chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sinus congestion
Clinical narrative: Initial report received from healthcare professional on 24 September 2014. Follow-up information received from the pharmacist on 03 February 2015 provided the information that the patient was hospitalized; as a result, the case has been upgraded to serious. A 92-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5016AA, intramuscular and anatomical site of administration was not reported) having expiry date 29 March 2015 on 10 September 2014. It was reported that on 10 September 2014, on the same day after receiving FLUZONE HD vaccine, the patient experienced head congestion and cough. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Follow-up information for this unsolicited report was received from the pharmacist on 03 February 2015. The vaccine was administered in the left deltoid; no previous vaccines were given in 2014. According to the reporter, the patient was hospitalized for 2 days, and the event fully recovered. The event has been upgraded to serious. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blister, Bone pain, Death, Impaired driving ability
Clinical narrative: Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient's medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient's daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient's daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Oxygen supplementation, Peripheral swelling, Pneumonia
Clinical narrative: Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient's medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient's daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient's daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash pruritic
Clinical narrative: Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient's medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient's daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient's daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.
Sex: U
Vaccine: DTP
Symptoms: Febrile convulsion
Clinical narrative: Initial unsolicited report was received on 02 February 2015 from a healthcare professional (registered nurse). This reporter also reported one other non-serious adverse event which is captured in case number 2015SA013040, same reporter, same product, different patient. An unidentified patient, gender and date of birth not reported who is currently in their 30's received DTP vaccine as a child on an unreported date (manufacturer, batch, route and site of administration were not reported). The patient experienced a febrile seizure on an unspecified date and time. The patient's medical history and concurrent medications were not reported. Treatment details were not reported. The patient recovered on an unreported date. Documents held by sender: None.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: No adverse event. Pt was given vaccine incorrectly. The Rotarix vaccine was not mixed with the diluent. Patient only received the diluent no vaccine.
Age: 0.51
Sex: U
Vaccine: RV1
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient. On 12-AUG-2014, the patient was vaccinated with the first dose of ROTATEQ (lot # not reported) orally. On 27-OCT-2014, the patient received the second dose of ROTATEQ (lot # not reported) orally and on 04-DEC-2014, the patient received a dose of ROTARIX to complete the 3 dose schedule of rotavirus vaccine. The ROTARIX was given at the patient's age of approximately 24 weeks and 3 days. The physician stated that this was outside of the dosing schedule for ROTARIX. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: HIV test positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of human immunodeficiency virus test positive in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLULAVAL TETRA (unknown route and injection site, batch number not provided). In February 2014, less than one year after vaccination with FLULAVAL TETRA, the subject was tested positive for Human Immunodeficiency Virus. At the time of reporting, the outcome of the event was unspecified. The pharmacist wondered if FLULAVAL TETRA could cause false-positive readings for HIV.
Sex: F
Vaccine: HPV4
Symptoms: Aphonia
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). The consumer mentioned that a friend of hers, whose daughter experienced aphonia described as the patient could no longer speak after getting GARDASIL shot (onset date was not specified). Upon internal review aphonia was considered medically significant. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of oral, ROTATEQ dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This is one of several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Pain to left arm that started a few hours after administration described as throbbing, numbess to (L) hand thumb, index and middle fingers.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Tinnitus
Clinical narrative: Ringing in the ears. Bad flu symptoms.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pharyngeal oedema, Swollen tongue
Clinical narrative: About 4 P.M.  I started swelling in my lips, tongue and throat area. Went to hospital for care.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Muscle fatigue
Clinical narrative: Severe pain in the injection muscle and surrounding area for 48 hours. Arm was tender to the touch. Severe neck pain began in the left side, closest to the injection area, then spread to both sides of the neck. The neck pain lasted an entire week. Muscle fatigue, general fatigue, chills, fever, massive amount of sweating especially when trying to sleep.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pyrexia, Tenderness
Clinical narrative: Severe pain in the injection muscle and surrounding area for 48 hours. Arm was tender to the touch. Severe neck pain began in the left side, closest to the injection area, then spread to both sides of the neck. The neck pain lasted an entire week. Muscle fatigue, general fatigue, chills, fever, massive amount of sweating especially when trying to sleep.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Blood uric acid increased, Gout, Oedema peripheral
Clinical narrative: Gouty edema lower legs & feet. By the 25th was unable to walk. Hospitalized from Dec 30th to Jan 3rd. Blood tests revealed a dramatic increase in uric acid level.
Age: 0.84
Sex: M
Vaccine: DTPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NORMAL.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient left pharmacy premises immediately after vaccination, against the advice of the myself the vaccinating pharmacist. Patient reported that maybe 10 min after leaving, while driving home, he experienced chest tightness (shortness of breath) and felt faint. He pulled over and called 911, he was taken to the hospital and was discharged 2/6/15. Patient did not recall names of medications he was treated with at the hospital. He came to the pharmacy 2/7/15 to inform us of the event and to fill some prescriptions given to him at discharge.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Pain, Ultrasound scan
Clinical narrative: Influenza vaccination administered on 10-16-14 resulted in intense pain, decreased range of motion and weakness/loss of functionality.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: While standing at checkout window child passed out for 1-2 min. She then came to, when trying to get her into a chair she passed out again lasting 1-2 mins. Paramedics called and was evaluated. Pt. declined going to hospital. Pt walked to car.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Peripheral swelling, Ultrasound scan
Clinical narrative: Swelling at injection site noted 12/18/14. Continued to worsen throughout day. Swelling extended down to hand. Severe pain.
Age: 0.44
Sex: M
Vaccine: DTAP, RVX
Symptoms: Crying, Decreased appetite, Dyskinesia, Moaning, Seizure
Clinical narrative: Inconsolable crying for 12 hours, seizures, jerking, vomiting, loss of appetite, moaning.
Age: 0.44
Sex: M
Vaccine: DTAP, RVX
Symptoms: Vomiting
Clinical narrative: Inconsolable crying for 12 hours, seizures, jerking, vomiting, loss of appetite, moaning.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Shooting pain from mid-upper (R) arm to elbow starting 12/18/14, now continuous ache and weakness to (R) hand.
Age: 18.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ
Symptoms: Headache, Papilloedema
Clinical narrative: Papilledema-no increased ICP on LD headaches-persistent beginning day after vaccines given, evaluated by neurology later felt to be Drusen on reevaluation.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: About 15 min after receiving vaccine, pt mom call and says pt is having a seizure.
Age: 1.08
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Viral rash
Clinical narrative: Per grandmother, infant had rash appear approx 8 days after vaccines given. Appeared on abdomen, back and 1 spot on face. States "very minor rash". Daughter took to ER and was diagnosed as a "viral rash". Resolved in 3 days with no problems.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Cellulitis, Pain, Skin warm, Swelling
Clinical narrative: Cellulitis-swelling, hot to the touch, pain. Right arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Had flu shot in right shoulder and developed impringement syndrome like symptoms.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Onset of rash 2/9/15 on torso. Rash spread to face, neck, buttocks and legs 2/10/15.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: No fever, 8 cm x 10 cm erythematous indurated area on 3rd day after vaccine was administered. Minimal erythema and warmth by 3rd day.
Age: 0.64
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site induration, Injection site mass
Clinical narrative: (R) thigh with hard lump after immunization.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine on 2/1/15 pt returned on 2/10/15 to pharmacy with area from area of immunization to inner arm towards elbow red, hot, swollen advised to PCP.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Audiogram, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Respiratory tract congestion, Sudden hearing loss
Clinical narrative: I received the flu vaccine - Oct. 31 - no adverse effects. I received the Pneumonia vaccine - Nov. 10: Nov 11 arm swelled in armpit; stiff neck and congestion. Nov 15 sudden severe hearing loss. Nov 19 - visited PCP - 10 day course Prednisone. Dec 17 - visited Dr (ENT) who ordered Brain MRI and intratympanic dexamethasone injections.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: I received the flu vaccine - Oct. 31 - no adverse effects. I received the Pneumonia vaccine - Nov. 10: Nov 11 arm swelled in armpit; stiff neck and congestion. Nov 15 sudden severe hearing loss. Nov 19 - visited PCP - 10 day course Prednisone. Dec 17 - visited Dr (ENT) who ordered Brain MRI and intratympanic dexamethasone injections.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe pain in shoulder where vaccine was administered. After almost 2 months and physical therapy, pain is improving.
Age: 1.01
Sex: F
Vaccine: DTAP
Symptoms: Aggression, Blood heavy metal increased, Connective tissue disorder, Diarrhoea, Hypersensitivity
Clinical narrative: Initially Fever, Irritability, Change from a quiet calm child to having tantrums. Waking up in middle of night when normally sleeps 11 hours straight. Over the span of 2 months she had random vomiting and diarrhea (2-6 times a week). After doing a foot zoning (ment to detox toxins in body) She starting swelling and getting rash, followed by vomiting. The swelling was really severe one night and made her face and lips swollen and was starting to go to her throat. We almost took her to ER but we were able to get the swelling to go down. We took her to doctor next day and he said she had hives like reaction to some allergy. I took her to a nutritionist who did a full body scan and He concluded that her nervous system, lymphatic system, connective tissue were severely stressed due to heavy metals in her system.
Age: 1.01
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Lip swelling, Lymphatic disorder, Middle insomnia, Nervous system disorder
Clinical narrative: Initially Fever, Irritability, Change from a quiet calm child to having tantrums. Waking up in middle of night when normally sleeps 11 hours straight. Over the span of 2 months she had random vomiting and diarrhea (2-6 times a week). After doing a foot zoning (ment to detox toxins in body) She starting swelling and getting rash, followed by vomiting. The swelling was really severe one night and made her face and lips swollen and was starting to go to her throat. We almost took her to ER but we were able to get the swelling to go down. We took her to doctor next day and he said she had hives like reaction to some allergy. I took her to a nutritionist who did a full body scan and He concluded that her nervous system, lymphatic system, connective tissue were severely stressed due to heavy metals in her system.
Age: 1.01
Sex: F
Vaccine: DTAP
Symptoms: Pharyngeal oedema, Pyrexia, Rash, Swelling, Swelling face
Clinical narrative: Initially Fever, Irritability, Change from a quiet calm child to having tantrums. Waking up in middle of night when normally sleeps 11 hours straight. Over the span of 2 months she had random vomiting and diarrhea (2-6 times a week). After doing a foot zoning (ment to detox toxins in body) She starting swelling and getting rash, followed by vomiting. The swelling was really severe one night and made her face and lips swollen and was starting to go to her throat. We almost took her to ER but we were able to get the swelling to go down. We took her to doctor next day and he said she had hives like reaction to some allergy. I took her to a nutritionist who did a full body scan and He concluded that her nervous system, lymphatic system, connective tissue were severely stressed due to heavy metals in her system.
Age: 1.01
Sex: F
Vaccine: DTAP
Symptoms: Urticaria, Vomiting, Whole body scan
Clinical narrative: Initially Fever, Irritability, Change from a quiet calm child to having tantrums. Waking up in middle of night when normally sleeps 11 hours straight. Over the span of 2 months she had random vomiting and diarrhea (2-6 times a week). After doing a foot zoning (ment to detox toxins in body) She starting swelling and getting rash, followed by vomiting. The swelling was really severe one night and made her face and lips swollen and was starting to go to her throat. We almost took her to ER but we were able to get the swelling to go down. We took her to doctor next day and he said she had hives like reaction to some allergy. I took her to a nutritionist who did a full body scan and He concluded that her nervous system, lymphatic system, connective tissue were severely stressed due to heavy metals in her system.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe pain on injection and persisting for 2 months.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Migraine
Clinical narrative: This RN administered a flu vaccine to client's left deltoid. Client reported a "migraine" shortly after administration. Client denied any other complaints or complications. Client stated having a "long history of migraines, but didn't have one before getting the flu shot". Assessed client and injection site. Vital signs stable and within normal limits; Resp 16, Pulse 72,B/P 118/70. Injection site skin intact, no swelling, redness, or bruising present. Client denied the need for any follow-up.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Diarrhoea, Injection site pain, Injection site swelling
Clinical narrative: The night of the vaccination, I had what seemed like food poisoning.  This included abdominal pain and diarrhea.  This quickly subsided.  As of today (2/10/15) I still have injection site pain and swelling of about an inch in diameter.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: BIG WELP ON LEG.
Age: 13.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Dizziness, Syncope, Visual impairment
Clinical narrative: Syncope. At age 13, I was walking out of the doctor's office after receiving an MMR shot and Tdap shot simultaneously. I became dizzy and then yellow spots appeared in my field of vision and then I fainted. The nurse caught me and sat me in a chair. She had me place my head between my legs. I felt fine after about 20 minutes.  My (biological) mother also recalls fainting when she received her Polio vaccine as a child.
Age: 0.42
Sex: F
Vaccine: HIBV, PPV
Symptoms: Culture, Dyspnoea, Irritability, Pyrexia, Urine analysis
Clinical narrative: Fever of 104.5, difficulty breathing, fussing, discomfort at vaccination site.
Age: 0.42
Sex: F
Vaccine: HIBV, PPV
Symptoms: Vaccination site discomfort, X-ray
Clinical narrative: Fever of 104.5, difficulty breathing, fussing, discomfort at vaccination site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Computerised tomogram, Computerised tomogram head, Seizure
Clinical narrative: Had a seizure at home.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around upper arm.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Computerised tomogram abnormal, Eye pain, Headache, Visual field defect
Clinical narrative: W 10/29/14 - flu shot. Fri 10/31-Mon 11/3 - headache. Mom 11/10-Tues 11/11/14 vision loss (R) eye, small scotoma spread over next 2 days inferior 1/2 vision, periocular "ache".
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Visual field tests abnormal
Clinical narrative: W 10/29/14 - flu shot. Fri 10/31-Mon 11/3 - headache. Mom 11/10-Tues 11/11/14 vision loss (R) eye, small scotoma spread over next 2 days inferior 1/2 vision, periocular "ache".
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema, Pruritus, Purpura
Clinical narrative: Patient received influenza vaccine. One week later she presents to outpatient clinic with swelling of lips, eyes, and throat. She had a diffuse rash on trunk of body. Patient was taken via ambulance to hospital where she was admitted. (Of note: patient was also taking lisinopril and had recently been started on allopurinol). Diphenhydramine 50 mg prn, sodium chloride 125 mL per hour.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Patient received influenza vaccine. One week later she presents to outpatient clinic with swelling of lips, eyes, and throat. She had a diffuse rash on trunk of body. Patient was taken via ambulance to hospital where she was admitted. (Of note: patient was also taking lisinopril and had recently been started on allopurinol). Diphenhydramine 50 mg prn, sodium chloride 125 mL per hour.
Age: 0.35
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother refers an approximately 1 year old male patient of unknown age without pertinent medical history. He did not have drug reactions and allergies. On unknown date in 2009 the patient was vaccinated with ROTATEQ orally (dose and lot # were not reported). There were no concomitant medications. On unknown date in 2009 the patient experienced vomiting, fever and diarrhea after receiving oral ROTATEQ, however, the patient did not seek medical attention. There were no laboratory diagnostics studies performed. The outcome the above mentioned events was unknown. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse reports that 13 patients received FLUARIX recently after the vaccine was stored at -0.4C. No additional information is known at this time.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Injection site pain, Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial soreness led to pain traveling to left shoulder, lower back, right side buttocks and down right leg; seen at ER and diagnosed w/ muscle spasm; currently experiencing pain in left shoulder when driving, turning, or talking on phone and in right leg.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Discomfort, Headache, Tremor
Clinical narrative: Dizziness, feeling weak, feeling hot 3-4 hrs after GARDASIL #1 immunization.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Feeling hot
Clinical narrative: Dizziness, feeling weak, feeling hot 3-4 hrs after GARDASIL #1 immunization.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown ages and genders. The reporter reported that improperly stored RECOMBIVAX HB injection (Lot#, strength, dose, frequency and route were unspecified) was given to unspecified number of patients since 24-NOV-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to 18 patients of unknown demographics. The pertinent medical history was not reported. On an unknown date the patients were vaccinated with ZOSTAVAX, subcutaneously. The concomitant medications were not reproted. The physician reported that over an unspecified amount of time the 18 patients developed shingles. The VZV packet was faxed to the physician. The outcome of the event was unknown. The causality was unknown. 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 registered nurse refers to a patient of unknown demographics. The pertinent medical history and concomitant medications was not reproted. On 29-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX that was improperly stored. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. The pertinent medical history was unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. The concomitant medications were unspecified. On an unknown date the patient developed cellulitis at injection site. It was reported that on an unknown date, the patient was seen at an unspecified emergency room as she developed a rash that was very painful. The pharmacist reported that it seems like the rash was going to be shingles. The outcome of the events was unknown. The causality was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On an unknown date the patient was vaccinated with GARDASIL injection (dosing regimen unspecified). No concomitant medications reported. On an unknown date inappropriate schedule of drug administration was reported. The pharmacist was reporting that she heard that an unspecified physician administered GARDASIL to an unspecified 55 year old woman on an unspecified date. NO adverse effects reported. No product quality complaint involved. No further information provided. The outcome of the medication error was unknown. Additional information is not expected. Consent to contact reporter was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Pertinent medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck). No symptoms were reported. The outcome of the events was unknown. The case is linked to MARRS # 1502USA002982 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Pertinent medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck). No symptoms were reported. The outcome of the events was unknown. The case is linked to MARRS# 1502USA004127 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as certified medical assistant (C.M.A)) referring to unspecified number of patients of unknown ages and genders. On 19-JAN-2014 the patients were vaccinated with improperly stored VAQTA (route, lot#, dose and frequency unknown). No adverse effects reported. It was not specified if the patients sought for medical attention. Additional information is not expected as the correspondence physician didn't hope to be contacted.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site warmth, Joint swelling
Clinical narrative: Rash started 24 hours after receiving MENVEO vaccine on left upper arm. Redness and warmth started there, now resolved, but redness and swelling in wrists and hands bilaterally some redness on thighs. Not itchy, not painful.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Severe upper arm pain for two weeks, causing shoulder immobility. Pain gradually improved during next week. Visited ER for pain relief two days after injection - received DILAUDID injection, and PERCOCET for home use. Also  had nausea for several days after injection. Now three weeks after injection, pain is nearly gone and I can again use my arm.
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 nurse practitioner refers to a 60 year old female patient with none pertinent medical history, drug reactions or allergies. On 24-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm). There was none concomitant medication. On 24-OCT-2014, the patient experienced swelling, redness and warmth at the injection site in her left arm after receiving ZOSTAVAX. The patient was treated with an unspecified steroid shot. None lab diagnostics studies were performed. The patient sought medical attention via visiting an office. The outcome of swelling, redness and warmth at the injection site in her left arm was reported as recovered (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist referring to a 14 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL, lot#, dose, frequency and route unknown. The patient was 13 weeks pregnant at the time that she received her first dose of GARDASIL. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Intermittent numbness lasting approx. 30 mins, 3-4 times per day since 1/26/2015 of hands and feet, occasionally lower legs. Never had this before.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. It was reported that the patient was pregnant, four week gestation with last menstrual period (LMP) approximately on: 06-JAN-2015 and estimated date of delivery (EDD) on 13-OCT-2015. On 04-FEB-2015 the patient was vaccinated with MMR II (dose, route of administration, lot number and expiration date were not reported). No adverse effect was noted. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Rash erythematous, Rubella antibody positive, Urticaria
Clinical narrative: This spontaneous report was received from a the patient's mother and refers to a male patient of unknown age. The patient's current conditions and medical history were not provided. In approximately 2013 (reported as: "two years ago") the patient was vaccinated with the first dose of MMR II (dose, LOT and batch numbers were not provided, therapy type was not specified, route of administration was not specified by reporter), for prophylaxis (also reported as: immunization). Subsequently the patient broke out in hives, which his mother described as: big red bumps all over his vaccine arm. It was not specified if the patient received any treatment. On unspecified date, the patient had not recovered from the event. The patient's mother stated that he was due to his next dose of vaccine and she took him to have titers drawn. She stated that he showed positive titers for measles and rubella, but showed negative immunity for mumps on unspecified dates. Action taken with therapy with MMR II was not applicable. It was not reported if the events were related to MMR II. Additional information is not expected, as consumer declined to provide any additional information.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Dry skin, Erythema, Pyrexia
Clinical narrative: Fever x 5 days tmax 104, cough, rash/blisters appeared in left cheek on 2/7/15. Treatment: Acyclovir 1/2 tsp po TID x10 days. Dry patches, oozing and red, yellow blistering lesions over (L) side of face around (L) earlobe.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Fever x 5 days tmax 104, cough, rash/blisters appeared in left cheek on 2/7/15. Treatment: Acyclovir 1/2 tsp po TID x10 days. Dry patches, oozing and red, yellow blistering lesions over (L) side of face around (L) earlobe.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HAVRIX 1440 adult (batch number 4G7P2, expiry date 3rd October 2015). On 15th December 2014, the patient received the 2nd dose of HAVRIX 1440 adult. On an unknown date, the dose was an unknown dose. On 15th December 2014, an unknown time after receiving HAVRIX 1440 adult, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: On 6/13/14 this patient received their 1st dose of HAVRIX as the pediatric dose. On 12/15/14 the patient received the 2nd dose of HAVRIX as the adult dose when they should have been given the pediatric dose.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). On 5th December 2014, the patient received KINRIX. On 5th December 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: MA reports inadvertent administration of KINRIX to a 12 month old.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Paraesthesia oral
Clinical narrative: This spontaneous report was received from 64 year old female consumer with drug hypersensitivity to ampicillin and with no pertinent medical history. On 17-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as 1 ZOSTAVAX injection)(lot number and expiration date were not reported), subcutaneous route. The patient was not on co-suspect and concomitant therapies. The patient reported that on 21-JAN-2015, she experienced tingling under her bottom lip and she developed what looks like a "cold sore" and three pimples surrounding it. At the time of the report, the outcome of "tingling under her bottom lip" and "cold sore" was unknown. The patient seek medical attention at the infirmary at her job. No lab diagnostics test were performed. The patient was treated with "Savex". Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received HAVRIX (batch number XD72G, expiry date 5th November 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: HAVRIX given to a 2years old.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report of expired product administered was received from a registered nurse and refers to a patient of unknown age and gender who on 28-JAN-2015 was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), 0.5 ml, intramuscular. Dose supported. No adverse experience was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of PROQUAD (Merck) (Lot # not provided) which were exposed to unknown temperature conditions, had been administered to unspecified patients on unspecified dates since November 2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema
Clinical narrative: Bruise after 2 days and redness on upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Patient complaining of injection site being red, hot and inflamed about a quarter in size reports no fever, taking ibuprofen to help with pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unknown number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. The causality of the event with (Oka/Merck) VARIVAX was not reported. This case is linked to #1502USA004417 via 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 a healthcare worker refers to a 2 patients of unknown age and gender. Concomitant therapy pertinent medical history or drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB (0.5 ml, intramuscularly) that underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. 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 medical assistant refers to unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unknown number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the event was unknown. The causality of the event with PROQUAD (Merck) was not reported. This case is linked to # 1502USA004176 via same reporter link. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 7 year old female patient. The patient's medical history included light symptoms of flu after receiving an unspecified influenza virus vaccine four years ago, it was reported as a mild case and the patient recovered quickly. On 05-FEB-2015, the patient was vaccinated with (Oka/Merck) VARIVAX, (route, anatomical location, dose number, lot # and expiration date were not reported) 0.5 ml to prevent chicken pox.On 08-FEB-2015, three days after vaccination, the patient developed chicken pox like rash all over her body. The patient was complaining that it was very itchy. On 08-FEB-2015, the spots were really red and bumpy. On 09-FEB-2015, the spots seemed to be smaller, flat and blended, and the patient seemed to be getting better. The reporter considered it as a mild case and the patient did not have a fever. There was no treatment given for the adverse event. There were none lab diagnostic studies performed. The patient did not seek medical attention. The outcome of the event was reported as recovering/resolving. The relatedness between the event and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information has been requested.