chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017, reported as since 26-JAN-2017, the unspecified number of improperly stored doses of M-M-R II (lot number M028130, expiration date 03-JUN-2018, lot number M022407, expiration date 02-MAY-2018 and lot number M022408, expiration date 02-MAY-2018) (dose, route of administration and were not reported) were administered to the patients. The reporter did not have access to the lot number and expiration date of the sterile diluent (MRK) (dose and route of administration were not reported) that was used to reconstitute the doses. The doses were stored in temperatures from 47F Fahrenheit degrees to 77 Fahrenheit degrees for 1 hour and 42 minutes.  Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Injury, Neuralgia, Physical disability
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding a female patient of unknown age who on 15-JUN-2016 was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration was not provided). Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles". On or about 24-JUN-2016, the patient was diagnosed with herpes zoster, also known as a shingles outbreak. On or about 24-JUN-2016, the patient was prescribed valacyclovir hydrochloride (VALTREX) for the treatment of shingles and shingles-related nerve pain. As direct result of the vaccine, the patient suffered, is suffering and /or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX the patient sustained severed and permanent personal injuries. She suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased
Clinical narrative: Information was received from a lawyer regarding a case in litigation regarding a female patient of unknown age who on 15-JUN-2016 was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration was not provided). Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles". On or about 24-JUN-2016, the patient was diagnosed with herpes zoster, also known as a shingles outbreak. On or about 24-JUN-2016, the patient was prescribed valacyclovir hydrochloride (VALTREX) for the treatment of shingles and shingles-related nerve pain. As direct result of the vaccine, the patient suffered, is suffering and /or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX the patient sustained severed and permanent personal injuries. She suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. 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 concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug  reactions/allergies and concomitant medications were not reported.      On unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion at an unspecified temperature for an unspecified time frame. It was not reported if there were previous temperature excursions. Data logger was involved. No adverse symptoms were reported. A product quality complaint was not involved.        Additional information has been requested.
Age: 1.42
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant/ clinical supervisor and  refers to a 17 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2017, the patient was vaccinated with an expired dose of VAQTA 25 U/ 0.5 ml, lot # L032749, expiration date 04-NOV-2016 (dose, route of administration was not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.     Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Computerised tomogram, Confusional state, Dizziness, Electrocardiogram
Clinical narrative: Severe weakness unable to move arms and legs with confusion mental status changes and severe nausea vomiting  lightheadedness.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Laboratory test, Mental status changes, Mobility decreased, Nausea, Vomiting
Clinical narrative: Severe weakness unable to move arms and legs with confusion mental status changes and severe nausea vomiting  lightheadedness.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Facial pain, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Fever to 40 deg celsisus, vomiting, diarrhea, localized injection site redness, swelling, and associated pain on the ipsilateral arm, face.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 40 deg celsisus, vomiting, diarrhea, localized injection site redness, swelling, and associated pain on the ipsilateral arm, face.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: Seizure from MMR vaccine.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Full blood count, Hyperhidrosis, Lumbar puncture, Metabolic function test, Pyelonephritis
Clinical narrative: Parents noted patient drenched in sweat. Fever of 101.4. Given TYLENOL. Could not reduce fever. Saw pediatrician early AM who referred to ED. Labs/ultrasound confirmed bilateral pyelonephritis. Two IV antibiotics administered.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Ultrasound kidney abnormal
Clinical narrative: Parents noted patient drenched in sweat. Fever of 101.4. Given TYLENOL. Could not reduce fever. Saw pediatrician early AM who referred to ED. Labs/ultrasound confirmed bilateral pyelonephritis. Two IV antibiotics administered.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Trouble with muscles in arm in vicinity of injection site, spasmatic. Notified my PCP in December. Currently undergoing physical therapy.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a company representative on behalf of the pharmacist concerns a currently 62 year old female patient. The patient's concurrent conditions and concomitant medications were not reported. The patient was taking valacyclovir (VALTREX) daily (unknown dosage, indication, formulation, strength, lot# and expiration date). On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (formulation, dose, frequency, route of administration, lot # and expiration date were not reported) for an unknown indication. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose 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, drug reactions, allergies and concomitant medications were not reported. On the same unspecified day, the patient was vaccinated with 2 doses of VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis.  No adverse symptoms reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Diplegia, Dysstasia, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal
Clinical narrative: This spontaneous report was received from a neurologist and refers to a 67 year old female patient. The patient's concurrent conditions included posterior cortical atrophy and a neurodegenerative condition of brain (reported also as "in the neurodegenerative Alzheimer's family"). The patient's medical history included upper respiratory tract infection. The patient's historical drugs included PREVNAR 13 and influenza virus vaccine (unspecified), which the patient did not experienced any adverse events; ZOCOR which the patient did not tolerate; and amoxicillin and citalopram with which the patient experienced unspecified adverse experiences. The patient was not taking any concomitant medications. On 05-JAN-2017, the patient received an unspecified dose of injectable PNEUMOVAX23 intramuscularly in her left deltoid for routine vaccination (lot# M037669) (strength, dose, and expiration date were not reported). Reportedly, the reporter stated did not know when the patient's symptoms began, but on 11-JAN-2017, the patient could not stand. Subsequently, on 12-JAN-2017, the patient sought medical attention with the neurologist because she was experiencing paralysis of her legs. On the same date, the neurologist performed an electrical testing which resulted "essentially normal, but it usually is early in the development of Guillain-Barre syndrome (GBS)" as stated by the reporter. On 13-JAN-2017, the patient was diagnosed with GBS and she was hospitalized. During the hospitalization, the patient received intravenous immunoglobulin G (IgG) treatments, to which "she responded well". Moreover, on an unknown date in 2017, the patient was performed a magnetic resonance imaging (MRI) (results not provided) and a lumbar puncture that resulted normal. On an unspecified date in 2017, the patient was transferred from the hospital to an affiliated rehabilitation center, and on 06-FEB-2017, she was discharged from the rehabilitation center. At the time of reporting, the patient was recovering from the adverse event as the reporter indicate that the patient was "stable", she was walking without assistance, her reflexes were recovering, and she was currently "about 80% recovered". The relationship between the event and PNEUMOVAX23 was not provided. The event of Guillain-Barre syndrome was considered to be disabling and life threatening by the reporter. Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant. This is one of two reports received for the same patient. Additional information has been requested. Sender's Comments: US-009507513-1703USA010659.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a neurologist and refers to a 67 year old female patient. The patient's concurrent conditions included posterior cortical atrophy and a neurodegenerative condition of brain (reported also as "in the neurodegenerative Alzheimer's family"). The patient's medical history included upper respiratory tract infection. The patient's historical drugs included PREVNAR 13 and influenza virus vaccine (unspecified), which the patient did not experienced any adverse events; ZOCOR which the patient did not tolerate; and amoxicillin and citalopram with which the patient experienced unspecified adverse experiences. The patient was not taking any concomitant medications. On 05-JAN-2017, the patient received an unspecified dose of injectable PNEUMOVAX23 intramuscularly in her left deltoid for routine vaccination (lot# M037669) (strength, dose, and expiration date were not reported). Reportedly, the reporter stated did not know when the patient's symptoms began, but on 11-JAN-2017, the patient could not stand. Subsequently, on 12-JAN-2017, the patient sought medical attention with the neurologist because she was experiencing paralysis of her legs. On the same date, the neurologist performed an electrical testing which resulted "essentially normal, but it usually is early in the development of Guillain-Barre syndrome (GBS)" as stated by the reporter. On 13-JAN-2017, the patient was diagnosed with GBS and she was hospitalized. During the hospitalization, the patient received intravenous immunoglobulin G (IgG) treatments, to which "she responded well". Moreover, on an unknown date in 2017, the patient was performed a magnetic resonance imaging (MRI) (results not provided) and a lumbar puncture that resulted normal. On an unspecified date in 2017, the patient was transferred from the hospital to an affiliated rehabilitation center, and on 06-FEB-2017, she was discharged from the rehabilitation center. At the time of reporting, the patient was recovering from the adverse event as the reporter indicate that the patient was "stable", she was walking without assistance, her reflexes were recovering, and she was currently "about 80% recovered". The relationship between the event and PNEUMOVAX23 was not provided. The event of Guillain-Barre syndrome was considered to be disabling and life threatening by the reporter. Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant. This is one of two reports received for the same patient. Additional information has been requested. Sender's Comments: US-009507513-1703USA010659.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning five patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies, or concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (strength and dose were not reported) (lot # M042497, expiration date 17-APR-2018) for prophylaxis. According to the reporter, PROQUAD doses were exposed to the following temperatures excursions: 7 hours and 29 minutes between -9 degrees Celsius (C) and 8 C. No adverse symptoms were reported. A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 injection (lot # L003227 with expiration date at 13-OCT-2016; dose, route of administration and anatomical location were not reported) for prophylaxis. There were no side effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. An 80-year-old patient of an unspecified race/ethnicity and gender received PREVNAR 13 (Lot # R49358, Exp. date 30Apr2018), via an unspecified route of administration at single dose in the arm on 14Mar2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced golf ball size lump at injection site, pain and swelling on entire arm, fever, chills, headache. The outcome of the events was unknown.
Age: 80.0
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. An 80-year-old patient of an unspecified race/ethnicity and gender received PREVNAR 13 (Lot # R49358, Exp. date 30Apr2018), via an unspecified route of administration at single dose in the arm on 14Mar2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced golf ball size lump at injection site, pain and swelling on entire arm, fever, chills, headache. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Local swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable office manager calling on behalf of a physician, who reported similar events for 3 patients. This is the first of three reports.  A female patient of an unspecified age received PREVNAR 13 (LOT R19477; expiration Jan2018), on an unspecified date at single dose for immunization .  The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced local swelling and pain in arm . The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017129542 same reporter/drug, different patient;US-PFIZER INC-2017129456 same reporter/drug, different patient.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Local reaction, Rash generalised, Rash pruritic
Clinical narrative: 3/24/2017 Parent contacted clinic after patient called from school regarding an itchy rash all over body. Parent states that reaction started with a local reaction of pain and tenderness at injection site. After a day patient began itching and experiencing the rash all over body. Per Dr., patient may take Benadryl and parent states that she will do an oatmeal bath tonight as well. Parent advised that she can take patient to our clinic after hours or if patient has any trouble breathing, excessive sneezing or coughing to take patient to the nearest emergency room. Parent verbalized understanding. Advised parent that someone from agency or Vaers may contact her and that I would follow up with her on Monday.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hard, red spot at injection site (R thigh) size of a quarter
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Intake note 3-21-17: Right leg, red and swollen, warm to touch. OV notes 3-21-17: 12 mo old with "red spot on leg" x1 day.   At site for MMR vaccine 8 days ago.  Earlier today was "more bumpy".  No fevers, good appetite, drinking well, slightly fussy (his baseline), cutting teeth.  Starting new foods- pasta, milk, eggs. Mom cautious of abx - sister with c diff. Hx not straightforward for local injection reaction- delayed, ? cellulitis from injection - will start Keflex. Mom to monitor closely. mom wants to limit abx.  Reassess at 5 days by phone. Pt Plan: Please start antibiotic as directed.  Please use cool compress at least 5 times per day. Recommend trial of Benadryl as well 3 milliliters by mouth every 6-8 hours as needed for swelling.  Medication can make sleepy. Phone call on 3-24-17 at 11:00 am: Mom R/C & said the redness & swelling is going down but still present. Concerned w/ loose stools, had 3 dirty diapers yesterday. To try adding yogurt to diet. ABX, diarrhea & yogurt teaching done. Mom stated understanding.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Teething
Clinical narrative: Intake note 3-21-17: Right leg, red and swollen, warm to touch. OV notes 3-21-17: 12 mo old with "red spot on leg" x1 day.   At site for MMR vaccine 8 days ago.  Earlier today was "more bumpy".  No fevers, good appetite, drinking well, slightly fussy (his baseline), cutting teeth.  Starting new foods- pasta, milk, eggs. Mom cautious of abx - sister with c diff. Hx not straightforward for local injection reaction- delayed, ? cellulitis from injection - will start Keflex. Mom to monitor closely. mom wants to limit abx.  Reassess at 5 days by phone. Pt Plan: Please start antibiotic as directed.  Please use cool compress at least 5 times per day. Recommend trial of Benadryl as well 3 milliliters by mouth every 6-8 hours as needed for swelling.  Medication can make sleepy. Phone call on 3-24-17 at 11:00 am: Mom R/C & said the redness & swelling is going down but still present. Concerned w/ loose stools, had 3 dirty diapers yesterday. To try adding yogurt to diet. ABX, diarrhea & yogurt teaching done. Mom stated understanding.
Sex: M
Vaccine: VARZOS
Symptoms: Gastric disorder, Incorrect route of drug administration
Clinical narrative: Information was received from a pharmacist via a company representative concerning a male patient with unknown age who is a company employee.  No information was provided regarding patient's medical history or concomitant medications. The patient was vaccinated  Intramuscularly with ZOSTAVAX  19400 PFU  (Lot number and dosage unknown) on 07-MAR-2017. The patient experienced "stomach issues" on  07-MAR-2017 after receiving ZOSTAVAX. The patient went to the restroom and the symptoms subsided. The patient recovered. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Myalgia
Clinical narrative: Information was received by a pharmacist regarding a female of unknown age who received GARDASIL9 on approximately 22-FEB-2017 (reported as 3 weeks ago)( lot number, dosage and route of administration was not provided). The patients medical history and concomitant medications are unknown.  On a unspecified date in 2017, "the patient began to experience pain along the back of her muscle". The pharmacist also stated that "the pain was not at the injection site where the GARDASIL 9 was administered".  The patient has not recovered. No treatment was received. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Information was received by a pharmacist regarding a female of unknown age who received GARDASIL9 on approximately 22-FEB-2017 (reported as 3 weeks ago)( lot number, dosage and route of administration was not provided). The patients medical history and concomitant medications are unknown.  On a unspecified date in 2017, "the patient began to experience pain along the back of her muscle". The pharmacist also stated that "the pain was not at the injection site where the GARDASIL 9 was administered".  The patient has not recovered. No treatment was received. No further information was provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 year old female patient. The patient's pertinent medical history, drug reactions allergies, concurrent conditions and concomitant medications were not reported. The patient reported a previous adverse event with ZOSTAVAX on a different country (1703CAN011148). On an unspecified date in 2007 (reported as "ten years ago"), the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (dose, route, lot # and expiration date were not reported).  In December 2016, the patient experienced shingles. The patient went to the physician and received unspecified pills and unspecified eye drops. At the time of reporting the patient stated she was a healthy lady (outcome: recovered). A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703CAN011148:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of GARDASIL 9; lot numbers reported as M041990 and M040412, with expiration dates of 28-JUN-2019 and 30-JUN-2019 respectively; (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011175: US-009507513-1703USA011176: US-009507513-1703USA011177: US-009507513-1703USA011178:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of RECOMBIVAX HB lot numbers reported as M042322, N002913, N002202 and L038499; with expiration date of 21-FEB-2019, 23-FEB-2019, 04-NOV-2019 and 26-JUN-2017 respectively (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010669:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of VAQTA, lot numbers reported as M047658 and N002921, with expiration date of 28-OCT-2017 and 08-APR-2018 respectively (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger".  No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010669:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of M-M-R II, lot numbers reported as M037096 and M044351, with expiration date of 23-AUG-2018 and 04-NOV-2018 respectively (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger".  No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA010669:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of ROTATEQ orally, lot numbers reported as M035456, M040268 and M041181, with expiration date of 01-MAY-2018, 14-MAY-2018 and 31-MAY-2018 respectively (dose was not reported) for prophylaxis.   The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010669:
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Significant generalized rash over multiple areas of body in absence of anaphylactic findings or angioedema.
Age: 43.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Gait disturbance, Joint swelling, Pain
Clinical narrative: Patient took last of 4 doses of VIVOTIF 3.20. awoke 3.21 with slight knew pain but as day progressed, pain increased dramatically and knee swelled. Could barely walk by end of day. Took ibuprofen on 3.22 and elevated and iced. Saw PT on 3.22 who could not identify source of sx. Some improvement noted on 3.23 and better on 3.24.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: The patient reported soreness and pain at the injection site.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Hypoaesthesia, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: Face turned pale, anxiety, numb hands, didnt feel well, immediately after shot, pharmacist and manager came to calm patient down.  After 15 minutes patient felt fine and left.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site pustule, Injection site swelling
Clinical narrative: Swollen itchy area with pustules at injection site.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling of (L) deltoid, 8/10 pain, low grade fever (100.0).
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: 03/21/17 10:15am - MMR booster given. 03/21/17 12pm - itchy rash on back started 03/22/17 3:30pm - came to clinic for same day appt and given Cetirizine for rash 03/24/17 3:30pm - came to clinic with worsening rash, hives all over back, chest, abdomen, bilateral arms, face. Prednisone 20mg x5 days given.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, SMALL, TYP
Symptoms: Culture, Headache, Influenza like illness, Monocyte percentage increased, Myalgia
Clinical narrative: Pt reported to Outside ER for HA, subjective fever and muscle aches. Reports receiving fluids and being dx with a flu like illness and discharged with Zofran. Pt reports that night he developed a pruritic skin rash on his back and shoulders. Came to medical this following morning on 23Mar with 7 scattered 2-4mm umbilicated pustules on his back and shoulders, and a few tiny erythematous papules on his right thigh. Pt treated symptomatically with Tylenol and atarax. After conferring with the Director of immunization Healthcare Branch cultures were taken to determine if rash is 2/2 autoinoculation vs nonviral pustulosis vs generalized vaccinia. Strict precautions given to patient - given sick leave for the weekend, keep lesions covered with bandages, and wear shirt, sleep in separate bed/sheets then wife, use towels only once then wash, etc.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, SMALL, TYP
Symptoms: Pyrexia, Rash, Rash papular, Rash pruritic, Rash pustular
Clinical narrative: Pt reported to Outside ER for HA, subjective fever and muscle aches. Reports receiving fluids and being dx with a flu like illness and discharged with Zofran. Pt reports that night he developed a pruritic skin rash on his back and shoulders. Came to medical this following morning on 23Mar with 7 scattered 2-4mm umbilicated pustules on his back and shoulders, and a few tiny erythematous papules on his right thigh. Pt treated symptomatically with Tylenol and atarax. After conferring with the Director of immunization Healthcare Branch cultures were taken to determine if rash is 2/2 autoinoculation vs nonviral pustulosis vs generalized vaccinia. Strict precautions given to patient - given sick leave for the weekend, keep lesions covered with bandages, and wear shirt, sleep in separate bed/sheets then wife, use towels only once then wash, etc.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, SMALL, TYP
Symptoms: White blood cell count normal
Clinical narrative: Pt reported to Outside ER for HA, subjective fever and muscle aches. Reports receiving fluids and being dx with a flu like illness and discharged with Zofran. Pt reports that night he developed a pruritic skin rash on his back and shoulders. Came to medical this following morning on 23Mar with 7 scattered 2-4mm umbilicated pustules on his back and shoulders, and a few tiny erythematous papules on his right thigh. Pt treated symptomatically with Tylenol and atarax. After conferring with the Director of immunization Healthcare Branch cultures were taken to determine if rash is 2/2 autoinoculation vs nonviral pustulosis vs generalized vaccinia. Strict precautions given to patient - given sick leave for the weekend, keep lesions covered with bandages, and wear shirt, sleep in separate bed/sheets then wife, use towels only once then wash, etc.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Began signs of shingles, thatis raash with severe itching.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Inflammation
Clinical narrative: Local inflammatory reaction developed two days after administration.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Rash
Clinical narrative: Proximal lateral half of left arm probably erythema unable to move left shoulder because of pain. Seen at ER 3 days after given IV steroids which resolved the pain but rash persist.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: 3:30 pm - 11:00 pm dizziness, no treatment went to bed.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Approximately 2 min febrile seizure, sent to hospital via EMS from home.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Blood iron decreased, Haematocrit normal, Haemoglobin normal, Metrorrhagia
Clinical narrative: Patient began spotting 2 days after receiving #1 HPV She continued with series and had #2 HPV. She had continued with prolonged menstrual cycle. Mom to sched. appt. with GUN. She is becoming anemic.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Oligomenorrhoea, Transferrin saturation decreased
Clinical narrative: Patient began spotting 2 days after receiving #1 HPV She continued with series and had #2 HPV. She had continued with prolonged menstrual cycle. Mom to sched. appt. with GUN. She is becoming anemic.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Prolonged crying - severe and inconsolable for 3 hrs.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Electroencephalogram, Syncope
Clinical narrative: Syncope 3/8/2017.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm injection site redness, tenderness and swelling of the entire upper left arm.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Dry skin, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Father stated that 12hrs after vaccines given child's hands where swollen, dry and redden encircling wrists. "It looks like a sunburn." C/O itchiness. No fever or other rashes. Instructed to seek medical care.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Limb discomfort, Neck pain, Pain
Clinical narrative: Patient called to C/O (R) side neck pain moving after T2 injection. 2 hours after receiving vaccine, C/O soreness no redness or swelling noted. Applied cold to (R) arm x 2. Exercised (R) arm ("windmill rotations") in circles x 5 minutes. Upon arising 3/9/17 6:00 AM had (R) sided neck pain pain continued throughout day. This AM 3/10/17 continues to have discomfort when raising arm above head. Neck pain resolving 3-10-2017 (R) arm discomfort continues 3/10/2017.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Body temperature increased, Eye swelling, Urticaria
Clinical narrative: 4 days later had hives, swollen eyes temp 99.5 8 days later along with hives.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity, Periarthritis, Ultrasound scan, X-ray
Clinical narrative: On August 16, 2016, had a appointment with my doctor for regular 6 months check up, she said I needed to get a pneumococcal vaccine, never had a shot 1st time. After shot I had pain from left shoulder down to hand. Diagnosis frozen shoulder.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Local swelling, Myalgia
Clinical narrative: Onset of localized swelling, chills/fever and myalgias within 2 hours of receiving PNEUMOVAX vaccine/ZOSTAVAX/TDaP. Swelling/redness at site of PNEUMOVAX only.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Onset of localized swelling, chills/fever and myalgias within 2 hours of receiving PNEUMOVAX vaccine/ZOSTAVAX/TDaP. Swelling/redness at site of PNEUMOVAX only.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria on trunk and extremities.
Age: 33.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients arm became red and swollen at injection site. She was given an injection of dexamethasone and betamethasone.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Local itching/redness/swelling. She was examined at 18:30 on 3/8/17 and had a 16 cm long area of redness, swelling and warmth along her left upper outer arm to width of 5 mm. I am reporting it because it was so large.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Swelling
Clinical narrative: Local itching/redness/swelling. She was examined at 18:30 on 3/8/17 and had a 16 cm long area of redness, swelling and warmth along her left upper outer arm to width of 5 mm. I am reporting it because it was so large.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Immediate post-injection reaction, Nodule, Swelling
Clinical narrative: "Knot" immediately following injection, redness and swelling started later and increased over several days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to injection site left arm deltoid.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash at site of injection.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Rash pruritic, Scab
Clinical narrative: Small blister, then crusts in 1-2 days. Itchy and sore rash developed on face, arm and torso on 3-19-17. Was given cephalexin 500 mg 1 Tab BID for 10 days.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: One day following injection of 9-valent HPV vaccine (1st 2 injections were 4-valent), developed mild tenderness, heat, redness to injection site. Measured 5 cm diameter.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain Barre. Hospitalized for necessary treatment.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash R deltoid x 2 days, pain at injection site x 8 days; RX ibuprofen 600 mg TID.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Erythema, Injection site erythema, Swelling face
Clinical narrative: Red raised spot on check, redness at injection site. No treatment done.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Peripheral swelling, Swelling, Temperature intolerance
Clinical narrative: Redness initially with minor swelling on 3/22/17. After 3/23/17 into 3/24/17, the area of the swelling is increasing between armpit and elbow. The area is painful but decreasing. Patient can not tolerate cold; so she is using ibuprofen and BENADRYL.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Large welt at site of injection. Welt measures 4 1/2 inches long by 2 inches wide. Welt is very hot, painful, red. I also have a dull headache that will not go away.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Large welt at site of injection. Welt measures 4 1/2 inches long by 2 inches wide. Welt is very hot, painful, red. I also have a dull headache that will not go away.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Areflexia, Electrocardiogram normal, Electroencephalogram abnormal, Hypotonia, Peripheral coldness
Clinical narrative: First episode was about 30 seconds first noticed cold hands feet and cheeks along with delayed breathing no response then resolved. Second episode lasted approximately 1 minute 30 seconds on 03/23/2017 at approximately 3:30 AM noticed cold hands, feet and cheeks no breathing no reflexes or response she was completely limp.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: First episode was about 30 seconds first noticed cold hands feet and cheeks along with delayed breathing no response then resolved. Second episode lasted approximately 1 minute 30 seconds on 03/23/2017 at approximately 3:30 AM noticed cold hands, feet and cheeks no breathing no reflexes or response she was completely limp.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No signs or symptoms of adverse event.  Inappropriate dosage of vaccination given for patient's age.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: MILD DIZZINESS.
Age: 1.83
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abasia, Blood test, Dehydration, Diarrhoea, Dysstasia
Clinical narrative: Vomiting (24 hours) severe diarrhea (3 days) high fever (100-104 degrees, 3 days), swelling in thighs, unable to walk or stand (3 days), extremely lethargic (4 days), dehydration.
Age: 1.83
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site swelling, Lethargy, Pyrexia, Rotavirus test, Stool analysis
Clinical narrative: Vomiting (24 hours) severe diarrhea (3 days) high fever (100-104 degrees, 3 days), swelling in thighs, unable to walk or stand (3 days), extremely lethargic (4 days), dehydration.
Age: 1.83
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Vomiting (24 hours) severe diarrhea (3 days) high fever (100-104 degrees, 3 days), swelling in thighs, unable to walk or stand (3 days), extremely lethargic (4 days), dehydration.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AND PAIN FROM INJECTION TO ELBOW, WARM TO TOUCH. SAW DR WHO RECOMMENDED APPLYING ICE AND USING OTC PAIN RELIEVERS FOR SYMPTOMS.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Injection site induration, Musculoskeletal stiffness
Clinical narrative: SLIGHT DISORIENTATION FOR 1 DAY FOLLOWING INJECTION, OVERALL MUSCLE STIFFNESS AND HARDNESS OF TISSUE AT SITE OF INJECTION CONTINUING THROUGH 3RD DAY.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Peripheral swelling, Skin warm
Clinical narrative: HOT, SWOLLEN ARM UP TO SHOULDER. FEEL BLISTERS COMING ON.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Ache at injection site with some redness.  Ache continues to present (3-25-2017. Initial treatment with cold compresses and ibuprophen for 2 days. Ongoing treatment with ibuprophen.  Ache getting progressively worse.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: First time he took it (2/15/17) - systemic itching; Second time (2/17/17) developed a macropapular rash on back.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Body temperature increased, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Seizure
Clinical narrative: Seizure x 1 minute associated with a rectal temperature of 100.5.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Entire limb (left arm) severely swollen, stemming from injection site.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation
Clinical narrative: RED INFLAMED AREA DELTOID AREA RIGHT ARM (ALLERGIC REACTION).
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Sore left arm, 3 proximal dots beneath the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Arm that was injected is very sore, raised skin on site of shot (upper arm), red ring around injected site, red center.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye swelling, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Rash, bump, red at injection site -sore blisters, swollen eyes -left shoulder pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Rash, bump, red at injection site -sore blisters, swollen eyes -left shoulder pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hypersensitivity
Clinical narrative: Possible allergic reaction to vaccine on left arm. No temp, no cellulitis.