chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Sneezing, Tachypnoea, Urticaria, Vaccination complication, Wheezing
Clinical narrative: Case number PHEH2016US021633, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 7 year old female patient. Medical history and concomitant medications were not reported. The patient received FLUCELVAX QUADRIVALENT (batch number: 185286) at a dose of 0.5 ml intramuscularly on 24 Aug 2016. On the same day approximately 15 minutes after receiving vaccination, the patient experienced upset stomach, tachypnea, wheezing and angioedema (the physician reported it as anaphylactic reaction to vaccine). The physician reported that, the patient experienced asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin. The physician reported that symptoms have resolved except patient was still coughing. The physician stated that steroids, albuterol and BENADRYL would be required as a treatment. The outcome of the events GI upset and cough was reported as complete recovery on 24 Aug 2016, of the event angioedema was reported as complete recovery on 25 Aug 2016, of the event wheezing reported as complete recovery on 26 Aug 2016 and outcome of other events was not reported. Seriousness of the events was not reported. The physician assessed the causality between the events and FLUCELVAX QUADRIVALENT as suspected. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event (NVS IME) list. Follow up report received from a physician on 10 Oct 2016: Added events (asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin). Updated event information (event end dates of the events angioedema, wheezing, GI upset and cough and outcome of event cough) and treatment information and updated the narrative accordingly.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Erythema, redness, itching and discomfort (late onset) approximately 1 wk. RXN caused significant area of thigh.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left Shoulder tenderness since she received the flu vaccine on 13 October 2016. Patient reported tender to touch, no arm tingling or numbness, no loss of ROM sensation or strength. Pulses present, vital signs were stable and WNL. Patient was afebrile. Neurovascular exam completed patient intact. R/O SIRVA 12 Jan 2017.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: DUPLICATE VACCINE GIVEN PENTACEL, PEDIARIX GIVEN ON SAME DAY.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose increased, Cellulitis, Differential white blood cell count normal, Erythema, Full blood count normal
Clinical narrative: Patient went to an urgent care with red and painful injection site. She was diagnosed with cellulitis and given oral abx. She followed up two day later with swelling pain and erythematous 10x6 cm. Patient was advised by urgent care to go to ER for IV antibiotic. Patient was called by urgent care the next day for a follow up and patient stated she was better.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Metabolic function test, Pain, Swelling
Clinical narrative: Patient went to an urgent care with red and painful injection site. She was diagnosed with cellulitis and given oral abx. She followed up two day later with swelling pain and erythematous 10x6 cm. Patient was advised by urgent care to go to ER for IV antibiotic. Patient was called by urgent care the next day for a follow up and patient stated she was better.
Age: 20.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and Swelling at injection site. Patient reported severe itching at site. Treatment included oral BENADRYL and hydrocortisone cream applied to injection site. Symptoms were no longer present 01/14/2017.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an multiple patients of unknown age and gender. There was no information about the patients, concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M011832 (expiry date: 25-JAN-2018), M031802 (expiry date: 09-NOV-2017), M019691 (expiry date: 02-NOV-2017), M004885 (expiry date: 23-OCT-2017), orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines underwent the temperature excursion of 0-2 degrees Celsius for 3 hours, which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014419.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning to a patient (age and gender not reported) who on an unknown date was inadvertently vaccinated with an expired dose of VARIVAX (Lot No. K021485, exp. 03-NOV-2016) (site and route not reported) for prophylaxis. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a female consumer (age not reported) who on 04-JAN-2017 (reported as "last Wednesday") was vaccinated with a dose of ZOSTAVAX (site and route not reported) for prophylaxis and had been experiencing itchiness. The patient did not state were the itchiness was. No product quality complaint involved. The relationship between itchiness and vaccination with ZOSTAVAX was not reported. Additional information is not expected as no consent to follow up was obtained.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Laboratory test, Pain in extremity, Pneumonia
Clinical narrative: This spontaneous report was received from a patient's daughter concerning her 80 year old mother. The patient's concurrent conditions included high blood pressure and heart arrhythmia. The patient's pertinent medical history was not reported. The patient took unspecified medication as concomitant medication. On 11-JAN-2017, while she was recovering from a cold, the patient was vaccinated with the first dose of PNEUMOVAX23 lot # M032635 with expiration date: 05-MAY-2018 (route and dose were not reported, unspecified arm) for prophylaxis. It was also reported that the same night after receiving the vaccine, the patient developed sore arm. However, on 14-JAN-2017, she was taken to an Urgent Care facility, then taken to the emergency room  and was admitted due to developing the influenza and pneumonia. The patient received unspecified treatment. There were unspecified diagnostic laboratory tests performed on an unknown date. At the reporting time, the outcome of influenza, pneumonia and pain in arm was reported as not recovered. The reporter did not assess causality between the influenza, pneumonia, pain in arm  and the use of PNEUMOVAX23. There was no product quality complaint (PQC) involved. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: EVENT: Administration of FLUARIX QUAD vaccine. SYMPTONS: Limited range of motion of left arm; perpetual sharp-stabbing pain in left arm. TREATMENT: Physical exam 01/23/2017; physical therapy ordered 01/23/2017.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Had pain in her right arm yesterday throughout the day, 10/10 in severity, feels like someone punching her in the arm, worse with movement and pressure, has not tried anything to make it better. Woke up this morning and the right arm was swollen, also associated warmth area. Has had other shots in the past and had no issue, never had pneumonia shot before.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Burning sensation, Ear pain, Ear swelling, Erythema
Clinical narrative: From Emergency room medical record "Multiple red, scabbed oozing lesions scattered over most of body, reports rash started...on legs and spread from there. Noted a couple of days after receiving influenza vaccine. Rash burns and itches, worse pain on back. Large swollen area L lat chest. L ear swollen, painful and solid red. Treatment- In ER- Ketorolac inj 30mg IV, Diphenhydramine 50mg IV, Methylpred Succ 125mg IV all x1,  Given rx for Bactrim DS, sig:1 bid x 10d, and Prednisone, descending dose pack.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain, Rash, Rash pruritic, Scab
Clinical narrative: From Emergency room medical record "Multiple red, scabbed oozing lesions scattered over most of body, reports rash started...on legs and spread from there. Noted a couple of days after receiving influenza vaccine. Rash burns and itches, worse pain on back. Large swollen area L lat chest. L ear swollen, painful and solid red. Treatment- In ER- Ketorolac inj 30mg IV, Diphenhydramine 50mg IV, Methylpred Succ 125mg IV all x1,  Given rx for Bactrim DS, sig:1 bid x 10d, and Prednisone, descending dose pack.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Skin lesion
Clinical narrative: From Emergency room medical record "Multiple red, scabbed oozing lesions scattered over most of body, reports rash started...on legs and spread from there. Noted a couple of days after receiving influenza vaccine. Rash burns and itches, worse pain on back. Large swollen area L lat chest. L ear swollen, painful and solid red. Treatment- In ER- Ketorolac inj 30mg IV, Diphenhydramine 50mg IV, Methylpred Succ 125mg IV all x1,  Given rx for Bactrim DS, sig:1 bid x 10d, and Prednisone, descending dose pack.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypopnoea, Musculoskeletal disorder, Neck pain, Pain in extremity
Clinical narrative: Pain-loss of use of left arm-breathing shallow-lots pain-arm-neck-head. Hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Redness, itching and rough skin at injection site. Injection site was a hard lump. Unknown when started, per patient was improving on Monday. Used ice pack to decrease reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Redness, itching and rough skin at injection site. Injection site was a hard lump. Unknown when started, per patient was improving on Monday. Used ice pack to decrease reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Red circle, swelling, hot to touch. Spread to 2" x 4" by 1/3/2017 resulting in cellulitis.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Arthralgia, Audiogram, Dizziness, Ear, nose and throat examination, Hypoacusis
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Neurological examination, Ophthalmological examination
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pruritus, Tinnitus, Vestibular function test
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Arthralgia, Audiogram, Dizziness, Ear, nose and throat examination, Injection site erythema
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site swelling, Myalgia, Neurological examination, Ophthalmological examination, Pruritus
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Tinnitus, Vestibular function test
Clinical narrative: Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-DEC-2016, the patient was inadvertently vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported) while taking mycophenolate mofetil (CELLCEPT). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date in 2014 (reported as 24 months since from the last year), the patient was vaccinated with the first dose VAQTA injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided) .On an unspecified date in 2016 (reported as "sometime last year) about 24 months after the first dose, the patient received the second dose of VAQTA Injection for prophylaxis (strength, route, dose, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M031567, expiration date 24-DEC-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010419: US-009507513-1701USA010420: US-009507513-1701USA010421: US-009507513-1701USA010422: US-009507513-1701USA010423: US-009507513-1701USA010424: US-009507513-1701USA010425: US-009507513-1701USA010426: US-009507513-1701USA010427: US-009507513-1701USA010428: US-009507513-1701USA010429: US-009507513-1701USA010430: US-009507513-1701USA010431: US-009507513-1701USA010432: US-009507513-1701USA010433: US-009507513-1701USA010434: US-009507513-1701USA010435: US-009507513-1701USA010436: US-009507513-1701USA010437: US-009507513-1701USA010438: US-009507513-1701USA010439: US-009507513-1701USA010440.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a military corpsman and refers to an unspecified number of patients of unknown age and gender. It was reported that on unspecified dates, the patients were administered a dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided) that was reconstituted with an unspecified "HIB diluent". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB injection, Lot number: M027884, expiration date: 19-APR-2019 (strength, dose, frequency and route of administration were not reported) vaccine, for prophylaxis with a temperature of >0 but < 2 degrees Celsius for 49 hours and 5 minutes. Additionally, this excursion was detected due to a digital data logger and there was no previous temperature excursion reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006818: US-009507513-1701USA006819.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical Nurse, referring to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II injection (Lot number, expiration date, strength, dose, frequency and route of administration were not reported) vaccine, for prophylaxis. Additionally, it was not reported if this excursion was detected due to a digital data logger. Temperature excursion was not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006813: US-009507513-1701USA006819.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, between 28-NOV-2016 and 19-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M022400, expiration date 01-NOV-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 8.2 degrees Fahrenheit for 30 minutes. Data logger was involved. Previous excursion of 7.7 degrees Fahrenheit for 1 hour 30 minutes was also reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M032148, expiration date 18-APR-2019 (dose and route of administration were not reported). There was no adverse symptom reported. Administered doses of vaccines experienced the temperature excursion between 32 and 36 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011008.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L020001, expiration date 02-JUN-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003754:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L020001, expiration date 02-JUN-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003754:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261, expiration date 30-JUL-2018 (dose and route of administration were not reported). There was no adverse symptom reported. Administered doses of vaccines experienced the temperature excursion between 32 and 36 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009292.
Age: 69.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 70-year-old male consumer received PREVNAR 13 on an unspecified date in Sep2016 in left upper arm at 0.5 ml single for immunisation. Concomitant medication included influenza vaccine, given on the same unspecified date in Sep2016 for immunisation. He was taking other several unspecified medications. Medical history included cardiac failure congestive. He had never had pneumonia as medical history. The consumer previously took an unspecified pneumococcal vaccine for immunization, several years (at least 4 or 5 years) before the report. The consumer experienced pneumococcal pneumonia on 13Jan2017 with unknown outcome.
Age: 63.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain 8/10 developed that night in left upper arm. Unable to lift arm above head. No swelling, bruising or discoloration. Pain still present.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Headache, Insomnia, Middle insomnia
Clinical narrative: I awoke in the middle of the night with extreme pain down my hips to the toes in both legs.  The pain was so intense I could barely walk.  The left arm pain was minimal to that pain.  Earlier that day when I came home I had a brief period of tachycardia followed by a headache, but I dismissed it after taking an aspirin. This pain was so intense I could not go back to sleep.  I called the doctor in the morning and was told I could take Tylenol.  This continued until mid-Thursday afternoon.  I had to use warm compresses on my legs and stay in bed. Today, 1/24, I have a 2 in diameter blotch at the side that is warm to the touch and my arm hurts.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash macular, Skin warm, Tachycardia
Clinical narrative: I awoke in the middle of the night with extreme pain down my hips to the toes in both legs.  The pain was so intense I could barely walk.  The left arm pain was minimal to that pain.  Earlier that day when I came home I had a brief period of tachycardia followed by a headache, but I dismissed it after taking an aspirin. This pain was so intense I could not go back to sleep.  I called the doctor in the morning and was told I could take Tylenol.  This continued until mid-Thursday afternoon.  I had to use warm compresses on my legs and stay in bed. Today, 1/24, I have a 2 in diameter blotch at the side that is warm to the touch and my arm hurts.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Sore, swollen, and fever.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chills, Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: Sore, swollen, and fever.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Sinus congestion
Clinical narrative: Sore, swollen, and fever.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever and chills lasting about 6 hours. Also moderate soreness at vaccination site for pneumococcal vaccine.
Age: 46.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: Patient woke with a very sore arm and swollen lymph nodes in her axilla area. She applied a heat pack and returned to sleep. By morning her arm was without indication of an injection site reaction, but the lymph nodes under her arms were still enlarged and sore the entire area under her arm and around her shoulder was swollen and tender to the touch. Patient did not feel it required any treatment, she just wanted to report that it had occurred. She stated if the reaction did not resolve in a few days, she would return to see the physician.
Age: 0.33
Sex: F
Vaccine: 6VAX-F, HBHEPB, IPV, MMR
Symptoms: Autism spectrum disorder, Irritability, Middle insomnia, Pyrexia
Clinical narrative: 12/6 became fussy. 12/7 fever for two days of 99.5. Ever since she stopped sleeping through the night (8-10 hours she was sleeping) and wakes up every two hours. She Also had milestone regression and stopped rolling over from her tummy to her back. She still cannot do it to this day at 6 months. She started doing it at 3 months.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # M029251, expiration date: 14-MAR-2018 (dose schedule was not provided) for prophylaxis. There were no adverse effects reported. The administered dose of vaccine experienced a temperature of 48 Fahrenheit for 1 hour. Data logger was involved and there was no previous temperature excursion reported. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 06-JAN-2017 from a medical assistant regarding a male patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient was vaccinated with VAQTA (lot # M052338 expiration date 31-MAY-2018)(dose not specified). The patient received the dose of VAQTA following a temperature excursion of 32-36F for 72 hours. No adverse effects were reported. The call was because of a "data logger". Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018; lot number M017983 with expiration date of 30-MAY-2018 (strength, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes (digital data logger) without any previous temperature excursion. There was no product quality complaint involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Urticaria
Clinical narrative: Bad case of hives head to toe. Took two doses of BENADRYL and it did not work. Awoke on 1/24 and hives were gone but now I have diarrhea and feel like I could throw up.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt reports swelling of deltoid where vaccine was given, rash on inner upper arm, pt reported pain in the shoulder and upper arm. No fever reported.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: A mild rash appeared a few hours after receiving the immunization. The rash did not last more than a couple of hours. She experienced no other symptoms.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Full blood count, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever; pain, tenderness and swelling at injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Cyanosis, Erythema, Faeces pale, Henoch-Schonlein purpura, Joint swelling
Clinical narrative: I was changing child's diaper, noticed left foot/ ankle edematous, erythema, and warmth. What appeared to be bruising (later ID'd as purpura) notable to posterior left ankle. Pedal pulse diminished, toes cyanotic. Left to ER. At assessment in ER noted irregularities to right foot as well with RN. Transient hives noted to bilateral lower and upper extremities. ER doctor administered X-rays which were negative. A diagnosis of vasculitis, likely HSP was given. After 3 days of steroids, swelling to ankles, feet and knees have subsided. 1/21/17 minimal urine output, small yellow BM with minimal mucous purpura seems worse and is present on thighs and medial legs bilaterally, as well as posterior forearms. 1/22 urine output better,no BM. 1/23 Edema is subsiding, purpura appears to be diminishing, output increasing.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Oedema peripheral, Pedal pulse decreased, Purpura, Skin warm, Urine output decreased
Clinical narrative: I was changing child's diaper, noticed left foot/ ankle edematous, erythema, and warmth. What appeared to be bruising (later ID'd as purpura) notable to posterior left ankle. Pedal pulse diminished, toes cyanotic. Left to ER. At assessment in ER noted irregularities to right foot as well with RN. Transient hives noted to bilateral lower and upper extremities. ER doctor administered X-rays which were negative. A diagnosis of vasculitis, likely HSP was given. After 3 days of steroids, swelling to ankles, feet and knees have subsided. 1/21/17 minimal urine output, small yellow BM with minimal mucous purpura seems worse and is present on thighs and medial legs bilaterally, as well as posterior forearms. 1/22 urine output better,no BM. 1/23 Edema is subsiding, purpura appears to be diminishing, output increasing.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Urticaria, Vasculitis, X-ray limb normal
Clinical narrative: I was changing child's diaper, noticed left foot/ ankle edematous, erythema, and warmth. What appeared to be bruising (later ID'd as purpura) notable to posterior left ankle. Pedal pulse diminished, toes cyanotic. Left to ER. At assessment in ER noted irregularities to right foot as well with RN. Transient hives noted to bilateral lower and upper extremities. ER doctor administered X-rays which were negative. A diagnosis of vasculitis, likely HSP was given. After 3 days of steroids, swelling to ankles, feet and knees have subsided. 1/21/17 minimal urine output, small yellow BM with minimal mucous purpura seems worse and is present on thighs and medial legs bilaterally, as well as posterior forearms. 1/22 urine output better,no BM. 1/23 Edema is subsiding, purpura appears to be diminishing, output increasing.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient developed a fever of 105 degrees for 5 hours after receiving an influenza vaccine. The fever lasted about 7 hours, which the Mother treated with Tylenol.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, Computerised tomogram head normal, Impaired driving ability, Intracranial pressure increased, Neurological examination normal
Clinical narrative: I woke up at 7:00 AM and immediately noticed that I was unable to see and had severe blurred vision to the point I could not drive or read anything.  I went to facility on 01/19/17.  I saw Dr. who did a vision check on me and ordered blood work regarding the sudden loss of vision.  He consulted with neurologist who ordered a stat CT and MRI of the brain which were both normal.  The following day I was referred by my primary physician on 01/20/17 to ophthalmothy who dilated me eyes and diagnosed me with bilateral elevated intraocular pressure.  Eye drops were prescribed Dorzolamide-Timolol.  On January 22, 2017, I had no improvement on my vision and presented to the emergency room.  Dr. was called into the emergency room to perform a neurological evaluation which he said was normal and told me he did not know why I lost my vision and could not link in to anything neurologcial.  The emergency room doctor prescribed a seond eye drop to try to lower the eye pressure Brimonidine to be used with the other eye drops previously prescribed.  I have a follow-up appointment on January 25, 2017 at 2:15pm with ophthalmology.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination, Pupil dilation procedure, Sudden visual loss, Vision blurred
Clinical narrative: I woke up at 7:00 AM and immediately noticed that I was unable to see and had severe blurred vision to the point I could not drive or read anything.  I went to facility on 01/19/17.  I saw Dr. who did a vision check on me and ordered blood work regarding the sudden loss of vision.  He consulted with neurologist who ordered a stat CT and MRI of the brain which were both normal.  The following day I was referred by my primary physician on 01/20/17 to ophthalmothy who dilated me eyes and diagnosed me with bilateral elevated intraocular pressure.  Eye drops were prescribed Dorzolamide-Timolol.  On January 22, 2017, I had no improvement on my vision and presented to the emergency room.  Dr. was called into the emergency room to perform a neurological evaluation which he said was normal and told me he did not know why I lost my vision and could not link in to anything neurologcial.  The emergency room doctor prescribed a seond eye drop to try to lower the eye pressure Brimonidine to be used with the other eye drops previously prescribed.  I have a follow-up appointment on January 25, 2017 at 2:15pm with ophthalmology.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blindness, Computerised tomogram head normal, Impaired driving ability, Intracranial pressure increased, Neurological examination normal
Clinical narrative: I woke up at 7:00 AM and immediately noticed that I was unable to see and had severe blurred vision to the point I could not drive or read anything.  I went to facility on 01/19/17.  I saw Dr. who did a vision check on me and ordered blood work regarding the sudden loss of vision.  He consulted with neurologist who ordered a stat CT and MRI of the brain which were both normal.  The following day I was referred by my primary physician on 01/20/17 to ophthalmothy who dilated me eyes and diagnosed me with bilateral elevated intraocular pressure.  Eye drops were prescribed Dorzolamide-Timolol.  On January 22, 2017, I had no improvement on my vision and presented to the emergency room.  Dr. was called into the emergency room to perform a neurological evaluation which he said was normal and told me he did not know why I lost my vision and could not link in to anything neurologcial.  The emergency room doctor prescribed a seond eye drop to try to lower the eye pressure Brimonidine to be used with the other eye drops previously prescribed.  I have a follow-up appointment on January 25, 2017 at 2:15pm with ophthalmology.
Age: 41.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Pupil dilation procedure, Vision blurred
Clinical narrative: I woke up at 7:00 AM and immediately noticed that I was unable to see and had severe blurred vision to the point I could not drive or read anything.  I went to facility on 01/19/17.  I saw Dr. who did a vision check on me and ordered blood work regarding the sudden loss of vision.  He consulted with neurologist who ordered a stat CT and MRI of the brain which were both normal.  The following day I was referred by my primary physician on 01/20/17 to ophthalmothy who dilated me eyes and diagnosed me with bilateral elevated intraocular pressure.  Eye drops were prescribed Dorzolamide-Timolol.  On January 22, 2017, I had no improvement on my vision and presented to the emergency room.  Dr. was called into the emergency room to perform a neurological evaluation which he said was normal and told me he did not know why I lost my vision and could not link in to anything neurologcial.  The emergency room doctor prescribed a seond eye drop to try to lower the eye pressure Brimonidine to be used with the other eye drops previously prescribed.  I have a follow-up appointment on January 25, 2017 at 2:15pm with ophthalmology.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 10-JAN-2017 from a medical assistant regarding unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date 3 doses of improperly stored PNEUMOVAX 23 (lot # L014458, expiration 11-FEB-2017, and lot # M013156, expiration 15-OCT-2017) were administered to unspecified patients (dose not specified). The temperature was 46.8 degrees F for 48 hours. No adverse effects were reported. The call was made because of a "data logger." No additional information was available. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot numbers M031695, expiration date 26-MAY-2017; M002268, expiration date 20-SEP-2017; M015290, expiration date 20-SEP-2017; M027879 expiration date 24-JAN-2018; M032492, expiration date 02-MAR-2018; M033611, expiration date 02-MAR-2018, dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008611:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008041:Original Case : 1701USA008041; US-009507513-1701USA008609:Original Case : 1701USA008041.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number M038216, expiration date 09-MAY-2018 dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008611:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008608:Original Case : 1701USA008041; US-009507513-1701USA008041:Original Case : 1701USA008041.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a unspecified number of patients patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist report that on an unknown date, the patients were vaccinated with ZOSTAVAX, subcutaneously in the triceps region of the arm  instead of the deltoid region of the arm , for prophylaxis, (strength, dosage, frequency and lot# were not provided). Concomitant therapies were not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Parent reported no adverse events.
Age: 3.0
Sex: M
Vaccine: FLU4, HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 21.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm started turning red, eventually became swollen and painful at the injection site.
Age: 40.0
Sex: F
Vaccine: ANTH, IPV, TD, TYP
Symptoms: Gastrointestinal disorder, Injection site rash
Clinical narrative: Pt stated has small rash on left deltoid. Pt also had GI complications.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Pt developed fever, rash, running nose, and cough the night after receiving the 4 month series vaccine.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: PATIENTS ARM IS STILL SORE FROM VACCINATION AS OF 1-22-2017.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Chills
Clinical narrative: intermit shivers, durations, "seconds" approx. #7 episodes  daily X 3 days. No other symptoms reported. No treatment required.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Colonoscopy, Intussusception, Surgery, X-ray
Clinical narrative: Intussusception 7 days after ROTATEQ given.