chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.2
Sex: F
Vaccine: FLU3, MMRV, VARCEL, FLUX, MMRV, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 14 month old patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, lot# and route were unknown), and a dose of PROQUAD (Merck) instead of M-M-R II, as prescribed at the office visit (Overdose, Drug prescribing error). No adverse effects were reported. Follow-up information has been received from a nurse. It was unknown if the patient had any allergies, birth defects, medical conditions or illness at the time of vaccination. It was reported that on 27-JAN-2015, female patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneously into the left leg, lot number J006358, expiration date 23-MAY-2015 and with the first dose of PROQUAD (Merck) subcutaneously into the right leg, lot number K005644, expiration date 17-OCT-2015. Concomitant therapies included: the second dose of Influenza virus vaccine (manufacturer Sanofi), intramuscularly into the left thigh, lot number was reported as 44983PH, administered on 27-JAN-2015 and the fourth dose of PREVNAR intramuscularly into the right thigh, lot number was reported as J16883 (date of administration was unknown). The patient did not seek medical attention. Additional information is not expected as no further information is available. Product information, event information and the narrative were updated.
Age: 1.2
Sex: F
Vaccine: FLU3, MMRV, VARCEL, FLUX, MMRV, PNC, VARCEL
Symptoms: Adverse event, Medication error
Clinical narrative: Information has been received from a nurse concerning a 14 month old patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, lot# and route were unknown), and a dose of PROQUAD (Merck) instead of M-M-R II, as prescribed at the office visit (Overdose, Drug prescribing error). No adverse effects were reported. Follow-up information has been received from a nurse. It was unknown if the patient had any allergies, birth defects, medical conditions or illness at the time of vaccination. It was reported that on 27-JAN-2015, female patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneously into the left leg, lot number J006358, expiration date 23-MAY-2015 and with the first dose of PROQUAD (Merck) subcutaneously into the right leg, lot number K005644, expiration date 17-OCT-2015. Concomitant therapies included: the second dose of Influenza virus vaccine (manufacturer Sanofi), intramuscularly into the left thigh, lot number was reported as 44983PH, administered on 27-JAN-2015 and the fourth dose of PREVNAR intramuscularly into the right thigh, lot number was reported as J16883 (date of administration was unknown). The patient did not seek medical attention. Additional information is not expected as no further information is available. Product information, event information and the narrative were updated.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, medical history or past drug history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot# were not reported). On an unknown date, 4 weeks later, the patient 'got the same strain in his eye'. It was unknown if any lab work was done. As of 09-APR-2015, it was unknown if the male patient would continue on the ZOSTAVAX and the outcome of 'got the same strain in his eye' was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. On 13-APR-2015, the patient who was not on dialysis, was inadvertently administered the dialysis formulation of RECOMBIVAX HB intramuscularly, dose and lot# were not reported. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a physician via field representative referring to a 13 year old female patient. On 07-APR-2015 the patient received her first therapy shot of GARDASIL (lot number and dose were unknown, intramuscular). On the same day in the doctor's office, after the administration of GARDASIL, the patient fainted and fell. She was not injured after the fall. No lab diagnostics studies were performed and no treatment was given for the events. The patient was recovered from the events on the same day. The causality between GARDASIL and the events was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 72 year old female patient. There was no patient's pertinent medical history or concurrent conditions. On 07-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). There was no concomitant medication. On an unknown date in April 2015, the patient experienced anaphylactic reaction such as difficulty breathing, numbness and pain in her arm where she got the injection. The patient sought medical attention, she saw the pharmacist. The patient did not receive treatment for the adverse events. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Dyspnoea, Injection site erythema, Injection site pain, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 72 year old female patient. There was no patient's pertinent medical history or concurrent conditions. On 07-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). There was no concomitant medication. On an unknown date in April 2015, the patient experienced anaphylactic reaction such as difficulty breathing, numbness and pain in her arm where she got the injection. The patient sought medical attention, she saw the pharmacist. The patient did not receive treatment for the adverse events. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients received improperly stored ROTATEQ (dose, frequency and lot# were not reported) orally. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning unspecified patients of unknown age and gender. On an unknown date, the patients were administered ZOSTAVAX (dose, frequency, route and lot number were not reported). On an unknown date, the patient experienced cellulitis of the entire upper arm (the arm in which they received ZOSTAVAX) along with a fever. The outcome of the events was not reported. Causality between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. 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 certified medical assistant refers to 5 patients of unknown age and gender who on unknown date were vaccinated with a dose of GARDASIL (dose, lot number and route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cough, Wheezing
Clinical narrative: At 1:20 PM Patient was coughing right after vaccines administration about 2-3 minutes after Albuterol 1.25 ml administered for mild wheezing.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 14 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL, intramuscular (lot number and expiration date were not provided). The patient received a second dose on 10-MAR-2015 and a third one on 10-APR-2015, both of GARDASIL, intramuscular (lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse effect. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Syncope immediately following injection. Pt. had pallor, was diaphoretic. BP remained stable. No significant medical Hx.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Found unresponsive.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified patients of unknown demographics. On an unknown date all the patients were administered with VARIVAX (Merck), that was reconstituted with frozen sterile diluent (Manufacturer unknown). The details of temperature excursion with the sterile diluent were unknown. Reporting pharmacist mentioned that he routinely stored sterile diluent in the freezer. No adverse symptoms were reported. Outcome of the event, incorrect product storage was unknown. Reporting pharmacist considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of injection site next day, redness and swelling the size of a quarter. Seen by physician.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia, Condition aggravated, Injection site haemorrhage, Psoriasis
Clinical narrative: 2/8/15: 4 in. band of ecchymosis around arm at injection site. 2/13/15: hair loss on arms/legs/back of neck/torso. Psoriasis hx on ankles, but new areas of exacerbation on toes, knuckles, elbows, knees.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. developed case of zoster within 12 hrs. of receiving ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age. Patient medical history and current condition was not reported. On an unspecified date since MARCH-2015 the patient administered VARIVAX (Merck) (Lot number and expiry date not provided) of unknown dose which underwent supported temperature excursions due to defrost cycling. No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Decreased appetite, Full blood count, Metabolic function test, Urine analysis
Clinical narrative: The day after the vaccine, she developed severe abdominal pain w/vomiting and loss of appetite. She was fine before.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: The day after the vaccine, she developed severe abdominal pain w/vomiting and loss of appetite. She was fine before.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 17 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL, intramuscular (lot number and expiration date were not provided). The patient received a second dose on 10-MAR-2015 and a third one on 10-APR-2015, both of GARDASIL, intramuscular (lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of two reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Chest X-ray, Chest pain, Differential white blood cell count, Dizziness
Clinical narrative: 4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Full blood count, Lethargy, Migraine, Muscle spasms
Clinical narrative: 4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Tremor
Clinical narrative: 4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood test, Chest X-ray, Chest discomfort, Dizziness
Clinical narrative: 4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Headache, Muscle spasms
Clinical narrative: 4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients. It was reported that improperly stored doses of ZOSTAVAX (lot # and expiration date were not provided), that were transported in dry ice, were administered subcutaneously to an unspecified number of patients in a one time dose of 0.65 ml. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Throat irritation
Clinical narrative: PATIENT DEVELOPED AN ITCHING SENSATION TO HER THROAT WHICH SHE THOUGHT WAS GOING TO GO AWAY, BUT IT IS CONTINUING TO LINGER.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematochezia, Vomiting
Clinical narrative: Bloody stools, vomiting.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no any pertinent medical history, concurrent conditions and no known drug reactions/allergies. On 06-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneously, lot # K018173 and expiry date in January 2016. Co-suspect therapies or concomitant medications were not provided. It was reported that on 09-APR-2015, the patient's wife contacted the pharmacist and stated that patient complained of swelling and pain at injection site. The pharmacist stated that no treatment was given to patient up to this point. The wife was considering contacting the physician. No laboratory diagnostic test was performed. At the time of the report, the patient had not recovered from adverse events. The relatedness between the vaccine and the events were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength and lot number were not reported). Co-suspect or concomitant therapies were not reported. On an unknown date, after receiving ZOSTAVAX the patient developed lesions and itching patches (rash) on unspecified location. At the time of the report, the outcome of rash was unknown. The causal relationship between the event and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: JEV1
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: The following information was received from a healthcare professional via distributor on 02 Apr 2015. A 27 year old female received IXIARO (batch number JEV13G42E) on 30 Mar 2015 i.m. On 02 Apr 2015 she had a positive pregnancy test. No adverse drug reaction reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: (L) for arm erythema, swelling (+) color.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood immunoglobulin M, Chest X-ray
Clinical narrative: Case number PHHY2015US044076 is an initial literature report received on 03 Apr 2015. The author presented the case of an elderly patient who experienced flu after seasonal influenza vaccination. This report refers to a 73 year old male patient. His current conditions included lymphoma and prostate cancer. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unspecified date he had fever, muscle aches, sore throat and fatigue for a day. He was brought the emergency department with a change in mental status and fall. It was reported that the flu vaccine was administered one month prior to his hospitalization. His body temperature was 99.5 degree Fahrenheit and rest of the physical examination was unremarkable. Laboratory data demonstrated a normal basic metabolic panel (BMP), mild elevation in white blood cell (WBC), elevation of liver enzymes (Aspartate aminotransferase (AST): 300 and Alanine aminotransferase (ALT): 100). His creatinine kinase (CK) was 3000 and continued to rise to as high as 12000 which were thought to be out of proportion to the duration of fall (30 minutes). Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive and polymerase chain reaction (PCR) was negative on an unknown date. His electroencephalogram (EEG) and chest radiograph were remarkable. He had aggressive intravenous fluids and was treated with azithromycin and TAMIFLU. His renal function stayed stable and patient improved remarkable within 3 days. His CK did trend down. The causality of the event was not reported. The author concluded the article stating that due to drifted influenza A (H3N2) viruses, CDC recommended influenza vaccine would protect against non-drifted circulating vaccine viruses and also it offers cross protection. The author also stated that prescribing neuraminidase inhibitor antiviral medications for treatment and chemoprophylaxis as an adjuvant to vaccination improved outcomes.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Electroencephalogram, Fall, Fatigue, Influenza, Influenza A virus test positive
Clinical narrative: Case number PHHY2015US044076 is an initial literature report received on 03 Apr 2015. The author presented the case of an elderly patient who experienced flu after seasonal influenza vaccination. This report refers to a 73 year old male patient. His current conditions included lymphoma and prostate cancer. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unspecified date he had fever, muscle aches, sore throat and fatigue for a day. He was brought the emergency department with a change in mental status and fall. It was reported that the flu vaccine was administered one month prior to his hospitalization. His body temperature was 99.5 degree Fahrenheit and rest of the physical examination was unremarkable. Laboratory data demonstrated a normal basic metabolic panel (BMP), mild elevation in white blood cell (WBC), elevation of liver enzymes (Aspartate aminotransferase (AST): 300 and Alanine aminotransferase (ALT): 100). His creatinine kinase (CK) was 3000 and continued to rise to as high as 12000 which were thought to be out of proportion to the duration of fall (30 minutes). Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive and polymerase chain reaction (PCR) was negative on an unknown date. His electroencephalogram (EEG) and chest radiograph were remarkable. He had aggressive intravenous fluids and was treated with azithromycin and TAMIFLU. His renal function stayed stable and patient improved remarkable within 3 days. His CK did trend down. The causality of the event was not reported. The author concluded the article stating that due to drifted influenza A (H3N2) viruses, CDC recommended influenza vaccine would protect against non-drifted circulating vaccine viruses and also it offers cross protection. The author also stated that prescribing neuraminidase inhibitor antiviral medications for treatment and chemoprophylaxis as an adjuvant to vaccination improved outcomes.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test normal, Mental status changes, Metabolic function test normal, Myalgia, Mycoplasma test positive
Clinical narrative: Case number PHHY2015US044076 is an initial literature report received on 03 Apr 2015. The author presented the case of an elderly patient who experienced flu after seasonal influenza vaccination. This report refers to a 73 year old male patient. His current conditions included lymphoma and prostate cancer. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unspecified date he had fever, muscle aches, sore throat and fatigue for a day. He was brought the emergency department with a change in mental status and fall. It was reported that the flu vaccine was administered one month prior to his hospitalization. His body temperature was 99.5 degree Fahrenheit and rest of the physical examination was unremarkable. Laboratory data demonstrated a normal basic metabolic panel (BMP), mild elevation in white blood cell (WBC), elevation of liver enzymes (Aspartate aminotransferase (AST): 300 and Alanine aminotransferase (ALT): 100). His creatinine kinase (CK) was 3000 and continued to rise to as high as 12000 which were thought to be out of proportion to the duration of fall (30 minutes). Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive and polymerase chain reaction (PCR) was negative on an unknown date. His electroencephalogram (EEG) and chest radiograph were remarkable. He had aggressive intravenous fluids and was treated with azithromycin and TAMIFLU. His renal function stayed stable and patient improved remarkable within 3 days. His CK did trend down. The causality of the event was not reported. The author concluded the article stating that due to drifted influenza A (H3N2) viruses, CDC recommended influenza vaccine would protect against non-drifted circulating vaccine viruses and also it offers cross protection. The author also stated that prescribing neuraminidase inhibitor antiviral medications for treatment and chemoprophylaxis as an adjuvant to vaccination improved outcomes.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Renal function test normal, White blood cell count increased
Clinical narrative: Case number PHHY2015US044076 is an initial literature report received on 03 Apr 2015. The author presented the case of an elderly patient who experienced flu after seasonal influenza vaccination. This report refers to a 73 year old male patient. His current conditions included lymphoma and prostate cancer. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unspecified date he had fever, muscle aches, sore throat and fatigue for a day. He was brought the emergency department with a change in mental status and fall. It was reported that the flu vaccine was administered one month prior to his hospitalization. His body temperature was 99.5 degree Fahrenheit and rest of the physical examination was unremarkable. Laboratory data demonstrated a normal basic metabolic panel (BMP), mild elevation in white blood cell (WBC), elevation of liver enzymes (Aspartate aminotransferase (AST): 300 and Alanine aminotransferase (ALT): 100). His creatinine kinase (CK) was 3000 and continued to rise to as high as 12000 which were thought to be out of proportion to the duration of fall (30 minutes). Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive and polymerase chain reaction (PCR) was negative on an unknown date. His electroencephalogram (EEG) and chest radiograph were remarkable. He had aggressive intravenous fluids and was treated with azithromycin and TAMIFLU. His renal function stayed stable and patient improved remarkable within 3 days. His CK did trend down. The causality of the event was not reported. The author concluded the article stating that due to drifted influenza A (H3N2) viruses, CDC recommended influenza vaccine would protect against non-drifted circulating vaccine viruses and also it offers cross protection. The author also stated that prescribing neuraminidase inhibitor antiviral medications for treatment and chemoprophylaxis as an adjuvant to vaccination improved outcomes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Tachypnoea, Urticaria, Wheezing
Clinical narrative: HIVES ON FACE, WHEEZING, COUGHING, TACHYPNEA.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient c/o arm swelling, warm, non tender 3-4 days after HPV #2.
Sex: U
Vaccine: HPV4
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. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of GARDASIL lot # K007264 and expiration date on 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: One week after Zostavax vaccine in Left arm pain up and down the arm, tightness. Also unable to raise arm above head.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Discomfort, Swelling
Clinical narrative: Extreme discomfort, not relieved through Tylenol, large swelling in the area that did not go away after 5 days.
Age: 16.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Within a few minutes of vaccine administration, client stated she felt like she might faint; pallor noted.  Client's mother stated both her daughters had "become anxious about receiving these shots" and mother stated she felt her daughter was "experiencing a vasovagal response."  (Mother is a nurse.)  Client was laid down on clinic cot with feet elevated.  BP taken - 84/48.  Cool cloth placed on her forehead.  After 10 minutes, the client states she felt better; color had returned to pink.  Client walked out of the health department and was driven home by her mother.  In a follow-up phone conversation with client's mother, mother stated her daughter was fine after she left the HD, that she had taken her to get something to eat and that she exhibited no further problems.  Mother thanked me for the call.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Patient received Rotarix mixed with Merck Diluent (for live vaccines) IM, instead of PO.  Currently no adverse reactions.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Neuralgia, Nuclear magnetic resonance imaging, Swelling, Tenderness
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm above (neuroforaminal stenosis).
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Neuralgia, Nuclear magnetic resonance imaging, Pain, Swelling
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm above (neuroforaminal stenosis).
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vertebral foraminal stenosis
Clinical narrative: Nerve pain throughout neck, shoulder, shoulder blade down into fingers and breast on left side with swelling throughout area, painful to touch, unable to raise arm above (neuroforaminal stenosis).
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age who was not pregnant. The patient had allergy to iodine. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported, 0.5 ml/unspecified frequency, intramuscular). Concomitant medications were not provided. On an unknown date the patient experienced an unspecified anaphylactic reaction after receiving PNEUMOVAX 23. The outcome of anaphylactic reaction was unknown. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. In the Fall of 2014 (approximately in September 2014), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# unknown). On an unknown date the patient developed a severe injection site reaction. The patient made an office visit, was evaluated by an unspecified physician and was prescribed unspecified corticosteroid medication. The outcome of injection site reaction was reported as recovered on an unknown date. Additional information is not expected as the reporter refused to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-JAN-2015, the patient was vaccinated with the first dose of VAQTA, (strength, dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter indicated that on 30-MAR-2015, the patient was inadvertently vaccinated with the second dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 in the arm (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. The physician informed that on an unknown date the patient experienced peripheral swelling, reported as swelling in the arm, the outcome of the peripheral swelling was unknown. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of VARIVAX (Merck) lot # K002915 and expiration date on 26-FEB-2016, (route was not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from healthcare professional, refers to a female patient onher20's. Medical history and concurrent conditions were not reported. The healthcare professional informed that on an unspecified date in April 2015 the patient was inadvertently vaccinated with ZOSTAVAX (strength, dosage, route lot# and expiration date were not reported), instead of the second dose of VARIVAX. No adverse effects were reported. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: PNC13
Symptoms: Rash maculo-papular
Clinical narrative: Macular papular rash - resolved after 10-15 min after BENADRYL.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Wide band redness/rash below injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood cholesterol increased, Ear pain, Herpes zoster, Pain, Pain of skin
Clinical narrative: Information has been received from a 70 year old female patient concerning herself with no pertinent medical history. The patient had drug reaction/allergies to SEPTRA/sulfer drugs. In roughly around 2008 or 2009, the patient was vaccinated with one dose of ZOSTAVAX (lot # was not reported). Concomitant therapies included ibuprofen and GABAPIN. The patient got shingles right after ZOSTAVAX administration. The patient explained the shingles lasted 3 months. In that time the patient was experiencing severe pain on her right side collarbone, the right side of her scalp real bad and her right ear. She reported she still had pain from time to time. The patient sought unspecified medical attention. Blood work was performed on unknown date, and it was found that the cholesterol was high. Anti-viral medicine was given for treatment of the adverse event. At the time of reporting, the outcomes of pain and cholesterol high were unknown. The relationship between shingles, pains and cholesterol high and ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Feeding disorder, Herpes zoster, Insomnia, Pain
Clinical narrative: Information has been received from a 70 year old female patient concerning herself with no pertinent medical history. The patient had drug reaction/allergies to SEPTRA/sulfer drugs. In roughly around 2008 or 2009, the patient was vaccinated with one dose of ZOSTAVAX (lot # was not reported). Concomitant therapies included ibuprofen and GABAPIN. The patient got shingles right after ZOSTAVAX administration. The patient explained the shingles lasted 3 months. In that time the patient was experiencing severe pain on her right side collarbone, the right side of her scalp real bad and her right ear. She reported she still had pain from time to time. The patient sought unspecified medical attention. Blood work was performed on unknown date, and it was found that the cholesterol was high. Anti-viral medicine was given for treatment of the adverse event. At the time of reporting, the outcomes of pain and cholesterol high were unknown. The relationship between shingles, pains and cholesterol high and ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Skin lesion, Weight decreased
Clinical narrative: Information has been received from a 70 year old female patient concerning herself with no pertinent medical history. The patient had drug reaction/allergies to SEPTRA/sulfer drugs. In roughly around 2008 or 2009, the patient was vaccinated with one dose of ZOSTAVAX (lot # was not reported). Concomitant therapies included ibuprofen and GABAPIN. The patient got shingles right after ZOSTAVAX administration. The patient explained the shingles lasted 3 months. In that time the patient was experiencing severe pain on her right side collarbone, the right side of her scalp real bad and her right ear. She reported she still had pain from time to time. The patient sought unspecified medical attention. Blood work was performed on unknown date, and it was found that the cholesterol was high. Anti-viral medicine was given for treatment of the adverse event. At the time of reporting, the outcomes of pain and cholesterol high were unknown. The relationship between shingles, pains and cholesterol high and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. On an unknown date the patient was vaccinated with the first and second dose of M-M-R II (dose, route, lot# were not reported). In April 1995, (unspecified date 20 years ago) the patient experienced severe thrombocytopenia after received the second dose. The patient sought medical attention by office visiting. The outcome of thrombocytopenia was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician referring to unspecified number of patients in their 30's and 40's. On an unknown date, these patients were vaccinated with a dose of PNEUMOVAX 23 (dose, lot#, route not reported). On an unknown date, these patients developed redness and tenderness at the site of injection. The physician stated that this happened "years ago". The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No current or historical conditions were reported. On 09-APR-2015, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot # K007981 and expiration date 03-JUN-2015). The vaccine of VARIVAX (Merck) was post temperature excursion, which excursion was supported. No adverse effects noted. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Next morning, pain at injection site with redness and swelling. Symptoms remitted over the course of 2-3 weeks, A hard knot remains at the injection site under the skin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given 4/8/15, 2-3 days later the right lateral leg became red, swollen around the site. Parents used topical antibiotic ointment. He was seen in office, advised to start oral BENADRYL and cool compress.
Age: 51.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Fatigue, Nausea, Pruritus, Rash
Clinical narrative: Pt started with rash, hives on R side of neck and general malaise, nausea.
Age: 51.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Malaise, Nausea, Rash, Urticaria
Clinical narrative: Pt started with rash, hives on R side of neck and general malaise, nausea.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist via a company representative referring to unspecified number of patients of unknown age and gender. On an unknown date these patients were vaccinated with PNEUMOVAX23 (dose, frequency and lot# were not reported). After vaccination, on an unknown date, the patients experienced injection site reactions which were pretty severe. The outcome of injection site reaction was unknown. The relationship between the event and PNEUMOVAX23 was not reported. It was unspecified whether these patients sought medical attention or not. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
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. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of ROTATEQ lot # K001198 exp. date 25-OCT-2015 and lot # reported as "K00645", exp. date "09-MAR-2016". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to 11 children patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications were not reported. On 19-MAR-2015 improperly stored PROQUAD (Merck) (dose, route of administration were not reported) was administered to these 11 children. Lot# and expiration date of PROQUAD (Merck) was reported as Lot# K02248 Exp 13-MAY-2016; Lot# K022445, Exp 13-MAY-2016, Lot# K022447, Exp 13-MAY-2016. The reporter did not specify which lot numbers of PROQUAD (Merck) were administered. No adverse events were reported. This is one of several cases reported by the same source. 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 nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were inadvertently vaccinted with GARDASIL (not GARDASIL 9) (unspecified dose and route) lot # K008931 expiry date 04-MAR-2017. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No furhter infromation provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that in an unknown date unknown number of patients were inadvertently vaccinated with M-M-R II (unspecified dose and route) lot # K005110 expiry date 04-APR-2016. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknonw. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were inadvertently vaccinated with VAQTA (unspecified dose and route) lot # J000366 expiry date 22-AUG-2015. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the sane reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were inadvertently vaccinated with PEDVAXHIB (unspecified dose and route) lot # J008427 expiry date 09-APR-2016. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.