chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist 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 an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N013868, expiration date 04-MAY-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune haemolytic anaemia, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Computerised tomogram thorax normal, Coombs direct test positive
Clinical narrative: Developed warm autoimmune hemolytic anemia a few days after receiving high dose flu vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Warm type haemolytic anaemia
Clinical narrative: Developed warm autoimmune hemolytic anemia a few days after receiving high dose flu vaccination.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in upper arm/shoulder area, pain is not constant and it did not develop after the immunization rather approximately a month later.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blood culture negative, CSF culture, CSF test normal, Computerised tomogram head normal, Developmental delay
Clinical narrative: 15-month-old female who is admitted to the PICU from emergency department with a concern of status epilepticus. The child was found by the mother early morning on the day of presentation with generalized tonic-clonic seizure and head deviation. EMS were called and they administered 1 mg of ATIVAN upon transporting the patient to the emergency department. Upon arrival to the ED, child received subsequent doses of ATIVAN due to continued seizure activity in total of 6 mg. This resulted in respiratory depression and RSI was done. Head CT was performed and was negative. She was loaded with KEPPRA and fosphenytoin then she was started on ATIVAN drip and transported to another Hospital. Patient had low-grade fever for the last 2-3 days. No history of trauma. There is negative family history of epilepsy. She has also had regression of motor and language milestones over the past months.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Developmental regression, Electroencephalogram abnormal, Endotracheal intubation, Full blood count normal, Generalised tonic-clonic seizure
Clinical narrative: 15-month-old female who is admitted to the PICU from emergency department with a concern of status epilepticus. The child was found by the mother early morning on the day of presentation with generalized tonic-clonic seizure and head deviation. EMS were called and they administered 1 mg of ATIVAN upon transporting the patient to the emergency department. Upon arrival to the ED, child received subsequent doses of ATIVAN due to continued seizure activity in total of 6 mg. This resulted in respiratory depression and RSI was done. Head CT was performed and was negative. She was loaded with KEPPRA and fosphenytoin then she was started on ATIVAN drip and transported to another Hospital. Patient had low-grade fever for the last 2-3 days. No history of trauma. There is negative family history of epilepsy. She has also had regression of motor and language milestones over the past months.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Human metapneumovirus test positive, Hyperreflexia, Intensive care, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 15-month-old female who is admitted to the PICU from emergency department with a concern of status epilepticus. The child was found by the mother early morning on the day of presentation with generalized tonic-clonic seizure and head deviation. EMS were called and they administered 1 mg of ATIVAN upon transporting the patient to the emergency department. Upon arrival to the ED, child received subsequent doses of ATIVAN due to continued seizure activity in total of 6 mg. This resulted in respiratory depression and RSI was done. Head CT was performed and was negative. She was loaded with KEPPRA and fosphenytoin then she was started on ATIVAN drip and transported to another Hospital. Patient had low-grade fever for the last 2-3 days. No history of trauma. There is negative family history of epilepsy. She has also had regression of motor and language milestones over the past months.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Posture abnormal, Pyrexia, Respiratory depression, Status epilepticus
Clinical narrative: 15-month-old female who is admitted to the PICU from emergency department with a concern of status epilepticus. The child was found by the mother early morning on the day of presentation with generalized tonic-clonic seizure and head deviation. EMS were called and they administered 1 mg of ATIVAN upon transporting the patient to the emergency department. Upon arrival to the ED, child received subsequent doses of ATIVAN due to continued seizure activity in total of 6 mg. This resulted in respiratory depression and RSI was done. Head CT was performed and was negative. She was loaded with KEPPRA and fosphenytoin then she was started on ATIVAN drip and transported to another Hospital. Patient had low-grade fever for the last 2-3 days. No history of trauma. There is negative family history of epilepsy. She has also had regression of motor and language milestones over the past months.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: At 8:15pm on 12/05/2017 the arm became immobile and excruciatingly painful. If I needed to move the arm, I had to lift it with the opposite hand. I could not sleep on 12/05 at all due to pain and immobility. There was no redness or swelling. I was able to nap on the afternoon of that day. By the morning of 12/07/2017, the pain had lessened and I was able to move my arm, although painfully. Today is 12/08/2017, and the arm/shoulder pain persists upon motion or pressure, but it is bearable.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash
Clinical narrative: Patient presented with mild rash at injection site now lasting nearly 2 months post administration. Patient has been recommended treating with antihistamines and steroid topical creams which have not resolved rash as of 12/7/17.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction, Pyrexia, Skin warm, Swelling
Clinical narrative: Large localized reaction to ULD extending to forearm, shoulder and upper chest 12/5/17 in clinic. Warm to touch, sig. swelling. No streaking. Worsening 12/06/17. Low grade fever 100.3 F and at home x 2 days.
Sex: M
Vaccine: VARCEL
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from a patient's mother and refers to an 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-NOV-2017 (reported as yesterday), the patient was vaccinated with VARIVAX injection, 1 dose (route of administration, lot#, expiration date were not reported) for prophylaxis (reported as unspecified live virus chickenpox vaccine). The patient's mother stated that her son had autism, however it could not be verified if the patient had autism before receiving the vaccine, so the report was being taken as a precaution. The patient's mother also verified that the patient had not received any vaccines before. The outcome of autism was unknown. The reporter did not assess relatedness between the event and therapy with VARIVAX. Upon internal review, the autism was determined to be medically significant.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II  lot # M045391 with an expiration date 14-NOV-2018 (dose, route of administration and anatomical location were not reported) and LIQUID PEDVAXHIB lot# N004632 with an expiration date 02-NOV-2019 (dose, route of administration and anatomical location were not reported). No adverse effect was reported. The administered dose of vaccines experienced the temperature excursion form 47 to 77 degrees Fahrenheit for 7 hours and 50 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA007177: US-009507513-1712USA004522:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 07-NOV-2017, the patient was vaccinated with an improperly stored PNEUMOVAX 23 lot # M037533 with an expiration date 17-MAY-2018. No adverse effect was reported. The administered dose of PNEUMOVAX 23 experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 7 hours and 50 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA007177: US-009507513-1712USA004521.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site streaking, Mobility decreased, Pain, Swelling
Clinical narrative: Swelling, erythema, pain, warmth, decreased mobility, streak from injection site to shoulder.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Computerised tomogram, Dysphagia, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Client had a varicella vaccine on 10-20-17 that was recommended by her MD. States she had no Hx of chicken pox disease. 12-8-17 she called to report she was allergic to the vaccine. She had the reaction over the weekend of 10-21 or 10-22-17. Started as a sore throat. Then had some problems swallowing and a swollen tongue and swollen lymph nodes. Self-treated with BENADRYL. Went to the emergency room in November for the same symptoms. Got antibiotics and saw an ENT specialist who she stated advised her that her symptoms were from the varicella vaccine. She had a CT on 11/20/17. Then saw her primary MD on 11/29/17.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Swollen tongue
Clinical narrative: Client had a varicella vaccine on 10-20-17 that was recommended by her MD. States she had no Hx of chicken pox disease. 12-8-17 she called to report she was allergic to the vaccine. She had the reaction over the weekend of 10-21 or 10-22-17. Started as a sore throat. Then had some problems swallowing and a swollen tongue and swollen lymph nodes. Self-treated with BENADRYL. Went to the emergency room in November for the same symptoms. Got antibiotics and saw an ENT specialist who she stated advised her that her symptoms were from the varicella vaccine. She had a CT on 11/20/17. Then saw her primary MD on 11/29/17.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-10-11.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-10-13.
Age: 21.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2017-10-16.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2017-10-16.
Age: 9.0
Sex: M
Vaccine: IPV, MMRV, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-10-23.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-10-23.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, UNK
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-11-01.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-11-02.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Photophobia
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Injection site cellulitis, Injection site discomfort, Injection site mass
Clinical narrative: Day of vaccine low grade temp. Day after vaccine fatigue and site discomfort. Day 3 large lump at inj site painful and itchy. Painful shoulder to elbow. Rx for cellulitis 12/7-17. Improved 12/8/17.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Day of vaccine low grade temp. Day after vaccine fatigue and site discomfort. Day 3 large lump at inj site painful and itchy. Painful shoulder to elbow. Rx for cellulitis 12/7-17. Improved 12/8/17.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Right upper arm hard, red, warm and swollen; radiating to elbow. Local reaction-symptomatic. Measures, to call office back if develops systemic symptoms.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Approximately 1 week beginning day after injection fever, achiness, vomiting.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Ill-defined disorder
Clinical narrative: Allergy status to serum and vaccine status on 2017-11-01.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-11-08.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Ill-defined disorder
Clinical narrative: Allergy status to serum and vaccine status on 2017-11-10.
Age: 22.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2017-11-14.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, subs on 2017-11-16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2017-11-20.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-12-01.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Patient received FLUZONE and PNEUMOVAX 23 on Monday 12/4/17. Patient developed a rash on Wednesday 12/6/17 that spread from the injection site to the patient's elbow.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of itching and pain at the site of injection. Mother viewed the site on 12/7/17 and saw redness with some swelling. She administered 12.5 mg of BENADRYL per instructions from an RN that she spoke with at office as well as drawing a circle around the edges of the swelling and redness. Patient was evaluated by Dr. on 12/8/17 which she reported increased redness at 3cm in width with blanching and 2 cm induration at the injection site and "not significantly warm". Patient reported pain in the area when not active.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 102-104 persisting after fever reducer administered.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was reported. On 13-JAN-2016, the patient was vaccinated with PEDVAXHIB (strength, frequency, route of administration, lot# and expiry date were not provided) dose 1 for prophylaxis. On 10-MAR-2016, the patient was vaccinated with PEDVAXHIB (strength, frequency, route of administration, lot# and expiry date were not provided) dose 2 for prophylaxis. No adverse effects were reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Nasopharyngitis, Pollakiuria
Clinical narrative: Break out in blisters on rear-end. Increased in urination. Cold symptoms. (Called provider or treatment *only change to routine may be related unsure 11/13/17). Traveled around 9/28/17 and noticed reactions then.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain
Clinical narrative: On 12/1/17 at 10AM patient came to pharmacy to fill report and ask if his back pain could be related to the flu shot he received on 11/18/17. Patient describing pain starting 2 days after flu shot was administered. Described as sharp pain that started on left lower back and has now moved to right lower back. Patient states that pain is progressively getting better but still bothers him. Patient says he has never had pain quite like that before which is why he was asking about the flu shot. Recommended to F/U with PCP.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A bag (swelling) of fluid formed on arm below the site of injection and got bigger each passing day down to my elbow and about 1/4 was around the arm. Site of injection was red, hard and hot and sore also. 6 months ago- (4-24-2017) I got a Pneumococcal Conjugate Vaccine (PCV 13) when the nurse gave me this shot she told me to come back in 6 months to get another on because it was a series of 2 shots.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: 3 vaccines administered. 2 min. post vaccination, patient experienced a syncopal episode lasting a few seconds. Patient reported feeling fine. Upon standing, patient experienced a 2nd episode. We laid patient down. Patient had loss of colors in lips/face. Orthostatic BP 97/68 mmHg w/Pulse of 62. EMS arrived and took over. Patient did not eat prior to receiving vaccinations; little to no fluids as well. Patient was monitored for 1 hour by EMS. Patient's father brought her food and she began to feel better. She left at approximately 2:40 P.M. Patient's annual physical with primary physician showed nothing remarkable.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complaining of extreme pain in injection site for the past month tried using Ibuprofen for pain relief nothing helps patient states.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Localised infection, Peripheral swelling
Clinical narrative: Came in w/left arm swelling/infection.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Sweating, pale, nausea, vomiting, dizzy, slight loss consciousness. Placed on gently on ground w/back against car. Cool water on head. Small sips water. Then ginger ale and she was back to normal. We insisted a friend drive her home and she left car overnight. She stayed with us for 1 hour and 15 minutes closely monitored for any side effects or more reactions. Patient felt much better after vomiting and drinking Ginger Ale has positive history of similar Rxn as a child during a blood draw. Patient left pharmacy at 6:20pm with roommate who drove her home.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Sweating, pale, nausea, vomiting, dizzy, slight loss consciousness. Placed on gently on ground w/back against car. Cool water on head. Small sips water. Then ginger ale and she was back to normal. We insisted a friend drive her home and she left car overnight. She stayed with us for 1 hour and 15 minutes closely monitored for any side effects or more reactions. Patient felt much better after vomiting and drinking Ginger Ale has positive history of similar Rxn as a child during a blood draw. Patient left pharmacy at 6:20pm with roommate who drove her home.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pain, Pruritus
Clinical narrative: Flu HD admin 11-17-17 I (L) deltoid pt states "itching and soreness occurred on 11-22-17". Seen today site with raised nodules and redness. Denies any soreness and itching at present checked with pharmacist given BENADRYL 25 PO to take when gets home and apply warm moist heat. Pt to return on 11-29-17.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: After dinner on day Varicella vaccine was received she experienced H/A and itching at site. Day 2-swelling Day 3-swelling gone- site red. No hardness at site Headache continues. Pt. taking TYLENOL for H/A.
Age: 12.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No reaction.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Swelling face
Clinical narrative: Patient experienced mild facial swelling and injection site reaction with redness/warmth. Counseled to place cold compress on arm and take benadryl.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reports that 2-3 days after receiving the vaccine her arm is fine, but after that she started to notice that it was painful and caused a burning pain in her arm. There is no redness or visible markings on the skin around the injection site. She says the pain is not constant but comes and goes, but can wake her up at night.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Pain in extremity, Vaccination complication
Clinical narrative: Pain in arm lasting since 9/11 - patient says Dr diagnosed her with "SIRVA."
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arteriogram coronary normal, Brain natriuretic peptide increased, Cardiac failure congestive, Cardiac stress test normal, Chest X-ray abnormal
Clinical narrative: Within 2-3 days the development of urticaria, itching, involving face, chest, arms.  Shortness of breath noted by day 3 with wheezing. Then symptoms of CHF with orthopnea, dyspnea on exertion. Workup noted CHF of CXR, decreased systolic function of echocardiogram at 33% EF, and CHF meds started. Further workup for cardiomyopathy included perfectly clean coronary angiogram and a month later normal cardiac MRI. Still needing carvedilol, lisinopril and furosemide for CHF with class 2 symptoms, now starting to improve.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram
Clinical narrative: Within 2-3 days the development of urticaria, itching, involving face, chest, arms.  Shortness of breath noted by day 3 with wheezing. Then symptoms of CHF with orthopnea, dyspnea on exertion. Workup noted CHF of CXR, decreased systolic function of echocardiogram at 33% EF, and CHF meds started. Further workup for cardiomyopathy included perfectly clean coronary angiogram and a month later normal cardiac MRI. Still needing carvedilol, lisinopril and furosemide for CHF with class 2 symptoms, now starting to improve.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging heart, Nuclear magnetic resonance imaging normal, Orthopnoea, Pruritus, Systolic dysfunction
Clinical narrative: Within 2-3 days the development of urticaria, itching, involving face, chest, arms.  Shortness of breath noted by day 3 with wheezing. Then symptoms of CHF with orthopnea, dyspnea on exertion. Workup noted CHF of CXR, decreased systolic function of echocardiogram at 33% EF, and CHF meds started. Further workup for cardiomyopathy included perfectly clean coronary angiogram and a month later normal cardiac MRI. Still needing carvedilol, lisinopril and furosemide for CHF with class 2 symptoms, now starting to improve.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Wheezing
Clinical narrative: Within 2-3 days the development of urticaria, itching, involving face, chest, arms.  Shortness of breath noted by day 3 with wheezing. Then symptoms of CHF with orthopnea, dyspnea on exertion. Workup noted CHF of CXR, decreased systolic function of echocardiogram at 33% EF, and CHF meds started. Further workup for cardiomyopathy included perfectly clean coronary angiogram and a month later normal cardiac MRI. Still needing carvedilol, lisinopril and furosemide for CHF with class 2 symptoms, now starting to improve.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pharyngeal oedema, Skin irritation
Clinical narrative: Throat swelling, skin irritation around throat.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Injection site swelling, Skin warm, Tenderness
Clinical narrative: Yesterday evening Mom saw swollen entire (L) upper arm. Arm is warm, pt. states feels like a piece of wood and is tender if touched. No fever or other constitutional symptoms. F/U in 5 days.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Muscle spasms, Nuclear magnetic resonance imaging brain normal, Visual impairment
Clinical narrative: Onset (10-26-17 - 10-27-17) 5PM approx.-severe cramps in legs (Both legs) all PM and AM through hrs and night until early AM. eased somewhat. Told husband I must see Dr.-Was told she was could not see me. I called back-got a recording-2 or 3x's-left message to please somebody call back-no call back. Husband took me to ER approx 8 AM (10-27-17)-saw Dr on call-MRI of head and lab work (blood and urine spec-all WNL's). Dx'd with muscle cramps-Vision still affected.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Sitting in church pt realized skin was itchy at injection and raised.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, warmth and swollen w/mild itching at injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Neck pain, Vaccination site swelling
Clinical narrative: Patient returned to the pharmacy the next day with a large, raised, red, swollen area on left arm around the vaccination site. It was approximately 7 inches in size. She reported the area was itchy and warm to the touch. She also reported pain from site and it radiated into the neck. She had already taken acetaminophen for the pain and pharmacist advised her to take diphenhydramine for the itching and swelling. She was also referred to her primary care physician for further care.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site warmth
Clinical narrative: Patient returned to the pharmacy the next day with a large, raised, red, swollen area on left arm around the vaccination site. It was approximately 7 inches in size. She reported the area was itchy and warm to the touch. She also reported pain from site and it radiated into the neck. She had already taken acetaminophen for the pain and pharmacist advised her to take diphenhydramine for the itching and swelling. She was also referred to her primary care physician for further care.
Age: 41.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Injection site swelling, Pain
Clinical narrative: Severe muscle pain under injection site, requiring round the clock ice pack for 2 days and continual TYLENOL dosing. Deltoid muscle felt like there was 'acid' in the arm for 3 weeks. Visible inflamed muscle 'bump' for 3 weeks. Motion limited, could not sleep on that arm for at least two weeks, pain with stretching of muscle. Never experienced other adverse reactions to immunizations before, except the first dose of BEXSERO as well (6 months ago) which produces the same excruciating symptoms. Concerned that it causes muscle damage with very slow healing. Would not have returned for this booster shot if I was not asplenic and absolutely needed the series. PLEASE look into having this vaccine reevaluated and adjusted.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fall, Laceration, Peripheral swelling
Clinical narrative: Pt's arm was swollen to twice its normal size the next morning when she woke up on 12/06/2017.  Became dizzy, fell and cut her forehead. Went to her primary md who referred her to the ER.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, MMRV, PNC13, VARCEL
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 06-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles (onset not reported). On or about 01-DEC-2016, the patient was treated by a physician for persistent and unbearable episodes of pain that has been persistent since she had outbreaks of shingles. The patient was diagnosed with post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to zoster infections. The patient was prescribed gabapentin and lidocaine hydrochloride for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 23-Oct-2017. This case involves 67 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE intramuscularly in right deltoid (batch number- UI870AA, expiry date - 13-May-2018 (Dose in series were not reported) on 19-Oct-2017. Medical history and concomitant medications were not reported. On an unknown date, 3 hours following vaccination patient developed fever, chills, yellowish discharge from eyes, congestion, headache, sore throat. It was unknown if patient was going to seek treatment. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from all the events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a pharmacist on 23-Oct-2017. This case involves 67 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE intramuscularly in right deltoid (batch number- UI870AA, expiry date - 13-May-2018 (Dose in series were not reported) on 19-Oct-2017. Medical history and concomitant medications were not reported. On an unknown date, 3 hours following vaccination patient developed fever, chills, yellowish discharge from eyes, congestion, headache, sore throat. It was unknown if patient was going to seek treatment. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from all the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from pharmacist on 08-Nov-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as last year). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient's arm was swollen and red. Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from events. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Initial unsolicited report received from a nurse on 28-Nov-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (lot number: U589DA, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post-vaccination, the patient had experienced large red rash. Relevant lab investigations and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Initial unsolicited report received from nurse on 28-Nov-2017. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml prefilled dose of FLUZONE QIV (Batch number: U589DA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced large red rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Initial unsolicited report received from nurse on 28-Nov-2017. This case involves a female patient (age not reported) who was vaccinated with 0.5 ml prefilled syringe dose of FLUZONE QIV (Batch number: U589DA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced large red rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Asthenia, Lethargy, Nodule, Temperature intolerance
Clinical narrative: Knot in armpit, lethargy for a week, cold sensitive, a weakness still, and aches in joints.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Hypoaesthesia, Injection site hypoaesthesia, Nausea, Pallor
Clinical narrative: Patient became pale, nauseous, diaphoretic, speech thick, numbness in the rt arm (from the injection site) extending to her face. Was given 50 mg of Benadryl po , sx's improved in 5 minutes. resolved in 20 minutes.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Speech disorder
Clinical narrative: Patient became pale, nauseous, diaphoretic, speech thick, numbness in the rt arm (from the injection site) extending to her face. Was given 50 mg of Benadryl po , sx's improved in 5 minutes. resolved in 20 minutes.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient's mother stated that later at night after receiving her flu vaccine, her daughter had a 2 inch by 2 inch red circle around the injection site which felt warm to touch and said that it itched. She said that she gave her BENADRYL and ibuprofen which seemed to help but it still felt warm and the itching was returning. If it continued, she was going to go to urgent care to make sure that it isn't infected. Her mother said that she thinks this has happened before when patient has received vaccines.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: 3 INCH DIAMETER REDNESS THAT SLOWLY DECREASED OVER 2 DAYS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Headache, Influenza virus test negative, Injection site erythema
Clinical narrative: INJECTION SITE REDNESS, PAIN. BODY ACHES,CHILLS. Fever, headache, decreased appetite.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: INJECTION SITE REDNESS, PAIN. BODY ACHES,CHILLS. Fever, headache, decreased appetite.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient/healthcare proxy did not mention that patient was not feeling well before vaccine. On the vaccine consent and administration record- patient checked off "no" to the question are you sick today- thus there was no indication that patient was not feeling well at the time. After the vaccine- per healthcare proxy and nearby customer patient seemed to be dizzy while walking out of the pharmacy. Ambulance was called by customer who observed the patient.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Dyspepsia, Eyelid oedema, Fatigue
Clinical narrative: The patient called the pharmacy on 12/08/2017 to describe reactions they believed to be from the vaccine they received 11/03/2017. The patient stated they experienced significant weakness, fatigue (particularly in the legs), and confusion/memory impairment for 3 to 4 days beginning approximately 24 hours after vaccination. The patient stated on the second or third day after the vaccination both eyes were swollen shut, which resolved 2 to 3 days after that with application of ice to the area. The patient also stated they felt like they had indigestion/heartburn and they were afraid to eat, beginning a day or two after vaccination. The patient did not have to have a Dr visit, ER visit, or hospitalization as a result of these suspected adverse events. The patient stated that all adverse events were resolved within one week, with the exception of still feeling more tired than usual at the time of reporting these adverse events.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Memory impairment
Clinical narrative: The patient called the pharmacy on 12/08/2017 to describe reactions they believed to be from the vaccine they received 11/03/2017. The patient stated they experienced significant weakness, fatigue (particularly in the legs), and confusion/memory impairment for 3 to 4 days beginning approximately 24 hours after vaccination. The patient stated on the second or third day after the vaccination both eyes were swollen shut, which resolved 2 to 3 days after that with application of ice to the area. The patient also stated they felt like they had indigestion/heartburn and they were afraid to eat, beginning a day or two after vaccination. The patient did not have to have a Dr visit, ER visit, or hospitalization as a result of these suspected adverse events. The patient stated that all adverse events were resolved within one week, with the exception of still feeling more tired than usual at the time of reporting these adverse events.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area around the injection site, approx. 3 inches across, turned red and was warm to the touch. This started the next day after the immunization (12/01/2017) and has remained mostly unchanged since then to reporting the event  12/08/2017. Pt has been icing the area. The pt was advised to report this to there Dr. as well.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, and pain posterior right upper arm. Mild blistering to the area.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Nervousness, Syncope
Clinical narrative: Patient was afraid of getting immunization so after the injection he waited in our imz room for approximately 5 minutes and was feeling okay. I asked him to wait on our benches in front of the pharmacy for a little longer period. He waited approximately 10 minutes there and appeared to be okay. He stood and walked about 30 yards and started to fall to the floor and was caught by his mother. He had fainted. He was immediately responsive so we raised his legs to help with blood flow while he laid on the floor. After approximately 10 more minutes he felt well enough to try and stand again. He was fine and proceeded to shop in our store.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient started to have pain about 2 days later and this soreness does not go away until 3 weeks later so plan to see Doctor soon. Have a 1 cm diameter size of swollen rash on the injection area. And he gets FLUZONE HD annually and complained it happened only this year.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site irritation, Injection site reaction, Injection site warmth, Swelling
Clinical narrative: Pt states after the vaccine was given, she developed symptoms of irritation at the site. States it was red/hardened yesterday 12/7/17. Today, 12/8/17 pt states she continues to have redness and that there is warmth to the site now. Localized swelling noted as well. Pt took 2 Benadryl last night.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: R deltoid swollen, warm, tender, slight erythema and pruritus. No associated lymphadenopathy, lymphangitis. Improved somewhat w/out intervention but still present so father, who is a nurse, brought patient in for evaluation today.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient stated that vaccination caused extreme pain during administration. Shortly afterward she developed a large blister at the injection site with persistent pain interfering with the ability to sleep. Woke up the next morning with pain, swelling, and redness covering a large portion of the upper arm that was warm to the touch. Patient contacted her primary physician who advised her to apply ice and seek medical attention at the immediate care center if swelling continued. Patient was advised to 1) mark the area of redness & return if it continues to spread. 2) apply cool compresses several times daily avoiding direct skin contact; 3) ibuprofen 600 mg every 6 hours PRN; 4) BENADRYL 25 mg PO nightly x 3 days; 5) follow up with PCP in 3 days if symptoms have not resolved.
Sex: U
Vaccine: PPV
Symptoms: Insomnia
Clinical narrative: Patient stated that vaccination caused extreme pain during administration. Shortly afterward she developed a large blister at the injection site with persistent pain interfering with the ability to sleep. Woke up the next morning with pain, swelling, and redness covering a large portion of the upper arm that was warm to the touch. Patient contacted her primary physician who advised her to apply ice and seek medical attention at the immediate care center if swelling continued. Patient was advised to 1) mark the area of redness & return if it continues to spread. 2) apply cool compresses several times daily avoiding direct skin contact; 3) ibuprofen 600 mg every 6 hours PRN; 4) BENADRYL 25 mg PO nightly x 3 days; 5) follow up with PCP in 3 days if symptoms have not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's concurrent conditions, medical history and concomitant medication use were not provided. On or about 27-FEB-2008 the patient was administered ZOSTAVAX, 1 DF, (lot# and route unknown) at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 17-SEP-2013, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 10-DEC-2015, the patient sought subsequent treatment from another physician for ongoing and worsening symptoms of shingles outbreaks. On or about 15-DEC-2015, the patient was treated again by a physician for new and worsening complications of shingles.  The patient has been prescribed VALTREX and ULTRAM for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's concurrent conditions, medical history and concomitant medication use were not provided.  In 2014, the patient was administered ZOSTAVAX, 1DF, (lot# and route unknown), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 10-OCT-2016 the patient was treated by a Physician Assistant for complaints of radiating and burning pain on her ribcage and back, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: 4 cm x 3.5 cm erythematous raised lesion on (R) thigh. Prescribed BENADRYL cream to be applied TID for 5 days. Area has improved as of 12-8-17.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and red at injection site, warm to the touch, treated for cellulitis with AUGMENTIN.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Scab
Clinical narrative: Crusting and scabbing of lips, nose, face, arms and feet for 2 weeks following flu shot. Resolved spontaneously.
Age: 0.92
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth, Irritability, Pyrexia, Vomiting
Clinical narrative: Client's guardian stated "the baby was vomiting a lot this morning: he also is having fever of 100 degree F, the injection area feels warm and red; he is very fussy, I'm giving him TYLENOL to treat the fever". Guardian was advise to take child to his pediatrician to be evaluated; also to keep child hydrated and to watch for signs and symptoms of dehydration.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Conjunctivitis, Eye pruritus, Eye swelling, Fatigue
Clinical narrative: Itching, swelling eyes-like conjunctivitis. Tightening of throat. Flu-like symptoms; Resolved overnight then just felt weak, tired. No local Rxn at injection site.