chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Abdominal pain, Nodule, Syncope
Clinical narrative: Syncope within 3-5 minutes of giving the  vaccines; slumped from the exam table to chair, briefly unaware what had happened. No difficulty breathing, no swelling of face; had normal BP, pulse and respiratory rates. No headaches, no dizziness and no seizure activity. After a brief interval of being unaware of what had happened, responded to name, asking what had happened. He complained of abdominal pain that felt like a knot. He had no nausea, vomiting, headaches or dizziness. Discharged home with Mom after 1 hr of observation.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Enterovirus test negative, Erythema, Erythema of eyelid, Fatigue
Clinical narrative: Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Herpes simplex serology negative, Herpes zoster, Hypophagia, Lymphadenopathy
Clinical narrative: Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Meningitis, Ophthalmological examination normal, Otitis media, Papule, Periorbital oedema
Clinical narrative: Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pleocytosis, Polymerase chain reaction positive, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Swelling face, Varicella virus test positive, White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article as stated above. A two-year- old boy presented with a three-day history of fever and headache and a one-day history of periorbital edema, erythema, and a progressive vesicular rash on the right face. His pediatrician initially diagnosed bilateral otitis media and prescribed amoxicillin/clavulanic acid for 10 days. The next day, he developed a vesicular, pinkish-red rash with swelling over the right eye and forehead, accompanied by fatigue, decreased oral intake, and intermittent abdominal pain. He was admitted for presumed meningitis and herpes zoster infection. There was no clinical suspicion for immunodeficiency. While there was no known previous exposure to chickenpox, the boy had received a single dose of varicella vaccine (manufacturer unknown) at 12 months of age. Physical exam revealed scattered pinkish-red vesicles and papules on the right forehead, glabella, and superior eyelid. The lesions respected the midline, extending to the nasal bridge and right frontoparietal scalp in a V1 distribution. The right superior eyelid had near-confluent erythema and edema with sharp demarcation at the right lateral canthus; subsequent ophthalmological examination revealed an otherwise normal eye. Right anterior cervical lymphadenopathy was present. Labs revealed an elevated serum white blood cell count with increased polymorphonuclear leukocytes, pleocytosis, and positive varicella polymerase chain reaction (PCR) on cerebrospinal fluid (CSF) analysis; and positive varicella PCR directly from a skin scraping. Herpes simplex virus and enterovirus CR of CSF were both negative. The patient was treated with intravenous acyclovir (60mg/kg/day) for 10 days with total clearance of his skin lesions and symptoms. Herpes zoster is a rare diagnosis in children with a reported decreasing incidence since the advent of the varicella vaccine. Upon internal review the event Meningitis was determined to be medically significant. Additional information has been requested
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a healthcare worker referring to a 50 year old male patient wiht uncontrolled diabetes. The patient had no drug reactions/allergies. On 21-MAY-2015 the patient was vaccinated with PNEUMOVAX23 lot# K020215, expiration date 15-MAY-2016 (dose and route were not reported). Concomitant therapies included LANTUS, atorvastatin, metformin, amlodipine, losartan potassium(manufacturer unknown) and glipizide. On 22-MAY-2015, the patient began to experience pain at the injection site and immobility of the injection arm. The patient placed a call to the office to notify and was prescribed tramadol for treatment. No lab diagnostics studies were performed. The outcome of the events was not reported. This is one of two cases received from the ssame reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh is swollen, red, and has heat in it approximately 6 in x 6 in diameter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Neuralgia, Pain, Rash
Clinical narrative: Rash from left butt down leg down to behind knee/enclosed treatments since 11-18-14-until present time and continuing nerve treatments deep nerves by neurology-MRI to be given then diagnosis. Enclosed all treatment pain clinic ER-now neurology. History of no chicken pox. Four times at age 70 to get shingle shot. Turned down. At age 77 yearly physical-doctor said I have shingle shot set up. I said no-doctor stated if I get shingles at my age-it would be bad. Took shot-January, 2014. November 18th 2014-got shingles. Doctor diagnosed-took picture stated-"Worse post shot shingles ever saw". The rash left completely January 9th 2015. Now-and onset 11/18/14-pain-a lot of pain continues to date-loss of sleep. Now-taking some toll on other ongoing active problems. Dec. 2014 take gabapentin 300 mg 3x daily. Take morphine 20mg 2x daily 1-AM/1-PM. Taken off-dose nothing for pain December 2014. Put compress 3x daily with Aloe Vera w/oats for two weeks-stop-rash is leaving. Put on tramadol-LYRICA, ointment Lidocaine 5% change to ointment-Lidocaine 2.5% prilocaine 2.5%. Ointments did not help with pain. Was to block nerve pain. Change tramadol-LYRICA-nortriptyline adverse effect when put on methadone 5mg 2x daily-does not relieve pain-stop. Given 4 injection by Dr. Jan. 12, 15. Given 3 injection by Dr. May 20, 15. Given infusion by Dr. (3x in ER Depts). Once given VALIUM shots helped for short period. Now neurology-nerve pain deep in leg nerves.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Poor quality sleep
Clinical narrative: Swelling of upper (R) lip 6/11 pm, 6/12 am poor sleep 6/11 pm.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lip swelling
Clinical narrative: Swelling of upper (R) lip 6/11 pm, 6/12 am poor sleep 6/11 pm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Pt has abt 2" size rash on injection site. On 6/11 and 6/12 (left arm).
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Nodule
Clinical narrative: (L) arm-red knot.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Rash, Skin warm
Clinical narrative: Rash (8cm x 10cm), soreness. Redness. Hot to touch.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein increased, Cellulitis, Chills, Full blood count normal, Injection site erythema
Clinical narrative: Pt received TDAP on 03/04/2015. On 03/04/2015 in the evening pt developed chills, nausea & myalgias. On 03/05/2015 pt developed vomiting. 03/06/2015 N/V resolved and pt noted increased pain and redness & swelling at inj site. Pt seen in F/U 3/6/15 and tx'd for cellulitis.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Myalgia, Nausea, Vomiting
Clinical narrative: Pt received TDAP on 03/04/2015. On 03/04/2015 in the evening pt developed chills, nausea & myalgias. On 03/05/2015 pt developed vomiting. 03/06/2015 N/V resolved and pt noted increased pain and redness & swelling at inj site. Pt seen in F/U 3/6/15 and tx'd for cellulitis.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Phone triage: arm red, swollen, warm recommended TYLENOL, cortisone cream.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Assessed 6/11/15 and noted left upper arm red, inflamed, tender, warm, itching since 6/9 evening per patient.
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Injection site pain, Nausea, Pharyngeal oedema
Clinical narrative: Fever, pain at injection site, nausea, dizziness, throat swelling and shortness of breath. Onset 4 hours after vaccination. Fully subsided within 48 hours.
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever, pain at injection site, nausea, dizziness, throat swelling and shortness of breath. Onset 4 hours after vaccination. Fully subsided within 48 hours.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Vaccination site rash
Clinical narrative: Round rash on the vaccine site received GARDASIL 2 days ago.
Age: 1.81
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Meningitis viral
Clinical narrative: Developed ?viral meningitis 4 days after 6 mo old check up and vaccines. Admit to hospital and suspect condition may link to DTaP vaccine per hospitalist.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Area of injection red and itchey.
Age: 3.0
Sex: M
Vaccine: HEP, HEPA, PNC13
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Morbiliform rash all over the body with no fever no itching 2 days after HAV; HBV; One pneumococcal.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Minor rash at injection site, no cellulitis at visit time. BENADRYL and cold compresses.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received doses of ROTATEQ lot # K010224, expiration date: 13-MAY-2016; lot # K011947, expiration date: 07-JUN-2016, lot # K009752, expiration date: 15-APR-2016 and lot # K020193, expiration date: 02-JUN-2015 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Lot numbers K009752 and K020183 have been verified to be valid lot numbers for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medications were not reported. On 05-JUN-2015, the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (dose and route were not reported, lot# reported as K000326, expiration date 27-FEB-2015). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis in arm patient received vaccine. Treated KEFLEX 500mg every 6 hours for 7 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored GARDASIL lot numbers K005083 Expiry date 04-NOV-2016, K008931 Expiry date 04-MAR-2017 and K023432 Expiry date 18-JUN-2016 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Spreading cellulitis, seen 4 days post vaccine, being treated with KEFLEX 500mg 1 capsule every 6 hours for 7 days.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous's report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored of ROTATEQ oral, lot number K005397 expiry date 29-FEB-2016, and lot number reported as L004453 Expiry date 27-MAY-2016 (dose was not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to three patient of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral suspension, lot # K016314, expiration date: 05-JUN-2016 (dose was not reported). Concomitant medication was not reported. No adverse effects reported. 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 Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored of RECOMBIVAX HB lot numbers reported as K007263 Expiry date 09-JUN-2016 and K018180 Expiry date 17-SEP-2016 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 29-MAY-2014, the patient was inadvertently vaccinate4d with an improperly stored dose of GARDASIL lot # K009482 expiry date: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 28-MAY-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K009482 expiry date: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This 4 year 5 month old female presentes for possible izzy reaction. Mother states that the pt has never previously had reactions to her immunizations. She says a red, hard bump developed on the pt's thigh over where she had her immunizations given on Wedneday that doubles in size overnight. Mother has not documented any fevers.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunology test, Pruritus generalised
Clinical narrative: This spontaneous report was received from a physician referring to a 69 year old male patient, with Diabetes Mellitus and Dyslipidemia as concurrent conditions. On 02-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as 1653AA, expiration date: 21-JAN-2013) (dose, frequency and route of administration were not reported). Concomitant therapies were not reported. On an unknown date in approximately 2012 (reported as "within weeks after receiving ZOSTAVAX"), the patient experienced chronic itch all over the body (pruritus generalized). It was stated that on an unknown date, the patient went to see the physician and was given gabapentin, hydroxyzine (manufacturer unknown), ZYRTEC and BENADRYL (doses, frequencies and routes of administration were unknown for this medications), to treat the pruritus generalized. The patient was not hospitalized. It was stated that the patient did not die nor had a significant disability or incapacity nor life threatening. At the time of the report, the outcome of pruritus generalized was reported as not recovered, and the relatedness of ZOSTAVAX with pruritus generalized was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 year old male patient with chronic obstructive pulmonary disease and diabetes mellitus. The patient was first time vaccinated with a pneumococcal vaccine (manufacturer unknown) on 30-SEP-2008. Then on 21-MAY-2015, the patient was re-vaccinated with an expired dose of PNEUMOVAX23 lot # J011045 and expiration date on 15-MAY-2015 (route and dose were not provided). The patient received the second dose of pneumococcal vaccine because of her history of obstructive pulmonary disease and diabetes mellitus. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a health care worker who was also the patient, a female patient of unknown age. The patient thought she was vaccinated in 2001 with M-M-R II lot # reported as "merck 0195K" and expiration date on 03-FEB-2002. On an unknown date, the patient had her titers drawn and the results showed she was negative for rubeola . At the time of the report, the outcome of rubella antibody negative was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL (lot # K006191 expiry date: 02-FEB-2017) (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to an unspecified number of patients of unknown demographics. Pertinent medical history and drug reactions/allergies were not reported. Reporting nurse stated that these patients may have been administered with improperly stored doses of either GARDASIL or ROTATEQ or improperly stored doses of both on unspecified dates. No adverse effects were report4ed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 09-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL (lot # K006191) expiry date: 02-FEB-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Interchange of vaccine products, Product use issue
Clinical narrative: This spontaneous report as received from a healthcare professional as part of a marketing research program conducted by HRA, title PENUMOVAX23, and refers to an unspecified number of patients of unknown gender and unspecified age. The patient's medical history and concurrent conditions were not reported. The reporter stated that in the last 3 months she/he had heard or seen to give PREVNAR 13 she/he to adults of 50 age and older (inappropriate schedule of vaccine administered) and if above age 65, gave PREVNAR 13 (dose, lot #. expiration date and route were not reported) first and then PNEUMOVAX23 8 weeks later (dose, route, lot # and expiration date were not reported). (interchange of vaccine products). Also the reported had heard the new Advisory committee on immunization practices (ACIP) recommendation of give to all adults greater than 65 years old, PNEUMOVAX23 naive at age 65 year give PREVNAR 13 first, then PNEUMOVAX23 8 weeks later. At the time of the report, the outcome of the patients was unknown. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician concerning a child patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 02-JUN-2015 (reported as today), the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # K016314, exp. date on 05-JUN-2016), (strength not provided), 2 ml, oral. There was no concomitant medication reported. No adverse effects were reported. Additional information is not expected, because the physician did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K009482 expiry date: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Vaccination site erythema, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient with allergy to CIPRO, DILANTIN and eggs. On 13-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 inj (lot # K023328 and expiration date 23-JUN-2016) 0.5 ml, intramuscular in the left arm. On 13-MAY-2015, a few hours after administration of pneumococcal vaccine, the patient experienced vaccination site erythema, vaccination site warmth and injection site pain. On 14-MAY-2015, the patient was found to have redness extending from the left shoulder to the left elbow. Patient sought medical attention, went to pharmacy. The pharmacist suggested the patient apply cold compresses to the area of reaction. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 year old female patient who was reporting on herself. No information regarding the patient's medical history was provided. The patient's concurrent conditions included high cholesterol. No drug reactions or allergies were reported. On an unknown date, about 5-6 years ago, the patient was vaccinated with a dose of ZOSTAVAX, injection, dose: 0.65 ml, (route, injection site, lot number and expiration date were not reported). Concomitant therapies included simvastatin (manufacturer unknown). The patient stated that 6 months after vaccination, she had developed shingles. According to the reporting female patient, the first time she developed shingles it was on her chest under her breast and she described it as being severe. Ever since then she had consistently had smaller outbreaks on different parts of her body. It was also reported that at the time of this report, the patient had a severe outbreak on her hands and face. The patient sought medical attention via office visit. No laboratory diagnostic tests were performed. The patient was given unspecified antiviral medications and unspecified cream for treatment of the event. The outcome of the event of shingles was reported as not recovered at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. No PQC involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a company representative refers to 13 year old patient who is one of his child. On an unknown date, the patient was vaccinated with 1 dose of GARDASIL (lot number, dose and route were not reported) prior to receiving GARDASIL 9 0.5 ml dose, intramuscularly on Monday evening 11-MAY-2015 as the second dose of his HPV vaccination series (lot number not reported). On 13-MAY-2015 (reported as Wednesday), the patient experienced injection site erythema, and injection site warmth and injection site swollen. The patient was not treated for the events. Patient did not sought medical attention. The outcome of events was not reported (also reported that the patient was fine at the time of report). The reporter did not provide the causality between the event and the suspect therapy. No product quality complaint (PQC) was filed. No additional information was provided. This is one of the two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Chemotherapy, Measles antibody negative, Mumps antibody test negative, Transfusion
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a male patient of currently 27 year old with acute myeloid leukaemia, aseptic necrosis of the bone, osteoarthritis of pelvic region and thigh, clindamycin and sulfa allergy and a history of bone marrow transplant. On 27-APR-1988, the patient was vaccinated with the first dose of M-M-R II (dose and route not reported). On an unspecified date, the patient had antineoplastic chemotherapy (unspecified), a bone marrow transplant and a blood transfusion for possibly one of his following diagnoses: acute myeloid leukemia, aseptic necrosis of the bone, osteoarthritis of pelvic region and thigh, and bone marrow transplant. On 11-MAR-2002, the patient was then administered a second dose of M-M-R II (dose and route were not reported). On an unspecified date, after the second dose of M-M-R II, the patient had negative titers for measles and mumps. The patient was currently in remission for the diagnoses listed above. No treatment was given for the events. The patient sought medical attention as he contacted the office to be revaccinated with M-M-R II. No PQC was involved. The outcome of the events was not reported. The relationship of the events with of M-M-R II (dose and route were not reported) was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K006191 expiry date: 02-FEB-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: 10-22-14 Flu shot administered. 10-24-14 Currently left shoulder/arm pain. 12-16-14- PCP left shoulder/pain-made referral. 12-31-14- Orthopedist rotator cuff/bursitis tendonitis. 03-31-15 Steroid shot, referral for physical therapy present physical therapy 04/28/15 left shoulder cortisone injection.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome
Clinical narrative: 10-22-14 Flu shot administered. 10-24-14 Currently left shoulder/arm pain. 12-16-14- PCP left shoulder/pain-made referral. 12-31-14- Orthopedist rotator cuff/bursitis tendonitis. 03-31-15 Steroid shot, referral for physical therapy present physical therapy 04/28/15 left shoulder cortisone injection.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: 10-22-14 Flu shot administered. 10-24-14 Currently left shoulder/arm pain. 12-16-14- PCP left shoulder/pain-made referral. 12-31-14- Orthopedist rotator cuff/bursitis tendonitis. 03-31-15 Steroid shot, referral for physical therapy present physical therapy 04/28/15 left shoulder cortisone injection.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately 67 year old patient of unknown gender. Concurrent and medical history were not reported. Pharmacist reported that in 2013, the patient with no increased risk for PNEUMOVAX 23, at the age of 65 years (Lot number, expiration date, dose and site of vaccination were unknown), then, in December 2014 was administered a dose of PREVNAR 13 and finally on 0-JUN-2015, the patient was revaccinated with a second dose of PNEUMOVAX 23 (Lot number, expiration date and site of vaccination are unknown). There was no adverse events reported. Additional information has been requested.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Constipation, Immediate post-injection reaction
Clinical narrative: Patient became immediately constipated, and has been constipated since. She had a bowel movement every feeding since she is exclusively breast fed, and right after the vaccine her bowel movements stopped.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: RAISED ITCHY WELTS ON LEFT THIGH AND BUTTOCKS EVENING AFTER INJECTION. TREATED WITH 50 MG PO BENADRYL. WELTS RESOLVED BY AFTERNOON OF 2ND DAY POST APPEARANCE.
Age: 25.0
Sex: M
Vaccine: 6VAX-F
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Erythematous rash, fever, injection site reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture negative, Debridement
Clinical narrative: Blisters appeared on old Ceasarean scar. Looked like a bad burn across a 3/4 wide by 4 inch long area. Applied triple antibiotic cream and bandage until 04/12/2015. Then went to urgent care who gave antibiotic and antibiotic cream. The on 04/27/2015 I went to Dr. who sent me to a wound center for treatment. Treated as a 3rd degree burn for 4 weekly visits by scraping dead tissue and applying "Santyl" collagenase Ointment and applying daily with new bandages. Until May 26th when the wound finally closed .
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Erythema, Pain
Clinical narrative: Local erythema and pain. Treated with topical cortisone.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site inflammation, Injection site irritation
Clinical narrative: Local erythema and pain. Treated with topical cortisone.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Injection site swelling, Rash pustular
Clinical narrative: Local erythema and pain. Treated with topical cortisone.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, CSF white blood cell count increased, Culture urine, Pleocytosis, Pyrexia
Clinical narrative: Fever and staring spell. Blood, urine, and CSF cultures were obtained with pleocytosis in CSF. Subsequently hospitalized for rule-out sepsis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Staring
Clinical narrative: Fever and staring spell. Blood, urine, and CSF cultures were obtained with pleocytosis in CSF. Subsequently hospitalized for rule-out sepsis.
Age: 60.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: Severe pain in R arm at the site of Prevnar-13 administration started in evening of 6/12, patient unable to sleep due to pain. No swelling, redness, fever or discharge.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: A few hours after receiving the Pneumovax23 vaccine, pt states she started feeling pain and numbness in the immunized arm. These sensations were to the point that she could not lift her arm or use that arm in any capacity. Two days after she received the vaccine, the patient reported being able to feel her hand and forearm again and having the ability to lift a glass of water. She still reported pain in the immunized arm and took Tylenol with codeine, which she had from an injury previous to this incident. Three days after receiving the vaccine, pt states that now she feels her arm is swollen, whereas she did not before. She states that she has regained a little more feeling up her arm, but still is in pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: Patient called complaining of lightheadedness and dizziness. She said she felt "funny" and was having trouble walking. Took two diphenhydramine 25 mg tabs and went to sleep. At 9am the following day she was feeling "a lot better".
Age: 53.0
Sex: F
Vaccine: DT
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: Headaches then the following day stomach upset most of the day re occuring headaches morning and night despite taking aspirin.  Pretty nauseated for most of the day.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Rash
Clinical narrative: Patient came in c/o rash to left deltoid. Pt states she had a pneumonia shot on 6/4/15 and now has a knot that keeps getting bigger.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site where vaccine given became red/swollen-about the size of a baseball. Pt states itchy, too.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: 3 days of arm tingling, weakness b/l rt more than left, also rt leg weakness, but pt got PCV13 on left shoulder. Symptoms started 5 hours after vaccination. No fever. Symptoms improved 90% today.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Choking, Erythema, Headache, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching - left pharmacy and on way home felt headache, chokey feeling throat - took Benadryl med, took nap & all was better when I woke up. To date I still have swelling, redness & itching and need Benadryl to relieve the itching in particular - site is bigger than originally noticed.  I originally felt that these were mild symptoms but because it has been  4 days and they haven't gone away, I felt I should report them.  The area on my arm that has been effected is about the size of a teacup saucer.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Nerve injury, Peripheral swelling
Clinical narrative: Arm became swollen from the deltoid down into the wrist. Patient presented to the same-day clinic and the provider suggested the needle from the vaccine hit a nerve causing the swelling. The provider recommended taking Benadryl OTC three times a day for the swelling as well as ice and rest.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Injection site pain, Middle insomnia, Musculoskeletal pain
Clinical narrative: Severe pain at injection site  (upper left arm) that has persisted to dat  (6/14/15). Pain can be dealt with by taking NSAIDS but becomes severe enough to wake me up at night. I can no longer do "easy" things such as picking up items with my left (dominant) hand, and interferes with putting on/removing clothing items. The pain persists/ is strongest around the injection site, but can spread as far as wrist and up into the shoulder.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Hypoaesthesia, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Stuffy Nose, headache, Fever, Soreness and Swelling at injection site, limitation of arm movement, muscle pain and tingling/numbness.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Nasal congestion, Paraesthesia, Pyrexia
Clinical narrative: Stuffy Nose, headache, Fever, Soreness and Swelling at injection site, limitation of arm movement, muscle pain and tingling/numbness.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site warmth, Pain, Skin warm
Clinical narrative: Onset of redness, pain, and hot to the touch the day after administration.  The patient presented on 06/14/2015 with continued redness, pain, and elevated skin temperature.  The injection site was hot to the touch.  I advised her to take 50mg diphenhydramine, Tylenol or Motrin, and apply ice. She will call physician on 06/15/2015.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Heart rate abnormal, Myocardial infarction, Vaccination error
Clinical narrative: Heart attack cause of medicine was given to me wrongly.
Age: 78.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Local injection site rash, pruritis, blanchable erythema, warmth  treated with topical hydrocortisone cream and Benadryl po x1.
Age: 78.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Rash, Vaccination site rash, Vaccination site warmth
Clinical narrative: Local injection site rash, pruritis, blanchable erythema, warmth  treated with topical hydrocortisone cream and Benadryl po x1.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Headache, Injection site nodule, Injection site warmth, Pain
Clinical narrative: Arm began to hurt Thursday, 5 pm. Then, got fever and body aches. All night Thursday and through Friday had headache. Missed work Friday. Still have sore arm Sunday. It has a knot at injection site and is not to touch.