chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, site, lot# an expiry date were not reported). On 23-MAR-2015, the patient received the second dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). The patient was in the office at the day of the report (on 23-JUL-2015), to receive the last third dose in the series. The patient would be getting the third dose of GARDASIL 9 (dose, route of administration, site, lot# and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish the further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 10-AUG-2015 the patient was vaccinated with expired (Oka/Merck) VARIVAX (0.5 ml, lot # J009729 with expiry date 07-AUG-2015), subcutaneously. No adverse effects were reported. Additional information is not expected as there was no permission was given to contact reporter.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to three unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with the same lot number of PNEUMOVAX 23 (lot # L008664; Expiration date: 03-NOV-2016; strength, dose and route unknown) in the thigh (it was unknown if the vaccine was administered in the right or left thigh). The concomitant therapy was not provided. On unknown dates, all the three patients experienced redness at the injection site and injection site reactions in general. At the time of the report, the outcome of the adverse events were unknown. The reporting pharmacist requested a lot check on this lot # of PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot# K012432 with expiration date of 20-MAY-2016, lot# K016263 with expiration date of 26-JUN-2016, Lot# K010754 with expiration date of 20-OCT-2016) (dose strength and route unknown) orally. No concomitant therapy was provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Vaccination complication
Clinical narrative: Information has been received from a registered nurse via a field employee concerning a female patient of unknown age who was also the nurse's sister. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date years ago, the patient was vaccinated with the third doses of GARDASIL (lot #, expiration date, dose and route not reported) for routine military immunization. On an unknown date, the patient developed an unspecified "autoimmune induced vaccine reaction" after receiving the third dose of GARDASIL. The patient sought medical attention and was seen by multiple unspecified physician on multiple unspecified dates. The outcome of the unspecified "autoimmune induced vaccine reaction" was not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant (M.A.)) referring to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (lot # and dose not reported). Information regarding concomitant medications was not reported. No adverse effect reported. The outcome of the event was unknown. There was no product quality complaint involved. All telephone attempts on 10-AUG-2015 to obtain follow-up information have been unsuccessful. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure, Herpes zoster
Clinical narrative: Information has been received from a 62 year old female patient referring to herself with blood pressure abnormal. The patient was allergic to anything with dye, metals or aluminum. Medical history was not reported. In approximately 2008 (reported as "about 7 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were not reported). In approximately 2011 (reported as "about 4 years ago") the patient experienced heart failure. In the beginning of June 2015, the patient was diagnosed with shingles. Concomitant medication included unspecified blood pressure medicine. The patient also mentioned that she went to an unspecified urgent care to seek medical attention on an unspecified date but was not admitted. On an unknown date the patient started therapy with famciclovir 500mg during 7 days as treatment of shingles. No lab diagnostic studies were reported. At the time of the report, the outcome of shingles was reported as resolved on approximately 07-JUL-2015 (reported as "about a week ago"). Outcome of heart failure was unknown. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Hypoaesthesia, Injection site pain, Swelling face, Swollen tongue
Clinical narrative: Initial report was received from a healthcare professional on 17 September 2012, with follow-up information received on 20 September 2012. The reporter for this case is the same as serious case number 2012-08814 and non-serious case number 2012-08815. A 48-year-old female patient received dose one (single dose, prefilled syringe) of a left deltoid intramuscular injection of ADACEL, Sanofi Pasteur Ltd., Sanofi Pasteur Inc lot number U4384AA, (corresponding Sanofi Pasteur Ltd. lot number C4203) on 17 September 2012. On 17 September 2012, five minutes after vaccination, the patient had numbness to left side of face and she was sent to the emergency room (ER). On follow-up, the reporter stated the patient also had a swollen tongue "felt thick", (outcome was not reported). (The reporter clarified information received on 17 September 2012, reporting one patient had a swollen tongue, one patient had a swollen cheek and one patient was hospitalized, stating that was all the same patient.) The reporter denied that the patient had a swollen cheek. On the 19 September 2012, two day post vaccination, the patient had pain radiating from her left shoulder to clavicle. At time of follow-up information, the patient remained hospitalized. Laboratory or diagnostic testing and treatments were not reported. The patient's past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Tongue disorder
Clinical narrative: Initial report was received from a healthcare professional on 17 September 2012, with follow-up information received on 20 September 2012. The reporter for this case is the same as serious case number 2012-08814 and non-serious case number 2012-08815. A 48-year-old female patient received dose one (single dose, prefilled syringe) of a left deltoid intramuscular injection of ADACEL, Sanofi Pasteur Ltd., Sanofi Pasteur Inc lot number U4384AA, (corresponding Sanofi Pasteur Ltd. lot number C4203) on 17 September 2012. On 17 September 2012, five minutes after vaccination, the patient had numbness to left side of face and she was sent to the emergency room (ER). On follow-up, the reporter stated the patient also had a swollen tongue "felt thick", (outcome was not reported). (The reporter clarified information received on 17 September 2012, reporting one patient had a swollen tongue, one patient had a swollen cheek and one patient was hospitalized, stating that was all the same patient.) The reporter denied that the patient had a swollen cheek. On the 19 September 2012, two day post vaccination, the patient had pain radiating from her left shoulder to clavicle. At time of follow-up information, the patient remained hospitalized. Laboratory or diagnostic testing and treatments were not reported. The patient's past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Testicular pain
Clinical narrative: Initial report received from a healthcare professional on 4 October 2013. A 17 year old male received MENACTRA (Lot # unknown, expiration date unknown) intramuscularly at left deltoid on 02-Oct-2013. Concomitant medication included "Chicken Pox" vaccine. After vaccination, on 02-Oct-2013 (onset of reaction not reported) he experienced pain in testicles. The patient did not recover from the event. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adrenergic syndrome, Antiacetylcholine receptor antibody, Antibody test negative, Cardiac electrophysiologic study normal, Cardiovascular autonomic function test abnormal
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diplopia, Dizziness, Dizziness postural, Dyspnoea, Echocardiogram
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Exercise tolerance decreased, Feeling abnormal, Immunology test normal
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Impaired work ability, Laboratory test normal, Nervousness, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensory disturbance, Tachycardia, Tilt table test positive, Urine analysis normal, Valsalva maneuver
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram, Heart rate abnormal
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Urine analysis
Clinical narrative: Information has been received from a 24 (also reported as 26) years old patient referring to herself. The patient had a kidney transplant at 18 years old and had a drug reaction to unspecified proton inhibitors. On 27-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route unknown). Concomitant therapies included prednisone and IMURAN. In July 2007, the patient experienced dizziness and shortness of breath. On an unspecified date in November of 2007, the patient went to the emergency room at an unspecified hospital. No diagnosis was made at the time. The patient was also admitted to the other hospital for an unspecified length of time. On an unspecified date, at an emergency room visit at another hospital, the patient's heart rate changed and was diagnosed with postural orthostatic tachycardia syndrome. During the hospital, the patient had unspecified blood work, electrocardiogram (EKG) and urinalysis without results. The patient was treated with unspecified beta blockers, unspecified medications and PLAQUENIL. On 21-AUG-2007, the patient was vaccinated with the second dose of GARDASIL (dose, lot number and route unknown). The patient confirmed she did not receive the third dose of the vaccine, and the vaccine was GARDASIL instead of GARDASIL 9. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Blood test abnormal, Decreased appetite, Lumbar puncture abnormal, Myelitis transverse
Clinical narrative: Fever, vomiting, diarrhea which progressed to dehydration and muscle weakness.  Had been seen 3 days prior with otitis media and was on cefdinir.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging abnormal, Paralysis, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea which progressed to dehydration and muscle weakness.  Had been seen 3 days prior with otitis media and was on cefdinir.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Human metapneumovirus test positive, Muscular weakness, Myelitis transverse
Clinical narrative: Fever, vomiting, diarrhea which progressed to dehydration and muscle weakness.  Had been seen 3 days prior with otitis media and was on cefdinir.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Otitis media, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea which progressed to dehydration and muscle weakness.  Had been seen 3 days prior with otitis media and was on cefdinir.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache, then next day around 8:00 PM injection site red, warm, itching, painful, whole left arm hurting, nauseated, ringing in ears, dizzy, diarrhea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain in extremity, Tinnitus
Clinical narrative: Headache, then next day around 8:00 PM injection site red, warm, itching, painful, whole left arm hurting, nauseated, ringing in ears, dizzy, diarrhea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Large bullseye like rash on injection site (right deltoid) developed 1 week post vaccination. Then developed multiple red, itchy bumps on front and back of neck.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Balance disorder, Dizziness, Fatigue, Gait disturbance
Clinical narrative: LIGHTHEADEDNESS, FEELING OFF BALANCE, LESS STEADY GAIT, INCREASED FATIGUE, FEELING OF ANXIETY.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Aphasia, Folate deficiency, Obsessive-compulsive disorder, Seizure
Clinical narrative: In the next two months after vaccination, her "lights went off."  She lost most of her speech, became OCD, and minimally interactive. She was diagnosed within 2 months ASD, Seizures, and cerebral folate deficiency.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Social avoidant behaviour
Clinical narrative: In the next two months after vaccination, her "lights went off."  She lost most of her speech, became OCD, and minimally interactive. She was diagnosed within 2 months ASD, Seizures, and cerebral folate deficiency.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6-month-old female patient. No information about patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 06-JUL-2015, the patient was orally vaccinated with the third dose of ROTATEQ lot # K023535, expiration date 22-MAY-2016 (dose was not reported). On 22-JUL-2015 (also reported as "while using ROTATEQ"), the patient experienced intussusception and on the same day she was hospitalized for the event. The patient was released from the hospital the following day (23-JUL-2015). The outcome of intussusception was reported as recovering. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Chest discomfort, Dyspnoea, Injection site pain, Injection site warmth
Clinical narrative: Entire left arm and armpit painful and warm to touch.  Tightness in chest and trouble taking deep breath.  Took 2 doses of Benadryl 4 hours apart.  Trouble sleeping.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain in extremity, Skin warm
Clinical narrative: Entire left arm and armpit painful and warm to touch.  Tightness in chest and trouble taking deep breath.  Took 2 doses of Benadryl 4 hours apart.  Trouble sleeping.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site swelling, Injection site warmth, Muscle spasms, Pain
Clinical narrative: Swelling in right deltoid, warmth to touch, muscle spasms, body aches, fever and headache.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Swelling in right deltoid, warmth to touch, muscle spasms, body aches, fever and headache.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Antiphospholipid antibodies positive, Blood test, Costochondritis, Dyspnoea
Clinical narrative: A couple hours after shot, got red in face, flushed, hot feeling, shortness of breath and face and hands puffy. 1-2 days later reported to my work. Lasted 2-3 days. 2 wks later got pancreatitis lasted 2 months. Then got pleurisy (chronic) that turned into costochondritis 12/2010-4/2011 (referred to a rheumatologist).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Flushing, Pancreatitis, Peripheral swelling
Clinical narrative: A couple hours after shot, got red in face, flushed, hot feeling, shortness of breath and face and hands puffy. 1-2 days later reported to my work. Lasted 2-3 days. 2 wks later got pancreatitis lasted 2 months. Then got pleurisy (chronic) that turned into costochondritis 12/2010-4/2011 (referred to a rheumatologist).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy, Swelling face
Clinical narrative: A couple hours after shot, got red in face, flushed, hot feeling, shortness of breath and face and hands puffy. 1-2 days later reported to my work. Lasted 2-3 days. 2 wks later got pancreatitis lasted 2 months. Then got pleurisy (chronic) that turned into costochondritis 12/2010-4/2011 (referred to a rheumatologist).
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Feeling abnormal, Restlessness
Clinical narrative: Mother described "restless/flailing, somewhat dazed" lasting 48 hours.  Requiring doctor's visit.
Age: 28.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: About 24 hours after administration of the varicella vaccine subcutaneously to my right upper arm I developed an area of erythema and warmth. The area spread to about 10cm in diameter. The area was not tender. It resolved without intervention 36 hours after it appeared.
Age: 0.53
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Patient inadvertently received the vaccine intramuscular instead of PO. No vaccine related adverse effects noted as a result of this error.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Injection site rash, Pyrexia, Rash
Clinical narrative: FEVER 101, TIRED, RASH NOTICED ON INJECTION SITE 08/10/2015. CLINIC NOTIFIED- MONITORING.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Malaise, Pain
Clinical narrative: Headache, Body aches, Malaise.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Discomfort, Immediate post-injection reaction, Injection site pain
Clinical narrative: Severe pain in arm where shot was given: Immediate - Point of injection: severe pain, soreness and burning. Immediate pain in shoulder joint  I could not lift my left arm or use it to lift due to severe pain. Pain radiates across to right shoulder; neck to base of skull resulting in headache. Pain radiates to left shoulder blade. Pain radiates from left shoulder joint down left arm to the middle, ring and pinky fingers. Restless sleep; throughout the weekend. Mild fever Friday evening. Sporatic through the weekend  would occur in waves. Weakness, throughout the weekend. Joint pain; throughout the weekend. Fuzzy vision; some feeling of vertigo; (avoid driving unless necessary) throughout the weekend. Mild swelling of  hands, body, legs throughout weekend (subsiding on Tuesday, August 11). Mild swelling in back of throat  began Sunday; continues Tuesday. Used ProAir inhaler for relief on Sunday night. Local pain; radiating pain down arm to fingers; still evident on Tuesday, August 11, 2015. August 11, 2015  late evening around 10 PM, swollen gland left side of throat. August 12, 2015  morning; swelling in left throat gland decreased; just uncomfortable feeling. Have a follow up at Dr's office at 1PM today.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe pain in arm where shot was given: Immediate - Point of injection: severe pain, soreness and burning. Immediate pain in shoulder joint  I could not lift my left arm or use it to lift due to severe pain. Pain radiates across to right shoulder; neck to base of skull resulting in headache. Pain radiates to left shoulder blade. Pain radiates from left shoulder joint down left arm to the middle, ring and pinky fingers. Restless sleep; throughout the weekend. Mild fever Friday evening. Sporatic through the weekend  would occur in waves. Weakness, throughout the weekend. Joint pain; throughout the weekend. Fuzzy vision; some feeling of vertigo; (avoid driving unless necessary) throughout the weekend. Mild swelling of  hands, body, legs throughout weekend (subsiding on Tuesday, August 11). Mild swelling in back of throat  began Sunday; continues Tuesday. Used ProAir inhaler for relief on Sunday night. Local pain; radiating pain down arm to fingers; still evident on Tuesday, August 11, 2015. August 11, 2015  late evening around 10 PM, swollen gland left side of throat. August 12, 2015  morning; swelling in left throat gland decreased; just uncomfortable feeling. Have a follow up at Dr's office at 1PM today.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pharyngeal oedema, Poor quality sleep, Pyrexia, Swelling
Clinical narrative: Severe pain in arm where shot was given: Immediate - Point of injection: severe pain, soreness and burning. Immediate pain in shoulder joint  I could not lift my left arm or use it to lift due to severe pain. Pain radiates across to right shoulder; neck to base of skull resulting in headache. Pain radiates to left shoulder blade. Pain radiates from left shoulder joint down left arm to the middle, ring and pinky fingers. Restless sleep; throughout the weekend. Mild fever Friday evening. Sporatic through the weekend  would occur in waves. Weakness, throughout the weekend. Joint pain; throughout the weekend. Fuzzy vision; some feeling of vertigo; (avoid driving unless necessary) throughout the weekend. Mild swelling of  hands, body, legs throughout weekend (subsiding on Tuesday, August 11). Mild swelling in back of throat  began Sunday; continues Tuesday. Used ProAir inhaler for relief on Sunday night. Local pain; radiating pain down arm to fingers; still evident on Tuesday, August 11, 2015. August 11, 2015  late evening around 10 PM, swollen gland left side of throat. August 12, 2015  morning; swelling in left throat gland decreased; just uncomfortable feeling. Have a follow up at Dr's office at 1PM today.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo, Vision blurred
Clinical narrative: Severe pain in arm where shot was given: Immediate - Point of injection: severe pain, soreness and burning. Immediate pain in shoulder joint  I could not lift my left arm or use it to lift due to severe pain. Pain radiates across to right shoulder; neck to base of skull resulting in headache. Pain radiates to left shoulder blade. Pain radiates from left shoulder joint down left arm to the middle, ring and pinky fingers. Restless sleep; throughout the weekend. Mild fever Friday evening. Sporatic through the weekend  would occur in waves. Weakness, throughout the weekend. Joint pain; throughout the weekend. Fuzzy vision; some feeling of vertigo; (avoid driving unless necessary) throughout the weekend. Mild swelling of  hands, body, legs throughout weekend (subsiding on Tuesday, August 11). Mild swelling in back of throat  began Sunday; continues Tuesday. Used ProAir inhaler for relief on Sunday night. Local pain; radiating pain down arm to fingers; still evident on Tuesday, August 11, 2015. August 11, 2015  late evening around 10 PM, swollen gland left side of throat. August 12, 2015  morning; swelling in left throat gland decreased; just uncomfortable feeling. Have a follow up at Dr's office at 1PM today.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Psychomotor hyperactivity, Restlessness
Clinical narrative: Mother describes "hyper behavior, restless" lasting for 48 hours.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Light headed, dizzy, nausea, pale.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, pain and redness at elbow of arm that received vaccination.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Discomfort, Pruritus, Rash, Rash macular
Clinical narrative: Areas of blotches and redness on legs and arms, more on legs around knees and calves.  Very uncomfortable and itchy.  Went away within an hour or two.  Has returned most but not all mornings and is now increasing moderately in severity and coverage, but still goes away quickly.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Middle insomnia, Pyrexia
Clinical narrative: Patient called clinic and states that he awoke during the night with a fever of 101 and chills. He took some Motrin and went back to bed. He woke up this morning with a temp of 102.7. He then took some more Motrin and used a cold cloth to lower fever. As of now patient is monitorting temp. at home with last reading (0745a.m. 08/12/2015) being 100.7, blood pressure of 136/68 and pulse of 91. Member further stated that the chills he had have dissipated. This is patient's 7th Anthrax shot and he has no hx of adverse reactions or effects. Patient denies any reaction at the site or hives, shortness of breath, dizziness or tachycardia. I told patient that his symptoms are consider less common with this particular vaccine and that it should resolve in less than a week and if symptoms persist or worsen to seek medical care/treatment.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: Client came to our office for a Hep A, Menactra, and, HPV vaccination.  He passed out 2 years ago in our office when he received a Tdap vaccination.  His dad came prepared with a water bottle and an ice pack.  I had another nurse assist me with the vaccines.  We had the client lie down on the exam table and we both administed the vaccines at the same time.  The client was alert and talking during the vaccinations.  He stated he felt fine and he sat up about 2 minutes later and took a drink of water.  He then dropped the water bottle and his eyes rolled back into his head and he "shook" a little bit for about 2 seconds.  His dad, the other nurse, and all helped lay him back down on the exam table.   He was alert and oriented and was joking slightly and was engaged in conversation.  He was very pale.  We put an ice pack on his head, neck, and chest.  We continued to instruct him to take deep breaths and relax.  He continued to lay down for about 15 minutes, engaging in conversation the whole time.  Once he sat up he was pink in color and a few minutes later we moved him to a chair.  He sat in the chair for about 15 more minutes and drank 1 1/2 bottles of water.  He left with his dad and was instructed to call with any concerns.  Of note: a VAERS was filled out on him 2 years ago for a very similar incident, as well as for his brother last week.  His dad states they have this type of reaction with any medical procedure.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, C-reactive protein increased, Gait disturbance, Muscular weakness
Clinical narrative: Beginning of Major joint pain, loss of muscle strength, inability to ambulate comfortably, pain. This increased over the next week. I was seeing a physical therapist for my knee and she saw me over the course of the next two weeks and became very alarmed at my increasing debilitation. I went to my physician on June 2 and had labs drawn- CRP and ESR very elevated. Diagnosed with polymyalgia rheumatica. Placed on steroids which I remain on- as yet unable to wean from them. Lost one and one half weeks of work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Beginning of Major joint pain, loss of muscle strength, inability to ambulate comfortably, pain. This increased over the next week. I was seeing a physical therapist for my knee and she saw me over the course of the next two weeks and became very alarmed at my increasing debilitation. I went to my physician on June 2 and had labs drawn- CRP and ESR very elevated. Diagnosed with polymyalgia rheumatica. Placed on steroids which I remain on- as yet unable to wean from them. Lost one and one half weeks of work.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose fluctuation, Condition aggravated, Glycosylated haemoglobin normal, Purpura
Clinical narrative: PT CALLED TO REPORT SEVERE SIDE EFFECTS. NOT SURE IF FROM INCREASE IN METFORMIN OR RECENT VACCINE (5 DAYS PRIOR) WITH PREVNAR13. Type II diabetes mellitus uncontrolled - Pt's sugars are all over the place, lows of 50s, high today of 247. While A1C has improved from 8.1 to 6.6 within the last month, pt does not seem to be tolerating increased dose of Metformin well. She is very shaky and weak, also developed a purpuric rash on body since starting 2000 mg dose, ? due to Metformin-induced vasculitis. Will cut back Metformin to 500 mg bid, as she was taking before for many years and tolerated well.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor, Type 2 diabetes mellitus
Clinical narrative: PT CALLED TO REPORT SEVERE SIDE EFFECTS. NOT SURE IF FROM INCREASE IN METFORMIN OR RECENT VACCINE (5 DAYS PRIOR) WITH PREVNAR13. Type II diabetes mellitus uncontrolled - Pt's sugars are all over the place, lows of 50s, high today of 247. While A1C has improved from 8.1 to 6.6 within the last month, pt does not seem to be tolerating increased dose of Metformin well. She is very shaky and weak, also developed a purpuric rash on body since starting 2000 mg dose, ? due to Metformin-induced vasculitis. Will cut back Metformin to 500 mg bid, as she was taking before for many years and tolerated well.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Arrhythmia, Asthenia, Blood test, Cardiac arrest, Dizziness
Clinical narrative: Palpitations, Arrhythmias, Tunnel Vision, Weakness, Dizzyness, and the onset of Cardiac Arrest.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Electrocardiogram, Palpitations, Tunnel vision
Clinical narrative: Palpitations, Arrhythmias, Tunnel Vision, Weakness, Dizzyness, and the onset of Cardiac Arrest.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient stated no ROM of right arm and neck stiffness. No treatment deemed necessary by MD.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt developed hives in the afternoon while at school.
Age: 3.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Incisional drainage, Injection site infection, Swelling
Clinical narrative: Patient developed a red raised are approx 2 cm on 8/4/15.  Pateint then was seen on 8/7/15, patient was seen again and the area was 3.5 cm.  Needed to have an I and D completed due to infection at the site.  Was placed on antibiotics and seen again on 8/11/15 for recheck.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: I am experiencing a near constant feeling of dizziness.  It has remained consistent for over a week now.  I am hoping it improves soon or I will see my physician soon.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Red, raised ring with white border. Silver dollar size. Tender and hot to touch, Itchy.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Patient complained of numbness and tingling on her left cheek.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Injection site movement impairment, Injection site pain, Injection site reaction, Middle insomnia
Clinical narrative: Course confirmed with MOC. Pt was not pre-medicated before injections on 8/10/15. Pt reported tenderness and soreness in the Left deltoid muscle with limited ROM first day 8/10/15. Pt was groggy next day but reported decreasing pain through the afternoon.  At bedtime, pt reported increased pain and awoke several times in the night crying 8/11/15.  MOC took oral temperature and reported that he was not febrile.  Pain was severe so MOC gave 7.5 mL of children's Motrin which helped.  MOC did not notice any redness until the next morning (8/12/15).  Pt complaining of increasing pain and redness.  Reported to urgent care for follow-up.  Pt presented with a large erythematous rash on the left lateral upper arm.  Irregular margins starting at the deltoid and spanning inferiorly to the middle of his upper arm and horizontally from the anterior margin of his deltoid to the posterior margin of his deltoid.  Pt was seen by a physician and diagnosed with cellulitis.  Margins were drawn with a sharpie and pt instructed to return for increasing margins, streaking or any changes and to follow-up in 24 hours.  Pt received Keflex 550 mg (11 mL) by mouth three times a day for 7 days and Tylenol or Motrin for pain or fever as needed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash erythematous, Somnolence
Clinical narrative: Course confirmed with MOC. Pt was not pre-medicated before injections on 8/10/15. Pt reported tenderness and soreness in the Left deltoid muscle with limited ROM first day 8/10/15. Pt was groggy next day but reported decreasing pain through the afternoon.  At bedtime, pt reported increased pain and awoke several times in the night crying 8/11/15.  MOC took oral temperature and reported that he was not febrile.  Pain was severe so MOC gave 7.5 mL of children's Motrin which helped.  MOC did not notice any redness until the next morning (8/12/15).  Pt complaining of increasing pain and redness.  Reported to urgent care for follow-up.  Pt presented with a large erythematous rash on the left lateral upper arm.  Irregular margins starting at the deltoid and spanning inferiorly to the middle of his upper arm and horizontally from the anterior margin of his deltoid to the posterior margin of his deltoid.  Pt was seen by a physician and diagnosed with cellulitis.  Margins were drawn with a sharpie and pt instructed to return for increasing margins, streaking or any changes and to follow-up in 24 hours.  Pt received Keflex 550 mg (11 mL) by mouth three times a day for 7 days and Tylenol or Motrin for pain or fever as needed.
Age: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Dysphagia, Pain, Peripheral swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever over 103, swollen face, throat, hands and feet.Hard to swallow. Body aches.
Age: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Swelling face
Clinical narrative: Fever over 103, swollen face, throat, hands and feet.Hard to swallow. Body aches.
Age: 1.07
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Otitis media, Pyrexia
Clinical narrative: Very high fever with multiple generalized tonic clonic seizures.  Some seizures assoc. with high fever and some not.  Also dx with otitis media.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Sweats began, low grade fever, all over body aches. Continued through 8/12/15.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: She has been breaking out in hives since the time listed. I woke up this morning (8/12) and the hives had minimized for most of the day but now they are back and as prominent as the first outbreak.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Swollen, hot to touch, blistering at injection site.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Feeding disorder of infancy or early childhood, Skin warm, Vomiting
Clinical narrative: The child awoke, and fed.  At the end of the bottle she vomited.  Grandmother (a nurse) noted she felt warm, and gave her Tylenol.  Later in the morning she was not eating well.  Taking a long time to drink a bottle.  Mother checked her temp and it was 102.9.  Was again given Tylenol.  Later Temp noted to be 100.7.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: At approx. 1540 CMS gave patient her third Hep. B vaccine. Following the vaccine the CMS waited the 15 minutes to watch for possible reaction to the vaccine. Patient did not display any signs at that time. Approx. 1610 she approached the same CMS saying she was going home and that she did not feel great. She told him that she was light headed, warm and had shortness of breath. Another CMS tried to call the nurse number. We were on hold for about 20 minutes and a message came on to put in the number to have the nurse return the phone call but no return call was returned. Employee was advised to lie down for a few minutes and was given a granola bar and Capri sun. The symptoms persisted for about 15 minutes when patient started feeling much better and was back to normal. She had called her husband to come pick her up "just in case" and went home feeling well. No medical treatment was needed as the symptoms had subsided. Patient was advised prior to leaving if the symptoms come back or get worse to come call the center. Patient later that evening felt sick and vomited. She went to the emergency room. They said they were not sure if it was a reaction to the shot. She received saline and during that time started to get a tight feeling in her chest and felt her airway closing. They gave her two doses of epinephrine 15 minutes apart. After that she felt fine and the observed her for a couple hours. Today patient is feeling better.