chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Head discomfort, Headache
Clinical narrative: Case number PHHY2016US023760 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 613278) on 19 Feb 2016. This report refers to a 72 year old female patient. Her current condition included hypothyroidism. Her concomitant medications included levothyroxine and NEXIUM. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 30 Nov 2015. On the same date after vaccination, the patient had unusual searing headache and feeling of pressure on brain. The feeling of pressure on head was persistent as of 04 Dec 2015. She took ibuprofen which helped, but interval between reliefs was becoming shorter. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Case number PHHY2016US023176, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 613569) on 19 Feb 2016. This report refers to a 43 years old female patient. Medical history and current illness were none. Concomitant medications were none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 03 Dec 2015. On the same day after vaccination the patient experienced cold like symptoms described as post nasal drip, cough and runny nose. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US023904 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614345) on 19 Feb 2015. This report refers to a 74 year old male patient. MG (not specified in detail) was reported as medical history. His concomitant medication included Prednisone, BROVANA, Ipratropium, Budesonide, Oxycodone, CHANTIX, Metoprolol, and Spironolactone. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 17 Sep 2015. On 10 Oct 2015, the patient developed pain in left shoulder. The outcome of the event was reported as condition unchanged. Event was reported as non-serious. Causality of the event was not reported.
Age: 1.1
Sex: F
Vaccine: FLUX
Symptoms: Dermatitis diaper, Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2016US023214, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614551) on 19 Feb 2016. This report refers to a 13 months old female patient. Medical history was not reported. The patient's concurrent condition included mild cough. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Dec 2015. On 09 Dec 2015 the patient developed red raised rash on bilateral legs and diaper area. Rash then spread to hands, lips, chin, feet and arms. It was noted that the rash was getting better slowly on 11 Dec 2015. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "rash erythematous" was upgraded based on information in the source document.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: Case number PHHY2016US023965 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614583) on 19 Feb 2016. This report refers to a 64 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2015. On 17 Oct 2015, the patient experienced cold symptoms. It worsened to flu like symptoms, the next day on 18 Oct 2015. It was reported that when she improved a little after taking over the counter, she visited physician on 22 Oct 2015. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US023991 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614586) on 19 Feb 2016. This report refers to a 44 year old female patient. It was reported that the patient underwent corneal transplant in past. Concomitant medication included prednisolone eye drops from the transplant. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported, site of vaccination: not reported) on 01 Sep 2015. On 10 Sep 2015, the patient experienced persistent upper arm and shoulder pain. It was reported that she cannot sleep on that side as the pain becomes unbearable. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2016US024018, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614841) website on 19 Feb 2016. This report refers to a 50-years-old male patient. Past medical history and concomitant medications were not reported. Current conditions included allergic to bi- valve shellfish (clams and mussels). He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 12 Dec 2015. On the same day, he experienced nausea, throw up, fever and swollen throat. On 13 Dec 2015 morning, he experienced severe headache and it was abated on 14 Dec 2015. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness of the event pyrexia, nausea, vomiting and pharyngeal edema was upgraded based on the information available in the source document.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2016US023906, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 616518) on 19 Feb 2016. This report refers to a 5 years old male patient. Medical history included vesicoureteral reflux and recurrent sinusitis. Current condition included allergy to dogs. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Post vaccination the patient experienced vomiting. The outcome, seriousness and causality of the event was not reported.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, MENHIB, RVX
Symptoms: Respiratory arrest
Clinical narrative: Stopped breathing 4 different times.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling to injection site.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Fatigue, Pain
Clinical narrative: Joint pain hip, back, pain moved everywhere in her body. Fatigue.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Disturbance in attention, Fatigue, Headache, Hot flush
Clinical narrative: Pain increased significantly, stopped having periods, hot flashes, increased fatigue, decrease in concentration, shocks of pain irradiating to head and all over body.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Osteopenia, Pain, Premature menopause
Clinical narrative: Pain increased significantly, stopped having periods, hot flashes, increased fatigue, decrease in concentration, shocks of pain irradiating to head and all over body.
Age: 50.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Bradyphrenia, Fatigue, Immediate post-injection reaction, Impaired work ability, Injection site hypoaesthesia
Clinical narrative: Patient with left side MEN-B (BEXSERO) (Meningococcal B) OMV given, right side MEN-ACYW (MENVEO) (meningococcal oligosaccharide ACYW-135).  1 month ago, Men-B (Bexsero given with neck pain).  Severe pain on injection radiating with numb/tingling on right side immediately.  Then severe fatigue, slowness in thought and movement, at least 3 days, still having symptoms - could not work.
Age: 50.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Injection site paraesthesia, Movement disorder, Neck pain
Clinical narrative: Patient with left side MEN-B (BEXSERO) (Meningococcal B) OMV given, right side MEN-ACYW (MENVEO) (meningococcal oligosaccharide ACYW-135).  1 month ago, Men-B (Bexsero given with neck pain).  Severe pain on injection radiating with numb/tingling on right side immediately.  Then severe fatigue, slowness in thought and movement, at least 3 days, still having symptoms - could not work.
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Headache, Lethargy, Malaise
Clinical narrative: Initial unsolicited report received from a nurse on 07-Oct-2015. This case involves a two male patiens (age was not reported), who were vaccinated with two doses of IMOVAX via intramuscular route (manufacturer: Sanofi Pasteur, batch number: L1260-3, expiry date and site of administration were not provided) on 15-Sep (year was not provided), two doses of RABAVERT (manufacturer: other, batch number, expiry date, route and site of administration were not provided) and one dose of HRIG (manufacturer: unknown, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not provided. On an unspecified date post vaccination, after the second Rabavert dose and prior to the Imovax dose, the patients experienced extreme lethargy, malaise, headaches and tiredness. Laboratory investigations and corrective treatment were not reported. It was reported that the patient required ER/doctor visit. The patient had not yet recovered from the above mentioned events. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report was received from a Licensed Practical Nurse referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On 26-JAN-2016, the patient was vaccinated with GARDASIL 9 0.5 ml, lot # L028083, expiry date 03-SEP-2017, first dose, (administration route and anatomical site were not reported). Concomitant therapies were not provided. In 2016, after the vaccination with GARDASIL 9, the patient had a urine pregnancy test which result was positive (maternal exposure during pregnancy), the nurse reported that the patient was unaware of the pregnancy at the time of the vaccination. The last menstrual period date (LMP), due date and estimated date of delivery were unknown. The pregnancy outcome was pending at the time of this report. No adverse events and no product quality complain (PQC) were reported. Follow up information has been received from a physician on 23-MAR-2016 concerning a 25 year old female patient with diabetes mellitus type I. The patient did not have any previous pregnancies, full term deliveries and preterm deliveries. It was reported that no elective terminations or fetal deaths occurred in the past. At 10:51 on 26-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left deltoid. The patient was also on insulin pump with HUMALOG daily (strength, dose and route of administration were not reported) for diabetes mellitus type I and was taking meclizine hydrochloride, pyridoxine hydrochloride (PNV) (strength, dose, frequency and route of administration were not reported) for pregnancy. The patient was pregnant (she was in her first trimester) at the time of the vaccination, which was confirmed later by the ultrasound performed in approximately January 2016 (at 4 weeks and 2 days). The LMP date was estimated to be 14-DEC-2015 (calculated by extracting 12 weeks and 3 days from the miscarriage date). The fetal outcome was unknown. Amniocentesis or Maternal Serum Alpha-Fetoprotein Screening (MSAFP) were not performed. On 10-MAR-2016, the patient experienced spontaneous abortion <20 weeks. It was confirmed by an ultrasound performed on the same day (for dating and viability) at 12 weeks and 3 days from LMP (also reported as "at 10 weeks pregnant"). The outcome of spontaneous abortion was not reported. The relatedness between the event and GARDASIL 9 was not provided. Upon internal review the event of spontaneous abortion was considered to be medically significant. Additional information is not expected as all scheduled correspondence has been received. Reporter information, patient's demographics and narrative have been updated. Adverse event, laboratory tests values and suspect products were added.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cardio-respiratory arrest, Chronic kidney disease, Chronic obstructive pulmonary disease, Death
Clinical narrative: Patient had her routine dialysis and was administered PPV23.  Went home, felt weak.  Husband found her slouched over.  911 called.  Patient sent to ICU.  Placed on comfort cares and passed away.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Hospice care, Intensive care, Lactic acidosis, Leukocytosis, Liver function test abnormal
Clinical narrative: Patient had her routine dialysis and was administered PPV23.  Went home, felt weak.  Husband found her slouched over.  911 called.  Patient sent to ICU.  Placed on comfort cares and passed away.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Posture abnormal, Respiratory failure, Shock
Clinical narrative: Patient had her routine dialysis and was administered PPV23.  Went home, felt weak.  Husband found her slouched over.  911 called.  Patient sent to ICU.  Placed on comfort cares and passed away.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Abasia, Arthralgia, Back pain, Blister, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with chronic graft versus host disease, hypothyroidism, depression, bone marrow transplant for acute myeloid leukaemia (AML). The physician reported reactions to medications as following: ATIVAN caused the patient to have delusions; vancomycin caused the patient to have Red Man Syndrome; both Azithromycin and BACTRIM resulted in rashes. On 11-MAR-2016, the patient was vaccinated with VARIVAX, 0.5 ml, lot # L040421, expiration date 15-OCT-2017, subcutaneously in the left arm (unspecified if this was the first or second dose). Concomitant therapies included betamethasone ointment, citalopram, vitamins (unspecified), melatonin, levothyroxine sodium (manufacturer unknown) and estradiol vaginal cream. On approximately 13-MAR-2016, after 2 days of vaccination, the patient experienced pain which developed in her lower back, left side of hip, left knee and left foot. On approximately 18-MAR-2016, after 7 days of vaccination, the patient developed 1 vesicle on the lower back and on approximately 19-MAR-2016, by 8 days had multiple vesicles on the left foot area. The patient sought medical attention on an unspecified date in March 2016 with an unspecified health care provider and was admitted to an unspecified hospital on 21-MAR-2016 for a diagnosis of pain control. Acyclovir and unspecified pain medications were prescribed for the events. Both a Magnetic Resonance Imaging (MRI) and an X-ray had been performed on an unspecified date in March 2016, but results were unspecified. On approximately 22-MAR-2016 (reported as now), the patient could not walk due to pain, but this was not anticipated to be long term. At reporting time, the patient did not recover from the events. The reporter did not assess the causality relationship of the events and VARIVAX. The reporting physician considered "could not walk due to pain" to be significant disability. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, X-ray
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with chronic graft versus host disease, hypothyroidism, depression, bone marrow transplant for acute myeloid leukaemia (AML). The physician reported reactions to medications as following: ATIVAN caused the patient to have delusions; vancomycin caused the patient to have Red Man Syndrome; both Azithromycin and BACTRIM resulted in rashes. On 11-MAR-2016, the patient was vaccinated with VARIVAX, 0.5 ml, lot # L040421, expiration date 15-OCT-2017, subcutaneously in the left arm (unspecified if this was the first or second dose). Concomitant therapies included betamethasone ointment, citalopram, vitamins (unspecified), melatonin, levothyroxine sodium (manufacturer unknown) and estradiol vaginal cream. On approximately 13-MAR-2016, after 2 days of vaccination, the patient experienced pain which developed in her lower back, left side of hip, left knee and left foot. On approximately 18-MAR-2016, after 7 days of vaccination, the patient developed 1 vesicle on the lower back and on approximately 19-MAR-2016, by 8 days had multiple vesicles on the left foot area. The patient sought medical attention on an unspecified date in March 2016 with an unspecified health care provider and was admitted to an unspecified hospital on 21-MAR-2016 for a diagnosis of pain control. Acyclovir and unspecified pain medications were prescribed for the events. Both a Magnetic Resonance Imaging (MRI) and an X-ray had been performed on an unspecified date in March 2016, but results were unspecified. On approximately 22-MAR-2016 (reported as now), the patient could not walk due to pain, but this was not anticipated to be long term. At reporting time, the patient did not recover from the events. The reporter did not assess the causality relationship of the events and VARIVAX. The reporting physician considered "could not walk due to pain" to be significant disability. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Electroencephalogram abnormal, Polymerase chain reaction positive, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician referring to a five month old male infant. The patient's concurrent condition included transposition of the great arteries, hypothyroidism, dysphagia, cerebrovascular accident with abnormal electroencephalogram (EEG), left ventricular dysfunction, blood clot in neck vein, lack of normal development and chylothorax. The patient's medical history included G-tube insertion for dysphagia. The patient was vaccinated with ROTATEQ (dose, lot# and route were unknown) on 31-JAN-2015 and 20-MAY-2015 (inappropriate schedule of vaccine administered). On 18-FEB-2016, the patient was vaccinated with VARIVAX (Merck) (dose, lot# and route were unknown). Concomitant therapies included acyclovir, furosemide (manufacturer unknown), zinc sulfate, aspirin (manufacturer unknown), spironolactone, benzocaine (manufacturer unknown), diazepam (manufacturer unknown), levothyroxine sodium (manufacturer unknown), simethicone, acetaminophen (manufacturer unknown), milrinone and lansoprazole. On 25-FEB-2016, the patient had a polymerase chain reaction (PCR) test which tested the patient's stool and the results were positive for rotavirus. From 26-FEB-2016 through 08-MAR-2016, the patient had diarrhea. On 15-MAR-2016, the patient developed chicken pox. The reporter stated that at time of report, the patient was hospitalization in the hospital and was waiting for a cardiac transplant. The patient had sought medical attention on an unknown date. The patient had not recovered from the events. The causality between the events and ROTATEQ and VARIVAX (Merck) was not provided. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician referring to a five month old male infant. The patient's concurrent condition included transposition of the great arteries, hypothyroidism, dysphagia, cerebrovascular accident with abnormal electroencephalogram (EEG), left ventricular dysfunction, blood clot in neck vein, lack of normal development and chylothorax. The patient's medical history included G-tube insertion for dysphagia. The patient was vaccinated with ROTATEQ (dose, lot# and route were unknown) on 31-JAN-2015 and 20-MAY-2015 (inappropriate schedule of vaccine administered). On 18-FEB-2016, the patient was vaccinated with VARIVAX (Merck) (dose, lot# and route were unknown). Concomitant therapies included acyclovir, furosemide (manufacturer unknown), zinc sulfate, aspirin (manufacturer unknown), spironolactone, benzocaine (manufacturer unknown), diazepam (manufacturer unknown), levothyroxine sodium (manufacturer unknown), simethicone, acetaminophen (manufacturer unknown), milrinone and lansoprazole. On 25-FEB-2016, the patient had a polymerase chain reaction (PCR) test which tested the patient's stool and the results were positive for rotavirus. From 26-FEB-2016 through 08-MAR-2016, the patient had diarrhea. On 15-MAR-2016, the patient developed chicken pox. The reporter stated that at time of report, the patient was hospitalization in the hospital and was waiting for a cardiac transplant. The patient had sought medical attention on an unknown date. The patient had not recovered from the events. The causality between the events and ROTATEQ and VARIVAX (Merck) was not provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: BROKE OUT IN HIVES.
Age: 37.0
Sex: F
Vaccine: RAB, TD
Symptoms: Chills, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain
Clinical narrative: Initial unsolicited report received from a healthcare professional on 11 August 2015. A 37-year-old female patient had received a third dose of IMOVAX RABIES and a dose of TENIVAC (dose, batch number and site of administration were not reported) via intramuscular route on an unknown date (post exposure series). Medical history, illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions and concomitant medications were not provided. Previous medications included two doses of Imovax. On an unknown date, after vaccination, the patient had developed myalgia, chills, nausea, pain and stiffness in her neck. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Soreness starting the night of vaccination, could not move arm the day after vaccination. Could not move arm for 2-3 days. Pain in the arm the whole time, could not tolerate touch to arm.
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Started with a headache and sore arm at injection site. Then pain moved on down the same arm, increasing as it manifested in other arm, legs, shoulders. Aspirin only vaguely quieted it enough so I could sleep intermittently.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, Redness, Pain at site.
Age: 52.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: PATIENT COMPLIANED OF MUSCLE AND JOINT ACHES, NAUSEA AND FEVER.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS SWELLING, PRURITUS ON THE INJECTION SITE.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: PATIENT HAS RAISED RED RASH FROM INJECTION SITE TO ELBOW, MOTHER STATED THAT SHE WAS MADE AWARE OF THE RASH IN THE EVENING.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Induration, redness, warmth, tenderness to touch, and bruising noted to injection site (left thigh).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electromyogram, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Pain in arch of left foot. Diagnosed as Plantar Fasciitis on 10/30/2014. Four injections over two months. Saw Orthopedic Foot & Ankle specialist 05/26/2015. After several injections and ASTM physical therapy over most of the year still with same pain. Wore rocker boot all of December 2015. After EMG testing, received Platelet-Rich-Plasma (PRP) injection on 02/25/2016. Foot is somewhat better as of 03/25/2016, but still not healed. Waiting for more improvement.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Plantar fasciitis
Clinical narrative: Pain in arch of left foot. Diagnosed as Plantar Fasciitis on 10/30/2014. Four injections over two months. Saw Orthopedic Foot & Ankle specialist 05/26/2015. After several injections and ASTM physical therapy over most of the year still with same pain. Wore rocker boot all of December 2015. After EMG testing, received Platelet-Rich-Plasma (PRP) injection on 02/25/2016. Foot is somewhat better as of 03/25/2016, but still not healed. Waiting for more improvement.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient immediately stated injection site itched and became red.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (dosing details were not reported) lot # L037560 expiry date 29-SEP-2017 which was exposed to a temperature of 6.1 degrees F for a time frame of 3 hour, no previous temperature excursion was reported. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2015US171359, is an initial literature report received on 30 Dec 2015. The authors discuss about T-follicular helper (Tfh) cell expansion during pregnancy. This report refers to a 36 female pregnant patients. Their last menstrual period (LMP) was not reported. These patients were vaccinated inactivated influenza vaccine (manufacturer and batch number: not reported). The influenza specific T-follicular cell response varied based on trimester or pregnancy in which the vaccine was given. There was a significant expansion of Tfh cells after vaccination among women in the firs trimester )p=0.036) but there was not a significant expansion after vaccination in either the second or third trimesters (p=0.091 and 0.347 respectively). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the reporter stated that patient had previously received one dose of PREVNAR 13 on an unspecified date, inadvertently received a second dose of PNEUMOVAX 23 (dosing details were not reported) (wrong vaccine administered). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unspecified dates since 03-JAN-3016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # L042846, expiration date 15-SEP-2017, dose and anatomical location were not reported) intramuscularly. No adverse events were reported. On an unspecified dates from 03-JAN-2016 to 24-FEB-2016, the doses were exposed to 49 Fahrenheit degree. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # L023118 expiry date 24-SEP-2016 (dose, route and site of administration not reported). This was following first temperature excursion of -7.4C for 8 hours. No adverse effects were reported. Temperature: 0.05C Time frame: 9 hours 20 minutes. Based on these supportive parameters the improperly stored vaccines were administered after first excursion. No doses were administered after second excursion. There was previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L025204 expiry date 07-JAN-2017; lot # L031600 expiry date 18-FEB-2017 (dose, route and site of administration not reported). No adverse effects were reported. Temperature: 0.05C Time frame: 9 hours 20 minutes. Based on these supportive parameters the improperly stored vaccines were administered after first excursion. No doses were administered after second excursion. There was previous temperature excursion (-7.4C for 8 hours). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reaction or allergies and concomitant therapies was provided. On an unspecified date in October 2015, the patient was vaccinated with the first dose of an unidentified Merck HPV vaccine (name, lot number, exact dose and route of administration were not provided). On an unspecified date in November 2015, the patient was vaccinated with the second dose of an unidentified Merck HPV vaccine (name, lot number, exact dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L016429, expiry date 09-SEP-2017 (dose, route of administration and anatomical location were not specified). Administered doses of GARDASIL 9 underwent temperature excursion at 48.6 Fahrenheit degrees for 1 hour and 45 minutes. It was reported that the vaccine underwent previous temperature excursion at 48.9 Fahrenheit degrees for 1 hour and 15 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with PROQUAD (Merck) (dosing details were not reported) lot # L045678 expiry date 09-MAR-2017 which was exposed to a temperature of 6.1 degrees F for a time frame of 3 hours, no previous temperature excursion was reported (incorrect product storage). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient (registered nurse) of unknown age via a company representative. The patient's concurrent conditions and medical history were not reported. On an unknown date (reported as "some time ago"), the patient was vaccinated with a dose of ZOSTAVAX (exact dose, lot #, expiration date, route of administration and anatomical location were not reported). There were no concomitant medications provided. On an unknown date, the patient experienced pain and redness at the injection site after receiving ZOSTAVAX . The outcome the events was reported as recovered. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated orally with an improperly stored doses of oral ROTATEQ lot # L023866, expiry date 24-MAR-2017 (dose was not specified). Administered doses of oral ROTATEQ underwent temperature excursion at 48.6 Fahrenheit degrees for 1 hour and 45 minutes. It was reported that the vaccine underwent previous temperature excursion at 48.9 Fahrenheit degrees for 1 hour and 15 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L017146, expiration date 13-MAY-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 8.1F for 30 minutes. Previous temperature excursion was reported and doses reached then 8.6F for 30 minutes (date was not provided). No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of MMR II (therapy type unspecified) with lot# L026550 and expiration dates: 16-JUL-2017 and with lot # L005290 with expiration date: 17-FEB-2017; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 57 year old patient of unknown gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. In November 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L026037, expiry date 17-JAN-2018, dose and route were unspecified). On 23-MAR-2016 the patient got the second dose of RECOMBIVAX HB (lot # L026037, expiry date 17-JAN-2018), which was 4 months after the first dose was administered. No adverse effect was reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of PNEUMOVAX 23 with lot# L018503 and expiration date: 16-MAR-2017 and with lot # K008409 with expiration date: 04-MAR-2016; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of RECOMBIVAX HB with lot# L044694 and expiration date: 04-FEB-2018 and with lot # L019298 with expiration date: 22-JUN-2017; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of VAQTA with lot# L036300 and expiration date: 04-NOV-2016 and with lot # L015460 with expiration date: 20-JUL-2017; with lot # L023232 with expiration date: 25-FEB-2017; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Transmission of an infectious agent via product
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of transmission of an infectious agent via a medicinal product in a female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced transmission of an infectious agent via a medicinal product (serious criteria GSK medically significant). On an unknown date, the outcome of the transmission of an infectious agent via a medicinal product was unknown. It was unknown if the reporter considered the transmission of an infectious agent via a medicinal product to be related to RABAVERT. Additional details were provided as follows: The reporter stated that the RABAVERT came with a non-safety needle for administration of the vaccine. The reporter understood the rationale of using a non-safety needle as a drawing up needle, but not for the one to be used for administering the vaccine to the patient. Recently, there was a blood borne pathogen exposure involving this device. Therefore the reporter requested to exchange the non-safety needles in the RABAVERT kit with safety needles for the safety of their healthcare professionals.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications and medical history were not provided. On 23-MAR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot # K0051110, expiry date 04-APR-2016, dose, route and dose number were unspecified). The excursion details were as follows: temperature: 49F; time frame: 16 hours, 30 minutes; previous temperature excursion No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of ROTATEQ (lot # K016263, expiration date 26-JUN-2016l; temperature: minimum 30.9 Fahrenheit (F) to maximum 31.6 F, time frame 292 hours, previous excursion: No; dose not reported) orally. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Influenza like illness, Joint stiffness, Myalgia
Clinical narrative: Flu-like symptoms, stiff joints, muscle soreness. NO fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient's immunized arm became red and swollen for 3 months after immunization received 9/6/15. Area is still sensitive to the touch as of 3/25/16, but swelling has decreased.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patients arm was swollen at point of injection and very red.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Low grade fever of 100.3* F.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Crying, Nausea, Pain, Pyrexia, Screaming
Clinical narrative: Persistent Fever 102, nausea, crying for hours, screaming in pain.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: I HAD A FLU SHOT IN SEPT. 2015 IN MY LEFT ARM.  IT HAS BEEN APPROXIMATELY SIX MONTHS AND I AM STILL HAVING TROUBLE WITH MY LEFT ARM.  IT IS EXTREMELY PAINFUL AND I HAVE LIMITED MOBILITY.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Crying
Clinical narrative: Inconsolable crying for the afternoon and evening; low grade temp.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Glassy eyes
Clinical narrative: Pt was given 4 month vaccines without complication. No illness. Fell asleep in car seat. Approximately 1/2 hour later, pt woke. Eyes were open and glassy, all body had jerking forward and backwards lasting 7 seconds.  Afterwards, pt then acting normally. Seen in office approximately 1 hour after episode- fully normal exam. No fever.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever and multiple seizures.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Full blood count, Hyperhidrosis, Inappropriate schedule of drug administration
Clinical narrative: Erythema, swelling, aching pain, chills, sweating, limited range of motion of left upper arm, lasting 3 days at time of evaluation at urgent care. Review of medical record shows patient had previous pneumonia vaccine in 1/26/15, and now again on 3/23/16.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Swelling
Clinical narrative: Erythema, swelling, aching pain, chills, sweating, limited range of motion of left upper arm, lasting 3 days at time of evaluation at urgent care. Review of medical record shows patient had previous pneumonia vaccine in 1/26/15, and now again on 3/23/16.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Nasal congestion, Pruritus generalised
Clinical narrative: Client complained of SOB, nasal congestion, and itching all over her body.  Client was given Benadryl 50 mg IM in RT Deltoid.  She was sent to the ER for evaluation.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching and rash on upper arm where shot was given.
Age: 32.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Dyspnoea, Mobility decreased
Clinical narrative: Patient called stating she had chest pain on R side of chest and unable to L R arm and difficulty breahting.  Patient believed related to vaccine.  RN advised her to go to ED.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Per patient's mother: He had swelling of the Left deltoid injection site. He had a "sleepless" night on Monday evening (3/21/16). He stated his head hurt, his neck hurt, and he had back pain. He also felt chills. He was photosensitive on 3/22/16. He felt weak and tired. Symptoms continued through 3/23/16.