chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: On 11/19/15, 49 yo F presented to clinic for scheduled appointment. During visit, pt was ordered to receive Flu vaccine (QUADRIVALENT) and Pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23). Per immunization records, both injections were administered into pt's left deltoid. The influenza vaccine was Lot #UI505AA, exp: 6/30/2016). The pneumococcal vaccine was Lot #L019835, exp: 3/23/2017). On 11/20, pt called clinic and reported that she had developed a fever and the injection site was erythemic and painful. Pt was advised to hydrate and "control her fever with alternating Tylenol 500 mg and Ibuprofen 400 mg (every 6 hours)". On 11/22, pt called and reported increased pain and erythema. Pt then went to ED for evaluation. Pt was diagnosed with cellulitis and prescribed treatment with cephalexin. On 11/23, pt returned to clinic for evaluation, as the area of erythema had expanded beyond the originally demarcated borders. On exam, pt was afebrile with erythema and warmth of left upper arm. Pt was advised to continue cephalexin, monitor site and notify MD if there is no improvement over next 24-48 hours. Pt was then discharged in stable condition. NOTE: Pt has a history of mixed connective tissue disease for which she takes methotrexate 20 mg PO once weekly. This therapy was held during time of event.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Fatigue, Headache, Myalgia
Clinical narrative: Short term memory loss, tiredness, headache, muscle pain.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eye infection, Eye pain, Eyelid oedema, Ocular hyperaemia
Clinical narrative: About two hours after taking the vaccine, she began to have eye pain.  That evening, both eyes became very red.  On 10/14/15, both eyes were "blood shot."  The blood vessels in her eyes appeared to have burst, both eyes swollen almost shut.  Left eye was worse than right eye.  The symptoms lasted for two weeks.  She saw an optometrist who diagnoses her with a severe infection in both eyes, possibly due to the preservative in the vaccine.  Treated with antibiotics.
Age: 63.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Mild maculopapular rash on forearms and legs.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area at site of injection became swollen, reddened and hot to the touch.  This inflammation area measured about 3-inches by 4-inches, oval shaped; and was painful.  It appeared similar to a burn.   This lasted three days and faded.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given 10/13/15.  That evening around 6:30 pm, she noticed her upper right arm was swollen and sore. When she woke up 10/14 am, her arm was swollen, red, and tingling down to her fingers.  At 11:30 am, her upper right arm was swollen and red, and warm to the touch, but her hand and fingers were cool to the touch.  When she leaves her arm dangling down, her fingers and hand and up to the elbow tingles and gets numb.  Pain and tingling worsened, so she went to the ER at 12:30 pm on 10/14.  The doctor stated that she either had a reaction to the vaccine which caused swelling which compressed a nerve in her arm, causing the numbness and tingling, or the shot itself hit a nerve when it was given.  She was treated to steroids.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Paraesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: Vaccine given 10/13/15.  That evening around 6:30 pm, she noticed her upper right arm was swollen and sore. When she woke up 10/14 am, her arm was swollen, red, and tingling down to her fingers.  At 11:30 am, her upper right arm was swollen and red, and warm to the touch, but her hand and fingers were cool to the touch.  When she leaves her arm dangling down, her fingers and hand and up to the elbow tingles and gets numb.  Pain and tingling worsened, so she went to the ER at 12:30 pm on 10/14.  The doctor stated that she either had a reaction to the vaccine which caused swelling which compressed a nerve in her arm, causing the numbness and tingling, or the shot itself hit a nerve when it was given.  She was treated to steroids.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Anxiety, Depression, Nodule, Parkinson's disease, Peripheral swelling
Clinical narrative: Arm swelled and knot formed.  It lasted nine months, including time I was abroad.  I developed anxiety, depression soon thereafter.  Finally diagnosed with idiopathic Parkinsons disease at age 41.  Dr believe I exhibited signs of Parkinsons long before diagnosis which was missed before.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Child developed generalized hives after having flu vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Injection site pain, Ophthalmic herpes zoster, Viral infection
Clinical narrative: (1) severe injection site pain that did not stop. (2) shingles that started on the face and spread to the mouth, throat, left eye and inside the nose.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Hypoaesthesia, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Pain in arm after shot, numbness/tingling in arm. Pain persisted for > 2 wks. MD suspected bursitis and prescribed exercises.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: (R) upper arm became edematous, red, hot to the touch and painful M.D. ordered Naproxen 500 mg BID and pt instructed to apply ice.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia, Tenderness
Clinical narrative: Neck stiffness, muscle tenderness of neck, upper back, shoulders, upper arms.  Intense for 10 days, persists at the time of this report (11/25/2015) but with less intensity.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold sweat, Dizziness, Dry skin, Nausea, Skin discolouration
Clinical narrative: Dizziness and Nausea at 10:00; Given crackers and juice since pt reports not eating breakfast; 1015 vital signs stable; 1020 reports clammy hands, dizziness, and nausea, but rest of skin is pink, warm and dry and pt denies SOB and lightheadedness; 1027 escorted to ER for further evaluation since sx's did not resolve.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Dizziness and Nausea at 10:00; Given crackers and juice since pt reports not eating breakfast; 1015 vital signs stable; 1020 reports clammy hands, dizziness, and nausea, but rest of skin is pink, warm and dry and pt denies SOB and lightheadedness; 1027 escorted to ER for further evaluation since sx's did not resolve.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: Throat started to feel as if I needed to clear it.  Soon felt as if I had swallowed a walnut.  Eyes began to swell shut.  Immediately took two Benadryl capsules by mouth and followed up with two more 2 hours later.
Age: 91.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: Patient presents symptoms of hives, rash, and swelling in hands. No shortness of breath and no chest pain were reported.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Delirium, Feeding disorder, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited case received from physician (reporting for self) on 09-Nov-2015 and additional information received on 11-Nov-2015. This case involves a 65-year-old male patient, who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number-UI432AA, expiry date: 30-Jun-2016 and dose was not reported) in left deltoid on an unspecified date in Oct-2015. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other medical history and concomitant medications were not reported. On unspecified date in Oct-2015, 2 days after vaccination he experienced delirium for 2.5 days, was in bed and unable to eat. Patient also had pain at the injection site which was initially only minor. It was reported that 5-6 days ago he began to have severe pain and significant swelling in the left arm from his shoulder down the arm. He stated that the left arm was almost incapacitated. Later on patient reported that shoulder was still painful. No lab tests were performed. Corrective treatments were not reported. At the time of the report, patient had  recovered from delirium on unspecified date and not recovered from the other reported events. Upon internal review, case was considered as serious due to important medical event: delirium. List of documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited case received from physician (reporting for self) on 09-Nov-2015 and additional information received on 11-Nov-2015. This case involves a 65-year-old male patient, who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number-UI432AA, expiry date: 30-Jun-2016 and dose was not reported) in left deltoid on an unspecified date in Oct-2015. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other medical history and concomitant medications were not reported. On unspecified date in Oct-2015, 2 days after vaccination he experienced delirium for 2.5 days, was in bed and unable to eat. Patient also had pain at the injection site which was initially only minor. It was reported that 5-6 days ago he began to have severe pain and significant swelling in the left arm from his shoulder down the arm. He stated that the left arm was almost incapacitated. Later on patient reported that shoulder was still painful. No lab tests were performed. Corrective treatments were not reported. At the time of the report, patient had  recovered from delirium on unspecified date and not recovered from the other reported events. Upon internal review, case was considered as serious due to important medical event: delirium. List of documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Angioplasty, Cardiac disorder, Chest discomfort, Computerised tomogram, Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 72 year-old female consumer received PREVNAR 13 on 17Sep2015, at single dose. Medical history included triple bypass on 16 June (unspecified year), heart problem, rock filled vessels, angioplasty and cholesterol. Concomitant drugs included carvedilol (manufacturer unknown) on 16Jun2015 and ongoing at 6.25 mg for unknown indication and LIPITOR on 16Jun2015 and ongoing at 80 mg for cholesterol. On 20Sep2015 the heart symptoms returned. After three months of continuing improvement and feeling good in cardiac therapy, the patient experienced chest discomfort 3 days after having vaccination, on unknown date in Sep2015. No admission in hospital was required for the events. The patient underwent an angioplasty on 05Oct2015. A test showed that three grafts have failed after triple bypass on unknown date. This had less than a one percent chance on an otherwise healthy individual. The patient felt that there appeared to be a body rejection triggered by this vaccination. After angioplasty they determined that all the grafts failed and she was searching for any clue that they could possibly had of why they failed as she was facing another open heart surgery and they did not want it to fail again. Lab data included CAT scan and MRI on an unspecified date in 2015 with unknown result. The patient was dealing with two heart surgeons and a cardiologist but they did not know what to do other than repeat surgery. The patient was not recovered from heart symptoms while the outcome of the other events was unknown. Follow-up (10Nov2015): New information reported from a contactable consumer includes: details of concomitant drugs, new events (chest discomfort and test showed that three grafts have failed after triple bypass), onset of the event (heart symptoms), clinical course, outcome.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Vascular graft complication
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 72 year-old female consumer received PREVNAR 13 on 17Sep2015, at single dose. Medical history included triple bypass on 16 June (unspecified year), heart problem, rock filled vessels, angioplasty and cholesterol. Concomitant drugs included carvedilol (manufacturer unknown) on 16Jun2015 and ongoing at 6.25 mg for unknown indication and LIPITOR on 16Jun2015 and ongoing at 80 mg for cholesterol. On 20Sep2015 the heart symptoms returned. After three months of continuing improvement and feeling good in cardiac therapy, the patient experienced chest discomfort 3 days after having vaccination, on unknown date in Sep2015. No admission in hospital was required for the events. The patient underwent an angioplasty on 05Oct2015. A test showed that three grafts have failed after triple bypass on unknown date. This had less than a one percent chance on an otherwise healthy individual. The patient felt that there appeared to be a body rejection triggered by this vaccination. After angioplasty they determined that all the grafts failed and she was searching for any clue that they could possibly had of why they failed as she was facing another open heart surgery and they did not want it to fail again. Lab data included CAT scan and MRI on an unspecified date in 2015 with unknown result. The patient was dealing with two heart surgeons and a cardiologist but they did not know what to do other than repeat surgery. The patient was not recovered from heart symptoms while the outcome of the other events was unknown. Follow-up (10Nov2015): New information reported from a contactable consumer includes: details of concomitant drugs, new events (chest discomfort and test showed that three grafts have failed after triple bypass), onset of the event (heart symptoms), clinical course, outcome.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Nausea
Clinical narrative: Extreme, excruciating pain in shoulder, grew worse and worse over 2 hours.....followed by nausea.  No physical signs, all interior pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 60.0
Sex: F
Vaccine: DTAP, PNC13, VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Red bump.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient reported that her right arm was still extremely sore three weeks after receiving Prevnar13 vaccine.  Advised her to take Tylenol for the pain based off med profile as well as increase arm movement.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Chills, Fatigue, Influenza virus test negative, Pyrexia
Clinical narrative: Tiredness (fatigue) fever, abdominal pains, chills.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Streptococcus test negative
Clinical narrative: Tiredness (fatigue) fever, abdominal pains, chills.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Arthralgia, Chest pain, Facial pain, Injected limb mobility decreased, Neck pain
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA via an unspecified route of administration in the left deltoid as single dose, and influenza vaccine (unspecified trade name) in the right arm, both on the same unknown date. Relevant medical history and concomitant medications were not reported. That evening and the next day, the patient reported to her mother that her left arm was very sore and she could not lift above her head when she went to sleep and her whole left side of body was sore and in pain. The next day (2nd day after vaccination), the mother called her doctor to report pain in the whole arm down to forearm, pain in left side of face, pain in left side of neck, and pain in left side of trunk from chest, back down to hip for the patient. The pain on the left side of body lasted approximately 24 hours. The patient declined to come to the doctor's office to be examined. There was no numbness or tingling. The left arm was a little blotchy, but not warm and red. The outcome of all events was unknown. Follow-up (14Oct2015): New information received from a contactable physician via Pfizer sales representative includes: patient's age: vaccine dose number, administration date and anatomical location; concomitant vaccine; clinical course; 'pain in left side of face', 'pain in left side of neck', 'pain in left side of trunk from chest, back down to hip' and 'left arm was a little blotchy' added as events.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Pain, Pain in extremity, Rash macular
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA via an unspecified route of administration in the left deltoid as single dose, and influenza vaccine (unspecified trade name) in the right arm, both on the same unknown date. Relevant medical history and concomitant medications were not reported. That evening and the next day, the patient reported to her mother that her left arm was very sore and she could not lift above her head when she went to sleep and her whole left side of body was sore and in pain. The next day (2nd day after vaccination), the mother called her doctor to report pain in the whole arm down to forearm, pain in left side of face, pain in left side of neck, and pain in left side of trunk from chest, back down to hip for the patient. The pain on the left side of body lasted approximately 24 hours. The patient declined to come to the doctor's office to be examined. There was no numbness or tingling. The left arm was a little blotchy, but not warm and red. The outcome of all events was unknown. Follow-up (14Oct2015): New information received from a contactable physician via Pfizer sales representative includes: patient's age: vaccine dose number, administration date and anatomical location; concomitant vaccine; clinical course; 'pain in left side of face', 'pain in left side of neck', 'pain in left side of trunk from chest, back down to hip' and 'left arm was a little blotchy' added as events.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the second of 2 reports for the patient 2. A 20-year-old female patient received on 04Aug2015 at 3:30 pm the second single dose of TRUMENBA. Relevant medical history included pink eye from 2015 (Ongoing). Had no allergies. Concomitant medications included birth control pills and antibiotic for Pink eye. The patient received the first dose on 05Jun2015 intramuscular and experienced minimal pain at the injection site. Immediately after second vaccination, the patient felt tingling throughout the body like someone was sticking needles in it. The event lasted for 2 hours. No treatment was provided. Laboratory tests were not performed. The same reactions occurred to her sister after first and second vaccination with meningococcal group b performed respectively on 05Jun2015 and 04Aug2015. Follow up (07Aug2015): New information received from the same contactable consumer includes: details of patient. Follow-up (03OCT2015): Follow-up attempts complete. No further information expected.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Activities of daily living impaired, Back pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 18-year-old male patient of unknown ethnicity received on an unknown date first single dose of TRUMENBA and first dose of HPV 4 (Merck). The vaccines were administered in different sites. Concomitant medications and medical history were not reported. On unspecified date, the patient had severe back pain and the patient was incapacitated for three days. Outcome was unknown. Follow-up (14OCT2015): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood test normal, Erythema, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician who reported for her daughter. A 19-year-old female patient of an unspecified ethnicity received third dose of TRUMENBA, intramuscular in the left arm at single dose on 20Aug2015 at 7 PM. The patient medical history and concomitant medications none. Previously the patient received two doses of vaccine in Feb2015 and in Mar2015 without reaction. On 21Aug2015, the patient developed a diffused more like an inflammatory cutaneous response, on her arm. The event was described as "very diffused superficial but erythematous reaction involving more than the injection site. At the time of the third injection it involved a pretty much whole interior surface of her upper arm." The routine blood work performed in Aug2015 (in the following 48 hours) was normal. Event resolved on 25Aug2015. The physician considered that there was a reasonable possibility that the event was related to suspect product. Follow-up (14Sep2015): New information received from a contactable physician includes: Start date for previous vaccinations, time of third dose, anatomical location, physician's assessment. Follow-up attempts completed. No further information expected.
Age: 0.33
Sex: F
Vaccine: PNC13, RV5
Symptoms: Cough, Diarrhoea, Insomnia, Irritability, Sneezing
Clinical narrative: Cough, Sneezing, Wheezing, Throwing Up, Diarrhea, Fussiness, Inability to Sleep Long Stretches.
Age: 0.33
Sex: F
Vaccine: PNC13, RV5
Symptoms: Vomiting, Wheezing
Clinical narrative: Cough, Sneezing, Wheezing, Throwing Up, Diarrhea, Fussiness, Inability to Sleep Long Stretches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hyponatraemia, Inappropriate antidiuretic hormone secretion, Musculoskeletal pain
Clinical narrative: 4 days of ascending weakness and paresthesias in the setting of a recent flu vaccination and shoulder pain. She has now developed severe syndrome of inappropriate secretion of antidiuretic hormone with dramatic hyponatremia over the past 48 hours. This is a described complication of Guillain- Barre syndrome.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: 4 days of ascending weakness and paresthesias in the setting of a recent flu vaccination and shoulder pain. She has now developed severe syndrome of inappropriate secretion of antidiuretic hormone with dramatic hyponatremia over the past 48 hours. This is a described complication of Guillain- Barre syndrome.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Vertigo
Clinical narrative: 6 hours post vaccine, patient complained of dizziness and if room was spinning. Denied associated clinical manifestional.  Took a 2 hour nap and felt better.   No lost time from work.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Muscular weakness, Peripheral swelling
Clinical narrative: Both feet swollen, generalized muscle weakness, worse in BLE.  Generalized joint pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient was given the vaccine by a fellow nursing student at a vaccine clinic.  Patient starting having significant pain in her shoulder and inability to raise or move her shoulder.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site
Clinical narrative: PATIENT STATES SHOT GIVEN TOO HIGH-SHOT GIVEN I.M. IN ARM.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity
Clinical narrative: Left arm pain that began after flu injection. Continues (1 month post vaccination) to still have pain in left arm (muscle and joint) and complains of pain in both arms with greater pain in left arm. Pain aggrevated with certain positions and throbbing at night.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: 45 min after flu injection, participant reported numbness and  to left arm and fingertips. she was advised to follow up with physician if pain persists. Participant stated she felt fine and after assessed by the nurse.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Patient reported arm is swollen below injection site and is about the width of a golf ball.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Pain, Swelling
Clinical narrative: Patient started feeling pain shortly after vaccine administration. She reported pain and swelling for the last days, not much improved w/TYLENOL. Cannot raise arm w/o pain and decreased strength in RUE.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Local reaction, Oedema, Pruritus
Clinical narrative: Large local reaction with erythema, edema, severe pruritus from shoulder to elbow.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Flushing, Injection site erythema
Clinical narrative: Red circle at injection site. BENADRYL, Ibuprofen, ice, ZYRTEC. Fatigue, face flushed.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Pt developed widespread macular papular rash on her extremities and torso the next day after vaccination. Rash gets more pronounced when child gets hot or after bath. No sx of URI. No treatment advised.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever - T - 102.0 F. Hives in differrent areas on body, legs, face at different times throughout the day after immunization.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm area swollen and slightly redness x 3 days. Per child's mother no fever, no rash occurred. No treatment is necessary per M.D.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient received the vaccine yesterday and a few hours later she started having generalized body aches and pain/swelling at vaccine area. She took TYLENOL and THERAFLU, but could not sleep all night due to aches.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client experienced widespread hives two days after the pediatric flu #1 was given. Client visited emergency room and was treated with a 5 day corticosteroid regimen. Today, 11-25-15, client's hives are still present but better than yesterday.
Age: 27.0
Sex: F
Vaccine: FLUR3
Symptoms: Anxiety, Erythema, Nausea, Pruritus generalised, Rash
Clinical narrative: Within a few minutes started having reaction - redness, rash and then began itching all over; taken to ER. Continued same and complained of nausea and anxiety; given DECADRON, BENADRYL and PEPCID.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mass
Clinical narrative: Immediately after administration pt had palpable lump from about 1" in diameter and visible to the eye.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Local reaction
Clinical narrative: Localized reaction. Vaccine - 11/20/15. Noticed rash - 11/22/15 (L) arm/deltoid. Appt for rash - 11/25/15. Topical BENADRYL or oral antihistamine.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Vaccines administered at 1300. Pt. became diaphoretic, dizzy, and tired. Sucker, fruit bar, water, fan to pt. Helped a lot. BP 107/65 - HR 59 - 97% RA at 1304. BP 116/76 - HR 59 - 97% RA at 1307. Pt walked out to waiting room at 1308. Pt. left facility at 1312.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid where both vaccines given was red and swollen, not that hot to touch. Think was PNA shot D/T has had Flu before w/o issues.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Raised red 2 x 2 area on left deltoid. Hot to the touch, remained red and raised for several days.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injection site erythema, Lymphadenopathy, Swelling, Ultrasound scan
Clinical narrative: Large amount of redness (L) upper arm, swelling in entire armpit. Swollen lymph nodes in axillary region. This lasted for almost 1 1/2 months (7 weeks).
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Pt reported rash on arms and legs, itching, shortness of breath, difficulty breathing. Went to ER, received epinephrine, Benadryl, and steroid injections.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Rash
Clinical narrative: Pt reported rash on arms and legs, itching, shortness of breath, difficulty breathing. Went to ER, received epinephrine, Benadryl, and steroid injections.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Intense flu like body pain, stiffness, headache, tired, muscle pain everywhere.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Intense flu like body pain, stiffness, headache, tired, muscle pain everywhere.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Patient's arm swelled up around vaccination site requiring several trips to the ER and a prescription for Bactrim DS.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Silver dollar size rash, not hot, little itching.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received single dose Flu vaccine in (L) deltoid on 11/11/15. Next day school nse notes arm red, hot; swollen and painful. Eval in office -> 9x13 cm red, warm, indurated (L) deltoid, able to lift arm 45 degrees but unable to lift to shoulder level. 11/15/15 redness resolved, still sl warm and swollen.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received single dose Flu vaccine in (L) deltoid on 11/11/15. Next day school nse notes arm red, hot; swollen and painful. Eval in office -> 9x13 cm red, warm, indurated (L) deltoid, able to lift arm 45 degrees but unable to lift to shoulder level. 11/15/15 redness resolved, still sl warm and swollen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site nodule
Clinical narrative: Large knot developed at injection site. Larger area surrounding knot. Dr. diagnosed infection at site of injection.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Pharyngeal ulceration
Clinical narrative: Patient developed a sore throat and multiple red and yellow sores on his posterior pharynx after receiving each of the HPV vaccines. The first time sores started 1-2 days after IZ and lasted 5 weeks. The second time sores started 1 day after IZ and lasted 2-3 weeks. The 3rd time sores started 1 day after IZ and continues 2 weeks later.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Headache, Pain, Tremor
Clinical narrative: Per phone call from pt's mother: headache, shaking, hot, gen body aches. Rec'd mom's call approximately 7 hrs after vaccine administered. Pt was evaluated in our express care dept.
Age: 10.0
Sex: M
Vaccine: FLU3, HEP, HEPA, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None. 11/25/15 T/C contacted mom for f/u to check status of child, child doing well, denies any problems and he is well.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pt complains of shoulder pain due to Flu shot.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: 5 cm area of erythema and tenderness beginning 1 wk after vaccine at site.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event reported. Pt was given vaccine too early per guidelines for time between PNEUMOVAX 23 (given 7/7/15) and PREVNAR 13 (given 10/14/15).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Injected limb mobility decreased, Nervousness
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 14Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant on behalf of physician, via a Pfizer sales representative. The medical assistant reported for 6 patients. This is the first of the six reports. A 18-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA (Lot# J28923, exp date Jun2016), intramuscular in the right deltoid, on 18Aug2015 at 10:11 am, at 0.5 ml single. Relevant medical history was not reported. Concomitant medication included JUNEL FE from 04May2015 and ongoing daily, for birth control. The patient previously received first dose of TRUMENBA, intramuscular in the right deltoid, on 02Jun2015, at 0.5 ml single. On 18Aug2015, approximately 2 hours after receiving vaccine the patient experienced dizziness, headache (severe), chills, shaky feelings and vomiting. She was advised to increase hydration and lay down/sleep. Events recovered on 19Aug2015. Then on an unspecified date the patient had extreme pain in the arm where the vaccine was injected, like to the point that could barely lift the arm and described it as dead arm; these events lasted about 7 to 10 days after the injection and recovered on an unspecified date. The reporter considered that the adverse events were due to TRUMENBA. Patient will receive TRUMENBA in Dec2015. Follow-up (01Oct2015): New information from the same healthcare professional on behalf of physician includes: vaccination history/scheduling, event details, concomitant.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Vomiting
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 14Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant on behalf of physician, via a Pfizer sales representative. The medical assistant reported for 6 patients. This is the first of the six reports. A 18-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA (Lot# J28923, exp date Jun2016), intramuscular in the right deltoid, on 18Aug2015 at 10:11 am, at 0.5 ml single. Relevant medical history was not reported. Concomitant medication included JUNEL FE from 04May2015 and ongoing daily, for birth control. The patient previously received first dose of TRUMENBA, intramuscular in the right deltoid, on 02Jun2015, at 0.5 ml single. On 18Aug2015, approximately 2 hours after receiving vaccine the patient experienced dizziness, headache (severe), chills, shaky feelings and vomiting. She was advised to increase hydration and lay down/sleep. Events recovered on 19Aug2015. Then on an unspecified date the patient had extreme pain in the arm where the vaccine was injected, like to the point that could barely lift the arm and described it as dead arm; these events lasted about 7 to 10 days after the injection and recovered on an unspecified date. The reporter considered that the adverse events were due to TRUMENBA. Patient will receive TRUMENBA in Dec2015. Follow-up (01Oct2015): New information from the same healthcare professional on behalf of physician includes: vaccination history/scheduling, event details, concomitant.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient: Upon receipt of follow-up information on 14Sep2915, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician via a Pfizer sales representative. The medical assistant reported six reports for six patients. This is the second report. A 20-year-old male patient of an unspecified ethnicity received second dose of TRUMENBA (Lot# J28923, exp date Jun2016), intramuscular in the left deltoid, on 18Aug2015 at 09:58 am, at 0.5 ml single. Relevant medical history included asthma. Concomitant medications were not reported. The patient previously received first dose of TRUMENBA, intramuscular in the left deltoid, on 02Jun3025, at 0.5 ml single. On an unspecified date the patient had extreme arm pain where the vaccine was injected, like to the point that could barely lift the arm described it as dead arm which lasted about 7 to 10 days after the injection. The reporter considered that the adverse events were due to TRUMENBA. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Blood pressure fluctuation, Bradycardia, Pruritus, Pulse abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer employer. A male patient of an unspecified age and ethnicity received TRUMENBA (Lot# 43514 Expiry date: 31Jul2016), via an unspecified route of administration on 30Aug2015 at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced itching and bradycardia. His blood pressure was 90, then his blood pressure went to 88/60 and then 88/77 at 4:30pm on Aug2015 with outcome of unknown. Pulsation was of 40 and went to 60 at 4:30 pm. All events occurred on unknown date in Aug2015 and the outcome was reported as unknown. The patient received 500cc of normal saline solution and then his pulse went to 87 and blood pressure to 110/84. The Pfizer employee mentioned the patient did not have any past medical history. Follow-up (09Sep2015): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Tuberculin test
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received TRUMENBA (lot number J28923) intramuscular on the left deltoid on 20Aug2015 at 16:30 at single dose, on unknown date. Relevant medical history included Hashimoto's thyroiditis and hypothyroidism for several years, well controlled on Levothyroxine. Concomitant medication included levothyroxine sodium (manufacturer unknown) at 75 mg daily for hypothyroidism. The patient underwent a TB skin test (manufactured by Sanofi Pasteur) on 23Jul2015. She got an unspecified vaccine on 14Jul2014 without issue. The day after the vaccination, on 21Aug2015, the patient developed bruising that extended from shot area to elbow, considered not serious. The patient recovered from the event on 23Aug2015. The physician reported that the patient provided to him/her information regarding the reported adverse event with the use of the vaccine. The physician considered the Pfizer vaccine had a causal effect to the adverse event. Follow up (13Oct2015): New information reported from the same contactable physician includes: patient's age, details of the vaccine, medical history, concomitant medication, lab data, outcome, physician's causality assessment and seriousness. Follow-up attempts completed. No further information expected. Follow-up (21Oct2015): This is a follow-up report combining information from duplicate reports 2015293929 and 2015291938. The current and all subsequent information will be reported under manufacturer report number 2015291938. Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Nausea, Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported two cases for same drug and different events/patient (brother and sister). This is one of the two reports. A 13-year-old healthy female patient of an unspecified ethnicity received. on 25Aug2015 at 09:30, TRUMENBA (Lot. L13515), intramuscular in the left arm, at 0.5 ml, single dose, for immunization (prevention of type b meningococcal infection). The vaccine was administered at the private doctor's office/hospital and was purchased with private funds. Relevant medical history and concomitant medications were unknown. The patient experienced nausea, swollen arm and lower back pain on an unspecified date. The events did not require an emergency room or physician visit. No hospitalization was required. The patient recovered from the event, nausea on 30Aug2015; while clinical outcome of the other events was unknown. The case was assessed as non-serious. There was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (09Oct2015): New information reported from the same contactable physician includes: patient details, suspect drug details, and reaction data. Follow-up attempts obtained. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site erythema, Pain, Swelling, Tenderness, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable physician (reporting for the daughter) via a Pfizer sales representative. A 18-year-old female patient received TRUMENBA (Lot # J29203, Exp date Jun2016, NDC number 100000003540), intramuscular in the left deltoid, on 05Aug2015 at 04:30 pm, at 0.5 ml single. Relevant medical history was not reported. Patient did not have illness at time of vaccination. Concomitant medications included TDAP (Lot # U4998AB), intramuscular in the left deltoid, on 05Aug2015; LEXAPRO tablet, oral, at 20 mg daily, for an unspecified indication and unspecified birth control tablets. The patient previously received first dose of TDAP on an unspecified date. The patient experienced tenderness, swelling, generalized aches on 05Aug2015 later in the evening and vaccination site rash (on left upper arm), patchy areas of raised redness on 07Aug2015. Event course was as follows: the patient initially had swelling, tenderness and generalized aches. Rash didn't show up until 07Aug2015. Rash appeared on left upper arm where injection site was. Rash was patchy areas of raised redness. No discharge. The patient was not admitted to the hospital. Events resolved on 08Aug2015. The reporter considered the reported events as related to TRUMENBA. Follow-up(10Sep2015); New information includes: reporter's details. Follow-up (28Sep2015): New information received from the same contactable physician includes: causality assessment. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cough, Decreased appetite, Dizziness, Dysphonia, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer calling for her daughter. A 18-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration, on 30Aug2015, at single dose, due to outbreak of meningitis in the campus. Relevant medical history was not reported. Concomitant medications included LOESTRIN, at 1x/day, for birth control and MENACTRA, in Aug2015, but was advised it would not cover this strain of outbreak. The patient experienced stuffy nose from 30Aug2015, hoarse voice from unspecified date, cough from unspecified date, no appetite from 30Aug2015, dizzy from 30Aug2015, flu-like symptoms from 30Aug2015, knocked out from 30Aug2015, the shot really hurt from 30Aug2015 and vomiting from 31Aug2015. The patient recovered from all events. The events did not require hospitalization. Patient was seen in the nurses' station. Therapeutic measures were taken as a result of the events and included treatment with fluids orally on 31Aug2015 at the college, and NYQUIL, DAYQUIL, cough drops/lozenges. The patient received first of three shots of vaccine. Follow-up (06Oct2015): Additional information reported from a contactable consumer includes outcome of the events. Follow up (10Nov2015): New information from a contactable physician included: the physician was not aware of any adverse reaction as he was not the one who administered the vaccine to the patient. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Nasal congestion, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer calling for her daughter. A 18-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration, on 30Aug2015, at single dose, due to outbreak of meningitis in the campus. Relevant medical history was not reported. Concomitant medications included LOESTRIN, at 1x/day, for birth control and MENACTRA, in Aug2015, but was advised it would not cover this strain of outbreak. The patient experienced stuffy nose from 30Aug2015, hoarse voice from unspecified date, cough from unspecified date, no appetite from 30Aug2015, dizzy from 30Aug2015, flu-like symptoms from 30Aug2015, knocked out from 30Aug2015, the shot really hurt from 30Aug2015 and vomiting from 31Aug2015. The patient recovered from all events. The events did not require hospitalization. Patient was seen in the nurses' station. Therapeutic measures were taken as a result of the events and included treatment with fluids orally on 31Aug2015 at the college, and NYQUIL, DAYQUIL, cough drops/lozenges. The patient received first of three shots of vaccine. Follow-up (06Oct2015): Additional information reported from a contactable consumer includes outcome of the events. Follow up (10Nov2015): New information from a contactable physician included: the physician was not aware of any adverse reaction as he was not the one who administered the vaccine to the patient. Follow-up attempts completed. No further information expected.