chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of GARDASIL 9 Lot # L023230, expiry date on 28-JUL-2017, were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patient were vaccinated with improperly stored PROQUAD (Merck) lot # L034931; expiry: 03-MAR-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended storage range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patient were vaccinated with improperly stored VARIVAX (Merck) lot # L023589; expiry: 26-JUN-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot # was administered) (dose, route of administration and location were not reported). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot # and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. 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 physician's assistant refers to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 83 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L033311, expiration date 01-DEC-2016), dose: 0.65 ml, administered subcutaneously. Post the vaccination, the patient advised pharmacist that, on an unspecified time in the past (reported as "years ago"), he received an earlier dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) (extra dose administered). Concomitant therapy was not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified multiple patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ oral, (lot numbers L008059 (expiration date 18-DEC-2016) and L013193 (expiration date 20-JAN-2017) (dose not provided). Concomitant therapies were not reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 13-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, route and site of administration 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of GARDASIL 9 lot # L007560 expiration date 16-JUN-2017 and lot # L016248 expiration date 30-JUL-2017 (indication and dose number were not reported), were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested .
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration 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: HEP
Symptoms: Adverse event, Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M- R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 form 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information  to complete the case was received.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received PNEUMOVAX at approx 2:50 PM. That evening developed softball size area of redness, warmth, pain, swelling at inj site (L) deltoid. ALEVE that night, symptoms have improved daily without any further treatment per pt.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Pt received PNEUMOVAX at approx 2:50 PM. That evening developed softball size area of redness, warmth, pain, swelling at inj site (L) deltoid. ALEVE that night, symptoms have improved daily without any further treatment per pt.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2015US164841, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601840) website on 14 Dec 2015. This report refers to a 17 years old male patient. The patient had no medical history and concurrent illness. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 15754P) intramuscularly into left arm on 11 Oct 2015. The patient was sitting down when the shot was given. Post vaccination while the patient was waiting in line to checkout, he fainted and fell to the floor. There was loss of consciousness. The patient regained consciousness quickly. Emergency (911) was called. The patient stated that he had not had anything to eat since 06:00 hours that day. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "faint", "fall" and "loss of consciousness" was upgraded based on information in the source document.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site inflammation
Clinical narrative: Case number PHHY2015US164750, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602150) website on 14 Dec 2015. This report refers to a 62 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into left arm on 21 Sep 2015. On 13 Oct 2015 the patient developed injection site reaction described as inflammation and possible infection. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "possible infection" was upgraded based on information in the source document.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Neuralgia
Clinical narrative: Severe pain (constant) originating from the intercostal nerves (left side).  Vaccine was administered in left deltoid.  Pain was exacerbated when respirating.  I applied BENGAY ointment and took extra strength TYLENOL with very little reduction in pain level.  Pain resolved by 9 PM on 13 December 2015.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Severe pain in the shoulder shot was given with difficulty moving the arm. Pain growing to the side of the arm and chest/neck area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash on right forehead from eyebrow through scalp.
Age: 49.0
Sex: F
Vaccine: DTP
Symptoms: Discomfort, Injection site pain, Injection site swelling, Injection site warmth, Lymph node palpable
Clinical narrative: Warmth and swelling at left upper arm injection site, sore. Palpable lymph node at left clavicle area, discomfort at outer front armpit area. No treatment. Seen and examined by MD.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Paraesthesia oral, Swollen tongue
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 32 year old female patient. It was reported that the patient had drug reactions/ allergies to LEVAQUIN (experienced tongue swelling after it) and Sulfa (described as hives and itching). The patient's historical condition included delivery (date not reported). No information regarding the patient's concomitant medications was provided. On 09-NOV-2015, the patient was vaccinated with a dose of M-M-R II (lot # reported as K016444 is non-valid, expiration date 10-JUL-2017), 0.5 ml, subcutaneously, therapy reason for use was reported as low titers for rubella postpartum. On the same day, the patient developed tingling in her mouth and tongue swelling after she received the vaccine. When the nurse practitioner learned that the patient was experiencing an allergic reaction that could progress to a life-threatening condition, the patient was immediately administered with BENADRYL. No lab diagnostic studies were performed. No PQC (product quality complaint) was involved. The outcome of the event was reported as recovered on 09-NOV-2015, while the patient was still in the reporter's practice. The patient was then allowed to go home on the same day. The relatedness between the event and M-M-R II was not reported. Upon internal review, the allergic reaction was considered to be medically significant as it required an intervention to prevent worsening to life threatening condition. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Ocular hyperaemia, Rash erythematous
Clinical narrative: PATIENT RECEIVED SHOT AROUND 8:30 AM ON 12/14/15 AT REQUEST OF HIS DOCTOR.  PATIENT STATED NO SICKNESS NOR PAST ILLNESS ON QUESTIONNAIRE.  HE STATED HE NOTICED RED SPOTS ABOUT 5:00 PM THAT EVENING.  HE WENT ON TO BED AND WHEN HE WOKE UP THE NEXT MORNING HIS UPPER LEFT QUADRANT OF FACE, EYE AND SCALP WAS BLISTERED AND RED. HE WENT TO DR ON 12/15 AROUND LUNCH. DR GAVE RX OF ACYCLOVIR 800MG FIVE TIMES A DAY AND SENT HIM TO EYE DR. THE EYE DR GAVE ERYTHROMYCIN OPTH OINT AND PREDNISOLONE DROPS.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Headache, Muscle fatigue, Muscle tightness, Pain
Clinical narrative: Headache, body ache, muscle fatigue, fever, chills, inability to speak, muscles locked up.  Person called 911 and carried patient to the ambulance to be taken to ER. Meds were administered via IV and prescriptions given to continue medication afterwards. Full recovery took 2-3 days.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Speech disorder
Clinical narrative: Headache, body ache, muscle fatigue, fever, chills, inability to speak, muscles locked up.  Person called 911 and carried patient to the ambulance to be taken to ER. Meds were administered via IV and prescriptions given to continue medication afterwards. Full recovery took 2-3 days.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Feeling cold
Clinical narrative: Excessive shivering, extreme feeling of cold, body and joint ache, weakness, dizziness, nausea, headache. Took ibuprofen.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain
Clinical narrative: Excessive shivering, extreme feeling of cold, body and joint ache, weakness, dizziness, nausea, headache. Took ibuprofen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Gait disturbance, Hypoaesthesia, Muscle spasms
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's pertinent medical history included Crohn's Disease. In recent past the patient had an accident (details not provided) that resulted in spinal injury for which the patient was going to physical therapy. She did not have any drug reactions or allergies. On 09-DEC-2015, at primary care physician office, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, frequency reported as once, subcutaneously (lot # and expiration date were not provided). The patient's concomitant therapies included mercaptopurine. On 11-DEC-2015 (also reported as "today"), the patient woke up with spasms from waist down, numbness in hand and feeling like hips were not releasing correctly when trying to walk. She sought medical attention and called pharmacy on 11-DEC-2015 (also reported as "today"). The patient was advised to call her primary healthcare physician as soon as possible. The patient's last blood test was done on an unknown date in November 2015 (results not provided). The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. The reporting pharmacist considered all the events to be serious as other medically significant. Additional information is not expected as no consent for further contact was given.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 7.5c.m wide and 10 c.m long Erythema noted 1.5 cm below the site of Flu vaccine given. Site is redness and warm to touch.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Rash
Clinical narrative: Small pink rash away from injection site, headache, soreness at injection site. Rash reported 12/12, headache and soreness 12/16. Referred to primary MD 12/16. Hydrocortisone helped rash temporarily.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Cough, Pain in extremity
Clinical narrative: Pt called Monday 12/7/15 re below. Received MMR on 12/4/15 noon and pt went to work and on the evening pt developed increased pain on both legs and unable to walk and continue on Saturday; Sunday AM leg pain decreased but developed pain on both arms and chest discomfort and dry cough, no rashes, no fever. Instr to go to ER for further evaluation. No egg allergy.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Loss of consciousness, Retching, Syncope, Urinary incontinence
Clinical narrative: Patient fainted 15 min after injection. During the time of unconsciousness patient urinated. When she regain conscious she then began gagging.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Abasia, Muscle spasms
Clinical narrative: Pt complained she had to go to hospital because of severe cramps in her legs. Was unable to walk at all.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Otitis media acute, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a physician referring to a 12 month old male patient. There were no pertinent medical history or drug reaction/allergies. On 02-NOV-2015 the patient was vaccinated with MMR II (lot # K024825, expiration date 02-DEC-2016, dose and route not provided), (Oka/Merck) VARIVAX (lot# L013824, expiration date 21-APR-2017, dose and route not provided), HAVRIX (manufacture unknown, dose, lot number and route not provided) and FLUZONE (manufacture unknown, dose, lot number and route not provided). The physician stated the patient was seen in the office on 08-DEC-2015 because of a "fever of 102F" and a rash on his abdomen. The physician stated the patient was seen again on 10-NOV-2015 and "the patient still had a 102F but now the rash all over his body, his face and chest were bright red like a sunburn, and the rest of his body, back, arms and legs, had a macular, papular rash that was very measles like and his feet appeared red and swollen". The physician stated that on 10-NOV-2015 it was also noted that the patient developed otitis media in the right ear. The physician stated she prescribed amoxicillin (manufacturer unspecified) for the otitis media. There were no diagnostics lab studies performed. The physician stated the patient's mother called the office on 13-NOV-2015 to report that the patient's fever had resolved but the rash on his face was "scabbing over" (although the physician stated, "the facial rash was never open or draining when the patient was in the office"). Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular, Scab, Swelling
Clinical narrative: Information has been received from a physician referring to a 12 month old male patient. There were no pertinent medical history or drug reaction/allergies. On 02-NOV-2015 the patient was vaccinated with MMR II (lot # K024825, expiration date 02-DEC-2016, dose and route not provided), (Oka/Merck) VARIVAX (lot# L013824, expiration date 21-APR-2017, dose and route not provided), HAVRIX (manufacture unknown, dose, lot number and route not provided) and FLUZONE (manufacture unknown, dose, lot number and route not provided). The physician stated the patient was seen in the office on 08-DEC-2015 because of a "fever of 102F" and a rash on his abdomen. The physician stated the patient was seen again on 10-NOV-2015 and "the patient still had a 102F but now the rash all over his body, his face and chest were bright red like a sunburn, and the rest of his body, back, arms and legs, had a macular, papular rash that was very measles like and his feet appeared red and swollen". The physician stated that on 10-NOV-2015 it was also noted that the patient developed otitis media in the right ear. The physician stated she prescribed amoxicillin (manufacturer unspecified) for the otitis media. There were no diagnostics lab studies performed. The physician stated the patient's mother called the office on 13-NOV-2015 to report that the patient's fever had resolved but the rash on his face was "scabbing over" (although the physician stated, "the facial rash was never open or draining when the patient was in the office"). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site urticaria, Lip swelling, Swelling face
Clinical narrative: Swelling in lips and cheeks; hive in injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: Feeling very bad, extreme fatigue, fever/chills, pt did not check tempature, injection site redness, (basball sized) hot to touch, extreme soreness/tenderness.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Feeling very bad, extreme fatigue, fever/chills, pt did not check tempature, injection site redness, (basball sized) hot to touch, extreme soreness/tenderness.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder, hurts when I lift arm up to ceiling
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Patient fainted while sitting in the administration chair. She felt funny, light headed, dizzy prior to fainting.  She was also sweating after she regained consciousness.  She was only unresponsive for about 30 seconds.
Age: 0.2
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea haemorrhagic, Occult blood positive, Stool analysis abnormal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of bloody diarrhea in a 3-month-old male patient who received ROTARIX (Batch number A41CB548A, expiry date 12th February 2017). The patient's past medical history included premature birth. In 2015, the patient received ROTARIX (oral) 1 ml. On 2nd December 2015, 2 days after receiving ROTARIX, the patient experienced bloody diarrhea (serious criteria GSK medically significant). On an unknown date, the outcome of the bloody diarrhea was unknown. It was unknown if the reporter considered the bloody diarrhea to be related to ROTARIX. Additional details were provided as follows: The health care professional reported that the premature patient experienced bloody diarrhea two days after receiving the ROTARIX vaccine as the first dose in series. The patient returned to the physician's office on 2nd December 2015 for a follow-up visit and test result for hemoccult was positive. No other follow-up treatments were provided. The health care professional called for clinical data regarding bloody stools following administration of ROTARIX vaccine as well as further guidance in the administration of the 2nd dose in series for this patient. No further information was reported regarding the event. The batch number was reported as A4FB548A, which does not exist. However according to the sales data the batch number was changed to A41CB548A.
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a child female patient who received DTPa. On an unknown date, the patient received dtpa vaccine .5 ml. On an unknown date, an unknown time after receiving dtpa vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to dtpa vaccine. Additional details were provided as follows: The pharmacist called to inquire about data regarding a dilution for a de-sensitizing challenge for BOOSTRIX or Tetanus-allergic patients. The reporter knew very little information but that a patient several years ago had anaphylactic reaction to a D-tap vaccine (brand unknown). No other details were provided. This adverse event might have been reported previously but the reporter caller was unsure.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein increased, Erythema, Erythema multiforme, Pain in extremity, Skin lesion
Clinical narrative: Initial unsolicited report received from a Pharmacist on 05-Oct-2015. This case involves a male patient (age was not reported) who was vaccinated with a intramuscular third dose of FLUZONE HD (batch number- UI478AB, expiry date- 09-May-2016 and site of administration was reported as unknown) on 01-Oct-2015. It was reported that patient received two previous doses of vaccinations. Patients illness at the time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included Amoxicillin and VICODIN as previous drugs. Other medical history and concomitant medications were not reported. On 02-Oct-2015, next day after vaccination, the patient experienced painful redness on both hands and feet which got worsened on 03-Oct-2015. Patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was not recovered from the events. Follow-up information received from a pharmacist on 04 December 2015. This case involves a 68-years old patient who was vaccinated with a dose of FLUZONE HD in right deltoid. The patient was vaccinated at private doctor's office/hospital. the patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergic to amoxicillin causing faintness, allergic to VICODIN causing chest discomfort, diabetes, cardiomyopathy, hypotension and hyperlipidemia. Concomitant medications included Aspirin, Furosemide, Lisinopril, Pravastatin, and Triamcinolone topically. On an unknown date, following the vaccination, the patient was diagnosed with erythema multiforme after developing painful planus and palmos lesions. The patient had ER visit on 03 October 2015 and was admitted to hospital. It was reported that there was no changes in diet, medications and furosemide was stopped during hospitalization due to reports of erythema multiforme with it. On 06 October 2015, the patient was discharged from the hospital in stable condition. The patient was previously vaccinated with FLUZONE HD in 2013 and 2014 with no reaction. On 04 October 2015, C-reactive protein was 88.5. On an unknown date, the patient was recovered from the events. The reporter assessed the causal relationship with suspect vaccine as related by temporal history. Documents held by sender: none.
Sex: F
Vaccine: MEN
Symptoms: Death, Encephalitis
Clinical narrative: Initial unsolicited case received from non healthcare professional (consumer) on 04-Dec-2015. This case was linked to 2015SA206294 and 2015SA206306 (same reporter and same vaccine). This case involves a female patient (age was not reported) who was vaccinated with a dose of Meningococcal vaccine (manufacturer: unknown, dose, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient had experienced encephalitis and then died. Lab tests and corrective treatments were not reported. The outcome of the event was fatal. Documents held by Sender: none.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Cardiac function test, Computerised tomogram, Decreased appetite, Haemorrhage, Headache
Clinical narrative: Later in the afternoon had fever, bad headache and loss of appetite. On 10/9 similar issues which continued through 10/10. Was eating although not hungry on 10/10 when eating reached for glass of water and passed out with no notice/warning. Did not feel dizzy ar all before passing out. Woke up on floor and realized was on the floor and passed out again. The next time that woke up got up and went to get his oxygen. Realized had hurt hand and elbow on the blood. Daughter took him to ER since he was bleeding. The admitted him and did CAT and heart test. Left hospital on 10/11 because he did not like care. The doctors wanted him to stay. On the week of October 12th - 16th went to Primary Care doctor who gave him orders for an ultrasound on 10/21 and 10/22 an MRI. Went back to doctor for results and everything was clear. No other aes so far. Decided to report because saw story on TV about hospitalization associated with pneumonia vaccine.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Joint injury, Limb injury, Loss of consciousness, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Later in the afternoon had fever, bad headache and loss of appetite. On 10/9 similar issues which continued through 10/10. Was eating although not hungry on 10/10 when eating reached for glass of water and passed out with no notice/warning. Did not feel dizzy ar all before passing out. Woke up on floor and realized was on the floor and passed out again. The next time that woke up got up and went to get his oxygen. Realized had hurt hand and elbow on the blood. Daughter took him to ER since he was bleeding. The admitted him and did CAT and heart test. Left hospital on 10/11 because he did not like care. The doctors wanted him to stay. On the week of October 12th - 16th went to Primary Care doctor who gave him orders for an ultrasound on 10/21 and 10/22 an MRI. Went back to doctor for results and everything was clear. No other aes so far. Decided to report because saw story on TV about hospitalization associated with pneumonia vaccine.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Ultrasound scan normal
Clinical narrative: Later in the afternoon had fever, bad headache and loss of appetite. On 10/9 similar issues which continued through 10/10. Was eating although not hungry on 10/10 when eating reached for glass of water and passed out with no notice/warning. Did not feel dizzy ar all before passing out. Woke up on floor and realized was on the floor and passed out again. The next time that woke up got up and went to get his oxygen. Realized had hurt hand and elbow on the blood. Daughter took him to ER since he was bleeding. The admitted him and did CAT and heart test. Left hospital on 10/11 because he did not like care. The doctors wanted him to stay. On the week of October 12th - 16th went to Primary Care doctor who gave him orders for an ultrasound on 10/21 and 10/22 an MRI. Went back to doctor for results and everything was clear. No other aes so far. Decided to report because saw story on TV about hospitalization associated with pneumonia vaccine.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Local swelling, Pruritus, Urticaria
Clinical narrative: Had itching and clear shingles area on Lt upper arm, back of neck whelps and front neck itching. Went to ER - given IV drugs. Large bump on upper (Lt) arm and Lt thigh back - itching profusely.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Rash
Clinical narrative: Widespread rash.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Autonomic nervous system imbalance, Dizziness, Headache, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Dizzy, Faint, heart racing, tachycardia, headache. Patent says they were diagnosed with POTS or dysautonomia.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Tachycardia
Clinical narrative: Dizzy, Faint, heart racing, tachycardia, headache. Patent says they were diagnosed with POTS or dysautonomia.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Noted soreness and redness at the site.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Arm muscle soreness, fever 102F, shaking from fever.
Age: 34.0
Sex: F
Vaccine: FLUC3
Symptoms: Bursitis
Clinical narrative: Case number PHEH2015US026032, is a combined initial spontaneous report received from a consumer and pharmacist on 09 Dec 2015. This report refers to a 34 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUCELVAX (batch number and expiry date: not reported) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. On 27 Nov 2015, patient developed bursitis from the injection. Seriousness, outcome and causality of the event bursitis were not reported. Seriousness of the event bursitis was upgraded as medical significant based on available information in the source document.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Folliculitis, Injection site reaction, Rash
Clinical narrative: Rash and nonspecific eruption red base in multiple stages, typical folliculitis sized scatter on face, torso and all 4 extremities.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Prolonged malaise, low grade fever, 99-100's for 13 days. After getting both MENACTRA and TRUMENBA (Meningitis A and B) vomiting x 12d.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt developed raised 3 inch wide red rash/bullseye ay injection site.
Age: 56.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness in the arm that had injection getting worse since injection. Patient cannot lift his arm due to pain. Patient believes the shot went into joint/tendons causing tendinitis.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given - no adverse reactions reported.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness all over arm a day after shot was administered. Site is itchy and slightly painful. Pt is taking clobetasol cream, MEDROL pack and CIPRO.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm
Clinical narrative: Redness, itching, burning, hot on touch 1 week after shot administered. 4 inches in diameter.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a pharmacy technician of unknown age and gender. Medical history, concurrent conditions concomitant medications were not reported. On an unknown date, the pharmacy technician suffered an accidental topical to exposure to the powder from ZOSTAVAX, 19400 unit 1 standard package vial of 1, lot # K018175 and expiration date in January 2016, that may have been leaking. The pharmacist reported also that ZOSTAVAX was stored at room temperature, as it had already been pulled from the freezer some time ago, and was slated for return to the distributor (incorrect product storage). No adverse events were reported and Product Quality Control (PQC) was filled on 18-NOV-2015. This is one of two reports received from the same source (MARRS # 1511USA009847). Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health professional referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 21-JUN-2014, the patient received one dose of Hep B vaccine (manufacturer unknown) (lot number, dose and route unknown) and Hep A vaccine (manufacturer unknown) (lot number, dose and route unknown). On 15-AUG-2007, the patient received another dose of Hep B vaccine (manufacturer unknown) (lot number, dose and route unknown) and Hep A vaccine (manufacturer unknown) (lot number, dose and route unknown). On 03-DEC-2015, the patient received the third dose of RECOMBIVAX HB (lot # L026598, expiration date 26-JUN-2017, dose and route unknown). It could not determine whether the unspecified vaccines were Merck products. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of VARIVAX (Merck) (lot # K010338, expiry date 22-JUL-2016; lot# K011801, expiry date 21-AUG-2016; lot # K016130, expiry date 21-SEP-2016; lot # K026387, expiry date 15-DEC-2016; lot#L001333, expiry date 13-JAN-2017; lot # L002871, expiry date 27-JAN-2-17; lot # L006383, expiry date 25-FEB-2017; lot # L015049, expiry date 29-SEP-2017; lot # L019124, expiry date 27-MAY-2017; lot # L019130, expiry date 27-MAY-2017; lot # reported as L023588, expiry date 26-JUN-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse (L.P.N) regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, patients were vaccinated with improperly stored oral, ROTATEQ (dose number, anatomical location frequency and route unknown) with lot # L026740 (expiry date 16-APR-2017) and lot number # L000571 (expiry date 26-JUL-2016) (incorrect product storage). However, the L.P.N. was not aware of which was administered to which patient. Concomitant medications of the patient were unknown. No other adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from  physician's assistant refers to a patient of unknown age and gender. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical nurse regarding an unknown number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, patients were vaccinated with improperly stored GARDASIL (dose number, anatomical location frequency and route unknown) with lot # K006117 (expiry date 14-JAN-2017) and lot number # K007264 (expiry date 02-MAR-2017). Concomitant medications of the patient were unknown. No other adverse events were reported. The outcome of the event incorrectly stored vaccines was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. 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 physician's assistant refers to a patent of unknown age and gender. On 20-AUG-2015, the patient as vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: PNC13
Symptoms: Chest discomfort, Pain, Pain in extremity
Clinical narrative: Pt was in for pre surgical visit - had PCV 13 on 12/15/15. Woke up feeling achy. (R) arm hurt and heavy chest. Wife brought him into office to determine localized illness vs. reaction.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated, Erythema, Induration, Malaise
Clinical narrative: The patient is a 69 yo female with a history of hypothyroidism who presents to clinic for evaluation and recommendations of a local site reaction after vaccine receipt. The patient reports she received IIV at clinic (GSK lot# 25N22). She noted mild pruritus at the site several hours later. By afternoon it was erythematic, warm to touch and mildly tender, and continued to enlarge in affected area. She developed induration and mild edema. It reached a nadir on Wednesday and they contacted us due to concern for adverse reaction. There was no burning, streaking or dermatitis of papules, vesicles, pustules or erosions. She did not treat it with anything. She has normal ROM, no numbness or tingling. Her arthritis to her hands may be a little worse. She had mild malaise initially which resolved without treatment. She had no fever, chills, headache, cough, chest pain, nausea, emesis or diarrhea. She had no immediate symptoms at the vaccine receipt of urticaria, pruritus, shortness of breath, oral/tongue/facial swelling, conjunctivitis, rhinorrhea, chest pain, wheezing or nausea.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Skin warm, Tenderness
Clinical narrative: The patient is a 69 yo female with a history of hypothyroidism who presents to clinic for evaluation and recommendations of a local site reaction after vaccine receipt. The patient reports she received IIV at clinic (GSK lot# 25N22). She noted mild pruritus at the site several hours later. By afternoon it was erythematic, warm to touch and mildly tender, and continued to enlarge in affected area. She developed induration and mild edema. It reached a nadir on Wednesday and they contacted us due to concern for adverse reaction. There was no burning, streaking or dermatitis of papules, vesicles, pustules or erosions. She did not treat it with anything. She has normal ROM, no numbness or tingling. Her arthritis to her hands may be a little worse. She had mild malaise initially which resolved without treatment. She had no fever, chills, headache, cough, chest pain, nausea, emesis or diarrhea. She had no immediate symptoms at the vaccine receipt of urticaria, pruritus, shortness of breath, oral/tongue/facial swelling, conjunctivitis, rhinorrhea, chest pain, wheezing or nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored of ZOSTAVAX (lot # L029482 with expired date 06-NOV-2016, dose and route were unknown). No concomitant therapy was reported. No adverse effects were reported. This is one of two reports received from the same reporter (1512USA008203). Additional information has been requested.