chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Maternal exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a physician refers to a 18 year old female patient. The patient has no pertinent medical history or drug reactions/allergies. On 30-AUG-2012, the patient was vaccinated with GARDASIL, lot number reported as (0420AE), expiration date 01-DEC-2014. Concomitant medications included: ADACEL which was administered on 30-AUG-2012 to a separate site. On an unknown date in September 2012, the patient was found to be pregnant with nausea. The last menstrual period (LMP) was on 06-AUG-2012 and an estimated date of delivery (EDD) of 13-MAY-13. The patient was exposed to GARDASIL during first trimester. On 30-AUG-2012, pregnancy test was performed (prior to GARDASIL vaccination) which was negative. On 05-SEP-2012, pregnancy test was performed which showed positive result. The reporter was not sure when the patient started to experience nausea. Treatment rendered for the events included over the counter vitamin B6 and an unspecified prenatal vitamin. The outcome of the events were reported as not recovered at the time of this report. The patient sought medical attention (office contact). Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: This spontaneous report as received from a 45 years old female patient with no pertinent medical history or drug reaction and allergies refers to herself. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) in December 2011. Other suspect therapies included ZOSTAVAX (lot number not reported) vaccinated simultaneously. Concomitant medications included: lovastatin (manufacturer unknown). In December 2011, immediately after vaccination, the patient experienced flu-like symptoms. The patient was given TYLENOL for treatment. No lab diagnostics studies performed. On therapy of TYLENOL, the patient's flu-like symptoms recovered approximately 1 week later. The patient did not sought medical attention. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Local swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of age 81 years with allergy to prednisone. The medical history included sinus problems. The patient was vaccinated with, 0.65 ml ZOSTAVAX on APR-2012 given subcutaneously. No other co-suspects were reported. Concomitant medications included unspecified blood pressure medication, SYNTHROID and CRESTOR. On an unknown date in 2012, two weeks after vaccination the patient experienced bulges on hips and thighs. No treatment was given for the patient. The laboratory diagnostics procedure included blood work with results not provided. She sought medical attention and had a follow up visit. She talked to her doctor about it and he told her it was nothing to worry about. She reported that it did not cause her pain. The outcome of bulges on hips and thighs was not recovered. The relatedness for bulges on hips and thighs is unknown for ZOSTAVAX. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old male patient. In early July of 2012 the patient developed undiagnosed shingles and was treated with ibuprofen but symptoms did not resolved. On 13-AUG-2012 the patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot# reported as 0168AE, expired on 06-MAY-2013). At the time of vaccination patient's active case of shingles was not known. There were no co-suspects or concomitant medications reported. The patient was experiencing burning around the injection site and still had circular red spots on his chest from previous noted shingles in early July of 2012. The patient contacted pharmacist for medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to 3 patients of unknown age. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On unknown dates, the patients developed what was described as shingles outbreak localized to the injection site after receiving ZOSTAVAX. No treatment information was reported. The outcome of shingles outbreak localized to the injection site after receiving ZOSTAVAX was unknown. The relatedness for shingles outbreak localized to the injection site after receiving ZOSTAVAX was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a female Certified Medical Assistant of unknown age reporting on herself. The reporter stated that on 04-OCT-2012, while reconstituting a vial of VARIVAX (Merck), the contents of vials sprayed out around the needle insertion site and some of the product covered her hand. No adverse effect reported. Product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot# and dose not reported) on 01-OCT-2012. While on ZOSTAVAX the patient experienced shingles (date not reported). The patient sought for unknown medical attention. The outcome of shingles was unknown. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 56 years old female patient. The patient's medical history included brain tumor (in 1984). The patient was vaccinated by her physician with ZOSTAVAX on 27-AUG-2012. Information regarding dose, frequency, or route was not provided. No other co-suspects were reported. Concomitant medications included PROVIGIL, VIIBRYD, NEXIUM, hydrocodone and PLAVIX. On 30-SEP-2012, 35 days after onset of therapy, the patient experienced sore throat, fever, and then broke out on her bottom with a rash, and was then diagnosed with shingles by her gynecologist. The patient received treatment with acyclovir. A blood test was performed (result not provided). The patient was not hospitalized. The event did not improve and the outcome for shingles was reported as not recovered/not resolved. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Balance disorder, Dysmorphism, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 76 years old male patient with scleroderma. The patient had no known drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX on 09-OCT-2012. The patient used no concomitant medications. The morning of 10-OCT-2012 the patient woke up and noticed that his mouth was twisted and balance was off. He found it very difficult to eat and talk. He went to the doctor's office on 11-OCT-2012 where the doctor diagnosed the patient with a condition of Bell palsy. The doctor prescribed the patient prednisone 10 mg which he should take twice a day. The outcome of Bell palsy was unknown. The relatedness per reporter for Bell palsy is unknown for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 76 years old male patient with scleroderma. The patient had no known drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX on 09-OCT-2012. The patient used no concomitant medications. The morning of 10-OCT-2012 the patient woke up and noticed that his mouth was twisted and balance was off. He found it very difficult to eat and talk. He went to the doctor's office on 11-OCT-2012 where the doctor diagnosed the patient with a condition of Bell palsy. The doctor prescribed the patient prednisone 10 mg which he should take twice a day. The outcome of Bell palsy was unknown. The relatedness per reporter for Bell palsy is unknown for ZOSTAVAX. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Blister, Injection site vesicles, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Blisters appeared all over body, with huge ones on the arms, especially at site of vaccine administration. The blisters resembled insect bites and after 3 physicians, the dermatologist tested a fluid sample which confirmed Varicella.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder, limited movement, possible nerve damage.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Itchy rash with raised bumps on right and left side of upper abdominal area. No treatment received.  Tried to avoid scratching.  Rash still itchy 3 days later.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Localised oedema, Oedema peripheral, Pruritus
Clinical narrative: Patient presented on 10/21/12 complaining of swelling in right hand, itching and swelling on right forearm, and itching, swelling and redness of the left torso area in the shape of a line.  Patient had no other systemic symptoms.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Fatigue, Palpitations
Clinical narrative: CHEST PRESSURE AND PALPITATIONS, EXTREME FATIGUE X 2 DAYS.  PALPITATIONS ON AND OFF FOR ONE WEEK.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: High dose influenza vaccine was administered to the upper right arm muscle.  Arm was immediately sore and has gotten progressively more painful.  Pain was treated with Tylenol Extra Strength Precise Pain Relieving Cream.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Rash, Hives, swollen lip.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Myalgia
Clinical narrative: 6:00PM - 10:00PM MUSCLE SORENESS, FATIGUE, CHILLS, HEADACHE. 10:00PM - 3:00AM SORENESS, FEVER, HEADACHE, AND INCREASED HEART RATE. 3:00AM - 11:00AM SORENESS, HEADACHE, FATIGUE.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: 6:00PM - 10:00PM MUSCLE SORENESS, FATIGUE, CHILLS, HEADACHE. 10:00PM - 3:00AM SORENESS, FEVER, HEADACHE, AND INCREASED HEART RATE. 3:00AM - 11:00AM SORENESS, HEADACHE, FATIGUE.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Tremor, Vomiting
Clinical narrative: Shaking chills, vomiting, muscular aching (legs, arms).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Throat irritation, Urticaria
Clinical narrative: Approximately 5 minutes after vaccination Pt stated that her throat felt "weird" and requested a drink of water, I immediately called 911 and explained to her that she could not have anything to drink. She was awake and oriented. She had some labored breathing while speaking but did not complain of shortness of breath. The Paramedics arrived around 3:55pm, administered Benadryl IM, at this point she started having hives. She was taken to the ER. At ER she was seen and as per RN she is stable, vital are normal, alert, awake and oriented.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Pain, Vomiting projectile, Wheezing
Clinical narrative: Achy, wheezy, projectile vomiting, water like stools. Feel very 'sick'. Two days later still the same.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site induration, Injection site swelling, Swelling
Clinical narrative: PATIENT DESCRIBES INJECTION SITE WAS HARD AND SWOLLEN.  SWELLING SPREAD TO UNDER THE ARMS.  PATIENT ALSO STATED WAS HARD TO BREATHE.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea
Clinical narrative: Difficulty breathing, hoarseness.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus generalised, Rash erythematous, Rash pustular
Clinical narrative: Acute, sporadic; comes and goes. Itchiness, red bumps accompanied by small pustules. Calamine may help but have only monitored. Will report to pharmacist.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injection site nerve damage, Joint stiffness, Musculoskeletal pain
Clinical narrative: Evening of injection, patient complains of constant upper L shoulder pain at injection site.  When he wakes up in the morning he had tightening of L elbow that sometimes experiences numbness.  The pain, still to this day is a constant sharp pain.  Pt believes that injection was given too high at the site and may have hit a nerve.  Wife has is expecting (EDD 11/02/12), pt is concerned that he is unable to carry newborn due to constant numbness and pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid antibodies positive, Contusion, Gingival bleeding, Haematoma, Hypothyroidism
Clinical narrative: Very large bruise with large hematoma center on right thigh, petechiae starting on feet but spread up legs and trunk, bleeding gums, easy bruising all over body - ITP. Also was left with hypothyroidism problems and Lupus antibodies.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Increased tendency to bruise, Petechiae, Platelet count decreased, Thyroid function test abnormal
Clinical narrative: Very large bruise with large hematoma center on right thigh, petechiae starting on feet but spread up legs and trunk, bleeding gums, easy bruising all over body - ITP. Also was left with hypothyroidism problems and Lupus antibodies.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Blood test, Catheterisation cardiac normal, Chest X-ray, Chest pain
Clinical narrative: Chest pain on inhalation of breath and shortness of breath, along with neck pain. Went to ER and was treated as either heart attack or embolism. Ruled out embolism but EKG showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Meanwhile blood pressure remained unstable overnight but an echo cardiogram came back normal.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Myocardial infarction
Clinical narrative: Chest pain on inhalation of breath and shortness of breath, along with neck pain. Went to ER and was treated as either heart attack or embolism. Ruled out embolism but EKG showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Meanwhile blood pressure remained unstable overnight but an echo cardiogram came back normal.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Painful respiration
Clinical narrative: Chest pain on inhalation of breath and shortness of breath, along with neck pain. Went to ER and was treated as either heart attack or embolism. Ruled out embolism but EKG showed some minor abnormality and was transferred by ambulance to another hospital for heart catheterization. No blockage was found. Meanwhile blood pressure remained unstable overnight but an echo cardiogram came back normal.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Meningitis
Clinical narrative: This spontaneous report as received from a consumer refers to her son who was a 13 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with PNEUMOVAX 23 (Lot# reported as U4262AC, dose and route unspecified) on 18-JUL-2012. There was no concomitant therapy. On 07-SEP-2012 the patient was then hospitalized and later diagnosed with meningitis. The patient had sought medical attention and antibiotics was given for the event. At the time of reporting the outcome of meningitis was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Hypogeusia, Hypotonia
Clinical narrative: Approx 3-4 hrs. after vaccine, pt. noticed a pronounced metallic taste in mouth with diminished taste. Pt also reports lack of muscle tone/control on right side of face (eye and mouth) as of this morning. Symptoms not improving or worsening.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site scab, Injection site warmth
Clinical narrative: Patient had redness around the site for 7 days, was scabbed & warm to the touch.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt (patient) is complaining of right arm soreness. Pt is feeling better and there is no restrictions of movement.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt noticed red swelling 2 days after shot. No other symptoms. Pt's husband noticed the swelling on pt's arm. Could have been there same day of shot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: Pt noticed 1 to 2 days after getting HD flu vaccine - he had the sensation you feel after eating hot peppers - on his lips to tip of tongue. Lips feel as though better but not gone.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Appx 6 hrs after pneumonia injection (R deltoid) patient noticed pain and erythema around site. Next morning had considerable erythema, pain, warmth on entire upper arm. Rash is slowly traveling upward toward neck. Pt also shows some redness on eyes. Pt incorrectly marked that she had not yet received PNEUMOVAX, but received previous dose 10/25/10.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ocular hyperaemia
Clinical narrative: Appx 6 hrs after pneumonia injection (R deltoid) patient noticed pain and erythema around site. Next morning had considerable erythema, pain, warmth on entire upper arm. Rash is slowly traveling upward toward neck. Pt also shows some redness on eyes. Pt incorrectly marked that she had not yet received PNEUMOVAX, but received previous dose 10/25/10.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain in extremity, Skin warm, Swelling
Clinical narrative: Left arm - pain in left arm all the way down to elbow. Muscles hurt, raised, red patches. Warm to the touch. Wheezing started yesterday afternoon.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Left arm - pain in left arm all the way down to elbow. Muscles hurt, raised, red patches. Warm to the touch. Wheezing started yesterday afternoon.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated redness, swelling, and itching at the site of injection site on Wed 17 Oct 2012 after she got injected.
Age: 0.52
Sex: U
Vaccine: DTAP, FLU3, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: High fever of 104.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none medical history. The patient was vaccinated with lot # (671416/1241AA, exp 12-MAR-2013) PNEUMOVAX 23 (no record of a previous PNEUMOVAX 23 vaccination) on 04-OCT-2012. The pharmacist reported that the patient developed an injection site reaction following vaccination. The injection site reaction was described as a swollen, red and warm to the touch area at the site of the PNEUMOVAX 23 vaccination, which developed the morning of 05-OCT-2012. The patient contacted the pharmacist for medical attention. The patient was given BENADRYL and ibuprofen for the adverse events treatment. The outcome of injection site swollen, injection site warm and injection site red were reported as not recovered/not resolved. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 82 years old male patient with pertinent medical history of hypertension, kidney damage, diabetes, sleep apnea and stroke and with no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (Lot# reported as H014366, exp date: 06-NOV-2013, subcutaneously, dose unspecified) on 12-OCT-2012. Concomitant medications included potassium, hydralazine, metformin, PROCARDIA, MICARDIS, LASIX, PROSCAR, FLORASTOR, QUESTRAN and UROXATRAL. On 13-OCT-2012 the patient developed the shingles. The patient had sought unspecified medical attention. No lab diagnostics studies were performed. Treatment of acyclovir and DOMEBORO solution were given for the event. The outcome of shingles was reported as not recovered/not resolved. VZVID packet faxed. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: This spontaneous report as received from a 68 years old female patient concerning herself with no medical history and no drug allergies. The patient was vaccinated with ZOSTAVAX (subcutaneous, lot# was unknown) on 03-OCT-2012. Concomitant medications included: vitamins (unspecified). On 03-OCT-2012 the patient had an inflamed area on her left arm at the injection site. She had itching, and it was swollen, she also had a pinching feeling. The patient said the area had white welt type bumps, which her pharmacist advised he had not seen. The patient sought medical attention and hydrocortisone was given for the treatment of the adverse events on 09-OCT-2012. No lab diagnostics studies performed. The outcome of the adverse events was unknown at the time of the report. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient. The patient had no pertinent medical history and drug reactions. The patient was vaccinated with ZOSTAVAX (lot number reported as H013017, expiration date 09-OCT-2013) subcutaneously on 11-OCT-2012. No other co-suspects were reported. There were no concomitant medications. On 12-OCT-2012 the patient experienced "a red rash one to one-and-a-half inches in diameter around the injection site which was also warm and had some hardness associated with it". No treatment was given for adverse event. No laboratory diagnostics studies were performed. The outcome of adverse event was reported as not recovered. The patient stopped into the pharmacy for seek medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 patients of unknown age. The 3 patients were vaccinated with PNEUMOVAX 23 (lot number reported as H010661, expiration date 02-FEB-2014) intramuscularly. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the 3 patients developed a fever, redness, and swelling around the injection site as well as "around the arm" after receiving PNEUMOVAX 23. TYLENOL, dexamethasone, cold compresses were given for adverse event as treatment. The outcome of adverse events was reported as recovering/resolving. No laboratory diagnostics studies were performed. The 3 patients had sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number not specified). Route was not reported. No other co-suspects were reported. NO concomitant medications were reported. On an unknown date the patient experienced pain and weakness in her vaccinated arm. The patient also had a thickened area in the deltoid region of her arm, with a 2 inch circumference. The patient sought medical attention by visiting the office. No treatment information was reported. At the time of report the patient had not recovered. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 months old patient (gender not reported). On 10-SEP-2012 or 11-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported) due to human error. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated at right arm with 0.5 ml of PNEUMOVAX 23 (Lot# reported as H009826 Exp date 11-FEB-2014) on 15-OCT-2012. Concomitant medications included FLUVIRIN, simvastatin (manufacturer unknown), metformin, JANUVIA and low dose aspirin. Subsequently the patient developed swelling and blotchy redness on her right arm from the injection site and down to her wrist in October 2012 after receiving PNEUMOVAX23. The patient has sought medical attention via coming back to the pharmacy. No lab diagnostics studies was performed. No treatment was given for the event. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated at right arm with 0.5 ml of PNEUMOVAX 23 (Lot# reported as H009826 Exp date 11-FEB-2014) on 15-OCT-2012. Concomitant medications included FLUVIRIN, simvastatin (manufacturer unknown), metformin, JANUVIA and low dose aspirin. Subsequently the patient developed swelling and blotchy redness on her right arm from the injection site and down to her wrist in October 2012 after receiving PNEUMOVAX23. The patient has sought medical attention via coming back to the pharmacy. No lab diagnostics studies was performed. No treatment was given for the event. The outcome was reported as not recovered/not resolved. Additional information has been requested.
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. The patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose, route unspecified) on 15-OCT-2012 that was exposed to a temperature excursion but the time and temperature associated with that excursion had not yet been determined. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an approximately 17 years old female patient. On an unknown date, the patient was vaccinated with dose 2 GARDASIL (lot# and route were not reported). No concomitant medications were reported. On an unknown date 3 days after receiving dose 2 of GARDASIL, the patient developed injection site reaction of redness and swelling the size of a tennis ball. The patient sought medical attention (unspecified contact). No treatment was given. The outcome of injection site reaction of redness and swelling was unknown. The relatedness for injection site reaction of redness and swelling was unknown for GARDASIL. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an approximately 17 years old female patient. On an unknown date, the patient was vaccinated with dose 2 GARDASIL (lot# and route were not reported). No concomitant medications were reported. On an unknown date 3 days after receiving dose 2 of GARDASIL, the patient developed injection site reaction of redness and swelling the size of a tennis ball. The patient sought medical attention (unspecified contact). No treatment was given. The outcome of injection site reaction of redness and swelling was unknown. The relatedness for injection site reaction of redness and swelling was unknown for GARDASIL. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 65 years old female patient with doxycycline allergy and with no pertinent medical history. On 02-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX which was in the back of her arm instead of deltoid region of the arm. Concomitant medications included multivitamin, potassium, hydrochlorothiazide and flu vaccine (manufacturer unknown). On 02-OCT-2012 the patient developed red, warm, and hard raised area the size of silver dollar at the injection site. She received the vaccine at pharmacy. The patient had not sought medical attention. No treatment was given for the adverse events and no lab diagnostics studies were perform. At the time of report the patient did not recover from the events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a 65 years old female patient with doxycycline allergy and with no pertinent medical history. On 02-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX which was in the back of her arm instead of deltoid region of the arm. Concomitant medications included multivitamin, potassium, hydrochlorothiazide and flu vaccine (manufacturer unknown). On 02-OCT-2012 the patient developed red, warm, and hard raised area the size of silver dollar at the injection site. She received the vaccine at pharmacy. The patient had not sought medical attention. No treatment was given for the adverse events and no lab diagnostics studies were perform. At the time of report the patient did not recover from the events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 65 years old female patient with doxycycline allergy and with no pertinent medical history. On 02-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX which was in the back of her arm instead of deltoid region of the arm. Concomitant medications included multivitamin, potassium, hydrochlorothiazide and flu vaccine (manufacturer unknown). On 02-OCT-2012 the patient developed red, warm, and hard raised area the size of silver dollar at the injection site. She received the vaccine at pharmacy. The patient had not sought medical attention. No treatment was given for the adverse events and no lab diagnostics studies were perform. At the time of report the patient did not recover from the events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a 60 years old female consumer reporting on herself, with allergy to sulfa, MOTRIN and penicillin which caused hives and abdominal pain and no pertinent medical history, who on 03-OCT-2012, was vaccinated with a dose of ZOSTAVAX (lot number B467AE, Exp. Date: 04-APR-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included daily unspecified medications. The consumer reported that after receiving her ZOSTAVAX she presented with cellulitis in her arm on 05-OCT-2012. The consumer was treated with azithromycin which was unsuccessful in treating the condition fully. At this time the consumer had been switched to doxycycline for treatment. Unspecified blood testing was conducted to confirm her condition. At the time of the report, the consumer explained that she was improving slowly. The consumer had now had developed pain from her right elbow to her shoulder. The consumer sought unspecified medical attention. The relatedness for patient presented with cellulitis in her arm was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Cellulitis, Pain in extremity
Clinical narrative: This spontaneous report was received from a 60 years old female consumer reporting on herself, with allergy to sulfa, MOTRIN and penicillin which caused hives and abdominal pain and no pertinent medical history, who on 03-OCT-2012, was vaccinated with a dose of ZOSTAVAX (lot number B467AE, Exp. Date: 04-APR-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included daily unspecified medications. The consumer reported that after receiving her ZOSTAVAX she presented with cellulitis in her arm on 05-OCT-2012. The consumer was treated with azithromycin which was unsuccessful in treating the condition fully. At this time the consumer had been switched to doxycycline for treatment. Unspecified blood testing was conducted to confirm her condition. At the time of the report, the consumer explained that she was improving slowly. The consumer had now had developed pain from her right elbow to her shoulder. The consumer sought unspecified medical attention. The relatedness for patient presented with cellulitis in her arm was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, FLU3, PPV
Symptoms: Erythema, Insomnia, Joint effusion, Mobility decreased, Oedema peripheral
Clinical narrative: This spontaneous report as received from an office administrative team member refers to a 66 years old male patient with allergy to BACTRIM and no other pertinent medical history. The patient was vaccinated in the arm with the first 0.5 ml dose of PNEUMOVAX23 on 10-OCT-2012. Lot number H012972 (in validation), Exp date 09-MAR-2014. No other co-suspects were reported. Concomitant medications included: FLUZONE which was administered the same day in the opposite arm with no reaction. On 10-OCT-2012, the patient's arm was very tender and unable to rise above his head. The arm was very hard around where the vaccine was given. The reaction spread down to his forearm and the patient also developed a rash. The patient sought medical attention. No laboratory tests were performed. Treatment for the adverse events included KEFLEX. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from an office administrative team member refers to a 66 years old male patient with allergy to BACTRIM and no other pertinent medical history. The patient was vaccinated in the arm with the first 0.5 ml dose of PNEUMOVAX23 on 10-OCT-2012. Lot number H012972 (in validation), Exp date 09-MAR-2014. No other co-suspects were reported. Concomitant medications included: FLUZONE which was administered the same day in the opposite arm with no reaction. On 10-OCT-2012, the patient's arm was very tender and unable to rise above his head. The arm was very hard around where the vaccine was given. The reaction spread down to his forearm and the patient also developed a rash. The patient sought medical attention. No laboratory tests were performed. Treatment for the adverse events included KEFLEX. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, FLU3, PPV
Symptoms: Injection site induration, Mobility decreased, Rash, Tenderness
Clinical narrative: This spontaneous report as received from an office administrative team member refers to a 66 years old male patient with allergy to BACTRIM and no other pertinent medical history. The patient was vaccinated in the arm with the first 0.5 ml dose of PNEUMOVAX23 on 10-OCT-2012. Lot number H012972 (in validation), Exp date 09-MAR-2014. No other co-suspects were reported. Concomitant medications included: FLUZONE which was administered the same day in the opposite arm with no reaction. On 10-OCT-2012, the patient's arm was very tender and unable to rise above his head. The arm was very hard around where the vaccine was given. The reaction spread down to his forearm and the patient also developed a rash. The patient sought medical attention. No laboratory tests were performed. Treatment for the adverse events included KEFLEX. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: VERY SORE, CANT RAISE ARM ABOVE CHIN. 1 MONTH LATER AND STILL VERY SORE AND HARD TO MOVE SHOULDER HIGH.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Erythema, Feeling abnormal, Pain, Pruritus
Clinical narrative: Itching and raised redness, but then a day later it was a sharp pain just under where the shot was given, and STILL if I raise my arm it feels like it is going to crack deep inside my upper arm, I can't brush my hair, or lift anything over my head the pain is just to much. I am not sure if this shot has given me arthritis, or tendonitis. I do not have any insurance right now so I can't go back to see the Dr but I have never had a problem with my arm before. This is going on three months now. I can't even sleep on my side due to this upper arm pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Itching and raised redness, but then a day later it was a sharp pain just under where the shot was given, and STILL if I raise my arm it feels like it is going to crack deep inside my upper arm, I can't brush my hair, or lift anything over my head the pain is just to much. I am not sure if this shot has given me arthritis, or tendonitis. I do not have any insurance right now so I can't go back to see the Dr but I have never had a problem with my arm before. This is going on three months now. I can't even sleep on my side due to this upper arm pain.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: The night of my flu vaccine I got a terrible metallic taste in my mouth.  The following night I got a severe headache (so bad that it brought me to tears) and just felt awful.  I felt weak. I don't know any of the information about flu vaccine. I was vaccinated at work.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Fall, Laceration, Syncope, Tongue biting
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old male patient. The patient was vaccinated intramuscularly with GARDASIL (lot number not reported) on 09-OCT-2012. Concomitant medications included: MENACTRA. On 09-OCT-2012 the patient was administered GARDASIL later, experienced a seizure and fainted on the floor cutting his chin after his first administration. The patient also bit his tongue from the impact when hitting the floor. The patient was taken to the Hospital where he was placed under further medical care. No treatment information was reported. The outcome of the events was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Asthenia, Computerised tomogram normal, Electromyogram normal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Weakness, facial droop-diagnosed with Guillain Barre in hospital.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: Weakness, facial droop-diagnosed with Guillain Barre in hospital.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Left arm red-about 2" in diameter circle, swollen, firm to the touch and warm to the touch. Patient will take Benadryl before bed and Ibuprofen for the discomfort. Will ice and massage area.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Crying, Decreased appetite, Urine output decreased
Clinical narrative: Inconsolable crying most of the night, decreased appetite, reduced urine output.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on the lower arm and lower leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blister, Blood test, Erysipelas, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to his wife, a 63 years old female patient with pain. The patient's medical history included MRSA, neuropathy and previous shingles history before receiving the vaccine. She received an unspecified pneumonia vaccine 8 months prior to ZOSTAVAX. No previous drug reactions or allergies were reported. The patient was vaccinated with ZOSTAVAX on 18-APR-2012 (also reported as 18-APR-2011). Dose and route of vaccination were unknown. No other co-suspects were reported. Concomitant medications included gabapentin, metformin, hormones (unspecified) and hydrocodone. On an unknown date in April 2012 (7-10 days after receiving the vaccine) the patient developed rash and blisters after receiving ZOSTAVAX. The blisters appeared on both arms between the shoulders and the wrists, with little sores that eventually scabbed over. A week after that outbreak had healed she had another breakout with the same sores that eventually scabbed over in the same location, and 3 weeks after that breakout healed there was another breakout that occurred in the same manner. The physician biopsied the blisters and send them to the company (results unknown). About 1 month after the patient had her third outbreak of blisters the reaction developed again, this time appearing on the patient's face accompanied by a severe headache all of which required admittance to the hospital for a 1 week hospital stay. The physician who treated the patient diagnosed her condition as Erysipelas. The patient was with clindamycin, which helped to stop the reaction from becoming a full breakout. The patient was then switched to penicillin, which has worked better to control the breakout symptoms. The patient has not had any further breakouts since switching to the penicillin. Unspecified blood work was taken. The outcome of erysipelas was reported as recovering/resolving. The relatedness for erysipelas was not reported for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab, Skin lesion
Clinical narrative: This spontaneous report as received from a consumer refers to his wife, a 63 years old female patient with pain. The patient's medical history included MRSA, neuropathy and previous shingles history before receiving the vaccine. She received an unspecified pneumonia vaccine 8 months prior to ZOSTAVAX. No previous drug reactions or allergies were reported. The patient was vaccinated with ZOSTAVAX on 18-APR-2012 (also reported as 18-APR-2011). Dose and route of vaccination were unknown. No other co-suspects were reported. Concomitant medications included gabapentin, metformin, hormones (unspecified) and hydrocodone. On an unknown date in April 2012 (7-10 days after receiving the vaccine) the patient developed rash and blisters after receiving ZOSTAVAX. The blisters appeared on both arms between the shoulders and the wrists, with little sores that eventually scabbed over. A week after that outbreak had healed she had another breakout with the same sores that eventually scabbed over in the same location, and 3 weeks after that breakout healed there was another breakout that occurred in the same manner. The physician biopsied the blisters and send them to the company (results unknown). About 1 month after the patient had her third outbreak of blisters the reaction developed again, this time appearing on the patient's face accompanied by a severe headache all of which required admittance to the hospital for a 1 week hospital stay. The physician who treated the patient diagnosed her condition as Erysipelas. The patient was with clindamycin, which helped to stop the reaction from becoming a full breakout. The patient was then switched to penicillin, which has worked better to control the breakout symptoms. The patient has not had any further breakouts since switching to the penicillin. Unspecified blood work was taken. The outcome of erysipelas was reported as recovering/resolving. The relatedness for erysipelas was not reported for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint swelling
Clinical narrative: This spontaneous report as received from an office manager refers to a patient. On approximately 04-OCT-2012 the patient was vaccinated with a recommended 0.5 ml dose of PNEUMOVAX23 (Lot# and route not reported) co-administered with high-dose of FLUZONE which was indicated for the patient's aged 65 year old in either arm respectively. On 05-OCT-2012 the patient experienced redness and swelling in both wrists. The patient sought for unspecified medical attention. No lab diagnostics studies were performed. Redness and swelling in both wrists did not improve. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia, Swelling face
Clinical narrative: Patient called complaining of swelling in her face and a weird pins and needles feeling in her mouth.  Having some difficulty breathing.  Sent patient directly to the ER.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, bruising, swelling at injection site 5x4cm.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, Platelet transfusion, Viral infection
Clinical narrative: Noticed Petechiae on his arms and legs went to primary sent for lab work PLT count 3 repeated lads PLT 1 given solucortef and 10 unit platelet pack @ 6 AM on 10/17/2012 transfered from one hospital to Hematologist told pt that they may never know what caused drop n PLT most likley viral stated textbook ITP plan to remain in hospital till PLT 15 or > as of 10/18/2012 plt 12 remains asymptomatic other than Petechaie
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling near infection site. Red 3 days later.