chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified dates, the multiple patients could had been vaccinated with improperly stored doses of ROTATEQ oral solution (dose and frequency were not reported) lot # M019708 with expiration date of 25-OCT-2017, lot # M025563 with expiration date of 06-NOV-2017 and lot # M031807 with expiration date of 02-APR-2018. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005698: US-009507513-1702USA001654.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified dates, the multiple patients could had been vaccinated with improperly stored doses of GARDASIL (dose, frequency and route not reported) lot # M020103 with expiration date of 15-FEB-2018 and lot # reported as M031557 with expiration date of 07-APR-2019. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Lot # M031557 is an invalid lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001654: US-009507513-1702USA005697:
Sex: U
Vaccine: VARCEL
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. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M035141 exp date 03-AUG-2018) (doses and route were not provided). The temperature of excursion was -14°C for 30 minutes in a range > -15°C but < -10°C. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter does not want to be contacted. Sender's Comments: US-009507513-1702USA000288.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Bronchitis
Clinical narrative: Initial unsolicited report received from consumer via other company, Pfizer (under reference number: 2017022711) on 01 Feb 2017. This case involves a female patient (age not reported) who was vaccinated with third dose of INFLUENZA VACCINE (flu shot) (batch number, expiry date, dose, route and site was not reported) on an unspecified date. Patient had also received pneumonia shot and PREVENAR 13 on an unspecified date (reported as patient not even had a cold). The patient's medical history and concomitant medications were not reported. On an unspecified date, within 12 hour post vaccination; the patient had experienced bronchitis. Patient had also vaccinated with first and second dose of Flu shot previously on an unspecified date and had bronchitis within 12 hours of taking it. Laboratory data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event (reported as it takes six weeks to get over it). List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Emotional distress, Gastric dilatation, Gastroenteritis viral, Headache, Muscle spasms
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2017021955) on 01-FEB-2017. This case involves a 76-year-old female patient who was vaccinated with doses of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and dose in series, site of administration were not reported) on an unknown date. Patient's medical history were reported as patient had arthritis, tumor or cancer, depression, hypertension, high cholesterol, had rotator cuff repair in the right side on 2013 and left knee on 2016. The patient was non-smoker and also had codeine allergy and patient's family history reported as Headache or migraines and Stroke. Patient had developed blotted sensation in bowels with distension of the stomach. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which leading to head twitch, stress and headache. The patient had doctor visit on 08-Dec-2016. Laboratory investigations was reported as patient's body mass index 28.36, blood pressure 120/89 millimeter mercury and pulse rate 118 beats per minutes. Corrective treatment was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Muscle twitching, Respiratory muscle weakness, Stress, Vomiting
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2017021955) on 01-FEB-2017. This case involves a 76-year-old female patient who was vaccinated with doses of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and dose in series, site of administration were not reported) on an unknown date. Patient's medical history were reported as patient had arthritis, tumor or cancer, depression, hypertension, high cholesterol, had rotator cuff repair in the right side on 2013 and left knee on 2016. The patient was non-smoker and also had codeine allergy and patient's family history reported as Headache or migraines and Stroke. Patient had developed blotted sensation in bowels with distension of the stomach. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which leading to head twitch, stress and headache. The patient had doctor visit on 08-Dec-2016. Laboratory investigations was reported as patient's body mass index 28.36, blood pressure 120/89 millimeter mercury and pulse rate 118 beats per minutes. Corrective treatment was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Emotional disorder, Gastroenteritis viral, Headache, Movement disorder, Muscle spasms
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2017021955) on 01-FEB-2017. This case involves a 76-year-old female patient who was vaccinated with doses of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and dose in series, site of administration were not reported) on an unknown date. Patient's medical history were reported as patient had arthritis, tumor or cancer, depression, hypertension, high cholesterol, had rotator cuff repair in the right side on 2013 and left knee on 2016. The patient was non-smoker and also had codeine allergy and patient's family history reported as Headache or migraines and Stroke. Patient had developed blotted sensation in bowels with distension of the stomach. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which leading to head twitch, stress and headache. The patient had doctor visit on 08-Dec-2016. Laboratory investigations was reported as patient's body mass index 28.36, blood pressure 120/89 millimeter mercury and pulse rate 118 beats per minutes. Corrective treatment was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Large swelling on the shoulder and arms. Feels hot and red and itchy. No pain. Cold compress does not help.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling from the vaccine site down the right arm. No fever. Patient was prescribed Cephalexin antibiotic medication.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a physician via medical records through Pfizer (reference # 2017016276) and concerns a currently 57 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. On an unknown date, the patient experienced allergic reaction to PNEUMOVAX23. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX23. All available medical records will be provided upon request. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with ROTATEQ orally, for prophylaxis (dosage information and lot number were not informed). Information regarding concomitant medication was not provided. The registered  nurse reported a temperature excursion that lasted 22 hours. However the reporter was unable to provide a temperature range for the excursion, was not even sure if it went beyond the (>46F to <77F) range or even out of the (36F to 46F range) because her data logger malfunctioned. It could not be ruled out if the vaccines experienced out of range temperatures or not. The nurse also stated that the temperature was in recommended storage range prior to the malfunction of the data logger. No adverse effects reported. There was no product quality complaint involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006715:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager. On an unknown date, PROQUAD was mistaken for M-M-R II. The mistake resulted in the PROQUAD being improperly stored in the refrigerator for 21 days. No patients received the improperly stored PROQUAD. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patient's of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly, with lot # M014925 with expiration date on 16-FEB-2019 and lot # M027881 with expiration date on 13-APR-2019 for prophylaxis. The medical assistant reported, that LIQUID PEDVAXHIB, was exposed to a temperature of 0 °C for a time frame of 6 hours. The vaccine was not expose to any previous temperature excursion and call was made die to a data logger involved. Furthermore, no adverse effects were reported and no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-FEB-2017, the patient was vaccinated with an expired dose of VARIVAX (lot # K026385, expiration date: 15-DEC-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: GARDASIL 9 (lot# L037554, expiration date 25-DEC-2017; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006077: US-009507513-1702USA006078: US-009507513-1702USA006079:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: ROTATEQ (lot#L042216, expiration date 13-JUN-2017; lot#M016238, expiration date 07-DEC-2017, administered orally; dose was not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006078: US-009507513-1702USA006079: US-009507513-1702USA005322:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: RECOMBIVAX HB (lot# M032649, expiration date: 11-NOV-2018; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006077: US-009507513-1702USA006079: US-009507513-1702USA005322.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates,those patients received doses of improperly stored vaccines: VAQTA (lot#M036459, expiration date 18-JAN-2018; lot#M027879, expiration date 24-JAN-2018; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006077: US-009507513-1702USA006078: US-009507513-1702USA005322:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not reported.     On an unknown dates, the patients were vaccinated with GARDASIL 9 for prophylaxis (dosage information, route and lot number were not informed). Information regarding concomitant medication was not provided. The registered nurse reported a temperature excursion that lasted 22 hours. However the reporter was unable to provide a temperature range for the excursion, was not even sure if it went beyond the (>46F to <77F) range or even out of the (36F to 46F range) because her data logger malfunctioned. It could not be ruled out if the vaccines experienced out of range temperatures or not. The nurse also stated that the temperature was in recommended storage range prior to the malfunction of the data logger. No adverse effects reported. There was no product quality complaint involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000376:
Sex: U
Vaccine: PNC13, TDAP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a nurse via partner company Pfizer (Manufacturer control number: 2016499162) on 01-FEB-2017. This case involves a patient, (age and gender was not reported) who was vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiry date, route, dose not reported) and PREVNAR 13 (batch number, expiry date, route, dose not reported) (Manufacturer: Pfizer) in an unknown site on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, after the vaccination, the patient had a reaction. Lab test and corrective treatment was not reported. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Blood culture, Culture urine, Differential white blood cell count, Full blood count, Infantile apnoea
Clinical narrative: Preterm infant with severe apnea requiring resuscitation following administration of PEDIARIX vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Resuscitation
Clinical narrative: Preterm infant with severe apnea requiring resuscitation following administration of PEDIARIX vaccine.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Anal incontinence, Appendicectomy, Colectomy, Colitis ulcerative, Diarrhoea
Clinical narrative: Diarrhea and flu-like symptoms. Though may be developing dairy allergy. Changed diet. Symptom got worse. No bowel control. Diagnosed with ulcerative colitis. Attempted to control with medication. Still resulted in surgery to remove colon and appendix. Had ileostomy and pouch for several months before j pouch and closure surgeries.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Influenza like illness, Pelvic pouch procedure
Clinical narrative: Diarrhea and flu-like symptoms. Though may be developing dairy allergy. Changed diet. Symptom got worse. No bowel control. Diagnosed with ulcerative colitis. Attempted to control with medication. Still resulted in surgery to remove colon and appendix. Had ileostomy and pouch for several months before j pouch and closure surgeries.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, errthymic, painful and warm to touch upper Left arm where injection was given plus flushed face and chest with hives to face.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Swollen, errthymic, painful and warm to touch upper Left arm where injection was given plus flushed face and chest with hives to face.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 19-JAN-2017 and 25-JAN-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unspecified dates since October 2016, doses of ROTATEQ (lot number, expiration, dose, and route not reported) and GARDASIL 9 (lot number, expiration, dose, and route not reported) which were improperly stored were administered to unspecified patients for prophylaxis. The medical assistant reported multiple temperature excursions >46degrees F but <77degrees F since October 2016. No adverse effects have been reported. No additional information was provided. Follow up was received on 25-JAN-2017 from a medical assistant. On 01-NOV-2016, 23-OCT-2016, and 12-JAN-2017, doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number M025565 expiration 06-NOV-2017 (dose and route not reported) were administered to patients which were stored at 46.65 degrees for 3 months (2160 hours, onset 01-OCT-2016.) On 28-DEC-2016, 29-DEC-2016 and 05-JAN-2017, doses of GARDASIL 9 (lot number M032650 expiration 31-MAR-2019 (dose and route not reported) were administered to patients which were stored at 46.65 degrees for 3 months (2160 hours, onset 01-OCT-2016.) No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, and due to a product confusion a patient who was supposed to be administered "Varicella" was vaccinated with M-M-R II which had a lot # of L011528, an expiration date of 03-APR-2017, for prophylaxis instead PROQUAD which contained measles, mumps, rubella  (MMR) and Varicella. The nurse also reported that the patient was not given the age recommended vaccine and she would administer the "Varicella today". Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Photosensitivity reaction, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer-Sponsored Program, from a non-contactable consumer reporting for himself. This male patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration in Mar2015 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced bad hives and he became photo sensitive in Mar2015. Therapeutic measures (over the counter medications) were taken as a result of bad hives but they did not help. The patient was not recovered from bad hives, outcome of photophobia was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 1st of 15 reports. A patient of an unspecified age gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060853 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060869 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060872 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060874 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060891 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060909 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060922 Same reporter/drug/AE, different patient. US-PFIZER INC-2017060901 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060906 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060916 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060917 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060920 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060923 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060927 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 10th of 15 reports. A patient (of an unspecified age, gender and race/ethnicity received PREVNAR 13 lot number N4385, expiry date 31Oct2017) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Dyspepsia, Photosensitivity reaction, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. A 70-years-old other ethnic group male patient received PREVNAR 13 , via an unspecified route of administration in Mar2015 at 0.5 ml, single for immunisation.  The patient medical history was not reported.  The patient took many unspecified concomitant medications.  The patient experienced broke out in hives with outcome of recovering and was photosensitive on an unspecified date about 18 or 20 hours after vaccination with outcome of unknown.  The patient underwent lab tests and procedures which included blood test on unspecified date, no results were provided. The patient went to a dermatologist he prescribed prednisone, fexofenadine hydrochloride (ALLEGRA), hydroxyzine ointment; betamethasone dipropionate and  ulobetasol propionate (HALOBETASOL PROPIONATE) Cream, later received ranitidine (ZANTAC) and experienced heartburn so took aluminium/magnesium hydroxide (MAALOX).
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A 65-year-old male patient of an unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date after the vaccination. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017063169 Same reporter/drug/event, different patient.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 72-years-old female patient started to receive PREVNAR 13 , lot number R33239 , expiration date Mar2018 , NDC  0005197102   on 03Feb2017 at 0.5 ml, single intramuscular in lefd deltoid for immunisation, because of her age recommendation over 55.  The patient medical history and concomitant medications were not reported.  The patient experienced pain at the injection site and above the injection site on 09Feb2017 with outcome of unknown. There was no rash, no redness, the area was not warm it looked normal, the patient stated it was more like a muscle pain. The patient was advised to take ibuprofen (MOTRIN).
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Respiratory viral panel, Skin discolouration, Systemic inflammatory response syndrome
Clinical narrative: Systemic Inflammatory Response Syndrome (discoloration of lower limbs).
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Muscular weakness
Clinical narrative: Burning sensation at injection site. Weakness. Whole arm pain can't lift up without pain. Headache. Fatigue. Flu like symptoms.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Burning sensation at injection site. Weakness. Whole arm pain can't lift up without pain. Headache. Fatigue. Flu like symptoms.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Crying, Depressed mood, Faeces discoloured, Insomnia, Mucous stools
Clinical narrative: Severe crying, not sleeping, greenish poop with some mucus, very unhappy baby.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 02-FEB-2017, the patient was vaccinated with an expired dose of GARDASIL 9 intramuscularly, with lot # K026246 and expiration date on 28-JAN-2017 (anatomical route of vaccination not provided) for prophylaxis (expired product administered). It was reported that, no adverse effects were suffered and that no product quality issue was involved. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Initial unsolicited report received from nurse on 01 Feb 2017. This case involves a 39-year-old male patient who was vaccinated with first dose of ADACEL (batch number: U5458DB, expiry date: 28 Sep 2018 ) in left deltoid; tested with a first dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (batch number: C5022BA, expiry date: 14 Oct 2018) in left forearm; with a first dose of HEPATITIS B VACCINE (HEP B) (manufacturer: Merck ) in right deltoid on 27 Jan 2017. The patient had no Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. The patient did not received any concomitant medications. On 28 Jan 2017, one day following the vaccination, the patient had developed arm soreness at the injection site (which was noticed on 30 Jan 2016, when patient came for PPD reading). On an unknown date, following the vaccination the patient had pain in the axilla and he can't palpate any lymph nodes (at the time of this report). It was reported that, he will be seen by the physician depending on the am evaluation. Lab investigations were not performed. The patient was treated with anti-inflammatories. The patient was not recovered from both the events. List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Brain oedema
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016541225) on 02-Feb-2017. This case involves an 18-month-old male patient, who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) and HAEMOPHILUS TYPE B (HIB) VACCINE (HIB) and PNEUMOCOCCAL VACCINE (batch number, expiry date, dose, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, following the vaccination, patient had brain swelling. Lab test and corrective treatment was not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: brain swelling. List of the documents held by sender: none. Sender's Comments: This case concerns 18 month old patient who received DIPTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE along with HAEMOPHILUS TYPE B (HIB) VACCINE and PNEUMOCOCCAL VACCINE. Patient developed brain swelling. Time to onset is not reported. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope episode.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient called on 1/9 with complains of local bruise and pain at injection site. She was told to make appointment if these symptoms worsened. She was seen on 1/24, 2/2, and 2/10 for other medical issues but continued to mention soreness at the injection site. No other associated complaints or findings.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 03-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX with lot # L035285 and expiration date on 15-DEC-2016 (anatomical route of vaccination was not provided) for prophylaxis (expired product administered). Furthermore, it was reported that no adverse event occurred and that no product quality issue was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Rash generalised
Clinical narrative: Initial unsolicited report received from a physician on 02-Feb-2017. This case involves a two-month-old male patient who was vaccinated with a first dose of DAPTACEL (batch number: C4780AA, expiry date, dose form and frequency not reported) intramuscularly in left thigh and first dose of ACT HIB (batch number UI415AAB, expiry date, dose form and frequency not reported) intramuscularly in the right thigh on 06-Jan-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at time of vaccination was reported as none. It was reported that the patient received soy formula along with breast feeding. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 07-Jan-2017, 12 hours following the vaccination, the patient experienced diarrhea and generalized rash. The patient was evaluated in the emergency department. Relevant laboratory investigations were not reported. The patient received topical steroids as corrective treatment. On an unspecified date, the patient recovered from the events. List of documents held by the sender: None.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Redness on the arm that received the vaccine between the vaccine location below the shoulder and the elbow on the left arm. The next day the redness spread covering almost all upper arm and is puffy and warm with one very hard lump on the inside of the arm just above the elbow.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site rash, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in arm of injection from neck down to hand. Localized swelling and rash at injection site.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash, Secondary transmission, Varicella post vaccine
Clinical narrative: CHILD BROKE OUT IN RASH APPROXIMATELY 1-2 WEEKS AFTER VACCINATION WITH VARICELLA DOSE #2,  WAS SEEN BY PMD AND DIAGNOSED WITH CHICKEN POX. PARENT BROUGHT CHILD BACK TO OUR CLINIC, 2/13/2017. FATHER STATES THAT CHILD GAVE CHICKEN POX TO HER 1 YEAR OLD UNVACCINATED SISTER.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Patient stated that the next day after vaccination he broke out in hives all over the body.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Seizure, Syncope
Clinical narrative: Client experienced a syncopal episode lasting 10-15 seconds, with arms and legs convulsing twice during episode. Client then became alert & confused with rapid improvement to oriented to person, place & time.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 100.2.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site ulcer, Pain
Clinical narrative: Pain deep in upper left arm and shoulder affecting movement. Not severe, but troubling enough to take anti-inflammatory drugs for relief. Also, the injection site did not fully heal for about 10 weeks. It was a small knot on my upper arm with a sore that would not go away. The sore finally healed but the knot is still in my arm. The pain from moving my arm and laying on my arm is still there today (2-15-17). Again, it is not debilitating, but definitely painful enough to force me to make modifications to the way I do certain things.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain deep in upper left arm and shoulder affecting movement. Not severe, but troubling enough to take anti-inflammatory drugs for relief. Also, the injection site did not fully heal for about 10 weeks. It was a small knot on my upper arm with a sore that would not go away. The sore finally healed but the knot is still in my arm. The pain from moving my arm and laying on my arm is still there today (2-15-17). Again, it is not debilitating, but definitely painful enough to force me to make modifications to the way I do certain things.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Angina bullosa haemorrhagica, Computerised tomogram, Contusion, Full blood count, Gingival bleeding
Clinical narrative: NOTICED GIANT PURPLE BRUISES ON FOREARMS, LEGS COVERED IN SMALL PURPLE SPOTS, GUMS BLEEDING AND BIG BLOOD BLISTERS INSIDE MOUTH UNDER TONGUE.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count abnormal, Platelet transfusion, Thrombocytopenia
Clinical narrative: NOTICED GIANT PURPLE BRUISES ON FOREARMS, LEGS COVERED IN SMALL PURPLE SPOTS, GUMS BLEEDING AND BIG BLOOD BLISTERS INSIDE MOUTH UNDER TONGUE.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan, X-ray
Clinical narrative: NOTICED GIANT PURPLE BRUISES ON FOREARMS, LEGS COVERED IN SMALL PURPLE SPOTS, GUMS BLEEDING AND BIG BLOOD BLISTERS INSIDE MOUTH UNDER TONGUE.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: PAIN AT INJECTION SITE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: As reported by MD office patient presented to office with rash on upper arm above elbow but area where shot would have been given. not warm, not swollen, ink in color 13cm x 6.5 cm, no streaking. patient told to take benadryl otc.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swealling at the site of injection, red, and hot to touch.
Age: 6.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The entire shoulder where injection was given was red swollen, I have a picture of it.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in my arm that will not go away. Hurts all the time. Doctor told me that it had nothing to do with the flu shot. Gave me meloxicam for pain. It gave me acid reflux. So now I try ADVIL for pain. It does not help. Neither did the doctor.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: Pain in my arm that will not go away. Hurts all the time. Doctor told me that it had nothing to do with the flu shot. Gave me meloxicam for pain. It gave me acid reflux. So now I try ADVIL for pain. It does not help. Neither did the doctor.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Decreased appetite, Hyporesponsive to stimuli, Mobility decreased, Oral mucosal eruption, Poor feeding infant
Clinical narrative: Fever 103, decreased feeding, not rolling over; seen in clinic 2/13/17 and had normal exam; fever again overnight and had some clear rhinorrhea and slight throat clearing and seen in clinic 2/14/17 with normal exam other than slight increase in previously noted rash on side of mouth; parent reported fever again 2/15/17 and decreased responsiveness and poor feeding-indicated parent preference to have further evaluation elsewhere.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Fever 103, decreased feeding, not rolling over; seen in clinic 2/13/17 and had normal exam; fever again overnight and had some clear rhinorrhea and slight throat clearing and seen in clinic 2/14/17 with normal exam other than slight increase in previously noted rash on side of mouth; parent reported fever again 2/15/17 and decreased responsiveness and poor feeding-indicated parent preference to have further evaluation elsewhere.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Chest discomfort, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Patient started experiencing unusual  symptoms starting the morning of 2/11/17. Symptoms included extreme pounding headache sometimes relieved by APAP. She had muscle and joint  pain and nerve pain radiating throughout the body. Patient had on and off heavy breathing, chest tightness and intermittant increased heart rate. She also has a rash that stretches from the front to back side of her body concentrating mainly on the right side of the body where shot was given. Fever spiked to 102F on the 1st and 2nd day after the shot. Temp back to 99F on 2/13/17. Patient also felt drowsy and loss of appetite.  Fingers were somewhat swollen.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Heart rate increased, Myalgia, Neuralgia, Peripheral swelling, Pyrexia
Clinical narrative: Patient started experiencing unusual  symptoms starting the morning of 2/11/17. Symptoms included extreme pounding headache sometimes relieved by APAP. She had muscle and joint  pain and nerve pain radiating throughout the body. Patient had on and off heavy breathing, chest tightness and intermittant increased heart rate. She also has a rash that stretches from the front to back side of her body concentrating mainly on the right side of the body where shot was given. Fever spiked to 102F on the 1st and 2nd day after the shot. Temp back to 99F on 2/13/17. Patient also felt drowsy and loss of appetite.  Fingers were somewhat swollen.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Somnolence
Clinical narrative: Patient started experiencing unusual  symptoms starting the morning of 2/11/17. Symptoms included extreme pounding headache sometimes relieved by APAP. She had muscle and joint  pain and nerve pain radiating throughout the body. Patient had on and off heavy breathing, chest tightness and intermittant increased heart rate. She also has a rash that stretches from the front to back side of her body concentrating mainly on the right side of the body where shot was given. Fever spiked to 102F on the 1st and 2nd day after the shot. Temp back to 99F on 2/13/17. Patient also felt drowsy and loss of appetite.  Fingers were somewhat swollen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient experienced itchiness that started at the back of the neck and spreaded to the chest and upper body.  The itching areas are red and flat and occured quite frequently.  The injection area was also red and swollen.  When the presciber was contacted on 2/14/2017, they felt  that the reactions that patients was experiencing may not be immunization related.  They recommended that patient take benadryl when necessary.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. given PNEUMOVAX 23 vaccine 2/13/17 at 10:30 am. On 2/14/17 she had a warm feeling at injection site with erythema down to elbow. TX with Doxycycline for 10 days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: Lump in left leg with bruising. 10 mm by 10 mm bruise.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Chills, Feeling cold, Injected limb mobility decreased, Injection site pain
Clinical narrative: About 4 hours after getting my pneumovax, I experienced pain from the injection site to the tip of my fingers. I was unable to lift my arm because the pain was so severe. When I went to bed around 10 pm, I was awakened around 11:30 pm because I felt extremely cold, as if I the heat system in my house had failed. I got up an push my thermostat up, added two blankets to the bed, put on a robe over my flannel pj's and tried to sleep. The chills were uncontrollable and I felt my bones were aching due to the severe chills, I was unable to sleep. I got back up and took 2 TYLENOL to see if it would help, but I have been instructed by my cardiac physician not to take TYLENOL. I did it anyway to see if I could get some relief. Around approx. 4pm, I fell asleep. When I woke up this morning my arm still hurts quite a bit, but the chills are gone.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: About 4 hours after getting my pneumovax, I experienced pain from the injection site to the tip of my fingers. I was unable to lift my arm because the pain was so severe. When I went to bed around 10 pm, I was awakened around 11:30 pm because I felt extremely cold, as if I the heat system in my house had failed. I got up an push my thermostat up, added two blankets to the bed, put on a robe over my flannel pj's and tried to sleep. The chills were uncontrollable and I felt my bones were aching due to the severe chills, I was unable to sleep. I got back up and took 2 TYLENOL to see if it would help, but I have been instructed by my cardiac physician not to take TYLENOL. I did it anyway to see if I could get some relief. Around approx. 4pm, I fell asleep. When I woke up this morning my arm still hurts quite a bit, but the chills are gone.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm swelling, redness, warm to touch and itching. Patient advised to apply cold compress and antihistamine for itching. Denies fever.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: Site enlarged around injection size of a quarter - advised to take BENADRYL as directed.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Haemangioma, Swelling
Clinical narrative: Vaccine was administered approximately 2 in away from where there was a hemangioma. Next day patient noticed significant swelling of the hemangioma.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Full blood count, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Patient received Tdap on 2/10/17, R am. Came in 2/15/17 to be seen. Positive pain, positive warm, no erythema whole arm hurts - injection site appears to be too far anterior of deltoid, swelling noted.