chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash macular
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 2 year old female patient with no medical history and no drug reaction. In March 2013, the patient was vaccinated with (Merck) VARIVAX (lot # H010958, exp. date 31-MAY-2014 0.5 ml, subcutaneous. No concomitant medication reported. On 26-NOV-2014 the patient experienced shingles. The patient had developed blotches of redness on the left leg. The patient was evaluated in the office on 26-NOV-2014, and had been diagnosed with possible shingles. There were no lesions present at the time of the report. No treatment was given for AE. No lab was performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with diabetic. The reporter was not certain regarding the patients medical history. On 04-NOV-2014 the patient was vaccinated with ZOSTAVAX (lot # K008881, expiry date: 20-SEP-2015, 0.65 ml, subcutaneous posterior right upper arm). Concomitant medical history was unspecified by reporter. On 05-NOV-2014 the patient began to experience being light headed and just not feeling right. The reporter stated that the patient called on 06-NOV-2014 to ask her if she should consult her physician about these events. The reporter stated that the patient has felt like this in the past. The reporter also stated that the patient called her while at work, and she has not experienced any loss of consciousness. The reporter did not notify her physician about this adverse experience also did not think that the patient was experiencing a rash. No treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillian Barre Syndrome. Parasthesia of hands and feet, Muscle weakness, loss of balance, High blood pressure.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Balance disorder, Electromyogram, Guillain-Barre syndrome, Hypertension, Lumbar puncture
Clinical narrative: Guillian Barre Syndrome. Parasthesia of hands and feet, Muscle weakness, loss of balance, High blood pressure.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Guillian Barre Syndrome. Parasthesia of hands and feet, Muscle weakness, loss of balance, High blood pressure.
Age: 23.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of unknown age. On 27-OCT-2041, a 27 weeks pregnant patient was vaccinated with M-M-R II (dose, route not reported), (lot # reported as J00200, expiration date 01-SEP-2014). Last Menstrual Period of 21-APR-2014 and Estimated Date of Delivery of 26-JAN-2015. The patient sought medical attention and did not receive any treatment for the event. At the time of the report the pregnancy outcome was pending. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: I have pain in left shoulder and the dull pain goes down to my elbow. I am unable to move left arm outward. I visited my family doctor on 11/17/2014 and the doctor told me I had a frozen shoulder. I had MRI on 11/22/2014 and returned to family doctor on 11/25/2014. I now have an appointment with an ortho doctor on 12/02/2014.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: I have pain in left shoulder and the dull pain goes down to my elbow. I am unable to move left arm outward. I visited my family doctor on 11/17/2014 and the doctor told me I had a frozen shoulder. I had MRI on 11/22/2014 and returned to family doctor on 11/25/2014. I now have an appointment with an ortho doctor on 12/02/2014.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Joint crepitation, Pain in extremity
Clinical narrative: Pain in left shoulder area that radiates to left hand, limited range of motion, popping feeling upon movment.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Felt fatigue went to bed with hot throat. Woke up with shoulder pains, joint pains on Shoulders, knees. worst is the back of my upper thighs fell like I walked or hiked (Severe Muscle pain to the touch. NO fever just wide spread pain all over especially the shoulders, elbows and knees. So far I have not gone to the doctor but will if not better by this MONDAY coming.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Felt fatigue went to bed with hot throat. Woke up with shoulder pains, joint pains on Shoulders, knees. worst is the back of my upper thighs fell like I walked or hiked (Severe Muscle pain to the touch. NO fever just wide spread pain all over especially the shoulders, elbows and knees. So far I have not gone to the doctor but will if not better by this MONDAY coming.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Local swelling, Pain, Sensation of heaviness, Tenderness
Clinical narrative: Soreness at vacination site, heaviness in arms, bruising feeling arms hurt to move, cannot sleep because of pain, I have tried icy hot, biofreeze, Advil, Benadryl with Aleve, how do I get rid of these side effects I HURT.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Soreness at vacination site, heaviness in arms, bruising feeling arms hurt to move, cannot sleep because of pain, I have tried icy hot, biofreeze, Advil, Benadryl with Aleve, how do I get rid of these side effects I HURT.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: First told pharmacy of pain in her Right shoulder on 11/9/14. She did not say when the pain initially started, but that she was in pain on 11/8/14. She said she had decreased range of motion. She asked her physician about it at a previously scheduled appointment. Her physician said to keep using her arm, it would feel better. She continued to complain of pain and decreased range of motion in her left arm. She went to see her doctor again due to level of pain and continued limited range of motion on 11/18/14. At this time, her physician referred her to an orthopedic doctor and told her to avoid using her arm and prescribed pain relievers. She saw the orthopedic doctor on 11/20/14. She received a shot in her arm from that doctor and was told to rest her arm and referred for outpatient physicial therapy.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Pain in her right arm.  Patient stated that she has difficulty taking her shirt off, or any task that she has to raise her arm over her head.  Patient has notseen the doctor.
Age: 33.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia, X-ray normal
Clinical narrative: Extreme limited mobility of right arm and sharp pain in muscle directly where shot was administered. Pain has increased daily since the shot was given. Tingling and numbness in lower arm and fingers is beginning to set in. Visited urgent care on 11/28/2014, 3 weeks after the shot, as symptoms were getting worse. Doctor diagnosed as an adverse reaction to the flu shot and said there was nothing he could do. His quote was "You are one of the unlucky ones who will most likely have pain in your arm the rest of your life. There is nothing I can do."
Age: 33.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injection site pain, Injection site reaction, Muscle oedema, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Extreme limited mobility of right arm and sharp pain in muscle directly where shot was administered. Pain has increased daily since the shot was given. Tingling and numbness in lower arm and fingers is beginning to set in. Visited urgent care on 11/28/2014, 3 weeks after the shot, as symptoms were getting worse. Doctor diagnosed as an adverse reaction to the flu shot and said there was nothing he could do. His quote was "You are one of the unlucky ones who will most likely have pain in your arm the rest of your life. There is nothing I can do."
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt noticed the morning after the injection that her arm was very sore and lost range of motion. On 11/29/2014 the patient presented back to the pharmacy, still with very limited range of motion in the left arm and experiencing significant amounts of pain.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of Left Arm asked patient to measure biceps and wrist to compare arms and patient refused, just wanted to report it before she went to immeadiate care-had rotator cuff surgery pending didn't want it held up.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain after shot, got worse over time, including loss of mobility in shoulder, difficulty raising arm, lifting things with that arm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Condition aggravated, Eyelid oedema, Herpes zoster, Lymphadenopathy
Clinical narrative: Severe nerve pain on right side banding from abdomen to back- this lasted until November 15th and then a rash broke out where the nerve pain was, and doctor diagnosed me with Shingles. I also had a pvc/pac episode 4 days after being administered the shot. My glands in neck were also swollen one week after shot, and my eyelids swelled up 2 days after shot. I also felt tightness in my chest about 6 hours after the shot. I will NEVER get a flu shot again. I was in generally great health prior to this flu shot administered. I've never had the shingles before in my life.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Rash, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Severe nerve pain on right side banding from abdomen to back- this lasted until November 15th and then a rash broke out where the nerve pain was, and doctor diagnosed me with Shingles. I also had a pvc/pac episode 4 days after being administered the shot. My glands in neck were also swollen one week after shot, and my eyelids swelled up 2 days after shot. I also felt tightness in my chest about 6 hours after the shot. I will NEVER get a flu shot again. I was in generally great health prior to this flu shot administered. I've never had the shingles before in my life.
Age: 20.0
Sex: F
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Asthenia, Feeling jittery, Loss of consciousness, Syncope
Clinical narrative: Patient became very faint with severe syncope and briefly blacked out.  This was after administration of 4 vaccines.  Patient rested and was given orange juice and crackers.  Blood pressure was checked and was 120/79.  Patient felt weak and jittery.  Did not display signs/symptoms of anaphylactic reaction. No effect on breathing. No rash.  Lasted about one hour total and the patient was able to walk out with her mother.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthenia, Dysstasia, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: Tiredness, Weakness, Fever that lasted for about 2 or 3 days.  On day 3 and 4, began having severe leg pain, particularly immediately after waking or sitting still for a little while.  Pain was so severe that patient had difficulty walking and standing.  After about 10 minutes of trying to "walk it off" it would improve considerably.  The episodes of leg pain resolved after 2 days.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Tiredness, Weakness, Fever that lasted for about 2 or 3 days.  On day 3 and 4, began having severe leg pain, particularly immediately after waking or sitting still for a little while.  Pain was so severe that patient had difficulty walking and standing.  After about 10 minutes of trying to "walk it off" it would improve considerably.  The episodes of leg pain resolved after 2 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Multiple large blisters at the injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Raised red rash surrounding the injection site.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Dyspnoea, Foaming at mouth, Immediate post-injection reaction, Nasal flaring
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old female patient without known drug allergies and reactions. On 25-NOV-2014 the patient was vaccinated with ROTATEQ dose 1, 1 ml, oral, lot # reported as K009745, expiration date reported as 17-FEB-2016. On 25-NOV-2014, immediately after receiving the dose of ROTATEQ, she started to foam at the mouth and have difficulty breathing. The patient also had nostril flaring and experienced shortness of breath. The unspecified Emergency Services were called to the physician's office. The Medical assistant considered this to be both life threatening and a significant incapacity to the patient. The patient was given an unspecified nebulizer treatment while in the physician's office and then taken by ambulance to an unspecified hospital. It was unspecified as to if the patient was admitted to a hospital. The outcome of the events was unknown. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray normal, Cyanosis, Full blood count normal, Peripheral swelling, Rash generalised
Clinical narrative: This spontaneous report was received from the mother of a 12-month-old female patient without drug reactions, allergies or pertinent medical history. On 06-OCT-2014 the patient was vaccinated with VARIVAX (Merck) (lot # K003420, expiry date March 2016. Strength, route and dose not provided). There was no concomitant medication. On 14-OCT-2014, 9 days after onset of therapy, patient developed a rash on her abdomen, which eventually spread all over her body. Patient also experienced swelling of her arms and legs, and became cyanotic. These issues resulted in hospitalization on 15-OCT-2014, during which daughter was diagnosed with urticaria. Lab diagnostics performed included full blood count (CBC) and chest X-ray, both with normal results. Treatment included ATARAX and ranitidine, which reporter stated were ineffective at suppressing the rash and were discontinued. Additional treatment included unspecified intravenous (IV) steroids and an unspecified antiviral medication. Patient was discharged from the hospital on 16-OCT-2014. Reporter said everything resolved except the rash, which, at the time of the report, was still persistent. No further information provided. Upon internal review, urticaria was considered as medically significant. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from the mother of a 12-month-old female patient without drug reactions, allergies or pertinent medical history. On 06-OCT-2014 the patient was vaccinated with VARIVAX (Merck) (lot # K003420, expiry date March 2016. Strength, route and dose not provided). There was no concomitant medication. On 14-OCT-2014, 9 days after onset of therapy, patient developed a rash on her abdomen, which eventually spread all over her body. Patient also experienced swelling of her arms and legs, and became cyanotic. These issues resulted in hospitalization on 15-OCT-2014, during which daughter was diagnosed with urticaria. Lab diagnostics performed included full blood count (CBC) and chest X-ray, both with normal results. Treatment included ATARAX and ranitidine, which reporter stated were ineffective at suppressing the rash and were discontinued. Additional treatment included unspecified intravenous (IV) steroids and an unspecified antiviral medication. Patient was discharged from the hospital on 16-OCT-2014. Reporter said everything resolved except the rash, which, at the time of the report, was still persistent. No further information provided. Upon internal review, urticaria was considered as medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Mass
Clinical narrative: Received ZOSTAVAX inj-Wedn next day, site was swollen, hot and red but small (3 in) by Friday, rash spread/redness spread and lump is palpable (walnut) and is itchy-pt also rec'd flu shot on 11/26/14.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Received ZOSTAVAX inj-Wedn next day, site was swollen, hot and red but small (3 in) by Friday, rash spread/redness spread and lump is palpable (walnut) and is itchy-pt also rec'd flu shot on 11/26/14.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Medical history was not reported. On 22-NOV-2014 the patient was vaccinated with ZOSTAVAX approximately 0/7 ml, subcutaneous, in the arm (unspecified arm) (lot number and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified)(Manufacturer unknown) administered in the other arm on the same day. Concomitant therapy was not reported. The pharmacist informed that on 22-NOV-2014, in the evening the patient developed a red, swollen and itchy rash in the injection site of the arm that ZOSTAVAX was administered. There were not laboratories diagnostics performed; The patient sought medical attention calling to the pharmacy. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patient were vaccinated with an improperly stored dose ROTATEQ oral (strength, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patients were vaccinated with an improperly stored dose of VAQTA (strength, route of administration, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with ZOSTAVAX (dose and lot number was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is linked to MARRS # 1411USA011625 with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, route of administration, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of 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: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patients were vaccinated with an improperly stored dose of GARDASIL (strength, route of administration, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old male patient. Medical history was not reported. On 15-NOV-2014 the patient was vaccinated with ZOSTAVAX single dose, subcutaneous in the right arm, lot # K009199, expiration date: 27-SEP-2015. Concomitant therapy was not reported. The pharmacist informed that on 16-NOV-2014 the patient developed a 3-4 inch painful area of redness and warmth at the injection site. The pharmacist suggested the patient to apply cool compress to the area of reaction and to take ibuprofen as needed for pain. The pharmacist was requesting a lot check. There were not laboratories diagnostics performed. The patient's wife sought medical attention speaking with the pharmacist. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-OCT-2014, the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. Healthcare worker reported that a patient accidentally received a dose of (Merck) VARIVAX instead of a dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The registered nurse reported that on 03-NOV-2041, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J011211 (expiration date 31-JUL-2014), 0.65 ml, subcutaneous. No adverse effect reported. No other information was available at this time. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 74 year old female patient reporting on herself. The patient's medical history included shingles. In AUG-2014 the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, lot number and expiration date not reported). On 05-NOV-2014 the patient just contracted shingles but it was worse than when she had shingles before without a vaccine shot. It was a lot more pain and a lot more blisters. At the time of the report the outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-NOV-2014 the patients were vaccinated with an improperly stored dose of (Merck) VARIVAX (strength, route of administration, dose and lot # were not reported). The reporter was not able to provide a cumulative time frame of these excursions, so the total time out of range was not know at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-NOV-2014 the patients were vaccinated with an improperly stored dose of ZOSTAVAX (strength, route of administration, dose and lot # were not reported). The reporter was not able to provide a cumulative time frame of these excursions, so the total time out of range was not known at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient referring on himself with no pertinent medical history and concurrent conditions. On 08-OCT-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU. Dose, route, lot number and expiration date were not reported. Concomitant therapies included methocarbamol, risperidone, clonazepam, FLOMAX and VOLTAREN. On an unknown date in 2014 the patient developed shingles. The outcome of shingles was reported as not recovered. The patient was treated with acyclovir and NORCO. No lab diagnostics studies were performed. The patient sought medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a 61 year old female patient reporting on herself. The patient's pertinent medical history, drug reactions/allergies were not provided. On 20-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, lot # and expiration date were not provided). Co-suspect therapies and concomitant medications were not provided. On 25-NOV-2014, reported as time of the report, the patient had a bump on her neck. The patient did not seek medical attention but she stated that she will call her doctor. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were not provided. Additional information is not expected since no contact information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). The doses were exposed to temperatures of -9.5 degrees C for 1 hour and 43 minutes, and then were administered. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous (lot # and expiration date were not provided). The doses were exposed to temperatures of -9.5 degrees C for 1 hour and 43 minutes, and then were administered. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Medical history included splenectomy. In 2009 (reported as 5 years ago) the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route, lot number and expiration date not reported). On 10-NOV-2014 the patient was vaccinated with a second dose of PNEUMOVAX 23 (dose, route, lot number and expiration date not reported). On 11-NOV-2014 the patient experienced severe injection site reactions from elbow to shoulder, further describes as stiff, painful and swollen. The patient sought medical attention. At the time of the report the outcome of the events was not recovered (reported as events remained ongoing). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient of unknown gender. The reporter stated that the patient was supposed to receive (Oka/Merck) VARIVAX, but inadvertently received ZOSTAVAX 0.5 ml, subcutaneous on 21-NOV-2014. No dose of (Oka/Merck) VARIVAX was administered. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 26-NOV-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. Medical assistant reported that patient was administered PROQUAD (Merck) that had been improperly stored. No adverse effects reported. 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 Licensed Practical Nurse refers to 24 patients of unknown age and gender. On an unknown date the patients were vaccinated improperly stored doses of (Merck) VARIVAX, 0.5 ml, subcutaneous (lot # was not reported). No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Pt. received HPV #2 on 11-24-14. Called office on 11-28-14 stating that pt. has had a headache since then. Headache worse in the AM ad with movement of head from side to side. Pt. taking 2 EXCEDRIN which helps with headache.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 07-NOV-2041 the patient was vaccinated with expired ZOSTAVAX, lot # H019092, expiration date 09-FEB-2014, (dose, dose number, route and anatomical location were unspecified). No concomitant therapies were reported. No adverse symptoms reported. The pharmacist reported that there were no previous temperature excursions and that ZOSTAVAX was not supported with post-expiracy data. The outcome of the events was unknown. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Nuclear magnetic resonance imaging, Pain, Rash
Clinical narrative: This spontaneous report as received from a 78 year old male consumer reporting of himself. None medical history and drug reactions/allergies were provided. In 2013 (a year ago), the patient was vaccinated with the first dose of ZOSTAVAX (route, lot number, expiry date were not reported). It was reported that the patient was on therapy with "Pretizone". On 09-OCT-2014 (also reported as after receiving the ZOSTAVAX), the patient experienced a rash on his left hip and buttocks, 10-11 red spots that did not hurt at all. The reporting consumer also mentioned that he had a stabbing pain in his left knee and soreness after getting out of his jacuzzi. The patient sought medical attention and was prescribed antivirals. Magnetic resonance imaging (MRI) on knee was performed (date and results were not provided). The outcome of the events was unknown. 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 an unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX (dose and lot number was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is linked to MARRS # 1411USA013452 with the same reporter link. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported that injection site area has red, swollen and hot to touch for 3 days after administration. She reported this to pharmacy staff on 11-23-14 at 2:25 PM. She received the vaccine on 11-16-14.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was administered PNEUMOVAX 23 (dose, frequency, route of administration, lot # and expiry date not reported) when the medication got into patient's skin because it was leaking. PQC (product quality complaint) was filed. No adverse effect was reported. Outcome of the event was not reported. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer (patient's husband) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiry date not reported). On an unknown date the patient experienced a case of the shingles after receiving ZOSTAVAX. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with GARDASIL (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. This case is linked to (MARRS# 1411USA011250, 1411USA013446) with the same reporter link. No further information provided. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 4 year old patient of unknown gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 12-SEP-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (injection, lot # K003423, expiry date 06-MAR-2016, 1 shot in the right thigh, route unspecified). Concomitant therapies included Immune Therapeutic Vaccine (ITV), which was vaccinated with at the same time. On an unspecified date, in approximately September 2014, the patient developed a varicella-like blister at injection site after receiving VARIVAX (Merck). The reaction was reported to the office on 17-SEP-2014. The patient did not seek medical attention. No treatment was given for the adverse event. No lab diagnostics study was performed. The outcome of the event was reported as recovered on an unspecified date of 2014. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with RECOMBIVAX HB (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. This case is linked to (MARRS# 1411USA11250, 1411USA013447) with the same reporter link. No further information provided. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This case is linked to (MARRS# 1411USA013447, 1411USA013446) with the same reporter link. No further information provided. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Impaired work ability
Clinical narrative: Severe aches in my joints and muscles, pronounced weakness and fatigue, red, watery and pussy eyes, extreme continual headache and sinus congestion. (I was unable to work)
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Myalgia, Ocular hyperaemia, Purulent discharge, Sinus congestion
Clinical narrative: Severe aches in my joints and muscles, pronounced weakness and fatigue, red, watery and pussy eyes, extreme continual headache and sinus congestion. (I was unable to work)
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe Headache
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder acute and chronic (ache) pain. Possible adhesive capsulitis?
Age: 29.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle oedema
Clinical narrative: Acute edema in all muscles. Inability to move legs after waking from overnight sleep. Abnormal restriction of bodily movement.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Sharp pain in left arm where flu shot was administered. Also, unable to move left arm over head and or to perform activities of daily living without substantial pain.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Gait disturbance, Hypersomnia, Influenza, Injection site erythema
Clinical narrative: Severe red, burn pain from point of vaccine on upper arm to elbow which lasted several days. a week later redness is gone, looks like large bruise and continues to be sensitive.  Could not have a sheet on it because it hurt so much to touch, for several night. Also approx 11 hours later I woke up with severe flu sypmtoms, shaking profusely, temp 103, could barely walk. This lasted severly 3 days but have not been 100 yet and it is a week.  was given tamilflu on 11/24/2014 I went to the pharmacist who administered the shot on 11/26/2014 to show her and get her opinion, she was shocked and said to go to my doctor (I had another appt on Monday and that Dr. gave me the Tamiflu) I went to the doctor but the office closed early for Thanksgiving, so I just went home to sleep.  I slept a lot as well.  The pharmacist called on Thanksgiving to check up which was very nice, she had to look up my information because we really do not know each other but was obviously concerned.  Ironically I began to feel a little better on this day.  As I write I feel better but am still lethargic, I believe my fever went away.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Lethargy, Malaise, Pain, Pyrexia, Tremor
Clinical narrative: Severe red, burn pain from point of vaccine on upper arm to elbow which lasted several days. a week later redness is gone, looks like large bruise and continues to be sensitive.  Could not have a sheet on it because it hurt so much to touch, for several night. Also approx 11 hours later I woke up with severe flu sypmtoms, shaking profusely, temp 103, could barely walk. This lasted severly 3 days but have not been 100 yet and it is a week.  was given tamilflu on 11/24/2014 I went to the pharmacist who administered the shot on 11/26/2014 to show her and get her opinion, she was shocked and said to go to my doctor (I had another appt on Monday and that Dr. gave me the Tamiflu) I went to the doctor but the office closed early for Thanksgiving, so I just went home to sleep.  I slept a lot as well.  The pharmacist called on Thanksgiving to check up which was very nice, she had to look up my information because we really do not know each other but was obviously concerned.  Ironically I began to feel a little better on this day.  As I write I feel better but am still lethargic, I believe my fever went away.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site reaction
Clinical narrative: Severe red, burn pain from point of vaccine on upper arm to elbow which lasted several days. a week later redness is gone, looks like large bruise and continues to be sensitive.  Could not have a sheet on it because it hurt so much to touch, for several night. Also approx 11 hours later I woke up with severe flu sypmtoms, shaking profusely, temp 103, could barely walk. This lasted severly 3 days but have not been 100 yet and it is a week.  was given tamilflu on 11/24/2014 I went to the pharmacist who administered the shot on 11/26/2014 to show her and get her opinion, she was shocked and said to go to my doctor (I had another appt on Monday and that Dr. gave me the Tamiflu) I went to the doctor but the office closed early for Thanksgiving, so I just went home to sleep.  I slept a lot as well.  The pharmacist called on Thanksgiving to check up which was very nice, she had to look up my information because we really do not know each other but was obviously concerned.  Ironically I began to feel a little better on this day.  As I write I feel better but am still lethargic, I believe my fever went away.
Age: 1.73
Sex: F
Vaccine: DTPHIB
Symptoms: Convulsion, Cough, Crying, Discomfort, Dyskinesia
Clinical narrative: Convulsing. Jerking of limbs. Gasping for breath. Coughing. Extreme discomfort. Inconsolable crying. Severe swelling rash and redness around injection site. Vomiting. Child was given Advil for pain doctor said not to take child to ER unless childs condition continues to increase in severity.
Age: 1.73
Sex: F
Vaccine: DTPHIB
Symptoms: Dyspnoea, Injection site erythema, Injection site rash, Injection site swelling, Vomiting
Clinical narrative: Convulsing. Jerking of limbs. Gasping for breath. Coughing. Extreme discomfort. Inconsolable crying. Severe swelling rash and redness around injection site. Vomiting. Child was given Advil for pain doctor said not to take child to ER unless childs condition continues to increase in severity.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Hypoaesthesia, Impaired work ability, Injection site pain, Middle insomnia
Clinical narrative: I went to pharmacy to receive my flu shot. I have had many flu shots before but this is different. The pharmacist seemed hurried I guess that should had been a sign but I know they were very busy that day. I went with my mother we both got shots the same day right at the same time. I felt the prick of the needle but honestly no burning I was very relaxed being I had in the past went through 10 years of depo shots, so needles don't bother me, I knew I would have some pain and burning but I kid you not this is nothing like I had ever had before. I have severe pain daily from the injection site going down my arm into my elbow and forearm including tingling numbing feeling in my fingers as well. If I lay on that arm or roll over on it in my sleep it goes completely numb and will wake me up in terrible pain. Extending my arm out or lifting any kind of weight makes it worse. Typing or using the arm hurts to the point of where I have to stop and rest it. I am going to the ER tomorrow, I just don't know what this is I think maybe she broke the needle off in my arm or something. I looked up side effects and nothing, I read where most injection site pain ends in three days, it's been far longer than that and hasn't gotten any better at all, and lifting is a huge part of my job. Without lifting I can't work, no work = no money. I mean this is just crazy and I'm tired of the pain and want to get better.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Paraesthesia, Weight bearing difficulty
Clinical narrative: I went to pharmacy to receive my flu shot. I have had many flu shots before but this is different. The pharmacist seemed hurried I guess that should had been a sign but I know they were very busy that day. I went with my mother we both got shots the same day right at the same time. I felt the prick of the needle but honestly no burning I was very relaxed being I had in the past went through 10 years of depo shots, so needles don't bother me, I knew I would have some pain and burning but I kid you not this is nothing like I had ever had before. I have severe pain daily from the injection site going down my arm into my elbow and forearm including tingling numbing feeling in my fingers as well. If I lay on that arm or roll over on it in my sleep it goes completely numb and will wake me up in terrible pain. Extending my arm out or lifting any kind of weight makes it worse. Typing or using the arm hurts to the point of where I have to stop and rest it. I am going to the ER tomorrow, I just don't know what this is I think maybe she broke the needle off in my arm or something. I looked up side effects and nothing, I read where most injection site pain ends in three days, it's been far longer than that and hasn't gotten any better at all, and lifting is a huge part of my job. Without lifting I can't work, no work = no money. I mean this is just crazy and I'm tired of the pain and want to get better.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Woke up from laying on right side with left arm slung over partner. Extreme pain in left shoulder joint & left upper back. Pain & numbness down backside of arm. Numbness & tingling in fingers.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Influenza like illness, Malaise, Pain, Pain in extremity
Clinical narrative: Patient reports increase pain on movement of left arm followed by numbness and tingling to left arm. Pt reports she did become sick with flu-like symptoms and did take Theraflu and Alka-Seltzer on 29 November 2014 (two days ago).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient reports increase pain on movement of left arm followed by numbness and tingling to left arm. Pt reports she did become sick with flu-like symptoms and did take Theraflu and Alka-Seltzer on 29 November 2014 (two days ago).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Lethargy, Pyrexia
Clinical narrative: Reported to pharmacy 11/29/2014.  Described fever, redness and itching at the sight and below sight of the injection, and lethargy.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient arm/shoulder was swollen so patient went to ER that night. Patient was prescribed Benadryl, pain killers, and steroid and was sent home.