chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site nodule, Pain in extremity
Clinical narrative: Immediately after injection some blood came out I placed a band aid and with in 40 second like a nodule raised to size of slightly more than quarter to half dollar diameter bruised showed. I had the patient wait longer. No other affect on patient. I called patient a today. Nodule went away no bruising but soreness in arm. Patient to call doctor and in have documented in his records what occurred.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Asthenia, Chills, Pyrexia, Rash
Clinical narrative: Rash to scalp, chest and back. Approx 7 vesicles. Low grade fever, chills, joint pain and weakness.
Age: 0.17
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a practitioner nurse, concerning an 8 weeks old patient of an unknown gender. There were no concurrent conditions, medical history and concomitant medications reported. On 06-FEB-2017 (reported as "today"), the patient was vaccinated with a dose of VARIVAX and a dose of M-M-R II (dose, frequency and route not reported; lot # and expiration date were unspecified, for both vaccines), which were outside of the recommendations per these vaccines prescribing information. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in 2009, the patient was vaccinated intramuscularly with the first dose of VAQTA (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On 07-FEB-2017, the patient was vaccinated intramuscularly with an expired dose of VAQTA (dose number, dose and frequency not reported; lot # L031196 and expiration date: 05-FEB-2017) for prophylaxis. Temperature: "36 to 46 F." There were no previous storage excursion occurred for the vaccine per the reporter. No adverse effects were reported. No product quality complaint was involved (PQC). This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA003665.
Age: 69.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in 2009, the patient was vaccinated intramuscularly with the first dose of VAQTA (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On 07-FEB-2017, the patient was vaccinated intramuscularly with an expired dose of VAQTA (dose and frequency not reported; lot # L031196 and expiration date: 05-FEB-2017) for prophylaxis. Temperature: "36 to 46 F". There was no previous temperature storage excursion occurred for the vaccine per the reporter. No adverse effects were reported. No product quality complaint was involved (PQC). This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003657:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a twin patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an inappropriate storage dose of PROQUAD (dose, frequency and route not reported), lot # reported as M037652 with expiration date of 28-FEB-2018 for prophylaxis. No adverse effects were reported. The temperature excursion of the vaccine was greater than -15 °C degrees but less than -10 °C degrees with a highest temperature of -12.97 °C, for a time frame of 4.5 hours. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M023169 with an expiration date of 13-JUN-2018 (doses and route of administration were not provided). Administered doses of vaccine underwent the temperature excursion at >46 degrees Fahrenheit but < 77 degrees Fahrenheit for 1 hour and 45 minutes which was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009656:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a 78-year-old female patient, who was reporting on herself. The patient had no pertinent medical history. It was reported that she had drug reaction or allergy to "Gulten S". On 23-SEP-2016, the patient was vaccinated with one dose of ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported) to prevent shingles. She did not take any concomitant medications. On an unknown date after vaccination, the patient developed muscle pain. Unspecified treatment was given for the event. No lab diagnostic studies were performed. She did not seek medical attention. Product quality complaint (PQC) was not involved. The pain still continued at the time of the report. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on 11-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case). Previous temperature excursion: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case). The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376.
Sex: U
Vaccine: VARCEL
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. No pertinent medical history, drug reactions/ allergies or concomitant medications were reported.  On 18-FEB-2017, the patient was vaccinated with a single dose of improperly stored VARIVAX, subcutaneously for prophylaxis (the lot # for which was reported as M0038859 with an expiration date of 14-SEP-2018; however, the dose, frequency, dosage number, and anatomical location were unknown). The vaccine had experienced a temperature excursion of 40 F for a time frame of 24 hours. No previous temperature excursions had occurred and the stated one was called because of a data logger. Despite this, no adverse effects were reported. Additional information is not expected since consent to contact the patient's physician was denied.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M016238 with an expiration date of 07-DEC-2017 (doses were not provided). Administered doses of vaccine underwent the temperature excursion at >46 degrees Fahrenheit but <77 degrees Fahrenheit for 1 hour and 45 minutes which was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008404:
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Pain, swelling, tenderness, warmth and redness worsening s/p injection.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt Received PCV-13 vaccine on 2/14/17 to L deltoid and has been having throbbing pain ever since. Pt also having limited range of motion to L shoulder.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning his son, an 11 year old male patient. The patient had not any pertinent medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications reported. On an unknown date, the patient was vaccinated with VARIVAX intramuscularly (dose number, dose, anatomical location, lot number and expiration date were not provided) for prevention of chicken pox. On 13-FEB-2017, the patient experienced chickenpox. The patient did not seek medical attention or received any treatment for the event. At the time of report, the patient had not recovered from chickenpox. The relatedness between the chickenpox and VARIVAX was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 01-OCT-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported.  Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:  >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 28-JUL-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 28-JUL-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Sex: M
Vaccine: MEN, PPV
Symptoms: Asthma
Clinical narrative: Initial unsolicited report received from consumer via Pfizer on 09 Feb 2017. Manufacturer report number: 2016554702. This case was linked with 2017SA025687 and 2017SA025717 (same reporter). This case involves a male patient who was vaccinated with first dose of MENINGOCOCCAL VACCINE (Vaccine against meningitis) and first dose of PNEUMOCOCCAL VACCINE (batch number, expiry date, dose and site of administration was not reported) on an unspecified date (few month ago). The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had asthma. On an unspecified date, the patient was hospitalized. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Poorly document case of child who was vaccinated against meningitis and pneumococcal and had asthma. Additional information regarding time to onset, details regarding the asthma and hospitalization, medical history is needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Pt vomitted after providing rota vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Inconsolable crying for at least 3 hours.  MOP took child to the emergency department who reported as stable, normal vital signs and normal exam.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Feeling cold, Head injury, Hyperhidrosis
Clinical narrative: Patient received vaccination and soon there after became lightheaded and fainted. Patient fell and hit the back of his head. He became pale, cold, and started sweating. No swelling, redness, or any apparent other reactions were apparent. Pupils were checked and were normal.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Pupillary light reflex tests normal, Syncope
Clinical narrative: Patient received vaccination and soon there after became lightheaded and fainted. Patient fell and hit the back of his head. He became pale, cold, and started sweating. No swelling, redness, or any apparent other reactions were apparent. Pupils were checked and were normal.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swelling of Injection Site, Fever, Chills and Nausea.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a nurse via a company representative, referring to an approximately 20 year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 08-AUG-2009, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route, lot # and expiration date were not provided) for prevention of human papilloma virus (HPV). Subsequently, she received the the second and third doses of GARDASIL injection on 30-OCT-2009 and 20-APR-2010 (strength, dose, route, lot # and expiration date were not provided), also for prevention of HPV. On 29-NOV-2016 (also reported as "recently"), the patient tested positive for HPV. At the time of the report, the outcome of the event was not recovered. No action was applied with GARDASIL (also reported as therapy was continued; conflicting information). The causal relationship between GARDASIL and the event was, was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased, Viral test negative
Clinical narrative: This solicited report was received from a consumer and refers to her daughter, a female patient of unknown age. The patient was enrolled in a Market Research. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Shortly after receiving the vaccine, on an unspecified date, the patient experienced immune thrombocytopenic purpura (I.T.P.). Shortly after, the patient was in hospital with "no platelets" (platelet count decreased). Laboratory exams for the plague ("peste") virus came back negative. At the time of the report, the patient was "conic" (adverse event). The outcome of the event immune thrombocytopenic purpura was unknown. The reporter did not assess the causality between the events immune thrombocytopenic purpura and "conic" (adverse event") and therapy with M-M-R II. Upon internal review, the event immune thrombocytopenic purpura (I.T.P.) was determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the product therapy and the reported event cannot be established. More information is requested. This report includes a non serious adverse event. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the product. Sender's Comments: US-009507513-1702USA009655.
Age: 12.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 20-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: L042265; Expiration date: 26-OCT-2017) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005376:
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 11-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005376:
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased, Viral test negative
Clinical narrative: This solicited report was received from a consumer and refers to her daughter, a female patient of unknown age. The patient was enrolled in a Market Research. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Shortly after receiving the vaccine, on an unspecified date, the patient experienced immune thrombocytopenic purpura (I.T.P.). Shortly after, the patient was in hospital with "no platelets" (platelet count decreased). Laboratory exams for the plague ("peste") virus came back negative. The patient had a low platelet count for 6 months. The outcome of the events immune thrombocytopenic purpura was unknown. The reporter did not assess the causality between the events and therapy with M-M-R II. Upon internal review, the event  immune thrombocytopenic purpura (I.T.P.) was determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the therapy and the reported event cannot be established. More information is requested. Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the product. Sender's Comments: US-009507513-1702USA006192.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Haemorrhage urinary tract, Laboratory test, Loss of consciousness, Lung disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for himself. This 91 year-old male patient received the second single dose of PREVNAR 13 06Oct2016 for immunization. The patient was inadvertently given this second dose as he had already received for immunization a first single dose of the same vaccine on 11Aug2015. Relevant medical history and concomitant medications were reported as none. On 06Oct2016 in the evening at 11 pm the patient had bleeding through the urinary tract. That evening he also felt nauseated, he got up, blacked out and was unconscious for a couple of hours. Due to these events he was hospitalized from 06Oct2016 to 08Oct2016. On an unspecified date the patient also experienced a lung condition for which received a treatment with ALBUTEROL inhaler. An unspecified laboratory work was done on 07Oct2016. Outcome of events was unknown.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for himself. This 91 year-old male patient received the second single dose of PREVNAR 13 06Oct2016 for immunization. The patient was inadvertently given this second dose as he had already received for immunization a first single dose of the same vaccine on 11Aug2015. Relevant medical history and concomitant medications were reported as none. On 06Oct2016 in the evening at 11 pm the patient had bleeding through the urinary tract. That evening he also felt nauseated, he got up, blacked out and was unconscious for a couple of hours. Due to these events he was hospitalized from 06Oct2016 to 08Oct2016. On an unspecified date the patient also experienced a lung condition for which received a treatment with ALBUTEROL inhaler. An unspecified laboratory work was done on 07Oct2016. Outcome of events was unknown.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Eyelid function disorder, Herpes zoster, Hypoaesthesia, Neuralgia
Clinical narrative: This is a spontaneous report from a contactable 75-year-old female consumer reporting for herself. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 26Jan2017 11:00 at 0.5 ml, single in left arm for routine immunisation.  The patient's concomitant medications were not reported.  The patient previously took influenza vaccine, pneumococcal vaccine.  The patient experienced shingles on her face and head and shingles affected her eye on 30Jan2017 with outcome of recovering. She also experienced nerve pain and numbness since unknown date with outcome of not recovered.  The patient underwent blood tests resulted good.  She has had both primary care and eye doctor visits.  She was seen first on 30Jan2017, then was seen again when her eye closed shut as it was all on the right side.  Her physician  prescribed acyclovir at 5 times a day for 7 days and prednisone. She also was prescribed gabapentin for the nerve pain, strength of 100mg.  She started taking 1 a day for 3 days, then 2 a day for 3 days, then 3 a day for 3 days. It helped, but she still had the pain and numbness.   Another doctor had said since caller's daughter was going through a breast biopsy that the stress the caller was experiencing may have triggered it.  She has never had a problem with stress before going through a divorce and other breast biopsies her daughter has had.  She attributed the events to the vaccine.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Ophthalmic herpes zoster, Stress
Clinical narrative: This is a spontaneous report from a contactable 75-year-old female consumer reporting for herself. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 26Jan2017 11:00 at 0.5 ml, single in left arm for routine immunisation.  The patient's concomitant medications were not reported.  The patient previously took influenza vaccine, pneumococcal vaccine.  The patient experienced shingles on her face and head and shingles affected her eye on 30Jan2017 with outcome of recovering. She also experienced nerve pain and numbness since unknown date with outcome of not recovered.  The patient underwent blood tests resulted good.  She has had both primary care and eye doctor visits.  She was seen first on 30Jan2017, then was seen again when her eye closed shut as it was all on the right side.  Her physician  prescribed acyclovir at 5 times a day for 7 days and prednisone. She also was prescribed gabapentin for the nerve pain, strength of 100mg.  She started taking 1 a day for 3 days, then 2 a day for 3 days, then 3 a day for 3 days. It helped, but she still had the pain and numbness.   Another doctor had said since caller's daughter was going through a breast biopsy that the stress the caller was experiencing may have triggered it.  She has never had a problem with stress before going through a divorce and other breast biopsies her daughter has had.  She attributed the events to the vaccine.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable consumer. A 2-month-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in the left thigh on 15Feb2017 15:00 to for immunisation. Medical history included thrush from 13Feb2017 to an unknown date (taken care of with an antifungal). Concomitant medication included oral rotavirus vaccine and  immunoglobulin antihepatitis B (HEPATITIS B) injection in the right thigh, both on 13Feb2017 for immunisation. The patient previously took hepatitis B at birth for immunization with no adverse events. Relevant family medical history included that older sister had reaction to DTP vaccine.   On 16Feb2017, the patient experienced low grade temperature of 100 degrees Fahrenheit under armpit and low appetite with outcome of recovered on the same date. Therapeutic measures were taken as a result of low grade temperature of 100 degrees under armpit included a dose of Tylenol.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: L deltoid pain. No localized reaction other than pain. Self treated with Motrin. Dizziness & Nausea, worse in AM, diminishing throughout the day.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling to right thigh after she got 2 months vaccines, per vaccine records, received HIB and PCV13 in this location, denies spreading rash, difficulty breathing, cough, or vomiting, fever 101F, applied cold compress with some improvement Mom states was "4 quarters (coins) width, given Tylenol, mom also noticed small reaction at injection site on left thigh in the AM on 2/14/17, eating and drinking well.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Anxiety, Confusional state, Feeling abnormal, Hallucination, auditory, Intentional overdose
Clinical narrative: Patient woke me up saying she was hearing voices and they had told her to overdose. She found her brothers medication and had overdosed. She was confused and didon't know why she was feeling this way. She was admitted to the hospital that night. The couple weeks prior she had been chewing off the skin on her fingers and reported feeling anxious.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Intentional self-injury
Clinical narrative: Patient woke me up saying she was hearing voices and they had told her to overdose. She found her brothers medication and had overdosed. She was confused and didon't know why she was feeling this way. She was admitted to the hospital that night. The couple weeks prior she had been chewing off the skin on her fingers and reported feeling anxious.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Fluid intake reduced, Urine output decreased, Vomiting
Clinical narrative: Vomiting from 11:30 PM to 2:30 Am, went to ER, given pedialyte, took 3 oz formula AM 02/21/2017 and kept down until 4 PM but has refused other fluids, temp 101.6 today. Parents taking child back to ER as no urine output today.
Age: 68.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Decreased appetite, Pyrexia, Rash
Clinical narrative: Patient stated on 02/21/2017 she developed a rash on both hands, fever, chills, and decreased appetite. She went to the urgent care and received anti itch medications. She is fully recovered.
Age: 11.0
Sex: M
Vaccine: DTAP, FLUX, HPVX, MEN, DTAP, FLUX, HPVX, MEN
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Large red raised welt that is hot to touch at injection site on left arm extending through about half the length of top portion of arm.
Age: 11.0
Sex: M
Vaccine: DTAP, FLUX, HPVX, MEN, DTAP, FLUX, HPVX, MEN
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Large red raised welt that is hot to touch at injection site on left arm extending through about half the length of top portion of arm.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: A few hours after vaccination infant developed hives on stomach, chest, arms, legs, and back. Within an hour of initial onset, hives spread to infant's face. Parent contacted on call pediatrician who advised to monitor for other symptoms of an allergic reaction. No other symptoms were apparent. Hives were gone by the next morning, February 21, 2017.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Erythema, Malaise, Swelling face, Throat tightness, Urticaria
Clinical narrative: About 10 mins after receiving PROQUAD and KINRIX vaccines, pt told mom his throat felt tight and he felt sick. Mom took him to the clinic lobby bathroom where he began to vomit. Face was red, developed hives on face and facial swelling. Taken back to exam room by wheelchair. HR 125, RR 20, O2 96%. Dr called into room immediately and ordered dose of EPIPEN Jr, which was given about 9:50. O2 @ 2 l/min by cannula applied. Pt taken to hosp ER by wheelchair, accompanied by Dr and RN. Given IV fluids along with BENADRYL, SOLU-MEDROL and famotidine. Discharged home about noon.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: About 10 mins after receiving PROQUAD and KINRIX vaccines, pt told mom his throat felt tight and he felt sick. Mom took him to the clinic lobby bathroom where he began to vomit. Face was red, developed hives on face and facial swelling. Taken back to exam room by wheelchair. HR 125, RR 20, O2 96%. Dr called into room immediately and ordered dose of EPIPEN Jr, which was given about 9:50. O2 @ 2 l/min by cannula applied. Pt taken to hosp ER by wheelchair, accompanied by Dr and RN. Given IV fluids along with BENADRYL, SOLU-MEDROL and famotidine. Discharged home about noon.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: About 10 mins after receiving PROQUAD and KINRIX vaccines, pt told mom his throat felt tight and he felt sick. Mom took him to the clinic lobby bathroom where he began to vomit. Face was red, developed hives on face and facial swelling. Taken back to exam room by wheelchair. HR 125, RR 20, O2 96%. Dr called into room immediately and ordered dose of EPIPEN Jr, which was given about 9:50. O2 @ 2 l/min by cannula applied. Pt taken to hosp ER by wheelchair, accompanied by Dr and RN. Given IV fluids along with BENADRYL, SOLU-MEDROL and famotidine. Discharged home about noon.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Chills, Injection site irritation, Injection site rash, Injection site swelling
Clinical narrative: Patient reported local site irritation (rash, swelling, hot to touch) and fever, chills and stomachache.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient reported local site irritation (rash, swelling, hot to touch) and fever, chills and stomachache.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Urticaria
Clinical narrative: Acute urticaria (hives) without angioedema, airway compromise, or anaphylaxis.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Rotator cuff syndrome, Shock
Clinical narrative: Immediate shock. Shoulder became very painful within a few hours. Over the subsequent days it got worse. I visited an urgent care doctor and was told I have a rotator cuff injury. It is still painful to this date.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Painful administration of Flu injection to left deltoid followed by severe impaired range of motion with pain for 3 weeks. Continued impaired range of motion with pain but not to the degree.The extent of injury is unknown. (Administered during employee  flu vaccination clinic)
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vaccination failure in an unspecified number of child patients who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination of the patients was not reported. The physician stated that she had seen many kids with the flu on the date of reporting and some had already received the flu shot. The exact flu vaccine manufacturer and flu vaccine was unknown. It was unknown if there was any seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event. This case was considered as the suspected vaccination failure, since the time to onset, laboratory test confirmation of influenza were unknown. The reporter did not want any follow-up forms.
Age: 20.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 20-year-old patient who received HAVRIX Pediatric. Co-suspect products included ENGERIX B Pediatric. On an unknown date, the patient received HAVRIX Pediatric at an unknown dose and ENGERIX B Pediatric at an unknown dose. In January 2017, several years after receiving HAVRIX Pediatric and not applicable after receiving ENGERIX B Pediatric, the patient experienced therapeutic response decreased and therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and therapeutic response decreased were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to HAVRIX Pediatric. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B Pediatric. Additional details were provided as follows: This case was reported by a physician assistant (PA). The age at vaccination was not reported. In childhood, the patient had completed his hepatitis B and hepatitis A vaccination series. In last week of the reporting date, the titers were pulled and no antibodies were found. Thus, leading the patient to be a therapeutic response decreased.
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 30-year-old female patient who received Flu Seasonal QIV Dresden. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had received the flu vaccine only once and the next day patient experienced she ached from head to toe. The patient never got the flu vaccine again.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received MENVEO. On an unknown date the patient received MENVEO (subcutaneous). On an unknown date, 5 days after receiving MENVEO, the patient experienced injection site swelling, injection site itching and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site itching and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching and intramuscular formulation administered by other route to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient received MENVEO subcutaneously. This led to incorrect route of administration. The health care professional did not provide lot number and expiration date of the MENVEO; in addition, the reporter did not provide full patient demographics. The health care professional did not provide any additional information about the injection site reaction when speaking to the medical information system.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Rash, Rash generalised, Tenderness
Clinical narrative: On 2/14/17 - TDAP was administered to the (R) upper deltoid - IM. On 2/17/17 - Employee reported with tenderness, redness, rash to lower (mid) Rt. forearm, no respiratory symptoms. On 2/21/17 - she calls, reported that she went to the ER for worsening symptoms - including generalized rashes, aches.
Age: 0.92
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Patient administered KINRIX, which is marketed for 4-6 year olds.
Age: 65.0
Sex: M
Vaccine: DTP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus. Prednisone 20 mg every day.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Allergy to metals, Dermal cyst, Granuloma annulare, Injection site reaction, Skin test positive
Clinical narrative: The patient is a 3yo female with a history of eczema and asthmatic bronchitis who developed an epidermal inclusion cyst attributed to vaccine. The cyst to her R thigh professed over a 6 month period after receipt of dose #1 and 2 of HAVRIX, dose #4 PEDVAX Hib PRP-OMP and dose #4 of INFANRIX. Surgeons note states pathology report: 'Right lateral thigh mass-benign reactive tissue with granuloma annulare pattern. Persistent itchy subcutaneous nodules may arise after childhood vaccination secondary to a histiocytic reaction to aluminum, and additive used to hasten the immune response. Deep granuloma annulare-like infiltrates, are one describe histologic pattern.' Aluminum patch testing performed by allergy demonstrated Weak positive results to aluminum hydroxide.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Limb injury, Monoplegia, Pain in extremity
Clinical narrative: Arm became immobile, painful and sore went Dr. Physical therapy needed.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Epistaxis, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Pt seen 2/6/17 for well child and vaccines, returned 2/13/17 with petechiae to lower extremities and zero platelets-diagnosed as ITP-treated once with IVIG for nosebleed-requiring ongoing labs and specialty appts.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Platelet count decreased
Clinical narrative: Pt seen 2/6/17 for well child and vaccines, returned 2/13/17 with petechiae to lower extremities and zero platelets-diagnosed as ITP-treated once with IVIG for nosebleed-requiring ongoing labs and specialty appts.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: PNEUMOVAX 23 injected at L deltoid 2/13; pain immediately, swelling and decreased use of arm due to pain. Examined at office 2/17; she reports it resolved by 2/21/17.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Ill-defined disorder
Clinical narrative: Four hours after shot I came down with it. Took 6 weeks to get back on my feet.
Sex: U
Vaccine: HEPAB
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased
Clinical narrative: Received TWINRIX (Hep A/B) #3 vaccine IM (R) deltoid on 1/5/2017. Had pain on injection and on-going pain ever since in (R) upper arm. Pain worse with abduction >45 degrees of external rotation of (R) shoulder.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site haematoma
Clinical narrative: Left thigh hematoma. Rx: warm compress.
Age: 21.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Underdose
Clinical narrative: Pt. was given pediatric dose of Hep A - should have been adult dose.
Age: 1.17
Sex: M
Vaccine: FLU4, HIBV, MMR, VARCEL
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: Child's mother reported to me that child had been hospitalized with "ITP". She said the hospital said it may have been caused by MMR vaccine. Child is home recovering.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Pain and swelling at injection site x 1 month. Pain at shoulder with flexion and abduction above 90 degrees.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: Pt. was given diluent and not the vaccine. I didn't realize it needed to be reconstituted.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Local redness at injection site and swelling, LA. Tingling in (Lt) middle finger.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: Pt was given diluent and not the vaccine. I didn't realize that it needed to be reconstituted.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Oral herpes
Clinical narrative: "Felt drained for better than a week" and the day after the vaccine, he got cold sores in his mouth under his lip. Had never had cold sores before. No treatment sought/given. (Pt just mentioned this at appt on 2/7/17).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site oedema, Injection site pain, Pyrexia, Radioallergosorbent test
Clinical narrative: (L) thigh edema and tenderness, fever. Limping, occurred 2 hrs post vaccine and for the following 24 hours.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) shoulder - area 11x8 cm red, warm, no Hp. Improving fr. one day of vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Erythema, Local swelling
Clinical narrative: Redness, swelling (local).
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Presyncope, Vomiting
Clinical narrative: A few minutes after administration, pt. had a near syncopal episode and vomited. She then went on to have a severe headache and vomiting which resolved 8-10 hrs. after vaccine.