chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Transfusion, Unresponsive to stimuli, Vaccination failure, Waterhouse-Friderichsen syndrome, White blood cell count normal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Back pain, Chest pain
Clinical narrative: Pt. given ZOSTAVAX and PNEUMOVAX at same time and day 09/1/2016. Pt. came in 3/8/17 stating she has been experiencing chest pain that radiates to her spine. I recommend she go to the ER and follow up with doctor as these symptoms developed early last month approximately 2/01/2017. Pain is off and on.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Chest pain, Spinal pain
Clinical narrative: Pt. given ZOSTAVAX and PNEUMOVAX at same time and day 09/1/2016. Pt. came in 3/8/17 stating she has been experiencing chest pain that radiates to her spine. I recommend she go to the ER and follow up with doctor as these symptoms developed early last month approximately 2/01/2017. Pain is off and on.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Bradycardia, Cyanosis, Pyrexia, Rash
Clinical narrative: Bradycardia  (so bad turned blue), small red bumps all over face, swelling in face, fever, redness/splotty, and weakness.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Rash macular, Swelling face
Clinical narrative: Bradycardia  (so bad turned blue), small red bumps all over face, swelling in face, fever, redness/splotty, and weakness.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-FEB-2017, the patient received an expired dose of M-M-R II Lot # K011317 and expiration date: 13-AUG-2016, subcutaneously (dose was not reported) for prophylaxis. The patient had not experienced an adverse effect. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced swelling, warmth and itchiness at the injection site after ZOSTAVAX administration. The outcome of injection site swelling, injection site pruritus and injection site warmth was unknown. The causality between these events and vaccination with ZOSTAVAX was not assessed. There was no product quality complaint involved. Additional information is not expected as there is no contact details.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant referring to unspecified patients of unknown genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX Lot number reported as "M036293" with expiration date on 17-AUG-2018 (strength and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 22 grades F (Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions for vaccines. The temperature excursion was recorded by a data logger. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006986: US-009507513-1703USA006985: US-009507513-1703USA006984: US-009507513-1703USA006983.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female patient of unknown age. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 29-JUL-2016, when she was 14 years old, the patient was vaccinated CERVARIX (strength, dose, route, lot# and expiration date were unknown) for human papillomavirus (HPV) vaccination. On 23-FEB-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot# and expiration date were unknown) to complete the HPV vaccination series (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information on concomitant medication, medical history and drug allergies was not provided.   On 23-FEB-2017, the patient was vaccinated with a dose of VARIVAX (lot# M032358, expiration date: 05-JUL-2018; dose and route unknown) and a dose of PROQUAD (lot# M031943, expiration date: 27-DEC-2017, therapy type: rHA; dose and route unknown) for prophylaxis (overdose). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medication drug reactions or allergies. On 07-MAR-2017, the patient was vaccinated with an expired dose of VAQTA (lot # L048460 and expiration date of 14-JAN-2017) (strength, dose, frequency and route of administration were not provided) for prophylaxis. Additionally, no adverse effect was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from an approximately 24 year old female patient referring to herself. Information about concurrent condition, concomitant medication and medical history was not provided. On 08-FEB-2017, the patient was vaccinated with VARIVAX(dose, frequency, lot# and expiry date unknown) subcutaneously for the prevention of varicella. On an unknown date, after receiving VARIVAX, she found out that she was 3 weeks pregnant (The last menstrual period of and estimate due date was as unknown date in 2017). The patient did not want to specify what method was used to find out she was pregnant either. The patient did not seek medical attention and no treatment was given for the event.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On approximately 27-FEB-2017, reported as multiple unknown dates since 27-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780 with an expiration date 15-APR-2019 and lot# M041212 with an expiration date 21-JUN-2019 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion between 0 and 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001517: US-009507513-1703USA005123: US-009507513-1703USA005121.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot # M008589, expiration date: 16-FEB-2018, therapy type: rHA; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 06-DEC-2016, M-M-R II was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for 135.5 hours. The M-M-R II was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 40.5 hours. 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 source. Additional information has been requested. Sender's Comments: US-009507513-1703USA005338: US-009507513-1702USA012145.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant and an office manager, referring to an unspecified number of patients of unknown age and gender. The patients' current condition, concomitant medication and medical history were not provided. On unspecified dates between 23-JAN-2017 and 21-FEB-2017, the patients received unspecified doses of improperly stored VARIVAX (concentration, frequency and route were unknown; lot # M035142 with expiration date 03-AUG-2018 and lot# M039317 with expiration date 20-SEP-2018, respectively) for prophylaxis. No adverse effects were reported. VARIVAX was stored between 5 Fahrenheit degree (F) and 14 F for 18 hour 40 minutes, and between 14 F and 46 F for 4 hour 30 minutes. There was no previous temperature excursion, and the data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012230:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M020926, expiry date: 11-AUG-2018) (lot # M031574, expiry date: 11-NOV-2018) (lot # M034894, expiry date: 11-NOV-2018), for prophylaxis (dose number and route of administration were unknown). The doses of RECOMBIVAX HB were stored between 32 Fahrenheit degrees and 36 Fahrenheit degrees (34.7 Fahrenheit degrees) for 48 hours. There was no previous temperature excursion and no data logger involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 13-MAR-2017, the patient was vaccinated with improperly stored PNEUMOVAX 23, lot number as reported N000508, expiration date 19-OCT-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was from 9 to 25 Celsius degrees, in a time frame of 56 hours. The digital data logger was involved. No previous temperature excursion and no product quality complain was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unknown dates in "November 2016", the patients were administered improperly stored vaccine products (dose, route) for prophylaxis (also reported as "these vaccines have not been administered to any patients"). The products was VAQTA (lot # L017757, expiration date 08-APR-2018 was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, lot # M022531, expiration date 23-FEB-2018, some was stored in the temperature of between 32 and 36 degrees Fahrenheit for 780 minutes, other was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, lot # M036459, expiration date 18-JAN-2018, some was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, other was stored in the temperature of between 32 and 36 degrees Fahrenheit for 780 minutes, lot # M027879, expiration date 24-JAN-2018 was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes;   No adverse effect was reported. The report involved a "data logger".  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA000989:
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Headache, Painful respiration, Pneumonia
Clinical narrative: Pneumonia - dry cough, pain with breathing, fatigue! Headache.
Age: 54.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (ZOSTAVAX site). Redness around injection site, swollen around injection site for 48 hrs following injection (resolved 3/12/17).
Sex: U
Vaccine: HPV4
Symptoms: Skin lesion, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a currently 70 year old male patient. The patient did not have any allergies. Patient's medical history included cancer started on an unknown date in 1998 and 50 skin cancer surgeries between the years 1998 and 2012. The patient had spleen removed due to his cancer spreading on an unknown date in June 2012. The patient's concurrent condition included stage 4 Leukemia cancer and poor immune system. On an unknown date (reported as after the surgery), the patient was vaccinated with a dose of GARDASIL subcutaneous (dose, lot # and expiration date were not provided). Concomitant therapies included unspecified thyroid and statin medication. The patient stated that GARDASIL helped get rid of his stage 4 Leukemia cancer and he "hasn't had skin cancer" since getting the vaccination. On 14-FEB-2017 (reported as at the time of the call), the patient stated that his cancer was currently in stage 2 and that he still got lesions but did not have to get any skin biopsies or surgeries done since getting the GARDASIL. No treatment was prescribed for adverse event. No product quality complaint was involved. The outcome of the event was assessed as recovering/resolving. The reporter considered get rid of his stage 4 Leukemia cancer to be related to GARDASIL. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a healthcare professional (who was also an office manager) via Poison and Drug Center (PDC) (ref# US17-008179) and refers to a 53 year old female patient. She did not have any relevant medical history. On 27-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (expiration date 05-FEB-2017; lot #, site, exact dose and route of administration were not reported). Concomitant therapies included LIPITOR, aspirin (manufacturer unknown) and vitamins (unspecified). The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report was received from a pharmacist via Poison And Drug Center referring to a male patient of unknown age. There was no information about patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient started vaccination with M-M-R II (lot #, expiration date, frequency, route and dose unknown) for prophylaxis. On 11-MAR-2017 at 11: 00, the patient received M-M-R II (lot # M039914, expiration date: 26-SEP-2018) subcutaneously because he needed a booster. Around 16:00, he texted the pharmacist to let her know that his arm turned purplish and black. The pharmacist thought that it was a bruise (Contusion). It was unknown if there was relevant lab work. As of 11-MAR-2017, it was unknown if the patient would continue with M-M-R II and had not recovered from the event. The causality between the event and M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # and dose were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported the same event for two patients. This is the second of two reports. A female patient of unknown age and race/ethnicity received on 02Mar2017 PREVNAR 13 (lot number R48403, Expiration date: Apr2018, NDC: 00005197102, UPC: 300051971022) at 0.5 ml single dose to prevent infection by pneumococcus. Relevant medical history included constipation. Concomitant medications included Albuterol every 4 hours as needed for respiratory disorder; rectal DULCOLAX, suppository 10 mg, daily as needed for constipation; rectal FLEET ENEMA daily as needed; ophthalmic XALATAN 2 Gtt, one drop in each eye daily; oral levothyroxine 88 ug, once daily; and oral TYLENOL (tablet, 325 mg) 650 mg, thrice daily (two tablets three times daily). In Mar2017, the patient experienced a little bit of red area at the injection site. Outcome was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2017108862 Same reporter/drug/event different patients.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer (parent's patient). This consumer reported similar events for 2 patients. This is the first of two reports. A 16-month-old male patient received PREVNAR 13 at single dose for immunization on unknown date. Medical history and concomitant medication were unknown. On unknown date the patient experienced pneumonia with fever spiked about 105. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017113222 same reporter/different patient, same product, same event.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Fever of 103.1.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction- swelling and redness at injection point.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: After PCV13 vaccination 3/3/17. She noted pain in site (she did not really look). On day 3 she noted redness at the site (left upper arm). The redness has since expanded, 20x20 cm now- the redness subsided after one week.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Chest X-ray abnormal, Chills, Culture urine negative, Haematocrit decreased
Clinical narrative: Shaking, chills with fever of 103.6 degrees F as well as pain/redness at surrounding site of PNEUMOVAX injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Haemoglobin decreased, Injection site erythema, Injection site pain, Platelet count, Platelet disorder
Clinical narrative: Shaking, chills with fever of 103.6 degrees F as well as pain/redness at surrounding site of PNEUMOVAX injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking, chills with fever of 103.6 degrees F as well as pain/redness at surrounding site of PNEUMOVAX injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: 03/02/17 None. 03/05/17 None. 03/09/17 - None. 03/16/17 - None.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: 3/2/17 - none 3/5/17 - none 3/9/17 - none 3/16/17 - none.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received via a company representative from a patient's mother who is also the company representative's sister in law and refers to a non-pregnant, 17 year old female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On approximately 21-FEB-2017, (reported as "about one week ago"), the patient was vaccinated with the first dose of unidentified Merck Human Papillomavirus (HPV) vaccine (name reported as "either GARDASIL or GARDASIL 9") (route of administration, lot number and expiry date were not reported) for HPV vaccination. On approximately 21-FEB-2017, (reported as "about one week ago"), the patient experienced some redness and a little swelling. On an unknown date in February 2017, the patient recovered from the events (reported as "redness and swelling went away". Then, redness and swelling came back on an unknown date in February 2017, reported as "a week later". The patient went to physician who examined the swelling and redness and said that it was fine and that it was just an injection site reaction. No treatment was given for the events. The patient was still planning to continue the dosing series but had no additional doses at the time of the report. As of 28-FEB-2017, the patient did not recover from the events. The reporter considered events to be related to unidentified Merck Human Papillomavirus vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. Information on medical history, concomitant medications and drug allergies was not provided.   On known dates, multiple unspecified patients were vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018; dose unknown) for prophylaxis.  The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1hour and 2 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638:
Sex: U
Vaccine: MMRV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received on 06-MAR-2017 from a receptionist at physician's office and refers to an unspecified 12 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. The receptionist reported that the patient mistakenly received a dose of PROQUAD injection (exact dose, route of administration, lot # and expiry date were not reported) instead of M-M-R II injection. No adverse effect reported. No additional information was provided. Product quality complaint was not involved. Demographic information incomplete due to receptionist disconnecting before getting information. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 06-MAR-2017 from a pharmacist regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 05-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX lot # L044529 expiration 09-FEB2017, 0.65 ml, subcutaneous for prophylaxis which was expired. No adverse effected reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly (exact dose, lot # and expiry date were not reported) to prevent human papilloma virus (HPV). It was unspecified which dose the patient was receiving. Subsequently, on an unknown date after receiving GARDASIL 9, the patient fainted. The outcome of the event and causality between the event and GARDASIL 9 were not reported. Product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2017 (reported as "in the last two weeks"), the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Unit, for prevention of shingles (dose, route, lot # and expiration date were not reported). On an unspecified date in 2017 (reported as "in the last two weeks"), the patient experienced cellulitis on an unspecified site. It was stated that an unspecified treatment was given for the adverse event and that the patient was hospitalized for 5 days, then released from the hospital and was admitted again for an unspecified length of time at an unspecified time. At the time of reporting the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between cellulitis and ZOSTAVAX was not provided. Upon internal review cellulitis was determined to be a medically significant event. 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 healthcare professional referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M005972 with expiration date 02-FEB-2018 and lot # M031970 with expiration date 30-JUN-2018, for prophylaxis (dose and route were not reported). It was stated that the vaccines were exposed to a temperature between 6 and 14 Fahrenheit degrees with a time frame of 20 minutes and that the diluent for both vaccines did not experienced any temperature excursion. A previous excursion was reported with a temperature between 6 and 14 Fahrenheit degrees with a time frame of 15 minutes. A data logger was used to control temperature. No adverse events were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007367:
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 14-MAR-2017, the patient was vaccinated with an expired dose of VARIVAX lot # L008271 with expiration date 11-MAR-2017, for prophylaxis (dose and route were not reported). It was stated that the patient did not experience any adverse effect. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001150 with expiration date 05-JUL-2017 and lot # M022400 with expiration date 01-NOV-2017, for prophylaxis (dose and route were not reported). It was stated that the vaccines were exposed to a temperature between 6 and 14 Fahrenheit degrees with a time frame of 20 minutes and that the diluent for both vaccines did not experienced any temperature excursion. A previous excursion was reported with a temperature between 6 and 14 Fahrenheit degrees with a time frame of 15 minutes. A data logger was used to control temperature. No adverse events were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA006791:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT HAS DEVELOPMENT AN ACTIVE CASE OF SHINGLES, IS BEING PLACED ON AN ANTIVIRAL, UNKNOWN EXACT DATE OF TIME OF CONVERSION TO ACTIVE CASE, WAS DIAGNOSED TODAY BY DR.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site infection, Pain, Sinusitis, Swelling
Clinical narrative: 62 yo female who recieved PPSV23 vaccine in R deltoid on 1/13. Pt also recieve influenza vaccine in L deltoid on 1/13. Per pt, she had received a pneumococcal vaccine in the past without any reactions. Initially, pt developed erythema, swelling, drainage, pain (took NSAIDs, used cold compresses, neosporin, witch hazel) on R arm. No reactions on L arm site. Saw clinic NP, "The injection reaction seems more infectious than allergic. Would probably be ok to get future pneumonia vaccines." Advised to keep area clean, was given antibiotics for sinus infection and infection at R arm injection site. One month later, induration still present, referral to surgery for second opinion about repair of area.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Blood test, Bronchitis, Cough, Differential white blood cell count
Clinical narrative: Wednesday 8 March 2017 excited to work with as a volunteer, doing really good until after I had Hepatitis B shot. Within an hour I was feeling tired, nauseous, dizzy, and headache. I came home and lay down. I woke up - was worse. I started taking my migraine medications, thinking that I had a migraine  tried to sleep. (Allergies trigger migraines for me). I called an immunization clinic on Thursday and talk to them about systems. They said I just had the flu bug. I said it wasn't the flu bug, I know what that's like and this was not it. They offered nothing else, accept Tylenol, fluids, and rest. I was running a fever and I didn't break my fever till sometime on Friday morning about 3:30am.  Haven't been able to eat anything substantial. Every time after I ate - I would get a stabbing pain that in my lower right bottom rib area up sideways.  I've been able to tolerate water, Jell-O, ginger ale, and broth. Just two days ago started to eat applesauce. Today I ate some carrots. Today Monday - still fighting the headaches/ head pressures off and on.  The pain in my right side is about an inch or two below my lower rib cage to the right. At times the massive pain there was intense about an 8 - can't seem to get the pain to quit. I have been sleeping all these days only up for a couple hours and then back to sleep. Pain so bad today, Monday 13 March 2017. I'm trying to ignore it while at the HIPAA office. Came home and laid down. Pain would not quit so I called the chiropractor to look me over at 4:30. I explained the pains I was having, where they were, how I want to sleep all the time, couldn't eat without pain. He checked me out and said it was my liver. He asked what I did and I told him that I had the Hepatitis B shot on Wednesday. He said that will do it. He also said it triggered bronchitis. I came home call my sister who is a nurse. Told her what was going on, she then looked the Hepatitis B shot side effects. It states that if you are allergic to yeast - not to receive shot. I said no one asked me if I was allergic to yeast, just latex. She informed me to let you know right away. Later symptoms - I had a fever, throat hurt, stuffy nose, drank not drank not eat, sore and hurt, really weak, coughing, and chilled to the bones. My mouth was distorted just like my allergic reaction, but I didn't notice it right away because I was sleeping so much. After a week - still now feeling right - tired, weak, headache, stomach doesn't tolerate fatty foods - on a very bland diet.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Fatigue, Feeling cold, Food intolerance, Full blood count
Clinical narrative: Wednesday 8 March 2017 excited to work with as a volunteer, doing really good until after I had Hepatitis B shot. Within an hour I was feeling tired, nauseous, dizzy, and headache. I came home and lay down. I woke up - was worse. I started taking my migraine medications, thinking that I had a migraine  tried to sleep. (Allergies trigger migraines for me). I called an immunization clinic on Thursday and talk to them about systems. They said I just had the flu bug. I said it wasn't the flu bug, I know what that's like and this was not it. They offered nothing else, accept Tylenol, fluids, and rest. I was running a fever and I didn't break my fever till sometime on Friday morning about 3:30am.  Haven't been able to eat anything substantial. Every time after I ate - I would get a stabbing pain that in my lower right bottom rib area up sideways.  I've been able to tolerate water, Jell-O, ginger ale, and broth. Just two days ago started to eat applesauce. Today I ate some carrots. Today Monday - still fighting the headaches/ head pressures off and on.  The pain in my right side is about an inch or two below my lower rib cage to the right. At times the massive pain there was intense about an 8 - can't seem to get the pain to quit. I have been sleeping all these days only up for a couple hours and then back to sleep. Pain so bad today, Monday 13 March 2017. I'm trying to ignore it while at the HIPAA office. Came home and laid down. Pain would not quit so I called the chiropractor to look me over at 4:30. I explained the pains I was having, where they were, how I want to sleep all the time, couldn't eat without pain. He checked me out and said it was my liver. He asked what I did and I told him that I had the Hepatitis B shot on Wednesday. He said that will do it. He also said it triggered bronchitis. I came home call my sister who is a nurse. Told her what was going on, she then looked the Hepatitis B shot side effects. It states that if you are allergic to yeast - not to receive shot. I said no one asked me if I was allergic to yeast, just latex. She informed me to let you know right away. Later symptoms - I had a fever, throat hurt, stuffy nose, drank not drank not eat, sore and hurt, really weak, coughing, and chilled to the bones. My mouth was distorted just like my allergic reaction, but I didn't notice it right away because I was sleeping so much. After a week - still now feeling right - tired, weak, headache, stomach doesn't tolerate fatty foods - on a very bland diet.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Headache, Metabolic function test, Mouth swelling, Nasal congestion, Nausea
Clinical narrative: Wednesday 8 March 2017 excited to work with as a volunteer, doing really good until after I had Hepatitis B shot. Within an hour I was feeling tired, nauseous, dizzy, and headache. I came home and lay down. I woke up - was worse. I started taking my migraine medications, thinking that I had a migraine  tried to sleep. (Allergies trigger migraines for me). I called an immunization clinic on Thursday and talk to them about systems. They said I just had the flu bug. I said it wasn't the flu bug, I know what that's like and this was not it. They offered nothing else, accept Tylenol, fluids, and rest. I was running a fever and I didn't break my fever till sometime on Friday morning about 3:30am.  Haven't been able to eat anything substantial. Every time after I ate - I would get a stabbing pain that in my lower right bottom rib area up sideways.  I've been able to tolerate water, Jell-O, ginger ale, and broth. Just two days ago started to eat applesauce. Today I ate some carrots. Today Monday - still fighting the headaches/ head pressures off and on.  The pain in my right side is about an inch or two below my lower rib cage to the right. At times the massive pain there was intense about an 8 - can't seem to get the pain to quit. I have been sleeping all these days only up for a couple hours and then back to sleep. Pain so bad today, Monday 13 March 2017. I'm trying to ignore it while at the HIPAA office. Came home and laid down. Pain would not quit so I called the chiropractor to look me over at 4:30. I explained the pains I was having, where they were, how I want to sleep all the time, couldn't eat without pain. He checked me out and said it was my liver. He asked what I did and I told him that I had the Hepatitis B shot on Wednesday. He said that will do it. He also said it triggered bronchitis. I came home call my sister who is a nurse. Told her what was going on, she then looked the Hepatitis B shot side effects. It states that if you are allergic to yeast - not to receive shot. I said no one asked me if I was allergic to yeast, just latex. She informed me to let you know right away. Later symptoms - I had a fever, throat hurt, stuffy nose, drank not drank not eat, sore and hurt, really weak, coughing, and chilled to the bones. My mouth was distorted just like my allergic reaction, but I didn't notice it right away because I was sleeping so much. After a week - still now feeling right - tired, weak, headache, stomach doesn't tolerate fatty foods - on a very bland diet.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Somnolence
Clinical narrative: Wednesday 8 March 2017 excited to work with as a volunteer, doing really good until after I had Hepatitis B shot. Within an hour I was feeling tired, nauseous, dizzy, and headache. I came home and lay down. I woke up - was worse. I started taking my migraine medications, thinking that I had a migraine  tried to sleep. (Allergies trigger migraines for me). I called an immunization clinic on Thursday and talk to them about systems. They said I just had the flu bug. I said it wasn't the flu bug, I know what that's like and this was not it. They offered nothing else, accept Tylenol, fluids, and rest. I was running a fever and I didn't break my fever till sometime on Friday morning about 3:30am.  Haven't been able to eat anything substantial. Every time after I ate - I would get a stabbing pain that in my lower right bottom rib area up sideways.  I've been able to tolerate water, Jell-O, ginger ale, and broth. Just two days ago started to eat applesauce. Today I ate some carrots. Today Monday - still fighting the headaches/ head pressures off and on.  The pain in my right side is about an inch or two below my lower rib cage to the right. At times the massive pain there was intense about an 8 - can't seem to get the pain to quit. I have been sleeping all these days only up for a couple hours and then back to sleep. Pain so bad today, Monday 13 March 2017. I'm trying to ignore it while at the HIPAA office. Came home and laid down. Pain would not quit so I called the chiropractor to look me over at 4:30. I explained the pains I was having, where they were, how I want to sleep all the time, couldn't eat without pain. He checked me out and said it was my liver. He asked what I did and I told him that I had the Hepatitis B shot on Wednesday. He said that will do it. He also said it triggered bronchitis. I came home call my sister who is a nurse. Told her what was going on, she then looked the Hepatitis B shot side effects. It states that if you are allergic to yeast - not to receive shot. I said no one asked me if I was allergic to yeast, just latex. She informed me to let you know right away. Later symptoms - I had a fever, throat hurt, stuffy nose, drank not drank not eat, sore and hurt, really weak, coughing, and chilled to the bones. My mouth was distorted just like my allergic reaction, but I didn't notice it right away because I was sleeping so much. After a week - still now feeling right - tired, weak, headache, stomach doesn't tolerate fatty foods - on a very bland diet.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Purulent discharge, Radioallergosorbent test, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: Patient reported she is moving in 3 weeks and was referred for evaluation possible adverse reaction to influenza vaccine (see 2/13/2017 note). Patient advised she received her first annual flu vaccine on 9/22/2016 (FLUARIX by SKB lot#CS979) am during mass shot-ex (was after breakfast). Less than 1 hour later while in class her neck was itchy and a classmate advised it was red. She removed her blouse shirt and noted both arms had fine red single bumps, some areas in grouping with pus like heads that also itched. Her instructor sent her immediately to medical even though she advised she had no chest pain, difficulty breathing, angioedema or any other issues. Once at medical, she recalls a nurse advising her to "apply a topical cream to rash and take a bath" but this visit/reaction was not documented. Patient advised she contacted her mother (a nurse) who advised some topical cream and to use BENADRYL. The reaction resolved in 2-3 days without any sequelae. This is when patient's mother advised her about family history of egg allergy is sister/father and that she may have same allergies. Patient advised she doesn't eat eggs because she dislikes them, but can eat items cooked with eggs (breads, cookies, etc...she has never had meringue pies). Patient advised she experiences a similar rash when given IVP dye with MRI, and with food allergies (red peppers, lettuce, blueberries). Patient advised she doesn't recall what she ate that day as too long ago, but has not changed dietary habits since eating all food groups prior to and since vaccinated. Patient was referred by attending MD at same clinic on 2/13/2017 who verified with nurse that this patient was seen at the clinic (nurse recalls the patient) and referred patient to hospital for further evaluation and to immunization clinic for documentation of 9/22/2016 flu vaccination.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Burning sensation, Injection site erythema, Injection site induration
Clinical narrative: Received call from patient asking for assistance in treating the following and spoke with patient on his reaction: 39 YO adult male received 2nd AVA vaccine on 2/3/2017. No other vaccines given since 12/29/2017 (AVA1 and VAR). Patient is deploying overseas on 2/25/17. 2/3/2017 patient reported had burning sensation to left arm, similar to first AVA vaccine, with receipt of 2nd AVA vaccination. Next day (Sat. 2/4 evening) his deltoid was hot, red and painful. Redness covered about 1/2 of arm (anterior portion only, did not encircle arm). He reported he had a mild fever day of vaccination, but none on Saturday or since. He advised he had some diffuse joint pain to shoulders and lower back, but has history of back/neck pain. He presented to medical today 2/6 at Clinic with swelling, redness and patient describing upper anterior arm/deltoid as red, warm, and deltoid was hard to touch/indurated with redness extending down to mid humerus close to elbow. No paresthesia, weakness, tingling or restricted ROM in shoulder/elbow. No fever or rash. No axillary lymphadenopathy. No chest pain, headache, difficulty breathing or other systemic symptoms. Symptoms: Localized edema, other skin changes.