chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients received improperly stored doses of RECOMBIVAX HB lot # M010212, expiration date 21-JAN-2019 (dose and route of administration were not provided) for prophylaxis. There were no adverse events reported. Administered doses of RECOMBIVAX HB were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007868: US-009507513-1701USA007869: US-009507513-1701USA007870: US-009507513-1701USA007871:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored dosages at -11C for 63 hours, of VARIVAX (Lot numbers M006156, exp. 13-JUL-2018 and M006156, exp. 05-FEB-2018), subcutaneously for prophylaxis. Excursion temperatures were: -12C for 4 hours and 20 minutes; -8.5C for 13 hours; -8C for 3 hours and 40 minutes, and -12.6C for 1 hour and 40 minutes. No adverse effects were reported. The call was made because of a "data logger". Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a Medical assistant concerning to a 20 year old female patient. The patient had no concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 09-JAN-2017 in the morning, the patient was vaccinated with the second dose of GARDASIL 9 (lot number M031557, expiration date 07-APR-2018; dose and route were not reported) for prophylaxis. On 09-JAN-2017 at night, the patient experienced fever, chills, body ache and headache. The patient took ibuprofen to try to help alleviate the symptoms and had no laboratory diagnostics studies performed. The patient did not seek medical attention. A product quality complaint was not involved. At the time of the report, the patient was not recovered from any of the events. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a medical technologist, referring to an 18 year old female patient. The patient had no pertinent medical history, no known drug reactions or allergies, and was not pregnant at the time of the report. Concurrent conditions were not reported. On an unknown date in 2004, the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2015, the patient was administered the booster shot of the vaccine (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included ethinyl estradiol, norethindrone acetate (LOESTRIN). On 26-JUL-2016, the patient visited her doctor for a physical and to get updated on her vaccines. A titer test performed on that date showed negative results (antibody test negative). No treatment was given for the negative titers. The outcome of antibody test negative was reported as not recovered/not resolved. The reporter did not assess the causality between the antibody test negative and therapy with VARIVAX. No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unspecified age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications reported. On 10-JAN-2017, the patient was vaccinated with an expired dose of VAQTA, concentration: 50/1.0 U/ml, lot number: L048222 with expiration date: 19-DEC-2016 (dose was not provided) administered intramuscularly for prophylaxis.  No adverse effects were reported.  There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on unspecified dates, an unspecified number of patients might had received doses of improperly stored VARIVAX for prophylaxis (dose, route, anatomical location, lot/batch number and expiration date 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. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacteraemia, Cellulitis, Erythema, Malaise, White blood cell count increased
Clinical narrative: This spontaneous report was received from a 35 year old female patient, who was reporting on herself. The patient's pertinent medical history was not reported. The patient's concurrent conditions included asthma. The patient's allergies included allergy to gluten. The patient's concomitant medications included MICROGESTIN and DULERA. On 06-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (reported as "advice to receive vaccine"; route, lot # and expiration date were not reported). It was reported that after receiving the PNEUMOVAX 23 the patient experienced redness in the arm on the same date. Then, on 07-JAN-2017, the patient went to the emergency room because she was not feeling well where she was told that her white blood count was "high", so she was given unspecified medications and was sent to home. After that, the patient returned to the same hospital's emergency room  (adverse event) and was later admitted on 08-JAN-2017 to the emergency room and was hospitalized the same day. During hospitalization, it was stated that the patient was diagnosed with a blood infection and cellulitis. The patient was released from hospital on 11-JAN-2017. At the time of reporting the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review blood infection and cellulitis were determined to be medically significant events. Additional information is not expected because the reporter refused consent for follow up.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein increased, Cellulitis, Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from a 35 year old female patient, who was reporting on herself. The patient's pertinent medical history was not reported. The patient's concurrent conditions included asthma. The patient's allergies included allergy to gluten. The patient's concomitant medications included MICROGESTIN and DULERA. On 06-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (reported as "advice to receive vaccine"; route, lot # and expiration date were not reported). It was reported that after receiving the PNEUMOVAX 23 the patient experienced redness in the arm on the same date. Then, on 07-JAN-2017, the patient went to the emergency room because she was not feeling well where she was told that her white blood count was "high", so she was given unspecified medications and was sent to home. After that, the patient returned to the same hospital's emergency room  (adverse event) and was later admitted on 08-JAN-2017 to the emergency room and was hospitalized the same day. During hospitalization, it was stated that the patient was diagnosed with a blood infection and cellulitis. The patient was released from hospital on 11-JAN-2017. At the time of reporting the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review blood infection and cellulitis were determined to be medically significant events. Additional information is not expected because the reporter refused consent for follow up.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: This spontaneous report was received from a 35 year old female patient, who was reporting on herself. The patient's pertinent medical history was not reported. The patient's concurrent conditions included asthma. The patient's allergies included allergy to gluten. The patient's concomitant medications included MICROGESTIN and DULERA. On 06-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (reported as "advice to receive vaccine"; route, lot # and expiration date were not reported). It was reported that after receiving the PNEUMOVAX 23 the patient experienced redness in the arm on the same date. Then, on 07-JAN-2017, the patient went to the emergency room because she was not feeling well where she was told that her white blood count was "high", so she was given unspecified medications and was sent to home. After that, the patient returned to the same hospital's emergency room  (adverse event) and was later admitted on 08-JAN-2017 to the emergency room and was hospitalized the same day. During hospitalization, it was stated that the patient was diagnosed with a blood infection and cellulitis. The patient was released from hospital on 11-JAN-2017. At the time of reporting the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review blood infection and cellulitis were determined to be medically significant events. Additional information is not expected because the reporter refused consent for follow up.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacteraemia, Cellulitis, Erythema, Malaise, White blood cell count increased
Clinical narrative: Fevers, chills, myalgias, local cellulitis.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein increased, Cellulitis, Chills, Myalgia, Pyrexia
Clinical narrative: Fevers, chills, myalgias, local cellulitis.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Fevers, chills, myalgias, local cellulitis.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of LIQUID PEDVAXHIB lot # M025194, expiration date 22-MAR-2019 (dose and route of administration were not provided) for prophylaxis. There were no adverse events reported. Administered doses of LIQUID PEDVAXHIB were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007869: US-009507513-1701USA007870: US-009507513-1701USA007871: US-009507513-1701USA003063:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of GARDASIL 9 with lot numbers L040054 and M024261; and expiration dates 26-DEC-2017 and 30-JUL-2018 respectively (dose and route of administration were not provided) for prophylaxis. There was no adverse events reported. Administered doses of GARDASIL 9 were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007868: US-009507513-1701USA007870: US-009507513-1701USA007871: US-009507513-1701USA003063.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of PNEUMOVAX 23 lot # L019836, expiration date 24-MAR-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse events reported. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of 35 degree F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007868: US-009507513-1701USA007869: US-009507513-1701USA007871: US-009507513-1701USA003063.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of ROTATEQ with lot numbers M007301 and M011832; and expiration dates 19-NOV-2017 and 25-JAN-2018 respectively, orally (dose was not provided) for prophylaxis. There were no adverse events reported. Administered doses of ROTATEQ were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007868: US-009507513-1701USA007869: US-009507513-1701USA007870: US-009507513-1701USA003063:
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's medical history and concurrent condition were not reported. He had no illness at the time of vaccination. His concomitant therapies included an unidentified Merck HPV vaccine, RECOMBIVAX HB, hepatitis a virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and VACCIN TD. On 04-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K016153, expiration date 24-SEP-2016, exact dose was not reported), subcutaneously, in the right arm. No adverse effects were reported. A safety report was run and it was stated that the vaccine was safe and effective even though expired. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA002517.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure, Syncope
Clinical narrative: Syncope vs. seizure.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Seizure
Clinical narrative: 15 second Seizure with fever to 102.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician referring to an 85 year old female patient with hypertension, mitral valve prolapse, osteoarthritis, chronic colitis ulcerative and sulfonamide allergy. The patient's medical history included cerebrovascular accident. On 25-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX administered subcutaneously (strength, dose, lot number and expiration date were not provided) for prophylaxis, at unspecified local facility. Concomitant therapies included naproxen sodium (ALEVE), alprazolam, aspirin (manufacturer unknown), losartan potassium (manufacturer unknown), metoprolol, sertraline hydrochloride, spironolactone and colostrum. On approximately 27-OCT-2016, 3 days after vaccine administration, the patient experienced diffuse umbilicated rash at the injection site (injection site rash) and it spread to both arms and legs, which looks like chicken pox (rash vesicular). At the time of reporting, the outcome of injection site rash and rash vesicular was reported as not recovered. The causal relationship between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 63 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The reporter stated that a dose of ZOSTAVAX was reconstituted previously and stored for 2 months in a refrigerator, subsequently, on 05-JAN-2017 (also reported as "today"), the patient was vaccinated with that dose of ZOSTAVAX (concentration, dose number, dose and route were not reported) which had a lot # of L031272, an expiration date for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The pharmacist reported that on 05-OCT-2016, the patient was administered a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient was inadvertently administered a second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) on 09-JAN-2017. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from Physician Assistant (PA) concerning a 17 year old male. Medical history and concomitant medications were not specified. On 26-AUG-2016 and 26-OCT-2016, the male received his first and second GARDASIL 9 vaccinations, respectively. The PA reported that the male received his third vaccination of GARDASIL 9 too early. He received the third vaccination on 09-JAN-2017 intramuscularly (lot # M033583; expiration 14-APR-2019). The patient did not report any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender.      The patient's medical history or concomitant medications were not reported. On an unknown date in 2013 (reported as 4 years ago), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot number not reported). On an unknown date, the patient developed chickenpox. The outcome of of the event was unknown.       The relationship between vaccination with ZOSTAVAX and the event was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Malaise, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 10Jan2017 at single dose for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced nausea and threw up, chills, feels achy and did not feel well on 13Jan2017 with outcome of unknown.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Feeling hot, Injection site warmth, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 67-year-old male patient received on 16Sep2016 11:38 PREVNAR 13, (lot number M98915, expiration date 30Sep2017, NDC number 0005197101) at 0.5 ml single dose in the left arm as routine vaccination. Concomitant medication included ongoing losartan for blood pressure since an unknown date (it was reported that has been taking for at least 1 year). Medical history included elevated blood pressure and diabetes, both ongoing. On 16Sep2016 the patient had redness, injection site warmth, body aches, weakness, felt warm and painful arm. Course was as follows: the patient received vaccination on 16Sep2016.  He came back into the office on 19Sep2016 and reported that the evening that he received the pneumococcal 13-val conj vac (dipht crm197 protein), he experienced redness, warmth at the injection site, body aches, weakness and felt warm. His arm pain was initially a 7/10, then a 5/10 and when he came to the office on 19Sep2016 it was a 4/10.  He has noticed improvement in the redness and pain. He followed up again on 22Sep2016 and the redness and pain had improved further. He has not been in contact with the office since, so the caller does not know if the side effects have continued to improve or resolve. He was supposed to come into the office on 09Dec2016, but he canceled that appointment. The patient was advised to continue taking Ibuprofen, 400mg, for the pain and to contact the office if the side effects did not resolve. Outcome was unknown.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse. A 67-year-old male patient received on 16Sep2016 11:38 PREVNAR 13, (lot number M98915, expiration date 30Sep2017, NDC number 0005197101) at 0.5 ml single dose in the left arm as routine vaccination. Concomitant medication included ongoing losartan for blood pressure since an unknown date (it was reported that has been taking for at least 1 year). Medical history included elevated blood pressure and diabetes, both ongoing. On 16Sep2016 the patient had redness, injection site warmth, body aches, weakness, felt warm and painful arm. Course was as follows: the patient received vaccination on 16Sep2016.  He came back into the office on 19Sep2016 and reported that the evening that he received the pneumococcal 13-val conj vac (dipht crm197 protein), he experienced redness, warmth at the injection site, body aches, weakness and felt warm. His arm pain was initially a 7/10, then a 5/10 and when he came to the office on 19Sep2016 it was a 4/10.  He has noticed improvement in the redness and pain. He followed up again on 22Sep2016 and the redness and pain had improved further. He has not been in contact with the office since, so the caller does not know if the side effects have continued to improve or resolve. He was supposed to come into the office on 09Dec2016, but he canceled that appointment. The patient was advised to continue taking Ibuprofen, 400mg, for the pain and to contact the office if the side effects did not resolve. Outcome was unknown.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Feeling hot, Nausea, Pruritus, Vomiting
Clinical narrative: c/o dizziness, lightheadedness, itching, Nausea and feeling hot. Client vomited x1. No hives noted.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood test, Electroencephalogram, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Seizures, spent 3 days in ICU had tons of tests done, baby now on seizures medication, leg also swelled up and still has hard lump.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging, Seizure, Urine analysis
Clinical narrative: Seizures, spent 3 days in ICU had tons of tests done, baby now on seizures medication, leg also swelled up and still has hard lump.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Ear discomfort, Ear pain, Head discomfort, Inflammation
Clinical narrative: Right inner earache - persistent. Sense of balance upset - unsteady feeling. Discomfort and sensitivity to touch on top of head. Painful swelling of lymph node under right jaw leading to discomfort on swallowing. Migration of touch and discomfort sensitivity of area to back of neck and both ears and continued swallowing discomfort on 13, 14 and 15 January. Made doctor's office visit on Monday January 16 at 11:30 AM and was examined by Dr., who found no active infection, but concurred that the effects being experienced were likely an adverse reaction to the PREVNAR 13 vaccination shot administered on 6 Jan 17. She prescribed an antibiotic (azithromycin 250 mg) to be taken if symptoms persisted or worsened. Advised taken Ibuprofen 400 mg twice a day to reduce inflammation. Symptoms persisted on 17 and 18 Jan with continued. Have not started taken antibiotic.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal discomfort, Odynophagia, Tenderness
Clinical narrative: Right inner earache - persistent. Sense of balance upset - unsteady feeling. Discomfort and sensitivity to touch on top of head. Painful swelling of lymph node under right jaw leading to discomfort on swallowing. Migration of touch and discomfort sensitivity of area to back of neck and both ears and continued swallowing discomfort on 13, 14 and 15 January. Made doctor's office visit on Monday January 16 at 11:30 AM and was examined by Dr., who found no active infection, but concurred that the effects being experienced were likely an adverse reaction to the PREVNAR 13 vaccination shot administered on 6 Jan 17. She prescribed an antibiotic (azithromycin 250 mg) to be taken if symptoms persisted or worsened. Advised taken Ibuprofen 400 mg twice a day to reduce inflammation. Symptoms persisted on 17 and 18 Jan with continued. Have not started taken antibiotic.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Right inner earache - persistent. Sense of balance upset - unsteady feeling. Discomfort and sensitivity to touch on top of head. Painful swelling of lymph node under right jaw leading to discomfort on swallowing. Migration of touch and discomfort sensitivity of area to back of neck and both ears and continued swallowing discomfort on 13, 14 and 15 January. Made doctor's office visit on Monday January 16 at 11:30 AM and was examined by Dr., who found no active infection, but concurred that the effects being experienced were likely an adverse reaction to the PREVNAR 13 vaccination shot administered on 6 Jan 17. She prescribed an antibiotic (azithromycin 250 mg) to be taken if symptoms persisted or worsened. Advised taken Ibuprofen 400 mg twice a day to reduce inflammation. Symptoms persisted on 17 and 18 Jan with continued. Have not started taken antibiotic.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: I gave a PROQUAD and a varicella to a 1 year old.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report has been received from a female consumer of unknown age reporting on herself. None patient's medical history, drug reactions or allergies were reported. Concomitant therapies included calcium (unspecified) and vitamin d (unspecified). On 10-JAN-2017, the patient was vaccinated during an unspecified meeting with ZOSTAVAX, subcutaneously  (dose, frequency, lot# and expiration date were unknown by the reporter) for prevent shingles. On 12-JAN-2017, the patient experienced "a big red spot that was the circumference of a golf ball and felt hot", around the injection site. Product quality was not involved. The patient reported that she did not received treatment for the adverse event and also none laboratory diagnostic studies were performed. Additionally, she did not sought medical attention. At the time of reporting the outcome of "a big red spot that was the circumference of a golf ball and felt hot" was reported as not recovered.  The relatedness between the event and ZOSTAVAX, was not reported    Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Crying, Decreased appetite, Urine output decreased
Clinical narrative: This is a spontaneous report from a contactable nurse.   A 8-month-old female patient received on 25Apr2016, at 1 day old, the first single dose of pneumococcal 13-val conj vac (dipht crm197 protein) intramuscular in leg , first dose of hepatitis B vaccine intramuscular in leg, first dose of diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP) , intramuscular in leg and first dose of polio vaccine (IPV) intramuscular in leg , all for routine immunization.On 24Jun2016 at 2 months, she received the first dose rotavirus vaccine orally before noon and second dose of hepatitis B vaccine intramuscular in leg, all for routine immunization. The patient medical history was not reported.  Concomitant medication included ergocalciferol (VITAMIN D) from May2016 to 24Oct2016 as supplement for breastfed babies. On 24Jun2016 the patient did not nurse well, as far as breast feeding and experienced uncontrollable crying and had only two maybe three wet diapers the first two days after receiving these injections. In 2016 HIPPA violation occurred since patient missed all of her four months vaccines and all of her six months vaccines, which were not given because events experienced with previous vaccinations. Event did not nurse well completely recovered in Jun2016 (reported as around 26Jun2016); uncontrollable crying completely recovered on 25Jun2016 and  urine volume decreased completely recovered on 26Jun2016. Events were all related to suspect  vaccines. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine  has submitted the same report to the regulatory authorities.
Age: 1.58
Sex: M
Vaccine: DTAPH
Symptoms: Eye operation, Strabismus
Clinical narrative: I started to notice that his left eye was crossing.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling cold, Injection site pain, Pain
Clinical narrative: Pain at injection site, overall body pain, feeling of cold.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: Fluzone Quad administered SQ.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed hives and rash directly after given PNEUMOVAX 23 IM administered at the pharmacy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction. Patient saw primary doctor for evaluation.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Food intolerance, Rash generalised, Rash pruritic, Temperature intolerance
Clinical narrative: Patient reports "small knots" that appear and disappear over body that and are itchy associated with heat and acidic foods.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Anaphylactic reaction, Diarrhoea, Dizziness, Malaise
Clinical narrative: Evening 1/17:  Stomach pain and diarrhea Mid-day 1/18:  Anaphylactic reaction (airway constriction, dizziness, sore throat, general malaise and involuntary tremors in upper arms); Required visit to urgent care where doctor gave patient 125MG IM Solu-Medrol and symptoms immediately subsided.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Evening 1/17:  Stomach pain and diarrhea Mid-day 1/18:  Anaphylactic reaction (airway constriction, dizziness, sore throat, general malaise and involuntary tremors in upper arms); Required visit to urgent care where doctor gave patient 125MG IM Solu-Medrol and symptoms immediately subsided.
Age: 25.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Urticaria
Clinical narrative: Patient reports hives.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Lethargy, Neck pain, Pain in extremity
Clinical narrative: Arm and neck completely sore, large bump at injection site, and very lethargic. Patient is fine now.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash pruritic, Skin irritation
Clinical narrative: Had mosquito-like bumps, bigger than regular mosquito bites, about 4 or 5 bumps in  area of arm close to elbow.  bumps were irritating and itchy.  went away after 12 hours. no signs of bumps, itchiness after 12 hours.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Local reaction, Peripheral swelling
Clinical narrative: Pt came back today & had localized reaction to IMZ. She had redness & swelling across arm area. No bruising at injection site. She told me after the injection that she had been having therapy on her right arm & I asked her why she didn't tell us that previously & we would of done IMZ in her other arm & she said because she had injected her insulin in her left arm & we discussed why she was giving that in her arm & not her thigh or abdomen. I told her to be sure to let Dr know she had IMZ when she went back to therapy. She tensed up when getting IMZ & said it hurt. And I told her she may have soreness or bruising due to that. When she presented with the reaction today I instructed her to apply ice packs & got her some Benadryl to take every 4 to 6 hours as needed. I called her back tonight to check on her & she said it was still swollen some but she was able to rest with no problem.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Eye oedema, Face oedema, Injection site discolouration, Injection site erythema, Injection site mass
Clinical narrative: Patient called to report reaction to TDaP vaccine received in (L) deltoid on 1-9-17. Patient reports that after approximately 6 hours from receiving vaccine, she developed pain/ache in (L) deltoid with a baseball size lump, which she reports has now decreased to the size of a half dollar. She reports injection site was originally erythemic, edematous, and tender to touch. She now reports area as being purple in color, pruritic, with (L) shoulder pain, tingling sensation down left arm and into (L) 4th and 5th digit. She states she had also experienced edema to the (L) side of her neck, jaw and eye, with associated tenderness. She reports those S/S have now dissipated with a small amount of residual tenderness. She reports full ROM to (L) arm, continued tenderness with movement, and no HX of allergic reaction. She denies anaphylaxis, SOB, chest pain, wheezing, difficulty breathing, headache, abdominal pain, N/V/D. She states she read on the CDC website that above stated symptoms are associated with this injection and that she just wanted it documented in her record. Patient triaged with recommendation to be seen by PACT to which she declined, stating S/S are improving. Educated patient as to worsening S/S, anaphylaxis and to seek immediate medical attention. She verbalized understanding. Informed her this nurse would place note for team, and am requesting F/U call for them to discuss with her. She verbalized understanding and was agreeable. Team notified.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Injection site pain, Injection site paraesthesia, Injection site pruritus, Localised oedema
Clinical narrative: Patient called to report reaction to TDaP vaccine received in (L) deltoid on 1-9-17. Patient reports that after approximately 6 hours from receiving vaccine, she developed pain/ache in (L) deltoid with a baseball size lump, which she reports has now decreased to the size of a half dollar. She reports injection site was originally erythemic, edematous, and tender to touch. She now reports area as being purple in color, pruritic, with (L) shoulder pain, tingling sensation down left arm and into (L) 4th and 5th digit. She states she had also experienced edema to the (L) side of her neck, jaw and eye, with associated tenderness. She reports those S/S have now dissipated with a small amount of residual tenderness. She reports full ROM to (L) arm, continued tenderness with movement, and no HX of allergic reaction. She denies anaphylaxis, SOB, chest pain, wheezing, difficulty breathing, headache, abdominal pain, N/V/D. She states she read on the CDC website that above stated symptoms are associated with this injection and that she just wanted it documented in her record. Patient triaged with recommendation to be seen by PACT to which she declined, stating S/S are improving. Educated patient as to worsening S/S, anaphylaxis and to seek immediate medical attention. She verbalized understanding. Informed her this nurse would place note for team, and am requesting F/U call for them to discuss with her. She verbalized understanding and was agreeable. Team notified.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Patient called to report reaction to TDaP vaccine received in (L) deltoid on 1-9-17. Patient reports that after approximately 6 hours from receiving vaccine, she developed pain/ache in (L) deltoid with a baseball size lump, which she reports has now decreased to the size of a half dollar. She reports injection site was originally erythemic, edematous, and tender to touch. She now reports area as being purple in color, pruritic, with (L) shoulder pain, tingling sensation down left arm and into (L) 4th and 5th digit. She states she had also experienced edema to the (L) side of her neck, jaw and eye, with associated tenderness. She reports those S/S have now dissipated with a small amount of residual tenderness. She reports full ROM to (L) arm, continued tenderness with movement, and no HX of allergic reaction. She denies anaphylaxis, SOB, chest pain, wheezing, difficulty breathing, headache, abdominal pain, N/V/D. She states she read on the CDC website that above stated symptoms are associated with this injection and that she just wanted it documented in her record. Patient triaged with recommendation to be seen by PACT to which she declined, stating S/S are improving. Educated patient as to worsening S/S, anaphylaxis and to seek immediate medical attention. She verbalized understanding. Informed her this nurse would place note for team, and am requesting F/U call for them to discuss with her. She verbalized understanding and was agreeable. Team notified.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Head discomfort, Musculoskeletal discomfort
Clinical narrative: Mom reports child had dose of MENVEO last week and has had head and neck discomfort since; afebrile. Appt here to evaluate.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Skin rash. Treatment: Diphenhydramine 50 mg once.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling and redness at site of left thigh immunization. Worsened after 24 hrs. No fever. Swollen 5 cm in diameter with small urticarial lesion. Gave BENADRYL 1/2 tsp. Q6H.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Doing 12 month shots I gave varicella and grabbed a PROQUAD instead of MMR.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Polymyositis
Clinical narrative: Approx. 1 week after vaccination with FLUZONE-developed generalized muscle weakness. Treated with IV steroids, methotrexate. Dx - polymyocitis.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Syncope, Tremor
Clinical narrative: Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.Pt received HPV 9 vaccine at 3:20 pm. pt began to feel shaky in arms and legs, weak and faint. Pt BP 80/52 did not lose consciousness. Recovered and BP WNL after lying down, juice and crackers.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling
Clinical narrative: Vaccines given 1/13 and pt presented to ED (on 1/14) with redness/swelling/pruritus to (R) deltoid without fever. Symptoms did not improve and was seen again for additional lip swelling 1/16. Given Rx for ORAPRED/clindamycin. Little improvement and seen again 1/17 for similar.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling, X-ray
Clinical narrative: Vaccines given 1/13 and pt presented to ED (on 1/14) with redness/swelling/pruritus to (R) deltoid without fever. Symptoms did not improve and was seen again for additional lip swelling 1/16. Given Rx for ORAPRED/clindamycin. Little improvement and seen again 1/17 for similar.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives at site of injection at 10:48 am, both MMR and Varicella. BENADRYL 10 mg given in office at 10:50 am.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Vaccination complication
Clinical narrative: Reported as an adverse reaction to vaccine administration, but notes suggest that it may have been related to something the patient ate. Diarrhea. Hepatitis A 1 ml once.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis and concern for developing abscess at site of injection, 10 d. post immunization. Started treatment with BACTRIM, will f/u and consider I and D if needed.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: 2 hrs after vaccines (TDaP and MENACTRA) developed rash on face, back progressed scattered on body. No resp. symptoms/cardiac or GI. Went to ER. Given BENADRYL, diagnosed with allergic reaction sent home on BENADRYL. 1/14 still with on and off hives 1/17 JCC. hives - BENADRYL daily Claritin x 2wks.
Age: 14.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Cough, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: Fever, rash, red eyes, cough. Supportive care at home given. Symptoms 5-7 days.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and pain in the left upper arm. Started the night after she got her PNEUMOVAX. Erythema and warmth along upper left arm. Tx: Doxycycline Hyclate 100 mg BID x 10 days.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Rash, Swelling, Tenderness
Clinical narrative: (L) arm developed redness, swelling, tenderness, pain, 4" rash.
Sex: F
Vaccine: HPV2
Symptoms: Abdominal pain, Asthenia, Cognitive disorder, Constipation, Deafness
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of headache in a 16-year-old female subject who received CERVARIX. Concomitant products included CERVARIX. In June 2012, the subject received CERVARIX (Intramuscular). On an unknown date, unknown after receiving CERVARIX, the subject experienced headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), deafness (serious criteria clinically significant/intervention required), tinnitus (serious criteria clinically significant/intervention required), sensation of block in ear  (serious criteria clinically significant/intervention required), dizziness  (serious criteria clinically significant/intervention required), cognitive disorder (serious criteria clinically significant/intervention required), sleep disorder (serious criteria clinically significant/intervention required), constipation (serious criteria clinically significant/intervention required), diarrhoea (serious criteria clinically significant/intervention required), menstruation irregular (serious criteria clinically significant/intervention required), generalised aching (serious criteria clinically significant/intervention required), malaise (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), sensory aberrations (serious criteria clinically significant/intervention required), nystagmus (serious criteria clinically significant/intervention required), weakness (serious criteria clinically significant/intervention required), abdominal pain (serious criteria clinically significant/intervention required), queasy (serious criteria clinically significant/intervention required), orthostatic dysregulation (serious criteria clinically significant/intervention required), and pain in jaw (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation , diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw were unknown. The reporter considered the headache, ear pain, deafness, tinnitus, sensation of block in ear, dizziness, cognitive disorder, sleep disorder, constipation, diarrhoea, menstruation irregular, generalised aching, malaise, tremor, sensory aberrations, nystagmus, weakness, abdominal pain, queasy, orthostatic dysregulation and pain in jaw to be related to CERVARIX.