chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Influenza like illness, Injection site discolouration, Injection site pain
Clinical narrative: 10/3/14 - noon - rec shot. 10/4/14 - pt woke up with severe flu like sx (HA and increased fever) and inj site swelling/hot/tender size about 1/2 dollar. 10/5/14 Flu sx a little better - arm had halo around site and was getting bigger. 10/6/14 - flu sx gone - saw Dr - Dx cellulitis - Rx KEFLEX - area on arm getting larger. 10/9/14 saw Dr - Didn't think it was cellulitis but advised pt to finish KEFLEX. Felt it was a very bad rxn to the vaccine and would take "a while" to go away. 10/11/14 - lightened up in color and has not shrinking in size - now like a bulls eye and still tender. Is in process of recovering.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 10/3/14 - noon - rec shot. 10/4/14 - pt woke up with severe flu like sx (HA and increased fever) and inj site swelling/hot/tender size about 1/2 dollar. 10/5/14 Flu sx a little better - arm had halo around site and was getting bigger. 10/6/14 - flu sx gone - saw Dr - Dx cellulitis - Rx KEFLEX - area on arm getting larger. 10/9/14 saw Dr - Didn't think it was cellulitis but advised pt to finish KEFLEX. Felt it was a very bad rxn to the vaccine and would take "a while" to go away. 10/11/14 - lightened up in color and has not shrinking in size - now like a bulls eye and still tender. Is in process of recovering.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unkonwn dates (reported as several years ago, number of years was unknown) the patient was vaccinated with the first two doses of GARDASIL (exact dose, route, lot# and expiration date were not reported) and at the time of the report (reported as "now") the patient was in the office asking if she could receive the third PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (nurse) refers to a patient of unknown age and demographics. Medical history and current conditions were not reported. On 17-JUL-2009, the patient was vaccinated with RECOMBIVAX HB dose 1, for unknown indication. Concomitant mediations were not reported. On 08-SEP-2014, the patient was vaccinated with RECOMBIVAX HB dose 2, for unknown indication. No adverse experience was reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. Medical history and current conditions were not reported. On 03-OCT-2014 the patient was vaccinated with ZOSTAVAX, 0.65 milliliter, subcutaneous for unknown indication. Concomitant medications were not reported. On 03-OCT-2014, patient received a dose of ZOSTAVAX that underwent a temperature excursion. It was reported that the patient experienced no adverse experience. Product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date in 2009, the patient was vaccinated with GARDASIL dose 1, for the prevention of HPV (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with GARDASIL dose 2, for the prevention of HPV (dose, route and frequency were not reported). The patient did not follow the recommended dosing schedule. Treatment was not given. The representative could not confirm if the patient received a 3rd dose. No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 06-OCT-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K009769, expiration date: 09-OCT-2015, subcutaneous for to prevent shingles. Concomitant therapies included Lisinopril (Manufacturer unspecified), hydrochlorothiazide (reported as HCTZ) Metformin, LIPITOR, Omeprazole (Manufacturer unspecified) and potassium chloride (Manufacturer unspecified). On 08-OCT-2014,the patient experienced redness, swelling and warmth at the injection site following the administration of ZOSTAVAX. There was no treatment given for adverse events and no lab diagnostics studies performed. The outcome of redness, swelling and warmth at the injection site was reported as recovering/resolving. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with asthma and hypercholesterolemia. No known allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route of administration, dose, lot number, anatomical location was unknown). Concomitant medications were unspecified by reporter. The reporter stated that on an unknown date the patient had an injection site reaction, the patient's injection site was red and slightly swollen. She was also experiencing numbness in her hand and fingers. The patient was advised to take acetaminophen as needed. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient received GARDASIL 0.5 ml (lot numbers and expiration dates were not reported), intramuscular in her gluteal muscle on the following dates: 11-JAN-2007 (first doe), 15-MAR-2007 (second dose) and 17-SEP-2007 (third dose). The pharmacist reported that the patient was very think and did not want injections in her arm. The pharmacist also reported that in the documentation in the patient's chart had the first two GARDASIL injections documented as "RDL" and the third injection documented as "LVL". No adverse effects were reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 27 year old female patient with none pertinent medical history drug reactions or allergies. On 23-SEP-2014 the patient was vaccinated with GARDASIL (in the gluteus maximus, dose, units, route of administration, lot number were not reported) instead of RHOGAM (anti-Rh gamma globulin). None concomitant medications was reported. Then, the patient was administered a second injection which was the correct dose of RHOGAM (anti-Rh gamma globulin) without incident. The patient became pregnant with LMP (last menstrual period) of February 2014 (reported as 7 months). Initial exposure to GARDASIL was at 28 weeks. The pregnancy outcome was not reported. The patient also stated that in 2009 (reported as when she was about 22 years old) the received one dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) but the series of three was not completed. The patient did not experience any adverse reactions GARDASIL. There was no treatment given for the event. None lab diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 27 year old female patient with none pertinent medical history drug reactions or allergies. On 23-SEP-2014 the patient was vaccinated with GARDASIL (in the gluteus maximus, dose, units, route of administration, lot number were not reported) instead of RHOGAM (anti-Rh gamma globulin). None concomitant medications was reported. Then, the patient was administered a second injection which was the correct dose of RHOGAM (anti-Rh gamma globulin) without incident. The patient became pregnant with LMP (last menstrual period) of February 2014 (reported as 7 months). Initial exposure to GARDASIL was at 28 weeks. The pregnancy outcome was not reported. The patient also stated that in 2009 (reported as when she was about 22 years old) the received one dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) but the series of three was not completed. The patient did not experience any adverse reactions GARDASIL. There was no treatment given for the event. None lab diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: Lips were swollen; Arm/injection site red/tender: W/in 8-12 hrs of injection.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fevers up to 101.8 degrees F, headache, myalgias, right upper arm pain and local erythema. Treatment: TYLENOL, ADVIL.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Headache, Vomiting
Clinical narrative: Donor felt stomach upset, head was hurting, and threw up about 24 hours after 10/11/14 injection was administered. Referred to HCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Rash
Clinical narrative: Patient said she had a low grade fever for 3 days following vaccination and flu-like symptoms. She had a rash on arm as big as "potato" in her words which was bigger the 4th day when she called pharmacy. Pt was feeling better by 5th day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Pain
Clinical narrative: Thurs (next day) - quarter size area bright red, pain, extreme pain at ZOSTAVAX site. Friday - Area bigger - still painful and swollen. - Temperature - normal / severe headache. Pt feeling better on 10/11/14.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a pharmacist refers to a paediatric patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with a 0.5 ml pediatric dose of VAQTA (route not reported) from a 50U/1-mL single use VAQTA vial intended for adult patients. No adverse symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Viral titre increased
Clinical narrative: This spontaneous report as received from a female patient (also healthcare professional) of unknown age regarding herself. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with HEPTAVAX-B VIAL 10/0.5 for an unknown indication (dose, route were not reported). Concomitant medications were not reported. On an unknown date, the patient reported that she received a booster dose of HEPTAVAX-B VIAL 10/0.5 and mentioned she had high titers approximately 30 days after vaccination. The outcome of high titers was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Erythema, Local swelling, Nervousness
Clinical narrative: This spontaneous report as received from a consumer regarding herself refers to a 63 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The patient reported side effects she was experiencing with the ZOSTAVAX. Approximately on an unknown date in May 2012 the patient was vaccinated with ZOSTAVAX (dose strength, route not reported) in the left arm. The reporter stated that she said that a little after she got ZOSTAVAX administered in approximately on an unknown date in May 2012 she started experiencing like something wanted to come out of her body, nervousness and some chest pains approximately on an unknown date in 2012. The patient got heart calf done in October 2012 in a hospital and everything was ok with her heart. Approximately on an unknown date in March 2013 the patient started experiencing more tingling sensations in her toes, fingers, mouth and lips and stated that these symptoms came in spurts. Approximately on an unknown date in April 2014 the patient experienced swelling on hands and feet and getting big red marks on her body then they start fading into black and blue marks. The patient consulted a doctor and advised her these symptoms she was having is do to the ZOSTAVAX. The patient was not treated for all these events. The outcome of events reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral, Sensory disturbance, Skin discolouration
Clinical narrative: This spontaneous report as received from a consumer regarding herself refers to a 63 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The patient reported side effects she was experiencing with the ZOSTAVAX. Approximately on an unknown date in May 2012 the patient was vaccinated with ZOSTAVAX (dose strength, route not reported) in the left arm. The reporter stated that she said that a little after she got ZOSTAVAX administered in approximately on an unknown date in May 2012 she started experiencing like something wanted to come out of her body, nervousness and some chest pains approximately on an unknown date in 2012. The patient got heart calf done in October 2012 in a hospital and everything was ok with her heart. Approximately on an unknown date in March 2013 the patient started experiencing more tingling sensations in her toes, fingers, mouth and lips and stated that these symptoms came in spurts. Approximately on an unknown date in April 2014 the patient experienced swelling on hands and feet and getting big red marks on her body then they start fading into black and blue marks. The patient consulted a doctor and advised her these symptoms she was having is do to the ZOSTAVAX. The patient was not treated for all these events. The outcome of events reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Chills, fever (101 degrees), body aches, headache, sore throat. Fever broke after 12 hours.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Headache, Pain, Vertigo, Vision blurred
Clinical narrative: Extreme vertigo, unable to focus vision, unable to walk upright for any distance. Accompanied by headache and general body pain. Vertigo still present on 10/12/2014 but lessened.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Dizziness, Gait disturbance, Mobility decreased
Clinical narrative: Extreme vertigo, unable to focus vision, unable to walk upright for any distance. Accompanied by headache and general body pain. Vertigo still present on 10/12/2014 but lessened.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain in shoulder going down into right hand. Tingly feeling going down arm into hand. Can not move shoulder away from body without sharp pain. Right hand is also weaker.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Haemorrhage, Skin exfoliation, Swelling
Clinical narrative: Patient has redness, swelling and skin pulled off about the size of a quarter, some bleeding.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT RECEIVED FLU VACCINE, APPROXIMATELY 3 MINUTES FOLLOWING ADMINISTRATION PATIENT STOOD UP AND REPORTED FEELING DIZZY.  THE PATIENT WAS RESEATED.  PATIENT AGAIN REPORTED DIZZINESS AND FAINTED.  PATIENT WAS LAID DOWN ON THE GROUND AND HIS FEET WERE ELEVATED AT WHICH POINT HE BECAME RESPONSIVE.  EMT SERVICES HAD BEEN INITIATED AND PATIENTS VITALS WERE TAKEN UPON THEIR ARRIVAL.  VITALS WERE UNREMARKABLE AND WITHIN NORMAL LIMITS.  PATIENT DECLINED ANY ADDITIONAL SERVICES INCLUDING TRANSPORT TO HOSPITAL AND WAS ABLE TO TRAVEL HOME SAFELY WITHOUT ADDITIONAL ASSISTANCE.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Ear pain, Pain, Pain in jaw
Clinical narrative: Just wanted to let you know I have had a flu shot every year and this is the first time I have been really sick from it. Not life threatening, but a very strong reaction. I am a nurse and have had vaccine many times. This time it started with a sharp pain in my ear, traveled down my jaw and into my spine. Then I developed a fever, body aches and weakness as well as abdominal pains, that lasted for 3 days. I am finally feeling better, but I wanted to let you know that this was my experience with this injection this time. Afluria. 0.5 ml. I realize you probably want more serious side effects reported, but this was way more debilitating than any I have ever had so I wanted to share this with you. Two years ago I had the flu shot and I had such pain in my arm I had to have PT to lift my arm after the pain continued for over six weeks. This time my arm is just sore, but the physical side effects are way stronger.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Spinal pain
Clinical narrative: Just wanted to let you know I have had a flu shot every year and this is the first time I have been really sick from it. Not life threatening, but a very strong reaction. I am a nurse and have had vaccine many times. This time it started with a sharp pain in my ear, traveled down my jaw and into my spine. Then I developed a fever, body aches and weakness as well as abdominal pains, that lasted for 3 days. I am finally feeling better, but I wanted to let you know that this was my experience with this injection this time. Afluria. 0.5 ml. I realize you probably want more serious side effects reported, but this was way more debilitating than any I have ever had so I wanted to share this with you. Two years ago I had the flu shot and I had such pain in my arm I had to have PT to lift my arm after the pain continued for over six weeks. This time my arm is just sore, but the physical side effects are way stronger.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Dizziness, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Became very dizzy, fainted, vomited, had severe muscle and joint pain and pain at the injection site. Unable to lift arm above head.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Syncope, Vomiting
Clinical narrative: Became very dizzy, fainted, vomited, had severe muscle and joint pain and pain at the injection site. Unable to lift arm above head.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Local swelling, Pruritus
Clinical narrative: Patient is reporting a 4 inch diameter hard bump that is itchy.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Oral herpes
Clinical narrative: Cold sore eruption on lip and palate.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Headache, fever, chills/whole body shivering, weakness, malaise, finger numbness, aching thoughout injection arm. Pt feeling better on 11/12/2014 but still feels bad.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, chills/whole body shivering, weakness, malaise, finger numbness, aching thoughout injection arm. Pt feeling better on 11/12/2014 but still feels bad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade temp., extreme soreness in upper arm, hurts to move. Ibuprofen for fever, bedrest, not use arm, red swath across upper arm,  temp gone, soreness easing but redness still apparent after 2 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Cold sore developing on upper left lip. I have no cold, and have not been in the sun, and have not had a cold sore in several years.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling drunk, Thinking abnormal
Clinical narrative: Feeling dizzy, intoxicated. Faint. Cannot think straight.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became swollen, red and hot. Patient was questioned about reactions to injections before.  Patient discussed being treated for hives related to allergic reaction when having infections.  Patient then said they felt faint.  I retrieved Epi-Pen and 0.3mg was administered. Patient then bucked back and her eyes rolled back in head.  Patient then started to speak, but had no recollection of the possible seizure. She was very relaxed but speaking when the EMS arrived.  They took her vitals, that were low but normal.  She was referred to go to the emergency room by the EMS.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Opisthotonus
Clinical narrative: Injection site became swollen, red and hot. Patient was questioned about reactions to injections before.  Patient discussed being treated for hives related to allergic reaction when having infections.  Patient then said they felt faint.  I retrieved Epi-Pen and 0.3mg was administered. Patient then bucked back and her eyes rolled back in head.  Patient then started to speak, but had no recollection of the possible seizure. She was very relaxed but speaking when the EMS arrived.  They took her vitals, that were low but normal.  She was referred to go to the emergency room by the EMS.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Impaired work ability, Muscle spasms, Myalgia, Serum sickness
Clinical narrative: Symptoms began next morning after vaccing administered.  Patient states tongue felt dry and "hairy". She kept drinking plenty of fluids and my Friday she had to leave work because all her muscles and joints in head and neck were achy and felt like she had been "hit by a truck". she took Tylenol and Benadryl and slept all day Friday and Saturday. went to ER Sunday and was diagnosed with serum sicknes.  No rash. She also had muscle jerks and was given IV saline for hydration.  Went to PCP on Monday and was prescribed Ativan. Went to neurologist Tuesday and prescribed prednisone for 5 day taper and Benadryl for tongue symptoms.  She did not work all week and has follow-up neuro appt on Monday oct 13, 2014. Patient states she received the influenza vaccine every year since 1999.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue discolouration, Tongue dry
Clinical narrative: Symptoms began next morning after vaccing administered.  Patient states tongue felt dry and "hairy". She kept drinking plenty of fluids and my Friday she had to leave work because all her muscles and joints in head and neck were achy and felt like she had been "hit by a truck". she took Tylenol and Benadryl and slept all day Friday and Saturday. went to ER Sunday and was diagnosed with serum sicknes.  No rash. She also had muscle jerks and was given IV saline for hydration.  Went to PCP on Monday and was prescribed Ativan. Went to neurologist Tuesday and prescribed prednisone for 5 day taper and Benadryl for tongue symptoms.  She did not work all week and has follow-up neuro appt on Monday oct 13, 2014. Patient states she received the influenza vaccine every year since 1999.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Malaise, Pruritus
Clinical narrative: Patient presented with red welt at injection site. It was warm to the touch and she began to feel "sick" and the are began to itch.  After monitoring the site for 24 hours the welt did not get larger or smaller.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient presented with red welt at injection site. It was warm to the touch and she began to feel "sick" and the are began to itch.  After monitoring the site for 24 hours the welt did not get larger or smaller.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Headache, Impaired driving ability, Injection site erythema, Injection site swelling
Clinical narrative: Pt. called today stating that since the flu shot her left arm has been hurting, she never had such problem with flu shots before. She states that she has been hurting a lot, has taken meloxicam and morphine that she got from her PCP for back problems for the pain but it is not relieved. The site is red and swollen and she is unable to dress herself or do anything with the arm. Has been uanble to sleep because of pain. Pain radiating to her neck and has headaches as well. I advised her to come into the clinic so I could check for the reaction but she refused stating that her arm hurts her too much and she is unable to drive. So I advised her to call 911 and seek help at the emergency room but she refused that as well due to cost. She states that she would go to her doctor tomorrow. Advised her to call her doctor today and not delay it to see what they can do remotely. I informed my market manager oncall and market educator on call as well.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Neck pain, Pain in extremity
Clinical narrative: Pt. called today stating that since the flu shot her left arm has been hurting, she never had such problem with flu shots before. She states that she has been hurting a lot, has taken meloxicam and morphine that she got from her PCP for back problems for the pain but it is not relieved. The site is red and swollen and she is unable to dress herself or do anything with the arm. Has been uanble to sleep because of pain. Pain radiating to her neck and has headaches as well. I advised her to come into the clinic so I could check for the reaction but she refused stating that her arm hurts her too much and she is unable to drive. So I advised her to call 911 and seek help at the emergency room but she refused that as well due to cost. She states that she would go to her doctor tomorrow. Advised her to call her doctor today and not delay it to see what they can do remotely. I informed my market manager oncall and market educator on call as well.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Electromyogram, Hypoaesthesia, Injection site nodule, Nerve conduction studies, Pain in extremity
Clinical narrative: Pain and numbness radiating down the left are and a knot at the injection site - reported it to doctor on 12/24/2013, in March 2014, July 2014 and September 2014. Was referred to a neurologist and am no receiving physical therapy.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling, redness and pain to touch at point of inoculation 2 days. (Left triceps.) Reduced swelling and pain transition to itchiness for next 2 days. Mild fever and swollen glands for two days.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling, redness and pain to touch at point of inoculation 2 days. (Left triceps.) Reduced swelling and pain transition to itchiness for next 2 days. Mild fever and swollen glands for two days.
Age: 0.72
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, Malaise
Clinical narrative: I was advised by Dr. of the CDC to report this as an administration error.  My grandson was mistakenly given the nasal flu vaccine with live cultures, even though only the flu shot without the live culture is approved for children under the age of 24 months.  The mistake was caught after the vaccine was administered in one nostril only.  The healthcare facility then contacted the vaccine manufacturer and decided that the patient should also be given the flu shot. Approximately 10 days later the child became ill and he has an appointment with a physician on Monday, October 13, 2014.
Age: 56.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Localised oedema, Skin warm, Tenderness
Clinical narrative: Local edema and reddening, tender & warm to touch.
Age: 12.0
Sex: F
Vaccine: FLUX, MNQ, TDAP
Symptoms: Erythema, Eye pain, Fatigue, Induration, Pain
Clinical narrative: Swelling and hardness, redness of left arm, fever 102.4, body aches, eye pain, fatigue, upset.
Age: 12.0
Sex: F
Vaccine: FLUX, MNQ, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling and hardness, redness of left arm, fever 102.4, body aches, eye pain, fatigue, upset.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 28.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Syncope
Clinical narrative: Patient fainted, hit his head on the floor upon falling, within 2-3 minutes after standing after flu vaccination.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: 10/10/14 Patient called and stated she had received a flu shot about 3 weeks ago. Arm was sore yet, with pain, weakness and some limited mobility.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: 12-18 hrs after shot, pt developed large, warm red area on entire upper arm. This reaction lasted about 24 hrs. Was swollen at some parts of injection site. Arm returned to normal after 24 hrs.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness in her arm from where she wad given the shot (deltoid) down to her elbow. Also experiencing warmth in the affected arm but no pain.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 21.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 45.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 22.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 26.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No symptoms at this time.
Age: 23.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 43.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 24.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Groin pain, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 69 year old female patient. Patient was not pregnant. Medical history and current conditions were not reported. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, lot # K000327, expiry date 05-MAR-2015, via an unknown route (dose and frequency was not reported). Concomitant therapies included VYVANSE 30 milligram (mg), BUPROPION XL 150 mg, progesterol 100 mg and baby aspirin. On 04-OCT-2014, the patient experienced horrible headache, fever, injection site was little red, swelling and itching at the injection site and pain in her groin. The pharmacist reports that the patient reports that the swelling was of the size of "half od a large apple". Patient sought medical attention by calling the pharmacy and her dermatologist for advice. Treatment rendered for the events included CLARITIN, ZOVIR AX (only used once), and patient put ice on her arm. Lab tests were performed. The outcome of pain in her groin, fever, swelling at the injection site and horrible headache was reported as recovered on approximately in October 2014. The outcome of itching at the injection site was reported as not recovered. The outcome of injection site little red was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old female patient with allergy to lisinopril, aspirin, TYLENOL, non steroidal anti inflammatory drugs (NSAIDS). On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 in the arm (reported as right deltoid region) (dose and route of administration was unknown) for vaccination. Concomitant therapies included doxepin hydrochloride, cetirizine hydrochloride, vitamins (unspecified), FLOVENT HFA, fluticasone, SYNTHROID, amlodipine and PREMARIN. On 24-SEP-2014 the patient experienced redness, swelling and pain in her right shoulder that spread to her back and down her right arm. The reporter stated that the patient had visited physician on 25-SEP-2014 and was noted to have redness and minor edema on the right shoulder and down her arm. It was later found that the patient also had the PNEUMOVAX 23 (0.5 ml, intramuscular, lot# J04332, expiry date: 26-SEP-2014, in the arm) on an unknown date in August 2013. The patient was treated with BENADRYL. An X-ray of the right shoulder was completed on an unspecified date and noted to be within normal limits. The outcome of the events was reported as recovered/resolved on 07-OCT-2014. The causality was unknown. No further information provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, X-ray limb normal
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old female patient with allergy to lisinopril, aspirin, TYLENOL, non steroidal anti inflammatory drugs (NSAIDS). On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 in the arm (reported as right deltoid region) (dose and route of administration was unknown) for vaccination. Concomitant therapies included doxepin hydrochloride, cetirizine hydrochloride, vitamins (unspecified), FLOVENT HFA, fluticasone, SYNTHROID, amlodipine and PREMARIN. On 24-SEP-2014 the patient experienced redness, swelling and pain in her right shoulder that spread to her back and down her right arm. The reporter stated that the patient had visited physician on 25-SEP-2014 and was noted to have redness and minor edema on the right shoulder and down her arm. It was later found that the patient also had the PNEUMOVAX 23 (0.5 ml, intramuscular, lot# J04332, expiry date: 26-SEP-2014, in the arm) on an unknown date in August 2013. The patient was treated with BENADRYL. An X-ray of the right shoulder was completed on an unspecified date and noted to be within normal limits. The outcome of the events was reported as recovered/resolved on 07-OCT-2014. The causality was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that the patient was administered a 2nd dose of PNEUMOVAX 23 (dose, route of administration and anatomical location was unknown) on 08-OCT-2014, while the first dose was administered approximately on 17-SEP-2014 (reported as 2 to 3 weeks ago). Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effect was reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Malaise, Vaccination complication
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection , dose route and frequency were not provided). The patient then called the physician's office on an unspecified date and stated that she, the patient, had an unspecified allergic reaction to the PNEUMOVAX 23 and visited an unspecified emergency room. The patient was not admitted to the hospital. The patient also stated that she did not feel well after receiving the vaccine. The outcome of the events was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cardiac murmur, Computerised tomogram head normal, Echocardiogram normal, Electrocardiogram abnormal, Hypersensitivity
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection , dose route and frequency were not provided). The patient then called the physician's office on an unspecified date and stated that she, the patient, had an unspecified allergic reaction to the PNEUMOVAX 23 and visited an unspecified emergency room. The patient was not admitted to the hospital. The patient also stated that she did not feel well after receiving the vaccine. The outcome of the events was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Loss of consciousness, Malaise, Sinus bradycardia, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection , dose route and frequency were not provided). The patient then called the physician's office on an unspecified date and stated that she, the patient, had an unspecified allergic reaction to the PNEUMOVAX 23 and visited an unspecified emergency room. The patient was not admitted to the hospital. The patient also stated that she did not feel well after receiving the vaccine. The outcome of the events was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 4 patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date the patients was vaccinated with PNEUMOVAX 23 (lot # K007773, expiry date: 01-MAY-2015, dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced injection site reactions of redness, fever and itching at the injection site. The outcome of reactions of redness and itching at the injection site was reported as recovered/resolved. The outcome of fever was unknown. The causality was unknown. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K009105, expiry date: 21-JAN-2016, dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patients "broke out" in fever and chills. The outcome of fever and chills was reported as recovered/resolved without treatment. The causality was unknown. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from medical assistant, concerning a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (dose, lot # was unknown) instead of a dose ZOSTAVAX (dose and route was unknown) inadvertently. No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to about 25 patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reported stated that on unspecified dates between 26-SEP-2014 and 07-OCT-2014 (Merck) VARIVAX was improperly exposed to -10 degrees C for short (unspecified) time frames, and however the average temperature has been kept in the correct range of < -15 degrees C. It was also reported that about 25 patients received one of these vaccines (related case 1410USA005552) approximately on an unknown date in 2014 (reported as unspecified dates during this time frame of 26-SEP-2014 to 07-OCT-2014). No know adverse effects. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA005552 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to about 25 patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reproter stated that on unspecified dates between improperly exposed to -10 degrees C for short (unspecified) time frames, and however the average temperature has been kept in the correct range of <-15 degrees C. It was also reported that about 25 patients received one of these vaccines (related case 1410USA004844) approximately on an unknown date in 2014 (reported as unspecified dates during this time frame of 26-SEP-2014 to 07-OCT-2014). No known adverse effects. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA004844 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (licensed practical nurse) refers to a patient of unknown age. Medical history and current condition were not reported. On an unkonwn date, the patient was vaccinated with PROQUAD (Merck), 0.5 milliliter, subcutaneous. Concomitant medications were not reported. It was reported that PROQUAD (Merck), was exposed to temperatures warmer than -15 degrees Celsius (C) but no warmer than -8.5 degrees C on 17 different occasions for a total time of 17 hours out of range, have been administered. No adverse effect reported. No product quality complaint reported. This case is linked to 1410USA003460 (same reporter). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (licensed practical nurse) refers to a patient of unknown age. Medical history and current condition were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 milliliter, subcutaneous for unknown indication. Concomitant medications were not reported. It was reported that (Oka/Merck) VARIVAX was exposed to temperature warmer than -15 degrees Celsius (C) but no warmer than -8.5 degrees C on 17 different occasions for a total time of 17 hours out of range, have been administered. No adverse effect reported. No product quality complaint reported. This case is linked to 1410USA005550 (same reporter). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. Since July 2014, unspecified patients were vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose not reported, orally). No adverse effects were reported. This is one of the several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a physician is also the patient in this case of unknown age reported to the representative regarding himself/herself. Medical history and current conditions were not reported. On 02-OCT-2014, the patient was vaccinated with 1 single shot of ZOSTAVAX vial, via an unknown route. Concomitant medications were not reported. On 02-OCT-2014, the patient experienced huge red reaction at the injection site. Lab diagnostics were not performed. The outcome of huge red reaction at the injection site was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old female patient. No information about medical history, drug reactions and allergies was specified. On 17-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter MARRs # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585 and 1410USA005587). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Pt passed out and had muscle jerks after admin. of flu shot.