chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of VARIVAX (dosage, frequency and route of administration were not reported), lot#: N025933 (expiration date: 19-SEP-2019), lot#: N020686 (expiration date: 27-JUL-2019,) lot # N014630 (expiration date: 11-AUG-2019 "also reported on 11-MAY-2019", for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-MAY-2016 the patient received a dose of ZOSTAVAX (lot number L036454, expiration 22-DEC-2016) (dosing regimen and frequency unknown) and sterile diluent (manufacturer unknown) for an unknown indication. On 15-FEB-2018 the patient received a dose of ZOSTAVAX (N021171, expiration 01-NOV-2018) (dosing regimen and frequency unknown) and sterile diluent (manufacturer unknown) for an unknown indication. No adverse events were reported. There was no product quality complaint reported.
Age: 1.33
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-FEB-2018, the patient was inadvertently administered both PROQUAD (lot # and expiry date were not reported) and MMR II (lot # and expiry date were not reported). No adverse effects were reported in the patient. No other information was available.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Orthopoxvirus test positive, Post vaccination autoinoculation, Rash vesicular, Vaccinia virus infection, Vulval disorder
Clinical narrative: Information was received on 09FEB2018 from a review of scientific literature. This is a case of a 25 year-old female who underwent smallpox vaccination and experienced auto transfer of smallpox vaccinia virus to both labia minora. The patient denied history sexually transmitted infections. In 2014, the female received her first smallpox vaccination percutaneously. She subsequently developed the typical blister-like lesion at the vaccine site (left deltoid). On day-10, during the course of a  bandage change, she wiped the lesion with a paper toweland reportedly inadvertently wiped her labia minor and majora with the same paper towel. She presented approximately 1 week later (day-17) with 1-2 cm non-painful, non-tender lesions on both labia minora. The lesions had the same vesicular appearance as the original immunization site and upon evaluation by culture had the same strain of vaccinia virus as the original immunization solution. In 20 days, the lesions completely resolved without sequelea; Sender's Comments: This case is considered medically significant; as a requirement under 21 CFR 600.90(c)(d2) as stated in the approval letter (31AUG2007), 15-day submission is required for cases of autoinoculation. There is a positive temporal association. Autoinoculation is a known effect of immunization with smallpox vaccine and therefore these events are considered related to ACAM2000.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site vesicles, Orthopoxvirus test positive, Rash vesicular, Skin lesion, Vaccination complication
Clinical narrative: Information was received on 09FEB2018 from a review of scientific literature. This is a case of a 28 year-old female who underwent smallpox vaccination and experienced smallpox vaccinia virus lesions on the abdomen and vulva. The patient's gynecological history was negative for sexually transmitted infections. On an unspecified date, the female received her first smallpox vaccination. On day-7, development of typical blistering lesions on the left deltoid were observed. She reported removing the occlusive dressing during the course of a shower. Subsequently, she developed small satellite non-painful lesions around the original immunization site, as well as several on her abdomen and vulva. No lesion exceeded 0.3 cm. Laboratory evaluation revealed vaccinia virus. Within 20 days, the lesions resolved.; Sender's Comments: This case is considered medically significant; as a requirement under 21 CFR 600.90(c)(d2) as stated in the approval letter (31AUG2007), 15-day submission is required for cases of autoinoculation. There is a positive temporal association. Autoinoculation is a known effect of immunization with smallpox vaccine and therefore these events are considered related to ACAM2000.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccinia virus infection, Vulval disorder
Clinical narrative: Information was received on 09FEB2018 from a review of scientific literature. This is a case of a 28 year-old female who underwent smallpox vaccination and experienced smallpox vaccinia virus lesions on the abdomen and vulva. The patient's gynecological history was negative for sexually transmitted infections. On an unspecified date, the female received her first smallpox vaccination. On day-7, development of typical blistering lesions on the left deltoid were observed. She reported removing the occlusive dressing during the course of a shower. Subsequently, she developed small satellite non-painful lesions around the original immunization site, as well as several on her abdomen and vulva. No lesion exceeded 0.3 cm. Laboratory evaluation revealed vaccinia virus. Within 20 days, the lesions resolved.; Sender's Comments: This case is considered medically significant; as a requirement under 21 CFR 600.90(c)(d2) as stated in the approval letter (31AUG2007), 15-day submission is required for cases of autoinoculation. There is a positive temporal association. Autoinoculation is a known effect of immunization with smallpox vaccine and therefore these events are considered related to ACAM2000.
Sex: M
Vaccine: PNC13
Symptoms: Incomplete course of vaccination, Intensive care, Liver disorder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 3-year-old male patient of an unspecified ethnicity received the 3rd dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date at the age of 9 months, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously took 2 doses of PREVNAR 13, for immunisation: 1st dose at 4 months, 2nd dose at 6 months. The patient experienced liver problems on an unspecified date with outcome of unknown. The event caused patient's hospitalisation. As the patient was in the NICU, the vaccine was delayed and he wound up only getting three of the 4 recommended doses.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, (unknown batch/lot and expiry date), via an unspecified route of administration on an unspecified date at a single dose for Pneumococcal Pneumonia. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated she was sick 4 weeks ago and was given the Z-PAK, exhausted and had unproductive cough. The outcome of the events was unknown.  No follow up attempts are possible. No further information expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for herself). A 70-year-old female patient received PREVNAR 13 via unspecified route of administration in the right arm on 03Feb2018 at 0.5 ml, single dose for immunization. Medical history included thyroid issue. Concomitant medications included ongoing thyroid medication and vitamins. The patient received the vaccine almost two weeks ago and since then has been unable to move her right arm; she woke up the next morning and couldn't move her arm, it hurt so bad (started to experienced on 04Feb2018). It's even worse today than it was yesterday. She can't sleep on unspecified date in Feb2018. It was reported that the patient can't eat due to she's unable to lift her hand up to her mouth. She's lost 7lbs on Feb2018; she was 111lbs when she got the vaccine and was now 103lbs. She has to sit in a recliner to sleep, she has tried using heat and cold on her arm but it doesn't help any and the cold hurts worse. She has to use her left arm to move her right arm because she can't move her right arm by itself. She can't use the bathroom by herself; her husband has to help her with her pants. It was reported that she has always gotten her flu shot like she's supposed to and never had this problem before. It feels like the shot is still going into her arm, like someone is twisting a knife in her arm, it hurts so bad. She has called her regular doctor and was told to go to the ER, but she can't afford to be going to the emergency room every day for this pain. She confirmed that she has not been to the ER yet. She has been living on TYLENOL, (Exp: Apr2018) and MOTRIN; (Lot: 7FE1339A, exp date: Apr2019) and it's not doing any good at all. The patient some pain pills left from when she was in the hospital in Dec2017. Pain pills are oxycodone 10-325mg, generic for PERCOCET. She has been taking these and they don't phase the pain either, they aren't helping. They only let her sleep for a couple hours. The patient went to an orthopedist and had an X-ray done. They didn't find anything wrong with her arm. The patient stated it has to be the vaccine that is causing all this pain and her not being able to move her arm. Therapeutic measures were taken for the event. Outcome of the event unable to move her right arm and Right arm hurts so bad was not recovered; outcome of other event was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for herself). A 70-year-old female patient received PREVNAR 13 via unspecified route of administration in the right arm on 03Feb2018 at 0.5 ml, single dose for immunization. Medical history included thyroid issue. Concomitant medications included ongoing thyroid medication and vitamins. The patient received the vaccine almost two weeks ago and since then has been unable to move her right arm; she woke up the next morning and couldn't move her arm, it hurt so bad (started to experienced on 04Feb2018). It's even worse today than it was yesterday. She can't sleep on unspecified date in Feb2018. It was reported that the patient can't eat due to she's unable to lift her hand up to her mouth. She's lost 7lbs on Feb2018; she was 111lbs when she got the vaccine and was now 103lbs. She has to sit in a recliner to sleep, she has tried using heat and cold on her arm but it doesn't help any and the cold hurts worse. She has to use her left arm to move her right arm because she can't move her right arm by itself. She can't use the bathroom by herself; her husband has to help her with her pants. It was reported that she has always gotten her flu shot like she's supposed to and never had this problem before. It feels like the shot is still going into her arm, like someone is twisting a knife in her arm, it hurts so bad. She has called her regular doctor and was told to go to the ER, but she can't afford to be going to the emergency room every day for this pain. She confirmed that she has not been to the ER yet. She has been living on TYLENOL, (Exp: Apr2018) and MOTRIN; (Lot: 7FE1339A, exp date: Apr2019) and it's not doing any good at all. The patient some pain pills left from when she was in the hospital in Dec2017. Pain pills are oxycodone 10-325mg, generic for PERCOCET. She has been taking these and they don't phase the pain either, they aren't helping. They only let her sleep for a couple hours. The patient went to an orthopedist and had an X-ray done. They didn't find anything wrong with her arm. The patient stated it has to be the vaccine that is causing all this pain and her not being able to move her arm. Therapeutic measures were taken for the event. Outcome of the event unable to move her right arm and Right arm hurts so bad was not recovered; outcome of other event was unknown.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Dizziness, Dry mouth, Heart rate increased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, X-ray
Clinical narrative: Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Arthralgia, Asthenia, Dizziness postural, Food intolerance, Heart rate increased
Clinical narrative: Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Dizziness, Dry mouth, Heart rate increased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 06-FEB-2018. This case involves a 61-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series, route and site of administration were not reported) on 31-OCT-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed sharp pains in her fingers that went to her hand, wrist joints as well as her knees, ankles and feet, burning pain in both feet which Dr feels is a neuropathy pain, elevated heart rate of 180. also stated she had experienced weakness and dizziness upon standing, couldnot eat certain foods, lives everyday in horrible pain and cannot take OTC pain medication. She felt that the vaccine was attacking her body as a whole and vice versa. Other laboratory investigations were not reported. As corrective treatment, the patient received given prednisone. Outcome of all events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: X-ray
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 06-FEB-2018. This case involves a 61-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series, route and site of administration were not reported) on 31-OCT-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed sharp pains in her fingers that went to her hand, wrist joints as well as her knees, ankles and feet, burning pain in both feet which Dr feels is a neuropathy pain, elevated heart rate of 180. also stated she had experienced weakness and dizziness upon standing, couldnot eat certain foods, lives everyday in horrible pain and cannot take OTC pain medication. She felt that the vaccine was attacking her body as a whole and vice versa. Other laboratory investigations were not reported. As corrective treatment, the patient received given prednisone. Outcome of all events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, X-ray
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 06-FEB-2018. This case involves a 61-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series, route and site of administration were not reported) on 31-OCT-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed sharp pains in her fingers that went to her hand, wrist joints as well as her knees, ankles and feet, burning pain in both feet which Dr feels is a neuropathy pain, elevated heart rate of 180. also stated she had experienced weakness and dizziness upon standing, couldnot eat certain foods, lives everyday in horrible pain and cannot take OTC pain medication. She felt that the vaccine was attacking her body as a whole and vice versa. Other laboratory investigations were not reported. As corrective treatment, the patient received given prednisone. Outcome of all events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Arthralgia, Asthenia, Dizziness postural, Food intolerance, Heart rate increased
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 06-FEB-2018. This case involves a 61-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series, route and site of administration were not reported) on 31-OCT-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed sharp pains in her fingers that went to her hand, wrist joints as well as her knees, ankles and feet, burning pain in both feet which Dr feels is a neuropathy pain, elevated heart rate of 180. also stated she had experienced weakness and dizziness upon standing, couldnot eat certain foods, lives everyday in horrible pain and cannot take OTC pain medication. She felt that the vaccine was attacking her body as a whole and vice versa. Other laboratory investigations were not reported. As corrective treatment, the patient received given prednisone. Outcome of all events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 06-FEB-2018. This case involves a 61-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series, route and site of administration were not reported) on 31-OCT-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed sharp pains in her fingers that went to her hand, wrist joints as well as her knees, ankles and feet, burning pain in both feet which Dr feels is a neuropathy pain, elevated heart rate of 180. also stated she had experienced weakness and dizziness upon standing, couldnot eat certain foods, lives everyday in horrible pain and cannot take OTC pain medication. She felt that the vaccine was attacking her body as a whole and vice versa. Other laboratory investigations were not reported. As corrective treatment, the patient received given prednisone. Outcome of all events was not reported. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a 21-year-old female patient who refers to herself. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 05-JAN-2018, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) to prevent HPV. On an unknown date, there was a pregnancy test performed which confirmed pregnancy. On 23-JAN-2018, it was confirmed that the patient was pregnant at the time she received GARDASIL 9 injection. The patient became pregnant with last menstrual period (LMP) date of 22-DEC-2017 and estimated delivery date (EDD) of 28-SEP-2018. At the time of the report, the patient's pregnancy gestation was 5 weeks. The patient was vaccinated in first trimester of pregnancy. The patient did not experience any side effects. The patient did not seek medical attention. No treatment was given for the event. The outcome of pregnancy was pending.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant medications included sterile diluent. On 29-JAN-2018, the patient received an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU), lot # N021170, expiration date 27-OCT-2018 for prophylaxis (dose, anatomical location and route of administration were not reported). No adverse effects were reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 2 hours and 30 minutes. The reporter stated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction, allergies and concomitant medications were not reported. On 25-JAN-2018, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 pre-filled syringe (dose and route of administration was not reported), (lot # N029303, expiration date: 21-APR-2019) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 6 Hours and below 32 degrees Fahrenheit (30F) for 1 Hour (incorrect product storage). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this case was reported due to a digital data logger.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a doses of PNEUMOVAX 23 on a yearly basis (dose, route of administration, lot # and expiry date were not reported). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse via a company representative referring to a female patient approximately 32 years old. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported. On 07-FEB-2018 the patient was vaccinated with second dose of M-M-R II (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. The patient had received first dose of M-M-R II (strength, dose, frequency, route, lot# and expiry date were not reported) on an unspecified date. It was reported that, the patient and her husband have been trying to get pregnant, and the patient was unsure if she was pregnant. The patient sought medical attention, she visited the Physician office on 07-FEB-2018 to receive second dose of M-M-R II. No product quality complaint was not involved. At the time of reporting, the outcome of exposure during pregnancy was unknown. The relationship between exposure during pregnancy and M-M-R II was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ROTATEQ (dose, units, frequency, route, lot number, expiration date not reported) (product storage error). After administration the dose was determined to be invalid by the state (agency unspecified) due to a temperature excursion on an unspecified date before administration of ROTATEQ. No further information was provided. The temperature and time frame was unknown. It was unknown if there was any previous temperature excursion and if the call was because of a data logger. No product quality complaint (PQC) was involved.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: This spontaneous report as received from an unspecified reporter via a field representative refers to a 16 year old male patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported. On 12-FEB-2018, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N019103, expiry date: 12-FEB-2019) for prophylaxis. Dosing details and route were not reported. On 12-FEB-2018, immediately after administration of the vaccine the patient became lightheaded, pale and dizzy and vomited right after administration. The patient was still at the office at the time of the events and was treated with ZOFRAN. It was reported that the patient vomited 3-4 times throughout the night. The patient's current status was unknown. The outcome of the events was unknown. Product quality complaint was not involved. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent (MRK INJ). On an unknown date the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017), (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was multiple temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018), on 09-NOV-2017 temperature excursion was at 6 F to 14 F (14 F) for 9 hours 30 minutes, on 15-DEC-2017 temperature excursion was at 6 F to 14 F (7.9 F) for 15 minutes and on 31-DEC-2017 temperature excursion was at 6 F to 14 F (13.1 F) for 1 hour. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. The outcome of events product storage error and no adverse event was unknown. The causal relationship between the events product storage error, no adverse event and ZOSTAVAX was not provided by the reporter. There was no product quality compliant reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 60 year old female patient with allergy to penicillin. The patient's concomitant medication included an unspecified "thyroid pill". On 15-JAN-2018, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously in the left arm for shingles prevention, lot # N020943 and expiration date on 26-OCT-2018. On 17-JAN-2018, the patient began complaining of redness and itching throughout the entire body. The patient went to see her primary care doctor and was diagnosed with shingles. She was prescribed two weeks worth of an unspecified antiviral medication which did not relieve the symptoms. On an unknown date, the patient began using unspecified topical steroid creams and was using them by the time of the reporting, however, she was still experiencing the systemic reaction. The reporter did not assess the causal relationship between ZOSTAVAX and the event.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-FEB-2016, the patient was treated at a healthcare facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from employee via healthcare worker refers to a 6 week old patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On an unknown date the patient was vaccinated with PEDVAXHIB injection (dose, units and frequency were unknown) (lot number and expiration date unknown) for prophylaxis. In the prescribing information it was reported that it was not recommended under 2 months. The outcome of event drug administered to patient of inappropriate age was unknown. The causal relationship between the event drug administered to patient of inappropriate age and PEDVAXHIB was not provided by the reporter. There was no product quality compliant reported.
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 11-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, (lot # N013541, Exp date: 23-JAN-2019), dose 1, 1 DF, intramuscularly for vaccination. On the same day, the patient experienced generalized local reaction that went away in a day and a half after receiving the vaccine. The outcome of event was reported as unknown (also reported as not recovered). No other information was available. Sought to medical attention was yes. No product quality compliant (PQC) was found. Lab diagnostics/Studies performed were reported as none. The reporter did not report the causal relation of event with respect to PNEUMOVAX 23. Pharmacist requested that a lot check needed to be performed. This case is cross linked with 1802USA007344 (same reporter).
Age: 1.42
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date, the patient was administered a dose of PROQUAD (dosing details were not reported) at age 1, and was given a second dose at age 17 months (lot numbers and expiration dates were not available to the reporter) for prophylaxis. No adverse effects were reported in the patient. No product quality complaint involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis, lot # N014486 and expiration date on 10-MAY-2019. The dose, route of administration and anatomical location were not reported. The administered dose of the vaccine experienced a temperature excursion of 62.2 F for 1 hour and 15 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SHE STATES THAT IT STARTED AT 2:00 PM ON 2/18/2018. HER LEFT UPPER ARM BECAME RED, SWOLLEN, HOT TO THE TOUCH AND VERY SORE. SHE STATES THAT THE PAIN IS INTENSE. WHEN SHE CAME INTO THE PHARMACY ON 2/19/2018 I OBSERVED THAT HER LEFT ARM WAS SWOLLEN FROM SHOULDER TO ELBOW AND HOT TO THE TOUCH.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Mother called to say pt. developed Guillain-Barre.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received an unnecessary dose of Hep A.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Pain
Clinical narrative: Body aches, low grade temp, fatigue lasted about 24 hours occurred the same day of administration, and lasted about 24 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site reaction, Pain, Pruritus, Pyrexia
Clinical narrative: PATIENT DESCRIBED DEVELOPED FEVER RAPIDLY THE DAY AFTER, NOW 02/20/2018 PATIENT DESCRIBED IT HAS IMPROVED. PATIENT AFTER 6 DAYS DEVELOP LIKE A CHICKEN POX RASH AROUND THE AREA OF INJECTION. PATIENT DESCRIBED A LOT IF ITCHING SOME PAIN AND WARMING SENSATION.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: PATIENT DESCRIBED DEVELOPED FEVER RAPIDLY THE DAY AFTER, NOW 02/20/2018 PATIENT DESCRIBED IT HAS IMPROVED. PATIENT AFTER 6 DAYS DEVELOP LIKE A CHICKEN POX RASH AROUND THE AREA OF INJECTION. PATIENT DESCRIBED A LOT IF ITCHING SOME PAIN AND WARMING SENSATION.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Altered state of consciousness, Tremor
Clinical narrative: Per mother, patient received Hepatitis A vaccination in our office on Friday [2/16/18]. By Saturday [2/17/18] morning, she was experiencing extreme stomach pain, trembling, and felt like she was going to pass out. Mother states she gave patient 4 ADVIL, and she applied warm compress to both her abdomen and arm where shot was given. Eventually, symptoms subsided and patient returned to self by Saturday afternoon. Patient never experienced fever and did not have flu like symptoms.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 month old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 05-FEB-2018, the patient was vaccinated with an expired dose of ROTATEQ orally, lot # M011832; expiry date 25-JAN-2018 (dose was not reported). No adverse effects were reported. The vaccine did not undergo a temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA005086: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA007559.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the varicella virus vaccine live (oka/merck)(VARIVAX) as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided.This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA005090: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005085: US-009507513-1802USA003097: US-009507513-1802USA005086.