinrix adult (intramuscular). On 18th December 2019, 9 days after receiving Boostrix and 7 days after receiving Twinrix adult, the patient experienced joint pain, muscle pain and pain in arm. On an unknown date, the outcome of the joint pain, muscle pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, muscle pain and pain in arm to be related to Boostrix and Twinrix adult.  Additional details were reported as follows: The patient received a dose of Twinrix Adult and Boostrix on the left deltoid. The patient experienced muscle ache with joint pain in both the left and right hand and both the knees after receiving Boostrix and Twinrix adult vaccines. The aching in her arms and knees was not resolved till the time of reporting. No additional information was provided. The reporter consented to follow up.
Age: 93.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: SkinRash & This was reported in January, but occurred in December. Drug was given 1 month prior to rash.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test positive, Hypersensitivity, Rash, Seasonal allergy, Urticaria
Clinical narrative: Pt received the Influenza vaccine on 10/30/2019. The pt was seen at a local Urgent Care on 11/29/2019 with complaints of allergic reaction causing a rash x 2 days. She was noted to have hives in multiple areas. New exposures included a soft toy, a po decongestant, and a new fabric softener. Urgent Care prescribed prednisone taper, Xyzal, and Pepcid. The pt presented to our office on 12/11/2019 for allergic reaction and hives to her face, back, chest and bilateral upper extremities. Her mother explained that her hives returned during the prednisone taper prescribed by the Urgent Care. She was then prescribed another prednisone taper, hydroxyzine prn and was told to continue Xyzal and Pepcid daily. She was also referred to an allergist. The patient followed up at our office on 01/30/2020. Her hives have improved approximately 50%. Her mother explained that her work-up at the allergist has been negative other than allergy panel showing allergies to different grasses which the mother explained the allergist did not feel was related to her hives. The mother explained the allergist mentioned her hives might have been related to the Influenza vaccine she received but he is not certain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swelling at injection site for several days, pain in arm of injection for over a month, bruise that lasted more than a week, a red spot still remains where the injection was given and is still painful to touch. She is following up with her physician next month (February) at her already scheduled annual appointment to discuss red injection site and pain.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Lethargy, Unresponsive to stimuli
Clinical narrative: Dad reported that the day after the vaccine she was "lethargic" "she was out of it" "not responsive" "not smiling to father" from across the room. They went to the ER and the exam showed no abnormal findings, vaccine site was normal and child was acting normal. They followed up in the office today 01/31/2020 and everything was normal on exam.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Headache, Tenderness
Clinical narrative: 6cm X 5 cm oval shaped contusion (RED/ TENDER) with headaches and shoulder blade Px
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PROLONGED ARM SORENESS GREATER THAN 14 DAYS
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: There error was found during an audit
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site rash, Nausea, Peripheral swelling
Clinical narrative: Patient has complaints of chills, dizziness, rash under armpit, moderate left arm swelling, and mild nausea. Reaction is at the site of injection and in the armpit.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient has complaints of chills, dizziness, rash under armpit, moderate left arm swelling, and mild nausea. Reaction is at the site of injection and in the armpit.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hypersomnia, Loss of consciousness
Clinical narrative: Extreme fatigue after receiving the injection. She slept for 20 hours of the next 24 hours and now three weeks later she is sleeping nine hours compared to her normal sleep pattern of seven hours. She blacked out in her bathroom on the third night after the injection.  The patient is still having some mild dizziness.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine error  was  found  during an audit
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Lethargy, Pain
Clinical narrative: Headache, body aches, lethargic, dizziness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Headache, Pain in extremity
Clinical narrative: SORE ARM, FEVER, WEAKNESS, HEADACHE, SHIVERING AND UPSET STOMACH
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: SORE ARM, FEVER, WEAKNESS, HEADACHE, SHIVERING AND UPSET STOMACH
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: dose of improperly stored PROQUAD (Lot S013712 Exp 11/1/2020) was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 15-JAN-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S013712 with expiration date of 01-NOV-2020, for prophylaxis. The sterile diluent used to reconstitute mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.   It was stated that the vaccine underwent a temperature excursion of -12.2°C (degrees Celsius) for 25 minutes. No previous temperature excursion was done. The call was because of a "data logger".
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: injection site reaction after receiving an unspecified flu shot; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; the reaction appeared to be a rash that appeared to be 4 inch long, red. radiated into her soft tissue, felt inflamed and itched; she experienced an inject site reaction within four hours of receiving PNEUMOVAX23; This spontaneous report was received from an 83-year-old female patient reporting on herself. Her concurrent condition included allergy to mango oil. Concomitant therapies included levothyroxine sodium, metoprolol 50 mg, aspirin, unspecified hair skin and nails medications and lorazepam 0.5 mg. No information regarding the patient's medical history was provided. On 31-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one vaccination, intramuscularly (exact dose, lot # and expiration date were not reported) for prevention of pneumonia. Other suspect therapies included unspecified influenza virus vaccine inactivated (reported as flu shot) received on an unknown date.  On 31-DEC-2019, within 4 hours of receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced injection site reaction. The patient mentioned the reaction appeared to be a rash that appeared to be 4 inch long, redness radiated into her soft tissue, felt inflamed and itched. As a treatment, the patient used ice pack, prednisone and diphenhydramine hydrochloride (BENADRYL). No lab diagnostics or studies were performed. The patient did not seek for medical attention. On an unknown date, she experienced an injection site reaction after receiving an unspecified flu shot. The outcome of injection site reaction after receiving an unspecified flu shot was unknown. The outcome of the rest of the events was reported as recovered on 04-JAN-2020.  No causality assessment was provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received doses of GARDASIL 9 on 10-JUN-2019, 13-AUG-2019 and 21-OCT-2019.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported).      On 10-JUN-2019, 13-AUG-2019, and 21-OCT-2019 (inappropriate schedule of product administration), the patient received doses (also reported as 1 dose) of vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administrations, and anatomical location were not reported) (lot number N014464, expiration date 19-DEC-2019).
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Eczema, Mass, Pruritus, Rash
Clinical narrative: developed rash that the dermatologist diagnosed as eczema; developed Rash; bump as localized swelling; Condition aggravated; Itching; This case was reported by a consumer via call center representative and described the occurrence of eczema in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and Shingrix, the patient experienced eczema, rash, mass, condition aggravated and pruritus. On an unknown date, the outcome of the eczema and rash were recovering/resolving and the outcome of the mass, condition aggravated and pruritus were unknown.   It was unknown if the reporter considered the eczema, rash and mass to be related to Shingrix and Shingrix. It was unknown if the reporter considered the condition aggravated and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient developed rash that the dermatologist diagnosed as eczema. It presented after the 1st dose that was administered in either April or May 2019.  It became a little worse after the second dose that was administered in August or September 2019. It was present on the sides of the stomach, feet, the backside of the upper legs and on the left calf. The follow up consent was granted. This case has been linked with case US2020AMR011807, reported by same reporter for same patient. This case US2020011396  was case of recored and US2020AMR011807 would be deleted.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure fluctuation, Fatigue, Guillain-Barre syndrome, Nausea
Clinical narrative: Guillain Barre Syndrome; Fatigue; nausea; decreases and increases in blood pressure; weakness; This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), fatigue (serious criteria hospitalization), nausea (serious criteria hospitalization), change in blood pressure (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, fatigue, nausea, change in blood pressure and weakness were resolved with sequelae.   It was unknown if the reporter considered the guillain barre syndrome, fatigue, nausea, change in blood pressure and weakness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and reporter was not sure whether it was 1st or 2nd dose of vaccine. Few weeks after receiving the vaccine, patient was diagnosed with Guillain Barre Syndrome. The patient also experienced weakness, fatigue, nausea and decreased and increased in blood pressure (blood pressure fluctuation). The patient went to the emergency room  and also went to a walk in clinic. He was hospitalized from 12th January 2019 to 12th November 2019 and then went to a rehabilitation center for some time. The patient was at home at the time of reporting.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: bad allergic reaction to Prevnar13; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 27Jan2020, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from Pfizer-sponsored programs, received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not engage to a doctor, health care professional or pharmacist to get vaccinated in the past 3 months as she had a bad allergic reaction to pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: edema and slight erythema of left lateral thigh surrounding the varicella vaccine injection site. day #1 of swelling was just itchy so mom gave Benadryl. night #2 of swelling started getting painful and child with slight limp due to pain. mom brought to clinic 1/31 and child given ibuprofen with improvement in pain. advised mom to apply cool pack as often as able. no fever since reaction started (did have slight fever after vaccine).
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: edema and slight erythema of left lateral thigh surrounding the varicella vaccine injection site. day #1 of swelling was just itchy so mom gave Benadryl. night #2 of swelling started getting painful and child with slight limp due to pain. mom brought to clinic 1/31 and child given ibuprofen with improvement in pain. advised mom to apply cool pack as often as able. no fever since reaction started (did have slight fever after vaccine).
Age: 15.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine error was found with an audit
Age: 15.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: error found on an audit
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given a second dose of Pneumovax in error.  Two doses were 2 years and 9 months a part.  (Prevnar 13 was ordered0
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Left arm is red,swollen and tender to touch,patient denies fever.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Haematoma, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm Pain, stiffness, sore, redness where shot given.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Ultrasound scan abnormal
Clinical narrative: Arm Pain, stiffness, sore, redness where shot given.
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dysgeusia, Headache, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Severe muscle weakness, redness and swelling at injection site, headache, muscle pain that seemed to  move throughout body, insominia, medal taste in mouth
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Severe muscle weakness, redness and swelling at injection site, headache, muscle pain that seemed to  move throughout body, insominia, medal taste in mouth
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever 101.5, severe muscle pain, lethargy
Age: 115.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: error found on an audit
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dysstasia, Fall
Clinical narrative: Fell to floor when getting out of recliner I could not get up. A neighbor came to my house and eventually was able to get me up (It was very hard). Unsteady for most of day
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Child had pain to Righ Thigh and redness Had temp of 100 following day.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles/ shingles lasted several months causing severe pain and suffering which; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about June 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (dose, administration route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles.  On or about August 2016, the patient was diagnosed with shingles by the attending physicians at the hospital. Patient's shingles lasted several months causing severe pain and suffering which required multiple trips to the Emergency Department. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. The patient sustained severe and permanent personal injuries.  The outcome of the shingles was unknown and the causality assessment between this and the vaccination with zoster vaccine live (ZOSTAVAX) was considered to be related. Upon internal review, the singles was consider as serious due to disability.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: experienced no symptoms; expired dose of VAQTA administered; Information has been received from an X-ray technician and refers to a patient of unspecified age and gender.  The patient's concurrent conditions medical history or concomitant medications were not reported.  On 24-JAN-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (dose number, dose, frequency and anatomical location were not reported) lot number R032910 with expiration date 18-NOV-2019.  The patient experienced no symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Shingles; Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced neuropathy and shingles.  As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events of neuropathy and shingles was considered as not recovered. The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of neuropathy was determined to be medically significant. The events of neuropathy and shingles were considered to be disabling.
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 24 day old patient was inadvertently administered a dose of PEDVAX HIB; This spontaneous report as received from a other health professional refers to a 24 day old patient. On 30-JAN-2020 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S006470, .5 milliliter for prophylaxis. On 30-JAN-2020, 1 day after onset of therapy the patient experienced product administered to patient of inappropriate age. The outcome of product administered to patient of inappropriate age is unknown.
Sex: M
Vaccine: DTAP, HEP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: child received 2 Daptacel immunizations 2 weeks apart/no AE; child received 2 Daptacel immunizations 2 weeks apart instead of Hepatitis B/no AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old male patient who received two DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of HEPATITIS B VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation, Lot number- C5621AA, expiry date- 5/23/2021.  On 26-Dec-2019, the patient received 0.5mL third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5621AA via intramuscular route in the left vastus lateralis and recieved one more dose of DAPTACEL in 2 weeks apart instead of HEPATITIS B VACCINE for prophylactic vaccination .  It was a case of actual medication error due to inappropriate schedule of product administration and wrong vaccine administered.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: muscle aches; temperature; 10 cm area around her injection site of raised, red, warm and tender to touch; 10 cm area around her injection site of raised, red, warm and tender to touch; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a other non-health professional.  This case involves a 74 years old female patient who experienced patient had temperature (Body temperature increased) and muscle aches (myalgia) and 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation and vaccination site reaction) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Influenza Vaccine and she did not had any reactions.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Jan-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ27488 and expiry date: not reported) via unknown route in the left arm.  On unknown date, the patient developed a non-serious 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation) two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On unknown date, the patient developed a non-serious muscle aches (myalgia) and temperature (Body temperature increased) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was myalgia, Body temperature increased, vaccination site reaction and Inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for muscle aches and temperature,   On 22 jan 2020, the patient was Recovering from inflammation and it was still somewhat tender to touch.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Myalgia
Clinical narrative: muscle aches; temperature; 10 cm area around her injection site of raised, red, warm and tender to touch; 10 cm area around her injection site of raised, red, warm and tender to touch; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a other non-health professional.  This case involves a 74 years old female patient who experienced patient had temperature (Body temperature increased) and muscle aches (myalgia) and 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation and vaccination site reaction) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Influenza Vaccine and she did not had any reactions.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Jan-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ27488 and expiry date: not reported) via unknown route in the left arm.  On unknown date, the patient developed a non-serious 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation) two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On unknown date, the patient developed a non-serious muscle aches (myalgia) and temperature (Body temperature increased) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was myalgia, Body temperature increased, vaccination site reaction and Inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for muscle aches and temperature,   On 22 jan 2020, the patient was Recovering from inflammation and it was still somewhat tender to touch.
Age: 1.0
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 4th dose at aged 12 months of age/no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12-month-old patient of unknown gender who experienced received 4th dose of IPV (VERO) [IPOL] at inappropriate schedule. Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due inappropriate schedule of vaccine administered.   At the time of report, it was unknown whether adverse event was experienced or not.  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 and Module VI of the 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.  Information on the batch number was requested.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: nurse pulled the diluent and did not mix the powder and administered just the diluent to the patient, no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six month old patient (gender not reported) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to active ingredient not added to diluent.  It was reported that one of the nurse pulled the diluent and did not mix the powder and administered just the diluent.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was administered separately(just the DTaP-IPV portion) and then a second combined dose was administered later / no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who received DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel ) (0.5 mL dose, Carton- UJ083AAA, expiry date: 13-Oct-2020, DTaP-IPV - UJ104AA, Exp: 13-Oct-2020) via intramuscular route in right thigh for prophylactic vaccination on 22-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), INFLUENZA VACCINE (INFLUENZA) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to Wrong technique in product usage process.  It was reported that dose of Pentacel was administered separately (just the DTaP-IPV portion) and then a second combined dose (Carton- UJ056AAA, expiry date 24-Oct-2020, Hib - UJ056AA, Expiry date 27-Oct-2020, DTaP-IPV - UJ6257AA, Expiry date 27-Oct-2020) was administered later.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HEP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Adacel to a newborn baby instead of the Hep B/ no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 hour old (neonate) male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of the HEPATITIS B VACCINE (Wrong product administered).   The past vaccination and family history were not provided.  On 22-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (batch number- U6511AQA, expiry date- 22-Oct-2021) via intramuscular route in right leg for immunization.  Concomitant medications included VITAMIN K for Immunisation.  It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting no adverse event was observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was given to a 2 yr old instead of pediatric DTap/no AE; Adacel was given to a 2 yr old instead of pediatric DTap/no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 24 month old male patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5519AA)  via an unknown route at an unknown administration site instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (Batch number, expiration date, dose, route and site of administration were not reported) on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided  It is an actual medication error case due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was reported that by mistake Adacel was given to a 2 yr old instead of pediatric DTap for the 3rd dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: nurse gave Adacel instead of the 4th Daptacel dose, NO AE; nurse gave Adacel instead of the 4th Daptacel dose, NO AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 15 months 9 days old male patient who was vaccinated with 0.5 ml dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Prefilled syringe instead of the fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] On 21-Jan-2020 for prophylactic vaccination.  It was actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.   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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 7.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok vaccine was given to a seven year old patient, no AE; Initial information was received on 23-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a seven years old patient (gender not reported) who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1942 and expiry date 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, past medical treatment, vaccination and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration..  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Erythema, swelling, pain, and warmth that started the night of the injection. Has continued on evaluation three days after the injection.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Suspected SIRVA
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Poor quality sleep
Clinical narrative: Patient experienced pain the morning after her vaccine and the pain continues through to now.  Her pain prevents her good sleep and inhibits her range of motion.  She was counseled by her physician to report the injury and was given any other diagnosis for pain.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: paresthesias in R arm, loss of sensation, decreased pain sensation in hand
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Patient received Prevnar-13 vaccine on 1/29/2020 Itching and rash onset 5 hours after injection; he denies started new medications or eating new food items or being outdoor prior to onset of symptoms. Prednisone 10 mg- take daily 5 tablets on day 1. 4 tablets on day 2, 3 tablets on day 3, 2 tablets on day 4, 1 tablets on day 5, Disp #15/0 refill Hydroxyzine 25 mg one tablet Q6H PRN Itching, #30/0 refill Take prescribed Medications as prescribed Avoid hot shower- take tepid warm shower, use mild soap or Aveeno body wash Avoid prolonged sun exposure or heat or very cold temperature Ok to use Calamine lotion OTC as needed Report to the nearest emergency room for worsening symptoms or any respiratory symptoms such as shortness, throat tightness or discomfort or chest pain Patient voiced understanding and agreed to plan of care
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Exposure during pregnancy
Clinical narrative: Very easy pregnancy. Due date June 6th.  No prior issues   After given the shot digestive issues began Diarrhea 3/ daily with accompanying stomach pain   Noticed eating cereals/oatmeal?s made symptoms worse   5lbs birth weight
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling hot, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: MILD FLU-LIKE SYMPTOMS (FEVER, CHILLS, FEELING HOT, SWEATING) AND RASH ON SKIN ON BOTH RIB CAGE AREAS THAT DOES NOT ITCH. TOLD PATIENT TO TAKE BENADRYL AND SEE IF THAT HELPED.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: MILD FLU-LIKE SYMPTOMS (FEVER, CHILLS, FEELING HOT, SWEATING) AND RASH ON SKIN ON BOTH RIB CAGE AREAS THAT DOES NOT ITCH. TOLD PATIENT TO TAKE BENADRYL AND SEE IF THAT HELPED.
Age: 1.33
Sex: F
Vaccine: DTAPIPV, FLU4, PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Quadracel (DTaP/ IPV) which is not recommended for children under age 4yrs patient should have received Pentacel
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Pediarix after 7th birthday on 11/15/2019.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint injection, Magnetic resonance imaging abnormal
Clinical narrative: Patient is a nurse it was given influenza vaccine at her workplace.  She believes vaccine administration was done higher and deltoid then should have been.  Reported immediate pain with the injection that felt abnormal.  She continued to feel increasing pain in the shoulder later in the day.  Same day she began to have anterior biceps and deltoid tightness and was unable to raise her right arm overhead across her body or behind her back.  She sought evaluation and care from occupational medicine nearly 2 weeks later on October 25, 2019.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Osteoarthritis, Product administered at inappropriate site
Clinical narrative: Patient is a nurse it was given influenza vaccine at her workplace.  She believes vaccine administration was done higher and deltoid then should have been.  Reported immediate pain with the injection that felt abnormal.  She continued to feel increasing pain in the shoulder later in the day.  Same day she began to have anterior biceps and deltoid tightness and was unable to raise her right arm overhead across her body or behind her back.  She sought evaluation and care from occupational medicine nearly 2 weeks later on October 25, 2019.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Urticaria, X-ray normal
Clinical narrative: left shoulder welt initially, severe pain x 2 wks leading to urgent care visit; left shoulder range of motion decreased x 4+ months
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Administration site odour, Injection site cellulitis, Injection site discharge, Injection site rash
Clinical narrative: Rash like cellulitis formation around injection site noted on 25 Jan 2020. Patient noticed site still weeping accompanied with foul odor on 31 Jan 2020.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site paraesthesia, Musculoskeletal disorder
Clinical narrative: Lot: Y5J27 Patient reported tingling at the site immediately that resolved. Then later reported the arm was numb and loss use of it.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: 1/17/2020 Telephone call to clinic. . C/o of having a rough night unable to sleep.  due to pain to (L arm)  at site of pneumonia, c/o of chill and  high fever..  1/21/2020 called client doing better, still complaining of arm soreness, and low grade temperature.