chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 year old female patient with no pertinent medical history or drug reactions or allergies. The patient was not pregnant. On 22-JUL-2014, the patient was vaccinated with the first dose of GARDASIL intramuscularly (lot #, expiration date and dose were not reported). On 20-OCT-2014, the patient was vaccinated with the second dose of GARDASIL intramuscularly (lot #, expiration date and dose were not reported). The patient did not experience any symptoms after these doses were administered. On 11-JUN-2015, the patient was vaccinated with the third dose of GARDASIL lot # L007531, expiration date 04-NOV-2016, intramuscularly (dose was not reported). Concomitant therapy included VENTOLIN. On 11-JUN-2015, within 1 hour of receiving the third dose of GARDASIL, the patient experienced sudden onset of symptoms including headache, stomach pain, diarrhoea and vomiting. The patient's mother was advised by the physician assistant via phone call to offer rehydration and ensure rest for her daughter. No lab tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt received Tdap booster vaccine and 1 hr later developed severe itching (L) arm & low back, dorsal torso, but no rash. Urticaria pruritus. Loratadine 10 mg once, diphenhydramine 25 mg once.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated orally with doses of, oral, ROTATEQ (dose, frequency, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives on left arm and neck. Diphenhydramine 25 mg once.
Age: 73.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pt received two vaccinations on 4/2/13 including pneumococcal  (R deltoid) and Tdap (L deltoid). Two days later pt presented with rash and minor swelling of (R) arm. Denied SOB, or other systemic sxs of hypersensitivity. Tx plan included diphenhydramine 50mg QHS and cetirizine. Pt denied ED visit or prednisone taper.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dry mouth, Injection site pain, Injection site vesicles, Musculoskeletal pain
Clinical narrative: Received phone call from patient reporting c/o chest tightness, pain & blistering at injection site, shoulder pain and cotton mouth. She denied fever. Skin rash, rash & chest pressure. Acetaminophen/hydrocodone 1 tab TID, omeprazole 1 tab every day, prednisone 3 tab every day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Received phone call from patient reporting c/o chest tightness, pain & blistering at injection site, shoulder pain and cotton mouth. She denied fever. Skin rash, rash & chest pressure. Acetaminophen/hydrocodone 1 tab TID, omeprazole 1 tab every day, prednisone 3 tab every day.
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 number of patients of unknown age or gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient reported erythema and warmth at injection site one day receiving zoster vaccine. Was seen a few days later by MD to evaluate rash that was spreading. MD noted injection site erythema and warmth and suggested cool compresses on the area. Patient denied difficulty breathing, swallowing/chest pain, dizziness, change in vision, confusion, nausea/vomiting/diarrhea, and headache.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a registered nurse referring to a 23 year old female patient with no historical conditions or allergies. On 08-JUN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (0.5 ml, lot # K006139, expiration date 29-APR-2016, subcutaneous) for routine vaccination. There was no concomitant therapy. On 09-JUN-2015, the patient developed a "bulls eye area" at the injection site that was itchy, reddened and warm to the touch. The nurse stated that the bulls eye area was an one inch diameter ring around the injection site. The patient was in the office at the time of the call. There were no lad diagnostics studies performed. BENADRYL cream was given for the events as a treatment. The outcome of the events was reported as not recovered. Additional information is not expected since the reporter was not consent to be contacted.
Age: 1.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from 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 medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral (dose, lot number and expiration date were not reported). No adverse experiences reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Dizziness, Feeling hot, Hyperhidrosis, Retching
Clinical narrative: Patient first became dizzy, then did not have dizziness after 2 minutes. Patient then became dizzy again, felt like bubbles in throat, abdominal pain, got hot, started sweating, and started heaving.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: Patient first became dizzy, then did not have dizziness after 2 minutes. Patient then became dizzy again, felt like bubbles in throat, abdominal pain, got hot, started sweating, and started heaving.
Age: 0.13
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 13-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports 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 medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the 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 medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient were vaccinated with doses of VAQTA (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.24
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated for GARDASIL 9 (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 35 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). It was reported that the patient received dose 2 of VAQTA 2 months after receiving dose 1. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions/allergies was provided. On 16-JUN-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# not reported) which expired on 05-JUN-2015. No adverse effects were reported. Additional information has been requested.
Age: 1.14
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-JUN-2015, the patient was inadvertently vaccinated with one dose of improperly stored ZOSTAVAX (dose and route of administration were not reported; lot# L007222, expiry date 03-JUN-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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse experiences reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of PEDVAX HIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.64
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 7 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAX HIB lot #K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 14-JAN-2015, the patient was vaccinated with a dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports 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 medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiration date were not reported). No adverse experiences reported. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 23 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). It was reported that the patient received dose 2 of VAQTA 2 months after receiving dose 1. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.77
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever that lasted from evening on 06/17/15 until the morning on 6/19/15.  We let it run it's course on it's on without any fever reducers.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Rash
Clinical narrative: Dad states child had a rash one day after the HPV/Hep A  vaccines.  He is unsure where rash was or type of rash.  Rash lasted 2-3 days.  Does not have now.  Dad did not see the rash as he was not with child.  Patient took Benadryl for the rash and it went away.  Explained to father unknown if rash was from HPV/Hep A vaccine or something else.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mobility decreased
Clinical narrative: Limited arm movement.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Limited arm movement.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 15-JAN-2015, the patient was vaccinated with a dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received form a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastrointestinal necrosis, Intensive care, Ischaemia, Laparotomy, Necrosis ischaemic
Clinical narrative: Found unresponsive in crib on 6/28/15. 20 min of CPR in ER before rhythm obtained in emergency room. Admitted to PICU. Necrosis of bowel due to ischemia. In Silo after laparotomy. Prognosis currently poor.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: Found unresponsive in crib on 6/28/15. 20 min of CPR in ER before rhythm obtained in emergency room. Admitted to PICU. Necrosis of bowel due to ischemia. In Silo after laparotomy. Prognosis currently poor.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Chills, Headache, Injection site swelling
Clinical narrative: Sever headache, swollen arm around injection site, chills, chest pain.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: High fever
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 9 week old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Decreased appetite, Feeling cold, Laboratory test, Myalgia
Clinical narrative: This spontaneous report was receive from a physician via Pfizer (Manufacturer report number # 2015131602) refers to a 72 year (also reported as 65+) old male patient. The patient's concurrent condition included diabetes mellitus. No previous drug allergies were reported. On 19-FEB-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # K012424 expiry date: JUNE 2016) (dose 1, 0.5 ml in the left arm). It was also reported that the patient would not get second dose for 5 years. No concomitant medications were reported. On 20-MAR-2015, the patient experienced fever. On an unknown date, the patient experienced chills, rashes, decreased appetite, muscle aches and joint pain. Patient received unspecified treatment for the events. On an unknown date, the patient was subjected to unspecified diagnostic test, results were not reported. The event of fever was not recovered at the time of this report. The outcome of the other events were unknown. The reporter considered fever to be related to PNEUMOVAX 23 and the causality was not reported with respect to other events with PNEUMOVAX 23. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was receive from a physician via Pfizer (Manufacturer report number # 2015131602) refers to a 72 year (also reported as 65+) old male patient. The patient's concurrent condition included diabetes mellitus. No previous drug allergies were reported. On 19-FEB-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # K012424 expiry date: JUNE 2016) (dose 1, 0.5 ml in the left arm). It was also reported that the patient would not get second dose for 5 years. No concomitant medications were reported. On 20-MAR-2015, the patient experienced fever. On an unknown date, the patient experienced chills, rashes, decreased appetite, muscle aches and joint pain. Patient received unspecified treatment for the events. On an unknown date, the patient was subjected to unspecified diagnostic test, results were not reported. The event of fever was not recovered at the time of this report. The outcome of the other events were unknown. The reporter considered fever to be related to PNEUMOVAX 23 and the causality was not reported with respect to other events with PNEUMOVAX 23. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was receive from a physician via Pfizer (Manufacturer report number # 2015131602) refers to a 72 year (also reported as 65+) old male patient. The patient's concurrent condition included diabetes mellitus. No previous drug allergies were reported. On 19-FEB-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # K012424 expiry date: JUNE 2016) (dose 1, 0.5 ml in the left arm). It was also reported that the patient would not get second dose for 5 years. No concomitant medications were reported. On 20-MAR-2015, the patient experienced fever. On an unknown date, the patient experienced chills, rashes, decreased appetite, muscle aches and joint pain. Patient received unspecified treatment for the events. On an unknown date, the patient was subjected to unspecified diagnostic test, results were not reported. The event of fever was not recovered at the time of this report. The outcome of the other events were unknown. The reporter considered fever to be related to PNEUMOVAX 23 and the causality was not reported with respect to other events with PNEUMOVAX 23. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was receive from a physician via Pfizer (Manufacturer report number # 2015131602) refers to a 72 year (also reported as 65+) old male patient. The patient's concurrent condition included diabetes mellitus. No previous drug allergies were reported. On 19-FEB-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # K012424 expiry date: JUNE 2016) (dose 1, 0.5 ml in the left arm). It was also reported that the patient would not get second dose for 5 years. No concomitant medications were reported. On 20-MAR-2015, the patient experienced fever. On an unknown date, the patient experienced chills, rashes, decreased appetite, muscle aches and joint pain. Patient received unspecified treatment for the events. On an unknown date, the patient was subjected to unspecified diagnostic test, results were not reported. The event of fever was not recovered at the time of this report. The outcome of the other events were unknown. The reporter considered fever to be related to PNEUMOVAX 23 and the causality was not reported with respect to other events with PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The patient reported that she experienced redness, swelling, a hard lump, and warmth where the shot was given, after receiving ZOSTAVAX (on an unknown date). The outcome of vaccination site swelling, vaccination site warmth, injection site induration and injection site erythema was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of RECOMBIVAX HB, (lot #, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient had been administered unspecified doses of VAQTA, (lot #, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.11
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 week old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. 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 Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of ROTATEQ (lot number, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of GARDASIL 9, (lot number, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 8 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.61
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 19-DEC-2014, the patient was vaccinated with a dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 30-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 13-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Seen in office today noted to have (R) deltoid swelling red, warm to touch indurated, received KINRIX in (R) arm 6/29/2015 (L) deltoid 5x3 cm, red mild warm non tender received PROQUAD in (L).
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Malaise, Pallor, Syncope
Clinical narrative: Client felt dizzy, faint while sitting in chair 5 minutes after HPV GARDASIL vaccine. Became diaphoretic, pale and stated did not feel well. Took 20 minutes for client to reopen eyes and walked to car with help.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: Patient has rash on her arms, legs and previously on face. She uses lotion, which is not helping much. She also says her skin peels off when she showers. She first came and told me on 6/22.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Client given SQ injection of ZOSTAVAX on 6-19-15. Client reports to provider on 6-26-15 that injection site was extremely swollen, red, and had to touch for 4 days after injection. Denies rash or blister. On 6-26-15 client presents with slight yellow-tan bruise noted on Lt SQ site.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Joint stiffness, Muscular weakness, Pain
Clinical narrative: Since the vaccine my left arm is very weak, due to numbness, my joints is very stiff since 10/16/2014. The pain started after the vaccine was administered.
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 two patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot numbers and expiration date were not reported) 0.5 ml, intramuscular. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 20 year old female patient without pertinent medical history, drug reactions or allergies. On 27-AUG-2014, the patient was vaccinated with the first dose of GARDASIL 120 Y, lot # J015378, expiration date 09-APR-2016 (dose and route were not reported) and on 29-OCT-2014, the patient was vaccinated with the second dose of GARDASIL 120 Y, lot #J015378, expiration date 09-APR-2016 (dose and route were not reported. There was no concomitant therapies. The medical assistant reported that the patient became pregnant. On an unknown date in 2015, the patient performed a pregnancy test. No treatment was received for the event. It was reported that the patient sought medical attention by visiting the physician's office. The patient became pregnant with Last Menstrual Period (LMP) of 06-MAR-2015, estimated date of conception on approximately 20-MAR-2015 and Estimated Date of Delivery (EDD) of 11-DEC-2015. The pregnancy outcome was pending. The event did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional informaiton has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.12
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 12-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Pt. developed fever up to 101 on 06/26/15 then rash developed on arm at injection site on 06/27/15.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Electroencephalogram abnormal, Epilepsy, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging normal
Clinical narrative: As soon as I woke up I began having very strong petit mal seizures and absence seizures. Which should have been controlled by my prescribed medications. Days later I had Two Generalized Grand mal seizures. I was already diagnosed with epilepsy before the vaccination, but my seizures have not been this bad in years. I got an MRI on 06/28/2015 and it came out normal so there should be no reason for the increased amount of seizures. The treatment is increasing my daily zonisimide intake.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Petit mal epilepsy
Clinical narrative: As soon as I woke up I began having very strong petit mal seizures and absence seizures. Which should have been controlled by my prescribed medications. Days later I had Two Generalized Grand mal seizures. I was already diagnosed with epilepsy before the vaccination, but my seizures have not been this bad in years. I got an MRI on 06/28/2015 and it came out normal so there should be no reason for the increased amount of seizures. The treatment is increasing my daily zonisimide intake.
Age: 0.23
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 31-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 30-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Low grade fever 4 hours after injection. Inconsolable crying 5 hours after injection. Pt brought back into office. Symptoms had improved 6.5 hours after injection. Parents advised to recheck if other symptoms noted or if not better in the next 24-48 hours.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain upper, Abnormal behaviour, Allergy test negative, Crying, Decreased appetite
Clinical narrative: Was given Hib Rotavirus, DTP, Hep B. Immediately started hysterical crying as soon as the vaccine was given. Continued from 11:00 to almost 4:00 that day when he finally fell asleep- would not nurse and could not be consoled. Assured that this is normal. Fever of 104 that evening and continue for the next three days and then it decreased to 101 for about three weeks. He continued getting fevers 99-101 degrees several times a month lasting for several days for the next five months (August 2007). Had no appetite for those three days and would drift in and out of sleep. Eyes were glassed over and he was not interactive (Which was very unlike him). He had been sleep for 6 -7 hours at a time prior to the vaccine and started only sleeping 1/2 hour up to 2 hours at a time if I held him. Very fussy when awake. What appeared to be seizures began after the first week. He would be completely unresponsive, put his fisted hands next to his head and shake with a blank stare. He would also begin shaking while nursing off to sleep. These seizure like behaviors continued until late August 2007 (about 5 months after the vaccines were given. He had horrible stomach pain and diarrhea that continued until he was almost three years old (October 2009). Was given Zantac which aggravated the problem. Was also tested for allergies. None were found.