chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were not reported), lot # M020103 and expiry date: 15-FEB-2018 for prophylaxis. The vaccine was exposed to a temperature of 47.8 Fahrenheit for a time frame of 7 minutes. The call was because of a data logger and there were no previous temperature excursions. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information about patients' medical histories, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of vaccination unknown, lot number and expiry date were not reported). On an unknown date, the patient experienced syncope. The outcome of the events was unknown at the time of the report. The relationship between the events and vaccination with GARDASIL 9 was not reported. This case is linked with MARRS # 1611USA007576 (same reporter). Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from a non health care professional on 18 Nov 2016. This case was linked with case 2016SA214043. This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QIV MDV (Batch number: UI678AB, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were reported as none. On an unknown date, following the vaccination, the patient had developed some arm swelling with pain and a low grade fever of 100.8 F. The patient visited an urgent care (emergency room or ER) on 10 Nov (year unspecified) three days after receiving the vaccine. Other laboratory investigations were reported as none. The patient was treated with ice as corrective treatment. The patient was recovered from all the events on an unknown date. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction positive, Vaccination failure
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 01 December 2016. This case involves a nine-year-old female patient who was vaccinated intramuscularly with fifth doses of DAPTACEL (batch number: C3916AA, expiry date: 02 December 2013, dose was not reported), IPOL (batch number, expiry date, dose and dose in series were not reported), MMR (Manufacturer: MSD) (batch number, expiry date, dose and dose in series were not reported) and VARICELLA (Manufacturer: MSD) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 01 July 2011. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 04 November 2016, 5 Year and 3 months following the vaccination, patient had cough and vomiting associated with whooping cough and claimed lack of effect because patient was diagnosed of having pertussis (via PCR test) on 30 November 2016. It was a case of vaccination failure. Patient received four doses of DTaP on 17 September 2007, 29 October 2007, 11 January 2008 and 16 December 2008. The patient required emergency room (ER)/ doctor visit. Other laboratory tests were not reported. Corrective treatment was prescribed as "Zythromycin" (azithromycin). The outcome of event was reported as unknown. Upon internal review the case was considered as serious due to important medical events: whooping cough and vaccination failure. List of documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with diphtheria, tetanus and pertussis vaccine may not protect 100% of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication) and medical history are needed to further assess this case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 01 December 2016. This case involves a nine-year-old female patient who was vaccinated intramuscularly with fifth doses of DAPTACEL (batch number: C3916AA, expiry date: 02 December 2013, dose was not reported), IPOL (batch number, expiry date, dose and dose in series were not reported), MMR (Manufacturer: MSD) (batch number, expiry date, dose and dose in series were not reported) and VARICELLA (Manufacturer: MSD) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 01 July 2011. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 04 November 2016, 5 Year and 3 months following the vaccination, patient had cough and vomiting associated with whooping cough and claimed lack of effect because patient was diagnosed of having pertussis (via PCR test) on 30 November 2016. It was a case of vaccination failure. Patient received four doses of DTaP on 17 September 2007, 29 October 2007, 11 January 2008 and 16 December 2008. The patient required emergency room (ER)/ doctor visit. Other laboratory tests were not reported. Corrective treatment was prescribed as "Zythromycin" (azithromycin). The outcome of event was reported as unknown. Upon internal review the case was considered as serious due to important medical events: whooping cough and vaccination failure. List of documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with diphtheria, tetanus and pertussis vaccine may not protect 100% of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication) and medical history are needed to further assess this case.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had redness and swelling up and down her arm, as well as stiffness and general soreness.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test abnormal, Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Rheumatoid factor increased
Clinical narrative: POLYMYALGIA RHEUMATICA, SHOULDERS, HIPS AND KNEES.  INCREASE SYMPTOMS AT NIGHT. UNRESOLVED.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site red, swollen, hard, with induration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Extensive swelling, aching pain, extensive redness and itching, slight temperature.  Continuing at 12/8/2016.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Sleep disorder
Clinical narrative: Left shoulder soreness, has continued for 6 weeks.  Patient is in my office today describing the pain.  It feels like someone punched him in the shoulder. Cannot sleep on the shoulder, good strength, but favors the right arm due to pain from the vaccine site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 68-year-old non-pregnant female patient. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M032635, expiration date: 20-MAY-2018, exact dose and route of administration were not reported). On 30-NOV-2016, the patient came to office and had redness, swelling and pain at injection site on the right arm. A physician assistant recommend acetaminophen (TYLENOL) or ibuprofen (MOTRIN) for the treatment of pain, diphenhydramine hydrochloride (BENADRYL) and steroids. It was not known if the patient had complied (also reported as there was no treatment for the adverse events given). There were no laboratory tests performed. The patient sought medical attention by visiting the physician's office. The outcome of injection site erythema, injection site pain and injection site swelling was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX23 was not reported. Lot check requested. This is one of several reports concerning the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1612USA000260:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates (reported as since 18-NOV-2016), the patients might have been administered with M-M-R II (lot # L039551, expiry date: 07-OCT-2017) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 9 C for 176 hours (a maximum temperature reading of 9 C in the morning for 11 days, from 18-NOV-2016 to 28-NOV-2016 evaluated for 16 hours each day). There was no previous temperature excursion. Data logger was not involved. No adverse effects have been reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001924: US-009507513-1612USA001916: US-009507513-1612USA001929.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (route: subcutaneous). On an unknown date, the patient experienced warmth, swelling and pain at the injection site. The patient did not receive any treatment for the events. The outcome of the events was reported as not recovered. The causality of the events was unknown. Additional information is not expected, as no consent to contact the reporter.
Age: 31.0
Sex: M
Vaccine: JEVX
Symptoms: Peripheral swelling, Rash
Clinical narrative: After receiving the second shot for Japanese Encephalitis, I experienced a large rash and swelling that continued to my forearm.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX 23 in right deltoid. Arm started swelling and painful and red few hours after receiving the injection.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23 in right deltoid. Arm started swelling and painful and red few hours after receiving the injection.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: On 12/06/16, 46 yo F presented to clinic for annual exam. During this visit, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23). Per immunization record, pt received 0.5 mL injection intramuscularly in right deltoid (NDC #0006-4837-01, Lot # m041394, exp: 5/23/2018). Pt was then discharged home. On 12/08, pt returned to clinic with redness, pain and swelling at the pneumococcal vaccination site. MD assessed the site and noted that it was erythematous and warm to the touch. Pt had no symptoms of respiratory difficulty. Pt was advised to use ibuprofen for symptomatic relief. Pt was subsequently discharged with instructions to report any worsening or changing symptoms.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 12/06/16, 46 yo F presented to clinic for annual exam. During this visit, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23). Per immunization record, pt received 0.5 mL injection intramuscularly in right deltoid (NDC #0006-4837-01, Lot # m041394, exp: 5/23/2018). Pt was then discharged home. On 12/08, pt returned to clinic with redness, pain and swelling at the pneumococcal vaccination site. MD assessed the site and noted that it was erythematous and warm to the touch. Pt had no symptoms of respiratory difficulty. Pt was advised to use ibuprofen for symptomatic relief. Pt was subsequently discharged with instructions to report any worsening or changing symptoms.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: I am quite petite and the vaccination was administered very high in my left deltoid. Immediately after the injection I had intense pain in that shoulder/arm. The pain did not go away over the next few days as I have experienced in the past. Now it is nearly a month later and I still have significant weakness and pain with certain arm movements. I cannot sleep on my left side without pain and burning in my left shoulder. I take 400mg ibuprofen twice a day and get some relief from that. I have made an appointment with my family physician.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Death
Clinical narrative: Pt found dead on AM of 11/16/16 at home in bed.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain and achiness at injection site and upper arm. Decreased range of motion. Decreased strength for pushing, pulling and lifting.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Difficultly breathing.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient states her joints are in pain, hands and both joints are painful.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients started the HPV vaccine series with GARDASIL and finished the series with GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. Follow up information was received on 30-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments:  MERCK 1610USA004961:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to 9 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 27-SEP-2016 and 10-OCT-2016, the patients were inadvertently administered with improperly stored ZOSTAVAX (8 doses of lot # L046896, expiration date 23-FEB-2017; 1 dose of M032139, expiration date 02-OCT-2016; dose and route were unknown) for prophylaxis. The vaccines were stored under the temperature 6 Celsius degree for 432hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. Product quality complaint (PQC) was not involved. A call was placed to the pharmacist on 07-DEC-2016, that requested patient identifiers and date of vaccination.  All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected since no further information was available. Narrative updated.; Sender's Comments: , MERCK 1610USA005098:Mfr number.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLU4, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72-year-old female patient. The patient did not have any known drug allergies. The patient's pertinent medical history was not reported. In 2015 (reported as "a year ago"), the patient was vaccinated with PREVNAR 13 with no adverse effects. On 07-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly, in the arm, lot # M029680, expiration date 17-JAN-2018 (dose and frequency were not reported) for prevention of pneumococcal disease. On the same date, the patient was vaccinated with a dose of INFLUENZA VIRUS VACCINE (UNSPECIFIED) (reported as "Flu shot") in the opposite arm (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included losartan potassium (manufacturer unknown), omeprazole, CYTOMEL (reported twice) and SYNTHROID. On 07-NOV-2016, the patient's arm that received the PNEUMOVAX23 had swelling and redness in "the whole arm from the shoulder to an inch above the elbow". On that day, the injection site was red and swollen of  "the size of a baseball". On 09-NOV-2016, the patient was vomiting and she "felt weak". On an unknown date in approximately November 2016, the patient was seen by an unknown healthcare provider and was treated with unspecified "topical steroids". The outcome of the events and the relatedness between the events and the suspect vaccines were not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA006698.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Dizziness, Vomiting
Clinical narrative: Lack of appetite, ate a little and threw up several times. Was dizzy and weak. Seemed fine in the morning, but threw up several times in daycare.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Disturbance in attention, Erythema, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Patient became fatigued and irritable. She was having trouble focusing after injection. Injection was hard and sore. It was reddened as well. Both of her elbows became reddened.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Irritability
Clinical narrative: Patient became fatigued and irritable. She was having trouble focusing after injection. Injection was hard and sore. It was reddened as well. Both of her elbows became reddened.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 4 inches in diameter redness. Slightly warm to touch. Denies itching. Only painful upon pressure.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itching, small red rash.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized swelling, redness and warmth.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein increased, Erythema, Red blood cell sedimentation rate increased, Skin warm
Clinical narrative: Arm was warm, didn't redden until later and continued to spread over about 4 days until I went to Urgent Care. Antibiotics-which was taken off by the doctor at urgent care, high dose advil, benadryl, ice pack.There is very little information out there on NOMID and the PNEUMOVAX vaccine and apparently my provider missed it.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong Vaccine was given to 9wk old child. Child not having any adverse reactions at this time.
Age: 18.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Muscle fatigue
Clinical narrative: From 11/22 to 11/26, High fever, chills, constant headache, nausea (nor vomiting or diarrhea).  Extreme fatigue, muscle aches, muscle fatigue, joint aches, esp. hips.  Temp range 100-104.  Muscles weak.
Age: 18.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Muscular weakness, Myalgia, Nausea, Pyrexia
Clinical narrative: From 11/22 to 11/26, High fever, chills, constant headache, nausea (nor vomiting or diarrhea).  Extreme fatigue, muscle aches, muscle fatigue, joint aches, esp. hips.  Temp range 100-104.  Muscles weak.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of ROTATEQ (lot number L033543, expiration date 30-MAY-2017) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009626: US-009507513-1611USA009623: US-009507513-1611USA009625.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 21-NOV-2016 from an office manager referring to unspecified patients (number of patients, ages and genders are unknown.) The patient's concurrent conditions, medical history and concomitant therapy are unknown. The office manager reported that improperly stored doses of GARDASIL 9 lot number M067764 expiration 30-JAN-2018 and ROTATEQ lot number M019691 expiration 02-NOV-2017, L048857 expiration 15-OCT-2017, and L042215 expiration 02-OCT-2017 doses may have been administered to unspecified patients on unspecified dates. The vaccine doses were exposed to 34 degrees F for 4.5 hours. The vaccine doses were exposed to a previous temperature excursion of 35 degrees F for 279 hours. No adverse effects were reported. No further information was reported. Lot number M067764 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast.) Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Information was received on 28-NOV-2016 from a pharmacist via Pfizer (manufacturer # 2016528115) concerning a 65 year old female.  No medical history or concomitant medications were reported. It was reported that the patient had received a dose of PREVNAR 13 (dose, lot,  site and exact date received was not reported) one year ago for prophylaxis. She received a dose of PNEUMOVAX (lot, dose, site not reported) a week ago for prophylaxis and experienced shooting pain down arm. The outcome of shooting pain down the arm was not reported. The causality was not reported. No other information was provided. 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 registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2016 (reported as between 30-NOV-2016 and 01-DEC-2016),  the patient was vaccinated with a first dose of improperly stored VARIVAX (lot # M023383, expiration date: 11-MAY-2018) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 14.4 degrees Fahrenheit for 2 hours and 20 minutes. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Received influenza vaccine in left deltoid Oct 10. In the six weeks since I've developed pain in left arm radiating from shoulder to elbow and began having periodic burning pain, left subscapular, approx 2 days ago. Started MEDROL pack today (Nov 17),
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt describes pain at time of vaccination. Pain persisted in area at injection site which was treated with morphine. Also says she was given an antibiotic. Symptoms improved although lingering pain.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Pain
Clinical narrative: On 11/17/16 the patient reported persistent left deltoid pain with abduction/extension greater than 90 degree post influenza vaccine which required a follow-up visit on 11/18/16. No further treatment since 11/18/2016.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Tremor, Vaccination complication
Clinical narrative: Patient called the day after receiving the flu/shingles immunization and stated he had a severe reaction to the shingles vaccine. He said he experienced chills and severe shaking (incontrollable). He did not think that it was the flu vaccine because he had that vaccine in the past.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Hypotension, Mood altered, Pain in extremity
Clinical narrative: Patient started complaining of arm pain, became very tired and weak, she began to turn very pale. I ran with her back to the clinic and the nurse elevated her legs, had her lay down, gave her water, and checked her vitals. Her blood pressure was low,  but within a few minutes her BP came back up, her color returned, and her mood returned to normal.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor
Clinical narrative: Patient started complaining of arm pain, became very tired and weak, she began to turn very pale. I ran with her back to the clinic and the nurse elevated her legs, had her lay down, gave her water, and checked her vitals. Her blood pressure was low,  but within a few minutes her BP came back up, her color returned, and her mood returned to normal.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Soreness at injection site with occasional radiating, shooting-like pain up arm to neck.  Feels like arm is "locked" and tight occasionally.  Improving with time, but still bothersome.  Relieved with heat therapy.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain
Clinical narrative: Soreness at injection site 12/7/16.  At 3:30 AM on 12/8/16, she woke up with pain at the injection site that radiated up her shoulder to the base of her skull.
Age: 60.0
Sex: M
Vaccine: FLUC4, PPV, TDAP, VARZOS
Symptoms: Dizziness, Lethargy, Nausea, Pain, Rash erythematous
Clinical narrative: 2 raised large red spots. Extreme soreness. Hot to the touch. Extreme lethargy. Dizziness. Nausea.
Age: 60.0
Sex: M
Vaccine: FLUC4, PPV, TDAP, VARZOS
Symptoms: Skin warm
Clinical narrative: 2 raised large red spots. Extreme soreness. Hot to the touch. Extreme lethargy. Dizziness. Nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Had some swelling of his right leg.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Chest pain, Erythema, Infection, Pain
Clinical narrative: Injection done and the next day left arm became infected with pain and red blotch down arm almost to the forearm. Pain then was felt under the arm and across the chest and still persists to this day. Dr. prescribed antibiotic that did not solve the redness so an addition antibiotic was prescribed. Redness went away but did not help the all the pain.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Injection done and the next day left arm became infected with pain and red blotch down arm almost to the forearm. Pain then was felt under the arm and across the chest and still persists to this day. Dr. prescribed antibiotic that did not solve the redness so an addition antibiotic was prescribed. Redness went away but did not help the all the pain.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Influenza like illness, Joint swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: The right arm and hand, where the shot was given became swollen By the following month, this had moved to my body joints and muscles becoming achy and stiff. The symptoms were just like the flu, but they did not go away.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Peripheral swelling
Clinical narrative: The right arm and hand, where the shot was given became swollen By the following month, this had moved to my body joints and muscles becoming achy and stiff. The symptoms were just like the flu, but they did not go away.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia after MMR vaccine, platelet count of 2 (normal 140-385).
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Lip swelling, Pain in extremity, Swelling face
Clinical narrative: Right side face/lip swelling, coughing, difficulty breathing, and right arm pain.  Denies going to hospital - reports just taking Benadryl 50mg then going to sleep.  Waking up next morning with facial swelling.  Reports taking Chlorotabs x 2 and Zyrtec x 1.  States facial swelling resolved.  Patient came to see me today: gave daily Zyrtec and Zantac BID to block both histamines.  f/u one week for evaluation - was educated to go to ER if s/s progressed or did not improve.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Muscle Aches, Fatigue, Diarrhea, Abdominal Pain, Headache.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Nervousness, Oedema peripheral, Peripheral swelling, Rash, Skin warm
Clinical narrative: On 12/6/2016 in the evening patient started feeling shaky. On 12/7/2016 patient developed on left arm near elbow a rash. The area felt warm to the touch and was swollen. She explained that it felt like she had extra fluid in that area.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aspartate aminotransferase normal, Computerised tomogram head normal, Febrile convulsion, Laboratory test normal
Clinical narrative: Complex febrile seizure.
Age: 31.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Contusion, Erythema, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Shooting pain down arm, burning, inability to move arm, swelling, redness, bruising, fever.
Age: 31.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling, Ultrasound scan
Clinical narrative: Shooting pain down arm, burning, inability to move arm, swelling, redness, bruising, fever.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Flu like symptoms, patient reported major vomiting and fever.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest discomfort, Chills, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Flu like symptoms, patient reported major vomiting and fever.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain, Throat tightness, Vomiting
Clinical narrative: Flu like symptoms, patient reported major vomiting and fever.
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: He received hep A, hep B, HPV, MMR, varicella, Tdap, poliovirus, influenza and subsequently developed immune thrombocytopenia 2 weeks following administration of vaccines.  His platelet count is 1 and following hospitalization for IVIG recovered to 17.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Redness at the site of injection. Hard nodule underneath the skin, at the site of the injection. Both symptoms were about the size of a dime.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, MMRV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Swelling, erythema, tenderness, streaking consistent with cellulitis within 24 hours.  No abscess at this time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Left arm began to ache at night. The next morning I thought I had the flu. Fever of 101-102. Was achy all day and slept. My left arm was swollen and red. Could not lift it.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: Left arm began to ache at night. The next morning I thought I had the flu. Fever of 101-102. Was achy all day and slept. My left arm was swollen and red. Could not lift it.
Age: 19.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Immediate pain following vaccination. I was told it would "burn," but the pain was more of a constant dull throughout. Pain lasted for 3 days, and would be especially bad (sharp pain) any time I moved my arm that received the vaccination. I was basically unable to move my left arm at all for those days.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. In November 2016, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and pneumonia were unknown and the outcome of the influenza was recovering/resolving. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter was a GSK employee and was a patient's friend. The reporter wished to submit this report anonymously. The age at vaccination was not reported. In 2016, the patient received Influenza vaccine Quadrivalent unspecified season. This case was considered to be suspected vaccination failure as the exact time to onset and lab test confirmation for influenza was unknown. The patient denied permission to contact the physician.
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 14-year-old female patient who received Flu Seasonal TIV Dresden. Previously administered products included ADVAIR (refer case US2016157860), PROAIR HFA (refer case US2016157860), ZANTAC (refer case US2016157860) and Steroids (patient's weight may have been from the use of steroids over time). Concurrent medical conditions included contact dermatitis (Sensitive skin, due to allergies, there are very few products that can be used since birth), allergic reaction to antibiotics (allergy to antibiotics cause red marks on the skin within 30 min.) and latex allergy (allergy to antibiotics cause red marks on the skin within 30 min.) On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, less than an hour after receiving Seasonal Influenza vaccine, the patient experienced allergy to vaccine and erythema. On an unknown date, the outcome of the allergy to vaccine and erythema were unknown. It was unknown if the reporter considered the allergy to vaccine and erythema to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient's family had a history of being allergic to many items. The patient was very sensitive to shampoo, body wash, and soap. Shampoos could make sores on the head, itching and if you scratch the head, it bleeds and causes scabs. The patient received Flu vaccine and within 30 minute after vaccination the patient experienced allergy to vaccine. It was reported that, GlaxoSmithKline was not previously contacted about any adverse event for this patient. This case had been linked with the US2016157860, reported for the same patient.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Irritability, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 20-month-old male patient who received FLUARIX QUADRIVALENT (batch number J97D2, expiry date 17th June 2017). In October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2016, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The healthcare professional inadvertently administered FLUARIX to a 20 months old patient, which led to an inappropriate age at vaccine administration. Follow up information received from nurse on 28th November 2016: The reporter's contact details were updated. The patient's demographic details were updated. On 14th October 2016, the patient had had 15 month old well child. Billixy flagged, on 17th October 2016, the patient received 2nd dose of Flu vaccine intramuscularly at nurse visit. DTaP Flu shot deferred due to recent illness. On 17th October 2016, nurse visit the patient was given DTaP and FLUARIX (3+) instead of FLUZONE. In October 2016, less than week after receiving FLUARIX, the patient experienced injection site pain and injection site redness and cranky. On 1st December 2016, the patient had 1 flu shot but never had the follow up dose. It was a medication error without harm. He was scheduled to get FLUZONE (6-35 month old) on 28th November 2016 to complete the primary 2 doses. The VAERS information was updated.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness where injection was given.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood test, Body temperature increased, Cough, Culture
Clinical narrative: On 12/6/16 pt had temp 100.5 with back/neck pain, TYLENOL given by father. On 12/7/16 T. 103, coughing and ER visit. Treated at ER with antibiotic. Pt better 12/8/16 with no fever.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: On 12/6/16 pt had temp 100.5 with back/neck pain, TYLENOL given by father. On 12/7/16 T. 103, coughing and ER visit. Treated at ER with antibiotic. Pt better 12/8/16 with no fever.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: C/O chills, fatigue, myalgia.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse event, Impaired work ability, Mobility decreased, Pain in extremity
Clinical narrative: Pt stated arm is sore had adverse events and needed to take day off has hard time with movement.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Mom called and stated arm injection site was red and inflamed.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Feeling hot
Clinical narrative: She received Influenza vaccine 12/2/16, within 35 minutes she stated she had redness and warm sensation to face and neck, and light headedness.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (R) upper thigh swelling 3 inch diameter and redness around injection site. Positive mild pain positive itch.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 18 x 15 cm erythematous slightly swollen (L) upper arm.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MMR, MNQ
Symptoms: Contusion, Erythema, Injected limb mobility decreased, Nodule, Pain in extremity
Clinical narrative: Client in HD on 12/6/16. Reported having a sore arm from the vaccines. Client reports, "it swelled to the size of a tennis ball or an orange, was red and splotchy and she couldn't move it for a few days. She had a fever 99-100 about 8 hrs after the vaccine. Checked arm, small bruise and a knot the size of a quarter present. Client moving arm without difficulty, no redness, edema, noted. Checked clients shot record and noted to have had HPV and BEXSERO in that arm. Instructed pt on signs of side effect per VIB such as soreness, redness, swelling, fever and difficulty moving arm. Client encouraged to keep moving arm and monitoring area and if any side effects become worse or persist seek medical attention. Verbalized understanding and very thankful.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MMR, MNQ
Symptoms: Peripheral swelling, Pyrexia, Rash macular
Clinical narrative: Client in HD on 12/6/16. Reported having a sore arm from the vaccines. Client reports, "it swelled to the size of a tennis ball or an orange, was red and splotchy and she couldn't move it for a few days. She had a fever 99-100 about 8 hrs after the vaccine. Checked arm, small bruise and a knot the size of a quarter present. Client moving arm without difficulty, no redness, edema, noted. Checked clients shot record and noted to have had HPV and BEXSERO in that arm. Instructed pt on signs of side effect per VIB such as soreness, redness, swelling, fever and difficulty moving arm. Client encouraged to keep moving arm and monitoring area and if any side effects become worse or persist seek medical attention. Verbalized understanding and very thankful.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received INFANRIX. Co-suspect products included INFANRIX. Concurrent medical conditions included milk protein allergy. Concomitant products included Polio vaccine and Polio vaccine. On an unknown date, the patient received the 1st dose of INFANRIX (intramuscular). On 23 November 2016, the patient received the 2nd dose of INFANRIX (intramuscular). On an unknown date, 8 hrs after receiving INFANRIX and not applicable after receiving INFANRIX, the patient experienced vomiting, diarrhea, vomiting and diarrhea. On an unknown date, the outcome of the vomiting, diarrhea, vomiting and diarrhea were recovered/resolved. The reporter considered the vomiting and diarrhea to be almost certainly related to INFANRIX. The reporter considered the vomiting and diarrhea to be almost certainly related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received 1st dose of INFANRIX at the standard time, after receiving 1st dose of INFANRIX, the patient experienced vomiting and diarrhea. Eight hours after receiving dose of INFANRIX, the patient experienced vomiting and diarrhea. Both times the patient also received a polio vaccine. The reporter believed they were administered in the same leg. The reporter not reported any other vaccines when asked. The patient had a severe allergy to milk protein, and the reporter thought the presence of milk product in the vaccine might had caused the reaction.
Age: 9.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Rash
Clinical narrative: Developed raised painful rash over (R) arm. Seen at urgent care. Improving and less painful but still red 4 days later.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 37-year-old female patient who received DTPa (Reduced antigen). On 24th November 2016, the patient received DTPa (intramuscular). In November 2016, less than a week after receiving DTPa, the patient experienced injection site coloration. On 25th November, the patient experienced injection site swelling, injection site redness, injection site warmth and injection site pain. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site warmth, injection site pain and injection site coloration were not recovered/not resolved. The reporter considered the injection site swelling, injection site redness, injection site warmth and injection site pain to be almost certainly related to DTPa. It was unknown if the reporter considered the injection site coloration to be related to DTPa. Additional details were received as follows: The patient received a dose of TDaP on the left deltoid and after approximately 24 hours her left arm became red, swollen, painful and hot to the touch. An area of approximately 4 inches around the injection site was noted to be black and blue. On 30th November 2016, the patient visited her local medical doctor and was prescribed Prednisone for the reaction. The reporter did not administer the vaccine and did not know the brand of TDaP administered. The reporter has provided the information he had and would call if able to determine the brand involved.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 11/28: Pt. rec'd shot at 1:30 pm. 11/29: Temp 102.1 degrees. RPh recommended MOTRIN. 11/30: Temp 100 degrees. Pt. still taking MOTRIN. 12/1: Red, inflamed, hot below site of injection. Pt. visited MD. MD filled antibiotic. No local site rcn. till 12/1.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Muscle tenderness and weakness.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Headache and severe shaking and chills approximately 3 hours after receiving his vaccines. Fever at 1540 - 103.1(O), 1430 - 98.1 (O), BENADRYL 50 mg. Temp. at 1630 - 99.6 (O) ibuprofen 400 mg. 12-8-16 at 1430 no fever or chills overnight but tired today, will stay home from school.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed classic shingles rash (R) mid chest on 11/21. Two days after receiving vaccine (L) arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A child aged 4yrs. 5mos 15 days received: DTaP #4 5mos. following Dose #3 (KINRIX used). IPV #4 6mos. after first dose. No adverse event occurred.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Skin lesion
Clinical narrative: From knee to ankle small slightly raised lesions.