chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling, Vomiting
Clinical narrative: Severe swelling, extreme redness (eg. very ripe strawberry). Very extreme headache. Fever, dizziness, vomiting. Was seen at a local medical facility. I was seen there 3 times, given 3 shots (one each day) plus a prescription of CEPHALEXIN, 500 mg. The condition was determined to be cellulitis.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Cardiac disorder, Diarrhoea, Dyspnoea, Echocardiogram
Clinical narrative: Trouble breathing, heart problems, lethargy, diarrhea.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Lethargy
Clinical narrative: Trouble breathing, heart problems, lethargy, diarrhea.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Patient reports feeling tired, shortness of breath and stumbling.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT SAID THAT THE INJECTION SITE WAS RED, SWELLED AND ITCHING AND THAT GETTING GROWING. WHEN PATIENT CALLED TO PHARMACY A WEEK LATER, THE SITE WAS AROUND 4 SQUARE INCHES.
Age: 1.52
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Noticed a lump on her leg when changing her diaper that morning. Was thinking it was an insect bite (possibly a tick), it was hot and red so I took her to the doctor. It was 10 days after her vaccine and I wasn't even thinking it could be that until the doctor that read her records noted that she was just seen for her check up. It was then that I realized it was at the injection site because it was in a slightly different spot than usual. Dr. treated her for cellulitis and recommended we follow up with her doctor on Monday and see which vaccine it was. Her leg didn't seem to be getting any better so they switched her antibiotic. She did respond to this one. In the meantime she was at the urgent care on Saturday and on Sunday her twin brother had a lump on his other leg. When I took them both on Monday I found out that it was the Varicella injection site where they were infected. Something is not right!!
Age: 1.52
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site infection
Clinical narrative: Patient's twin sister had a lump start on her leg the day before. I had taken her to urgent care thinking it was a tick bite but found out it was where her injection was and it was cellulitis. I made an appointment to get them both into their pediatrician on Monday to find out more. It was the injection site of the Varicella vaccine for both of them. Something is wrong with this batch. They were both badly infected!! His sister didn't respond to the first antibiotic so they switched her and started him on the stronger one they put her on. They responded to the antibiotic but it took a few days. It was a nasty infection at the injection site. Please note that they had the MMR shot in the opposite leg with no reaction.
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives from Tailbone to neck.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV, RVX
Symptoms: Muscle spasms, Pyrexia, Tremor
Clinical narrative: High temperature, shaking and cramps for 10 minutes.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: I received a quad flu shot in my left arm.  The arm was sore and hurt when I moved it for about a day.  A few days later, somewhere around the 19th, my upper arm became sore again and hurt to move.  I thought it was because I had slept on it wrong, but it has been three weeks and my arm is still sore.  I have been taking OTC naproxen when the pain and soreness becomes too much for daily activities.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Middle insomnia, Pain in extremity
Clinical narrative: My arm pain was significant enough that I could not sleep that night. I kept waking up.  The next day my arm was still in a great amount of pain. I had taken so me BC powder and Tylenol. It wore down when I applied ice to my shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous, Urticaria
Clinical narrative: A year after the event the patient described raised red rash with hives and the length of her arm up to the injection site that lasted for over a week.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema
Clinical narrative: Erythema at site of Hepatitis A noted the day following administration.
Age: 24.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Eyelid rash, Oropharyngeal pain, Pain
Clinical narrative: Soar throat. Body ache. Eye rash. Made appointment with a dermatologist for the eye rash.
Age: 24.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Eyelid rash, Herpes zoster, Viral test positive
Clinical narrative: Soar throat. Body ache. Eye rash. Made appointment with a dermatologist for the eye rash.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Cyanosis, Pallor, Unresponsive to stimuli
Clinical narrative: After vaccine reaction appears pale/cyanotic, unresponsive has history of atypical seizure disorder and on medication (anti-seizure) daily.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles, Localised infection
Clinical narrative: Arm pain, infected bump (L) arm. (L) deltoid with 2 cm induration/erythema with small crusted pinpoint vesicles. (+) firm with pain at shoulder. NV intact likely rxn. Pain: 7/10. Pain to move, tingly (L) arm. MOTRIN.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Pulmonary thrombosis, Vomiting
Clinical narrative: Arm pain, infected bump (L) arm. (L) deltoid with 2 cm induration/erythema with small crusted pinpoint vesicles. (+) firm with pain at shoulder. NV intact likely rxn. Pain: 7/10. Pain to move, tingly (L) arm. MOTRIN.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Peak expiratory flow rate, Pharyngeal oedema, Throat tightness
Clinical narrative: At 4:40 pt. received FLULAVAL IM (L) delt one minute later pt. felt that her throat swelling and closing up. Pt. was asked if she could breathe she yes but her throat was itchy and felt funny. Pt. was assessed by dr.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Pt. came to pharmacy 10/8/15 in the morning with arm (left) bruised and a little swollen. I directed her to her dr. and told her we could would follow up (+) report incident.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Haemoglobin normal, Loss of consciousness
Clinical narrative: Gave immunizations, patient was sitting in chair and mom screamed for someone to come help her. Ran over to her another nurse cracked the ammonia and she came to. Picked her up, layed her down in procedure room. Checked her blood pressure. Had her lay down for a while and gave her water. Completed orthostatic blood pressures to ensure she would not faint. Kept her for 2 hours monitoring her.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic throat clearing, Urticaria
Clinical narrative: Hives over entire body within 3 hrs of vaccine. Also stated, frequent throat clearing.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Dizziness, Fatigue, Lacrimation increased
Clinical narrative: Achy feeling, pain in joints, runny nose (severe), watery eyes, sneezing, sleepy, slight dizzy spells, cough, sore throat, fatigue. Symptoms are ongoing.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing, Somnolence
Clinical narrative: Achy feeling, pain in joints, runny nose (severe), watery eyes, sneezing, sleepy, slight dizzy spells, cough, sore throat, fatigue. Symptoms are ongoing.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Rash morbilliform
Clinical narrative: Pt. received PROQUAD 9-28-15. Rash developed 10-7-15. Measles like rash. No fever. Happy, playful.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen red sore arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reported red, raised rash after injection occurring on arm of injection. When patient reported reaction she stated redness had gone down quite a bit.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Pruritus, Skin warm
Clinical narrative: Patient received FLUVIRIN vaccine on 10/5/2015 and came to pharmacy 10/8/2015 4 inch red sore deltoid when vaccine given. Also complaining of itching and warm to touch.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness - in the area of the PREVNAR shot.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cold sweat, Diarrhoea, Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccine administered 10/6/15 approximately 9 AM. Four and a half hours later pt felt ill, cold sweat/shivering, nausea, diarrhea x 2. Right arm became swollen "like a balloon", shoulder hurt and difficult to lift arm. Pt used Bayer ASA and APAP, ADVIL OTC and ice x 3 days.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Nausea, Peripheral swelling
Clinical narrative: Vaccine administered 10/6/15 approximately 9 AM. Four and a half hours later pt felt ill, cold sweat/shivering, nausea, diarrhea x 2. Right arm became swollen "like a balloon", shoulder hurt and difficult to lift arm. Pt used Bayer ASA and APAP, ADVIL OTC and ice x 3 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness at injection site. Swelling at injection site. Fever, diarrhea, back pain.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Full blood count normal, Haematoma, Red blood cell sedimentation rate normal, Ultrasound scan normal
Clinical narrative: Large bruise/hematoma developed. Pt. showed me on 10/6/15 and said it had been there about four days. Dark blue and purple mostly in the underarm area. I would estimate bruise to be at least 6-8 inches long and 4-5 inches wide.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Large bruise/hematoma developed. Pt. showed me on 10/6/15 and said it had been there about four days. Dark blue and purple mostly in the underarm area. I would estimate bruise to be at least 6-8 inches long and 4-5 inches wide.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large reddened area at shot site 15 x 15 cm area mild swelling, increased warmth, itchy.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Burning sensation, Chills, Headache, Oropharyngeal pain
Clinical narrative: Fever, chills, sore throat, headaches, runny nose, body aches. Burning sensation during the vaccination. Stomach/gut distress.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills, sore throat, headaches, runny nose, body aches. Burning sensation during the vaccination. Stomach/gut distress.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Dizziness, Electrocardiogram
Clinical narrative: Pt went to the restroom and stated he started feeling dizzy. Pt sat on the floor so he would not fall.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: 10/5/15, intense tingling on left leg then right leg then right arm and upper back. 10/7/15 muscle cramping and burning. Still tingling intense on forehead and arm. Advised to see Dr.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site papule, Vaccination site rash
Clinical narrative: Rash at site of the vaccine 4 days after vaccine administration. Flesh colored papules 4 x 7 cm.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Back pain, Body temperature increased, Chills, Herpes zoster
Clinical narrative: A couple of hours after the injection I got the chills aches and pain bad, temperature of 100.2. The next morning I got up with burning pain in my thigh, lower back and stomach, and my feet. Went to the doctor he thinks its Shingles gave me a prescription for valacyclovir Hcl- 1 gram tab but I don't have the red blisters.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: A couple of hours after the injection I got the chills aches and pain bad, temperature of 100.2. The next morning I got up with burning pain in my thigh, lower back and stomach, and my feet. Went to the doctor he thinks its Shingles gave me a prescription for valacyclovir Hcl- 1 gram tab but I don't have the red blisters.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Discomfort, Fatigue, Injection site pain
Clinical narrative: Chills, shivering, body discomfort, muscle aches, tenderness at injection, fatigue, loss of appetite.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Chills, shivering, body discomfort, muscle aches, tenderness at injection, fatigue, loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Fatigue, Pneumonia
Clinical narrative: Pt reports onset of fatigue on 9/25/15 PM that progressed over the weekend. Saw MD on Monday 9/28/15 and was diagnosed with bronchitis and pneumonia. Was prescribed Z-PAK, nebulizer and steroid.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Itching all over (L) side worse than the right.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Contusion, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: Bruising up and down arm painful - weakness, exhaustion x 24 hrs unable to get OOB/no other Rx.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Received vaccine 10/1/15 - 10/2/15 developed itching and redness at site. 10/4 developed stiff neck. 10/6 developed fever.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (lot # L010141 with expired date 24-SEP-2016, lot# L023113 with expired date 24-SEP-2016; dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient received first and second dose of VAQTA (dose, lot#, expired date and route were unknown) on 11-JAN-2010 and 12-APR-2010, respectively (inappropriate schedule of drug administration). No adverse symptoms were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure fluctuation, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a 72 year old female patient regarding herself. No concurrent conditions and medical history were reported. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (dosing regimen and frequency unknown) (lot number and expiry date unknown) as doctor recommended (details unspecified). Concomitant therapies included nitrofurantoin (manufacturer unknown). On 24-SEP-2015 (also reported as 5 hours after receiving PNEUMOVAX 23, the patient's arm where she received the injection started to hurt, the patient also experienced swelling in her arm where she received the injection, felt very nervous and was not sleeping well. On 24-SEP-2015 the patient's arm where she received the injection had a rash and was red and the patient experienced blood pressure fluctuation 20 points below and 20 points above. It was reported that the patient sought medical attention and visited an office. The patient was treated with oral BENADRYL for the events. The action taken with the therapy PNEUMOVAX 23 was unknown. The outcome of blood pressure fluctuation, poor quality sleep, vaccination site rash, vaccination site erythema, nervousness, vaccination site swelling and vaccination site pain was reported as recovering. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Nervousness, Poor quality sleep
Clinical narrative: This spontaneous report as received from a 72 year old female patient regarding herself. No concurrent conditions and medical history were reported. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (dosing regimen and frequency unknown) (lot number and expiry date unknown) as doctor recommended (details unspecified). Concomitant therapies included nitrofurantoin (manufacturer unknown). On 24-SEP-2015 (also reported as 5 hours after receiving PNEUMOVAX 23, the patient's arm where she received the injection started to hurt, the patient also experienced swelling in her arm where she received the injection, felt very nervous and was not sleeping well. On 24-SEP-2015 the patient's arm where she received the injection had a rash and was red and the patient experienced blood pressure fluctuation 20 points below and 20 points above. It was reported that the patient sought medical attention and visited an office. The patient was treated with oral BENADRYL for the events. The action taken with the therapy PNEUMOVAX 23 was unknown. The outcome of blood pressure fluctuation, poor quality sleep, vaccination site rash, vaccination site erythema, nervousness, vaccination site swelling and vaccination site pain was reported as recovering. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 12 month old patient (gender unknown). Information regarding concurrent conditions and medical history was not provided. On an unknown date the patient was inadvertently administered (Merck) VARIVAX and (Merck) PROQUAD concomitantly (dose, dose #, lot #, application site and route were not reported) (overdose). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer concerning his grandmother (patient) of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot # unspecified). No concomitant medications were reported. Consumer stated that his grandmother got shingles vaccine but got shingles last Thursday (Approximately on 01-OCT-2015). Patient sought medical attention. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 15 year old female patient. The patient's medical history included juvenile rheumatoid arthritis (RA). On an unknown date and on 18-SEP-2015 ("10 days ago") the patient was vaccinated with her first and second dose of GARDASIL or GARDASIL 9 respectively. Pharmacist did not know if the vaccine injections were GARDASIL or GARDASIL 9. It was reported that the patient had experienced pain at the injection site, after the first dose of vaccination, on an unspecified date. Pharmacist reported that patient's mother informed her that the patient experienced redness, "significant swelling", pain and a raised area, "similar to the bubble formed with a para-phenylenediamine (PPD)" at the injection site, immediately after the second dose of vaccination. Pharmacist reported she was informed by patient's mother that the patient did not believe the second injection was administered the same way, as the first injection. Patient sought medical attention by calling pharmacist. No treatment was given for events. The outcome of all the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with improperly stored ZOSTAVAX (dose, strength, frequency and route were not reported, lot # L006381, expiry date: 25-MAY-2016) by an unspecified physician. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unknown number (reported as "few patients") of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date were not reported). On unknown dates, six months to a year after receiving ZOSTAVAX, all these patients developed shingles. The outcome of the events was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown demographics. There was no medical history or drug reaction/allergies reported. On unknown date, dose of improperly stored VARIVAX (lot# K006138 with expired date 29-APR-2016, lot# K003413 with expired date 06-MAR-2016, lot# L002870 with expired date 27-JAN-2017, lot# L000456 with expired date 06-JAN-2017, lot# L010145 with expired date 24-MAR-2017, lot# L012036 with expired date 07-APR-2017, lot# K006133 with expired date 29-APR-2016; dose and route were unknown) might have been administered to the patients. No concomitant medication was provided. No adverse experiences were reported. This is one of two reports received from the same reporter (1508USA005691). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 23-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The patient's medical history and concurrent conditions were not reported. On 07-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to three unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) injection, lot # J012773, expiry date: 09-OCT-2015 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further details were provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided.  On 15-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 16-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 14-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 20-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent medications and medical history were not reported. On an unknown date, the patient was vaccinated with incorrect stored VARIVAX (Merck)(unknown strength, route and dose). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a currently 41 year old patient of unknown gender. On 29-SEP-2015 the patient was vaccinated with expired dose of VARIVAX (Merck) injection (lot # J009167; expiry: 24-JUL-2015) (dose, route and frequency unspecified). No concomitant medications were reported. The patient had not reported an adverse effect. No additional information was provided. The outcome of medication error was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to 11 unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, 11 patients were vaccinated with improperly stored doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016; lot# K007264, expiration date unknown) (dose, indication and route of administration were not reported). Concomitant therapy was not provided. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 years old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Addiitonal information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 years old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Decreased appetite, Irritability, Restlessness
Clinical narrative: Temp to 100.2; Mild fussiness/restlnessness. Decreased appetite.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash 7x7 cm, swelling to injection site, warm, redness.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, swelling to 5 x 2 size. Warm to touch, painful to touch, nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding medical history, concurrent conditions and drug reactions/allergies were not reported. On multiple unspecified dates, these patients were vaccinated with improperly stored ZOSTAVAX (lot # L011533, expiry date: 03-JUL-2016). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12 months old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, route, frequency and lot # unspecified). No concomitant medications were reported. On an unknown date the patient had some redness up her arm after receiving a dose of ZOSTAVAX on an unspecified date. There was no PQC involved. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected. Consent to follow up was not provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 years old patient. The patient's medical history and concurrent conditions were not reported. On 29-JUL-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L001335, expiry date 13-JAN-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to three patients of unknown age and gender. No information regarding the patients's medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23, lot # k012424, (dose, route of administration, injection site and expiration date were not reported). According to the reporter, within two to three hours of vaccination, each patient experienced redness, swelling and pain at the injection site. The outcome of the events was unknown at the time of the report. The relatedness between redness, swelling and pain at the injection site and PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patient were vaccinated with improperly stored doses of VARIVAX (Merck) (6 doses of lot # L011084, expiration date: 01-APR-2017 and 10 doses of lot # L006384, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 13 month old patient. The patient's medical history and concurrent conditions were not reported. On 29-JUL-2015, the patient was vaccinated with an imporperly stored VARIVAX (Merck) (lot # L001335, exiry date 13-JAN-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additonal information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported), lot# L014415 with expiration date 25-JUL-2017 or lot# L016428 with expiration date 30-JUL-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has bee received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 02-OCT-2015 the patient was vaccinated with a dose of expired VAQTA (lot # J007781, expiration date: 19-SEP-2015), dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route were not reported, lot # reported as L014429 with expiration date 15-MAR-2018 or lot #L009649 with expiration date 29-NOV-2017) There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified pediatric patient of unknown age and gender. There was no information about patient's concomitant medication, pertinent medical history, drug reactions or allergies provided. On 02-OCT-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot# H015537, expiration date 09-JUL-2015, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (lot #, dose and frequency unspecified). Concomitant medication were not reported. On an unknown date, the patient developed a case of shingles an unspecified amount of time after receiving a dose of ZOSTAVAX. The patient was treated with VALTREX. The outcome of the event was unknown. The patient sought medical attention as he visited the physician's office. The reporter did not provide the causality assessment between the event shingles and ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap and MENACTRA given in left deltoid area and warmth, swelling, erythema at and around injection site after 2 days. No fever, KEFLEX given on 10/1/15. Also told to give BENADRYL and apply cool compresses.
Sex: U
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Sluggishness
Clinical narrative: This case was reported by a consumer and described the occurrence of sluggishness in a patient who received BOOSTRIX. On 25th July 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced sluggishness, fever and rash. On an unknown date, the outcome of the sluggishness was recovered/resolved and the outcome of the fever and rash were not recovered/not resolved. It was unknown if the reporter considered the sluggishness, fever and rash to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The patient developed sluggishness that lasted one week. On 8th September 2015, fever symptoms and rash were still present. medication attention was sought.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient received PNEUMOVAX in right upper arm on 1 Oct 2015 due to being told he needed PNEUMOVAX prior to receiving ZOSTAVAX. Patient said by Friday night he started having a fever, started shivering, and joints began aching. He said at 04:00 on 2 Oct 2015 his temperature reached 102 degrees F. Patient developed a significant rash around the injection site along with swelling, redness, and pain. He said by 3 Oct 2015 his flu-like symptoms dissipated. He dosed ADVIL and TYLENOL around the clock on Friday, Saturday, and Sunday. He presented in clinic on 5 Oct 2015 and had an office temperature less than 100 degrees F.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Patient received PNEUMOVAX in right upper arm on 1 Oct 2015 due to being told he needed PNEUMOVAX prior to receiving ZOSTAVAX. Patient said by Friday night he started having a fever, started shivering, and joints began aching. He said at 04:00 on 2 Oct 2015 his temperature reached 102 degrees F. Patient developed a significant rash around the injection site along with swelling, redness, and pain. He said by 3 Oct 2015 his flu-like symptoms dissipated. He dosed ADVIL and TYLENOL around the clock on Friday, Saturday, and Sunday. He presented in clinic on 5 Oct 2015 and had an office temperature less than 100 degrees F.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date in 2014 (reported as "about a year ago"), the patient was vaccinated with an unknown dose of ZOSTAVAX (route, lot# and expiry date were not reported). Then, on 04-OCT-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot # L016284, expiry date 07-AUG-2016; dose and route were not reported). No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route were not reported, Lot # K005175 with expiration date 10-OCT-2016  or lot # K020188 with expiration date 22-OCT-2016). There were not adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Arm was red, itchy and warm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ (route, lot number and expiration date were not provided). On unknown dates, there was an incorrect product storage as the multiple unspecified patients were administered improperly stored ROTATEQ. No adverse events were reported. It was unknown if the patients sought medical attention. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.56
Sex: F
Vaccine: HEP, HEPA
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Large area of erythema on anterior thighs - bilateral, including some wheals. Wheals appeared on arms a day later. Initial erythema appeared 5 days following vaccines administration.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a 77 year old male patient with high blood pressure, fingertip neuropathies and allergic to ciprofloxacin. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subdermal injection (dose, frequency and lot number were not provided). There was no concomitant medication described. The reporter stated that the patient went to the pharmacy on 07-OCT-2015, complaining of pain and neuropathy in the arm of the injection. Lab diagnostics studies were not performed. Product quality complaint (PQC) was not involved. At the time of the report the outcome of pain in extremity and neuropathy peripheral was not recovered. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Diffuse rash rx: IM steroids.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Feeling abnormal, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician (who was also the patient) via Pfizer Inc (manufacturer # 2015321469) on 30-SEP-2015, and refers to a 64 year old patient (gender not reported) with asthma and allergy to tetanus toxoid vaccine (administered when the patient was 22 year old). The patient's medical history included pyrexia and peripheral swelling (when the patient was 22 year old). On an unspecified date in 2002, when the patient was 58 year old, she was vaccinated with the first dose of PNEUMOVAX 23 (lot number, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2008, the patient was vaccinated with the second dose of PNEUMOVAX 23 in the deltoid (arm was not specified) (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient reported that her whole shoulder down to her arm swelled up and she felt lousy. The patient also reported that she did not have fever. At the reporting time, the outcome of feeling abnormal and peripheral swelling was reported as recovered on an unspecified date (reported as "it took several days for the reaction calm down"). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site urticaria, Lip swelling, Urticaria
Clinical narrative: Pt's lips swelled and hives were present on trunk and upper arms.