chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza A virus test positive, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old male patient. No medical history, concurrent diseases and concomitant medications were reported. On 11-Jan-2013, the patient received FLUMIST. Dosing and frequency were not reported. This patient was tested positive for influenza A on 14-Jan-2013. The patient also had fever and cough. The outcome of the events of tested positive for flu A, cough and fever were unknown. The event of tested positive for flu A was considered to be non-serious by the reporter. The events of fever and cough was considered to be non-serious by the company physician.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Jan-2013. The patient experienced tested positive today for influenza A which started on 15-Jan-2013. The outcome of the event of tested positive today for influenza A is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear infection, Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST started on 23-Aug-2012. The patient experienced tested positive for flu which started on 24-Dec-2012 and ear infection. The patient recovered from the event of ear infection and tested positive for flu on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 26-Feb-2013 from Health Professional: New event of ear infection was added. Event outcome of event tested positive for flu was updated. New reporter added as other. Dose regimen of suspect drug was updated.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling face, Urticaria
Clinical narrative: A report was received from a consumer concerning a 10 years old female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 09-Jan-2013, the patient started receiving a treatment with nasal FLUMIST. On 11-Jan-2013, the patient developed hives and on an unknown date, she developed and facial swelling. Action taken of FLUMIST was unknown. FLUMIST's Lot number was AJ2159 and expiry date was 14-Jan-2013. At the time of reporting, the events of hives and facial swelling were improving. According to the reporter the report was considered to be non-serious. Follow up of insignificant information received by AstraZeneca/MedImmune on 07-Mar-2013: patient's initials, lot number and expiry date added. Reporter type as other added. Narrative was updated.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Throat irritation
Clinical narrative: A report has been received from a Health Professional concerning a 47 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 11-Jan-2013. The patient experienced GAVE EXPIRED FLUMIST which was started on 11-Jan-2013 and SCRATCHY THROAT. The outcome of the event of SCRATCHY THROAT and GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between SCRATCHY THROAT and FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 05-Mar-2013 from consumer: New event of scratchy throat was added. Corrected report 15-Mar-2013: start date of FLUMIST was added.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from consumer concerning a female patient  of unknown age. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST which started on an unknown date. The patient's mother reported that the patient experienced multiple episodes of flu. She also reported that every time someone comes in her house within 234 hours of receiving it, her daughter gets the flu. This had happened every year since she was born. At the end of 2012 her friend with FLUMIST came into their home and was only here for about 30 minutes, she was diagnosed with the flu once again in that weekend. The outcome of the reported event was unknown. The reporter considered the event  of multiple episodes of flu to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Injury
Clinical narrative: A report has been received from a physician concerning, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that physician cut herself when administering FLUMIST. At the time of reporting, the event of physician cut herself when administering FLUMIST was improving. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 15-Jan-2013 from Physician: No new information to add in this case. Coding of physician cut herself when administering FLUMIST was changed to accidental injury. Based on this investigation, no root cause can be determined. All inspection results were within specified limits. The evaluation of the return sample confirms the reported complaint. Summary of follow-up information received by AstraZeneca/MedImmune 25-Feb-2013: exp date updated, complaint report summary added.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Headache, Influenza
Clinical narrative: A spontaneous report has been received from consumer concerning 10 years old female patient. The relevant history, concurrent diseases and concomitant medication of patient were not reported. From 11-Jan-2013 the patient had been receiving nasal FLUMIST for unknown indication. The reporter stated that the patient who got FLUMIST also had a flu symptoms which started on 15-Jan-2013 symptoms were fever of 102, fatigue, abdominal pain, headache, loss of appetite, vomiting. Reporter confirmed that patient had not received an influenza test at that time. Action taken with FLUMIST was not applicable. The outcome of the event of flu symptoms was unknown. The report was considered to be non-serious by reporter. Summary of follow-up of insignificant information received by AstraZeneca/MedImmune 24-Jan-2013: Reporter's information updated. Form completed date updated.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A spontaneous report has been received from consumer concerning 10 years old female patient. The relevant history, concurrent diseases and concomitant medication of patient were not reported. From 11-Jan-2013 the patient had been receiving nasal FLUMIST for unknown indication. The reporter stated that the patient who got FLUMIST also had a flu symptoms which started on 15-Jan-2013 symptoms were fever of 102, fatigue, abdominal pain, headache, loss of appetite, vomiting. Reporter confirmed that patient had not received an influenza test at that time. Action taken with FLUMIST was not applicable. The outcome of the event of flu symptoms was unknown. The report was considered to be non-serious by reporter. Summary of follow-up of insignificant information received by AstraZeneca/MedImmune 24-Jan-2013: Reporter's information updated. Form completed date updated.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Syncope, dizziness.  Called 911, paramedics arrived.  Pt's color returned and felt better and refused paramedics service.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt fainted after flu vaccine given.  Arousable.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted briefly after given flu vaccine and TB test.  Arousable.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Ear pain, Eye discharge, Pharyngeal oedema
Clinical narrative: Throat swelled, chills, ears hurt, eyes red and pus in them; vaccine site very sore; trouble breathing.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Throat swelled, chills, ears hurt, eyes red and pus in them; vaccine site very sore; trouble breathing.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Lip swelling, Pain, Paraesthesia oral, Pruritus
Clinical narrative: Redness, swelling, itching and localized pain, upper lip swollen and tingling.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Redness, swelling, itching and localized pain, upper lip swollen and tingling.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Injection site pain, Musculoskeletal pain, Periarthritis, X-ray
Clinical narrative: Pain at site injection point didn't clear, was spreading, also noticed slight pain in shoulder. Treated with ibuprofen. Continued to worsen until diagnosed 9/20/13 with frozen shoulder. After research and finding many same type injuries, decided to report. No other injuries.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Autoimmune disorder, Back pain, Mobility decreased, Rheumatoid factor positive
Clinical narrative: Pain began in back and knees.  Slight at first, hard to get up from sitting.  Substantially worse over next two months, and gradually worse from then to present.  Misdiagnosed for about a year.  Diagnosed now as autoimmune.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Autoimmune disorder, Back pain, Dysstasia, Rheumatoid factor positive
Clinical narrative: Pain began in back and knees.  Slight at first, hard to get up from sitting.  Substantially worse over next two months, and gradually worse from then to present.  Misdiagnosed for about a year.  Diagnosed now as autoimmune.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Dizziness, Feeling hot, Flushing, Hot flush
Clinical narrative: Faint feeling, hot-flash-like symptoms... Feeling like my face was flushed, I was incredibly hot and had to take off my suit jacket and could not get cool. I felt I was burning up. This happened three times that day - ~10, ~11:30, ~4:30pm. I'm usually cold and the room temperatures were a confimred 72. I usually prefer 74.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Pyrexia, Rash macular, Urticaria
Clinical narrative: Hives on neck, chest, back, arms, abdomen, and legs. On 9/20/2013 very tired and @ 2:00 PM ran temp. or 101.2. Took Benadryl for hives and Tylenol for fever.  Feeling better on 09/21/2013 but still very blotchy and a bit fatigued.  Had both the flu and pneumo on same day, but different arms.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: SEIZURES.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Extreme soreness, swelling and redness/had to go back to hospital.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Scab, Scar, Secretion discharge
Clinical narrative: Patient experience slight swelling, redness then oozing with pain. It would scab, then fall off. It took 2 weeks to heal and scarred.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient experience slight swelling, redness then oozing with pain. It would scab, then fall off. It took 2 weeks to heal and scarred.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electroencephalogram abnormal, Hemiparesis, Ischaemic stroke
Clinical narrative: I do not know the time of the incident. But he presented to ER with left sided weakness. He was found to have had a stroke and to have LV  noncompaction cardiomyopathy.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Ventricular arrhythmia
Clinical narrative: I do not know the time of the incident. But he presented to ER with left sided weakness. He was found to have had a stroke and to have LV  noncompaction cardiomyopathy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Vaccine site: SQ where biceps, clavicle and deltoid intersect. Pt exerience shingles flare follwing administration. Flare inititated locally at injection site and followed length of right arm.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Migraine, Nausea
Clinical narrative: Migraine headache, nausea.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site warmth
Clinical narrative: Bruised elbow area of vaccinated arm hot to touch, doctor consulted, pt told to monitor area at home, bruise result of blood under the skin from vaccine per MD.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Symptoms: Abdominal pain, fever, runny nose, malaise. Treatment: Tylenol and Ibuprofen.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Palpitations
Clinical narrative: Pt c/o severe pain, swelling and redness at injection site c/o fevers (102), sweats and racing heart. Sent to ER for evaluation.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Pt c/o severe pain, swelling and redness at injection site c/o fevers (102), sweats and racing heart. Sent to ER for evaluation.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt got shot on 8/28/13 in the morning, starting afternoon pt felt hot around area of shot (underneath the area) no fever, the area also swollen, pt put alcohol on it. When came on 8/30/13 11:45 am. Observe the area red but not hard swollenness is better. Pt inform also on new med warfarin. Check couple days later. Pt is ok. Swollen is gone.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: One day after receiving a PNEUMOVAX. The patient a red patch on skin that was about 4 inches away from the injection site. The red patch was 2 inches by about 4 inches. The red area was very warm to the touch. The patient went to the Dr. and was diagnosed w/ a cellulitis and put on KEFLEX.
Age: 56.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Lymphadenopathy, Nasal congestion, Pyrexia
Clinical narrative: After 2-3 days, suffered fever, swollen glands, cough, nasal congestion. After a day or 2, beginning to feel better. Received flu shot alone before with no issue.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Mucosal inflammation, Oral herpes, Rash
Clinical narrative: Cold sores outside of lips and inside my nose rash on my chest and back, rapid heart beat felt like I was going to faint, this happened within 24 hrs of vaccine.
Age: 56.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Dizziness, Hyperhidrosis, Muscle contracture
Clinical narrative: Pt left came back in < 5 mins. feeling faint, sweating, laid down and began having multiple back and abdominal contractions that lasted a total of 15-20 mins. Pt (MD) refused trip to the hospital and left after being checked out by EMTs.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed typical injection site pain the day of injection. The following day patient reports pain, redness, swelling and hot. Patient presented to pharmacy on 9/20/13 at which time the redness and swelling was 6" x 6" in size. Pt advised to seek medical care but does not want to go an urgent care or ED (over the weekend). Pt states redness has decreased in size today (9/21).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain
Clinical narrative: Patient received vaccine on 9/19/13, called 9/20/13 said her body was sore and she wouldn't do any thing. She took ADVIL and 9/21/13 said feel better.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelled across several inches, was bright red, painful and itching like a "bad bee sting".
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rash papular, Skin warm
Clinical narrative: Pt experienced raised rash from upper arm that covered about 8" round area. It was hot. She had a low grade fever and severe body ache for 24-48 hrs.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema
Clinical narrative: Redness along back side of right arm.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 18-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as H014561 and 21-MAR-2014 respectively, dose and route unspecified) which was not supported by stability data. It was exposed to five cycles of a low temperature range from 32 degrees Fahrenheit (F) to 34 degrees Fahrenheit (F) for a total time of 96 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Somnolence
Clinical narrative: This spontaneous report was received from a 26-year-old male pharmacy technician (also reported as healthcare worker and is also the patient) via a company representative. The patient had no pertinent medical history and drug reactions/allergies. On 15-AUG-2013 the patient was vaccinated with a dose 1, 0.5 milliliters (ml) GARDASIL (lot#, expiration date not reported) intramuscularly (reported 'route as directed'). Approximately on 17-AUG-2013 (reported as 2 days after receiving the vaccine) the patient became very sleepy and tired. The events resolved on an unspecified date in 2013. Treatment was not rendered for the events. No laboratory diagnostic studies were performed for the events. Medical attention was not sought by the patient. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Maternal exposure before pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a licensed practical nurse refers to a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date in September 2012 the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). Subsequently the patient became pregnant with Last Menstrual Period (LMP) of 14-OCT-2012 and Estimated Delivery Date (EDD) of 21-JUL-2013. ON 21-JUL-13 the patient delivered an infant in a hospital. There were not problems with the baby. The patient received the dose of GARDASIL at a different office and had care during the pregnancy at a different office. The patient started with this office after the delivery of the baby. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 02-AUG-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as H014561 and 21-MAR-2014 respectively, dose and route unspecified) which was not supported by stability data. It was exposed to five cycles of a low temperature range from 32 degrees Fahrenheit (F) to 34 degrees Fahrenheit (F) for a total time of 96 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On an unknown date in 2007, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). On an unknown date in 2009, the patient was vaccinated with dose 2 of VARVIAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as now), the patient developed shingles. The patient was seen in an urgent care facility on an unknown date but was not admitted to hospital. The patient was treated with mometasone furoate and acyclovir. The outcome of shingles was unknown. The relatedness for shingles was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unknown dates, unspecified number of patients were vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) that was exposed to 49 degrees Fahrenheit (F) for 31 days, which was an unsupported excursion based on in-house stability data. No concomitant therapy was reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unknown dates, unspecified number of patients were vaccinated with doses of M-M-R II (lot number, expiry date, dose and route unspecified) that were exposed to 49 degrees Fahrenheit (F) for 31 days, which was an unsupported excursion based on in-house stability data. No concomitant therapy was reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Skin mass, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a consumer, the patient's mother, refers to her 3 year old son. The patient's medical history was unknown. He did not have any drug allergies. On 26-JUL-2013, the patient was vaccinated with M-M-R II lot # J002502, administered subcutaneously. He did not receive any concomitant medications. On an unknown date, after receiving the M-M-R II, the patient developed a lump on the chest. The patient saw the physician due to the event. He did not receive any treatment, and no lab or diagnostic studies were performed. The outcome of lump on the chest was reported as recovering/resolving. A causality assessment between M-M-R II and the lump on the chest was not provided.  Additional information has been requested. This case has been cross referenced with case 1309USA00455, regarding the same same patient (and same reporter).
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Erythema, Mass, Pain
Clinical narrative: This spontaneous report as received from a consumer, the patient's mother, refers to her 3 year old son. The patient's medical history was unknown. He did not have any drug allergies. On 26-JUL-2013, the patient was vaccinated with M-M-R II lot # J002502, administered subcutaneously. He did not receive any concomitant medications. On an unknown date, after receiving the M-M-R II, the patient developed a lump on the chest. The patient saw the physician due to the event. He did not receive any treatment, and no lab or diagnostic studies were performed. The outcome of lump on the chest was reported as recovering/resolving. A causality assessment between M-M-R II and the lump on the chest was not provided.  Additional information has been requested. This case has been cross referenced with case 1309USA00455, regarding the same same patient (and same reporter).
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL, MMR
Symptoms: Mass
Clinical narrative: This spontaneous report as received from a consumer, the patient's mother, refers to her 3 year old son. The patient's medical history was unknown. He did not have any drug allergies. On 26-JUL-2013, the patient was vaccinated with M-M-R II lot # J002502, administered subcutaneously. He did not receive any concomitant medications. On an unknown date, after receiving the M-M-R II, the patient developed a lump on the chest. The patient saw the physician due to the event. He did not receive any treatment, and no lab or diagnostic studies were performed. The outcome of lump on the chest was reported as recovering/resolving. A causality assessment between M-M-R II and the lump on the chest was not provided.  Additional information has been requested. This case has been cross referenced with case 1309USA00455, regarding the same same patient (and same reporter).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Pain, Pain in extremity
Clinical narrative: SOB - 3-4 hr after, sore arm, little achy, increase in BP, 6 hr after administration, went to ER because of SOB.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest X-ray, Chills, Electrocardiogram, Ocular hyperaemia
Clinical narrative: Red eyes then 1 hr later chills, shaky, vomit.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Red eyes then 1 hr later chills, shaky, vomit.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray abnormal, Chills, Hypotension, Lung infiltration, Nausea
Clinical narrative: Red eyes then 1 hr later chills, shaky, vomit.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Vomiting
Clinical narrative: Red eyes then 1 hr later chills, shaky, vomit.
Age: 25.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Back pain, Chest pain, Cold sweat, Headache, Mobility decreased
Clinical narrative: Loss of mobility in arm followed by aches in chest, back, arms, hands, and head. Also, sharp pains in back of head area and cold sweats. Arm still has minimal mobility and headache persists but other symptoms have subsided.
Age: 25.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Pain in extremity
Clinical narrative: Loss of mobility in arm followed by aches in chest, back, arms, hands, and head. Also, sharp pains in back of head area and cold sweats. Arm still has minimal mobility and headache persists but other symptoms have subsided.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient was having difficulty breathing approximately 3 hours after vaccination.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Anger, Crying, Head injury, Headache, Loss of consciousness
Clinical narrative: Patient received Menactra (does #2) and Gardasil (dose #1) as part of well exam.  Within a few minutes of nurse leaving the room, patient fainted; regained consciousness right away and came out of the exam room crying. Patient may have hit head and complained of headache, but no obvious injuries on exam.  Later in the day, patient seemed upset and mother took her to the ER.  No studies were done in ER as patient was noted to be fine on exam.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient received Menactra (does #2) and Gardasil (dose #1) as part of well exam.  Within a few minutes of nurse leaving the room, patient fainted; regained consciousness right away and came out of the exam room crying. Patient may have hit head and complained of headache, but no obvious injuries on exam.  Later in the day, patient seemed upset and mother took her to the ER.  No studies were done in ER as patient was noted to be fine on exam.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Hypersensitivity, Injection site erythema
Clinical narrative: Raised, red bump on site of injection.  Later in the day, I had extreme body aches, my body temperature was not staying consistent (severe chills and sweating bullets), and no motor function in my arm.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Pain
Clinical narrative: Raised, red bump on site of injection.  Later in the day, I had extreme body aches, my body temperature was not staying consistent (severe chills and sweating bullets), and no motor function in my arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient claims when she woke up the next day, she had broke out on her arms/shoulder around the injection site and a spot below her left eye.  Over the next 2 days, the rash lessened and then went away.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Dermatitis, Inflammation, Pyrexia, Rash generalised, Skin warm
Clinical narrative: Fever 102, administrator Tylenol, recurring fevers throughput the day and night. Following morning, fever and rash on face and body. Administered Tylenol as needed. Fever broke during the night. On 9/22, no fever, rash has worsen. Skin is hot to touch and inflamed.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: On Friday 09/20/2013 I began experiencing dizzy episode while moving head lying in a prone position. Several time Friday Sat and Sunday. On Sunday I experienced a dizzy spell while driving and feel that I am putting myself at risk as well as others and don't think I should drive.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Myalgia, Sleep disorder
Clinical narrative: Muscle pain in arm going down to elbow. As days go on it gets worse. No pain reliever is helping. No redness or rash. Just extreme pain in muscle. It's very hard to sleep on this arm. I also had a tetanus shot in the right arm at the same time. It's not hurting nearly as bad. I called County Health Dept. they haven't had any reactions like this, also called nurse hotline. This was the Quadrivalent shot. It didn't hurt when she gave it to me. What can I do?
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lip swelling, Pain, Pain in extremity
Clinical narrative: Swelling of lower lip on left side, cough, body aches, sore left arm (vaccinated in left arm).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching & hives on legs.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Erythema, Pruritus, Rash generalised, Rhinorrhoea
Clinical narrative: Rash all over his body, elevated bumps with red borders, itchy, he couldn't stop scratching. Runny nose. Cough. Doctor said he had hives due to the vaccine.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Rash all over his body, elevated bumps with red borders, itchy, he couldn't stop scratching. Runny nose. Cough. Doctor said he had hives due to the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Area where shot administered had bright red, itchy rash about 3 inches long and 2 inches wide.  Also sore and tender to touch.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Intially employee complained at itching on arm given at 10 am. By 11 am she had small pin point bumps/hives both arms and was scratching her all upper body as she complained of increase in itching.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Abasia, Aphasia, Asthenia, Computerised tomogram head, Dyskinesia
Clinical narrative: Lost control of her arms and legs, stumbling, couldn't walk, arms jerking, legs jerking.  She was able to talk and was scared because she couldn't make her arms and legs stop moving.  After two weeks she still seems a bit weaker than before.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Fear, Gait disturbance, Laboratory test, Loss of control of legs, Nuclear magnetic resonance imaging brain
Clinical narrative: Lost control of her arms and legs, stumbling, couldn't walk, arms jerking, legs jerking.  She was able to talk and was scared because she couldn't make her arms and legs stop moving.  After two weeks she still seems a bit weaker than before.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Balance disorder, Chorea, Computerised tomogram head normal, Condition aggravated, Dyskinesia
Clinical narrative: Lost control of her arms and legs, stumbling, couldn't walk, arms jerking, legs jerking.  She was able to talk and was scared because she couldn't make her arms and legs stop moving.  After two weeks she still seems a bit weaker than before.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Dysstasia, Gait disturbance, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: Lost control of her arms and legs, stumbling, couldn't walk, arms jerking, legs jerking.  She was able to talk and was scared because she couldn't make her arms and legs stop moving.  After two weeks she still seems a bit weaker than before.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness, painful, warm to touch. Symptoms increasing since administration.
Age: 87.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient complains of itchy rash on both arms. She has been prescribed triamcinolone by her primary physician.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had itching and swelling and the area was bright purple red next day and it was warm to touch per patient description but it faded away so when pt was at the pharmacy on 9/20/13 the injection area was slightly red (or pink) and not any visible swelling.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Inflammation, Injection site warmth, Pain in extremity
Clinical narrative: On Friday patient felt fever, pain in left arm, inflammation in left arm, redness in left arm, area felt hot (site of injection). Also felt shivering. Called Sunday Sept 22 to report.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: On Friday patient felt fever, pain in left arm, inflammation in left arm, redness in left arm, area felt hot (site of injection). Also felt shivering. Called Sunday Sept 22 to report.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt was administered the vaccine and developed a red bulls eye at inj site the pt was counseled to take BENADRYL. The pt contacted the pharmacy on 9/21/13 and reported a hard ball at the site the pt is going to f/u w/her PCP.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, tenderness, lumpiness, warmth at injection site continuing after 3 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Chills, Fatigue, Pain of skin, Skin exfoliation
Clinical narrative: Patient said 24 hrs after vaccine administration she came down with chills, low temp, skin hurt to touch all over and fatigue. As of approximately 130 pm Sun. 9-22-13 feels better, just tired.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus
Clinical narrative: Around 4 or 5 in the pm patient started to have itching at site. Apply hydrocortisone cream to area then noticed swelling around 6 pm upon awakening swelling had spread down to wrist. Patient went to urgent care was told maybe infected or perhaps reaction.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Noticed rash on 9/16 on upper part of arm that she received flu shot-no itching just redness.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information has been received from a 40 year old female, for GARDASIL, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history and no drug allergies. The patient became pregnant on an unknown date. The LMP and EDD was not known. On 19-AUG-2013 the patient was vaccinated with her first dose of GARDASIL injection, dose and frequency unspecified. No concomitant medication reported. The patient did not know she was pregnant when she was receiving the GARDASIL. On 23-AUG-2013, the patient experienced miscarriage. The patient saw the doctor for medical attention. No treatment was given for the event. No lab diagnostics studies performed. Upon internal review, miscarriage was considered to be medically significant event. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient received shot around 12:40pm on 9/21/13. She returned home. Approximately 2:30-3pm she began feeling short of breath. She says it was not severe but did last approximately 3 hours. She says she now has no symptoms or difficulty and feels fine as of 12:30pm today (9/22/13). She exhibits no symptoms of illness or even soreness at injection site. No other symptoms were present.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date (reported as "years ago"), the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose frequency and route not reported) that had been improperly stored "in another practice". The ZOSTAVAX that was administered had been exposed to warmer than 77 Fahrenheit temperature (F) during transport from the pharmacy to an unspecified physician's practice. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 67 year old female patient with asthma and BENADRYL allergy. On 17-SEP-2013, the patient was vaccinated with dose 2 of, 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date were reported as H018380 and 12-MAR-2014 respectively), intramuscularly in an unspecified arm. Concomitant therapy included FLUVIRIN administered on 17-SEP-2013 in an unspecified arm. The patient thinks she previously (approximately on an unknown date in September 2009), received a dose of (dose 1) of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). On 17-SEP-2013, the patient developed a rash at the injection site and soreness at the injection site. The patient sought medical attention (called pharmacist). She was treated with aspirin to treat the soreness. It was unspecified if any lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from the patient's cousin refers to the female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration, dose and route unspecified). On an unknown date the patient broke out in a red rash at the injection site. The event outcome was unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with ZOSTAVAX (Lot number J001002, and expiration date 25-APR-2014, dose not reported). On 05-SEP-2013, the patient called the pharmacist and stated she had developed a rash at injection site. On 06-SEP-2013, the pharmacist learned from the patient that the rash had resolved. The pharmacist stated that no treatment information was discussed with the patient. This is one of the reports from the same reporter (the other report: MARRS# 1309USA003814). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with ZOSTAVAX (Lot number J001002, and expiration date 25-APR-2014, dose not reported). On 05-SEP-2013, the patient called the pharmacist and stated she had developed a rash at injection site. On 06-SEP-2013, the pharmacist learned from the patient that the rash had resolved. The pharmacist stated that no treatment information was discussed with the patient. This is one of the reports from the same reporter (the other report: MARRS# 1309USA003814). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. On 04-SEP-2013, the patient was vaccinated with ZOSTAVAX (Lot number J001002, and expiration date 25-APR-2014, dose not reported). On 05-SEP-2013, the patient called the pharmacist and stated she had developed a rash at injection site. On 06-SEP-2013, the pharmacist learned from the patient that the rash had resolved. The pharmacist stated that no treatment information was discussed with the patient. This is one of the reports from the same reporter (the other report: MARRS# 1309USA003814). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist  refers to a 64 year old female patient with diabetes and no drug reactions/allergies. On 10-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#J002865, expiration date 07-JUN-2014, dose not reported, subcutaneously) in the right arm. Concomitant therapies included lisinopril (Manufacturer unknown), furosemide (manufacturer unknown), citalopram and metformin. There were no drug reactions/allergies. In September 2013 the patient developed an injection site reaction, had a 1.5 inch to 2 inch long raised red area at the injection site. There was no treatment given for the event. The patient sought medical attention via contacted pharmacist. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Body aches, low grade fever and runny nose.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Myalgia, Pyrexia, Rash
Clinical narrative: Fevers continuing for 6 days along with headaches, chills, sweats, body aches and cellulitis left arm. Fevers spiking to 102.5 a couple times a day.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Fevers continuing for 6 days along with headaches, chills, sweats, body aches and cellulitis left arm. Fevers spiking to 102.5 a couple times a day.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fevers continuing for 6 days along with headaches, chills, sweats, body aches and cellulitis left arm. Fevers spiking to 102.5 a couple times a day.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Local swelling, Pain in extremity, Tenderness
Clinical narrative: 9-16-13 Mom called to state took pt to ER 9-15-13 and family doctor on 9-16-13 for lt arm being swollen tender and painful and swelling going up arm. Pt went to see DR per mom DX with cellulitis given 3 medicines (steroids, antibiotics, mom not sure what third medicine was).
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received PNE vaccine and Flu vaccine in (R) arm on Friday 9/20/13. Sat. night area around injection site became red. By Sunday, a large area around injection site on upper arm red, swollen and warm. Monday morning she came to the HD to be evaluated. Instructed to place cold rag on area, take TYLENOL and BENADRYL and report back if the area becomes worse.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Blood test normal, Computerised tomogram normal, Diarrhoea
Clinical narrative: This case was forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 12-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of VIVOTIF (batch number 3000421, expiry date not reported). First dose of VIVOTIF was taken on an unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported that the patient had a normal physical examination with normal routine chemistries and Complete Blood Count (CBC) before vaccination. Concomitant medication was not provided. On 26-Aug-2013, the patient experience diarrhea. On 27-Aug-2013, he took the second dose and he experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After the intake of the third capsule of VIVOTIF, on 29-Aug-2013, the patient reported the recurrence of intense abdominal pain and diarrhea. Tests and examinations performed showed negative / normal abdominal CT and MRI, and normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment was taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the reporter physician, at the time of the report, the patient is still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: This case was forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 12-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of VIVOTIF (batch number 3000421, expiry date not reported). First dose of VIVOTIF was taken on an unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported that the patient had a normal physical examination with normal routine chemistries and Complete Blood Count (CBC) before vaccination. Concomitant medication was not provided. On 26-Aug-2013, the patient experience diarrhea. On 27-Aug-2013, he took the second dose and he experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After the intake of the third capsule of VIVOTIF, on 29-Aug-2013, the patient reported the recurrence of intense abdominal pain and diarrhea. Tests and examinations performed showed negative / normal abdominal CT and MRI, and normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment was taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the reporter physician, at the time of the report, the patient is still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided.