chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old male patient. On 02-JUL-2015 the patient was vaccinated with first dose of VARIVAX (Merck) (dose, strength, route unspecified). No concomitant therapy was reported. On 03-JUL-2015, the patient experienced hives treated with BENADRYL. The outcome of hives was reported as recovering/resolving. The patient sought medical attention. No product quality complaint was involved. The causality was not provided by the reporter. Additional information has been requested,
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. In approximately July 2014, "about a year ago", the patient was vaccinated with a dose of GARDASIL (injection, lot#, dose, route were unspecified). No concomitant therapy was provided. On an unknown date after receiving the GARDASIL, the patient developed a "large swollen red area" at the injection site that was "warm to the touch". The physician stated that the patient recovered "within a week or two". The physician declined to provide any further information as he stated that this was already reported via the VAERS system. Additional information has been requested.
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 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K004541, expiration date: 04-DEC-2016 (dose, strength and route of administration 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: 0.33
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 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 exucrsion (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: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: 3 in by 7in rash on (L) arm. Warm, raised & red. Not itchy.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination, Periarthritis
Clinical narrative: Frozen shoulder Adhesive Capsulitis.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates in approximately June 2015 (reported as since 06/11/2015), the patients were vaccinated with a doses of PROQUAD (Merck) subcutaneous injection (strength, dose, lot# and expiration date were not reported) which were improperly stored. No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. 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 medical assistant refers to an unspecified number of patients. On an unknown date, unspecified patients received doses of improperly stored M-M-R II (dose, lot#, expiration date, therapy type, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.13
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 02-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 (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 registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with GARDASIL (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Erythema, Malaise, Pruritus, Swelling
Clinical narrative: Redness, severe swelling, temperature, itching, malaise.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash, Rash vesicular, Scab
Clinical narrative: Large area of erythema near the site of injection appeared with multiple vesicular lesions.  2 days later the lesions have crusted and scabbed over, however a more dissemineted rash began to appear covering my son's back, face, and chest.
Age: 0.22
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 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K004541, expiration date: 04-DEC-2016, (dose, strength and route of administration 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: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash erythematous, Skin lesion
Clinical narrative: Large erythematous, raised rash near the site of injection. 2 days later, rash appeared on her face and several lone red lesions spread on the legs.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 41-year-old male patient. The patient has a medical history of arteritis, treated with REMICADE infusions, and diabetes. The patient was allergic to AVELOX, LEVAQUIN, and amoxicillin(reactions unspecified). On 17-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K021881, expiration date 30-JUL-2016 intramuscular in the left deltoid (dose was not reported). On an unspecified date approximately in June 2015, the patient developed erythema, pain and a rash at the injection site of the left deltoid area. The patient initially called the office and was suggested to take TYLENOL. The patient was subsequently evaluated at a unspecified emergency room on 20-JUN-2015 due to fever of 103F, vomiting, and chills. The patient was treated in the emergency room with intravenous ANCEF and was sent home with a prescription for a 10 day course of oral KEFLEX. The outcome of injection site erythema, chills, vomiting, pyrexia, injection site rash and injection site pain was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested. This is one of several reports received from the same patient.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 41-year-old male patient. The patient has a medical history of arteritis, treated with REMICADE infusions, and diabetes. The patient was allergic to AVELOX, LEVAQUIN, and amoxicillin(reactions unspecified). On 17-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K021881, expiration date 30-JUL-2016 intramuscular in the left deltoid (dose was not reported). On an unspecified date approximately in June 2015, the patient developed erythema, pain and a rash at the injection site of the left deltoid area. The patient initially called the office and was suggested to take TYLENOL. The patient was subsequently evaluated at a unspecified emergency room on 20-JUN-2015 due to fever of 103F, vomiting, and chills. The patient was treated in the emergency room with intravenous ANCEF and was sent home with a prescription for a 10 day course of oral KEFLEX. The outcome of injection site erythema, chills, vomiting, pyrexia, injection site rash and injection site pain was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested. This is one of several reports received from the same patient.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that patient received first dose in the series of with GARDASIL (dose strength, route unspecified) approximately on an unknown date in 2014 (reported as a year ago). The patient's second dose was administered on 23-JUN-2015 (inappropriate schedule of drug administration). No adverse effects reported. The outcome of the events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 0.15
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 14-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: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. No medical history and concurrent conditions were reported. On an unknown date the patient was vaccinated with PROQUAD (Merck) (Lot number and expiry date unknown) (dosing regimen and frequency unknown) and VARIVAX (Merck) (Lot number and expiry date unknown) (dosing regimen and frequency unknown) instead of VARIVAX (Merck) and the prescribed dose of M-M-R II. No concomitant medications were reported. No adverse effect was reported. The action taken with the therapy with PROQUAD (Merck) and VARIVAX (Merck) was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a currently 62 year old female patient (health care professional) concerning herself via a company representative. In approximately December 2013 (reported as one and a half year ago), the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot # unspecified). On an unknown date the patient experienced injection site erythema and injection site mass. It was reported that the patient developed a four inch, round, red, raised area around the injection site. Patient did not seek medical attention. No treatment was given. The red raised area around the injection site disappeared (reported as resolved) in 2 weeks on an unspecified date. Causality assessment was not reported. Additional information has been requested.
Age: 0.82
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician via Poison and Drug Center (#15-029719) referring to a 9 month old female patient. The patient was "healthy and happy" and her relevant past drug history was unknown. On an unknown date the patient was vaccinated with ROTATEQ ("standard dose", oral; lot# and expiration date not reported). The patient had no concomitant medications. On 24-JUN-2015 the patient was inadvertently vaccinated her third dose of ROTATEQ (lot# K022992, expiration date 30-JUN-2016, dose not reported, oral) at 9 month of age (inappropriate schedule of drug administration). No relevant laboratory tests were performed. As of 24-JUN-2015, it was unknown if she would continue ROTATEQ and the outcome of receiving her third dose at 9 months of age was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, frequency and route of administration were not provided) that was stored improperly. No adverse effects reported. 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 pharmacist refers to a patient of unknown age and gender. On 20-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # K010630, expiration date reported as 30-OCT-2015 (dose, route and site of administration were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected, because there was no consent to contact the pharmacist.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with an expired dose of ROTATEQ, orally, (lot # unspecified, expiration date: April 2015). There was no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated either with GARDASIL (dose and Lot# were not reported), oral ROTATEQ (dose and Lot# were not reported) or PEDVAXHIB (dose and Lot# were not reported) which were improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates in approximately June 2015 (reported as since 06/11/2015), the patients were vaccinated with a doses of VARIVAX (Merck) subcutaneous injection (strength, dose, lot# and expiration date were not reported) which were improperly stored. No information on patients concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at the injection site.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Irritability, Lethargy, Nausea, Somnolence
Clinical narrative: Stomach cramping, nausea, lethargy, drowsiness, irritability.
Age: 0.21
Sex: M
Vaccine: HIBV, PPV
Symptoms: Abdominal distension, Injection site pain, Irritability, Pyrexia
Clinical narrative: Irritability and Fever, treated with Tylenol.  Irritability and pain at injection site has continued. Overnight it developed into gas pain. We are treating with Tylenol and mylecon drops.  Fever of 100.5 is still present the next day.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse to a 12 month old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 01-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiry date, dose and route of administration not reported) and then was administered a dose of PROQUAD (Merck) (lot#, expiry date, dose and route of administration not reported) instead of a dose of M-M-R II as prescribed. No adverse events were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient c/o of left arm redness and itchiness after PREVNAR 13 shot. Had fever 102 degrees F few hours, then had redness and itchiness. Redness and warm to touch, at the site of PREVNAR injection, concerned for cellulitis. Gave KEFLEX qid x 7 days.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient c/o of left arm redness and itchiness after PREVNAR 13 shot. Had fever 102 degrees F few hours, then had redness and itchiness. Redness and warm to touch, at the site of PREVNAR injection, concerned for cellulitis. Gave KEFLEX qid x 7 days.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Measles
Clinical narrative: Information has been received from a pharmacy technician referring to a 46 year old female patient. Information about patient's concurrent conditions and medical history was not reported. On an unknown date, when the patient was a child, she received an unspecified dose of M-M-R II (lot#, dose, route not reported) in an unspecified country. On an unspecified date the patient experienced measles. In April 2013 the patient received another dose of M-M-R II (lot#, dose, route not reported) (inappropriate schedule of vaccine administered). Outcome of measles was not reported. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 29-JUN-2015, the patient was vaccinated with an expired dose of M-M-R II, subcutaneously, (batch# J006139, lot # 1684AA, expiration date 17-APR-2015) (dose and indication were not reported). No known adverse effects were reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Injury associated with device, Laceration, Syringe issue
Clinical narrative: Information has been received from a certified medical assistant and a office manager referring to the 32 years old female certified medical assistant. The patient was not pregnant. Pertinent medical history and drug reactions/allergies were not reported. On 22-JUN-2015, the medical assistant was cut by a prefilled RECOMBIVAX HB syringe (dose was not reported, lot# L009155, expiration date 29-OCT-2016) when the syringe broke as she was preparing a dose for administration. Concomitant drug was not reported. The patient did not seek medical attention. On an unknown date, the patient treated her cut by bandaging it. Product quality complaint was involved in the case. On 29-JUN-2015, the patient was recovered from the injury associated with device. 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 registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with VAQTA (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient presents to office with diarrhea for one week post vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Crying a lot, redness, swollen and warm to the touch left thigh.
Age: 24.0
Sex: M
Vaccine: PNC13
Symptoms: Band neutrophil count increased, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Severe febrile systemic reaction 103.6. Myalgia. Erythema at the site of the injection (10 by 5 cm) tender, no fluctuant.
Age: 24.0
Sex: M
Vaccine: PNC13
Symptoms: White blood cell count increased
Clinical narrative: Severe febrile systemic reaction 103.6. Myalgia. Erythema at the site of the injection (10 by 5 cm) tender, no fluctuant.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: Patient did NOT need vaccine and had labs supporting this.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac electrophysiologic study, Catheterisation cardiac, Confusional state, Dizziness, Echocardiogram
Clinical narrative: Dizziness, confusion, syncope, tachycardia. Went for follow up with physicians to try to find a diagnosis.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tachycardia, Tilt table test positive
Clinical narrative: Dizziness, confusion, syncope, tachycardia. Went for follow up with physicians to try to find a diagnosis.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # K010630, expiration date reported as 30-OCT-2015 (dose, route and site of administration were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected, because there was no consent to contact the pharmacist.
Age: 1.02
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-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.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative regarding a male patient, who was under 12 months of age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014, the patient (under 12 months of age) was vaccinated with GARDASIL (Lot number, expiry date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Peripheral swelling
Clinical narrative: My arm started swelling & getting a short time after the shot. Called the pharmacy & was told this was normal. The next day arm was getting worse and I was running a fever. Called doctors office and was unable to get an appointment. The next day I went to ER. Still wasn't getting better went to doctor for stronger medication.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On unknown dates since 11-MAY-2015, the patients were vaccinated with unspecified number of improperly stored doses of PEDVAXHIB (dose and route of administration not reported, lot # K015464, expiry date 09-JUL-2017 and lot # K026532, expiry date 07-AUG-2017). It was unspecified which lots were administered to which unspecified patients. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On an unknown dates since 11-MAY_2015, the patients were administered unspecified number of improperly stored doses of ROTATEQ(dose not reported, orally, lot # K013661, expiry date 26-MAY_2016; lot # L0044533, expiry date 27-MAY-2015; lot # K016314, expiry date 05-JUN-2016; lot # L000425, expiry date 21-JUN-2016). It was unspecified which lots were administered to which unspecified patients. No adverse effects were reported. Additional information has been requested. This is one several reports from the same reporter/
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever (100.2 F), Aches, headache.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient noticed severe itching on both legs and feet and he developed hives on right inner thigh and outside right foot and left foot.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site rash, Neck pain
Clinical narrative: Four hours after shot was given pt states she began having severe arm pain where shot was given. An hour later pt began having neck pain, and back pain that radiated down to "tip of toe".  Pt started having a fever that evening around 10pm, 101.2. Pt self medicated with Motrin, then Bayer.  Yesterday morning pt states she woke up with red, painful spots on arm where shot was given.  Pt was seen by doctor today (08 July 15).  Pt was given rx for Tylenol 500mg and advised to rest.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Four hours after shot was given pt states she began having severe arm pain where shot was given. An hour later pt began having neck pain, and back pain that radiated down to "tip of toe".  Pt started having a fever that evening around 10pm, 101.2. Pt self medicated with Motrin, then Bayer.  Yesterday morning pt states she woke up with red, painful spots on arm where shot was given.  Pt was seen by doctor today (08 July 15).  Pt was given rx for Tylenol 500mg and advised to rest.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Malaise, Pallor
Clinical narrative: Patient was given immunization and reported "not feeling well" and becoming pale in color after administration.  Patient was instructed to lie down for 30 minutes, eat, drink and ambulate prior to leaving the clinic.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Pt started with a red knot at the site of injection, sore and warm to the touch. It lasted approximately one week. Then 07/05/2015 she developed a blister type rash in a circular shape surrounding the area where the original reaction had occurred. The rash is itchy a warm to the touch.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Pt started with a red knot at the site of injection, sore and warm to the touch. It lasted approximately one week. Then 07/05/2015 she developed a blister type rash in a circular shape surrounding the area where the original reaction had occurred. The rash is itchy a warm to the touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Rash
Clinical narrative: Woke up with rash. Right thigh- red and swollen. Left thigh- red pinpoint rash. Afebrile. Seen in ER 7/4/15 treated with IV Rocephin, sent home with Benadryl and Keflex 450mg TID, Prednisone and Motrin. Return to ER 7/6/15 redness on right thigh has increased but swelling decreased. Afebrile.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous
Clinical narrative: Woke up with rash. Right thigh- red and swollen. Left thigh- red pinpoint rash. Afebrile. Seen in ER 7/4/15 treated with IV Rocephin, sent home with Benadryl and Keflex 450mg TID, Prednisone and Motrin. Return to ER 7/6/15 redness on right thigh has increased but swelling decreased. Afebrile.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Injection site erythema, Pain in extremity
Clinical narrative: Both the patient and her husband had trouble swallowing, severe pain in the vaccinated arm, and redness at the site of administration.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Raised rash that progresses over his back, trunk, and legs.
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: Induration, Pain, Swelling
Clinical narrative: Localized induration.  Painful and swollen approximately 8cm by 5cm.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: RED PATCH ON THE ARM THAT DID ITCH VERY BAD.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. noticed itching of lower right arm followed by several welts on her lower right arm.  No other problems reported.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Torso completely covered in hives.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Raised red area approximately 7cm x 7cm and warm to the touch.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Blood test, Computerised tomogram, Dysphagia, Feeling abnormal
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Dizziness, Eating disorder, Gait disturbance, Guillain-Barre syndrome, Speech disorder
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Back pain, Computerised tomogram normal, Constipation, Dizziness
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Dizziness postural, Dysgeusia, Dyspnoea, Eating disorder, Electrocardiogram normal
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Eyelid function disorder, Fall, Flank pain, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Immunoglobulin therapy, Injection site pain, Lacrimation increased, Loss of consciousness, Lumbar puncture abnormal
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Mobility decreased, Neck pain, Nuclear magnetic resonance imaging normal, Renal pain, Respiratory tract congestion
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Visual impairment, Walking aid user, Weight decreased
Clinical narrative: Patient began feeling numbness, difficulty with legs, and swallowing.  Patient described it as "thought I was having a stroke". Patient felt weak and lost weight beginning in May. Patient was diagnosed with Guillain -Barre and spent until 7/8/15 in rehab facility.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, C-reactive protein increased, Erythema, Impaired work ability
Clinical narrative: All over joint pain, specifically neck and hand pain, stiffness, swelling, redness.  Immobility of joints.  Treated in ER x 2.  Spinal tap, MRI of neck.  Currently on prednisone prescribed by primary care MD.  Has been on steroids for 6 weeks. Out of work for almost 3 weeks and unable even now to return to full schedule.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture, Mobility decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Swelling
Clinical narrative: All over joint pain, specifically neck and hand pain, stiffness, swelling, redness.  Immobility of joints.  Treated in ER x 2.  Spinal tap, MRI of neck.  Currently on prednisone prescribed by primary care MD.  Has been on steroids for 6 weeks. Out of work for almost 3 weeks and unable even now to return to full schedule.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: As per patient, following subcutaneous administration of the vaccine, Pneumovax 23 injection, the patient experienced extensive swelling at the site of injection aver 24 - 48 hours. The patient had to see a doctor on 7/5/2015 who suspected that it was a reaction to the vaccine at the injection site.
Age: 1.31
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Entire leg swelled to twice normal size, and became hot and red.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Central nervous system lesion, Hemiparesis, Hyperaesthesia, Injection site pain
Clinical narrative: site of injection burning, severe sensitivity touch,aching
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: site of injection burning, severe sensitivity touch,aching
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports redness and swelling in area where vaccine administered beginning the night of vaccine.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Gastric disorder, Injection site swelling, Pyrexia
Clinical narrative: Stomach problems, difficulty breathing which lasted for 3 days but very bad the 1st night. Fever 1st night. Swollen area where the shot was administered. Lasted for 2 months.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Entire leg swelled up, hot to touch, and child could not walk on it or touch it (screamed with pain).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles exactly after 4 weeks of shingles vaccine administered was prescribed VALTREX 1 gram for 7 days.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Received vacc. in the am. Devel nausea at 10 pm -> dizziness slowly devel chills -> headache very intense (8/20) stiff neck and soreness, headache lasted whole night, next day he was fine!! but weak, then 7 pm had chills and body ache and fatigue and headache with sweating and stiff neck, went to ER. Noted done. Next day was weak then got 100% better.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Nausea, Neck pain, Pain
Clinical narrative: Received vacc. in the am. Devel nausea at 10 pm -> dizziness slowly devel chills -> headache very intense (8/20) stiff neck and soreness, headache lasted whole night, next day he was fine!! but weak, then 7 pm had chills and body ache and fatigue and headache with sweating and stiff neck, went to ER. Noted done. Next day was weak then got 100% better.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Meningism, Meningitis
Clinical narrative: Received vacc. in the am. Devel nausea at 10 pm -> dizziness slowly devel chills -> headache very intense (8/20) stiff neck and soreness, headache lasted whole night, next day he was fine!! but weak, then 7 pm had chills and body ache and fatigue and headache with sweating and stiff neck, went to ER. Noted done. Next day was weak then got 100% better.
Age: 20.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Vomiting
Clinical narrative: Received vacc. in the am. Devel nausea at 10 pm -> dizziness slowly devel chills -> headache very intense (8/20) stiff neck and soreness, headache lasted whole night, next day he was fine!! but weak, then 7 pm had chills and body ache and fatigue and headache with sweating and stiff neck, went to ER. Noted done. Next day was weak then got 100% better.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around area of injection.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: 30 seconds after vaccines, child felt=faint and looked pale. P60 BP110/58. I placed him in a supine positn & he improved immediately. Dad states he always feels faint with shots.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Depressed level of consciousness, Lethargy
Clinical narrative: After vaccines baby was "zonked out all day," "barely ate", "difficult to arouse," "fine next day" per mom.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 1-2 inch wide wheel. It's red, hot and itches.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt. received 2nd varicella within 24 hours a red welt developed at the injection site. Approximately 3 inch diameter red and raised.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site urticaria
Clinical narrative: Localized redness and edema surrounding (R) thigh injection site 5 min after receiving vaccines. 4-5 small raised wheals around injection site. No tenderness. No facial swelling or SOB. No vomiting.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient denied any allergies to the components of the vaccine, or reaction to an earlier Pneumococcal vaccine. Patient's wife called on 6/30/15 and stated that patient is feeling feverish (does not have thermometer, unsure if he has fever), also reported patient had a cold recently. Explained that patient;s complaints might be side effects from PCV13 and also since he just had a cold; advised adequate fluid intake, rest, applying ice on injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Screaming
Clinical narrative: Parent called after hours and reported 102 temp & screaming to on call provider Dr who recommended TYLENOL.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Itching, redness.
Age: 1.17
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Feeling hot, Hypersomnia, Rash, Scab
Clinical narrative: (1) tiny bump noticed on 7/3/15-it scabbed on 7/5/15. More bumps developed on upper, then lower back on 7/4/15 and 2 more bumps on abdomen on 7/5/15 and one below nose on 7/6/15. Felt warm-on and off and has been sleeping more.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Headache, Pyrexia
Clinical narrative: Patient stated that she felt feverish at the night of PREVNAR 13 shot, was weak and dizzy in the morning when she first woke up, but feels better later. She hasn't measured her temperature, so she doesn't know if she really has a fever. Patient still has some weakness and headache. Advised drinking at least 6-8 cups of water a day, adequate rest, measure temperature and notify staff if fever or condition does not improve.
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Cold sweat, Injection site erythema, Injection site pain, Pain
Clinical narrative: Post Tdap at RA/IM, arrived with c/o pain at site with erythema 22 cm. S x S of "aches" and "cold sweats" post 4 6 hours from Tdap on 7/6/15 at 1:40.
Age: 61.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Immediately after injection pt's arm turned red and swelled. 5 wks later pt c/o continuing pain and unable to raise arm (abduct).
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Fever > 104 degrees. Nausea/vomiting and stomach cramps. Stiff neck and headache. (Patient will see PCP 7/8/15).
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fever > 104 degrees. Nausea/vomiting and stomach cramps. Stiff neck and headache. (Patient will see PCP 7/8/15).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to four unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patients were vaccinated with expired doses of M-M-R II, lot # J006953 (dose and route were not reported). All four doses of M-M-R II had an expiration date of 07-JUN-2015. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. No concurrent condition or medical history was reported. On 05-JUN-2015, the patient was vaccinated with VARIVAX (Merck) (dose and route of administration not provided). No concomitant therapy was reported. The physician reported that patient conceived 8 days later (Maternal exposure before pregnancy) and her last menstrual period was 14-MAY-2015 (estimated date of delivery was 18-FEB-2016). No treatment was provided for the event. The outcome of the event was unknown. The event was considered to be not related to VARIVAX (Merck). No product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. Information regarding concurrent conditions and medical history was not provided. On 06-JUL-2015 the patient was vaccinated with a dose of GARDASIL that was improperly stored, lot # K008931, exp. date: 04-MAR-2017, dose/frequency: single dose vaccination, intramuscularly (injection site was not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Rash, Skin warm
Clinical narrative: May 26, 2015 (shot date) arm hurt, slept off and on for 2 days. After shot May 30 got rash on left arm. May 30 pharmacy reported rash (June 1st still arm hurt and rash. June 1 went to Dr. - gave antibiotic cephalexin 500mg 7 days. 5 days rash June 19 arm still aches.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Rash, Somnolence
Clinical narrative: May 26, 2015 (shot date) arm hurt, slept off and on for 2 days. After shot May 30 got rash on left arm. May 30 pharmacy reported rash (June 1st still arm hurt and rash. June 1 went to Dr. - gave antibiotic cephalexin 500mg 7 days. 5 days rash June 19 arm still aches.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt had some localized swelling and pain in the area 6/25.  Increased over the following week.  Seen in clinic for continued pain.  Warm compresses and meloxicam (Mobic) recommended.  When pain worsened, pt returned to clinic for rule out hematoma vs abscess.  Surgical drainage of purulent material on 7/6/15.  Given 10 day course of antibiotics.