chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Rash macular, Sensitive skin
Clinical narrative: Shot was extremely painful; Arm was sore; Swelling; Warm to the touch; Red Spots / they were red with swelling; Spots were the size of quarters and they were painful, warm to the touch and sensitive; Spots were the size of quarters and they were painful, warm to the touch and sensitive; area was light pink; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included systemic antibacterial therapy (drug allergies including allergy to penicillin, Zithromax, Avelox and Sulpha drugs).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration. On an unknown date, the outcome of the pain, pain in arm, swelling and skin warm were recovered/resolved and the outcome of the erythromacular rash, painful rash, sensitive skin and skin discoloration were unknown.   It was unknown if the reporter considered the pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm her pharmacy. The shot was extremely painful and her arm was sore that day. 1 day after receiving Shingrix, the patient had three red spots that appeared and they were red with swelling. The other 2 spots were the size of quarters and they were painful, warm to the touch and sensitive. The first day the area was light pink. The second and third days they were red and swollen. By the forth day, the spots dissipated and her symptoms have full resolved at the reporting date.  The patient also reported that she had an allergy to some drugs so she was not certain if her reaction was a possible allergic reaction to the shot. The patient reported that she previously had the other shingles shot and had shingles after that shot. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin warm, Swelling
Clinical narrative: Shot was extremely painful; Arm was sore; Swelling; Warm to the touch; Red Spots / they were red with swelling; Spots were the size of quarters and they were painful, warm to the touch and sensitive; Spots were the size of quarters and they were painful, warm to the touch and sensitive; area was light pink; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included systemic antibacterial therapy (drug allergies including allergy to penicillin, Zithromax, Avelox and Sulpha drugs).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration. On an unknown date, the outcome of the pain, pain in arm, swelling and skin warm were recovered/resolved and the outcome of the erythromacular rash, painful rash, sensitive skin and skin discoloration were unknown.   It was unknown if the reporter considered the pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm her pharmacy. The shot was extremely painful and her arm was sore that day. 1 day after receiving Shingrix, the patient had three red spots that appeared and they were red with swelling. The other 2 spots were the size of quarters and they were painful, warm to the touch and sensitive. The first day the area was light pink. The second and third days they were red and swollen. By the forth day, the spots dissipated and her symptoms have full resolved at the reporting date.  The patient also reported that she had an allergy to some drugs so she was not certain if her reaction was a possible allergic reaction to the shot. The patient reported that she previously had the other shingles shot and had shingles after that shot. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: Joint ache in hands and knees; Fever; Muscle ache in neck; Headache; Received the second dose one month and 10 days after getting the first dose; Nausea; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced nausea. On 22nd October 2019, the patient experienced arthralgia, fever, myalgia, headache and drug dose administration interval too short. On an unknown date, the outcome of the arthralgia, fever, myalgia, nausea, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the arthralgia, fever, myalgia, nausea and headache to be related to Shingrix.  The patient received Shingrix about 10 hours experiencing joint ache in hands and knees, fever, muscle ache in neck and headache. The fever and headache are improving. Patient also stated that he received the second dose one month and 10 days after getting the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up. No further details were provided.  The caller was reporting adverse event for himself and his wife.  This case is 1 of 2 cases, reported by same reporter.  From the case description it seems that US2019193745 is duplicate of US2019192798. As the case US2019192798 was reported earlier, it should be considered as case of record. Case US2019193745 would be deleted from system.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Joint ache in hands and knees; Fever; Muscle ache in neck; Headache; Received the second dose one month and 10 days after getting the first dose; Nausea; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced nausea. On 22nd October 2019, the patient experienced arthralgia, fever, myalgia, headache and drug dose administration interval too short. On an unknown date, the outcome of the arthralgia, fever, myalgia, nausea, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the arthralgia, fever, myalgia, nausea and headache to be related to Shingrix.  The patient received Shingrix about 10 hours experiencing joint ache in hands and knees, fever, muscle ache in neck and headache. The fever and headache are improving. Patient also stated that he received the second dose one month and 10 days after getting the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up. No further details were provided.  The caller was reporting adverse event for himself and his wife.  This case is 1 of 2 cases, reported by same reporter.  From the case description it seems that US2019193745 is duplicate of US2019192798. As the case US2019192798 was reported earlier, it should be considered as case of record. Case US2019193745 would be deleted from system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fever; Headache; Back pain; Joint pain at wrist; Received the second dose one month and 10 days after getting the first dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd October 2019, 10 hrs after receiving Shingrix, the patient experienced fever, headache, back pain, arthralgia and drug dose administration interval too short. On an unknown date, the outcome of the fever, headache, back pain, arthralgia and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever, headache, back pain and arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received the second dose one month and 10 days after getting the first dose, which led to shortening of the schedule. The patient received 2nd dose of Shingrix, about 10 hours after vaccination, the patient experienced fever, headache, back ache, and joint pain at wrist and shortening of the schedule. The reporter consented to follow up. No further details were provided. This case is 1 of 2 cases, reported by same reporter for the patient (wife).
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the interior of her arm and thigh; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unspecified date, the patient had received the 1st dose of shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of the shingrix and experienced rash on the interior of her arm and thigh. The reporter has been given the consent for the follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Erythema, Headache
Clinical narrative: Diarrhea; Stomach does not feel rigth; Could not raise her arm up and down the rest of the day and the next day; Feeling weak; Headache; Arm was sore; Arm was red; Arm was swollen half way around and red; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received Shingrix. On 21st October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. On 22nd October 2019, the patient experienced mobility decreased, weakness and headache. On 24th October 2019, the patient experienced diarrhea and stomach upset. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine approximately 12:00pm. She reports her arm was sore before she went to bed that night.When she was taking a shower the next morning she noted that her arm was swollen half way around and red.  She could not raise her arm up and down the rest of the day and the next day. At the time of reporting, she reports that her arm was not as sore and red and she can now move it around. The next morning after receiving the vaccine she noted that she was feeling weak.  She had headaches on October and she took Advil to help treat them. At the time of reporting she has not had any headaches so far and not as weak as she was.   She did not that she was having stomach issues. Her stomach does not feel right and she has had some diarrhea. The reporter did not consent to follow up. The reporter unable to obtain additional information.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Diarrhea; Stomach does not feel rigth; Could not raise her arm up and down the rest of the day and the next day; Feeling weak; Headache; Arm was sore; Arm was red; Arm was swollen half way around and red; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received Shingrix. On 21st October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. On 22nd October 2019, the patient experienced mobility decreased, weakness and headache. On 24th October 2019, the patient experienced diarrhea and stomach upset. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine approximately 12:00pm. She reports her arm was sore before she went to bed that night.When she was taking a shower the next morning she noted that her arm was swollen half way around and red.  She could not raise her arm up and down the rest of the day and the next day. At the time of reporting, she reports that her arm was not as sore and red and she can now move it around. The next morning after receiving the vaccine she noted that she was feeling weak.  She had headaches on October and she took Advil to help treat them. At the time of reporting she has not had any headaches so far and not as weak as she was.   She did not that she was having stomach issues. Her stomach does not feel right and she has had some diarrhea. The reporter did not consent to follow up. The reporter unable to obtain additional information.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Erythema, Headache, Hypertension
Clinical narrative: Blood presure went to 175; headache; chills; off balance; Redness on arm/ huge mark from the shot, halfway around the arm; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included metoprolol.   On 13th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, 1 days after receiving Shingrix, the patient experienced blood pressure high. In October 2019, the patient experienced headache, chills, balance difficulty and erythema of extremities. The patient was treated with Tylenol. On an unknown date, the outcome of the blood pressure high, headache, chills and balance difficulty were recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the blood pressure high, headache, chills, balance difficulty and erythema of extremities to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the right arm, eleven days ago of the reporting date. The patient claimed that, she had quite a reaction to the vaccine. She reported that she was fine the first day she got the vaccination till around noon, however, the next day everything went downhill. The patient took her blood pressure medication which worked well, however, her blood pressure went to 175 so her physician increased her Metoprolol dose and then she was fine. She also experienced a headache, chills and she was a bit off balance and had to hold onto the door frame. The patient stated, she had a huge mark from the shot which was halfway around her right arm and 11 days later, the red circle was of the size of a baseball. The patient's other symptoms resolved quickly but she had to go the doctor's office twice. The doctor told her to take anti-inflammatory drugs but because of her blood pressure medication, she could only take Tylenol which she did and her redness on her arm was currently paler in color. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness below injection site; Raised area about 2-4 inches below the injection site of the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities and swelling. On an unknown date, the outcome of the erythema of extremities and swelling were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced raised and red area, about 2-4 inches below the injection site of the deltoid area. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site rash, Myalgia
Clinical narrative: Muscle Pain; Headache; Nausea; Diarrhea; Sore Arm; Rash around injection site with 4 inches in DIAMETER; Tired; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th October 2019, 12 hrs after receiving Shingrix, the patient experienced muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue. On an unknown date, the outcome of the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue to be related to Shingrix.  Additional details were received as follows: The patient stated that about 12 hours after getting the Shingrix vaccine, she experienced muscle pain, headache, nausea, diarrhea, sore arm, rash around injection site with 4 inches in diameter, and fatigue.  She recovered within 4 days. No further details were provided. The patient did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Muscle Pain; Headache; Nausea; Diarrhea; Sore Arm; Rash around injection site with 4 inches in DIAMETER; Tired; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th October 2019, 12 hrs after receiving Shingrix, the patient experienced muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue. On an unknown date, the outcome of the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue to be related to Shingrix.  Additional details were received as follows: The patient stated that about 12 hours after getting the Shingrix vaccine, she experienced muscle pain, headache, nausea, diarrhea, sore arm, rash around injection site with 4 inches in diameter, and fatigue.  She recovered within 4 days. No further details were provided. The patient did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: redness; swelling; hardened; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received Shingrix. On 23rd October 2019, 2 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and induration. On an unknown date, the outcome of the erythema of extremities, swelling arm and induration were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and induration to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient had couple of inches down from the injection site that become red and swollen and  when she touched it, it was hard. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUR4
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: swelling on arm; itchy red ring around the circumference of her arm; Based on additional information received on 25-Oct-2019, this case initially considered as non-Case was upgraded to valid case.   Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic patient who experienced swelling on arm (peripheral swelling) and itchy red ring around the circumference of her arm (rash), while 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.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1933 (Expiry date unknown) via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious swelling on arm (peripheral swelling) and itchy red ring around the circumference of her arm (rash) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was Local swelling and Localised rash.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for Rash over arms and Swelling arm.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received an ActHIB vaccine that was mixed with sterile water and not the diluent that came with the product (0.4 percent sodium chloride), no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported via unknown route in unknown administration site on an unknown date, which was mixed with sterile water and not the diluent that came with the product (0.4 % sodium chloride).  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 wrong solution used in drug reconstitution.  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.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel vaccine was administered to a patient, no adverse event; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who was vaccinated with a 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (4th dose in series) (lot C528LAA and Exp. Date 05-Oct-2019) via intramuscular route in the left thigh on 23-Oct-2019.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Medication error
Clinical narrative: had gotten Flublok instead of Fluzone, no adverse event; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA297905 (same reporter).  This case involves a female patient of unknown age who was vaccinated with a 0.5 ml dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via intramuscular route in the left arm on 21-Oct-2019.  The patient's medical history not reported and did not received other vaccines.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  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.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 year old female patient received a 0.5 ml dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 17 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid on 15-Oct-2019.  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 age at vaccine administration.  At the time of report no adverse event was reported.  Doctor visit for flu vaccination on 15-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Wrong product administered
Clinical narrative: a female patient received a 0.5ml dose of Flublok instead of Fluzone/No AE; a female patient received a 0.5ml dose of Flublok instead of Fluzone/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA297880 (same reporter).  This case involves an eight years old female patient who received a 0.5ml dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via intramuscular route in the left arm on 21-Oct-2019 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE].  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 age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: while administering a Fluzone HD injection to a 72 years old female patient it started to leak between the plastic collar and syringe/No AE; while administering a Fluzone HD injection to a 72 years old female patient it started to leak between the plastic collar and syringe, the vaccine was dripped in her arm/No AE; while administering a Fluzone HD injection to a 72 years old female patient it started to leak between the plastic collar and syringe/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old female patient who had vaccine underdose (underdose) and exposure via skin contact (exposure via skin contact), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ292AB, expiry date: 10-JUN-2020, dose: 0.5 ml via intramuscular route in the left arm on 24-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose and exposure via skin contact.  It was also a case of syringe leak.   It was reported that while administering a Fluzone High-Dose injection to a 72 years old female patient it started to leak between the plastic collar and syringe, the vaccine was dripped in her arm.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quad that was taken out of the fridge to be given to a patient but sat out for 45 mins at room temperature / no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6656KA (Expiry date 30-Jun-2020) 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 actual medication error case due to incorrect product storage.  It was reported that Fluzone Quad that was taken out of the fridge to be given to a patient but sat out for 45 minutes at room temperature.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: a 12-year-old male patient received a dose of Ipol vaccine that been involved in the excursion at 10.5 C for a cumulative time of one hour 5 minutes/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA297983 and 2019SA302643 .  This case involves a 12 years old male patient who received a 0.5 ml dose of IPV (VERO) [IPOL] vaccine that been involved in the excursion at 10.5 c for a cumulative time of one hour 5 minutes lot N1K931M, expiry date: 18-NOV-2019 via intramuscular route in the left deltoid on 16-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  Doctor visit and date: 16-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Initial information received on 25-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a female patient (age unknown) who experienced anaphylactic reaction (anaphylactic reaction), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2012, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a serious anaphylactic reaction (anaphylactic reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who presented with anaphylactic reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: 1 patient received Fluzone Quadrivalent and/or Fluzone High Dose was injected subcutaneously, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demography who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and/or INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] injected subcutaneously (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE and/or INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  At the 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.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Ear pain, Tendonitis
Clinical narrative: tendinitis; pain in his ears; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient of unknown age who experienced tendinitis (tendonitis) and pain in his ears (ear pain), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UT6657NA and expiry date: 20-Jun-2020 via unknown route in unknown administration site.  On an unknown date, (also reported as several hours after) following the vaccination the patient experienced tendinitis (tendonitis) and pain in his ears (ear pain). (Other relevant tests included no lab data.)  Final diagnosis was tendinitis and ear pain.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting. Events lasted for approximately 1 week.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars; a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involve 12 patients of unknown demography who experienced a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars (inflammation localized), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (5 mL multi-dose vial) lot UJ237AB and expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, following the vaccination the patients experienced a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars.  (Other relevant tests included no lab data.)  Final diagnosis was inflammation localized.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: got 2 doses of Fluzone High-Dose within 10 days, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 66 years old patient who was vaccinated with doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ283AA via intramuscular route in the right deltoid on 25-Oct-2019 and lot number not reported via unknown route in unknown administration site on 15-Oct-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 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.  Information on the batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a HD vaccination yesterday and come to find out the patient had received a HD vaccination 4 days ago as well, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a unknown demographic patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] twice (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 is an actual medication error case due to extra dose administered.   It was reported that the patient received a HD vaccination yesterday and come to find out the patient had received a HD vaccination 4 days ago as well.  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.  Information on the batch number was requested.
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: didn't realize until he looked at the receipt that he was given Flublok Quadrivalent 0.5 ml, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 85 years old male patient was vaccinated with a dose of 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]lot number not reported via unknown route in left arm instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 08-Oct-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 wrong vaccine administered. It was reported that he wanted a Fluzone High-Dose because it worked well for last year and he did not realize until he looked at the receipt that he was given Flublok Quadrivalent 0.5 ml in the left arm.  At the time of reporting the patient did not 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 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