chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Seizure, Yellow skin
Clinical narrative: Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with the first dose of GARDASIL (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis; and on unspecified dates, the series being completed with GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact for follow-up.; Sender's Comments: US-009507513-1701USA012273:
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Dyspnoea, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Within a week or so started with tingling in feet, legs getting weak, back hurting bad, hands going numb. By 11-10-16 admitted into hospital unable to move, couldn't breathe correctly.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Within a week or so started with tingling in feet, legs getting weak, back hurting bad, hands going numb. By 11-10-16 admitted into hospital unable to move, couldn't breathe correctly.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received PNEUMOVAX, developed red, painful swelling around site, went to ED x 2, got admitted overnight for abx.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING/HIVES.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Induration, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Shaking chills, rigors by 7pm same night. Fever to 102. Could not get out of bed for 24hours straight. Right arm became extremely hot hot hard swollen and very painful by next day. Rigored again night 2.    felt
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Tremor
Clinical narrative: Shaking chills, rigors by 7pm same night. Fever to 102. Could not get out of bed for 24hours straight. Right arm became extremely hot hot hard swollen and very painful by next day. Rigored again night 2.    felt
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient describes pain in left arm with numbness and tingling.  States the shot was very painful when she received it, and has progressively gotten more uncomfortable.  Patient has been seen twice more since original vaccination date with same complaint.  She received a 5 day course of Prednisone 10mg with some relief, but symptoms returned once she quit taking the steroid.  Currently trying Voltaren 1% gel to affected area.
Age: 62.0
Sex: M
Vaccine: FLUR3
Symptoms: Pain in extremity
Clinical narrative: Pt complained pain in his injection arm. I looked at his arm and there was no redness or irritation.  He said there wasn't a nodule or hard spot, and I also felt for one and couldn't find any.  He said it is painful and isn't improving.  I advised him that the injection could have nicked a blood vessel and caused some bruising or possible even a nerve and causing pain.  I told him to check with his doctor if it was really bothering him.  He also said that he had been taking some pain meds and muscle relaxers to try and alleviate the pain.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy and medical history provided. On 13-JAN-2017, the patient was vaccinated with an expired dose of VAQTA injection, lot # L048222, expiration date: 19-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002794: US-009507513-1702USA002795.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L037554, expiration date: 31-MAR-2019 and lot# M032650, expiration date: 31-MAR-2019 (dose and route of administration were not reported). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes.  Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002783: US-009507513-1702USA002784: US-009507513-1702USA002782:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site vesicles
Clinical narrative: This spontaneous report was received from an Office Manager referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, know allergies and concomitant medications was not reported. On 25-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported by the patient that, approximately in January 2017, the patient had several blisters (blister) that were oozing (secretion discharge) near the ZOSTAVAX injection site. On 26-JAN-2017, the patient called his physician to report his symptoms and stated he was going to visit his office on the same date. At the time of the report, the outcome of blister and secretion discharge was reported as not recovered. Additionally, the reporter did not provide for causality between the adverse events and vaccination with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002793:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). Subsequently, on an unknown date, the patient was diagnosed with shingles. The patient sought medical attention by contacting the reporting nurse. Product quality complaint was not involved. The outcome of the event and causality between ZOSTAVAX and the event were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M037248, expiration date: 21-FEB-2019 (dose and route of administration were not reported). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes. Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported. Product quality compliant was not involved. This one of several reports received from the same reporter.   Additional information has been requested. Sender's Comments: US-009507513-1702USA002783: US-009507513-1702USA002784: US-009507513-1701USA011637.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# M036459, expiration date: 18-JAN-2018 (dose and route of administartion were not reported). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes.  Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported.  Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011637: US-009507513-1702USA002784: US-009507513-1702USA002782:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# reported as M017518, expiration date: 11-DEC-2017 (dose was not provided). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes. Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002783: US-009507513-1701USA011637: US-009507513-1702USA002782:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from an Office Manager referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and expiration date were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients experienced  redness (injection site erythema) and soreness (injection site pain) at the injection site, after being vaccinated with ZOSTAVAX. The reporter stated, that no rash or blisters were developed by the patients. At the time of the report, the outcome of injection site erythema and injection site pain was unknown.  Additionally, the reporter did not provide for causality between the adverse events and vaccination with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013025:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002795: US-009507513-1701USA010824.
Sex: U
Vaccine: FLUX, MENB, MMR, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016538687) on 26 January 2017. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE on an unspecified date in 2015 and dose of TRUMENBA (batch number, expiry date, dose in series, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced Guillain Barre Syndrome. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review this case was considered as serious due to Important Medical Event: Guillain Barre syndrome. List of documents held by sender: none. Sender's Comments: This case concerns adult patient who received INFLUENZA VACCINE and simultaneously with MEASLES, MUMPS AND RUBELLA VACCINE (LIVE) and MENINGOCOCCAL GROUP B VACCINE developed Guillain Barre syndrome. Time to onset is not provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, reaction to previous vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: 24hr after vaccination - red circular spots on muscle where shot given. Hot to touch and spots became hard. fingers were numb few hours after flu shot, but this went away. Still appears pink, but MD says he believes it is going away.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling, itching at site of injection and generalized itching of arms, legs, back continuing for at least 3 days.  Patient takes Citirizine routinely in the mornings.  Notified provide on 02/06/2017. Suggested Follow-up with primary care provider.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR, PPV
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Pain, Pyrexia
Clinical narrative: My son had 103.5 fever for 3 days. I called their office multiple times and they told me this was normal. Starting crying in extreme pain for hours. My son was completely normal before this vaccine. 3 days after this vaccine it was like a light switched off in his brain. He no longer speaks, no eye contact, hides in corners and is now in therapy 4 days a week. He doesn't respond to me calling his name anymore and for 5 months after this wouldn't even allow me to hold him anymore.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR, PPV
Symptoms: Speech disorder, Unresponsive to stimuli
Clinical narrative: My son had 103.5 fever for 3 days. I called their office multiple times and they told me this was normal. Starting crying in extreme pain for hours. My son was completely normal before this vaccine. 3 days after this vaccine it was like a light switched off in his brain. He no longer speaks, no eye contact, hides in corners and is now in therapy 4 days a week. He doesn't respond to me calling his name anymore and for 5 months after this wouldn't even allow me to hold him anymore.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Headache, fever, swelling and redness at site of injection.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received a third dose longer than 6 months after receiving the first dose of RECOMBIVAX HB intramuscularly (doses, anatomical location, lot# and expiration date were not provided). No adverse effects were reported. No product quality compliant (PQC) was involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a 56-year-old female patient, who was also a pharmacist and was reporting on herself. The patient's current conditions included arthritis and allergy to celecoxib (CELEBREX). On an unknown date in September 2014, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vial 19400 plaque-forming units (PFU) (lot # and expiry date were not reported) as a prevention against shingles. Concomitant therapies included diclofenac, zolpidem tartrate (AMBIEN), pramipexole dihydrochloride (MIRAPEX) and losartan potassium (+) hydrochlorothiazide (HYZAAR). On 08-OCT-2016, the patient developed some blisters across her backside and "things that wanted to be blisters" below her left knee down her calf and across her foot between her big toe and a second toe. On 11-OCT-2016, the patient was seen by her physician and an unspecified treatment was given for the event. No lab diagnostics studies were performed. On approximately 19-NOV-2016 (reported as "within six weeks"), the patient recovered from the blisters, but occasionally she still developed numbness between her left foot big toe and a second toe since an unknown date. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011716:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a retired physician, referring to a female patient of unknown, who is a retired nurse also. The patient's medical history included bilateral hips replacement on an unspecified date. Concurrent conditions included back pain. Concomitant medications included ibuprofen and naproxen sodium (ALEVE) as needed for back pain. The patient's dug reactions/allergies were not reported. On 25-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 dose, subcutaneously, for prophylaxis (lot # and expiration date were not reported). On 26-JAN-2017, the patient experienced injection site redness. It was stated that the redness was "the size of a cupcake top and raised but there was not pain". No treatment was given for the adverse event as the patient stated "we did not really like to take medicine and I was sure it would subside". At the time of reporting, the outcome of the event was reported as recovering. A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010824: US-009507513-1702USA002794:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Differential white blood cell count normal, Full blood count normal, Injection site erythema, Metabolic function test normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself.  A 69-year-old female patient received PREVNAR 13, intramuscular, on 11Jan2017, at 0.5 ml single, for immunisation. Medical history included hysterectomy from 1989 and ongoing (performed at the age of 42 years) and blood pressure abnormal. Concomitant medication included losartan (unspecified trade name), oral, from/to an unspecified date, at 50 mg 1x/day, for blood pressure abnormal and estrogens conjugated (PREMARIN) tablet, oral, from 1989 and ongoing, at 1x/day (low strength, it was 0.3%), for hysterectomy. The patient experienced burning and itching were so severe that she wanted to rip her skin off on 15Jan2017 with outcome of not recovered, stinging on 15Jan2017 with outcome of not recovered, big red circular area on arm at the site of the shot on 17Jan2017 with outcome of unknown and vitamin B12 level elevated on 26Jan2017 with outcome of unknown. On 26Jan2017 the patient underwent lab tests and procedures which included: differential white blood cell count: normal; full blood count: normal; metabolic function test: normal; thyroid function test: normal; vitamin B12: elevated. The reporter described the events as episodes of severe sudden onset of burning, stinging and itch but no rash at different part of patients body, for 15-20 minutes every time, basically daily. The day before happened three times during the day that the itching and burning were so severe that she wanted to rip skin off. She went to her doctor and performed some blood test. Therapeutic measures were taken as a result of burning and itching were so severe that she wanted to rip her skin off and stinging and included treatment with Tricalm as needed and Benadryl as needed before bed.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Thyroid function test normal, Vitamin B12 increased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself.  A 69-year-old female patient received PREVNAR 13, intramuscular, on 11Jan2017, at 0.5 ml single, for immunisation. Medical history included hysterectomy from 1989 and ongoing (performed at the age of 42 years) and blood pressure abnormal. Concomitant medication included losartan (unspecified trade name), oral, from/to an unspecified date, at 50 mg 1x/day, for blood pressure abnormal and estrogens conjugated (PREMARIN) tablet, oral, from 1989 and ongoing, at 1x/day (low strength, it was 0.3%), for hysterectomy. The patient experienced burning and itching were so severe that she wanted to rip her skin off on 15Jan2017 with outcome of not recovered, stinging on 15Jan2017 with outcome of not recovered, big red circular area on arm at the site of the shot on 17Jan2017 with outcome of unknown and vitamin B12 level elevated on 26Jan2017 with outcome of unknown. On 26Jan2017 the patient underwent lab tests and procedures which included: differential white blood cell count: normal; full blood count: normal; metabolic function test: normal; thyroid function test: normal; vitamin B12: elevated. The reporter described the events as episodes of severe sudden onset of burning, stinging and itch but no rash at different part of patients body, for 15-20 minutes every time, basically daily. The day before happened three times during the day that the itching and burning were so severe that she wanted to rip skin off. She went to her doctor and performed some blood test. Therapeutic measures were taken as a result of burning and itching were so severe that she wanted to rip her skin off and stinging and included treatment with Tricalm as needed and Benadryl as needed before bed.
Age: 78.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 17cm x 17cm raised redness. Warm to touch. On Rt. upper arm. Sore to touch. Received PNEUMOVAX 2/3/17. Observe. No treatment.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic-hyporesppnsive event vs febrile sz.
Age: 40.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Oropharyngeal pain, Pruritus, Pyrexia, Streptococcus test negative
Clinical narrative: Patient had varicella and hep b vaccine administered at hospital - pt developed itchiness and redness to face, sore throat, and low grade fever. Pt seen at clinic on 2/6/17 and told to take Benadryl and Claritin. Rapid strep completed and negative.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Left arm swollen to wrist for 2-3 days. Pt. stayed in bed one day.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Body temperature decreased, Body temperature increased, Laboratory test, Seizure, Staring
Clinical narrative: Saturday morning patient had a seizure while at home, mother reports that seizure lasted approximately 1 minute, patient's mother immediately put patient in tub, and called firefighters, when firefighters arrived they stated that patient's temperature was 94 F. Then on 01/31/17, patient had a temperature of 100.4 F, and was just staring blank, patient was taken to ER for evaluation.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Urine analysis
Clinical narrative: Saturday morning patient had a seizure while at home, mother reports that seizure lasted approximately 1 minute, patient's mother immediately put patient in tub, and called firefighters, when firefighters arrived they stated that patient's temperature was 94 F. Then on 01/31/17, patient had a temperature of 100.4 F, and was just staring blank, patient was taken to ER for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Circumoral oedema, Respiratory distress, Wheezing
Clinical narrative: Peri-oral edema and respiratory distress, with wheezing, within minutes. Pulse ox >95% throughout.  Child given 5mL PO diphenhydramine and 3mL albuterol nebulizer in office, then also received 0.15mg IM epinephrine and 30mg PO prednisolone in the ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received Tdap-IPV in left thigh. Within 24 hrs leg was swollen, red, painful - the size of a baseball 48 hrs later she was taken to emergency room and treated with KEFLEX for cellulitis with resolution of SX rapidly after antibiotics started. DX cellulitis.
Age: 0.58
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Wrong patient received medication
Clinical narrative: 8 mo. old inadvertently given a Hep. A vaccine intended for a different patient.
Age: 0.83
Sex: M
Vaccine: IPV
Symptoms: Urticaria, Vomiting
Clinical narrative: Mother states "child had vomiting x2 on 2-2-17. On 2-2-17 child had hives on neck and cheeks. On Saturday had various hives on face and neck. "Reports "didn't take temp, didn't feel warm". mother called Dr's office was told to call HD since that was where vaccine was given. Mother called HD 2-6-17(pm).
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 16-JAN-2017, the patient was vaccinated with GARDASIL (lot #: K005881 with expiration date: 14-JAN-2017) (dose, dosage schedule and anatomical location were not reported) intramuscularly, for prophylaxis. The administered vaccine was expired. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001584:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M019643, expiration date 20-APR-2018, (dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported. The doses of VARIVAX were exposed to a temperature of 12F and were out of range for 39 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest X-ray normal, Chills, Cough, Extrasystoles
Clinical narrative: 4 hours after vaccine given: cough, headache, itchy and red eyes, fever and chills, body aches, fatigue, skipped heartbeats. A 69 year old male with no PMH presents to the ED for evaluation of cough onset this afternoon. Pt states that he received an influenza vaccination this afternoon. He states that 2 hours after the vaccination, he reports cough, headache, chills, and bilateral knee pain. Pt denies any shortness of breath and any fever. He notes that he did not have any sxs prior to today. He also states that he started taking Meloxicam today. He does not report taking any blood pressure or high cholesterol medications. Pt has no other complaints at this time.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Fatigue, Headache, Ocular hyperaemia, Pain
Clinical narrative: 4 hours after vaccine given: cough, headache, itchy and red eyes, fever and chills, body aches, fatigue, skipped heartbeats. A 69 year old male with no PMH presents to the ED for evaluation of cough onset this afternoon. Pt states that he received an influenza vaccination this afternoon. He states that 2 hours after the vaccination, he reports cough, headache, chills, and bilateral knee pain. Pt denies any shortness of breath and any fever. He notes that he did not have any sxs prior to today. He also states that he started taking Meloxicam today. He does not report taking any blood pressure or high cholesterol medications. Pt has no other complaints at this time.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 4 hours after vaccine given: cough, headache, itchy and red eyes, fever and chills, body aches, fatigue, skipped heartbeats. A 69 year old male with no PMH presents to the ED for evaluation of cough onset this afternoon. Pt states that he received an influenza vaccination this afternoon. He states that 2 hours after the vaccination, he reports cough, headache, chills, and bilateral knee pain. Pt denies any shortness of breath and any fever. He notes that he did not have any sxs prior to today. He also states that he started taking Meloxicam today. He does not report taking any blood pressure or high cholesterol medications. Pt has no other complaints at this time.
Age: 42.0
Sex: F
Vaccine: HIBV, IPV, MNQ
Symptoms: Extra dose administered, Grip strength decreased, Pain in extremity
Clinical narrative: Patient received MENACTRA in clinic in left arm. Patient went pharmacy after office visit and received another dose of MENACTRA in left arm. Patient had left arm pain/loss of grip.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Patient described redness down entire right arm and states it is sore to touch. Started the evening of her vaccination. Patient taking diphenhydramine 50 mg PO Q4-6hr until improved. Reports that the redness is gone today (2/1/17) when reporting the reaction to me.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Dizziness, Hypoaesthesia
Clinical narrative: After patient got the PREVENAR-13 shot, patient said she felt numbness on the hand and dizzy, stomach upset.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Partial seizures
Clinical narrative: Had focal seizures.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Local reaction, Pruritus, Skin warm, Urticaria
Clinical narrative: Localized (R) arm reaction from MENACTRA administered 2/1/17. Mom, patient's mother, states pt. had welt the size of half dollar that was red, raised and warm to touch, itchy. Came to the office 2/3/17 and seen by provider. Skin marking pen used to mark area. Mom states area a little bigger 2/4/17 half diameter of golf ball. Today 2/6/17 Mom states area has decreased in size and is not as red or welted.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Urticaria
Clinical narrative: Generalized urticaria. Numbness in the legs.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, painful, swollen at injection site. Gave patient ibuprofen and put ice on injection site.
Age: 90.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Pt received a PREVNAR 13 shot in her left deltoid on 2/1/17. On 2/5/17, her arm became red, warm and itchy. No other symptoms. Pt. was seen 2/7/17 and her arm was red and warm from just below deltoid to elbow. Started her on Prednisone 30mg QIDx3days, then 20mgx3days, then 10mgx3days.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Rash macular, Urticaria
Clinical narrative: Hives all over body (unraised, red blotches). Lasting 24+ hours.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood test normal, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder, Foaming at mouth
Clinical narrative: First seizure occurred Friday 2/27/17 at 5:45 PM lasting 1.5 minutes, included body tensing up, eyes rolling back, foaming at the mouth. Immediately following the seizure, the patient babbled for 30 seconds and then her body went limp and she fell into a deep sleep. The patient was taken to the hospital, had bloodwork done and was discharged at 2:10am on 2/28/17. Second seizure occurred on 2/28/17 at 6:45 PM. Seizure lasted 1.5 minutes and included body tensing up and going rigid, eyes rolling to the back of the head and foaming at the mouth. Again, the patient babbled for 30 seconds and immediately fell into a deep sleep. The patient was taken to the hospital where bloodwork was performed, a VEEG (for 60 hours) and EKG, all came back with  normal results. Patient was discharged from the hospital on Tuesday 1/31/17 at 2 PM. Patient was taken back to the hospital on Thursday 2/2/17 for an MRI of the brain (without dye) and results came back normal.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypotonia, Muscle rigidity, Muscle tightness, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: First seizure occurred Friday 2/27/17 at 5:45 PM lasting 1.5 minutes, included body tensing up, eyes rolling back, foaming at the mouth. Immediately following the seizure, the patient babbled for 30 seconds and then her body went limp and she fell into a deep sleep. The patient was taken to the hospital, had bloodwork done and was discharged at 2:10am on 2/28/17. Second seizure occurred on 2/28/17 at 6:45 PM. Seizure lasted 1.5 minutes and included body tensing up and going rigid, eyes rolling to the back of the head and foaming at the mouth. Again, the patient babbled for 30 seconds and immediately fell into a deep sleep. The patient was taken to the hospital where bloodwork was performed, a VEEG (for 60 hours) and EKG, all came back with  normal results. Patient was discharged from the hospital on Tuesday 1/31/17 at 2 PM. Patient was taken back to the hospital on Thursday 2/2/17 for an MRI of the brain (without dye) and results came back normal.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Sudden onset of sleep
Clinical narrative: First seizure occurred Friday 2/27/17 at 5:45 PM lasting 1.5 minutes, included body tensing up, eyes rolling back, foaming at the mouth. Immediately following the seizure, the patient babbled for 30 seconds and then her body went limp and she fell into a deep sleep. The patient was taken to the hospital, had bloodwork done and was discharged at 2:10am on 2/28/17. Second seizure occurred on 2/28/17 at 6:45 PM. Seizure lasted 1.5 minutes and included body tensing up and going rigid, eyes rolling to the back of the head and foaming at the mouth. Again, the patient babbled for 30 seconds and immediately fell into a deep sleep. The patient was taken to the hospital where bloodwork was performed, a VEEG (for 60 hours) and EKG, all came back with  normal results. Patient was discharged from the hospital on Tuesday 1/31/17 at 2 PM. Patient was taken back to the hospital on Thursday 2/2/17 for an MRI of the brain (without dye) and results came back normal.
Age: 13.0
Sex: M
Vaccine: IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Presyncope, Syncope
Clinical narrative: Syncopy, vasovagal reaction, laid patient down with feet raised and head down, took BP, cold compress to back of neck, offered water or juice and snack, waited for his BP to resume normal and HR normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Blood pressure decreased, Hyporesponsive to stimuli, Tryptase, Vomiting
Clinical narrative: After receiving the vaccine, patient and her mother walked out to the car and she began vomiting and was less responsive. She returned to the office where her BP was initially 84/40 and then dropped to 70/30 and she continued to be poorly responsive. She was given 0.15 mg epinephrine from Epi-pen, and HR and BP improved. 911 was called for paramedic transport to hospital. She did not require second Epi injection. She was transported to ED where she was given Benadryl 13 mg iV, Zofran 2 mg PO, Solu-Medrol 26 mg injection IV and a bolus of normal saline. She was much more responsive after about an hour, was observed in the ED for 4 hours and was back to normal state and behavior when discharged.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: PT ARRIVED AT CHECK WINDOW WAS PALE IN COLOR AND FELT FAINT. PT LOWERED TO FLOOR. VITAL SIGNS WNL. MONTIOTRED UNTIL PT FELT BETTER.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 6 month old female child patient. The patient's medical history, concurrent conditions, drug reaction or allergies and concomitant therapy were not provided. The nurse reported that on 23-JAN-2017, a 6 month old child received a dose of GARDASIL 9 intramuscularly (dose, lot # and its expiration date were unknown) for prophylaxis. No adverse effects were noted. No product quality complained was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On 31-JAN-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # L040442, expiration date 31-JAN-2017, (dosage and therapy route were not provided), for prophylaxis. The reporter was not aware of any adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical student concerning an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed.  On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M018453, expiration date 28-JUN-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. No adverse events were reported. The doses of ZOSTAVAX were exposed to a temperature  > 5F but < 14F and were out of range for 15 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.; Sender's comments: US-009507513-1702USA003007:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical student concerning an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed.  On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lots # M034586, M012990, M006731 with expiration dates 27-JUL-2018, 14-MAR-2018 and 09-FEB-2018 respectively, (dosages were not provided), administered per subcutaneous route, for prophylaxis. No adverse events were reported.   The doses of VARIVAX were exposed to a temperature  > 5°F but < 14°F and were out of range for 15 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001046:
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Condition aggravated, Hypersensitivity, Mast cell activation syndrome
Clinical narrative: Pt has mast cell activation disorder where she experiences allergic reactions from a wide variety of substances. Experienced extreme bone pain that lasted for about 4 days, possibly resulting from egg component of flu vaccine.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction including redness and swelling of the injected area.
Age: 34.0
Sex: M
Vaccine: YF
Symptoms: Influenza like illness, Pain
Clinical narrative: Body aches, no fever, feels flu-like symptoms, no symptoms of an allergic reaction.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Foetal hypokinesia, Ultrasound foetal abnormal
Clinical narrative: The morning after I received the vaccine I noticed my baby wasn't moving. I drove straight to the hospital where it was administered for and ultrasound where my doctor confirmed he had no heartbeat.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness
Clinical narrative: Faintness without syncope.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Extreme soreness at injection site, especially when raising arm.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Paraesthesia, Vaccination complication
Clinical narrative: Began with feet tingling progresses all over, diarrhea and progressively getting worse. Called Friday 2/03/17 to say she was on route to the hospital. Her primary care physician advised for her to go to the ER. He believed she was having an adverse reaction to her vaccination.
Age: 19.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Feeling uneasy, lightheaded, cheeks feeling hot.
Age: 18.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Local pruritic erythemic reaction.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe prolonged arm pain and soreness.  Lasted about a month.