chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I'm so sick; feel like I have the flu; can't move my arm hurts so much; can't move my arm hurts so much; my temp is 101; i have headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering. On an unknown date, the outcome of the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering to be related to Shingrix.  Additional case details were reported as follows: The patient got sick and felt  like the flu after receiving Shingrix. The patient could not move the arm it hurt so much, and had fever (101 degree C). The patient also experienced headache and shivering after receiving Shingrix. The patient asked getting a 2nd dose or would all the events get worse.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigued for about 3; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue 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 experienced fatigue for about 3 days after receiving 1st dose of Shingrix. For tolerance with the 2nd dose of Shingrix, refer linked case US2020AMR015679.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Swelling, Tenderness
Clinical narrative: tenderness/ tenderness that had radiated into her armpit; swelling; chills; fever; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received Shingrix. On 25th January 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 26th January 2020, the patient experienced tenderness and swelling. On an unknown date, the outcome of the chills and fever were resolved with sequelae and the outcome of the tenderness and swelling were recovering/resolving.   It was unknown if the reporter considered the chills, fever, tenderness and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and developed chills and a fever of 101 degrees F on 25th January 2019. She went to pharmacy and reported that she had tenderness that had radiated into her armpit and it was swollen. No other information was reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain from the shoulder to elbow; Neck pains; Middle 3 fingers are tingling and/or losing feeling; Dull pain/achiness/upper body aches and pain; Middle 3 fingers are tingling and/or losing feeling; Heaviness; This is a spontaneous case reported by other health professional (pharmacist) to agency (reference number: SEQ20-00436) and initially received on 29-Jan-2020, concerning a 60-year-old, female patient.  The patient's medical history included occasional seasonal allergies and polycystic kidney.  The patient's concomitant medications were not provided.  On 12-Nov-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 261983, expiration date: Jun-2020 and route of administration: intramuscular) for prevention of seasonal influenza.  On 14-Nov-2019, 2 days after getting the flu shot, the patient experienced neck pains, ongoing pain from the shoulder to elbow, dull pains, achiness, heaviness and the middle 3 fingers were tingling and/or losing feeling. It was also reported that the patient had ongoing upper body aches and pain.  On an unspecified date, the patient was treated with Tylenol (paracetamol).  At the time of initial reporting, the patient had not recovered from the events. The patient was still experiencing symptoms, so she was advised to contact a physician.  All the events were considered as serious due to criterion of medical significance, per reporter.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.; Sender's Comments: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Pain from the shoulder to elbow; Neck pains; Middle 3 fingers are tingling and/or losing feeling; Dull pain/achiness/upper body aches and pain; Middle 3 fingers are tingling and/or losing feeling; Heaviness; This is a spontaneous case reported by other health professional (pharmacist) to agency (reference number: SEQ20-00436) and initially received on 29-Jan-2020, concerning a 60-year-old, female patient.  The patient's medical history included occasional seasonal allergies and polycystic kidney.  The patient's concomitant medications were not provided.  On 12-Nov-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 261983, expiration date: Jun-2020 and route of administration: intramuscular) for prevention of seasonal influenza.  On 14-Nov-2019, 2 days after getting the flu shot, the patient experienced neck pains, ongoing pain from the shoulder to elbow, dull pains, achiness, heaviness and the middle 3 fingers were tingling and/or losing feeling. It was also reported that the patient had ongoing upper body aches and pain.  On an unspecified date, the patient was treated with Tylenol (paracetamol).  At the time of initial reporting, the patient had not recovered from the events. The patient was still experiencing symptoms, so she was advised to contact a physician.  All the events were considered as serious due to criterion of medical significance, per reporter.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.; Sender's Comments: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.
Age: 12.0
Sex: F
Vaccine: HEP, HPV9, MNQ, TDAP
Symptoms: Heart rate increased, Syncope
Clinical narrative: Patient fainted approximately 5 minutes after last vaccine (Hepatitis B) was administered.  Patient's guardian stated that patient had not eaten before arriving to clinic for vaccines.  Patient was nervous about pain from vaccines being administered and was instructed by nurse staff to relax and take deep breaths.  Patient was administered oxygen and EMS was called.  All vitals were normal other than accelerated heart rate (likely due to anxiety as per EMS personnel).  Guardian refused transportation to emergency room and stated that they would take patient home to eat and rest.  Staff attempted to contact guardian for follow up but there was no answer to telephone call and unable to leave voicemail.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, CSF protein increased, Computerised tomogram head, Computerised tomogram neck, Demyelination
Clinical narrative: symptoms started on 11/28 with tingling/numbness to hands/feet. By 12/01 she was having generalized parasthesias, weakness, and difficulty with ambulation. Admitted to hospital. Diagnosed with GBS  Numerous IVIG treatments. Receiving intense physical therapy at Hospital for Special Care due to weakness and inability to walk without assistance
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: symptoms started on 11/28 with tingling/numbness to hands/feet. By 12/01 she was having generalized parasthesias, weakness, and difficulty with ambulation. Admitted to hospital. Diagnosed with GBS  Numerous IVIG treatments. Receiving intense physical therapy at Hospital for Special Care due to weakness and inability to walk without assistance
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Paraesthesia, Walking aid user
Clinical narrative: symptoms started on 11/28 with tingling/numbness to hands/feet. By 12/01 she was having generalized parasthesias, weakness, and difficulty with ambulation. Admitted to hospital. Diagnosed with GBS  Numerous IVIG treatments. Receiving intense physical therapy at Hospital for Special Care due to weakness and inability to walk without assistance
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture positive, Herpes simplex test positive, Influenza like illness
Clinical narrative: Per the individual's report:  -Slept for 3 days after the injection due to flu like symptoms  1/11/2020- 3 small blisters on left lower back appeared 1/16/2020- Saw urgent care Dr.- told it was not concerning 1/17/2020- Saw dermatologist- blisters cultured- started on valacyclovir 500mg BID for 7 days and mupirocin ointment BID. 1/24/2020- follow up with dermatologist- 3 more blisters on right side of face- cultured- notified that first culture was positive for herpes virus 1/30/2020- notified that second culture was positive for herpes virus. Original course of treatment completed and blisters were healed at this point- no further course of treatment.  Client's blisters never itched, burned, hurt or caused any sort of discomfort per the individual.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: -Severe shoulder pain  -Rash developed 4 days later  -Sore arm upon reaching  -Fever
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Heart rate increased, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Father called 2-3-2020 - reported rapid HR - 188 Bilateral thighs - rash/welts/swelling above + below injection sights
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Heart rate increased, Injection site pain
Clinical narrative: Dizziness, rapid pulse (124bpm), temp 101df; site soreness for 3 days
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Posture abnormal
Clinical narrative: 01:10 PM-Patient consented to receive Bexsero vaccine. Mother present. 01:11 PM-Patient states, "I feel light headed like the last time." Began to slump down in seat. Moved patient into a safe position, legs elevated and Code Blue was called. 01:13 PM-Patient Alert and oriented X 3. Cool towel placed on forehead. Blood pressure 137/82, pulse 77. 01:15 PM-Alert and oriented. Sitting in upright position. Given juice and crackers. Tolerated well. No complaints voiced.  01:17 PM-Alert and oriented. Blood pressure 125/86, pulse 76. Able to stand without difficulty. Ambulated to lobby unassisted. Denies any dizziness or difficulty. Mother present. Instructed to notify MD if symptoms return.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Rash macular
Clinical narrative: Large area (20 cm x 30 cm) of redness, warmth, swelling at area of vaccination. Also headache and chills w no fever. Several areas of pruritic macular rash on ankle and hip. Treated for cellulitis of (L) arm with Keflex.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large area (20 cm x 30 cm) of redness, warmth, swelling at area of vaccination. Also headache and chills w no fever. Several areas of pruritic macular rash on ankle and hip. Treated for cellulitis of (L) arm with Keflex.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient experienced no symptoms; a dose of Rotateq was administered to a patient who is 36 weeks and 4 days old; This spontaneous report was received from a nurse and refers to a 36 weeks and 4 days old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JAN-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # R033251, expiration date 29-JUN-2020 (dose was not provided), for prophylaxis (Inappropriate schedule of vaccine administered). The patient experienced no symptoms. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Thrombocytopenic purpura
Clinical narrative: severe thrombocytopenic purpura.; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On approximately 11-DEC-2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on unknown date, the patient suffered and was diagnosed with severe thrombocytopenia purpura. The patient's symptoms resulted in physical limitations not present prior to using the Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient also sustained severe and permanent personal injuries, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the patient's outcome was unknown, and the event of severe thrombocytopenia purpura was assessed as related.  Upon internal review, the event of thrombocytopenia purpura was considered medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO additional adverse effect reported; patient was administered a dose of improperly stored Proquad; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 28-JAN-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, subcutaneously, lot # S012535, albumin status rHA, expiration date 20-OCT-2020 (exact dose and anatomical location were not reported) for prophylaxis. The vaccine was diluted with a properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of - 14 degrees Celsius to - 10 degrees Celsius (-12.6 degrees Celsius) for 9 hours and 53 minutes. Digital Data Logger was involved. The vaccine underwent previous temperature excursion of - 14 to - 10 degrees Celsius (- 13 degrees Celsius) for 14 hours and 22 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001486:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; an administered dose of V ARlV AX underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 28-JAN-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # R034396, expiration date 28-JAN-2020, (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   The vaccine underwent a temperature excursion of - 14.6 degrees Celsius for 17 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Deafness neurosensory, Dizziness, Nausea, Sudden hearing loss
Clinical narrative: right sudden sensorineural hearing loss; tinnitus; vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 26-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered dizziness, hearing loss, ringing in the ears and nausea. The patient was diagnosed with right sudden sensorineural hearing loss, tinnitus and vertigo. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the event of right sudden sensorineural hearing loss was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Vertigo
Clinical narrative: right sudden sensorineural hearing loss; tinnitus; vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 26-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered dizziness, hearing loss, ringing in the ears and nausea. The patient was diagnosed with right sudden sensorineural hearing loss, tinnitus and vertigo. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the event of right sudden sensorineural hearing loss was determined to be medically significant.
Age: 1.25
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adacel was given to a 15 month old in error, was due Daptacel/no AE; Adacel was given to a 15 month old in error, was due Daptacel/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age) (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included Prevenar 13 and HIB   On 28-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5577AA, expiry date: 20 Feb 2021) via intramuscular route in the right vastus lateralis instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for prophylactic vaccination. Patient was supposed to receive 4th dose of Daptacel in series.   This is a case of actual medication error due to product administered to patient of inappropriate age and wrong product administered.  At the time of this report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: ActHIB was reconstituted with sterile water and the DTAP-IPV portion was not administered at all, no AE; ActHIB was reconstituted with sterile water and the DTAP-IPV portion was not administered at all, no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who received ActHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was reconstituted with sterile water and the DTAP-IPV portion was not administered at all.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 28-Jan-2020, the patient received ActHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Act-Hib lot UJ053AA expiry date 27-Oct-2020 and Box lot UJ053AAA expiry date 27-Oct-2020) that was reconstituted with sterile water and the DTAP-IPV portion (lot number U6257AA expiry date 27-Oct-2020) was not administered at all, via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to wrong solution used in drug reconstitution and Inappropriate reconstitution technique.  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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inadvertent administration of just the HIB portion of the Pentacel vaccine to a child/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old male patient who was not administered the other part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml dose intramuscularly in left thigh on 27-Jan-2020 and reconstituted the HIB with sterile water/no AE (product preparation issue) for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  This is a case of actual medication error due to Inappropriate reconstitution technique.   It was reported patient had no adverse event.  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: 0.33
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: four month old male patient received Adacel vaccine, no AE; four month old male received Adacel in error and not the prescribed DTap, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received a 0.5mL second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via an intramuscular route in the right thigh, on 25-Feb-2019 for prophylactic vaccination, instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included HIB VACCINE (HIB) for Immunisation.  It was actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that 4- month old male received Adacel in error and not the prescribed DTap. Hence the patient received PediaRX for the Dtap in 6 months of age. The event was discovered while reviewing the chart when the patient came for 6 month vaccination.  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 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.
Sex: U
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given both Pediarix and Ipol about 30 minutes ago / no AE; Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a Consumer/Non-HCP (office Staff).  This case involves patient (with unknown demographics) who had received doses within 30 minutes ago of vaccine POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] and  DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] (lot number and Exp. 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 extra dose administered.   It was reported that A nurse pulled Pediarix, which contains a polio component, and also pulled IPOL. The patient was given both Pediarix and Ipol about 30 minutes ago.  At the time of reporting, the patient had no adverse reactions.  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.
Sex: U
Vaccine: IPV
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: some of the vaccine got into the medical assistant's eye while giving IPOL, no AE; some of the vaccine got into the medical assistant's eye while giving IPOL, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who was exposed to IPV (VERO) [IPOL] (lot number and expiry date not reported) in her eye while giving it to the patient.  Medical history, medical treatment, vaccination and family history were not provided.  This was a case of actual medication error due to accidental occupational exposure to product and Exposure via eye contact.   It was also a case of exposure via eye contact. It was reported that CMA (certified medical assistant) was giving patient Ipol vaccine when some of the vaccine got into the CMAs eye.   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 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: 42.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired Tenivac vaccine, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from other healthcare professional (Medical assistant).  This case is linked to case 2020SA028678 (same reporter).  This case involves 42 year old male patient who received an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U5856AA, Exp. Date 26-Jan-2020) via unknown route in unknown administration site on 30-Jan-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Tenivac was administered/no AE; Initial information was received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA028498 (same reporter).  This case involves a female patient who received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC (Dosage form- Injection) ]/no AE(expired product administered) for prophylactic vaccination[lot U5856AA, expiry date:26-JAN-2020, other dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the 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.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired Tenivac was administered to a patient/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 months old female patient who received an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] for prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.   On 31 Jan 2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number U5854AA (expiry date: 25-Jan-2020) via intramuscular route in right deltoid.  It was of actual medication error due to expired vaccine used (expired product administered).  It was unknown whether adverse event was noted 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 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: FLU4
Symptoms: Incorrect dose administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: given the adult dose of the Fluzone Quadrivalent instead of the kids dose/no AE; given the adult dose of the Fluzone Quadrivalent instead of the kids dose/no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who received adult dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (VACCINE lot UT6695LA via unknown route) instead of pediatric dose on an unknown date.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to inappropriate dose of vaccine administered and overdose.  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 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: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4th dose of DTaP was accidentally administered 1 month short of the ACIP recommended interval schedule for this vaccine. It was suppose to be administered 6 months after 3rd dose but was administered 5 months after. 3rd dose was administered on 08/24/2019. There was no reaction , patient tolerated well. We realized this occurred yesterday when our office received an "imms error report".
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 1/18/2020 19:19 pneumonia vaccine administered R arm. 1/19/2020 16:00 pt temp was 99.5 and on 1/20/2020 16:10 was 100.3.  On 1/21/2020 during doctors rounds pt presented with complaint of pain at injection site with 3x5 inch diameter area of erythema / edema.  Warm to the touch.  Diagnosis of cellulitis. Clindamycin 300mg po QID x 21 doses. Also had tylenol & motrin available for pain / fever.  1/21/2020 per nurse practitioner note area of edema / erythema was 2.5x4inches.  Pt later discharged routinely to home with instructions to complete clindamycin.  Cold packs encouraged.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Basedow's disease, Blood test, Goitre, Scan thyroid gland
Clinical narrative: Got my second HPV vaccine and two weeks later my thyroid was swollen. My regular doctor send me to get the thyroid scan done and blood work. Later was diagnosed with Graves disease by Endocrynology doctor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechia and ITP (thrombocytopenia)
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
Clinical narrative: Pt was seen in office 02/03/20 and received his kinrix (rt thigh) and proquad (left thigh) vaccine by MA . Mother of patient called office 02/06/2020 to advise and get advice on swelling in the patients left, mother spoke to Triage MA which than came to inform nursing supervisor about the situation, than advised triage MA to bring patient in for apt today to see NP. Patient arrived at office with father, Nursing supervisor went into room and assessed the patient?s legs which were swollen and warm to touch. Father upset about situation and spoke with nursing supervisor. Patient seen NP and she sent patient to the ER for further treatment and evaluation. Nursing supervisor looked up records on database and have given them to provider to review and place into patients chart, patient received Clindamycin 150mg oral three times daily and discharged patient home 02/06/2020
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Two days after receiving vaccination, developed 1/4 inch sized welts on abdomen and both legs
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: THE PATIENT RECEIVED THE SHINGRIX VACCINE ON 1/29/20 AND STATED THAT SHE DEVELOPED A SHINGLES RASH WHICH SPREAD INTO HER EYE ON 2/1/20. SHE RECEIVED MEDICAL ASSISTANCE AND WAS PRESCRIBED VALACYCLOVIR AND IS BEING CLOSELY MONITORED. SHE HAS A FOLLOWUP APPOINTMENT ON 2/8/20 WITH A PHYSICIAN.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Ophthalmic herpes zoster
Clinical narrative: THE PATIENT RECEIVED THE SHINGRIX VACCINE ON 1/29/20 AND STATED THAT SHE DEVELOPED A SHINGLES RASH WHICH SPREAD INTO HER EYE ON 2/1/20. SHE RECEIVED MEDICAL ASSISTANCE AND WAS PRESCRIBED VALACYCLOVIR AND IS BEING CLOSELY MONITORED. SHE HAS A FOLLOWUP APPOINTMENT ON 2/8/20 WITH A PHYSICIAN.
Age: 27.0
Sex: F
Vaccine: HEPA, JEV1, TYP
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Patient became nauseate, lightheaded and flushed. Lasted only 15 minutes. Vital signs stable.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: REDNESS ON ARM, STARTED ON SATURDAY AFTER INJECTION, AND ON TUESDAY SEEMED TO BE GETTING LARGER
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not have any adverse events .  She was supposed have been given her 4th DTaP,  but was given the Tdap instead.   Patient was monitored/observed for 20-25 minutes after injection was given and did not display any adverse reactions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Immediate post-injection reaction, Injection site swelling, Malaise
Clinical narrative: Significant swelling at injection site starting immediately after injection and lasting 3 weeks before clearing up.  Patient reported it was "baseball size" swelling with corresponding discomfort.  She also reported having a severe headache that began the day of vaccine and lasted approximately 24 hours and which kept her in bed.  She also reported feeling ill which did not resolve for approximately 1 week after vaccination.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: REDNESS ON ARM
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Exposure during pregnancy, Injection site swelling, Musculoskeletal pain, Pain
Clinical narrative: Patient is a 31 y.o  female G9P1 approx 31w4d with EDC of 4/5/20. Patient has a past medical h/o abnormal pap smear, migraines, ectopic pregnancy, and chlamydia. This pregnancy has been healthy. She does has a positive antibody screen for Anti-Leb which is relatively insignificant. She was seen at the office for a prenatal visit on 2/4/20 and was given a 3rd trimester TDAP injection in (L) deltoid. Injection was tolerated well but patient reported increased swelling in arm and around injection site the next day and increased shoulder and upper back pain. She was instructed to come into the office today, 2/6/20, for evaluation. Upon assessing her arm, writer noticed (L) upper arm was swollen with a circumference measuring 39.5cm (right arm which is dominant measured 38.2cm) with a 2cmx4cm raised, red hive. Writer also noted that patient's (L) upper arm, shoulder and scapula were very tender to touch and patient reported pain with any arm movement. Midwife, CNM came and evaluated patient as well.  No numbness, tingling, or weakness noted but swelling, hives and shoulder pain are concerning for brachial neuritis. Patient was instructed to take Benadryl and Tylenol and to monitor symptoms. Since swelling and pain were slightly improved from the day before, midwife was hopeful that patient is recovering from reaction. She was instructed to call her PCP immediately if pain or swelling worsens.