chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K014191 with expiration date 10-MAY-2017 and lot # K010574 with expiration date 08-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been regarding from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # M021124 with expiration date 02-FEB-2018; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received via a company representative from a physician referring to a female patient in her 30's. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L09113, expiration date: 27-MAR-2017, first dose, intramuscular, dose was unknown) for recommendation vaccination. On an unknown date the patient experienced, fever, soreness, muscle tenderness, and extreme redness after receiving PNEUMOVAX 23. The patient sought medical attention via phone call or office visit for the events. The outcome of the events was reported as recovered/resolved. The causality between the events and PNEUMOVAX was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received via a company representative from a physician referring to a female patient over 65 years old. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L029113, expiration date: 27-MAR-2017, first dose, intramuscular, dose was unknown). On an unknown date the patient experienced fever, soreness, muscle tenderness, and extreme redness after receiving PNEUMOVAX 23. The patient sought medical attention via phone call or office visit for the events. The outcome of the events was reported as recovered/resolved. The causality between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at administration site extending down to elbow. Pt visited PCP and received prednisone per pt report. (visit on  7/28/16). RPH called to check on pt 7/29/16 and learned of PCP visit.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Induration, Local swelling, Pruritus
Clinical narrative: The day after vaccination the area was 2" raised, red and indurated. St became itchy and other similar lesion appeared. They look bruised after 24 hours. No vesicles.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: The day after vaccination the area was 2" raised, red and indurated. St became itchy and other similar lesion appeared. They look bruised after 24 hours. No vesicles.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Stomatitis
Clinical narrative: Lips allergy, inflammation mouth.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Pyrexia
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Basophil percentage increased, Blood bicarbonate decreased, C-reactive protein increased, Dizziness, Dizziness postural
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Eosinophil percentage, Fatigue, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Lymphocyte percentage decreased, Metabolic function test normal, Monocyte percentage increased, Myalgia, Nausea
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Neutrophil percentage, Pain, Pallor, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Tachycardia, Vomiting, White blood cell count normal
Clinical narrative: Received vaccine at 1:35 pm. Ate normal dinner. Before bed, developed headache and body rashes, with possible chills - no fever. In AM, awakened with fever, headache, dizziness (without vertigo), nausea, vomiting and generalized body aches. Exam - pallor, orthostatic dizziness and tachycardia. Treated with IV fluids/po ZOFRAN. Persistent fatigue - muscle aches - esp. in upper legs. Symptoms resolved with rest x approximately 5 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient with hypertension, diabetes, high cholesterol and hypothyroidism. The patient's medical history included shingles. The patient had no drug reactions or allergies. Concomitant medication was unknown. On 13-JUL-2016 the patient was vaccinated with a dose ZOSTAVAX (dose unknown, lot # L046900, expiration date 23-FEB-2017, subcutaneous). On 14-JUL-2016, the patient experienced a recurrence of shingles. The distribution of this most recent shingles outbreak, as well as past outbreaks, was her hip area. The patient called pharmacy for medical attention. At the time of reporting, the patient had not recovered from the event. Additional information is not expected since we have no consent to contact the pharmacist.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient with hypertension, diabetes, high cholesterol and hypothyroidism. The patient's medical history included shingles. The patient had no drug reactions or allergies. Concomitant medication was unknown. On 13-JUL-2016 the patient was vaccinated with a dose ZOSTAVAX (dose unknown, lot # L046900, expiration date 23-FEB-2017, subcutaneous). On 14-JUL-2016, the patient experienced a recurrence of shingles. The distribution of this most recent shingles outbreak, as well as past outbreaks, was her hip area. The patient called pharmacy for medical attention. At the time of reporting, the patient had not recovered from the event. Additional information is not expected since we have no consent to contact the pharmacist.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 16-year-old female patient who received BEXSERO (batch number 151401, expiry date 31st December 2016). On 6th JULY 2016, the patient received BEXSERO  .5ml. In JULY 2016, less than a week after receiving BEXSERO, the patient experienced myalgia and dizziness. On an unknown date, the outcome of the myalgia and dizziness were recovering/resolving. The reporter considered the myalgia and dizziness to be related to BEXSERO. Additional details were received as follows:  Additional details were received as follows: This case was previously reported to a doctor. The patient contacted the physician's practice the next day after vaccination because she was experiencing myalgia, mostly in the back and arms and dizziness. The patient was contacted by the physician's practice 48 hours after vaccination and she stated that the symptoms were resolving. The reporter was unable to provide any further details.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 16-year-old female patient who received BEXSERO (batch number 151401, expiry date 31st December 2016). On 6th JULY 2016, the patient received BEXSERO  .5ml. In JULY 2016, less than a week after receiving BEXSERO, the patient experienced myalgia and dizziness. On an unknown date, the outcome of the myalgia and dizziness were recovering/resolving. The reporter considered the myalgia and dizziness to be related to BEXSERO. Additional details were received as follows:  Additional details were received as follows: This case was previously reported to a doctor. The patient contacted the physician's practice the next day after vaccination because she was experiencing myalgia, mostly in the back and arms and dizziness. The patient was contacted by the physician's practice 48 hours after vaccination and she stated that the symptoms were resolving. The reporter was unable to provide any further details.
Age: 55.0
Sex: M
Vaccine: TDAP, FLU4, TDAP
Symptoms: Back pain, Injection site pain, Mobility decreased
Clinical narrative: Initial unsolicited report received from consumer (patient's wife) on 20 Jul 2016. This case involves a 56-year-old male patient who received a first dose of TDAP (batch number: unknown and expiry date and route of administration: not reported) in left deltoid on 23 Jun 2016. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 23 Jun 2016, same day post vaccination, patient's left arm and back of shoulder was in pain. The patient's laboratory data and corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: TDAP, FLU4, TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from consumer (patient's wife) on 20 Jul 2016. This case involves a 56-year-old male patient who received a first dose of TDAP (batch number: unknown and expiry date and route of administration: not reported) in left deltoid on 23 Jun 2016. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 23 Jun 2016, same day post vaccination, patient's left arm and back of shoulder was in pain. The patient's laboratory data and corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 17-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On 6th July 2016, the patient experienced BEXSERO. On 8th July 2016, 2 days after receiving BEXSERO, the patient experienced fever. On 9th July 2016, the patient experienced hives. In July 2016, the outcome of the fever was recovered/resolved. On 16th July 2016, the outcome of the hives was recovered/resolved. The reporter considered the fever and hives to be probably related to BEXSERO. Additional details were provided as follows: On the same day, the patient received BEXSERO and MENACTRA in his arms. The hives took one week to resolve. The healthcare professional did not have any product information.
Age: 17.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 17-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On 6th July 2016, the patient experienced BEXSERO. On 8th July 2016, 2 days after receiving BEXSERO, the patient experienced fever. On 9th July 2016, the patient experienced hives. In July 2016, the outcome of the fever was recovered/resolved. On 16th July 2016, the outcome of the hives was recovered/resolved. The reporter considered the fever and hives to be probably related to BEXSERO. Additional details were provided as follows: On the same day, the patient received BEXSERO and MENACTRA in his arms. The hives took one week to resolve. The healthcare professional did not have any product information.
Age: 19.0
Sex: M
Vaccine: HEPA, SMALL, TYP, HEPA, SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: Cross inoculation, an inch from original injection site.
Age: 19.0
Sex: M
Vaccine: HEPA, SMALL, TYP, HEPA, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: Cross inoculation, an inch from original injection site.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: CSF test, Full blood count normal, Headache, Laboratory test normal, Liver function test normal
Clinical narrative: Very high fever 103.6 severe headache which has not gone away. 2 visits to emergency room. He was admitted to Hospital on Thursday where he still is. Headache condition will not go away. Still in the hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Pyrexia, Urine analysis normal, Venogram normal
Clinical narrative: Very high fever 103.6 severe headache which has not gone away. 2 visits to emergency room. He was admitted to Hospital on Thursday where he still is. Headache condition will not go away. Still in the hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Angiogram, Blood test, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Very high fever 103.6 severe headache which has not gone away. 2 visits to emergency room. He was admitted to Hospital on Thursday where he still is. Headache condition will not go away. Still in the hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Pyrexia, Venogram
Clinical narrative: Very high fever 103.6 severe headache which has not gone away. 2 visits to emergency room. He was admitted to Hospital on Thursday where he still is. Headache condition will not go away. Still in the hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Migraine, Pyrexia
Clinical narrative: Very high fever 103.6 severe headache which has not gone away. 2 visits to emergency room. He was admitted to Hospital on Thursday where he still is. Headache condition will not go away. Still in the hospital.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: CSF test, Full blood count normal, Headache, Laboratory test normal, Liver function test normal
Clinical narrative: Fever for three days after. Constant migraine like headaches.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Pyrexia, Urine analysis normal, Venogram normal
Clinical narrative: Fever for three days after. Constant migraine like headaches.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Angiogram, Blood test, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Fever for three days after. Constant migraine like headaches.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Pyrexia, Venogram
Clinical narrative: Fever for three days after. Constant migraine like headaches.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Migraine, Pyrexia
Clinical narrative: Fever for three days after. Constant migraine like headaches.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7/30/2016 - Spoke to patient on the phone - patient stated there was a small bruise at injection site - right deltoid and upper arm (above shoulder) was tender, red, and swollen slightly - warm to the touch with noticeable pain. 7/31/2016 - Per patient on the phone, right deltoid pain has gone down however upper arm (above elbow) remains swollen, red, warm to touch, and tender to touch with pain. There is a bruise about 1/2" at injection site. Advised the patient to use ice packs throughout the day to reduce swelling and acetaminophen 500mg QID prn if necessary for pain - per patient, able to tolerate pain for now. Pharmacy will contact her throughout the next 2-3 days to inquire about status if warrant a visit to MD if symptoms worsen and do not improve.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Influenza like illness, Nasopharyngitis, Pain, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (consumer) on 09 October 2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of  FLUZONE QIV (batch number: unknown) administration not reported) in the left deltoid on 05 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as headache and illness at time of vaccination was reported as unknown. The patient was taking Advil for headache as concomitant medication. On 07 October 2015, two days after post vaccination; the patient experienced cold and congestion and had flu like symptoms with aching. The patient was taking Advil for the headache. It was also reported that the patient's husband had flu like congestion and cold with sore throat and she did not know which brand vaccine that he had. The patient's son also had a flu vaccine and she did not know which brand vaccine it was and he had cold and cough symptoms. Laboratory investigations and the corrective treatments were not reported. The final outcome for the events was reported as not recovered. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Adverse event, Cough, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (consumer) on 09 October 2015. This case involves a 55-year-old female patient who was vaccinated with an intramuscular dose of  FLUZONE QIV (batch number: unknown) administration not reported) in the left deltoid on 05 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as headache and illness at time of vaccination was reported as unknown. The patient was taking Advil for headache as concomitant medication. On 07 October 2015, two days after post vaccination; the patient experienced cold and congestion and had flu like symptoms with aching. The patient was taking Advil for the headache. It was also reported that the patient's husband had flu like congestion and cold with sore throat and she did not know which brand vaccine that he had. The patient's son also had a flu vaccine and she did not know which brand vaccine it was and he had cold and cough symptoms. Laboratory investigations and the corrective treatments were not reported. The final outcome for the events was reported as not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 6 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced unspecified reaction to FLUZONE HD. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 9 October 2015. This case is linked to 2015SA160781 (same reporter, different patients). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced cold and cough symptoms. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were unknown) along with other unspecified vaccinations. On an unknown date the patient experienced Guillain-Barre syndrome. The patient was taken to the emergency room where she received unspecified treatment (date unknown). The outcome of Guillain-Barre syndrome was unknown. Upon internal review, Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Induration, Pain, Pain in extremity, Swelling
Clinical narrative: Hardening and swelling of area.  Burning pain traveling throughout entire right arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to four patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 10-AUG-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Sex: U
Vaccine: VARZOS
Symptoms: Food allergy
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a patient over 60 years of age. The patient's concurrent condition, medical history and concomitant therapy were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date the patient experienced allergy to peanut. The patient did not have a peanut allergy prior to receiving ZOSTAVAX. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 12-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot#, dose and route were not reported). Then the second dose of the series was GARDASIL administered on 13-JAN-2016 (lot#, dose and route were not reported) and the last dose of the series was GARDASIL 9 administered on 23-JUL-2016 (lot#, dose and route were not reported) (interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Injection site reaction, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Pruritic maculopapular erythematous rash (approx 3-4 cm) on left upper thigh where MMRV vaccine was administered. Treated with OTC BENADRYL cream. Seen in the office 8/1/2016 by Dr.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Drug administered at inappropriate site, Exposure during pregnancy, Gestational hypertension
Clinical narrative: Initial unsolicited pregnancy report received from nurse on 29 Mar 2016. This case involves a 33-year old female patient who was vaccinated with a dose of ADACEL (batch number: U5316AA, expiry date: 30 Apr 2018, site of administration not reported) by intramuscular route on 22 Mar 2016 while she was pregnant. Pregnancy information included last menstrual period: 06 Aug 2015, estimated delivery date: 27 May 2016 and pregnancy trimester: third and gestational period at exposure: 30 weeks. Medical history and Concomitant medications were not reported. It was reported that the patient had no health issues (current pregnancy history). At the time of this report, the patient had not experienced any adverse events. Pregnancy outcome was not reported. Follow up information received from nurse on 17 Jun 2016 and 20 Jul 2016. Patient's demographics were updated. It was reported that 0.5 ml ADACEL (frequency: once) was administered intramuscularly in right buttock. Pregnancy information: It was reported that patient did not have any history of previous pregnancy and this was her first pregnancy. Patient was healthy during pregnancy until 37 weeks of gestation. The patient had medical history of depression, obesity, Factor V Leiden, former smoker and alcohol user. Illness at the time of vaccination was reported as none. No other vaccines given within four weeks prior to vaccination. Patient did not experience any adverse event following prior vaccination. Concomitant medication included ASCORBIC ACID/BIOTIN/MINERALS NOS/NICOTINIC  CID/RETINOL/TOCOPHEROL/VITAMIN B NOS/VITAMIN D NOS (PRENATAL VITAMINS) once daily orally from first trimester to throughout delivery. On 30 Apr 2016, one month after vaccination, the patient developed gestational hypertension. Vaccine administered at inappropriate site and product use issue were considered as the vaccine was not administered in recommended site. Routine second trimester OB ultrasound on 06 Jan 2016 was performed and result was normal. Relevant laboratory tests for event and corrective treatment were not reported. The outcome of event gestational hypertension was not reported. Pregnancy outcome: Patient delivered a healthy female baby (weight- 3.825 kg, Apgar score 08/09 (at 1 and 5 minutes respectively) via caesarean section (LTCS - due to gestational hypertension and arrest of descent) without complications. No congenital anomaly or birth defect in the baby. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from non-healthcare professional (office manager, patient's father) on 21 Jul 2016. This case involves a 14-year-old female patient who received a first dose of IMOVAX (batch number: L1355-1 and expiry date: 04 August 2017 and route of administration: not reported) intramuscularly in left deltoid on 29 Jun 2016. The patient's illness at time of vaccination was reported as none, the patient had no known allergies, birth defects and medical conditions were not reported. Concomitant medications were not reported. On 29 Jun 2016, same day post vaccination, the patient had a fever and aches. It was reported that, they do not want to give any further vaccines. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender none
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016342736) on 21-Jul-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA, a 0.5 ml dose of TRUMENBA (manufacturer: other) and a dose of HPV9 (manufacturer: other) (batch number, expiry date, route and site of administration: not reported for all the vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified day, following the vaccinations, the patient had passed out for a few seconds. The patient's laboratory data and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. Upon internal review, the company decided to consider the event as serious due to important medical event: passed out for a few seconds. List of documents held by sender: none. Sender's Comments: This a poorly documented case as patient passed out for few seconds following MENACTRA, TRUMENBA and HUMAN PAPILLOMA VIRUS VACCINE. Detail medical history, past vaccination history and its tolerance are needed to further assess this case. As multiple vaccine are administered, the role each vaccine cannot be evaluated.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported to imms on 7/25 with complaints of redness and swelling to left arm following PCV 13 vaccination. Patient's arm examined. Patient had a redden area on the deltoid area approximately the size of patients palm and slightly raised. Patient denied any pain at the time of visit but did indicate pain the day of vaccination. Full range of motion demonstrated. Declined fevers. Instructed patient to put ice and monitor for s/s of infection.
Age: 22.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: Cross inoculation on ankle.
Age: 34.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Face injury, Fall, Loss of consciousness, Syncope
Clinical narrative: Patient experienced vasovagal/syncope response, very briefly lost consciousness (<30 seconds) and fell to the floor (minor impact to forehead/bridge of nose).
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Musculoskeletal disorder, Pain in extremity, Secretion discharge
Clinical narrative: Got pneumococcal conjugate vaccine (PCV-13) on Mon., June 6th, 2016, went back to doctor Tues., June 7, 2016 w/extreme pain, no use of right arm got shot in and still to 7-20-16 and continuing cough since shot, thick, white, foamy mucus.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 09-JUL-2016, the patient  was vaccinated with ZOSTAVAX (strength 19400 PFU, lot # L046295, exp date 17-FEB-2017) subcutaneously. During administration, the vaccine "leaked back out of the injection site" and went down the patient's arm, resulting in topical exposure and administration of a partial dose. No adverse effect was reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse at a health center, refers to unspecified patients of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 21-JUN-2016 or thereafter, it is possible that these unspecified patients received improperly stored VARIVAX (lot #M007287 and exp date 12-FEB-2018, lot#M002064 and exp date 12-JAN-2016) subcutaneously. The reporting nurse stated that she noticed several doses of VARIVAX from two different lots removed from their boxes after it was determined that those lots had undergone a temperature excursion of 4 hours and 6 minutes at a maximum temperature of 45.3 degrees Fahrenheit, but nurse reporter was not certain if the product had been administered prior to or after the temperature excursion had occurred. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (lot # M003434 with expiration date 19-JUL-2017, lot # L044056 with expiration date 02-MAY-2017; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # L041207 with expiration date 20-OCT-2017, lot # M002061 with expiration date 12-JAN-2018; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Influenza like illness, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, intramuscular at 0.5 ml single in the deltoid on 21Jun2016 at 6:000PM. Medical history included ongoing diabetes. The patient was taking regular medications, but the details of those medications were unknown. At the time the vaccine was administered, the patient stated that she had never had the PREVNAR 13 vaccine in the past, but apparently she had in fact received PREVNAR 13 on 30Sep2015. Reporter also stated the patient developed a rash on her arm at the injection site and flu like symptoms on an unspecified date with outcome of unknown. The patient was hospitalized for was given vaccine twice and flu like symptoms on 19Jul2016.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history an drug reactions or allergies were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (lot # M000592 and expiration date 12-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. ON an unknown date the patient was administered a recently expired dose of PNEUMOVAX23 injection (dose and route unknown). No adverse effect was reported. Additional information is not expected as there is no report's contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ZOSTAVAX (lot # M001746 with expiration date 07-APR-2017; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blister, Pruritus generalised
Clinical narrative: Information has been received from a consumer regarding to her 17 years old daughter, who had no concomitant medication, pertinent medical history or drug reactions/allergies. On 12-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date and dose were unknown; intramuscular). On an unknown date in July 2016 (reported as a few days later), the patient experienced itching all over her body and also developed pimple like blisters all over her body. It was reported that the itching got worse when the patient was outside and she was hot and sweating. The patient sought medical attention by visiting the physician's office. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date, the patient was administered a dose GARDASIL injection (lot#, expiry, dose and route unknown). On 25-JUL-2016, the patient was administered the 2nd dose of the series with GARDASIL 9 injection (lot#, expiry, dose and route unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M004116 with expiration date 12-OCT-2017, 0.5 ml, route unknown). The GARDASIL was improperly stored at 29.8 degree Fahrenheit for 256 hours. There was no previous temperature excursion and it was unknown whether data logger was involved or not. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history involved. On 27-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger:  unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15  hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 2 year old patient. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On 26-JUL-2016, the patient was vaccinated with the second dose in the series of VAQTA 25/0.5 (united not provided) (lot # M002268 with expiration date 20-SEP-2017, route unknown). It was reported that the patient moved while the vaccine was injected and the patient received unknown amount of VAQTA (accidental under dose). It was unspecified when the first dose of VAQTA (lot #, expiration date and route were unspecified) was administered. No adverse effects were noted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from a physician via field representative posted on the website, refers to a female patient of unknown age. The patient's medical history, concurrent conditions and medical history were unknown by reporter. The article on the website stated a rare warning against GARDASIL injection due to reports of premature ovarian failure. The article also mentioned that one country has halted use of GARDASIL due to fertility concerns. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Hypersensitivity, Incomplete course of vaccination, Induration, Injection site pain
Clinical narrative: Client came in for Men B #2 on 7/25/16. After screening, client reported that following dose # 1 on 6/20/16 she experienced erythema, pain to site, induration, discomfort on many extremities, fever (temp not given) and warmth to touch for 7 days after administration. Called mfg to discuss adverse reaction and hypersensitivity noted as possible cause for symptoms. Dose #2 was not administered due to reported symptoms and hypersensitivity/adverse reaction.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Limb discomfort, Pyrexia, Skin warm
Clinical narrative: Client came in for Men B #2 on 7/25/16. After screening, client reported that following dose # 1 on 6/20/16 she experienced erythema, pain to site, induration, discomfort on many extremities, fever (temp not given) and warmth to touch for 7 days after administration. Called mfg to discuss adverse reaction and hypersensitivity noted as possible cause for symptoms. Dose #2 was not administered due to reported symptoms and hypersensitivity/adverse reaction.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Client came in for Men B #2 on 7/25/16. After screening, client reported that following dose # 1 on 6/20/16 she experienced erythema, pain to site, induration, discomfort on many extremities, fever (temp not given) and warmth to touch for 7 days after administration. Called mfg to discuss adverse reaction and hypersensitivity noted as possible cause for symptoms. Dose #2 was not administered due to reported symptoms and hypersensitivity/adverse reaction.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Hypersensitivity, Incomplete course of vaccination, Induration, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st DECEMBER 2016). In JUNE 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration, injection site warmth, fever and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site warmth and fever were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site induration, injection site warmth, fever and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The vaccination date was unclear, it could be 20th JUNE 2016 or 30th JUNE 2016. In 2016, the patient experienced fever, warm to touch, erythema and an induration at the injection site (left deltoid). the side effects resolved 1 week later. The healthcare professional wanted information on administering the second dose. The call was transferred to medical information system (MIS).