chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Blood test, Cellulitis, Full blood count, Influenza, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from a consumer refers to a 14 year old female patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder, anxiety and depression. The patient's medical history and historical drugs were not reported. The patient's concomitant medications included ADDERALL and LEXAPRO. On an unknown date in October 2017, the patient was vaccinated with the first dose in the HPV vaccination series with GARDASIL or GARDASIL 9 intramuscularly for prevention of cervical cancer. The patient reported that the patient started having symptoms of cellulitis on 31-JAN-2018. It was unspecified where the cellulitis was located on the patient's body. The patient reported that the patient was hospitalized for cellulitis on 02-FEB-2018 and was still in the hospital. The patient also reported that on an unspecified date between 02-FEB-2018 and 05-FEB-2018, while hospitalized, the patient was diagnosed with "the flu." The patient underwent lab diagnostics: complete blood count and extensive blood tests: results were not provided. The patient received unspecified treatment for the events, on an unknown date. The outcome of events, cellulitis and influenza was reported as not recovered. The relationship between events and GARDASIL or GARDASIL 9 was not provided. No product quality complaint was involved. The patient had significant disability or incapacity and missed the school due to the events. Upon internal review, the event cellulitis was determined to be medically significant and also considered serious due to hospitalization.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2005 the patient was vaccinated with an expired dose of VARIVAX (lot # 0689N, expiry date: 14-MAY-2005) which was reconstituted with a sterile diluent (lot # and expiry date unknown) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding herself as a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 06-FEB-2018, the patient while administering the vaccine, M-M-R II, (lot # N013281, Exp date: 28-APR-2019), (Dose, route, frequency were not provided) for prophylaxis, some of the liquid came out and splashed her in the face. No adverse reaction was reported and no further clarifying information was provided. It was reported that product quality complaint (PQC) was not present.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Crying, Pyrexia, Vomiting projectile
Clinical narrative: About 15 minutes after leaving the doctor and receiving her 18 month I believe MMR vaccine, my child began projectile vomiting, and her fever spiked to 102. Her fever did come down but stayed at 99-101 for the next 2 or so days, her doctor said this was normal, but the projectile vomiting & inconsolable crying for a half hour after, didn't seem normal. A friend gave me the link to report, after her second reaction last night, to another vaccine.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Agitation, Back pain, Crying, Injection site erythema
Clinical narrative: Starting yesterday afternoon my child got a nasty rash on her back and bottom, and the injection site swelled, fevered and turned beet red. Her doctor's office was contacted, they told me just keep an eye out. The rash continued to spread up the back and the leg became more inflamed. She became agitated, restless, irritable and couldn't sleep. She woke at 4 am the day before, and didn't sleep until 1230 am the following day. She sobbed inconsolable in pain with her back arched from 9-11 pm. This has never happened in her life. She woke at 6. The leg is still swollen, rash is still visible, and my child is still irritable and acting unlike herself.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Insomnia, Irritability
Clinical narrative: Starting yesterday afternoon my child got a nasty rash on her back and bottom, and the injection site swelled, fevered and turned beet red. Her doctor's office was contacted, they told me just keep an eye out. The rash continued to spread up the back and the leg became more inflamed. She became agitated, restless, irritable and couldn't sleep. She woke at 4 am the day before, and didn't sleep until 1230 am the following day. She sobbed inconsolable in pain with her back arched from 9-11 pm. This has never happened in her life. She woke at 6. The leg is still swollen, rash is still visible, and my child is still irritable and acting unlike herself.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash, Restlessness
Clinical narrative: Starting yesterday afternoon my child got a nasty rash on her back and bottom, and the injection site swelled, fevered and turned beet red. Her doctor's office was contacted, they told me just keep an eye out. The rash continued to spread up the back and the leg became more inflamed. She became agitated, restless, irritable and couldn't sleep. She woke at 4 am the day before, and didn't sleep until 1230 am the following day. She sobbed inconsolable in pain with her back arched from 9-11 pm. This has never happened in her life. She woke at 6. The leg is still swollen, rash is still visible, and my child is still irritable and acting unlike herself.
Age: 49.0
Sex: F
Vaccine: FLU4, HEP, HEPA, TDAP, TYP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Patient developed area of erythema and increased warmth approximately 4 cm x 3 cm, 8 cm distal to injection sites and associated with pruritus. Seen at urgent care center on 02/07/18, and diagnosed with local allergic reaction per patient; no discharge papers available. Advised to take diphenhydramine and return if symptoms increased or failed to resolve. Had only local reaction; no periorbital or circumoral edema, no SOB/DOE, no N/V/D. Patient was referred to allergist on 02/08/18 after she related this diagnosis.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Patient presented next day with complaint of pain where shot was administered. Doctor quickly saw the patient and gave diagnosis of possible cellulitis.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Injection site induration, Injection site pain, Sleep disorder
Clinical narrative: Soreness of injection. Has not been pain free since injection. Much trouble sleeping on affected side and doing ADLS such as lifting. Firmness at injection site. Seen at occupational health clinic 4 months post injection. Orders for Prednisone, TYLENOL, cyclobenzaprine, and physical therapy.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Anger, Blister, Head discomfort, Injection site urticaria, Injection site vesicles
Clinical narrative: Extremely irritable, not sleeping or napping at all, screaming and holding head, hives all over abdomen and blisters and welts all over thighs, butt, pelvis and lower stomach. Started 3 days after shot was given and lasted 3-4 days. More than a week later child is still angry, not sleeping and in pain.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Irritability, Pain, Screaming, Urticaria
Clinical narrative: Extremely irritable, not sleeping or napping at all, screaming and holding head, hives all over abdomen and blisters and welts all over thighs, butt, pelvis and lower stomach. Started 3 days after shot was given and lasted 3-4 days. More than a week later child is still angry, not sleeping and in pain.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Patient had redness and itching with possible swelling on upper left arm. Redness extended a good 6 inches down arm. Patient states redness started on 2/6/18 but continued to get worse when she reported to pharmacy on 2/9/18. Instructed patient to take BENADRYL and contact prescriber to evaluate reaction and further treatment.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Client inadvertently was given influenza vaccine mixed with hepatitis A vaccine (HAVRIX-Peds Lot EMD4R Exp 9/18/18). No adverse effects reported at this time.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: Warmth and left arm heaviness within 30 minutes. Within 24 hours, headache and nausea. Without 48 hours, severe headache, generalized muscle weakness, blurred vision, dizziness, fatigue, and chills. Mild, gradual improvement over course of 1 year, but continues to have lower extremity weakness and generalized fatigue.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Muscular weakness, Nausea, Vision blurred
Clinical narrative: Warmth and left arm heaviness within 30 minutes. Within 24 hours, headache and nausea. Without 48 hours, severe headache, generalized muscle weakness, blurred vision, dizziness, fatigue, and chills. Mild, gradual improvement over course of 1 year, but continues to have lower extremity weakness and generalized fatigue.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Cough, Flushing, Injection site erythema, Injection site swelling
Clinical narrative: Cough, wheezing, flushing, angioedema of face, prominent localized swelling and redness at injection site.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Cough, wheezing, flushing, angioedema of face, prominent localized swelling and redness at injection site.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt. received the two injections. Next day had fever and vomiting. Pt. did have 2 other HPV injections and 1 TRUMENBA without reaction.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Febrile convulsion, Influenza virus test negative
Clinical narrative: Febrile seizure.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A 67-year-old female patient received, on 26Jan2018, PREVNAR 13, (Lot. S92740, Expiration date: Dec2019, NDC number: 00005197105) at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 02Feb2018, the patient experienced a slight feverish feeling, redness, and swelling in her arm at the injection site. On 05Feb2018, she was still having aching in her hands and feeling like she's swelling. The patient did not recover from the events at time of this report.
Sex: U
Vaccine: FLUX
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase normal
Clinical narrative: Initial unsolicited report received from the literature on 31-Jan-2018. Abstract Hydroxychloroquine is an antimalarial drug frequently used to reduce inflammation in autoimmune and inflammatory conditions. In adults, hydroxychloroquine can be used as an alternative agent totreat antihistamine-refractory chronic spontaneous urticaria (CSU).It was unknown whether hydroxychloroquine is safe and effective for treating antihistamine-refractory CSU in children. We present the case of a 9-month-old male infant with 5 months of recurrent, unprovoked hives and swelling who was treated safely and successfully with hydroxychloroquine. The patient was a previously healthy, full-term infant delivered by cesarean section. He was breastfed until 6 weeks of age and switched to a cow's milk-based formula without incident. After resolution of an upper respiratory tract infection at 4 months of age, patient developed recurrent and unprovoked full-body hives. The hives were occasionally associated with angioedema of the hands and feet, would resolve within 24 hours, and were not associated with fevers, residual bruising, lymphadenopathy, or joint swelling. Review ofsystems was negative for constitutional, respiratory, cardiovascular, gastrointestinal, genitourinary, or neurologic symptoms. The hives did not improve with an empiric trial of hypoallergenic formula or elimination of solid foods. The hives were refractory to treatment with diphenhydramine, high-dose cetirizine, ranitidine, and montelukast. The hives resolved with systemic corticosteroids, but quickly recurred when corticosteroids were tapered. Physical examination showed a well-appearing infant with multiple annular urticarial lesions involving the face and body and mild angioedema of the hands and feet. A stroke test revealed marked dermatographism. This case involves an 11-year-old patient (gender was not reported at the time of reaction), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. On an unknown date, patient performed urinalysis, lactate dehydrogenase, uric acid, vitamin b12, lactase dehydrogenase, immunoglobulin A, G, M and E, which results were in normal limits. On an unknown date patient had a medical history of urticarial. Concomitant medications included CETIRIZINE HYDROCHLORIDE (CETRIZINE), RANITIDINE, MONTELUKAST, PREDNISOLONE, and HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE). On an unknown date, following the vaccination patient had hives, recurrence of urticarial, Sporadic outbreak of hives. Patient's other laboratory test included- serum immunoglobulins and at the age of 14 months a opthalmalogic exam was done which results were normal. Corrective treatment was not reported. On an unknown date, patient was recovered from the event at the time of reporting. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Blood uric acid normal, Ophthalmological examination normal, Swelling, Urine analysis normal, Urticaria
Clinical narrative: Initial unsolicited report received from the literature on 31-Jan-2018. Abstract Hydroxychloroquine is an antimalarial drug frequently used to reduce inflammation in autoimmune and inflammatory conditions. In adults, hydroxychloroquine can be used as an alternative agent totreat antihistamine-refractory chronic spontaneous urticaria (CSU).It was unknown whether hydroxychloroquine is safe and effective for treating antihistamine-refractory CSU in children. We present the case of a 9-month-old male infant with 5 months of recurrent, unprovoked hives and swelling who was treated safely and successfully with hydroxychloroquine. The patient was a previously healthy, full-term infant delivered by cesarean section. He was breastfed until 6 weeks of age and switched to a cow's milk-based formula without incident. After resolution of an upper respiratory tract infection at 4 months of age, patient developed recurrent and unprovoked full-body hives. The hives were occasionally associated with angioedema of the hands and feet, would resolve within 24 hours, and were not associated with fevers, residual bruising, lymphadenopathy, or joint swelling. Review ofsystems was negative for constitutional, respiratory, cardiovascular, gastrointestinal, genitourinary, or neurologic symptoms. The hives did not improve with an empiric trial of hypoallergenic formula or elimination of solid foods. The hives were refractory to treatment with diphenhydramine, high-dose cetirizine, ranitidine, and montelukast. The hives resolved with systemic corticosteroids, but quickly recurred when corticosteroids were tapered. Physical examination showed a well-appearing infant with multiple annular urticarial lesions involving the face and body and mild angioedema of the hands and feet. A stroke test revealed marked dermatographism. This case involves an 11-year-old patient (gender was not reported at the time of reaction), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. On an unknown date, patient performed urinalysis, lactate dehydrogenase, uric acid, vitamin b12, lactase dehydrogenase, immunoglobulin A, G, M and E, which results were in normal limits. On an unknown date patient had a medical history of urticarial. Concomitant medications included CETIRIZINE HYDROCHLORIDE (CETRIZINE), RANITIDINE, MONTELUKAST, PREDNISOLONE, and HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE). On an unknown date, following the vaccination patient had hives, recurrence of urticarial, Sporadic outbreak of hives. Patient's other laboratory test included- serum immunoglobulins and at the age of 14 months a opthalmalogic exam was done which results were normal. Corrective treatment was not reported. On an unknown date, patient was recovered from the event at the time of reporting. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Vitamin B12 normal
Clinical narrative: Initial unsolicited report received from the literature on 31-Jan-2018. Abstract Hydroxychloroquine is an antimalarial drug frequently used to reduce inflammation in autoimmune and inflammatory conditions. In adults, hydroxychloroquine can be used as an alternative agent totreat antihistamine-refractory chronic spontaneous urticaria (CSU).It was unknown whether hydroxychloroquine is safe and effective for treating antihistamine-refractory CSU in children. We present the case of a 9-month-old male infant with 5 months of recurrent, unprovoked hives and swelling who was treated safely and successfully with hydroxychloroquine. The patient was a previously healthy, full-term infant delivered by cesarean section. He was breastfed until 6 weeks of age and switched to a cow's milk-based formula without incident. After resolution of an upper respiratory tract infection at 4 months of age, patient developed recurrent and unprovoked full-body hives. The hives were occasionally associated with angioedema of the hands and feet, would resolve within 24 hours, and were not associated with fevers, residual bruising, lymphadenopathy, or joint swelling. Review ofsystems was negative for constitutional, respiratory, cardiovascular, gastrointestinal, genitourinary, or neurologic symptoms. The hives did not improve with an empiric trial of hypoallergenic formula or elimination of solid foods. The hives were refractory to treatment with diphenhydramine, high-dose cetirizine, ranitidine, and montelukast. The hives resolved with systemic corticosteroids, but quickly recurred when corticosteroids were tapered. Physical examination showed a well-appearing infant with multiple annular urticarial lesions involving the face and body and mild angioedema of the hands and feet. A stroke test revealed marked dermatographism. This case involves an 11-year-old patient (gender was not reported at the time of reaction), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. On an unknown date, patient performed urinalysis, lactate dehydrogenase, uric acid, vitamin b12, lactase dehydrogenase, immunoglobulin A, G, M and E, which results were in normal limits. On an unknown date patient had a medical history of urticarial. Concomitant medications included CETIRIZINE HYDROCHLORIDE (CETRIZINE), RANITIDINE, MONTELUKAST, PREDNISOLONE, and HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE). On an unknown date, following the vaccination patient had hives, recurrence of urticarial, Sporadic outbreak of hives. Patient's other laboratory test included- serum immunoglobulins and at the age of 14 months a opthalmalogic exam was done which results were normal. Corrective treatment was not reported. On an unknown date, patient was recovered from the event at the time of reporting. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vomiting
Clinical narrative: Initial unsolicited report received from a physician in on 31-Jan-2018. This case involves a nine months old male patient, who was vaccinated with a 0.5 ml dose of FLUZONE (batch number, expiry date, dose in series and route of administration was not reported) in thighs down on an unknown date. Patient's medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced vomiting and redness in lower extremities. Lab data and corrective treatment were not reported. Event outcomes were not reported. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Arthralgia, Asthenia, Blood count, Blood magnesium
Clinical narrative: ER 7-14-17-Rt Hip pain muscle spasms-"Doctor". It was burning up my feet and legs terrible pain-weak-couldn't stand he sent me home with potassium CL ER and Relafen. Went to office 7/16/17 Diag. spinal stenosis-was not dian w/GBS for 4 wks. Hosp 7-14 (AM). Hosp 7-16 (AM)-diag. spinal stenosis, hosp for 3-4 days-sent to nursing Home for P.T. -they put me in bed or wheelchair and gave me med. Couldn't walk-spilled my food saw P.T. 2-3 times I think, short term memory up to year and 1/2 and no memory of nursing home at all. Dr. put me there. My husband and daughter called him every day finally he said bring her to my office. After conferring with associated they decided to find out what was really wrong. Dr. ordered spinal tap and they found G.B.S. Started med to get it out of my system. Very painful and still is.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chest X-ray, Dysstasia, Gait inability, Guillain-Barre syndrome
Clinical narrative: ER 7-14-17-Rt Hip pain muscle spasms-"Doctor". It was burning up my feet and legs terrible pain-weak-couldn't stand he sent me home with potassium CL ER and Relafen. Went to office 7/16/17 Diag. spinal stenosis-was not dian w/GBS for 4 wks. Hosp 7-14 (AM). Hosp 7-16 (AM)-diag. spinal stenosis, hosp for 3-4 days-sent to nursing Home for P.T. -they put me in bed or wheelchair and gave me med. Couldn't walk-spilled my food saw P.T. 2-3 times I think, short term memory up to year and 1/2 and no memory of nursing home at all. Dr. put me there. My husband and daughter called him every day finally he said bring her to my office. After conferring with associated they decided to find out what was really wrong. Dr. ordered spinal tap and they found G.B.S. Started med to get it out of my system. Very painful and still is.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Hepatitis viral test, Lumbar puncture abnormal, Metabolic function test, Muscle spasms, Pain
Clinical narrative: ER 7-14-17-Rt Hip pain muscle spasms-"Doctor". It was burning up my feet and legs terrible pain-weak-couldn't stand he sent me home with potassium CL ER and Relafen. Went to office 7/16/17 Diag. spinal stenosis-was not dian w/GBS for 4 wks. Hosp 7-14 (AM). Hosp 7-16 (AM)-diag. spinal stenosis, hosp for 3-4 days-sent to nursing Home for P.T. -they put me in bed or wheelchair and gave me med. Couldn't walk-spilled my food saw P.T. 2-3 times I think, short term memory up to year and 1/2 and no memory of nursing home at all. Dr. put me there. My husband and daughter called him every day finally he said bring her to my office. After conferring with associated they decided to find out what was really wrong. Dr. ordered spinal tap and they found G.B.S. Started med to get it out of my system. Very painful and still is.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Spinal column stenosis, Troponin, Wheelchair user, X-ray of pelvis and hip
Clinical narrative: ER 7-14-17-Rt Hip pain muscle spasms-"Doctor". It was burning up my feet and legs terrible pain-weak-couldn't stand he sent me home with potassium CL ER and Relafen. Went to office 7/16/17 Diag. spinal stenosis-was not dian w/GBS for 4 wks. Hosp 7-14 (AM). Hosp 7-16 (AM)-diag. spinal stenosis, hosp for 3-4 days-sent to nursing Home for P.T. -they put me in bed or wheelchair and gave me med. Couldn't walk-spilled my food saw P.T. 2-3 times I think, short term memory up to year and 1/2 and no memory of nursing home at all. Dr. put me there. My husband and daughter called him every day finally he said bring her to my office. After conferring with associated they decided to find out what was really wrong. Dr. ordered spinal tap and they found G.B.S. Started med to get it out of my system. Very painful and still is.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Shot was not painful; soreness started at local site after 3 hours, made sleeping difficult. Arm pain worse next day, followed by mild fever appx. 18 hours after injection. Fever continued up to 100° at 24 hrs after injection, as well as dizziness/severe headache. Headache could not be overcome by aspirin/ibuprofen. Fever relented at 48 hrs after injection; headache subsided by 60 hours after injection.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shot was not painful; soreness started at local site after 3 hours, made sleeping difficult. Arm pain worse next day, followed by mild fever appx. 18 hours after injection. Fever continued up to 100° at 24 hrs after injection, as well as dizziness/severe headache. Headache could not be overcome by aspirin/ibuprofen. Fever relented at 48 hrs after injection; headache subsided by 60 hours after injection.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Seizure
Clinical narrative: Seizures.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia oral, Injection site pain, Injection site paraesthesia, Injection site warmth
Clinical narrative: After 5 minutes of receiving the vaccination, the patient complained of a warm, tingly sensation at the site of injection (normal reaction) but then added that her lips felt numb, which was puzzling to me. After consulting drug reference materials and the package insert, there was no mention of "numbing" sensations. It was possible that she was experiencing an allergic reaction so I sat with her and kept her talking to keep her relaxed and calm. I then asked her specific questions regarding the areas of affect including "Does it feel as though your tongue is swelling" and "Have you noticed a change in your heart rate or breathing pattern?" She answered no to both of those questions. I had her remain seated for approx. 30min following the vaccination to watch for signs of worsening symptoms or anaphylaxis to which there were none. I had the patient stand up and she said she felt fine except for local pain at the injection site (normal) and the numb lips (abnormal). I let her go home and told her that if anything changed or worsened that she needed to call me or her PCP. Around 4:30pm or so, she had contacted her PCP's office and talked with the Triage nurse who contacted me for more information. We then collaborated on possible reasons for her adverse reaction including her latex allergy (I wasn't using latex gloves and all of the materials used in the vaccination were all latex-free) but ruled everything else out except for a generally mild (but alarming to the patient) allergic reaction. The Triage nurse then told the patient to report to the ER should she find her symptoms worsening or anything else that felt abnormal. The Triage nurse was then going to contact the patient in the morning to follow up. The following morning (2/9/18), the patient reported that she was fine and that everything was normal again.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Erythema, Lethargy, Papule, Pyrexia
Clinical narrative: Approximately 2 weeks after receipt of this vaccine my son developed high fevers of 103-104 and developed red raised papules all over his body. These persisted for approximately 4 weeks in duration. My son was lethargic and had regression in his verbalization and intermittent diarrhea. I tried to get into our pediatrician for an assessment but they were unable to see him in until much later in the afternoon so we opted to see another pediatrician that day. We were told it was a fever of "unknown origin" but the physician documented it in my sons chart as an "adverse vaccine reaction" within 1 month of receipt of the vaccine series. We were never told by either physician that his reactions were a vaccine related despite the fact both pediatricians noted in his medical records that his reactions was vaccine induced. I only discovered this after requesting his medical records in 2017. That is why there was a delay in reporting.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Regressive behaviour
Clinical narrative: Approximately 2 weeks after receipt of this vaccine my son developed high fevers of 103-104 and developed red raised papules all over his body. These persisted for approximately 4 weeks in duration. My son was lethargic and had regression in his verbalization and intermittent diarrhea. I tried to get into our pediatrician for an assessment but they were unable to see him in until much later in the afternoon so we opted to see another pediatrician that day. We were told it was a fever of "unknown origin" but the physician documented it in my sons chart as an "adverse vaccine reaction" within 1 month of receipt of the vaccine series. We were never told by either physician that his reactions were a vaccine related despite the fact both pediatricians noted in his medical records that his reactions was vaccine induced. I only discovered this after requesting his medical records in 2017. That is why there was a delay in reporting.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Formication, Impaired driving ability, Local reaction, Mobility decreased
Clinical narrative: Pt received PPSV23 to LD yesterday. Here this AM for lab draw. He reports that a few hours after receiving vaccine, his arm became very painful and difficult to move. He had to drive with one hand yesterday. Also "felt like ants were crawling under his skin". Crawling sensation is resolved. Upon visual evaluation there is a 7" x 4.5" reddened, warm area distal and anterior to the injection site. It was itchy yesterday, but that is now resolved. ROM a little better this AM, but when he puts straight out to side or front it is painful/sore. He has taken ibuprofen which seemed to help slightly. Dr. came in to evaluate and confirms this not allergic reaction, just local. Advised to take acetaminophen/ibuprofen. Could also take BENADRYL if itching returns but beware of drowsiness. Alternate ice/heat for comfort. Advised pt to notify us if this does not improve, or if it gets worse.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus, Skin warm
Clinical narrative: Pt received PPSV23 to LD yesterday. Here this AM for lab draw. He reports that a few hours after receiving vaccine, his arm became very painful and difficult to move. He had to drive with one hand yesterday. Also "felt like ants were crawling under his skin". Crawling sensation is resolved. Upon visual evaluation there is a 7" x 4.5" reddened, warm area distal and anterior to the injection site. It was itchy yesterday, but that is now resolved. ROM a little better this AM, but when he puts straight out to side or front it is painful/sore. He has taken ibuprofen which seemed to help slightly. Dr. came in to evaluate and confirms this not allergic reaction, just local. Advised to take acetaminophen/ibuprofen. Could also take BENADRYL if itching returns but beware of drowsiness. Alternate ice/heat for comfort. Advised pt to notify us if this does not improve, or if it gets worse.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Papule, Pyrexia, Vomiting
Clinical narrative: On approximately 05/28/2015 (3 weeks post vaccination) my son developed red raised papules on neck and hand. The papule on his hand measured approximately 2 cm wide. This was accompanied by low grade fevers and vomiting. He has a history of developing these same type of red raised papules with prior vaccinations.
Age: 0.33
Sex: M
Vaccine: MMRV
Symptoms: Speech disorder developmental
Clinical narrative: My son has had vaccine injuries that I was unaware of because my doctor never told me the signs to look for but after educating myself about the vaccines and the injuries and thinking back I now realize it's because of the vaccines that my son can't talk.
Age: 68.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Dizziness, Rash
Clinical narrative: Approximately 5 minutes after receiving the FLUAD vaccine, patient began experiencing a rash on the left hand and wrist and feeling dizzy. Patient reported the rash to remain the same within one hour after vaccination and slight improvement in dizziness with no other symptom.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JAN-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, subcutaneous for prophylaxis, lot # M041511 and expiration date on 08-JAN-2018. The sterile diluent used for reconstitution of ZOSTAVAX was properly stored and not expired (lot # M047667, expiration date 25-JUL-2019). The medical assistant reported that ZOSTAVAX had not had any temperature excursions and there were no adverse effects reported for the patient.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 27-JAN-2018, the patient was inadvertently vaccinated with expired dose of VARIVAX, via subcutaneous route for prophylaxis (lot # M003439, expiration date 19-JAN-2018). The vaccine was reconstituted with sterile diluent (lot # N023308, expiration date 04-FEB-2020). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from physician assistant refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (VIAL 19400 PFU) (lot # and expiry date were not reported) for prophylaxis. On an unknown date the patient developed a recurring shingles rash in the area of her lower back and buttocks. The rash clears up but "keeps coming back" and was treated with Acyclovir. The outcome of rash and herpes zoster was unknown. Causality assessment was not provided by reporter.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: I got the pneumonia shot in my left upper arm about 2 hrs. later my arm began to hurt and about 2 to 3 hrs later it was sore and swollen - red - feverish and hot to the touch by 9 PM it was swollen so big and red all around my arm from top of shoulder to my elbow. I had a bad time at night - couldn't sleep. I got the shot on 1-27-2018 on Saturday - It was very sore all over my arm. So swollen it didn't look like my other arm. It was sore and swollen. I could hardly move my arm, it hurt so bad. Sunday and Monday it began to get better, the swelling began to go down and the fever was better, by Tuesday it was a lot better. It I'd known all the pain and fever and discomfort I had endured a pneumonia shot, I wouldn't have gotten it. This adverse reaction was the direct cause of the pneumonia shot. There's no doubt in my mind what so ever. Shot ingredient name - Pneumococcal Polysaccharide Vaccine (23-valent). I am 72 yrs. old - I've gotten the flu shot every year for the past 35 yrs - and I've never had any problem except a little swelling at injection site and a little pain. Last year 1-26-2017 I got the pneumonia shot and it barely hurt later.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: I got the pneumonia shot in my left upper arm about 2 hrs. later my arm began to hurt and about 2 to 3 hrs later it was sore and swollen - red - feverish and hot to the touch by 9 PM it was swollen so big and red all around my arm from top of shoulder to my elbow. I had a bad time at night - couldn't sleep. I got the shot on 1-27-2018 on Saturday - It was very sore all over my arm. So swollen it didn't look like my other arm. It was sore and swollen. I could hardly move my arm, it hurt so bad. Sunday and Monday it began to get better, the swelling began to go down and the fever was better, by Tuesday it was a lot better. It I'd known all the pain and fever and discomfort I had endured a pneumonia shot, I wouldn't have gotten it. This adverse reaction was the direct cause of the pneumonia shot. There's no doubt in my mind what so ever. Shot ingredient name - Pneumococcal Polysaccharide Vaccine (23-valent). I am 72 yrs. old - I've gotten the flu shot every year for the past 35 yrs - and I've never had any problem except a little swelling at injection site and a little pain. Last year 1-26-2017 I got the pneumonia shot and it barely hurt later.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient experienced left arm numbness. Visited emergency room and then her doctor. Patient is now on VALIUM to help her sleep through the nite and is scheduled for an MRI.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itchy in injection area for 8 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site pain
Clinical narrative: On 2/1/18 the patient reported she was still having pain from her FLUZONE HD flu vaccine on 9/7/17. She said right after she had pain and bruising, now the pain continues from her shoulder to her elbow. She said it feels like she is still being "injected" with the needle.
Age: 1.17
Sex: M
Vaccine: FLU4, HIBV, MMR
Symptoms: Injection site induration
Clinical narrative: Large circular induration around (L) thigh.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Petechiae, Platelet count, Rash
Clinical narrative: (Note has had flu vaccine twice previously reported with no reaction). Pt c/o rash which started after FLUZONE vaccine - child says same day, not observed by parents till several days post. Present today for eval and found to have petechiae over legs (approx 2 inches apart), and more widely separated on arms and torso, not on palms or soles of feet. No other symptoms. No itching, no malaise, "rash" is flat.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: Pt developed a 4-5 cm urticaria spot over injection site 1 day after injection was given.   Recommended treatment was antihistamines & topical anti-itch cream in addition to monitoring.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Guillain-Barre syndrome, Mobility decreased
Clinical narrative: Two weeks after receiving these vaccines, I woke up unable to move my legs. I spent a few days in the hospital where they said it was most likely a mild case of Guillain-Barre.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's right arm became swollen, warm to touch and red. Redness was larger than patient's palm. Patient took BENADRYL after noticing reaction and symptoms cleared shortly after taking medication.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: After the administration of the flu vaccine the patient seemed to be okay. While ringing the customer out at the register he passed out, falling to the floor. He did not hit his head and was conscious and breathing. After confirming he was not having any difficulty breathing I called 911.  The paramedics arrived and took vitals. The patient felt fine after approximately 10 minutes and refused to go to the hospital in the ambulance.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Increased tendency to bruise, Peripheral swelling, Pruritus
Clinical narrative: Patients arm is swollen, sensitive to touch, itching and contains small blisters. Patient stated she has not put anything on it or treated it yet.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Pruritus, Swelling
Clinical narrative: Donor donated on 02/04/2018 and had her injection after her donation. Donor sat for 15 minutes after with no reaction noted. Donor came in today, 02/08/2018 to donate plasma and reported a reaction. When this medical staff associate looked at the donor's arm, she had a nickel sized lump. Donor reported that it started swelling the night of 02/04/2018. Donor also reported some mild itching, but it was not itching today. After donating today, 02/08/2018, the lump was approximately a 50 cent size or larger and showing some redness. Donor advised to use moist heat to the area as often as possible. If that did not help, then to use ice.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: Patient received vaccine at an on-site flu clinic and experienced no symptoms at the time. Two months after the immunization, the patient passed away.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Full blood count normal, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Fever 101, Dizzy, Light-headed, body aches. Given Tylenol, Benadryl and Decadron prior to transport to ED. Received IVF in ED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Renal function test normal
Clinical narrative: Fever 101, Dizzy, Light-headed, body aches. Given Tylenol, Benadryl and Decadron prior to transport to ED. Received IVF in ED.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Rash, Swelling
Clinical narrative: Parents reported pinpoint pink dots on skin (one on upper lip, two on right cheek, on right ear) and a flesh colored dot on left arm. Areas slightly raised, no warmth. Parents did not recall them being there prior to immunization. Patient monitored and released from office.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a adult patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the third nurse's adverse event. The reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. There might be a third nurse that experienced an unknown adverse event after receiving the FLULAVAL. The unrelated questions from the physician were sent to Agency, but that these events had not yet been reported to safety or the Regulatory Authority. This was 1 of 3 cases, reported by same reporter.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pyrexia
Clinical narrative: 2 cm - redness, around vaccine site, right thigh, itchy. No fever, chills, eating cooperatively. Rx - KEFLEX 125/5 ml 10 ml daily QID for 5 days. Warm compress. Rx Ibuprofen 100/5 ml 2.5 ml q6h prn fever, pain.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a adult patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the second nurse's adverse event. The reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. The patient experienced feeling unwell or malaise. The unrelated questions from the physician were sent to Agency, but that these events had not yet been reported to safety or the Regulatory Authority. This was 1 of 3 cases, reported by same reporter.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: The patient developed a pruritic rash on bilateral arms about 2 hours after receiving the vaccine.  Advised to use BENADRYL. She will also Calamine lotion that she has at home. Advised to be seen if she develops any further symptoms such as tightening of the airway, shortness of breath, or symptoms worsen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: Was seen on 2/9/18  in office after immunization given on 2/8/18 and reported hives, facial swelling of lips, eyes, cough within 20 min of immunization given in office; was taken to ER and received IV steroid and Benadryl.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area swollen, red, and warm to touch.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Lymph node pain, Neck pain, Pain
Clinical narrative: PT COMPLAINING PAIN IN UPPER LEFT CHEST (LYMPH PAIN - ) AND SOME PAIN IN LEST SIDE OF NECK -CONSTANT PAIN BECOMES WORSE WHEN LYING DOWN & MOVING LEFT ARM.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Dizziness, Hyperhidrosis, Pain in extremity, Pallor
Clinical narrative: I left office and went down to pharmacy with mother to pick up steroid cream rx. Given flu shot here before leaving. When downstairs, c/o arm pain to mother, crying. Was standing in line waiting for rx when she stated that she felt dizzy. Per mother, she became very pale and sweaty, pre-syncopal episode. Mother held her, no shaking episode. No full LOC. No fall. Rapid response called and pt taken to room where I found her sitting up. Per physician, vitals all ok - I took HR at 95.  I lowered HOB to 30 degrees. Responsive and answering questions appropriately. Given juice.  Advised to rest for 10min, then sit up and wait another 5 min before standing. When standing, wait to make sure no dizziness before leaving. Advised mother I would check in before leaving for the day.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: I left office and went down to pharmacy with mother to pick up steroid cream rx. Given flu shot here before leaving. When downstairs, c/o arm pain to mother, crying. Was standing in line waiting for rx when she stated that she felt dizzy. Per mother, she became very pale and sweaty, pre-syncopal episode. Mother held her, no shaking episode. No full LOC. No fall. Rapid response called and pt taken to room where I found her sitting up. Per physician, vitals all ok - I took HR at 95.  I lowered HOB to 30 degrees. Responsive and answering questions appropriately. Given juice.  Advised to rest for 10min, then sit up and wait another 5 min before standing. When standing, wait to make sure no dizziness before leaving. Advised mother I would check in before leaving for the day.