chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: The patient is an 1 year old female. The patient is a healthy 12mo old female infant who received varicella vaccine in addition to MMR and hep B on 01 APR 2015. The MOP reports she initially had typical fever and then did fine. Ten days after receipt she developed a vesicular exanthem, initially only to her face and then yesterday to her trunk. She has approximately 10 vesicles but hundreds of small red spots to all extremities and trunk. She was seen by Dr. at clinic and dx with vaccine induced varicella. She has no known exposure to an active infection and does not attend daycare and has limited exposure to other groups. Her symptoms have now fully resolved.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients (identifier unknown). The patients were inadvertently administered doses of improperly stored GARDASIL (dose, strength and route were not reported, lot#: K005881, expiration date: 14-JAN-2017). No adverse effects were reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pruritus, Swelling
Clinical narrative: RT. DELTOID.  REDNESS AND SWELLING, MILD ITCHING AT INJECTION SITE.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy and light headed.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Pt noticed stinging with vaccine administration. Rash developed on right deltoid a few hours after receiving injection. A few days later rash had spread to L deltoid and L leg.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Burning sensation, Drug administered to patient of inappropriate age, Immediate post-injection reaction, Rash, Underdose
Clinical narrative: Pt noticed stinging with vaccine administration. Rash developed on right deltoid a few hours after receiving injection. A few days later rash had spread to L deltoid and L leg.
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given a MMRV injection IM.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Dysphagia, Feeling hot, Glossodynia, Mydriasis
Clinical narrative: Heat, rash, and swelling of face, tongue sensitivity, throat swelling and difficulty swallowing, fever, abdominal pain, pupil dilation.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Pharyngeal oedema, Pyrexia, Rash, Swelling face
Clinical narrative: Heat, rash, and swelling of face, tongue sensitivity, throat swelling and difficulty swallowing, fever, abdominal pain, pupil dilation.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Local swelling, Nausea
Clinical narrative: Heat, rash, and swelling of face, tongue sensitivity, throat swelling and difficulty swallowing, fever, abdominal pain, pupil dilation.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Paraesthesia oral, Pyrexia, Swelling face, Vaccination complication
Clinical narrative: Heat, rash, and swelling of face, tongue sensitivity, throat swelling and difficulty swallowing, fever, abdominal pain, pupil dilation.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Huge welt on arm below injection site.  4" by 5".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Patient experienced chills, fever, muscle pain, and fatigue as well as a large 4 inch red area at the injection site.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site hypoaesthesia, Injection site reaction, Skin tightness
Clinical narrative: After received Tdap in left upper arm, patient started c/o of tightness and numbness in the left upper arm. Father in the room with the patient states he used to get this reaction when he had the tetanus shot in the past. VS recorded as temp 99.6, resp 18, pulse 70, O2 sat 98%, BP 110/70. Patient held ice pack for 10 minutes to the shot site. Patient was watched for 20 minutes after the reaction. Patient state it is resolving. Manager on call notified. Patient discharged at 4:10 PM in no acute distress, father and patient verbalizes understanding to follow up with primary care physician if any symptoms come back or get worse. Take Tylenol for temp. Drink extra fluids and rest for next 24 hours. Patient discharged with father in no distress. Follow called was made today 04/27/2015 at 9am this morning, patient and his father states no problem doing just fine.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Blood glucose normal, C-reactive protein increased, Coagulation test normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Diffuse pruritis and rash.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Neutrophil count increased, Pruritus, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Diffuse pruritis and rash.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Grip strength decreased, Muscular weakness, Paraesthesia
Clinical narrative: Client reports weakness in left arm and "tingling in hand "with difficulty  gripping. States she had a severe adverse reaction in October to a flu vaccine however reports symptoms not the same. Client also could not recall if the flu vaccine was given in the same arm she is experiencing discomfort.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: MILD FEVER & SORE THROAT 8-9 DAYS AFTER VACCINATION WITH SMALLPOX THEN RASH DEVELOPED ABOUT ABOUT 10 DAYS AFTER VACCINATION ON CHEST AND TRUNK.
Age: 2.0
Sex: M
Vaccine: PER
Symptoms: Ear infection, Ear tube insertion, Malaise, Mass, Respiratory disorder
Clinical narrative: Very large and harden lump that was the size of my hand. Took a month for it to go down. Still has a small lump. He also had this reaction to prior shot but not as severe. My son has become very ill after ever shot he has had. He now has active airways disease and has had many ear infections which started after his first shot. He has tubes but still has had two ear infections. He did have to be hospitalized after getting sick right after one of his earlier vaccines.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 69 year old female patient. The patient was allergic to penicillin and amoxicillin that caused hives. The patient was also allergic to egg and chicken. The patient had no medical history. On 19-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 25/0.5 (unit not provided) (0.5 ml, lot#: K008409, expiry date: 04-MAR-2016, intramuscular). Concomitant therapies included CELEXA, SYNTHROID, pantoprazole, Vitamin B6 and Vitamin B12. On 19-MAR-2015, after receiving PNEUMOVAX 23, the patient experienced a temperature of 103 (unit not reported) and severe arm pain. The patient did not obtain any medical treatment for the events and had not sought medical attention. The patient recovered from the events on approximately 26-MAR-2015 (reported as after one week/ for approximately one week). The causality between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had completed both VAQTA (dose, lot# and route not reported) and RECOMBIVAX HB (dose, lot# and route not reported) series on an unspecified date. On 08-APR-2015, the patient was inadvertently vaccinated with an extra dose of both VAQTA, (dose, lot#, expiration date, route and injection site were not reported) and RECOMBIVAX HB, (dose, lot#, expiration date, route and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: This spontaneous prospective report was received from a consumer refers to a 30 year old female patient. No pertinent medical history was reported. On 06-APR-2015, the patient was vaccinated with VARIVAX inj (Merck) while she was pregnant. Pregnant gestation was reported as 2 and half weeks and LMP was approximately on an unknown date in March 2015. Trimester(s) of exposure was first trimester. Pregnancy outcome was outcome pending. Due date and date of conception were unknown. Lab tests include blood test for pregnancy and results were unknown. Patient sought medical attention. Treatment was not given to the patient. Action taken was not applicable and outcome of event was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the unspecified number of patients were vaccinated with unspecified number of improperly stored doses of GARDASIL lot # H020901 with an expiration date of 05-JUL-2015 (also reported as 08-JUL-2015), administered through an unknown route. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, route, lot # were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 60 years old female physician via a company representative and refers to herself. No relevant medical history of the physician was reported. On an unspecified date in 2012, the physician was vaccinated with ZOSTAVAX (strength, dose, lot number and route of administration were not reported). There were no concomitant medications reported. On an unknown date the physician experienced herpes zoster, after receiving ZOSTAVAX. The physician treated herself with an unspecified medication. There was no product quality complaint involved. The action taken with the ZOSTAVAX was not applicable. The outcome of herpes zoster was reported as recovered on an unspecified date. The causality of the event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient was vaccinated with GARDASIL (confirmed not GARDASIL 9) on 06-AUG-2012, 11-OCT-2012, 18-FEB-2013 and 14-APR-2015. No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty breathing in a adult male patient who received Influenza vaccine. Co-suspect products included Fluticasone Propionate+Salmeterol Xinafoate unknown for chronic obstructive pulmonary disease and salbutamol sulphate unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, the patient received influenza vaccine at an unknown dose, Fluticasone Propionate+Salmeterol Xinafoate (unknown) at an unknown dose at unknown dosing and salbutamol sulphate (unknown) at an unknown dose at unknown dosing. On an unknown date, unknown after receiving Influenza vaccine, Fluticasone Propionate+Salmeterol Xinafoate and salbutamol sulphate, the patient experienced difficulty breathing and feeling unwell. The action taken with Fluticasone Propionate+Salmeterol Xinafoate was unknown. The action taken with salbutamol sulphate was unknown. On an unknown date, the outcome of the difficulty breathing and feeling unwell were unknown. It was unknown if the reporter considered the difficulty breathing and feeling unwell to be related to Influenza vaccine. The reporter considered the difficulty breathing and feeling unwell to be unrelated to Fluticasone Propionate+Salmeterol Xinafoate and salbutamol sulphate. Additional details provided as follows: The flu shot makes the patient really sick but did not go to in his lungs in any way, so he felt lucky.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Influenza, Sputum increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 93-year-old female patient who received Influenza vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder for difficulty breathing. Concurrent medical conditions included blood pressure high, leg syndrome and reflux esophagitis. Concurrent medications included unspecified heart medicine, unspecified blood pressure medicine, unspecified leg syndrome medicine, and unspecified reflux medication. Concomitant products included Pneumonia vaccine. In October 2014, the patient received Influenza vaccine. In 2014, the patient started ADVAIR DISKUS (inhaled) 250/50 ug 1 puff(s) twice daily (2 puff(s) daily). In February 2015, 122 days after receiving Influenza vaccine and several months after starting ADVAIR DISKUS, the patient experienced influenza, hoarseness and sputum increased. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the influenza was recovering/resolving and the outcome of the hoarseness and sputum increased were not recovered/not resolved. It was unknown if the reporter considered the influenza, hoarseness and sputum increased to be related to Influenza vaccine. It was unknown if the reporter considered the influenza to be related to ADVAIR DISKUS. The reporter considered the hoarseness and sputum increased to be possibly related to ADVAIR DISKUS. Additional information was provided: The patient reported that she had been using ADVAIR for about 23 years, but just last year, in 2014 started using it consistently and twice daily for her breathing. She stated in October of last year she had the flu shot, but in February 2015 she got the flu. Also in February with the flu incident she noticed voice changes and her doctor informed her it probably was the ADVAIR use. She stated she rinses her mouth after each dose. She also added that she has had increased fluid/mucous that she has to spit out. She was referred to her physician for treatment recommendations for the hoarseness. She added that she had also received the pneumonia vaccine at some point.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. Pertinent medical history and drug reactions were not provided. On 07-APR-2015 the patient was inadvertently administered with an expired dose of VARIVAX (Merck) (lot # J003223, expiry date: 15-MAR-2015). Concomitant medications were unspecified. No adverse effects were reported. Outcome of the event, expired product administered was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Loss of consciousness, Syncope
Clinical narrative: Pt fainted/became unconscious about 1 min - 2 min post-vaccination. She awoke and became conscious about 10 seconds later. She reported feeling dizzy and her head was sore (hit her head from falling?). She was asked to lay down until she could sit up, given water and food and remained seated until her family came up help about 15 min.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated after receiving the annual flu shot her arm became sore. It continues to be sore 5 months later. She states she can't lift her arm >90 degrees and this it is constantly aching, unrelieved by APAP or Ibu.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 0.5 ml, lot # K009809, expiration date 16-MAY-2015 (strength and route were not reported), that were improperly stored. No adverse experienced were reported. No product quality complain was reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered
Clinical narrative: Most medication squirted out due to unstable hold of pt's leg.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified dates since 11-MAR-2015, an unspecified number of patients were vaccinated with doses of ZOSTAVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored exposing to temperatures outside of the recommended range. No adverse effects were reported or observed and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Irritability, Pyrexia, Rash papular
Clinical narrative: Fever, fussiness on quarter sized area of papular rash on right thigh at site of varicella vaccine starting 8-9 days after vaccines.
Age: 22.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Student reported that same day she received Tdap vaccine she developed numbness and tingling; pain in the left arm from deltoid radiating down to left hand. By the next am she stated she could not feel her (L) hand.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified dates since 11-MAR-2015, an unspecified number of patients were vaccinated with doses of VARIVAX (Merck) 1350 U, (dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored exposing to temperatures outside of the recommended range. No adverse effects were reported or observed and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown ages and genders who on unknown dates were vaccinated with an improperly stored doses of VARIVAX (Merck) (dose, lot#, expiration date and route were not reported). No adverse effect reported. It was unknown if the patients sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 14-APR-2015, the patient was inadvertently vaccinated with an expired first dose of M-M-R II (lot # J004210 exp date 12-APR-2015) subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on an unknown date, the patient was administered ZOSTAVAX vial that had been improperly stored (dose, route and lot number not provided). No adverse effects were reported. This case was linked to case MARRS # 1504USA022603 (same reporter link). Additional information is not expected because the reporter did not provide consent to follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to three patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on an unknown date, the patients were administered PROQUAD (Merck) that had been improperly stored (dose, route and lot number not provided). No adverse effects were reported). This case is linked to case MARRS # 1504USA022234 (same reporter link). Additional information is not expected because the reporter did not provide consent to follow up.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist referring to a 45 year old male patient with penicillin allergies (also reported as unknown reaction). There was no other pertinent medical history. On 25-JUN-2014, 28-JUL-2014 and 10-JAN-2015, the patient was vaccinated with the first, second and third dose of RECOMBIVAX HB respectively (strength: 10mcg/ml; dose: 1 ml; route: intramuscular; lot # of dose 1 reported as J005211, expiration date 03-FEB-2016; lot # of dose 2 unknown; lot # of dose 3 K003727, expiration date 04-FEB-2016) (inappropriate schedule of vaccine administered). There was no concomitant medication. On an unknown date of 2015, after receiving three doses of RECOMBIVAX HB, the patient was evaluated by an unspecified physician and was found to be have negative Hepatitis B antibody titers. No treatment was given for adverse event. At the time of reporting, the titers still were negative. Causality was not provided. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal pain upper, Constipation, Diarrhoea, Dizziness
Clinical narrative: 1st headache, stomach mildly upset, diarrhea, constipation, slightly dizzy, tired, hot/cold, sore throat 2nd same as above with stomach cramps, nausea.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling of body temperature change, Headache, Nausea, Oropharyngeal pain
Clinical narrative: 1st headache, stomach mildly upset, diarrhea, constipation, slightly dizzy, tired, hot/cold, sore throat 2nd same as above with stomach cramps, nausea.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Axillary pain, Breast pain, Ultrasound breast
Clinical narrative: Large lump under (R) Axila with pain extending to (R) breast.
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: The left arm where I was vaccinated, began hurting to the point that I was unable to reach for my right ear. It would really hurt. This pain has not gone away, it persists I feel as if a bone chip is lodged on my elbow.
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: The left arm where I was vaccinated, began hurting to the point that I was unable to reach for my right ear. It would really hurt. This pain has not gone away, it persists I feel as if a bone chip is lodged on my elbow.
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Immediate post-injection reaction, Insomnia, Mobility decreased, Pain, Tenderness
Clinical narrative: The left arm where I was vaccinated, began hurting to the point that I was unable to reach for my right ear. It would really hurt. This pain has not gone away, it persists I feel as if a bone chip is lodged on my elbow.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal pain, Dysphagia, Feeling hot, Glossodynia, Mydriasis
Clinical narrative: Pt emailed the following "I visited your office 4/15/15 and obtained oral typhoid vaccine.  I took the first pill 4/25/15 as prescribed, and had only a few mild side effects.  When I took the second pill on 4/27/15 as prescribed, that afternoon I developed facial redness and swelling, tingling of tongue, swelling of the neck, fever, nausea, and difficulty swallowing.  I did not develop much difficulty breathing as I took Benadryl immediately.  My doctor believes that I had an allergic reaction to the vaccine and has told me not to take the other two pills.  I thought you would like to know this information for your records."
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Pharyngeal oedema, Pyrexia, Rash, Swelling face
Clinical narrative: Pt emailed the following "I visited your office 4/15/15 and obtained oral typhoid vaccine.  I took the first pill 4/25/15 as prescribed, and had only a few mild side effects.  When I took the second pill on 4/27/15 as prescribed, that afternoon I developed facial redness and swelling, tingling of tongue, swelling of the neck, fever, nausea, and difficulty swallowing.  I did not develop much difficulty breathing as I took Benadryl immediately.  My doctor believes that I had an allergic reaction to the vaccine and has told me not to take the other two pills.  I thought you would like to know this information for your records."
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Local swelling, Nausea
Clinical narrative: Pt emailed the following "I visited your office 4/15/15 and obtained oral typhoid vaccine.  I took the first pill 4/25/15 as prescribed, and had only a few mild side effects.  When I took the second pill on 4/27/15 as prescribed, that afternoon I developed facial redness and swelling, tingling of tongue, swelling of the neck, fever, nausea, and difficulty swallowing.  I did not develop much difficulty breathing as I took Benadryl immediately.  My doctor believes that I had an allergic reaction to the vaccine and has told me not to take the other two pills.  I thought you would like to know this information for your records."
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Paraesthesia oral, Pyrexia, Swelling face, Vaccination complication
Clinical narrative: Pt emailed the following "I visited your office 4/15/15 and obtained oral typhoid vaccine.  I took the first pill 4/25/15 as prescribed, and had only a few mild side effects.  When I took the second pill on 4/27/15 as prescribed, that afternoon I developed facial redness and swelling, tingling of tongue, swelling of the neck, fever, nausea, and difficulty swallowing.  I did not develop much difficulty breathing as I took Benadryl immediately.  My doctor believes that I had an allergic reaction to the vaccine and has told me not to take the other two pills.  I thought you would like to know this information for your records."
Age: 1.14
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: Leg that received vaccine became too painful to stand on.  Pain seems to originate in heel or ankle. Stands only on her toes on affected leg.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Blood glucose, Eye movement disorder, Fall, Malaise, Muscle rigidity
Clinical narrative: Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Pallor, Seizure, Skin discolouration, Syncope, Unresponsive to stimuli
Clinical narrative: Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Blood glucose, Eye movement disorder, Face injury, Fall, Malaise
Clinical narrative: Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Muscle rigidity, Pallor, Seizure, Skin discolouration, Syncope
Clinical narrative: Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Age: 48.0
Sex: M
Vaccine: FLUN3
Symptoms: Burning sensation, Fatigue, Gait disturbance, Limb discomfort, Muscular weakness
Clinical narrative: A report has been received from a consumer via Health Authority concerning a 48 year old male patient. The patient's concomitant diseases and concomitant medications were not reported. On an unknown date the patient started receiving FLUMIST (intranasal). The patient experienced burning sensation, gait disturbance, limb discomfort, muscular weakness and fatigue. The action taken of FLUMIST was unknown. At the time of reporting, the event of burning sensation, gait disturbance, limb discomfort, muscular weakness and fatigue was ongoing. The events of burning sensation, fatigue, gait disturbance, limb discomfort and muscular weakness were considered as serious with the serious criteria of disability and important medical event by the reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 04/22/15 - Redness and itching at injection site. 04/24/15 - Continued redness and itching at injection site, no worse/no better. 04/27/15 - Itching on chest, back, and scalp. R eye swelling and redness. Injection site also red, hot, itchy, and swollen still. Single lesion on right cheek. Referred to ophtho who confirmed diagnosis of shingles likely due to Zostavax. Given valtrex.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Ocular hyperaemia, Pruritus, Skin lesion
Clinical narrative: 04/22/15 - Redness and itching at injection site. 04/24/15 - Continued redness and itching at injection site, no worse/no better. 04/27/15 - Itching on chest, back, and scalp. R eye swelling and redness. Injection site also red, hot, itchy, and swollen still. Single lesion on right cheek. Referred to ophtho who confirmed diagnosis of shingles likely due to Zostavax. Given valtrex.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, Urinary tract infection, Urine analysis, Vulvovaginal mycotic infection
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 18 year old female patient with asthma and urinary reflux. The patient did not have any drug allergies or reactions. On 23-JAN-2015, the patient was vaccinated with first dose of GARDASIL (lot# K009811, expiration date: 19-JUN-2016, intramuscular, dose and anatomical location was unknown) which was improperly exposed to 67F for the preceding 13 days. Other suspect therapies included DEPO-PROVERA (dose and frequency was unknown) which was also started on 23-JAN-2015. On 06-MAR-2015, the patient was administered the second dose of GARDASIL (lot number, expiration date, dose and anatomical location was unspecified). There were no concomitant medications reported. On an unspecified date in 2015, after administration of first dose of GARDASIL and medroxyprogesterone acetate, the patient experienced urinary tract infection and vaginal yeast infection. There was no product quality complaint involved. On an unknown date urine specimen was examined and the results were unknown. The patient sought medical attention by visiting an unspecified physician. On an unknown date the patient was given DIFLUCAN and Cefdinir (200 mg, one tablet twice per day for 7 days, which was started on 07-FEB-2015) as a treatment for the infections. The outcome of urinary tract infection and vaginal yeast infection was reported as recovered/resolved. The causal relationship between the events and GARDASIL was not reported. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 18 year old patient who's a nurse practitioner (demographics unspecified). Pertinent medical history and drug reactions were not reported. On an unknown date the patient received PROQUAD instead of M-M-R II. Concomitant medications were unspecified. No adverse symptoms were reported. Outcome of the event, wrong drug administered was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MEN, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a patient's father refers to a 14 year old female patient with allergy to amoxicillin and with no pertinent medical history. On 17-MAR-2015 the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Other suspect therapies given on the same day included VARIVAX (Merck) (dose, route and lot number were not reported), hepatitis A virus vaccine (manufacturer unknown) (dose, route and lot number were not reported) and meningococcal vaccine (dose, route and lot number were not reported). During those vaccinations the patient was pregnant. The LMP and EDD is not known. The pregnancy outcome was pending. The patient's father stated that the patient's pregnancy was confirmed on 08-APR-2015 (office visit). Lab diagnostic studies included pregnancy test (urine and blood) and sonogram. The patient's father reported that the patient would not receive the two subsequent doses of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient was prescribed PNEUMOVAX 23 (dose, route and lot number were not reported) but received an unspecified product manufactured by Glaxo Smith Kline (lot number H45098, exp. date was not available) (dose, route and indication were not reported). No adverse event was reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 17-year-old malel patient who received BOOSTRIX (batch number 45MH5, expiry date 11th February 2017). Concurrent medical conditions included hospitalization. Concomitant products included Normal Saline and ZOFRAN. On 19th April 2015, the patient received BOOSTRIX .5 ml. On 19th April 2015, lelss than a day after receiving BOOSTRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter. Additional details provided as follows: Pharmacist reported adverse events for a patient in the hospital. The patient developed a localized rash (pharmacist believes rash was in area of injection). No treatment was given for this rash.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This prospective pregnancy report has been received from a husband concerning his wife of unknown age. Information concerning medical history and concurrent condition was not reported. On 07-APR-2015, the patient was vaccinated with GARDASIL 9 or GARDASIL (the husband could not confirm which was vaccinated), when the patient was 35 weeks pregnant. No adverse effects were reported. The last menstrual period (LMP) date was estimated as 05-AUG-2014. The due date was estimated as 12-MAY-2015. The trimester of exposure was ranged at the third trimester (28-42 weeks). The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. It was reported that M-M-R II and VARIVAX (Merck) were prescribed. On 14-APR-2015, the patient was vaccinated with PROQUAD (Merck) (dose 0.5 ml, subcutaneous, lot# and expiration date were not reported) instead of M-M-R II. The nurse practitioner stated the she felt that the PROQUAD box and M-M-R II box were so similar especially in color, that this might had contributed to the confusion. No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 62 year old patient of unknown gender. No relevant medical history or concurrent conditions was provided. On 08-APR-2015 the patient was vaccinated with an expired 0.65ml dose of ZOSTAVAX (lot # J014568, expiration date 18-FEB-2015) subcutaneously in the right arm. No adverse effects were reported. Additional information is not expected since the nurse is not allowed to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot # K009890 with expiry date: 11-JAN-2016 and lot# K019102 with expiry date: April 2016; strength, dose and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot# K009758 with expiry date: July 2016 and lot# reported as: K021935 with expiry date: 10-NOV-2015; strength, dose and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 25-year-old male patient who received BOOSTRIX (batch number 45MH5, expiry date 11th February 2017). Concurrent medical conditions included gun shot wound and hospitalization. Concomitant products included fentanyl, KEPPRA, mannitol, NURCURON, Rocephin and VERSED. On 19th April 2015, the patient received BOOSTRIX .5 ml. On an unknown date, the dose was an unknown dose. On 19th April 2015, less than a day after receiving BOOSTRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to BOOSTRIX. This was one of the 2 cases received from the same reporter. Additional details provided as follows: The patient developed a localized rash (caller does not know if this rash was at the injection point, but believes it may have been). The rash lasted about 30 minutes and no treatment was given for this rash.
Sex: U
Vaccine: FLU3
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cold in a elderly patient who received Influenza vaccine. Co-suspect products included salbutamol sulphate unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included chronic obstructive pulmonary disease. In November 2014, the patient received Influenza vaccine. On an unknown date, the patient started salbutamol sulphate at an unknown dose and frequency. In November 2014, less than a day after receiving Influenza vaccine and an unknown time after starting salbutamol sulphate, the patient experienced cold. The action taken with salbutamol sulphate was unknown. On an unknown date, the outcome of the cold was not recovered/not resolved. It was unknown if the reporter considered the cold to be related to Influenza vaccine. The reporter considered the cold to be unrelated to salbutamol sulphate. Additional information: the subject was sick, like a cold for the first 23 hrs. This case has been linked with case A1008396A, same patient. Please refer to case A1008396A for tolerance to salbutamol sulphate.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Chest X-ray normal, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Patient received MMR vaccine on 4/13/15. 3-4 days after the vaccine was administered, developed red spots on abd. 4/22 developed diffuse rash and fever. Rash was red, pimply, no blotches, no drainage or scabbing. Spread to neck, back and entire body excluding palms of hands and soles of feet. No oral lesions.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a 12 month 1 day old patient of unknown gender. No information about concurrent condition and historical medication was reported. On 14-APR-2015, the patient was vaccinated with PROQUAD (Merck) dose 1 and VARIVAX (Merck) dose 1 on the same day. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of accidental overdose was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. These patients were administered an unspecified number of improperly stored doses of GARDASIL (lot# K006960, expiration 19-FEB-2017, dose was not reported) intramuscularly on unspecified dates since 02-APR-2015. No adverse effect was reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Blister, Erythema, Full blood count normal, Papule, Rash erythematous
Clinical narrative: Woke with generalized red, maculopapular rash from head to toe this AM. (8 days after vaccine) confluent redness on face some papules/vesicles on red base throughout body. Some hive appearing lesions. No other signs of illness. Vaccine rxn vs allergic rxn to other. Seen this AM.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash generalised, Rash maculo-papular, Streptococcus test negative, Urticaria
Clinical narrative: Woke with generalized red, maculopapular rash from head to toe this AM. (8 days after vaccine) confluent redness on face some papules/vesicles on red base throughout body. Some hive appearing lesions. No other signs of illness. Vaccine rxn vs allergic rxn to other. Seen this AM.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patient's medical history and drug reactions/allergies were not reportetd. On unknown dates the patients were vaccinated with an unspecified number of doses of VAQTA injection, (strength: 25/0.5 (unit not reported; dose, frequency, route and lot# were not reported), which were improperly stored. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54-year-old female patient with diabetes mellitus and with no drug reactions or allerlgies. On 17-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml injected subcutaneously ("once"; lot 3 K015311 with expiry date: 17-DEC-2015). Other suspect therapies included DULERA. Concomitant therapies included ZOLOFT, LYRICA and hhdrocodone. On 19-APR-2015, the patient developed a "1 by 2 inch red, hard area" at the ZOSTAVAX injection site. The patient sought medical attention, she came into the pharmacist on 21-APR-2015 (reported as: today). No treatment was given and no laboratory test were performed. The pharmacist stated that the patient was currently taking DULERA and they warned the patient that it might cause problems with the ZOSTAVAX. The outcome of the events was reported as not recovered. The relatedness between the injection site red, hard area and DULERA or ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from the patient's friend refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not provided) while being pregnant. The last menstrual period (LMP) and expected date of delivery (EDD) were not known. The pregnancy outcome was outcome pending. It could not be confirmed whether the product was GARDASIL or GARDASIL 9 used. Additional information is not expected as no contact information provided for the reporter, patient or physician.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 6 month old female patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ROTATEQ third dose, lot #K023535, expiration date 22-MAY-2016 (dos was not reported). On an unknown date, the patient developed blood in the stool and experienced diarrhoea for 2 weeks straight. The patient was taken to the emergency room (unknown if the patient was admitted). Medical attention was sought in a doctor's office. No adverse effect were reported with the first 2 doses of the vaccine. The outcome of haematochezia and diarrhoea was reported as recovering. The relatedness between the events and ROTATEQ was not reported. Additional information has been requested.