chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Crying, Emotional disorder, Guillain-Barre syndrome, Irritability
Clinical narrative: Patient woke up with a moderate fever which lasted all day.  We gave her Tylenol every four hours.   The next day 8/20/10, she cried and was emotional all day.  Even with giving her Tylenol every 4 hours, her fever rose of above 103 and was difficult to keep down.  We sponged her all day, fed her ice cream, and gave her luke warm baths.  The next day 8/21/10 she woke up with a rash all over her body.  We took her back to the Dr. to be checked out.  She still had a fever and was fussy and crying all day.  Throughout the next week, she was extremely emotional and crying off and on (but very out of the ordinary behavior for her). On 8/27/10, she woke up from a nap and told up that she could no longer walk.  She complained that her right foot hurt.   We looked for any type of injury, but there was none.  For the rest of the day she was unable to walk and drug her body around the floor like a baby.  By the end of the day, these issues resolved themselves, but it was a terrifying experience for us.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: Patient woke up with a moderate fever which lasted all day.  We gave her Tylenol every four hours.   The next day 8/20/10, she cried and was emotional all day.  Even with giving her Tylenol every 4 hours, her fever rose of above 103 and was difficult to keep down.  We sponged her all day, fed her ice cream, and gave her luke warm baths.  The next day 8/21/10 she woke up with a rash all over her body.  We took her back to the Dr. to be checked out.  She still had a fever and was fussy and crying all day.  Throughout the next week, she was extremely emotional and crying off and on (but very out of the ordinary behavior for her). On 8/27/10, she woke up from a nap and told up that she could no longer walk.  She complained that her right foot hurt.   We looked for any type of injury, but there was none.  For the rest of the day she was unable to walk and drug her body around the floor like a baby.  By the end of the day, these issues resolved themselves, but it was a terrifying experience for us.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Depressed level of consciousness, Dyspnoea, Erythema, Feeling hot
Clinical narrative: Patient was given ADACEL vaccine at 2:38 pm. He became/develops redness, sweat, hot SOB. He started have tightening in his chest/neck. He almost lost consciousness. Gave the EPIPEN and patient became more alert after about a min. Ambulance came and took him away.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Muscle tightness
Clinical narrative: Patient was given ADACEL vaccine at 2:38 pm. He became/develops redness, sweat, hot SOB. He started have tightening in his chest/neck. He almost lost consciousness. Gave the EPIPEN and patient became more alert after about a min. Ambulance came and took him away.
Age: 21.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Patient fainted and convulsing after receiving GARDASIL vaccine.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotension, Malaise, Muscle rigidity, Unresponsive to stimuli
Clinical narrative: 6:20pm pt was noted following injection to experience a short 10-15 sec of tonic stiffening and unresponsiveness following reporting he did not feel well. Patient was hypotensive BP 110/58 improved with laying down over the course of 15 min. Given juice to drink during recovery time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had vaccination on 7/15/13. Pt reported redness at injection site with warmness to skin. Pt reported to take BENADRYL on f/u with MD
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.), refers to a 19 year old patient (gender unknown) who on 22-JUL-2013 was vaccinated with a pediatric dose of VAQTA (Lot # not reported) 0.5 ml, intramuscular route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Suicidal ideation
Clinical narrative: This spontaneous report as received from a female patient of unknown age with depression, anxiety and post-traumatic stress syndrome refers to herself. The patient's medical history included suicidal ideations. On an unknown date, a while ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not provided). Other suspect therapies included PRILOSEC, PEPCID, CYMBALTA, SEROQUEL, BENADRYL, CLARITIN, ciclopirox; LYRICA, clobetasol propionate, acyclovir, minerals (unspecified), THERAGRAN-M and aspirin. The consumer reported that after being admitted to the hospital (on an unknown date) for suicidal ideations, she developed a rash that spread slowly to her face, toes, genitals and both sides of her arms. The consumer stated that the physicians' in the hospital thought the rash might be related to one or more of medications she took daily. These medications were prescribed prior to her admission to the hospital. The consumer was scheduled to have a "patch" test on 22-JUL-2013, for allergy testing. At the time of the report, the patient was still hospitalized due to her suicidal ideations, and not related to the rash she developed. The patient's outcome was reported as not recovered. The action taken with other suspect therapies was not reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Activities of daily living impaired, Adverse event
Clinical narrative: This spontaneous report as received from a shareholder of Merck refers to a young female patient of unknown age which was his friend's daughter. On an unknown date the patient was vaccinated with an unspecified HPV vaccine (manufacturer unknown) (lot #, dose not provided). On an unknown date the patient experienced severe side effects from the vaccination. The patient was in such bad shape that there was no way that she can even return to school. The outcome of side effects was unknown. Upon internal review, the event was considered to be disabling since the patient could not return to school due to the event. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Dizziness, Influenza like illness, Nausea, Pain
Clinical narrative: Client called 7/24 as he had received 4 dose treatment and client c/o of nausea, "feeling achy like the flu", lightheadedness about 24 hr after 7/6 vaccination - 24 hr later client stated and symptoms a24 hr after 7/10 and 7/17 (nausea and flu like achy ness")
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus generalised, Urticaria
Clinical narrative: Left clinic and went to store. Fifteen minutes later noticed "whelps all over". Reports head, feet, fingers and hands started itching; fingers swelling. Took Benadryl 25mg "po" stat. Went home a gave self epi-pen injection - responding quickly per patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, 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 22-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H010656, expiration date 01-SEP-2013) (0.65 ml, subcutaneous route). Concomitant therapy was not reported. It was reported that the patient received an improperly stored ZOSTAVAX, the ZOSTAVAX was exposed to a temperature of 40F for 2160 hours. No adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Blood test abnormal, Incorrect dose administered, Seroconversion test negative
Clinical narrative: Initial information has been received from a physician refers to a male patient of unknown age with none pertinent medical history of drug reactions/allergies. The patient received 2 doses (on an unspecified date) of M-M-R II (lot number not provided) as a child. On 22-APR-2013, the physician gave a third dose of M-M-R II (lot and expiration date were not reported). On 18-JUN-2013, the patient came back to the office and had blood drawn to test for titers. The result were negative. On the same date, the patient was administered a 4th dose of M-M-R II (lot number and expiration date were not reported). There were not concomitant medications. The patient never seroconverted. The outcome was unknown. The action taken was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient with hypothyroidism and with no drug reactions or allergies. On 04-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in July 2013, the patient experienced pain in her whole arm after receiving ZOSTAVAX and she was having difficulty in raising her arm in the air. She was waking up earlier than usual because she was having difficulty sleeping due to the pain. The patient sought medical attention (contacted pharmacist). She was treated with ibuprofen. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (Lot#, dose and route not reported). On an unknown date the patient experienced "flu like symptoms" after receiving vaccine. The patient saw the doctor for medical attention. No treatment was given. On an unknown date the patient recovered from "flu like symptoms". Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age with no pertinent medical history and no drug reactions or allergies regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included ALLEGRA (reported as Allergra). On an unknown date, the patient developed a rash after receiving ZOSTAVAX. The patient sought medical attention (saw the doctor). No treatment was given. No lab tests were performed. The patient was recovering from rash (also reported as adverse event not improved). The relatedness for rash was unknown for ZOSTAVAX. Additional information is not expected.
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. On an unknown date the patient was vaccinated a dose of PNEUMOVAX23 (lot # not provided) dose, route, indication not reported. On an unknown date, the patient may had received PNEUMOVAX23 instead of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) concerning a female patient of unknown age. On an unknown date in August 2007, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On an unknown date in October 2007, the patient was vaccinated with the second dose of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly and would like to receive the third dose of GARDASIL at the time of report. Hence, the patient sought medical attention (clinic visit). No concomitant medications were reported. The patient had a physician but could not remember the name of her physician. No adverse effects were reported. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old female patient with seasonal allergies. On 30-AUG-2012 the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose, frequency, route unspecified). Concomitant therapies included unspecified medication for blood pressure, cholesterol, thyroid and "arthritis" (manufacturers and doses unspecified). On 10-JUL-2013, the patient developed shingles. The patient reported that she had a breakout of shingles on her face. The patient sought medical attention via office visit and was diagnosed by her primary physician. No laboratory diagnosis studies were performed. The outcome of the event was reported as not recovered/not resolved at reporting time. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a medical assistant. This medical assistant noted that unsupported PROQUAD (Merck) (lot# J002304, exp. 22-AUG-2014) 0.5 mL, subcutaneous was administered to 21 unspecified patients on unspecified dates between 19-JUN-2013 and 10-JUL-2013. No adverse effect was reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old male patient. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001700, exp date 08-MAY-2014) (0.65ml, once, subcutaneous route). Concomitant therapy was not reported. In July 2013, the patient experienced swelling of knees, the pharmacist was not aware when patient first experienced the adverse event and on 20-JUL-2013 the patient started MEDROL pack for swelling of knees. The patient stopped use of MEDROL on 21-JUL-2013 when patient became concerned, after reading unspecified information. The outcome of swelling of knees was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 19 year old male patient with no pertinent medical history reported. On 01-AUG-2012 the patient was vaccinated with the first dose of VAQTA 25/2.5 U/ml (lot number and expiration date not reported) (intramuscular, dose not reported). No other suspect therapies or concomitant medications were reported. The medical assistant reported that the first pediatric dose of VAQTA was administered to the patient while he was 18 years old, but a second pediatric dose was administered to the patient on 05-JUN-2013, after the patient had turned 19 years old. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt given Zostavax instead of Varicella.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In approximately July 2012, about 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX. On 22-JUN-2013 recently, 30 days ago, the patient came down with shingles which had now subsided and the rash had cleared. He wanted to know if he might get a second dose of zoster vaccine live. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Arm where injection was given was red, hot, and swollen.  Hives were noted on same arm.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose normal, Computerised tomogram normal, Convulsion, Electrocardiogram, Electroencephalogram abnormal
Clinical narrative: May 28, 2011, Grand mal seizure @2PM, 30 seconds. Took to ER, CAT scan normal, sugar normal, temp normal, sent home. Grand mal seizure @6PM, 15 min stopped by medication. Took to ER CAT scan, EEG normal, temperature normal, sugar normal. August 5, 2011, Seizure, 30 seconds, 2:30 AM, general. Drove to ER, discharged at 5:00 am. Seizure, 1 min, 8:00 AM, general. Ambulance to ER, checked sugar - 78. Seizure, 1 min, 10:00 AM, general. Seizure, 4 min, 1:15 PM, general, later on right side of body, captured on EEG. EKG done. Medication administered to suppress seizures. Discharged from hospital Saturday evening. Neurologist diagnosed with epilepsy and now taking Trileptal 3mL 2x/day to suppress seizures.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Epilepsy, Grand mal convulsion, Laboratory test normal
Clinical narrative: May 28, 2011, Grand mal seizure @2PM, 30 seconds. Took to ER, CAT scan normal, sugar normal, temp normal, sent home. Grand mal seizure @6PM, 15 min stopped by medication. Took to ER CAT scan, EEG normal, temperature normal, sugar normal. August 5, 2011, Seizure, 30 seconds, 2:30 AM, general. Drove to ER, discharged at 5:00 am. Seizure, 1 min, 8:00 AM, general. Ambulance to ER, checked sugar - 78. Seizure, 1 min, 10:00 AM, general. Seizure, 4 min, 1:15 PM, general, later on right side of body, captured on EEG. EKG done. Medication administered to suppress seizures. Discharged from hospital Saturday evening. Neurologist diagnosed with epilepsy and now taking Trileptal 3mL 2x/day to suppress seizures.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site joint swelling, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness at injection site (thigh).  Swollen knee on same leg, diagnosed as cellulitis.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Blood test, C-reactive protein, Full blood count, Joint swelling, Nuclear magnetic resonance imaging
Clinical narrative: Pain, swelling, redness at injection site (thigh).  Swollen knee on same leg, diagnosed as cellulitis.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Pain in extremity, Red blood cell sedimentation rate, Reticulocyte count, Skin warm
Clinical narrative: Pain, swelling, redness at injection site (thigh).  Swollen knee on same leg, diagnosed as cellulitis.
Age: 2.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Leg swollen/red, painful. Motrin helped.
Age: 2.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Drug administered to patient of inappropriate age, Erythema, Local swelling, Pain in extremity
Clinical narrative: Leg swollen/red, painful. Motrin helped.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Chest pain, Dyspnoea, Eyelid oedema
Clinical narrative: Back pain, chest pain, eye lid swelling and difficulty breathing.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Chest pain, Erythema, Eye swelling, Wheezing
Clinical narrative: Back pain, chest pain, eye lid swelling and difficulty breathing.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Injection site red/swollen/hot to touch, nausea, weakness, pain. Patient was readmitted to hospital following this event; however, readmission is thought to be due to exacerbation of underlying disease.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: Injection site red/swollen/hot to touch, nausea, weakness, pain. Patient was readmitted to hospital following this event; however, readmission is thought to be due to exacerbation of underlying disease.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Antibody test, Asthenia, Erythema, Full blood count, Local swelling
Clinical narrative: Injection site red/swollen/hot to touch, nausea, weakness, pain. Patient was readmitted to hospital following this event; however, readmission is thought to be due to exacerbation of underlying disease.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Reticulocyte count, Skin warm
Clinical narrative: Injection site red/swollen/hot to touch, nausea, weakness, pain. Patient was readmitted to hospital following this event; however, readmission is thought to be due to exacerbation of underlying disease.
Age: 30.0
Sex: M
Vaccine: JEV1, RAB
Symptoms: Urticaria
Clinical narrative: Hives on legs, back, arms.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Flatulence, Irritability
Clinical narrative: At daycare-teacher said patient had been complaining about foot and stomach pain throughout the morning. Awoke from nap and was irritable, lethargic, and extremely warm to touch. Teacher called me at approximately 3:05pm and took temp while on the phone. Temp was 101.9 under arm. When I arrived at approximately 3:15pm, patient was laying on the floor, shivering with blanket on him. Could hardly get up. When we got to the car I administered (2) junior strength Tylenol to help reduce fever. Called Drs. office to bring him in. Fever at time of appt was 101.9 under arm. Dr. examined patient and said she felt it was coincidental and thought he had a virus. His stomach at the time of evaluation was extremely gassy. She advised me to continue to monitor his fever and warned he may have diarrhea from the "virus." At approximately 8:00pm all symptoms and fever were completely gone. No diarrhea noted-normal stool.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Lethargy, Pain in extremity, Skin warm
Clinical narrative: At daycare-teacher said patient had been complaining about foot and stomach pain throughout the morning. Awoke from nap and was irritable, lethargic, and extremely warm to touch. Teacher called me at approximately 3:05pm and took temp while on the phone. Temp was 101.9 under arm. When I arrived at approximately 3:15pm, patient was laying on the floor, shivering with blanket on him. Could hardly get up. When we got to the car I administered (2) junior strength Tylenol to help reduce fever. Called Drs. office to bring him in. Fever at time of appt was 101.9 under arm. Dr. examined patient and said she felt it was coincidental and thought he had a virus. His stomach at the time of evaluation was extremely gassy. She advised me to continue to monitor his fever and warned he may have diarrhea from the "virus." At approximately 8:00pm all symptoms and fever were completely gone. No diarrhea noted-normal stool.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, redness and warmth to touch that started 'a few hours after the injection'. Patient came in to the clinic 2 days later due to symptoms not better. DepoMedrol 80mg and Decadron 6mg given IM.
Age: 0.32
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Dyskinesia, Posture abnormal, Unresponsive to stimuli, Weight increased
Clinical narrative: Pt had Pediarix at 2mo, no SZ symptoms, and mother stated that after DTaP at 4mo visit, and pt developed head body twisting movement, within 20 minutes, pt's eye was opened, but not responeded to parents, no vomiting, no another episodes since then pt gaining weight well.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth from site which continued from time of the shot to the following day when she was seen. She received a Decadron 6mg IM.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: He developed pain at arm the night of shot and the next morning swelling and rash developed on right upper arm which progressed on arm only.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Dizziness, Headache, Hyperventilation, Musculoskeletal stiffness
Clinical narrative: 102 degree fever, neck stiffness, leg stiffness, headache, dizzy, abdominal pain, hyperventilation. Mother gave pt. Tylenol at time of event. Mom call our office in the morning and gave ibuprofen and brought pt in to see doctor. Pt had received TDap and Varicella in the past with no problems.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: 102 degree fever, neck stiffness, leg stiffness, headache, dizzy, abdominal pain, hyperventilation. Mother gave pt. Tylenol at time of event. Mom call our office in the morning and gave ibuprofen and brought pt in to see doctor. Pt had received TDap and Varicella in the past with no problems.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin induration
Clinical narrative: Red skin, itchiness, hardness of skin.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Induration, Pain, Skin warm
Clinical narrative: 5 cm x 3 cm induration, with surrounding skin 7 cm of erythema and warmth, body aches with temp as high as 102.3 over the last 2 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: 7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Tenderness
Clinical narrative: 7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: 7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
Age: 1.27
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: High fever (104 degrees F) for 36 hours. Leg swelling on vaccination side.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Reported by private physician that client developed hives in right arm after immunization received from Co. H.D.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 year old patient of unknown gender. On an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (route and lot number not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The nurse reported that on an unknown date, the patient received an expired second dose. No adverse symptoms reported. Nurse was unable to provided dates of administration for the first and second dose as well as the lot number and expiration date for the expired second dose of VARIVAX (Merck) in question. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Abdominal pain upper, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 58 year old male patient with uncontrolled type II diabetes, hypertriglyceridemia and anemia. Patient had no history of drug allergies. On an unspecified date "before 04-JAN-2012", the patient received a dose of PNEUMOVAX23 (lot number, route unspecified), and developed throat tightness and difficulty swallowing. Outcome of throat tightness and difficulty swallowing were not reported. On 10-JUL-2013 the patient was vaccinated with another dose of PNEUMOVAX23 (lot number H021941, Exp. 11-JUL-2014) 0.5 ml intramuscularly. Concomitant therapies included gemfibrozil, losartan potassium (manufacturer unknown), TRADJENTA, glipizide, metformin, FLUTICASONE PROPIONATE and FLOVENT. On 10-JUL-2013 the patient developed flu-like symptoms with a fever, stomach pain and stomach upset. The patient had called physician's office for medical attention. No treatment was given and the patient's wife watched him carefully at home. No lab test was performed. At the time of reporting the patient was recovering from flu-like symptoms with a fever, stomach pain and stomach upset. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report was received from a consumer on 16 July 2013. A 12-year-old male patient had received an injection of RABIES VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced Guillain-Barre Syndrome (GBS). The reporter did not have any further information regarding the event as the patient was not in their practice at the time of vaccination. Outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiration date 24-APR-2014) (dose not reported). The healthcare worker reported that the patient contact they physician's office by phone on 08-JUL-2013 to report that she was experiencing "significant" redness and blistering of her arm at the injection site, after receiving ZOSTAVAX. The healthcare worker also reported that the patient took a photograph of her arm and sent it to the physician's office. At the time of reporting, the outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 03-OCT-2012, the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 05-DEC-2012, the patient was vaccinated with dose 2, GARDASIL (lot #, expiration date and route not reported). On 07-JAN-2013, patient was vaccinated with dose 3, GARDASIL (lot #, expiration date and route not reported). No adverse effects reported. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Rash erythematous
Clinical narrative: Onset. Received varicella on 7/17/13. TB skin was read the day prior to injection negative. . Reports small bump to (Lt) arm 7-21-13. Since this 6 addition red, raised bumps have appeared measuring pea size to quarter size. C/O pain and itching to site. Appt with doctor on 7-25-13 at 900 AM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt developed within 24 hrs erythematous rash, with pruritus no tender no fever.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Teen became dizzy and diaphoretic after the shots within 5 minutes of administration. The teen stated he had not eaten today. Had teen lay down on clinic exam table and examined by FNP. VS taken  - WNL. Cool compress placed on forehead and juice/snack given. Had teen stay for 40 minutes. Stated he felt better, walked out with standby assistance.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt presented to Emergency Dept with (L) upper arm posterior swelling, redness, and firmness at the injection site consistent with a cellulitis versus a delayed hypersensitivity reaction. Amoxicillin and prednisone prescribed by ED and pt followed up with PCP.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Full body papular rash.
Age: 1.27
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever of 105.2 rectal.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Case number PHEH2013US015551, is an initial spontaneous report received from the nurse on 18 Jul 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with 0.5 ml of MENVEO (batch number: A12011, expiry date: Feb 2014) intramuscularly on 12 Jul 2013. On 14 Jul 2013, he experienced redness, swelling and hardness at vaccination site and he also experienced temperature of 100 F. He was taken to urgent care practitioner where he was diagnosed with cellulitis. He was prescribed BACTRIM. The event outcome, seriousness and causality were not reported.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Crying
Clinical narrative: Persistent unusual crying x 2 days.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child male subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 1 in the literature article. The subject had an underlying medical condition which was not specified. The subject had no exposure to swine prior to illness onset but did have contact with a caretaker 2 days before onset who reported direct contact with healthy-appearing swine over the previous several weeks. No respiratory illness was identified in any closed contacts, including the caretaker and the caretaker's family. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). On 23 July 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced fever, cough, congestion (nos), fatigue. Upper respiratory viral infection was diagnosed and released without receiving influenza antiviral medications. The subject was hospitalised subsequently due to influenza A (H3N2). At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the MATRIX (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was closed to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2V virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Viral upper respiratory tract infection
Clinical narrative: This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child male subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 1 in the literature article. The subject had an underlying medical condition which was not specified. The subject had no exposure to swine prior to illness onset but did have contact with a caretaker 2 days before onset who reported direct contact with healthy-appearing swine over the previous several weeks. No respiratory illness was identified in any closed contacts, including the caretaker and the caretaker's family. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). On 23 July 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced fever, cough, congestion (nos), fatigue. Upper respiratory viral infection was diagnosed and released without receiving influenza antiviral medications. The subject was hospitalised subsequently due to influenza A (H3N2). At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the MATRIX (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was closed to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2V virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Diarrhoea, Dyspnoea, Influenza, Influenza A virus test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 4 in the literature article. The subject had an underlying medical condition which was not specified. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). The subject attended a local agricultural fair in August 2011 and had direct contact with a pig. In August 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza A (H3N2), fever, cough, dyspnea, diarrhea and vomiting on 18 August 2011. The subject was hospitalised due to influenza A. At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the matrix (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was close to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2v virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.