chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Myalgia
Clinical narrative: flu-like symptoms; Muscle ache; Lethargy; Chills; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced flu-like symptoms, muscle pain, lethargy and chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the flu-like symptoms, muscle pain, lethargy and chills were unknown.   It was unknown if the reporter considered the flu-like symptoms, muscle pain, lethargy and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On the day before reporting date, the patient received his 2nd Shingrix shot. The patient experienced side effects including flu-like symptoms, muscle ache, lethargy and chills but no fever. The patient was asking for treatment for Shingrix side effects and told he would be going to receive Ibuprofen. He took Tylenol for his flu-like symptoms. The patient did not want to provide his street address or MD contact information. No further information provided.
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Nausea
Clinical narrative: passed out; dizziness; feeling nauseos; fell; hitting his head; This case was reported by a other health professional and described the occurrence of passed out in a male patient who received HAV (Havrix) (batch number 299X2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, less than 6 months after receiving Havrix, the patient experienced passed out (serious criteria GSK medically significant), dizziness, nausea, fall and head injury. On an unknown date, the outcome of the passed out, dizziness, nausea, fall and head injury were unknown.   It was unknown if the reporter considered the passed out, dizziness, nausea, fall and head injury to be related to Havrix.  Additional information was reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced dizziness and feeling nauseous. The patient was stood up and passed out. The patient fell backwards hitting his head on floor. This accident occurred under circumstances for which super markets. The reporter requested that, GlaxoSmithKline (GSK) report this promptly to the insurer or arrange for proper investigation and disposition. Also requested that, GSK acknowledge receipt of this notice in writing within fifteen (15) days and advise the undersigned of the name and address of the insurer or other person to whom they might look for handling. This case has been linked with case US2019AMR172641, reported by the same reporter.
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness; feeling nauseos; This case was reported by a other health professional and described the occurrence of dizziness in a female patient who received HAV (Havrix) (batch number 299X2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, less than 6 months after receiving Havrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Havrix, the patient experienced dizziness and nausea. This accident occurred under circumstances for which super markets. The reporter requested that, GlaxoSmithKline (GSK) report this promptly to the insurer or arrange for proper investigation and disposition. Also requested that, GSK acknowledge receipt of this notice in writing within fifteen (15) days and advise the undersigned of the name and address of the insurer or other person to whom they might look for handling. This case has been linked with case US2019AMR172635, reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Formication
Clinical narrative: skin crawling sensation; This case was reported by a consumer via call center representative and described the occurrence of crawling sensation of skin in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced crawling sensation of skin. On an unknown date, the outcome of the crawling sensation of skin was recovered/resolved.   It was unknown if the reporter considered the crawling sensation of skin to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. Several years ago the patient had a reaction to a flu vaccine that caused a skin crawling sensation.  This lasted for almost one year before resolving.  At that time the patient thought it might be due to the thimerosal in the vaccine. The reporter did not consent to follow up. This case had been linked to the case US2019166421, reported for same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Injection site pain, Product preparation issue
Clinical narrative: Painful Injection; Accidental Exposure; exposure via skin contact; extra diluent was used; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (received 1st dose on 8th July 2019).   On 11th September 2019, the patient received the 2nd dose of Shingrix. On 11th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain, inadvertent exposure to vaccine, exposure via skin contact and inappropriate preparation of medication. On an unknown date, the outcome of the injection site pain, inadvertent exposure to vaccine, exposure via skin contact and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd Shingrix dose in her left arm and believed that vaccine was administered incorrectly and that she did not receive full dose of vaccine.  The patient reported that when the pharmacist attempted injection, the needle felt dull and not sharp causing her to jump due the extreme pain from reportedly dull needle. It was reported that clear, cold liquid ran down her arm causing her to suspect full dose was not administered, which led to inadvertent exposure to vaccine, exposure via skin contact. The pharmacist informed that the extra diluent was used while preparing vaccine and that the administered dose was sufficient, which led to inappropriate preparation of medication.  The patient did not experienced reaction to 2nd dose. The patient reported that if the vaccine received intramuscularly. The reporter was unsure of lot number/expiry date.  The reporter desired to know if she was protected from shingles and seeks guidance on either how she can get a refund from pharmacy or  how to receive a 3rd dose without paying for it again.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration, Yellow skin
Clinical narrative: rash; yellow rash; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced skin discoloration. On 17th September 2019, the patient experienced red rash. The patient was treated with avena sativa (Aveeno). On an unknown date, the outcome of the red rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient developed a red rash. He applied Aveeno cream and stated the rash was now yellow in colour. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Erythema, Injection site rash, Limb discomfort, Pain
Clinical narrative: increased discomfort on left arm; intermittent rashes; injection site rash; redness; Pain; looks like psoriasis; eczema; This case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 14th May 2019, refer case US2019169164).   On 17th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced psoriasis and eczema. On 18th July 2019, the patient experienced arm discomfort, rash recurrent, injection site rash, erythema and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema to be related to Shingrix.  Additional details were provided as follows: It was reported that with the second dose patient experienced redness and pain the day after vaccination.  The patient also experienced increased discomfort on her left arm, developed a rash on 18th July 2019. The patient experienced rash at the injection site after the second dose, and had been also experiencing random and intermittent rashes on her upper extremities.  She had one on her right arm that looks like psoriasis or eczema. These events were ongoing. The reporter consented to follow up.  No further details were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Psoriasis, Rash
Clinical narrative: increased discomfort on left arm; intermittent rashes; injection site rash; redness; Pain; looks like psoriasis; eczema; This case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 14th May 2019, refer case US2019169164).   On 17th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced psoriasis and eczema. On 18th July 2019, the patient experienced arm discomfort, rash recurrent, injection site rash, erythema and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort, rash recurrent, injection site rash, erythema, pain, psoriasis and eczema to be related to Shingrix.  Additional details were provided as follows: It was reported that with the second dose patient experienced redness and pain the day after vaccination.  The patient also experienced increased discomfort on her left arm, developed a rash on 18th July 2019. The patient experienced rash at the injection site after the second dose, and had been also experiencing random and intermittent rashes on her upper extremities.  She had one on her right arm that looks like psoriasis or eczema. These events were ongoing. The reporter consented to follow up.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever Blisters; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever blister. The patient was treated with antivirals nos. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient underwent a dental procedure after she developed fever blisters. The patient had been prescribed antiviral medications. The reporter did not want to provide any additional details.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Insomnia, Myalgia, Pain in extremity
Clinical narrative: fatigue; joint pain; muscle pain; Unable to sleep; Sore left arm/ injection ste pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. In September 2019, the patient experienced fatigue, joint pain, muscle pain and sleeplessness. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, joint pain, muscle pain and sleeplessness were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, joint pain, muscle pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient same day after receiving vaccine experienced pain at the injection site with sore left arm which resolved in three days. The patient also experienced fatigue, muscle pain and joint pain. For the muscle pain and join pain, the patient was taking ibuprofen which was not helping her much and she was unable to sleep because of that. On the day of reporting the joint pain was localized to both her hips and both the knees. The patient consented to follow up.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 21-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 14th September 2019, the patient received FluLaval Tetra 2019-2020 season. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The reporter stated that, the patient developed a rash after receiving vaccine. The reporter stated that, the patient had not taken any treatment. Rash has resolved. The healthcare provider did not provide the patient's initials and did not have the lot or expiry date.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was   Additional details were reported as follows: The pharmacist reports a patient was in emergency department with a rash on the day of reporting.  The reporter consented to follow up.  The vaccine was given at unknown location, details regarding product were unavailable at time of initial report.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Fatigue; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue and influenza-like symptoms. On an unknown date, the outcome of the fatigue and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The pharmacist reported that, the patient reported fatigue and flu like symptoms. The reporter did not provide number of patients and vaccine details. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nauseous; Vomiting; Severe headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced nausea, vomiting, headache and fever. On an unknown date, the outcome of the nausea, vomiting and fever were resolved with sequelae and the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the nausea, vomiting, headache and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. At 11:00 AM, the patient received a dose of Shingrix. During the day the patient started to feel nauseous. By night time she was vomiting and had a severe headache and a fever.   At the time of report, the patient was in bed due to the headache. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue, Urticaria
Clinical narrative: Welts/shoulder to her elbow; product supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced welts and product supply issue. On an unknown date, the outcome of the welts and product supply issue were unknown.   It was unknown if the reporter considered the welts and product supply issue to be related to Shingrix and Shingrix.  Additional details were received as follows: After 1st vaccination, the patient experienced  welts from her shoulder to her elbow. Pharmacist states when it was time for the patient's second dose, the Shingrix was out of stock at the pharmacy. The reporter consented to follow up. Pharmacist states she did not have further information available at the time of this call, but she could get additional details from the patient. Pharmacist granted permission for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 5 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received first dose of Shingrix in March 2019 and developed a rash on part of his body in August 2019. The rash was diagnosed as shingles. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo, Vomiting
Clinical narrative: vertigo; threw up; dizzy; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced vertigo, vomiting and dizziness. On an unknown date, the outcome of the vertigo, vomiting and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, vomiting and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's sister. The patient had the first dose of Shingrix and the same day vertigo, threw up and was dizzy.  Till the time of reporting the patient was experiencing the events. Reporter did not want to share any personal information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Injection site cellulitis; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The pharmacist reports that a patient developed cellulitis at the injection site the day after receiving the 1st dose of Shingrix.  The dose was given approximately one month ago. The patient was told by urgent care that she would need to repeat the 1st dose. The reporter consented to follow up. Pharmacist did not have many details at the time of the call.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vomiting; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the Spring of 2019 in the left arm. The patient reported that, in the night after vaccination, the patient experienced vomiting for about 5 hours and then it resolved in the next morning. The patient did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix. In August 2019, between 5 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, in August 2019, the patient experienced shingles after vaccination with dose of Shingrix. The pharmacist stated that, the acute stage of shingles resolved. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Injection site discomfort
Clinical narrative: little discomfort at the site of the injection; patient received 2 doses on Fluzone Highdose same day; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 66 years old female patient who experienced little discomfort at the site of the injection (vaccination site discomfort), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 19-Sep-2019, the patient received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (injection) lot AG8347 (Expiry date 06-May-2020), twice via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious little discomfort at the site of the injection (vaccination site discomfort), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error case due extra dose administered.  Other relevant tests were not reported.  Final diagnosis was little discomfort at the site of the injection.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for little discomfort at the site of 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 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: 31.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 31 years old female received Fluzone High Dose, no AE; 31 years old female received Fluzone High Dose, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 31 years old female breast feeding patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ238AB (Expiry date 14-Apr-2020) via unknown route in unknown administration site on 19-Sep-2019.  This case inked with case 2019SA268841 (baby case).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a 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.  List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: DT, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patients came in to get Adacel and the nurse accidently gave TD, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 59 years old female patient who received vaccine DIPHTHERIA AND TETANUS TOXOIDS lot number not reported via unknown route in unknown administration site instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that one of the patients came in to get Adacel and the nurse accidently gave TD or is there a pertusis vaccine.  At the time of reporting, no adverse reactions were 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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: red flat rash that was not a raised like a bee sting; rash over the back of the neck and over the right ear; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a four months old patient who experienced red flat rash that was not a raised like a bee sting rash over the back of the neck and over the right ear (rash erythematous and rash), while he/she received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received first set of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in the right thigh.  On an unknown date, the patient received first set of suspect HEPATITIS B VACCINE and PREVNAR not produced by Sanofi Pasteur lot number not reported via unknown route in the in left thigh.  On an unknown date, the patient developed a non-serious red flat rash that was not a raised like a bee sting (rash erythematous) and rash over the back of the neck and over the right ear (rash) 15 minutes following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, HEPATITIS B VACCINE and PREVNAR.  Other relevant tests not reported.  Final diagnosis was rash and rash erythematous.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the events.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event
Clinical narrative: nurse took a vial and the vial shattered in her hand having the vaccine to spill on the hand, no AE; nurse took a vial and the vial shattered in her hand having the vaccine to spill on the hand, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 47 years old female patient who was exposed to the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6543AB,exp. Date: 23-Feb-2021 on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to accidental exposure to product and exposure via skin contact. It was reported that nurse took a vial from a carton and the vial shattered in her hand having the vaccine to spill on her hand.  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.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product dose omission
Clinical narrative: didn't come come back in 8 weeks for the 2nd dose, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient did not come come back in 8 weeks for the second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and had a first dose lot number not reported via unknown route in unknown administration site on an unspecified date of Nov-2018.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant medications and family history were not provided.  It is an actual medication error case due to missed dose as the patient missed her second dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: received Ipol from a MDV that was opened and deemed not safe to use / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case is linked to case 2019SA264028 (same reporter).  This case involves a 12 years old female who received 0.5 ml dose of IPV (VERO) lot PIE70 via intramuscular route in the right arm on 12-Sep-2019.  The patient's past vaccination included OPV (Polio vaccine live oral). Past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HPV VACCINE (HPV VACCINE) and HEPATITIS A VACCINE (HEPATITIS A).  It was a actual medication error case due to incorrect product storage. It was reported that 2 patient's that received Ipol from a MDV that was opened and deemed not safe to use. The physician mentioned that she thinks that she should be able to use her clinical judgment as to whether or not to reinjection her patient's and she did not believe that this situation warrented it.  At a 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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: given the diluent portion only from Pentacel; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] VACCINE lot UJ098AAA via unknown route in the right thigh on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique.   It was reported that patient was given only the diluent portion of Pentacel.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: painful; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a male patient of unknown age who experienced that vaccine was painful, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced that vaccine was painful (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of lab data not reported.  Final diagnosis was painful.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was unknown.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: red, swollen, hot to the touch, all local reaction symtoms; red, swollen, hot to the touch, all local reaction symtoms; red, swollen, hot to the touch, all local reaction symtoms; red, swollen, hot to the touch, all local reaction symtoms; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves A female patient of unknown age who experienced red, swollen, hot to the touch, all local reaction symptoms (vaccination site inflammation, vaccination site warmth, vaccination site erythema, vaccination site swelling) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe) lot UT6647KA via unknown route in unknown administration site.  On an unknown date, the patient developed red, swollen, hot to the touch, all local reaction symptoms (vaccination site inflammation), (vaccination site warmth), (vaccination site erythema) and (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of lab data not reported.  Final diagnosis was red, swollen and hot to the touch, all local reaction symptoms.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: wet his pants after getting the flu shot; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 8 years old male patient who wet his pants after getting the flu shot (dysuria), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient wet his pants after getting the flu shot (dysuria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was dysuria.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for dysuria.  Information on the batch number was requested.  List of document held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received only the DTAP-IPV and not the ActHIB portionof Pentacel, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who received only the DTAP-IPV and not the ACT-HIB portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot and expiry date was not reported, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the 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 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 is requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: was accidentally given Pentacel with no AE; given an extra dose of ActHIB with no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that was accidentally given Pentacel with no AE (inappropriate schedule of product administration) and given an extra dose of ActHib with no AE (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-Sep-2019, the patient received 3rd dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ013AA and expiry date: 10-Oct-2020 via intramuscular route in the left thigh.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI957AA via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered and extra dose administered.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel that expired on Sep 18 was administered to a patient, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5254AA, expiry date: 18-Sep-2019 via intramuscular route in the left arm on 20-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to expired vaccine used.  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.  List of documents held by sender: none.