chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 615600) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 14-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L028083, dose 1, via unknown route in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 14-DEC-2015, via unknown route in the left arm, lot# 7XR47; dose and expiration date unknown), MENVEO (vaccinated date: 14-DEC-2015, via unknown route in the left arm, lot# M15029; dose and expiration date unknown), and FLUMIST (vaccinated date: 14-DEC-2015, via intranasal route, lot# FM2220; dose and expiration date unknown). Two days after injection left arm turned red, warm and swollen. Patient was diagnosed with mild cellulitis of left upper arm and treated with oral antibiotic. On 16-DEC-2015, the patient experienced erythema, skin warm, peripheral swelling and injection site cellulitis which required emergency visit. The outcome of erythema, skin warm, peripheral swelling and injection site cellulitis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 615735) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. Patient had no current illness. Information on patient's prior vaccinations was not reported. Patient's other medication included Topamax 25 mg once at night and Vyvanse 40 mg once a day. The patient's medical history included allergic to penicillin. On 16-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L028083, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included (e. coli) BEXSERO batch # 149001, via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). On 17-DEC-2015, the patient had extreme pain (8 out of 10) with baseball size swelling at the injection site and there was no redness or heat. No tests were performed and the patient was treated with ibuprofen around the clock from 18-DEC-2015 through 21-DEC-2015 and ice twice a day with no reduction in swelling. The outcome of injection site pain and injection site swelling was unknown. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Rash, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 615865) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. Information on the patient's current illness and prior vaccinations was not reported. Patient's historical condition included insulin dependent diabetes mellitus. Patient's other medication included Humalog 100 unit/ml, Lantus solostar 100 unit/ml, Zetia 10 mg. On 14-DEC-2015, the patient was vaccinated with the third dose of GARDASIL 9 lot # L025737, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUMIST QUADRIVALENT, dose 2, via internasal route and MENVEO batch # M15023, dose 1, via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). On 14-DEC-2015, after vaccination the patient experienced itchy rash on arms and legs in the evening and progressively got worse and spread. The patient required emergency room visit. The outcome of rash and rash pruritic were unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616388) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Patient had no current illness. Patient's medical history included allergies and chest pain on exertion. Patient's historical drugs included codeine and potassium clavulanate. Information on the patient's other medications and prior vaccinations were not reported. On 24-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9 lot # L016429, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUMIST QUADRIVALENT batch # FJ2073, via intranasal route for prophylaxis (dose number, dosage and expiry date unspecified). On 24-DEC-2015, the patient experienced syncope and immediate post-injection reaction. The outcome of immediate post-injection reaction and presyncope was reported as fully recovered at the clinic. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616656) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 24 year old female patient. Patient had no concurrent illnesses and medical history. Information on patient's prior vaccinations was not reported. Patient's other medication included Doxycycline. On 04-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9, via intramuscular route in the left arm for prophylaxis (lot/batch#, dosage and expiry date unspecified). On 24-DEC-2015, the patient had swollen bump under skin at injection site, painful and tender to touch and movement. Approximately quarter in size and was still present as of 29-DEC-2015. The outcome of the events injection site pain and injection site swelling was not reported. Causality for the events were not provided. Additional information is not expected from the Agency as follow up information cannot be obtained
Age: 90.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Dyspnoea, Fall, Femur fracture, Immune system disorder, Mobility decreased
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via other company (Pfizer) (Manufacturer Report Number: 2017089568) on 20-Apr-2017. This case involves a 90-year-old female patient who was vaccinated with a dose of Influenza vaccine and an injection of Prevenar 13 in the arm (batch number, expiry date, dose form, frequency and route of administration not reported for both vaccines) on an unspecified date in August 2016 (it was unknown if Influenza vaccine given before Prevenar 13). The patient's medical history and concomitant medications were not reported. On an unspecified date in August 2016, when the patient first got home, all of sudden for a couple of seconds she could not move her legs, when the patient ran after her dog, then she got very heavy breathing (not sure whether it was the same day of the shot) which lasted for about 3 months, and her heart doctor thought she may be allergic to it. She felt like in a race with the heavy breathing, patient also had hives around the same times that did not last too long. On 23-Aug-2016, unspecified days following the vaccination, the patient fell and broke her left femur and subsequently was hospitalized on an unspecified date in August 2016. Relevant laboratory investigations were not reported. The patient received physical therapy and pine rehabilitation as corrective treatment. On an unspecified date in August 2016 the patient recovered from hives, all of a sudden could not move legs, heavy breathing. Outcome of event allergic was not reported and outcome of event immune system was down was unknown (had performed tests to find out). List of documents held by the sender: None; Sender's Comments: This case concerns a 90 year old female patient who received INFLUENZA VACCINE (manufacturer unknown) and Prevnar 13 and had a femur fracture as a result of a fall. Time to onset is not provided. Further information on medical history including time to onset, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 90.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via other company (Pfizer) (Manufacturer Report Number: 2017089568) on 20-Apr-2017. This case involves a 90-year-old female patient who was vaccinated with a dose of Influenza vaccine and an injection of Prevenar 13 in the arm (batch number, expiry date, dose form, frequency and route of administration not reported for both vaccines) on an unspecified date in August 2016 (it was unknown if Influenza vaccine given before Prevenar 13). The patient's medical history and concomitant medications were not reported. On an unspecified date in August 2016, when the patient first got home, all of sudden for a couple of seconds she could not move her legs, when the patient ran after her dog, then she got very heavy breathing (not sure whether it was the same day of the shot) which lasted for about 3 months, and her heart doctor thought she may be allergic to it. She felt like in a race with the heavy breathing, patient also had hives around the same times that did not last too long. On 23-Aug-2016, unspecified days following the vaccination, the patient fell and broke her left femur and subsequently was hospitalized on an unspecified date in August 2016. Relevant laboratory investigations were not reported. The patient received physical therapy and pine rehabilitation as corrective treatment. On an unspecified date in August 2016 the patient recovered from hives, all of a sudden could not move legs, heavy breathing. Outcome of event allergic was not reported and outcome of event immune system was down was unknown (had performed tests to find out). List of documents held by the sender: None; Sender's Comments: This case concerns a 90 year old female patient who received INFLUENZA VACCINE (manufacturer unknown) and Prevnar 13 and had a femur fracture as a result of a fall. Time to onset is not provided. Further information on medical history including time to onset, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a 4-year-old female patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). Concomitant products included PROQUAD. On 4th April 2017, the patient received KINRIX. On 12th April 2017, 8 days after receiving KINRIX, the patient experienced injection site cellulitis. The patient was treated with antibiotics. In April 2017, the outcome of the injection site cellulitis was recovered/resolved. The reporter considered the injection site cellulitis to be related to KINRIX. Additional details were provided as follows: Concomitant drug PROQUAD was a non-GSK drug. The patient was seen by the nurse practitioner the following day of the injection site cellulitis. The patient was diagnosed and antibiotics were prescribed. The mother reported to the reporter that the symptoms had resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a 4-year-old female patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). Concomitant products included PROQUAD. On 4th April 2017, the patient received KINRIX. On 12th April 2017, 8 days after receiving KINRIX, the patient experienced injection site cellulitis. The patient was treated with antibiotics. In April 2017, the outcome of the injection site cellulitis was recovered/resolved. The reporter considered the injection site cellulitis to be related to KINRIX. Additional details were provided as follows: Concomitant drug PROQUAD was a non-GSK drug. The patient was seen by the nurse practitioner the following day of the injection site cellulitis. The patient was diagnosed and antibiotics were prescribed. The mother reported to the reporter that the symptoms had resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Erythema, Flushing
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). Concurrent medical conditions included seasonal allergy and penicillin allergy. Concomitant products included PROQUAD vaccine. On 13th April 2017, the patient received KINRIX. On 13th April 2017, less than an hour after receiving KINRIX, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), difficulty breathing, red face and cough. The patient was treated with Albuterol, epinephrine, BENADRYL (nos) and prednisone. On an unknown date, the outcome of the anaphylactic reaction, difficulty breathing, red face and cough were recovered/resolved. The reporter considered the anaphylactic reaction, difficulty breathing, red face and cough to be related to KINRIX. Additional details were reported as follows: The patient received PROQUAD vaccine (Non GSK) on right deltoid. The patient received a paediatric dose the day before reporting in afternoon in left deltoid and within 15 minutes he began to experience the reactions. The patient's mother said he brought his hands to his throat when he had a hard time breathing. The patient was treated in the emergency room next door to the facility and remained there for an hour and a half. The patient's mother reported that, there were no signs of the reactions on the day of reporting. The vaccination date was wrongly reported as 4th April 2017, however it was corrected to 13th April 2017.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). Concurrent medical conditions included seasonal allergy and penicillin allergy. Concomitant products included PROQUAD vaccine. On 13th April 2017, the patient received KINRIX. On 13th April 2017, less than an hour after receiving KINRIX, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), difficulty breathing, red face and cough. The patient was treated with Albuterol, epinephrine, BENADRYL (nos) and prednisone. On an unknown date, the outcome of the anaphylactic reaction, difficulty breathing, red face and cough were recovered/resolved. The reporter considered the anaphylactic reaction, difficulty breathing, red face and cough to be related to KINRIX. Additional details were reported as follows: The patient received PROQUAD vaccine (Non GSK) on right deltoid. The patient received a paediatric dose the day before reporting in afternoon in left deltoid and within 15 minutes he began to experience the reactions. The patient's mother said he brought his hands to his throat when he had a hard time breathing. The patient was treated in the emergency room next door to the facility and remained there for an hour and a half. The patient's mother reported that, there were no signs of the reactions on the day of reporting. The vaccination date was wrongly reported as 4th April 2017, however it was corrected to 13th April 2017.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 26 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She also did not take any concomitant medications. On 20-MAR-2017, the patient was vaccinated with the first dose of VARIVAX lot number M031969, expiration date 30-JUN-2017, for prophylaxis (exact dose and route of administration were not provided). The vaccine was reconstituted with sterile diluent (manufacturer unknown). On 21-MAR-2017, the patient called medical assistant to report that her arm was red and swollen at the injection site since an unknown date in March 2017 and she was advised by a physician to try cold therapy for treatment. On 23-MAR-2017, the patient came into the office to see the physician and she had redness and swelling at the injection site which was now 3 cm in size. The patient also stated that at that time the site of injection was itchy and painful since an unknown date in March 2017. The physician gave the patient diphenhydramine hydrochloride (BENADRYL) (form, dose, frequency were unspecified) and hydrocortisone (manufacturer unknown) cream for a treatment. The medical assistant stated also that the administered dose of VARIVAX was properly stored throughout its time at their facility and no temperature excursion had occurred prior to the administration. There were no lab diagnostic studies performed. There was no product quality complaint involved in this case. Action taken with sterile diluent (manufacturer unknown) was not provided. The outcome of adverse events and causality between the events and VARIVAX and sterile diluent (manufacturer unknown) were not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with M-M-R II, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the M-M-R II vaccine, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015066: US-009507513-1704USA015064: US-009507513-1704USA015065:
Sex: U
Vaccine: HPV9
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 15-APR-2017, the patient was vaccinated with GARDASIL 9, intramuscular, (strength, dose, lot number and expiration date were not reported) for prophylaxis. On 19-APR-2017, four days after the patient was vaccinated, the patient went to the doctor's office with flu like symptoms, and a low grade fever. At the time of reporting the outcome for the events was not reported. The causal relationship between the events and the suspect vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in January 2017, the patient received first dose of VARIVAX for prophylaxis (dosing details and lot# were not reported). The patient has not received the 2nd dose yet (Inappropriate schedule of drug administration). No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from an office manager referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2017, the patient received an improperly stored VARIVAX (dose, frequency not reported) (lot: M032493, expiry date: 06-NOV-2018). Temperature was in the range of 6F to 14F for 1 hour time frame. There was no previous temperature excursion. VARIVAX was reconstituted with a sterile diluent. Office manager confirmed that the sterile diluent did not undergo temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with PROQUAD, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the PROQUAD vaccine, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010521:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with VARIVAX, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the VARIVAX, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010521:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with ZOSTAVAX, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the ZOSTAVAX vaccine, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010521:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of PNEUMOVAX23 injection, (strength and dose were not reported) (lot # M036728, expiration date 20-MAY-2018, 23 vials/ lot # reported as "N005597", expiration date 19-OCT-2018, 23 syringes) for prophylaxis. According to the reporter, PNEUMOVAX23 doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000386: US-009507513-1705USA000387:
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Fever, SWELLING, red and warm. KEFLEX 500MG 1TAB tid X7DAYS.
Age: 60.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Localized pain and swelling, redness, lump at injection site that lasted days.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site with lump that lasted days.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. No concomitant medications, medical history, drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (lot # M000998, expiration date 07-JAN-2018; dose and route of administration were not reported) reconstituted with sterile diluent, (dose, route of administration, lot # and expiration date were not reported). The patient was vaccinated with the second dose of VARIVAX (lot # M000998, expiration date 07-JAN-2018; dose and route of administration were not reported) reconstituted with sterile diluent (dose, route of administration, lot # and expiration date were not reported), approximately one month later. The patient discovered that she was pregnant two weeks after receiving the second dose of the vaccine. No adverse effects were reported. No product quality complaint was involved. Date of last menstrual period and due date were not reported. The outcome of the pregnancy was pending. The fetal outcome was unknown. The patient was in the first trimester of pregnancy during the exposure to VARIVAX reconstituted with sterile diluent. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on an unknown dates, multiple unspecified patients received improperly stored doses of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017, the patients were vaccinated with an expired dose of PNEUMOVAX 23 (lot # L019836, expiry date: 24-MAR-2017, dose, strength, vaccination site unspecified) for prophylaxis. There were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on an unknown dates, multiple unspecified patients received improperly stored doses of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Soft tissue swelling, Vaccination site discomfort
Clinical narrative: 4/30 PM vaccine. Awoke AM 5/2 with discomfort at vaccine site (mild), noted moderate soft tissue swelling and erythema surrounding injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm to touch.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Dizziness, Headache, Pain in extremity
Clinical narrative: Back pain, Dizziness, Headache, Arm pain from elbow to shoulder.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: After receiving PROQUAD (R) thigh by LPN approx. 2 min, Mom stated that she wanted BENADRYL for patient's leg was red and swollen around PROQUAD site. Local itching present. Dr. assessed patient and then sent home, no distress.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Albumin CSF increased, CSF culture, CSF test abnormal, Electromyogram abnormal, Epstein-Barr virus infection
Clinical narrative: 5 days of increasing slowness in muscles of calves with ascending parasthesias (tingling and numbness up through the legs resulting in difficulty walking. Diagnosed with Poly neuropathy Guillian-Barre Syndrome (positive albumin in CSF fluid) and acute Epstein Barr Virus infection. Treated with IVIG 25gm daily for 5 doses.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscle disorder
Clinical narrative: 5 days of increasing slowness in muscles of calves with ascending parasthesias (tingling and numbness up through the legs resulting in difficulty walking. Diagnosed with Poly neuropathy Guillian-Barre Syndrome (positive albumin in CSF fluid) and acute Epstein Barr Virus infection. Treated with IVIG 25gm daily for 5 doses.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Nerve conduction studies, Paraesthesia, Polyneuropathy
Clinical narrative: 5 days of increasing slowness in muscles of calves with ascending parasthesias (tingling and numbness up through the legs resulting in difficulty walking. Diagnosed with Poly neuropathy Guillian-Barre Syndrome (positive albumin in CSF fluid) and acute Epstein Barr Virus infection. Treated with IVIG 25gm daily for 5 doses.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right Upper Arm Erythema, Swelling, Warmth and Tenderness.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age with a concurrent condition of arthritis. The patient's medical history, concomitant medications, and historical drugs were not reported. On 02-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, frequency, lot # and expiration date were unknown) for prophylaxis. The pharmacist reported that on 03-APR-2017, the patient had an appointment with his physician for his preexisting arthritis, he also reported that this was already made prior to receiving the ZOSTAVAX, on the appointment the physician prescribed the patient with an unspecified corticosteroid for his "stiff neck" that was related to his arthritis. Additional information is not expected, because there was no consent to contact reporter.
Sex: F
Vaccine: HPV4
Symptoms: Injury, Quality of life decreased
Clinical narrative: This spontaneous report has been received from a consumer regarding an unknown number of female patients of unknown ages. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (doses, frequencies, route of administration, lot numbers and expiration dates were not reported) for prophylaxis.  It was stated by the reporter that GARDASIL was "injuring girls" and "ruining lives" (dates unknown). The outcome of the events and the causality assessment between "injuring girls" and "ruining lives" with GARDASIL were unknown. Additional information is not expected as there is no contact information.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This prospective pregnancy report concerning a female patient of an unknown age, was received from the patient's sister. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in December 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route of administration, lot number and expiration date were not reported) as a vaccine for Human papillomavirus (HPV). On an unknown date in February 2017, the patient received the second dose of GARDASIL 9 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date in March 2017, the patient tested positive for pregnancy. The patient sought medical attention and did not receive treatment for the event. There was no additional information regarding the pregnancy provided. Additional information is not expected as there was no contact consent.
Age: 31.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 31 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 24-APR-2017, the patient inadvertently received an expired dose of VARIVAX for prophylaxis, lot # L013826 with expiration date of 21-APR-2017 (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB injection (lot number: L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided). The reporter stated that the administered doses of RECOMBIVAX HB of lot number: L025738 were stored at temperature of 17.6 degrees Celsius (C) for 1 hour 38 minutes on an unknown date. Previous temperature excursions included storage at the temperature of 13 degrees C for 72 hours 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014784: US-009507513-1704USA014783.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot number: M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided). The reporter stated that the administered doses of VAQTA of lot number: M039202 were stored at temperature of 17.6 degrees Celsius (C) for 1 hour 38 minutes on an unknown date. Previous temperature excursions included storage at the temperature of 13 degrees C for 72 hours 30 minutes. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012519: US-009507513-1704USA014783.
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a 30 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date "during childhood", the patient was vaccinated with a dose of VARIVAX (strength, dose number, rote, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unknown date, recent antibody titers drawn were negative for immunity to varicella (viral titre decreased). No treatment was given. The case did not involve cancer or overdose. At the time of the report, the outcome of viral titre decreased was not provided. Additionally it was reported that the patient had not developed any symptoms of varicella disease. The reporter did not assess the relatedness between viral titre decreased and VARIVAX. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Blood glucose increased, Decreased appetite, Fatigue, Injection site mass
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 74-year-old female consumer received PREVNAR 13 on 26Jan2016 at single dose for immunisation. Medical history and concomitant medications were not provided. She stated she did not have diabetes. After vaccination, since an unspecified date, she had been experiencing fatigue, muscle pain, joint pain, decreased appetite, tenderness in injection site and it itched and there was a lump there. On an unspecified date in 2017 her blood glucose came back very high and was labeled off the charts. She stated she felt like this vaccine was ruining her health. Events outcome was not provided.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 74-year-old female consumer received PREVNAR 13 on 26Jan2016 at single dose for immunisation. Medical history and concomitant medications were not provided. She stated she did not have diabetes. After vaccination, since an unspecified date, she had been experiencing fatigue, muscle pain, joint pain, decreased appetite, tenderness in injection site and it itched and there was a lump there. On an unspecified date in 2017 her blood glucose came back very high and was labeled off the charts. She stated she felt like this vaccine was ruining her health. Events outcome was not provided.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Blood glucose normal, Decreased appetite, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 74-year-old female consumer received PREVNAR 13 on 26Jan2016 at single dose for immunisation. Medical history and concomitant medications were not provided. She stated she did not have diabetes. After vaccination, since an unspecified date, she had been experiencing fatigue, muscle pain, joint pain, decreased appetite, tenderness in injection site and it itched and there was a lump there. On an unspecified date in 2017 her blood glucose came back very high and was labeled off the charts. She stated she felt like this vaccine was ruining her health. Events outcome was not provided.
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Drug administered at inappropriate site, Gait disturbance, Immediate post-injection reaction, Injection site pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age and race/ethnicity received PREVNAR 13 on 03Oct2016 at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 03Oct2016 the patient felt that the nurse put the needle in the wrong place (bone maybe), experienced pain immediately and since an unspecified date she had trouble walking, sitting, pain in lower back, felt shot has affected her muscles (buttocks, toes, back). Events outcome was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Muscle disorder
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age and race/ethnicity received PREVNAR 13 on 03Oct2016 at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 03Oct2016 the patient felt that the nurse put the needle in the wrong place (bone maybe), experienced pain immediately and since an unspecified date she had trouble walking, sitting, pain in lower back, felt shot has affected her muscles (buttocks, toes, back). Events outcome was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling abnormal, Induration
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting on behalf of the mother. An 83-year-old female patient received PREVNAR 13 on 04Apr2017, in arm, at single dose, for immunisation. The patient medical history was not reported. The patient family history included unspecified adverse reactions and unspecified severe adverse reactions to new drugs. The patient's concomitant medications were not reported. Since an unknown date in Apr2017 (reported as 2 days after vaccination) the patient experienced swollen arm, hard knot, that before was red, hot and as big as a baseball, diarrhea, itching that came and went on her legs/thighs and was extremely fatigued. She used to walk on the treadmill and she was unable to do that now. The patient went back to the doctor and called him twice. The doctor said there was nothing he could give her. She could not get over it, she felt miserable. At the time of report she could barely feel the knot, when she was using her arm it got a little bigger but not like it was. Diarrhea, itching, knot and fatigue were resolving at the time of report. The outcome of the other reported events was unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Nodule, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting on behalf of the mother. An 83-year-old female patient received PREVNAR 13 on 04Apr2017, in arm, at single dose, for immunisation. The patient medical history was not reported. The patient family history included unspecified adverse reactions and unspecified severe adverse reactions to new drugs. The patient's concomitant medications were not reported. Since an unknown date in Apr2017 (reported as 2 days after vaccination) the patient experienced swollen arm, hard knot, that before was red, hot and as big as a baseball, diarrhea, itching that came and went on her legs/thighs and was extremely fatigued. She used to walk on the treadmill and she was unable to do that now. The patient went back to the doctor and called him twice. The doctor said there was nothing he could give her. She could not get over it, she felt miserable. At the time of report she could barely feel the knot, when she was using her arm it got a little bigger but not like it was. Diarrhea, itching, knot and fatigue were resolving at the time of report. The outcome of the other reported events was unknown. No follow-up attempts possible. No further information expected.