chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product preparation error, Product preparation issue, Underdose
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to cases 2018SA393504 same reporter. This case involves a 6 months old male patient who received 0.25 mL dose of vaccine PENTACEL lot C54009AA, expiry date: 10-Oct-2019 via intramuscular route in the right arm on 07-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique and vaccine underdose. It was reported that 6 months old males were administered 0.25 ml, IM injections, of the powder part of the PENTACEL vaccine that were diluted with sterile water. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue, Underdose
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office staff). This case is linked to cases 2018SA39350, same reporter. This case involves a 6 months old male patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included ROTO-TECH via oral route. On 07-Dec-2018, the patient received a 0.25ml dose of suspect PENTACEL lot C54009AA, expiry date 10-Oct-2019 via intramuscular route in the right arm. It was an actual medication error due to inappropriate reconstitution technique and vaccine underdose. It was reported that PENTACEL vaccine was given to six month olds without it being properly mixed with the diluent. The powder part of the PENTACEL vaccine that were diluted with sterile water. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 24 months old female patient who supposed to vaccinated with a 0.5ml dose of PENTACEL (lot C5529AA and Exp. Date 04-OCT-2019) but only received the PENTACEL Hib component that was diluted with sterile water via unknown route in the right thigh on an unspecified date. The patient's medical history not reported and concomitant medications included PROQUAD and HEPATITIS B VACCINE for Immunization. It was an actual medication error case due to inappropriate reconstitution technique. No reported side effects. 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. List of documents held by sender: none.
Sex: M
Vaccine: DTAP, FLUC4, HIBV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a four- years old male patient who was inadvertently administered with a 0.5 ml single dose of ACTHIB] (lot number: UI912AAA; expiry date: 14-Nov-2019) via unknown route in the left thigh on 17-Dec-2018 instead of IPV (VERO). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; FLUCELVAX QUADRIVALENT for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to extra dose administered and wrong product administered. It was reported that the patient had received all ACHIB vaccinations and on 17-Dec-2018 was supposed to receive Ipol but instead got an extra ACTHIB. The patient did not experience any 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 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. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, MMR, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who received 0.5 ml fourth dose of vaccines PENTACEL (The Hib Lot # C5576AB. The PENTACEL Box Lot # C5576AB. PENTACEL Box NDC# 49281-510-05, The PENTACEL Vial NDC# 4928151005, Diluent DTap/Ipol Lot # C5447AA and the DTap/IPOL NDC# 49281-560-05) instead of KINRIX on 12-Dec-2018 via intramuscular route in the right deltoid. It was also reported that the child received an extra HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the child has only gotten 3 PENTACELS. Concomitant medications included MMR for Immunisation; VARICELLA VACC. for Immunisation; and FLUZONE QUADRIVALENT 0.5 ml  for Immunisation. On 12-Dec-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5576AB via intramuscular route in the right deltoid. On an unknown date, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to wrong vaccine administered and Extra dose administered. It was not reported if the patient had any adverse event. 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. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves Four years old female who was vaccinated with 0.5ml dose of vaccine PENTACEL (lot number C5576AB (Expiry date unknown) via intramuscular route in the right deltoid instead of KINRIX. Patient had earlier received three dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR, VARICELLA VACCINE, and FLUZONE QUADRIVALENT. It was an actual medication error case due Wrong vaccine administered. (It was reported that KINRIX vaccine was ordered and PENTACEL was given to a 4 year old patient by mistake). It was reported that the patient did not experience any 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 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. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Overdose
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 35-months-old male patient who received 0.5 ml dose of FLUZONE QUADRIVALENT on 28-Nov-2018 (lot number: UT6331LA and expiry date: 30-Jun-2019) (dose in series and route was not reported) in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of Hepatitis A vaccine on same visit. It was a case of actual medication error due to overdose. It was not reported if any adverse event occurred following vaccination. 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. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old patient of unknown gender who received vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. 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. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a four-years-old female patient who received a 0.5 ml dose of vaccine FLUBLOK QIV (lot number QFAA1831) via intramuscular route in the left deltoid on 18-Dec-2018 (reported as yesterday). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Alopecia
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious courtesy case received from Merck Research Laboratories via Non-Healthcare Professional or consumer. This case involves a 71 years old female patient who experienced severe hair loss, hair continues to come out when she combs it or wipes it, while she received vaccines FLUZONE HIGH DOSE and PNEUMOVAX 23. The patient's past medical history included Drug hypersensitivity (allergy to Sulfa drugs). Also no medical history of hair and no concomitant medication was administered. On 11-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX 23 (lot number, Exp. Date, route and administration site not reported for both vaccines). On an unknown date, the patient developed non-serious severe hair loss, hair continues to come out when she combs it or wipes it few days to a week following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX 23. No lab studies/ diagnosis performed. Final diagnosis was severe hair loss hair continues to come out when she combs it or wipes it. The patient did not receive any corrective treatment. The event outcome was not recovered. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein increased, Pain
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 75 years old female patient who experienced pain and it was the worst, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. At the time of the event, the patient had ongoing Autoimmune disorder (that include symptoms of Lupus, Rheumatoid Arthritis and Sjogren's Syndrome), Hypertension, Blood cholesterol, Diabetes mellitus takes meds for this and reports well controlled and Methotrexate Sodium for autoimmune issues. On an unknown date in October 2018, the patient received a 0.5 mL dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious pain and it was the worst (pain) within three days following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Labs were done and she reported all were normal except her CRP (C reactive protein) which was 38 but a week later it was back in normal range. Final diagnosis was pain and it was the worst. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old male patient who received a 0.5 ml of vaccine FLUBLOK QIV (lot number: QFAA1824, expiry date: 30-Jun-2019) via unknown route in the left deltoid on 20-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given to the patient. It was a case of actual medication error due to inappropriate age at vaccine administration because safety and efficacy does not establish in that age group to revaccinate with age appropriate flu vaccine. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 3 patients of unknown demography who received deteriorated vaccine IPOL (lot N1J451M and expiry date 05-Oct-2019) of which some opened and some unopened was left at 48F for 102 hours, via route in unknown administration site on an unknown date. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event. 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. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: This is a serious study case, initially received from Physician on 26-Jan-2018, concerning an elderly, male patient in his 80's, enrolled in market research study. The patient's relevant medical history and social history was not reported. On an unspecified date, the patient was administered with Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: injection (as reported), anatomical location, batch number and expiry date: not reported) for influenza vaccination. On an unspecified date, the patient diagnosed with Flu. The patient died due to flu over Xmas week, between 24-Dec-2017 and 31-Dec-2017. It was unknown, whether the autopsy performed. The reporter assessed the event (flu) as serious (death). Significant case amendment (26-Jan-2018): The as determined listedness' of the event 'Flu' was corrected from listed to unlisted in event assessment tab.; Reporter's Comments: A male patient of unspecified age was diagnosed with flu (influenza) which resulted in fatal outcome, unspecified period after receipt of Flu Vaccine Cell Subunit QIV NVD.The causal role of study vaccine for influenza can not be assessed, as minimal information is available regarding vaccination date, onset latency, clinical presentation, detailed investigations (swab and blood culture, immunological tests), immune status of the patient prior to vaccination, concurrent conditions and relevant medical history. Similarly, since the strain and type of influenza is not known, vaccination failure cannot be considered.; Reported Cause(s) of Death: Flu.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inflammation, Rash macular, Swelling, Tenderness
Clinical narrative: 3 cm round macular patch, slightly swollen, inflamed and tender to touch. No drainage or changes in skin texture. Skin pigment unchanged surrounding area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt reported same night after receiving vaccine, around 7pm, she noted itchy red irregular shaped rashes on both lower extremities from the hips down to her ankles. She reported the rash would come and go throughout the day and night and they would continue to show up in different locations as raised irregular shapes. Pt was seen in clinic yesterday with symptoms present and MD requested VAERS form be completed for possible allergic reaction to vaccine.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient received a flu shot on 12/11/2018 in the morning to the left deltoid and that night  he had some mild swelling and redness to the site. Next day (12/12/2018) morning his arm was  moderately swollen and red and painful. Mom called and sopke to the MA, who told her to give  Benadryl and do a warm compress. The swelling had not improved and we saw him at the clinic.  He has a low grade temperature. Plan: Benadryl every 4 hours Prednisolone as directed (gave first dose in office) Warm compress to arm Push fluids Motrin as needed for pain and fever F/u prn Medications  prednisolone solution, oral 15 mg/5 mL Dispense: 44 (forty-four) milliliter Take 11 mL by mouth once a day for 4 days He was feeling much better by Friday 12/14/2018.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain lower, Computerised tomogram, Herpes zoster, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Patient reports soreness, right lower quadrant front side, sore to touch which began exactly 2 weeks after receiving SHINGRIX. Patient states his doctor has told him he has Shingles, with no visible rash.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Neuralgia, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: A large painful lump developed on my shoulder, the injection area. This lasted for 7 days. Most significantly, I have experienced nerve pain in various areas of my left leg, above and below the knee, thigh and ankle areas for almost the past three months. This pain occurs in differing places on the left leg at different days and times. The pain feels similar to nerve pain that I experienced when I suffered shingles when I was 24 years old.  An MRI scan of my lower back on 11/30/2018 showed that that there is NO problem with my back that would cause this nerve pain in my leg.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Feeling hot, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: (Was also given a seasonal flu shot). About 3 hour after I began to feel hot with some chills, normal virus type symptoms I occasionally get with a flu shot, plus ache around the injection site (left bicep) which spread & worsened as night went on. Woke up about 3 am, and the pain extended from my left elbow to half way up the left side of my neck. The skin felt as though it was severely sunburned (worse than the usual dystrophy sensation), and my throat felt as if it was partially swollen (though it appeared normal in a mirror). Internist examination revealed no glandular swelling. He felt there was some reaction to the injections with my reflex sympathetic dystrophy which temporarily exaggerated the pain and touch sensations to their fullest despite my usual medications for symtom relief. It was about 6 days before the additional feelings of pain, swelling and burn subsided to their usual levels.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pharyngeal oedema, Sunburn, Viral infection
Clinical narrative: (Was also given a seasonal flu shot). About 3 hour after I began to feel hot with some chills, normal virus type symptoms I occasionally get with a flu shot, plus ache around the injection site (left bicep) which spread & worsened as night went on. Woke up about 3 am, and the pain extended from my left elbow to half way up the left side of my neck. The skin felt as though it was severely sunburned (worse than the usual dystrophy sensation), and my throat felt as if it was partially swollen (though it appeared normal in a mirror). Internist examination revealed no glandular swelling. He felt there was some reaction to the injections with my reflex sympathetic dystrophy which temporarily exaggerated the pain and touch sensations to their fullest despite my usual medications for symtom relief. It was about 6 days before the additional feelings of pain, swelling and burn subsided to their usual levels.
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Musculoskeletal pain
Clinical narrative: Continued shoulder pain 1 month after vaccine.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Decreased appetite, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: Woke up on 12/28/18 in A.M. with blotchy rash on forehead, runny nose and fever of 99.4- playing  normally and appetite decreased took nap and woke up around 2:30 and rash had spread to rest of face, upper arms and lower legs- rash blotchy and raised, no itching. Brought into office by Dad temp 98.1, runny nose and rash visibly raised and blotchy- treatment Tylenol as needed, call office if s/s worsen or other symptoms develop.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Chills, Fever, Achy for about 12 hours on Christmas Day, Felt like she was "hit by a truck".
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness at site, hardness at site and warmth at site. Mother told to put a cool compress at sight and take BENADRYL. She is to phone us as needed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: One and one half days after vaccination reported upper arm pain and could not raise arm above shoulder. Like holding 5 pound weight with arm out. Finally after about two and 1/2 months it was better. Can Still feel the pain and can not raise arm higher than previously. Kept thinking it was going to go away.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Depressed mood, Depression, Disturbance in attention, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of death wishes in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced death wishes (serious criteria GSK medically significant), tiredness, depression, abnormal dreams, feeling sad and sleepiness. On 14th December 2018, the patient experienced concentration impaired. On an unknown date, the outcome of the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness were unknown. It was unknown if the reporter considered the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient was in good shape. The patient received SHINGRIX shot in the afternoon, a day before the date of reporting and was tired so she went to bed at 8.00 pm until 5.00 am and had difficult dreams and woke up very depressed. The patient wanted to die. The patient was up on but felt very sad and unable to concentrate on anything and was going back to bed. The patient usually goes to bed at 10.00 or 11.00 pm and gets up at 6.00 am. At the time of reporting, the patient had not called her internal doctor of medicine (MD). The patient had provided contact details of her physician.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Suicidal ideation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of death wishes in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced death wishes (serious criteria GSK medically significant), tiredness, depression, abnormal dreams, feeling sad and sleepiness. On 14th December 2018, the patient experienced concentration impaired. On an unknown date, the outcome of the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness were unknown. It was unknown if the reporter considered the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient was in good shape. The patient received SHINGRIX shot in the afternoon, a day before the date of reporting and was tired so she went to bed at 8.00 pm until 5.00 am and had difficult dreams and woke up very depressed. The patient wanted to die. The patient was up on but felt very sad and unable to concentrate on anything and was going back to bed. The patient usually goes to bed at 10.00 or 11.00 pm and gets up at 6.00 am. At the time of reporting, the patient had not called her internal doctor of medicine (MD). The patient had provided contact details of her physician.
Sex: M
Vaccine: DTAP, RVX
Symptoms: Product storage error
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old male patient who was given DAPTACEL before they knew the product was invalid due to delay in transit, while he received vaccine DAPTACEL, on 17-Dec-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE. It is an potential medication error due to incorrect product storage. (It was reported that DAPTACEL was given before they knew the product was invalid due to delay in transit). It was not reported that if any adverse reaction 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 2 months old patient (gender not reported) who received an expired 0.5 ml first dose (frequency: once) of vaccine PENTACEL (lot C3552AA and expiry date 18-Dec-2018) via unknown route in the right thigh on 19-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation and Rhoda pack. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient had any adverse event. 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. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a patient (age and gender not reported) who experienced allergy, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, Exp. Date, route and administration site not reported). On an unknown date, the patient developed a non-serious tetanus toxoid (allergy) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Details of lab data not provided. Final diagnosis was tetanus toxoid allergy. It was not reported whether the patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a physician via phone. This case involves an adult patient who was administered only the liquid portion of the vaccine of PENTACEL (lot number and expiry date was not reported) on an unknown date. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to inappropriate reconstitution technique. Since the patients were administered only the liquid portion of the vaccine and not the powder. It was not reported whether the patients experienced any adverse events 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. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient of unknown age who couldn't lift up her arm, after she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 21-Nov-2018, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in the shoulder nos. On an unknown date, The patient couldn't lift up her arm following the administration of TETANUS TOXOID. No lab test reported. Final diagnosis was mobility decreased. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-months-old female patient who received third dose of 0.5 mL ACT-HIB lot UI803AAA, Expiration Date on ACTHIB Powder: 21Sep2018 via intramuscular route in the left thigh on 20-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTARIX for Immunisation; PREVNAR 13 for Immunisation; PEDIARIX for Immunisation; and FLUZONE QUADRIVALENT for Immunisation. It was a case of actual medication error due to Expired vaccine used. It was reported that she gave an expired ACTHIB today. ACTHIB and Saline box Lot UI803AAA, Expiration Date: 01-Jul-2018, ACTHIB Powder Lot UI803AAA, Expiration Date on ACTHIB Powder: 21Sep2018. There were no side effects. 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. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA395251 (same reporter). This case involves a four years old patient (gender not reported) who was vaccinated with a dose of wrong vaccine FLUZONE QUADRIVALENT (lot number, Exp. Date, route and anatomical site of administration not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and concomitant medications were not reported. It is an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any 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 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA395249 (same reporter). This case involves a 13 years old patient (gender not reported) who was vaccinated with a dose of wrong vaccine FLUZONE QUADRIVALENT (lot number, Exp. Date, route and anatomical site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any 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 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves two patients who was vaccinated with a dose FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Temperature excursion (fridge went down to 29 F for 75 minutes) that was reported on FLUZONE QUADRIVALENT for 6 to 35 months. HCP states that 3 patients received vaccines that were involved in excursion, 2 FLUZONE and 1 PENTACEL. It was unknown whether patients experienced any adverse event following vaccination. 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. List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainting episode. Got patient on to table laying flat on back with legs elevated. Employee checked pulse a few times while patient was on table. Another employee grabbed ice pack and apple juice for the patient. Also checked BP. Patient laid on table for 30 mins, then we placed her in a sitting position for another 30 minutes. Patient left after feeling better and parent walked her out to the car. Parents were advice to look for headache and vomiting. If patient states to vomit parent were to notify the office.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Adenovirus infection, Adenovirus test positive, Electroencephalogram normal, Febrile convulsion, Full blood count normal
Clinical narrative: Patient admitted to hospital 10/7/18 with prolonged febrile seizure requiring anticonvulsants and admission to the PICU. She was positive for adenovirus on evaluation and this was felt to be the most likely cause of her fever and seizure. She was released on 10/9. However, due to recent immunizations report seemed warranted.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Intensive care, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Pyrexia
Clinical narrative: Patient admitted to hospital 10/7/18 with prolonged febrile seizure requiring anticonvulsants and admission to the PICU. She was positive for adenovirus on evaluation and this was felt to be the most likely cause of her fever and seizure. She was released on 10/9. However, due to recent immunizations report seemed warranted.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Fainting upon vaccine administration.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Pt received a total of 3 vaccines. First MCV, second FLUZONE, and lastly HPV #1. Immediately after HPV, pt stated, "I am feeling lightheaded". Pt demonstrated vasovagal, paleness. Pt was placed in a supine position. Pt  responded to voice. Pt was given juice, was observed for 20 minutes after event. Pt's mother present. After juice and rest, pt's face color came back and denied lightheadedness, nausea, vomiting, headache. Pt discharged home with mother.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site bruise, Administration site swelling, Administration site warmth
Clinical narrative: The area of administration was warm to the touch, bruised and slightly swollen when the patient came in five days after the vaccination. The patient stated that the area was slowly improving since the symtpoms started the day after receiving the vaccination.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Consciousness fluctuating, Dizziness, Mydriasis, Pallor
Clinical narrative: Patient had history of fainting with needles/blood draws. Mother of patient still wanted to get the immunization. The patient became light headed and was in and out of consciousness/slouching in chair. Said her vision was blurry and her eyes were dilated. This is typical for the patient but this time it lasted about 20+ minutes before emergency medical help took her to an ambulance to evaluate her. Mother said it never lasted this long before. We had a fan on the patient and ice on her forehead but she was very pale. Patient was able to speak but sounded very weak.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Posture abnormal, Vision blurred
Clinical narrative: Patient had history of fainting with needles/blood draws. Mother of patient still wanted to get the immunization. The patient became light headed and was in and out of consciousness/slouching in chair. Said her vision was blurry and her eyes were dilated. This is typical for the patient but this time it lasted about 20+ minutes before emergency medical help took her to an ambulance to evaluate her. Mother said it never lasted this long before. We had a fan on the patient and ice on her forehead but she was very pale. Patient was able to speak but sounded very weak.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pyrexia, Urticaria
Clinical narrative: Felt really warm & feverish a hour or so after the shot (12/27). Had changed into pjs right away so I didn't notice the hives until the next morning when I got up to get ready for work (12/28).
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site bruising, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Patient complained of immediate burning pain in shoulder after infection, followed by persistent bruising at the injection site for some time. Patient stated that she still has chronic pain in the shoulder and muscle since the time of injection.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt has been having pain since the flu shot at injection site.