chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain, X-ray limb abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 13 October 2015. This case involves a 67-years-old female patient, who was vaccinated with first dose of FLUZONE HD (batch number: U1454AA, expiry date, and dose were not reported) intramuscularly in left deltoid on 24 September 2015. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On 24 September 2015, same day following the vaccination, the patient had experienced limited range of movement (ROM) and positional pain in left shoulder joint. The patient required ER/doctor visit. On 12 October 2015, X-ray examination of left shoulder showed joint changes and scheduled for MRI on 14 October 2015. The patient was treated with Aleve (NSAID) for pain. The patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 7 March 2016. No new information reported.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash vesicular
Clinical narrative: Initial unsolicited report received from a consumer on 15 October 2015. This case involves a 68-years-old male patient who was vaccinated with a dose FLUZONE HD (batch number, expiry date, dose, dose in series were not reported) intramuscularly in left arm on 05 October 2015. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as no known allergies, hypertension, and high cholesterol under control with meds. Concomitant medications were not reported. On 11 October 2015, six days following the vaccination, the patient developed vesicle like red bumps on his left arm at injection site and a few centimeters above his left antecubital area. It was reported that, injection site had muscle ache and tender to touch. The patient required to ER/doctor visit. Laboratory data was not reported. The patient was treated with BENADRYL. The outcome of events was unknown. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Body temperature increased, Febrile convulsion, Full blood count normal, Influenza virus test negative
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2015. This case involves a five years old male patient who was vaccinated with a second intramuscular dose of FLUZONE in the left arm (manufacturer: Sanofi Pasteur, batch number: UI464AA, expiry date: 30-Jun-2016) on 15-Oct-2015 at 17:00 hrs. The patient was a 33 week premature baby; he had a history of respiratory distress and febrile seizure. There was no illness at the time of vaccination. Concomitant medications were not reported. On 15-Oct-2015, at 18:00 hours, one hour post vaccination, the patient had a generalized seizure which lasted for 15 minutes. During the seizure, mother took the patient to the urgent care where his temperature was 103 degree (axillary). The patient was previously vaccinated with a dose of FLUZONE vaccine (batch number, expiry date, route and site of administration was not reported). The patient required ER/doctor visit for the events. Laboratory investigations included Complete Blood Count (CBC), flu test, strep test and blood work. The results were normal. Corrective treatment was not reported. The patient had not recovered from the above mentioned event. Upon internal review this case was considered serious due to important medical event: Febrile seizure. List of documents held by sender: none. Follow-up information received from a nurse on 21 December 2015 and additional information received from healthcare professional on 22 December 2015. On 4 December 2015 the patient was recovered "after five days" with no permanent sequel. Sender's Comments: This is a case of febrile seizures in a 5 year old male one hour post INFLUENZA QUADRIVAL A-B VACCINE administration, which is listed. Time to event onset is compatible with the role of the vaccine. The child has a past medical history of febrile seizures. Laboratory tests performed are negative for influenza, however total infectious work-up has not been provided for ruling out any infectious etiology for pyrexia (temperature 103 degrees F) and subsequently seizures. Based on the information provided, the role of the vaccine cannot be completely ruled out.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure, Streptococcus test negative
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2015. This case involves a five years old male patient who was vaccinated with a second intramuscular dose of FLUZONE in the left arm (manufacturer: Sanofi Pasteur, batch number: UI464AA, expiry date: 30-Jun-2016) on 15-Oct-2015 at 17:00 hrs. The patient was a 33 week premature baby; he had a history of respiratory distress and febrile seizure. There was no illness at the time of vaccination. Concomitant medications were not reported. On 15-Oct-2015, at 18:00 hours, one hour post vaccination, the patient had a generalized seizure which lasted for 15 minutes. During the seizure, mother took the patient to the urgent care where his temperature was 103 degree (axillary). The patient was previously vaccinated with a dose of FLUZONE vaccine (batch number, expiry date, route and site of administration was not reported). The patient required ER/doctor visit for the events. Laboratory investigations included Complete Blood Count (CBC), flu test, strep test and blood work. The results were normal. Corrective treatment was not reported. The patient had not recovered from the above mentioned event. Upon internal review this case was considered serious due to important medical event: Febrile seizure. List of documents held by sender: none. Follow-up information received from a nurse on 21 December 2015 and additional information received from healthcare professional on 22 December 2015. On 4 December 2015 the patient was recovered "after five days" with no permanent sequel. Sender's Comments: This is a case of febrile seizures in a 5 year old male one hour post INFLUENZA QUADRIVAL A-B VACCINE administration, which is listed. Time to event onset is compatible with the role of the vaccine. The child has a past medical history of febrile seizures. Laboratory tests performed are negative for influenza, however total infectious work-up has not been provided for ruling out any infectious etiology for pyrexia (temperature 103 degrees F) and subsequently seizures. Based on the information provided, the role of the vaccine cannot be completely ruled out.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse manager) on 28-Oct-2015. This case involves a 66-year-old male patient, who was vaccinated with a first dose of FLUZONE HD (batch number- UI453AA, expiry date- 30-Apr-2016, route and site of administration were not reported) on 27-Oct-2015. Concomitant medications were not reported. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions included NKA (no known allergies), Cancer, Iron deficiency and anemia. On 27-Oct-2015, same day within two hours following vaccination, patient had developed shortness of breath swelling, hives and chest pain. On 27-OCT-2015, patient was hospitalized and currently he was admitted for shortness of birth and at the time of report days of hospitalization was reported as one day. Patient was transported to the Emergency room and required ER/doctor visit. Laboratory investigations were not reported. Corrective treatments included oral zantac and Benadryl. At the time of report, the outcome of the events were unknown. Case was considered a serious due to hospitalization and life threatening illness. Documents held by sender: none. Follow up information received from a healthcare professional (nurse manager) on 16 December 2015. Any other vaccination within four weeks prior was reported as not applicable. It was reported that, patient received annual dose of FLUZONE HD intramuscularly.; Sender's Comments: Follow up received on 16-Dec-2015, dose not changes the assessment. Shortness of breath, hives and chest pain are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and are suggestive of an allergic reaction, time to onset is compatible with a role of the vaccination. However, additional information including but not limited to any adverse events to previous vaccinations, allergy testing, concomitant medications and a final diagnosis would be helpful to complete the case assessment. With the available information, no final conclusion can be drawn.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test negative, Allergy to vaccine, Cardiac stress test normal, Chest X-ray normal, Ear pruritus
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Enzyme level test, Eye pruritus, Heart rate decreased
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Insomnia, Mouth swelling, Oral pruritus, Palpitations
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Pruritus generalised, Respiratory tract congestion, Sleep disorder
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test, Cough, Fatigue, Lacrimation increased, Pain in extremity
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Throat irritation
Clinical narrative: Based on additional information received on 12 April 2016, the case became medically confirmed. Initial unsolicited report received from a non-health care professional (Patient) on 20 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI436AA and expiry date: 08 April 2016), dose and dose number were not reported via unspecified route and site of  administration on 30 September 2015. Patient's medical history included high cholesterol, multiple allergies, allergy to formaldehyde and concomitant medications were not reported. It was reported that, on 30 September 2015, approximately 3 hours after vaccination patient had developed itching all over, itchy throat, and itchy, watery eyes. On an unknown date, following the vaccination the patient had cough, very tired all the time and arm remains sore but no redness or itching to site. Patient required ER/doctor visit and doctor referred to allergist. Lab data included allergy testing for eggs. No corrective treatment was given to the patient. The outcome of the events itchy throat, water eyes, itching all over, cough, tired and pain in arm were unknown at the time of this report. Follow up information received from a health care professional on 12 April 2016. The route of administration was updated to intramuscular and site of administration was updated to deltoid. It was reported that no other vaccination was given within four weeks prior to date of vaccination. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MENB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event occurred.  She received a third Gardisil only 9 days after the second.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Influenza like illness, Nasopharyngitis, Pain, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a consumer on 09 October 2015. This case was linked with 2015SA162890. This case involves a female patient, (age not reported) was vaccinated with a dose of  FLUZONE HD (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following vaccination, the patient experienced coughing, running nose and an adverse event which was not specified. Laboratory investigation and corrective treatment was not reported. The outcome of the events was not reported. Follow-up information received from a consumer on 14 December 2015. This case involves a 55-years-old female patient who was vaccinated with a dose of FLUZONE HD on 05 October 2015. The patient was vaccinated at private doctor's office/hospital. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks prior to vaccination were reported as none. Other medications were reported as none. On 07 October 2015, two days following the vaccination, the patient was blowing her nose and coughing. On an unknown date, the patient was recovered from all the events. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Adverse event, Cough, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 09 October 2015. This case was linked with 2015SA162890. This case involves a female patient, (age not reported) was vaccinated with a dose of  FLUZONE HD (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following vaccination, the patient experienced coughing, running nose and an adverse event which was not specified. Laboratory investigation and corrective treatment was not reported. The outcome of the events was not reported. Follow-up information received from a consumer on 14 December 2015. This case involves a 55-years-old female patient who was vaccinated with a dose of FLUZONE HD on 05 October 2015. The patient was vaccinated at private doctor's office/hospital. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks prior to vaccination were reported as none. Other medications were reported as none. On 07 October 2015, two days following the vaccination, the patient was blowing her nose and coughing. On an unknown date, the patient was recovered from all the events. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Nausea
Clinical narrative: This spontaneous report as received from a 60 year old female patient refers to herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2016, at the pharmacy, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On 15-JUL-2016, about an hour after receiving ZOSTAVAX, the patient experienced severe pain at the injection site. On the same day, the patient also experienced nausea. The patient contacted the pharmacy, where she received ZOSTAVAX injection and her physician. The patient did not receive treatment for the events. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: This spontaneous report as received from a 60 year old female patient refers to herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2016, at the pharmacy, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On 15-JUL-2016, about an hour after receiving ZOSTAVAX, the patient experienced severe pain at the injection site. On the same day, the patient also experienced nausea. The patient contacted the pharmacy, where she received ZOSTAVAX injection and her physician. The patient did not receive treatment for the events. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a 60 year old female patient refers to herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2016, at the pharmacy, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On 15-JUL-2016, about an hour after receiving ZOSTAVAX, the patient experienced severe pain at the injection site. On the same day, the patient also experienced nausea. The patient contacted the pharmacy, where she received ZOSTAVAX injection and her physician. The patient did not receive treatment for the events. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 60 year old female patient refers to herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2016, at the pharmacy, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On 15-JUL-2016, about an hour after receiving ZOSTAVAX, the patient experienced severe pain at the injection site. On the same day, the patient also experienced nausea. The patient contacted the pharmacy, where she received ZOSTAVAX injection and her physician. The patient did not receive treatment for the events. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis type skin reaction that extened from the top of the shoulder to the elbow.
Age: 21.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Asthenia, Chills, Discomfort, Dizziness, Feeling abnormal
Clinical narrative: Dizziness, rapid heart rate, nausea, weakness, body felt heavy, light headed and foggy, body aches, fever, chills.
Age: 21.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: Dizziness, rapid heart rate, nausea, weakness, body felt heavy, light headed and foggy, body aches, fever, chills.
Sex: U
Vaccine: FLU3
Symptoms: Encephalitis
Clinical narrative: Initial unsolicited report received from a physician on 13 October 2015. This case is linked with 2015SA163125 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date after the vaccination the patient had experienced encephalitis and was also hospitalized. Laboratory investigations and corrective treatments were not reported. The event outcome was not reported. Documents held by sender: none. Sender's Comments: Encephalitis is listed with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset is not reported; however, alternative autoimmune or infectious etiologies, the most frequent being viral infections, were not excluded. Based on the available information, a role of the vaccine cannot be established.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 09 October 2015. This case involves a patient (gender and age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) administered on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient had experienced adverse event (not specified) from the flu shot. Laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Incorrect route of drug administration
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 23 October 2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of FLUZONE QIV (Batch number, dose, dose in series and site of administration were not reported) via intravenous route on an unspecified date. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient developed a hematoma. The patient required ER or doctor visit. It was an incorrect route of drug administration. Relevant diagnostic tests were not provided and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none. Follow up information received from pharmacist on 29 January 2016. Patient age was reported as approximately 25-45.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 23 October 2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (Batch number, dose, dose in series, route and site of administration were not reported) (not sure if it was FLUZONE) in the last year on an unspecified date. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced arm pain and stiffness. Relevant diagnostic tests and corrective treatments were not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration
Clinical narrative: Initial unsolicited report received from a consumer on 21 October 2015. This case involves a male patient (age was not reported) who was vaccinated with a dose of FLUZONE (batch number, dose, dose in series, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced bruising and greenish/brown spot. Lab data and corrective treatments were not reported. The patient was recovering from events bruising and greenish/brown spot as they eventually faded after administration. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 27 October 2015. This case involves a 69-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch number: UI486AA, expiration date: 24 May 2016, dose and route of administration were not reported) in left deltoid on 20 October 2015. The patient had medical history of penicillin allergy, diabetes and hypertension. Illness at time of vaccination was none reported. The patient did not receive any other vaccination within four weeks of FLUZONE HD vaccination. Concomitant medication was not reported. On 21 October 2015, one day after vaccination, the patient developed fever. On an unspecified date, the patient's blood sugars were running high. The patient required ER or doctor visit. The laboratory investigation includes finger sticks which performed on an unspecified date. Corrective treatment was not reported. The outcome of the event was unknown. Follow up information received from pharmacist on 30 November 2015. On 21 October 2015, the patient's blood sugar were running high (in 500s). List of documents held by sender: none. Follow up information received from a pharmacist on 28 December 2015. It was reported that, patient was advised by the physician to follow the sick day protocol. Patient's blood sugars returned to normal after 3 to 5 days.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chest discomfort, Injection site hypersensitivity
Clinical narrative: Initial unsolicited report received from a Physician  on 27 October 2015. This case involves a 30 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, route and site of administration not reported),on an unspecified date. The patient's illness at time of vaccination was none. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced pain in her joint, a heavy feeling in her chest and local allergic reaction at the site. Lab data was reported as none at that time. It was reported that the physician was planning to give some steroids and pain medication as corrective treatments. The patient required ER/doctor visit. The outcome of the events was not recovered. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Hypertension, Loss of consciousness, Syncope
Clinical narrative: Initial unsolicited report received from a pharmacist on 27-Oct-2015. This case involves a 72-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number- UI489AA, expiry date- 02-Jun-2016, route and site of administration were not reported) on 26-Oct-2015. Medical history and concomitant medications were not reported. Illness at time of vaccination was not reported and Pre-existing physician diagnosed allergies, birth defects, medical conditions included sulfa allergy. On 26-Oct-2015, same day four hours after vaccination, the patient had passed out while walking in neighborhood and also felt dizzy. It was reported that patient was referred to her own HCP for evaluation and treatment. Laboratory investigations and corrective treatments were not reported. As of 27-Oct-2015, the patient continued to be dizzy and was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: passed out. Follow up information received from pharmacist on 23-Nov-2015. The patient followed up with her (primary care physician) PCP on the same day. It was reported that the immunization was not responsible for syncope, prescriber had apparently altered hypertension therapy and determined an adjustment in patient's hypertension therapy medicines was responsible for the event. Documents held by sender: none; Sender's Comments: Follow up information received on 23 November 2015 changes the assessment: Syncope is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with a role of vaccination. The immunization was not responsible for the event syncope and an adjustment in her hypertension medications was the reason for the event.This case is poorly documented. Additional information regarding patient's medical history such as neurological pathologies as well as clinical and biological workup, previous vaccinations and their toleration, are needed to further assess the case. Bases on available information, case not fully assessable.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from pharmacist on 26-Oct-2015. This case involves a patient (age and gender was not provided) who was vaccinated with a dose of High Dose Flu Shot (batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced adverse event after administration with Fluzone high dose vaccine. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from Consumer on 26-Oct-2015. This case involves a patient (age and gender was not provided) who was vaccinated with a dose of INFLUENZA VACCINE (Trivalent Flu Vaccine) (Manufacturer: unknown, batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced potential adverse event. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a consumer on 26 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced an adverse event. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from consumer on 26-Oct-2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of High Dose Flu Shot (batch number, route of administration, site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. The patient felt that she might have had a reaction to the high dose flu shot on an unspecified date after vaccination. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Reference Number: 2016353319) on 27 July 2016. This case involves an female patient (age was not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, route and site of administration was not reported) on an unknown date. Patient had seizure following the pneumonia vaccine in 2000. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination with a flu shot that had thimerosal, the patient experienced her throat closed up but she never stopped breathing. It was reported that this was happened on 15 or more years ago. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) (Manufacturer Report Number: 2016359335) on 29 July 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu vaccine (batch number, expiry date, route and site of administration wasnot reported) and PREVNAR 13 (batch number, expiry date, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient had experienced Guillain-Barre Syndrome (GBS). Lab data and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event Guillain-Barre Syndrome. List of documents held by sender: none.; Sender's Comments: This is poorly documented case as patient had Guillain Barre syndrome following INFLUENZA VACCINE. Time of onset is unknown, further information on patient's medical history, concomitant medications, any recent infection, previous immunization and its tolerance are needed further assess this case. However patient received 2 vaccines on unknown date, making it difficult to assess the role of one vaccine in particular.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified nursing assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated improperly stored VAQTA (strength, dose, route and site of administration, lot # and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen, tender injection site.
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a patient's mother refers to a male young patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with the first dose of M-M-R II via subcutaneous route (dose, lot# and expiration date were not reported). On 27-JUL-2016, the patient was erroneously vaccinated with the second dose of M-M-R II via subcutaneous route (dose, lot# and expiration date were not reported). On 27-JUL-2016, the patient experienced injection site swelling, red circle appeared at the injection site and area of the injection was hot to the touch. The patient's physician advised ADVIL as a treatment and icing of the affected area. It was not specified if at the time of the report the patient was already given treatment for the events. The outcome of the events was not reported. The relatedness between the events and M-M-R ii was not provided. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified nursing assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL (strength, dose, route and site of administration, lot # and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions included asthma and allergy to cashews. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9, (lot # 040164 (not valid), expiry date: 20-FEB-2018 at a dose of 0.5 ml, (route of administration: intramuscular). Concomitant therapy included triamcinolone cream. After 3 hours of vaccination, the patient experienced an itchy rash on chin and back. The patient was not hospitalized. The patient contacted doctor and was treated with BENADRYL and ibuprofen. The event was recovered on 21-JUL-2016. The causality of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 61 year old female patient, reporting on herself. The patient concurrent conditions included high cholesterol, drug allergy to penicillin and sulfa drugs. The patient no concomitant medications. On 06-JUL-2016, the patient was vaccinated with ZOSTAVAX, in the right arm, 1 time, lot # L046896, (dose, route and expiry date not reported). Subsequently, on the same day, the patient had reaction at injection site, on the right arm. The injection site became red, swollen, tender, feverish and spreading up her arm. The outcome of the events and causality assessment was not provided. Additional information is not expected as reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner via company representative regarding a patient of unknown demographics. Pertinent medical history, drug reactions/allergies and concomitant medication information was not reported. On an unknown date, the patient was administered improperly stored VARIVAX 0.5 ml subcutaneously. The lot numbers involved were Lot# M004328 with expiry date: 26-Jan-2018, Lot# M009765 with expiry date: 23-FEB-2018 and Lot# M005971 with expiry date: 02-FEB-2018. Temperature: -9.6 degree Celsius. Time frame: 5 hours. The temperature was back in range. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner via company representative regarding a patient of unknown demographics. Pertinent medical history, drug reaction/allergies and concomitant medication information was not reported. On an unknown date, the patient was administered improperly stored VARIVAX 0.5 ml subcutaneously. The lot numbers involved were Lot# M004328 with expiry date: 26-JAN-2018, Lot# M009765 with expiry date: 23-FEB-2018 and Lot# M005971 with expiry date: 02-FEB-2018. Temperature: -9.6 degree Celsius. Time frame: 5 hours. The temperature was back in range. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of the two reports. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of GARDASIL 9 (lot # M009362, expiration date: 13-JUN-2018) (dose and route of administration were not provided). The vaccine was exposed to a temperature of 53.6 Fahrenheit degrees for 1.5 hours and to a temperature of 55.2 Fahrenheit degrees for 1 hour and 45 minutes. No previous temperature excursions were reported. The reporter stated that the temperature was back in ranges. There was no information provided if data logger was used. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot# L016429, expiration date 09-AUG-2017, dose and frequency unknown), intramuscularly. It was reported that the patient received an incomplete dose as he/she suddenly moved during the injection. No adverse events were reported. No product quality complaint (PQC) issue was involved. Additional information has been requested.