chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information was received from Freedom of Information Act (FOI line listing) regarding a 17 years old male patient. Current illness and history was reported as none. On 06-JUN-2016, the patient received GARDASIL 9 lot# L048459, 1 DF, intramuscular in the left arm. Other vaccines received on the same date were MENACTRA lot# U5272AA, 1 DF, intramuscular in the left arm and BEXSERO lot# 151301C, intramuscular in the right arm (also dose was reported as 0.0). Vaccines were administered at private doctor's office/hospital. 07-JUN-2016, the patient called the doctor complaining of severe pain in RA and not being able to lift the arm. The pain continued, on 08-JUN-2016 when the doctor saw him for a well check. She advised him to take ibuprofen. Other medications included mefloquine. Outcome of the event was reported as recovered. Causality of the events was not reported. Additional information is not expected as the report was received from agency.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of GARDASIL 9 (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA001795: US-009507513 1704USA014014: US-009507513-1704USA014013.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of M-M-R II (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA001795: US-009507513-1704USA014014: US-009507513-1704USA014012.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of ROTATEQ (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001795: US-009507513-1704USA014013: US-009507513-1704USA014012:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. Since an unknown date in January 2017, the patients were administered improperly stored doses of ROTATEQ orally (doses, lot # and expiration date were not reported). The administered doses of vaccine underwent a temperature excursion between 32 degrees Fahrenheit (F) to 35 degrees F, and between 47 degrees F to 77 degrees F, a time frame was not yet determined. There was no previous temperature excursion reported and a digital data logger was not involved. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009189:
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 17-APR-2017. This case involves a 37-year-old male patient who was vaccinated with a dose of YF-VAX batch number: UI607AA, expiration date: 07-NOV-2018 (dose, dose in series and site of administration not reported), subcutaneously, on 12-APR-2017. Patient's has no Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 12-APR-2017, same day following the vaccination, the patient had body aches, fatigue, fever and chills. Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from the events. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Asthenia, Bedridden, Pain, Pyrexia
Clinical narrative: Weakness, fever, unable to walk, bedridden 4 days, pain all over body.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Oedema
Clinical narrative: Alternating joint pain, redness and edema.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypersensitivity, Immune system disorder, Inflammation, Laboratory test
Clinical narrative: Patient developed hives with blisters and inflammation in her entire body that started later the same day of vaccination and continued for 18 months. Her family practice doctor and dermatologist did not believe these effects were due to the vaccine. After 18 months, she found an allergist whom told her that the vaccine had created environmental allergies and lowered her immune system. He put her on a gluten-free, wheat-free, and dairy free diet and then her rash and blisters resolved, though she says she has on-going pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Patient developed hives with blisters and inflammation in her entire body that started later the same day of vaccination and continued for 18 months. Her family practice doctor and dermatologist did not believe these effects were due to the vaccine. After 18 months, she found an allergist whom told her that the vaccine had created environmental allergies and lowered her immune system. He put her on a gluten-free, wheat-free, and dairy free diet and then her rash and blisters resolved, though she says she has on-going pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient reported extreme pain in the arm, low grade fever and malaise. He went to a walk in clinic and was seen 2 days after receiving the shot. He then came to his PCP on 4/26/17 and symptoms were resolving.
Age: 57.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Herpes zoster, Perineal abscess
Clinical narrative: Approximately 1 week post injection of yellow fever and twinrix #1 immunizations the pt developed a perineal abscess and later diagnosed w/ shingles. Client was told by PCP that twinrix may have brought on Shingles despite already receiving shingles vaccine.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Cold sweat, Pyrexia
Clinical narrative: 2:00 PM Fever 99.2 7:00PM - 2:00AM - Cold sweating 4/25/17: cold sweating on and off during day and night.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discharge, Injection site pain, Injection site reaction, Injection site scar, Skin lesion
Clinical narrative: Patient states painful, tender, lesion with white thick liquid to injection site, small pin size scar still visible after 1 month.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M037642, expiration date 01-SEP-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursions of: -12.3 degrees Celsius (-14 degrees Celsius to -10 degrees Celsius range) for 1 hour 49 minutes; >-15 degrees Celsius but <-10 Celsius range for 7 hours 14 minutes; >-10 degrees Celsius but <8 Celsius range for 2 hours 38 minutes. Data logger was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No concomitant medications, medical history, drug reactions or allergies were reported. On 12-APR-2017, the patient was vaccinated with expired dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L009213, expiration date 17-MAR-2017). Medical assistant reported no adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In April 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 14-APR-2017 from a pharmacist regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in April 2014 the patient was vaccinated with a properly stored dose of ZOSTAVAX (dose not specified) (lot #/exp date unknown) reconstituted with sterile diluent (DILUENT MRK) (lot #/exp date unknown). On an unspecified date in January 2017 the patient received a properly stored second dose of ZOSTAVAX (dose not specified) (lot #/exp date unknown) reconstituted with sterile diluent (DILUENT MRK) (lot #/exp date unknown). No side effects reported. No further information was reported.  The action taken is not applicable and outcome is unknown. The pharmacist did not rate the causal relationship. 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 pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 15-APR-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # M015925, expiration date: 15-JUN-2017, subcutaneously (dose was not reported). Other suspect therapies included properly stored sterile diluent (STERILE DILUENT) administered subcutaneously (lot#, expiration date and dose were not reported) to reconstitute ZOSTAVAX. The temperature excursion lasted for 1 hour and 33 minutes and indicated 9.9 degrees Fahrenheit. There was no previous temperature excursion. No side effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Flatulence, Gastrooesophageal reflux disease, Headache, Malabsorption
Clinical narrative: This spontaneous report as received from a 77-year-old female patient refers to herself. The patient's pertinent medical history included shoulder surgery on both shoulders, foot surgery on both feet, and pneumonia vaccination in 2008. She was sensitive to an unspecified pain medicine. On 29-MAR-2010, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided), for prevention of shingles. Her concomitant therapies included omeprazole (PRILOSEC), estrogens, conjugated (PREMARIN) and levothyroxine sodium (LEVOXYL). On about 20-APR-2010, the patient experienced fructose malabsorption, stomach cramps, and stinky gas. Additionally, she had headache and gastrooesophageal reflux disease (GERD). The patient sought medical attention and she had the "office visit". No treatment was given for the adverse events and and no diagnostic studies were performed. At the time of the report, the patient did not recover from the adverse events. Additional information is not expected, as there was no consent to contact the nurse.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 35 years old female patient. The patient's concurrent conditions included allergy to penicillin and sulfa drugs. Concomitant therapies included fluoxetine hydrochloride (PROZAC), simvastatin (ZOCOR) and omeprazole (PRILOSEC). On 17-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, lot # and expiration date were not reported) intramuscularly for asthma. In April 2017 after receiving the vaccine, the patient experienced pain going down the side to the ribs (musculoskeletal chest pain) and pain on the inside of the arm (pain in extremity). The patient received an unspecified treatment for the event. The patient sought medical attention by contacting her pharmacist but no laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered from the event. The causality between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # M007963 with an expiration date 15-AUG-2017 for prophylaxis instead of VARIVAX (dose, route of administration, lot# and expiration date was not reported). On the same day, the patient was vaccinated also with M-M-R II lot# M016234 with an expiration date 31-MAR-2018 (dose, route of administration was not reported). According to the reporter there was no product confusion. No adverse vent was reported. Additional information has been requested.
Sex: U
Vaccine: PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient might have received one of the improperly stored vaccines: either ROTATEQ oral liquid, lot number: M019691, expiration date: 02-NOV-2017 (dose was not reported) or PNEUMOVAX23 injection, lot number: M022085, expiration date: 09-OCT-2017 (dosage and route of administration were not reported). The reporter was not sure which of the vaccines the patient could have received. No adverse effects were reported. The vaccines experienced temperature excursion of 32-35 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Bacterial test negative, CSF glucose normal, CSF protein increased, Facial pain, Gram stain negative
Clinical narrative: Follow up information has been received on 18-APR-2017 as a part of media monitoring and as a literature article. During July 2015 to May 2016, a mumps outbreak occurred at the University diagnosed among students. To characterize the outbreak, an investigation was conducted through telephone interviews, medical chart abstractions, and review of immunization records. Among 287 (95%) students with mumps for whom clinical information was available, 20 (7%) patients with complications were identified (16 self-reported and four clinician diagnosed). The 20 cases included 15 (5%) cases of orchitis, three (1%) of transient hearing loss, two of mastitis, and one of meningitis (one patient had both orchitis and transient hearing loss). All 20 patients had documentation of receipt of at least 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Because data were limited regarding the presentation and clinical course of mumps complications in persons who have received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) three illustrative cases of complications (orchitis, transient hearing loss, and meningitis) in students with mumps were presented. This case pertains to a 21 year old male patient. On unspecified dates, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route and site of administration, lot # and expiry date were not reported). On 02-NOV-2015, he developed left facial pain and swelling and tested positive for mumps by polymerase chain reaction (PCR) on a buccal swab specimen. In approximately November 2015, twenty-two days after onset of symptoms, he was treated at an emergency department for neck stiffness, fever, and tachycardia. A lumbar puncture was performed, and he was empirically treated for meningitis with acyclovir and ceftriaxone. Volume of cerebrospinal fluid was inadequate for performing PCR testing for mumps, but Gram stain and bacterial culture were negative, and analysis was consistent with viral meningitis (40 lymphocytes/mm3, 60 mg/dl of protein, and 67 mg/dl of glucose). Because the onset of mumps-related meningitis was described as ranging from 4 days before the onset of parotitis until 3 weeks after, the patient's viral meningitis diagnosis was attributed to mumps. He was discharged with recommendations for symptomatic care, and meningeal symptoms resolved within 1 week in approximately 2015. The case studies underscored that complications occurred even within vaccinated populations and could present at varying times throughout the course of illness and even when parotitis ended.This case is linked with the same literature article (MARRS# 1704USA013976 and 1608USA004560). Additional information has been requested. Sender's Comments:  US-009507513-1704USA013976: US-009507513-1608USA004560.
Sex: M
Vaccine: MMR
Symptoms: Lumbar puncture, Lymphocyte count increased, Meningitis viral, Mumps, Musculoskeletal stiffness
Clinical narrative: Follow up information has been received on 18-APR-2017 as a part of media monitoring and as a literature article. During July 2015 to May 2016, a mumps outbreak occurred at the University diagnosed among students. To characterize the outbreak, an investigation was conducted through telephone interviews, medical chart abstractions, and review of immunization records. Among 287 (95%) students with mumps for whom clinical information was available, 20 (7%) patients with complications were identified (16 self-reported and four clinician diagnosed). The 20 cases included 15 (5%) cases of orchitis, three (1%) of transient hearing loss, two of mastitis, and one of meningitis (one patient had both orchitis and transient hearing loss). All 20 patients had documentation of receipt of at least 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Because data were limited regarding the presentation and clinical course of mumps complications in persons who have received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) three illustrative cases of complications (orchitis, transient hearing loss, and meningitis) in students with mumps were presented. This case pertains to a 21 year old male patient. On unspecified dates, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route and site of administration, lot # and expiry date were not reported). On 02-NOV-2015, he developed left facial pain and swelling and tested positive for mumps by polymerase chain reaction (PCR) on a buccal swab specimen. In approximately November 2015, twenty-two days after onset of symptoms, he was treated at an emergency department for neck stiffness, fever, and tachycardia. A lumbar puncture was performed, and he was empirically treated for meningitis with acyclovir and ceftriaxone. Volume of cerebrospinal fluid was inadequate for performing PCR testing for mumps, but Gram stain and bacterial culture were negative, and analysis was consistent with viral meningitis (40 lymphocytes/mm3, 60 mg/dl of protein, and 67 mg/dl of glucose). Because the onset of mumps-related meningitis was described as ranging from 4 days before the onset of parotitis until 3 weeks after, the patient's viral meningitis diagnosis was attributed to mumps. He was discharged with recommendations for symptomatic care, and meningeal symptoms resolved within 1 week in approximately 2015. The case studies underscored that complications occurred even within vaccinated populations and could present at varying times throughout the course of illness and even when parotitis ended.This case is linked with the same literature article (MARRS# 1704USA013976 and 1608USA004560). Additional information has been requested. Sender's Comments:  US-009507513-1704USA013976: US-009507513-1608USA004560.
Sex: M
Vaccine: MMR
Symptoms: Polymerase chain reaction positive, Pyrexia, Rubulavirus test positive, Swelling face, Tachycardia
Clinical narrative: Follow up information has been received on 18-APR-2017 as a part of media monitoring and as a literature article. During July 2015 to May 2016, a mumps outbreak occurred at the University diagnosed among students. To characterize the outbreak, an investigation was conducted through telephone interviews, medical chart abstractions, and review of immunization records. Among 287 (95%) students with mumps for whom clinical information was available, 20 (7%) patients with complications were identified (16 self-reported and four clinician diagnosed). The 20 cases included 15 (5%) cases of orchitis, three (1%) of transient hearing loss, two of mastitis, and one of meningitis (one patient had both orchitis and transient hearing loss). All 20 patients had documentation of receipt of at least 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Because data were limited regarding the presentation and clinical course of mumps complications in persons who have received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) three illustrative cases of complications (orchitis, transient hearing loss, and meningitis) in students with mumps were presented. This case pertains to a 21 year old male patient. On unspecified dates, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route and site of administration, lot # and expiry date were not reported). On 02-NOV-2015, he developed left facial pain and swelling and tested positive for mumps by polymerase chain reaction (PCR) on a buccal swab specimen. In approximately November 2015, twenty-two days after onset of symptoms, he was treated at an emergency department for neck stiffness, fever, and tachycardia. A lumbar puncture was performed, and he was empirically treated for meningitis with acyclovir and ceftriaxone. Volume of cerebrospinal fluid was inadequate for performing PCR testing for mumps, but Gram stain and bacterial culture were negative, and analysis was consistent with viral meningitis (40 lymphocytes/mm3, 60 mg/dl of protein, and 67 mg/dl of glucose). Because the onset of mumps-related meningitis was described as ranging from 4 days before the onset of parotitis until 3 weeks after, the patient's viral meningitis diagnosis was attributed to mumps. He was discharged with recommendations for symptomatic care, and meningeal symptoms resolved within 1 week in approximately 2015. The case studies underscored that complications occurred even within vaccinated populations and could present at varying times throughout the course of illness and even when parotitis ended.This case is linked with the same literature article (MARRS# 1704USA013976 and 1608USA004560). Additional information has been requested. Sender's Comments:  US-009507513-1704USA013976: US-009507513-1608USA004560.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Influenza virus test negative, Pain, Pyrexia, Rash
Clinical narrative: On 4/15/17 around 8pm pt. began experiencing flu-like symptoms including a fever of 101.6 F (oral temp), body aches. Pt. tested for flu/strep on 4/19. Also U/A, all were negative. Pt. noticed rash on 4/20/17 on face, neck, ears/back. Rash did extend to feet on 4-23-17. Rash still present, but not improved.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative, Urine analysis normal
Clinical narrative: On 4/15/17 around 8pm pt. began experiencing flu-like symptoms including a fever of 101.6 F (oral temp), body aches. Pt. tested for flu/strep on 4/19. Also U/A, all were negative. Pt. noticed rash on 4/20/17 on face, neck, ears/back. Rash did extend to feet on 4-23-17. Rash still present, but not improved.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Insomnia, Joint range of motion decreased, Musculoskeletal discomfort, Myalgia
Clinical narrative: Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Neuralgia
Clinical narrative: Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test normal, Burning sensation, Chills, Diarrhoea, Dyspepsia
Clinical narrative: Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Impaired driving ability, Influenza like illness, Injected limb mobility decreased, Laboratory test, Nerve injury
Clinical narrative: Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Paraesthesia, Vertigo
Clinical narrative: Nausea and chills first eve., followed by extreme muscle and nerve pulsating pain - L. arm lost mobility and limited range of motion for 2 wks., with radiating discomfort into L. shoulder and neck. Inability to sleep or find comfort for this period. Improved to dull achiness - worse at night. Treatment: Prescrip. methylprednisolone and scheduled P.T.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: General unwell, fever, sore arm.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Rash, Tremor
Clinical narrative: Burning feeling, shakes - returned to urgent care and was treated - shakes con't for 3 days. Then a rash on neck and face. Still there as of 4-21-2017. Going to allergy Dr. 4-24-2017.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Please note the following if from the Urgent Care physician who treated the patient. He mistakenly identified the patient as receiving the zoster vaccine but in fact received the pneumococcal 23 vaccine: HPI: 69 male presents c/o developing achy right shoulder pain shortly after getting an injection at the site where he had a zoster vaccination yesterday and a mild headache took aspirin which helped a little. Not worst headache of life. Denies dizziness, visual change, dyspnea, wheeze, throat/lip swelling, weakness, numbness, tingling, redness/streaking, nausea, vomiting, abdominal/back pain, chest pain, palpitations, or other complaints. Myalgia and headache pain at injection site. Acetaminophen 325 mg prn.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of chills in a 21-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced chills, pain, feeling unwell and fever. On an unknown date, the outcome of the chills, pain, feeling unwell and fever were unknown. It was unknown if the reporter considered the chills, pain, feeling unwell and fever to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. No additional patient information was provided. The reporter assumed that the reporter was also prescribing physician, but it was not certain. The reporter assumed that the vaccine was administered as protection against Pneumococcal Sero Group B. It was unknown whether any other medicines, medical conditions, or investigations were done. There was no medical information request. It was reported that, this case was previously reported to Food and Drug administration. The reporter had given consent to be contacted for further details.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: Post flu vaccine pt c/o right leg numbness pt was left in observation for 15 min. Pt had dizziness, headaches after 15 min patient stated his leg was feeling better by the time the patient was discharged, patient stated the numbness had gone away.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Swelling in the area of injection, muscle pain, back pain, redness approx. 5 in from injection site.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pruritus, Vomiting
Clinical narrative: PATIENT GOT LIGHT HEADED AND HAD ITCHINESS TO SITE OF HPV VACCINE. VOMITTED X 1.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Bone densitometry, Female sex hormone level, Laboratory test, Neurological examination
Clinical narrative: Prolonged amennorhea diagnosis. Daughter has had only only period in her whole life on her own. She is now 22 and seeing fertility doctors.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site nodule, Vaccination site pain
Clinical narrative: Inflammation/nodule with painful erythema at site of vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Colectomy, Computerised tomogram abdomen abnormal, Haematochezia, Intussusception
Clinical narrative: 4/15/17 presents with abd. pain and bloody BM, recurrent bilious emesis. CT showed concern for intussusception. On 4/15/17 pt. had right colectomy with primary end-to end small bowel to large bowel anastomosis.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Large intestine anastomosis, Small intestinal anastomosis, Vomiting
Clinical narrative: 4/15/17 presents with abd. pain and bloody BM, recurrent bilious emesis. CT showed concern for intussusception. On 4/15/17 pt. had right colectomy with primary end-to end small bowel to large bowel anastomosis.
Age: 22.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: States 5 hrs after injections weakness, H/A, pain in neck, diarrhea and vomiting. Muscles ache, backache, chills, "feel like brick hit back of head". Reporting to HD 12:00 pm 4/19/17. T-99.5.
Age: 22.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Headache, Myalgia, Neck pain, Vomiting
Clinical narrative: States 5 hrs after injections weakness, H/A, pain in neck, diarrhea and vomiting. Muscles ache, backache, chills, "feel like brick hit back of head". Reporting to HD 12:00 pm 4/19/17. T-99.5.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Back pain, Computerised tomogram, Electromyogram, Nuclear magnetic resonance imaging
Clinical narrative: Pain in upper left back into shoulder under arm and down left arm, elbow down to right above my wrist. Radiating deep ache, 3 MRI's, Doppler, EMG, 2 xrays, CT. Emergency Room-twice-pain for 5 weeks-physical therapy.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Ultrasound Doppler, X-ray
Clinical narrative: Pain in upper left back into shoulder under arm and down left arm, elbow down to right above my wrist. Radiating deep ache, 3 MRI's, Doppler, EMG, 2 xrays, CT. Emergency Room-twice-pain for 5 weeks-physical therapy.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Laboratory test, Nerve stimulation test, Nuclear magnetic resonance imaging
Clinical narrative: Pain in upper left back into shoulder under arm and down left arm, elbow down to right above my wrist. Radiating deep ache, 3 MRI's, Doppler, EMG, 2 xrays, CT. Emergency Room-twice-pain for 5 weeks-physical therapy.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-APR-2017 from a nurse regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date (reported as between 20-MAR-2017 to 14-APR-2017 the patients were vaccinated with improperly stored doses of GARDASIL 9, (lot # M036059, expiration 03-JUN-2019); PEDVAXHIB, (lot # M045206 (expiration 27-JUN-2019); and ROTATEQ, (lot # M039434, expiration 24-MAY-2018) (doses not reported). Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit; Time frame 8 hours; Was it administered: Yes; Previous temperature excursion: No; Was call because of a "data logger"?: Yes. No adverse events reported. No further information was reported. The action taken was not applicable and the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-APR-2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 injection (lot number: M043424, expiration date: 06-JUN-2018; exact dose and route of administration were not reported). No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB with lot number M027882 and expiration date on 14-APR-2019 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: S-009507513-1704USA009828:
Sex: M
Vaccine: HEP
Symptoms: Guillain-Barre syndrome, Hepatitis B virus test positive, Immunoglobulin therapy, Impaired work ability, Mobility decreased
Clinical narrative: This spontaneous report was received from the patient's uncle and a physician (who is also a patient's cousin) referring to a 49-year-old male patient. The patient did not have pertinent medical history, concomitant medications or drug reactions/allergies. The reporter explained that the patient who is a dentist was performing a root canal on an anonymous patient with a history of Hepatitis B, was poked with a needle used on the patient with a history of Hepatitis B. On 14-APR-2017, the patient went to a clinic and was vaccinated with RECOMBIVAX HB one injection of 1 ml, intramuscular (lot number M046373 and expiration date: 12-NOV-18) as a hepatitis B booster. On 15-APR-2017, the patient began to developed unspecified muscle pain and on 16-APR-2017, the muscle pain worsened. The patient though he was getting a cold. On 17-APR-2017, the patient was not able to finish his work because he was achy and slow in the muscles. On 18-APR-2017, the patient went to a pharmacy for unspecified over the counter cold medicine. While the patient was in the pharmacy, he collapsed (loss of consciousness). He subsequently drove to an emergency room; there, he was diagnosed with the Guillain-Barre syndrome and admitted to a hospital. His condition was worsening. On an unknown date, an unspecified hepatitis B test was performed and it showed a borderline hepatitis B. The patient was placed on a five-day treatment with intravenous immunoglobulin and unspecified pain killers. The patient walked into the emergency room by himself and at the time of the report, he was not able to move. The five-day treatment was done, and they physicians would treat the patient with either an unspecified plasma procedure or another five days round of intravenous immunoglobulin therapy. The physician confirmed the diagnosis of Guillain-Barre syndrome and reported that the patient was paralyzed, although the location of the paralysis was not confirmed. At the time of the report, the patient was still hospitalized and no further information was provided. The outcome of the event Guillain-Barre syndrome was not recovered and unknown for loss of consciousness. The causal relationship between the events and the vaccine was not reported. Upon internal review, the events Guillain-Barre syndrome and loss of consciousness were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Pain, Paralysis, Syncope, Viral upper respiratory tract infection
Clinical narrative: This spontaneous report was received from the patient's uncle and a physician (who is also a patient's cousin) referring to a 49-year-old male patient. The patient did not have pertinent medical history, concomitant medications or drug reactions/allergies. The reporter explained that the patient who is a dentist was performing a root canal on an anonymous patient with a history of Hepatitis B, was poked with a needle used on the patient with a history of Hepatitis B. On 14-APR-2017, the patient went to a clinic and was vaccinated with RECOMBIVAX HB one injection of 1 ml, intramuscular (lot number M046373 and expiration date: 12-NOV-18) as a hepatitis B booster. On 15-APR-2017, the patient began to developed unspecified muscle pain and on 16-APR-2017, the muscle pain worsened. The patient though he was getting a cold. On 17-APR-2017, the patient was not able to finish his work because he was achy and slow in the muscles. On 18-APR-2017, the patient went to a pharmacy for unspecified over the counter cold medicine. While the patient was in the pharmacy, he collapsed (loss of consciousness). He subsequently drove to an emergency room; there, he was diagnosed with the Guillain-Barre syndrome and admitted to a hospital. His condition was worsening. On an unknown date, an unspecified hepatitis B test was performed and it showed a borderline hepatitis B. The patient was placed on a five-day treatment with intravenous immunoglobulin and unspecified pain killers. The patient walked into the emergency room by himself and at the time of the report, he was not able to move. The five-day treatment was done, and they physicians would treat the patient with either an unspecified plasma procedure or another five days round of intravenous immunoglobulin therapy. The physician confirmed the diagnosis of Guillain-Barre syndrome and reported that the patient was paralyzed, although the location of the paralysis was not confirmed. At the time of the report, the patient was still hospitalized and no further information was provided. The outcome of the event Guillain-Barre syndrome was not recovered and unknown for loss of consciousness. The causal relationship between the events and the vaccine was not reported. Upon internal review, the events Guillain-Barre syndrome and loss of consciousness were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning a 30 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 26-APR-2017, the patient was vaccinated with PROQUAD (dose, route, lot number and expiration date were not reported) for prophylaxis, reconstituted with sterile diluent (dose, route, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Aphasia, Injected limb mobility decreased, Muscle rigidity, Musculoskeletal stiffness, Pain
Clinical narrative: Initial unsolicited report received from a Consumer (Patient's wife) on 18 April 2017. This case involves a 64-year-old (reported as 65 year) male patient who was vaccinated with a single dose of ADACEL (batch number: UI567AA, expiry date and route of administration not reported) in left deltoid on 07 December 2016. Patient had no ongoing illness, birth defects, medical conditions and concomitant medications were not reported. It was reported as pre-existing physician diagnosed allergies: NKA (No known allergy). On 07 December 2017, same day following the vaccination, the patient had experienced stopped talking, continues to have left arm pain with stiffness and rigidity and it hurts to use like arm has a rod down through it, it is ruining their lives as patient was so much discomfort. The patient required ER visit. No lab data was reported. The patient regularly with a yoga instructor and gets treatments 2 times a day. On an unspecified date the patient was recovered from stopped talking and not recovered from other events. List of documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a Consumer (Patient's wife) on 18 April 2017. This case involves a 64-year-old (reported as 65 year) male patient who was vaccinated with a single dose of ADACEL (batch number: UI567AA, expiry date and route of administration not reported) in left deltoid on 07 December 2016. Patient had no ongoing illness, birth defects, medical conditions and concomitant medications were not reported. It was reported as pre-existing physician diagnosed allergies: NKA (No known allergy). On 07 December 2017, same day following the vaccination, the patient had experienced stopped talking, continues to have left arm pain with stiffness and rigidity and it hurts to use like arm has a rod down through it, it is ruining their lives as patient was so much discomfort. The patient required ER visit. No lab data was reported. The patient regularly with a yoga instructor and gets treatments 2 times a day. On an unspecified date the patient was recovered from stopped talking and not recovered from other events. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 3 inch area of erythema and mild edema noted to right thigh.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, hot to touch, swelling, hurts to move arm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Diet refusal, Eye movement disorder, Feeling abnormal, Irritability, Pyrexia
Clinical narrative: Parents did not notify physician until todays appt. Family states several hours after inj. child developed low grade fever, very irritable refusing to nurse, spacing out, uncontrollable eye movement. Family states this lasted for about 2 wks.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized rash in a 19-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to BEXSERO. Additional details were provided as follows: This case was reported by medical assistant (MA). The age at vaccination was not reported. The patient developed rash all over after receiving dose of BEXSERO. No further information was available or reported regarding the event.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Hepatitis B vaccine given at 10 AM and 2 PM she felt itchiness, and reported to medical staff.