chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: MMR and varicella given in same arm, (L), and approximately 1/2" apart, and given in deltoid muscle. Client states she had ot go to ER for local reaction. (+) Cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to unspecified patients of unknown age and gender. Since December 2014 these patients were administered improperly stored VARIVAX (Merck) (lot#, dose, route not reported). Concomitant medications were not provided. No adverse events were reported. Additional information is not expected as the physician did not want to be contacted.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). In 1993, the subject had completed the hepatitis B series. Concurrent medical conditions included exposure via blood. On 18 September 2013 the subject received booster dose of ENGERIX B vaccine (unknown route and injection site) after a blood exposure. 2 days after vaccination with ENGERIX B vaccine, the subject experienced hepatitis B surface antigen positive. At the time of reporting, the outcome of the event was unspecified. This is one of the 2 cases reported by the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: This case was reported by a physician and described the occurrence of sick in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with ENGERIX B, the subject became sick. At the time of reporting, the outcome of the event was unspecified. No further information was provided.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Panic attack
Clinical narrative: This case was reported by a consumer and described the occurrence of shortness of breath in a male subject aged between 30 and 39 years old who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included dust mites allergy, gluten intolerance, lactose intolerance, latex allergy, migraine, penicillin allergy, seasonal allergy and soy intolerance. In 2007 the subject received unspecified dose of Hepatitis B vaccine (unknown). I 2007, at an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced shortness of breath and panic attack. Details regarding the vaccination or events were not provided. At the time of reporting the outcome of the events were unspecified. The subject experienced adverse event with BOOSTRIX vaccine, for that case please see A1062563A. Follow-up information was received on 04 March 2014 via consumer. Additional concurrent medical conditions included allergy to pet dander, grass allergy, pollen allergy and tree allergy. Historic vaccination included tetanus vaccine (non-gsk); non=GSK manufacturer;unknown; unknown given in 2008. The subject reported the shortness of breath from the Hepatitis B vaccine and lasted a couple of seconds. No other information was provided. The subject experienced adverse events with BOOSTRIX vaccine, for that case please see A1062563A and with previous flu vaccine, please see case A1062563C.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arthralgia in a 60-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medications included insulin, simvastatin, losartan, timolol, fluticasone, aspirin and dextrose (glucose). On 24 March 2014, the subject received 1st dose of ENGERIX B adult (Administration site and route unknown, batch number not provided). In April 2014, approximately 1 month after vaccination with ENGERIX B adult, the subject experienced arthralgia with bilateral soreness and stiffness. At the time of reporting, the outcome of the events was unspecified. The pharmacist considered the events were unrelated to vaccination with ENGERIX B. As no additional information could be obtained, the case has been closed.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Laceration, Product quality issue
Clinical narrative: This case was reported by a Certified Pharmacy Technician and described the occurrence of cut finger in a 30-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 May 2014, the subject (nurse) was attempting to administer a ENGERIX B vaccination to a patient. When she tried to flip the cap off the ENGERIX B vial, the vial broke in her hand and she received a cut on her finger. Nurse told pharmacy technician there was no liquid on her hand, and she felt the vial was empty. This case was associated to a product complaint. At the time of reporting, the cut on subject's finger was unresolved. Follow-up information received on 20 June 2014 from the Certified Pharmacy Technician: Subject's details were provided. No medical history was reported. The subject had no known drug allergy. On 22 May 2014, the subject (an infection preventionist) was popping the lid of the ENGERIX B vaccine when it broke in her hand. She discovered that the vial was already broken and glass was in the box where it was stored. There was no vaccine in the vial and there appeared to be no liquid in the box as well. Upon examination, the vial was broken on the bottom. On 22 May 2014, the cut on subject's finger was resolved. A new vial was obtained. Follow-up information received on 14 July 2014: The quality assurance investigation results were received. According to the thorough investigation performed at the different production steps, GSK Biologicals concludes that it is unlikely that the root cause of this complaint took place during the manufacturing process. GlaxoSmithKline Biologicals therefore considers this complaint as unsubstantiated.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Lethargy, Malaise, Syncope, Tinnitus
Clinical narrative: Ringing ears, malaise. Syncope 1130pm 12-31-14. 1-1-15 -> redness injection site and lethargy.
Age: 1.08
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Mom called office today stating baby had rash x 12 hrs. all over body, vomiting, diah and slight fever starting on 1-19-15 after receiving DTaP on 1/7/15.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Rash papular
Clinical narrative: Headache and skin-papular.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. On 17-DEC2014 the patient was vaccinated with ZOSTAVAX lot # J014851, subcutaneous. On 17-DEC-2014 the patient was vaccinated with expired ZOSTAVAX. No AE was reported. The outcome is unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Increased redness, swelling at site to left arm. Induration 20 mm. Skin intact. Area tender to touch. Denies pain at this time. Swelling x 2 days.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Fatigue, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in an adult female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKlilne). A physician or other health care professional has not verified this report. The subject's medical history included diverticulitis (but she has not had any issue with it for 2 or 3 years). Concurrent medical conditions included allergy, allergy to DEMEROL and PERCOCET. Concurrent vaccination included Tetanus Toxoid vaccine; manufacturer unspecified; given in March 2014 a few days before ENGERIX B adult. On 31 March 2014, the subject received 2nd dose of ENGERIX B adult (1 ml, unknown route and injection site) which had expired on 22 March 2014. On 31 March 2014, few hours of vaccination with ENGERIX B adult, the subject experienced headache and exhaustion. The subject stated that the headaches may be related to her allergies. At the time of reporting the headache was unresolved and the outcome of exhaustion was resolved.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Given PREVNAR 13 on 1/7/15. Developed redness, swelling, tenderness at vaccine site on 1/9-10. Worsening over time.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Anaemia, Gastric disorder, Hepatitis A antibody negative, Hepatitis B antibody negative, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer and described the occurrence of anemia in a 56-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was previously healthy. Concurrent medications included Hydroxyurea. On 27 December 2012 the subject received 1st dose of ENGERIX B (1.0 ml, unknown route, unknown arm) and one dose of an unspecified vaccine (unknown route, unknown arm). The subject had no information on this vaccine. In March 2014, 15 months after vaccination with ENGERIX B and unspecified vaccine, the subject experienced gastric problems. She went to emergency room and a whole series of tests was done on 20 March 2014. The results showed that she has no antibodies for hepatitis A and B and she has no immunity to Hep B virus. The subject also reported that she developed anemia 2 months after these vaccinations. At the time of reporting, her stomach problems were unresolved and her anemia was getting worse. The subject did not think there was a quality issue with the vaccine but she couldn't trust her doctor; she was never told that she had to receive additional doses for hep B. Follow up information received on 5 May 2014 from the consumer: The subject had no relevant medical history or allergy. On 27 December 2012, her blood pressure was 138/98 mmHg, her pulse was 64 bpm. On 27 December 2012, her physical examination was normal and she received 1st dose of hepatitis A vaccine in one arm and 1st dose of ENGERIX B in the other arm. She was never told that she had to receive a complete series of vaccination and she never received the following dose of vaccines. The consumer reported that 12 weeks after these vaccinations, she developed anemia. On 12 March 2014, a blood test showed that she had no antibodies for hepatitis A and B.
Sex: F
Vaccine: HEP
Symptoms: Laceration, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cut on middle finger in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 June 2014, the subject received unspecified dose of ENGERIX B (unknown route and injection site). On 27 June 2014, during she was giving a vaccination with ENGERIX B, the subject cut on her middle finger. When removing plastic cap from vial, one vial shattered and one vial cracked at the neck. The subject consulted the healthcare professional for the event. There was unknown if a medical attention was required. At the time of reporting the outcome of the events was unspecified. This case was associated to a pharmaceutical product complaint. Pharmacy technician stated there were 2 affected vials. Only 1 was available for return. The vial that was cracked at the neck was available for return. The product was purchased directly from GSK. The pharmacy will return sample vial. GSK will replace to pharmacy. Follow-up information received on 15 August 2014 from the medical assistant: Previous vial from box shattered when attempting to remove the plastic top. Other vials were also noted to be defective. QA final report was received on 02 September 2014: According to the thorough investigation performed at the different production steps, GSK Biologicals concludes that it is unlikely that the root cause of this complaint took place during the manufacturing process. GlaxoSmithKline Biologicals therefore considers this complaint as unsubstantiated. Follow-up information received on 03 September 2014 from the medical assistant: Additional information was not reported.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of numbness in finger in a 42-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Relevant medical history, medical conditions and concurrent medications, if any, were unspecified. Subject's previous vaccinations went uncomplicated. On 4 June 2014 at 3:50 pm, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left arm). On 4 June 2014 at 5:00 pm, 70 minutes after vaccination with ENGERIX B, the subject experienced numbness in her fingers, side of face, and tongue. At the time of reporting the events were improved.
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received ENGERIX B pediatric (batch number UNK, expiry date 6th September 2014). Concomitant products included ENGERIX B pediatric. On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: Expired ENGERIX-B given to a 2mo old male as 2nd dose in the series, a few weeks ago.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Facial pain, Fatigue, Muscle spasms, Pain in extremity
Clinical narrative: This spontaneous report as received from a 66 year old female patient refers to herself. The patient experienced on unspecified dates in the past severe bone pain with use of lisinopril (manufacturer unknown) and bronchitis, trouble breathing with use of CYMBALTA. The patient concurrent condition was diabetes and hypertension. On 08-JAN-2015 at 11 AM the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). Concomitant therapies included DIOVAN, JANUVIA and glimepiride. On 08-JAN-2015 by 5 PM the patient began to feel "real tired" and she developed spasms from the back of her calves, down to her ankles. On 09-JAN-2015 (reported as "today") the patient was still experiencing those symptoms and moreover on 09-JAN-2015 (reported as "now") she had pain in her hands, face and back. The patient did not seek medical attention and there was no lab diagnostic studies performed and no treatment was given for the event. By the time of the patient did not recover from adverse events. Relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 29-year-old male patient who received BOOSTRIX (batch number AC52B094AA, expiry date 8th November 2014). On 24th December 2014, the patient received BOOSTRIX. On 24th December 2014, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided. Answers to seriousness criteria questions was no to all. Called indicated there was nothing abnormal with the administration of the product except that the product was expired.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of urticaria on both feet in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included needle stick injury. At the time of reporting, there were no concomitant medications or relevant medical history. The subject may have "had a reaction to NOVOCAINE." The subject had a needle stick injury previously which was the reason for the ENGERIX B pediatric. There were no reported adverse reactions to previous vaccinations. On 28 January 2014 at 17:00 the subject received 1st dose of ENGERIX B pediatric (20 mcg/ml, unknown route, left arm). Per the reporter, the subject received 2 pediatric ENGERIX B vaccinations (to equal the adult dose). On 30 January 2014, 2 days after vaccination with ENGERIX B pediatric, the subject experienced urticaria on both feet (described as urticaria on feet, armpits and scalp). Per the reporter, the urticaria began on the subject's feet then moved up to her armpits and then her scalp area. It was unknown if the immunization series was delayed or discontinued. At the time of reporting the event was unresolved and ongoing. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B pediatric.
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline) or hepatitis A vaccine inactivated. A physician or other health professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown route, unknown lot number) or unspecified dose of Hepatitis A vaccine (unknown route, unknown lot number). In 1996, at an unspecified time after vaccination with Hepatitis A vaccine or Hepatitis B vaccine, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 15-year-old patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: This was one of the two cases received from the same reporter.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Nausea, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in a 51-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline). Concurrent medications included Vitamin B-5 and Omeprazole. On 14 January 2014 at 09:30 the subject received 1st dose of ENGERIX B (10 mcg, unknown route, right arm) and experienced underdose. The subject received less antigen than was indicated for her age. On the night of 14 January 2014, within hours of vaccination with ENGERIX B, the subject experienced nausea, headache, and fatigue. Per the pharmacist, the immunization series was not delayed or discontinued. At the time of reporting the events were resolved.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 77 year old male patient. Patient historical drugs included unspecified flu vaccine administered in October 2014. On 17-DEC-2014, the patient was vaccinated with ZOSTAVAX (lot number Expiry date, dose, route were not reported), Concomitant therapies included TD administered in November 2014. The pharmacist stated that the patient's wife informed him 02-24-2014 that the patient developed "something similar to shingles" on an unspecified date in December 2014. The patient went to unspecified emergency room and was diagnosed with shingles. It was unsure if the patient was hospitalized. On 08-JAN-2015 the pharmacist confirmed the patient's diagnosis of shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. 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 nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneously (site of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23, of dose 0.5 ml. It was reported that the patient missed a dose of PNEUMOVAX 23 due to a product quality complaint. Also reported that product quality complaint was filed. No adverse effect was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Underdose, Viral titre increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 20-year-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On an unspecified date, the subject received the complete ENGERIX B pediatric series in childhood (unknown route, injection site and batch number); but a recent titer showed a low level. Therefore, a new series was started. In 2014, the subject received 4th dose ENGERIX B pediatric (.5ml, unknown route, injection site and batch number) instead of an adult dose, which led to a vaccine underdose and inappropriate age at vaccine administration. Follow-up information received on 16 September 2014: The date of birth, the weight and the height had been added. The subject repeated titers and at the time of reporting, she had immunity to Hepatitis B.
Sex: M
Vaccine: HEP
Symptoms: Muscle rigidity, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of total body rigidity in a male subject of unspecified age who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B pediatric (unknown injection site and batch number). At an unspecified time after vaccination with ENGERIX B pediatric, the subject experienced total body rigidity and high fever. At the time of reporting, the outcome of the events were unspecified.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Peripheral swelling, Pyrexia, Sinusitis
Clinical narrative: Received varicella vaccine on 12-05-14. Mom states she noticed swelling of face on 12-7-14 a.m. and took him to ER at medical center. Dx with ear infection and rx cefdinir. Mom reported he had fever but did not take it. Noticed swelling of feet and hands this a.m. Brought to our health unit. Client received 2nd Varicella Vaccine at the Health Unit on 12/05/14 at approx. 1:00 p.m. Mom noticed child had a fever and his face was puffy on 12/07/14 at 10:00 a.m. She took him to the ER at Medical Center. The doctor diagnosed him with an ear and sinus infection. The MD states the facial swelling was due to the ear infection. He was rx cefdinir. Mom brought client to our health unit today, because she noticed his feet were swollen and hands. Client did have swelling/puffiness of hands and feet bilaterally. Denies fever since Sunday. Temp today 97.2 degree F. Consult CDNS. She states to complete a VAERS. Informed mom that it could be a reaction to the antibiotic. Discussed warning signs-increased swelling, hives, wheezing or trouble breathing. Instructed mom to seek ER care if his s/s worsen or do not appear. Instructed mom to call pharmacist and discuss s/s to ensure this is not a reaction to the antibiotic. Verbalized understanding. Client does not have insurance or a PCP.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine not valid, minimal interval between vaccine not met will need to be repeated.
Age: 72.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling right arm - later that evening - still slightly swollen 2 days post-immunization.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Muscle spasms, Nasopharyngitis, Pain in extremity, Peripheral swelling
Clinical narrative: Severely sore arm-hot-swollen-painful fever of 101.8, cramping in feet, severe headache which decreased proportionally as the fever reduced. This lasted until today. I am left with a head cold and sinus infection.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Sinusitis, Skin warm
Clinical narrative: Severely sore arm-hot-swollen-painful fever of 101.8, cramping in feet, severe headache which decreased proportionally as the fever reduced. This lasted until today. I am left with a head cold and sinus infection.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Hepatitis B surface antigen positive in a subject of unspecified age and gender who was vaccinated with ENGERIX B, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown route and injection site). Less than one day after vaccination with ENGERIX B, the subject experienced Hepatitis B surface antigen positive. At the time of reporting, the outcome of the event was unspecified. No further information was available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included exposure via blood. On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown route and injection site) due to a blood exposure. 1 day after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive. At the time of reporting, the outcome of the event was unspecified. This is one of the 2 cases reported by the same reporter.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash neck to lower back 1-9-15. Hives on leg 1-8-15.
Age: 65.0
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Product quality issue, Rash, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 65-year-old male subject who was vaccinated with ENGERIX B pediatric, GlaxoSmithKline), IPV (non-gsk) and Hib (non-gsk). The subject's medical history included stem cell transplant. Concurrent medications included Doxazosin and Albuterol. On 9 June 2014, the subject received 2 doses of ENGERIX B pediatric (route unknown, right arm), 2nd dose of IPV (Non-GSK) (unknown) and 2nd dose of Hib (Non-GSK) (unknown). The administration of 2 doses of ENGERIX B pediatric instead of 1 dose of ENGERIX B adult let to a wrong technique in drug usage process. On 9 June 2014, 3 days after vaccination with ENGERIX B pediatric, Hib (Non-GSK) and IPV (Non-GSK), the subject experienced rash all over his arms and legs. At the time of reporting, rash was unresolved. This case is linked to a pharmaceutical product complaint. Follow-up information received on 25 July 2014: Considering safety evaluation, it is unlikely that the reported events are related to a manufacturing problem. No further manufacturing investigation is required for the time being. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Follow-up information received on 19 August 2014: On 20 June 2014, rash was resolved.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vomiting
Clinical narrative: 1 day after injection - arm became swollen, tender, red at site - golf ball size lasting x4 days. Vomiting started 1 day post injection x 3 1/2d; Day 4 post injection - decreased swelling; Day 5 swelling resolved and no vomiting.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was with a dose of VARIVAX (Merck) 0.5 ml, intramuscular injection. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician via Merck and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B, (GlaxoSmithKline). In 2006, the subject received an unspecified dose of ENGERIX B (administration site and route unknown, batch number not provided). In 2006, at an unspecified time after vaccination after vaccination with ENGERIX B, the subject experienced injection site reaction. At the time of reporting, the outcome of the event was unspecified.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Emotional disorder, Faecal incontinence, Fatigue, Urinary incontinence
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of urine in a 5-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 29 July 2014, the subject received 3rd dose of ENGERIX B (left arm). On 29 July 2014, less than one day after vaccination with ENGERIX B, the subject experienced loss of urine, incontinence, loss of bowel control and emotional, mental and physical tiredness. Subject's mother reported that her son received other vaccines on the same day, however she did not want to report the names of those vaccines. She also reported that her son was on other medications, however she did not feel that that information was relevant. She did not know the expiration date of vaccine, and also did not know the exact address for the facility. At the time of reporting, the events were worse.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US000918, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507584) website on 06 Jan 2014. This report refers to a 57-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1307651) in the right arm on 16 Sept 2013. On the same date after vaccination, she experienced sore (right arm). Shot was given possibly to high. It has been over a month, now pain spreads to fingers of right hand. The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported. No additional information was available.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Nodule, Pruritus, Skin warm
Clinical narrative: Case number PHHY2014US001006 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508076) website on 06 Jan 2014: This report refers to a 61-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309601) in to the left arm along with ZOSTAVAX (other manufacturer, batch number: J006156) in to the right arm on 09 Oct 2013. On 10 Oct 2013, she experienced hot, itchy knot, which was the size of tennis ball on her arm along with redness in right arm. She had no trouble breathing. She visited the emergency room (ER) following these events. Final outcome of the events was reported as condition unchanged as on 15 Oct 2013. No further information about seriousness and causality was provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Computerised tomogram thorax, Diarrhoea, Full blood count, Migraine
Clinical narrative: Case number PHHY2014US001013 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508081) website on 06 Jan 2014: This report refers to a 56-year-old female patient. Her medical history included migraine headaches, chronic diarrhea, obesity and low T4. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13382P) in to the left arm on 11 Sep 2013. 48 hours after vaccination, she experienced pain in anterior chest wall, severe pain radiating into right and left chest and then into central dorsal spine. Laboratory tests performed included complete blood count (CBC) with increased shift and CBC, computed tomography (CT) for the chest, magnetic resonance imaging (MRI) for spine, neck and thorax, blood creatinine phosphokinase and Westergren sedimentation rate (WSR). Result for these tests were not reported. Final outcome of the events was reported as condition unchanged as on 11 Oct 2013. No further information about seriousness and causality was provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Obesity, Red blood cell sedimentation rate
Clinical narrative: Case number PHHY2014US001013 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508081) website on 06 Jan 2014: This report refers to a 56-year-old female patient. Her medical history included migraine headaches, chronic diarrhea, obesity and low T4. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13382P) in to the left arm on 11 Sep 2013. 48 hours after vaccination, she experienced pain in anterior chest wall, severe pain radiating into right and left chest and then into central dorsal spine. Laboratory tests performed included complete blood count (CBC) with increased shift and CBC, computed tomography (CT) for the chest, magnetic resonance imaging (MRI) for spine, neck and thorax, blood creatinine phosphokinase and Westergren sedimentation rate (WSR). Result for these tests were not reported. Final outcome of the events was reported as condition unchanged as on 11 Oct 2013. No further information about seriousness and causality was provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain, Thyroxine free decreased
Clinical narrative: Case number PHHY2014US001013 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508081) website on 06 Jan 2014: This report refers to a 56-year-old female patient. Her medical history included migraine headaches, chronic diarrhea, obesity and low T4. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13382P) in to the left arm on 11 Sep 2013. 48 hours after vaccination, she experienced pain in anterior chest wall, severe pain radiating into right and left chest and then into central dorsal spine. Laboratory tests performed included complete blood count (CBC) with increased shift and CBC, computed tomography (CT) for the chest, magnetic resonance imaging (MRI) for spine, neck and thorax, blood creatinine phosphokinase and Westergren sedimentation rate (WSR). Result for these tests were not reported. Final outcome of the events was reported as condition unchanged as on 11 Oct 2013. No further information about seriousness and causality was provided.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza
Clinical narrative: Case number PHHY2014US000910 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 508085) website on 06 Jan 2014. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: unknown) on 03 Oct 2013. On 07 Oct 2013, four days after vaccination, she developed flu. She was been taking medication for cough and TYLENOL from 07 Oct 2013 to 19 Oct 2013. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blister, Dysuria, Pain
Clinical narrative: Case number PHHY2014US001047 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 508328) on 06 Jan 2014. This report refers to a 26 year old male patient. He was vaccianted with FLUVIRIN (batch number: 1309401) intramuscularly on 18 Oct 2013. On the same day (18 Oct 2013), patient developed fluid like blister on arm. He also had lower back pain, body ache and burning urination. Outcome of the events were reported as condition unchanged as of 20 Oct 2013. Seriousness and causality were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2014US001049 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508329) website on 06 Jan 2014: This report refers to a to a 63-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in to the left arm along with PNEUMOVAX (batch number: H021941) intramuscularly in to the right arm on 19 Oct 2013. On the same day after vaccinations, she called back to the pharmacy stating she had a protruding swelling at the injection site. She advised to take ibuprofen and apply cool compresses. She called back again complaining of larger swelling and stiff neck. She was told to take BENADRYL . Pharmacist checked on her after an hour and was informed that she was better. No further information about seriousness and causality was provided.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Sinus congestion
Clinical narrative: Case number PHHY2014US001051 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508330) website on 06 Jan 2014: This report refers to a 71-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309201) in to the right arm on 14 Oct 2013. On the same day after vaccination, he experienced sinus congestion, cough and sore throat aches. The reaction as reported to the pharmacy on 18 Oct 2013. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fall
Clinical narrative: Case number PHHY2014US001056 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (reference number: 508331) website on 06 Jan 2014: This report refers to a 66-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in to the right arm on 02 Oct 2013. On the same day after vaccinations, suddenly while sitting, she started feeling dizzy; got up to go lie down; took a few steps and found herself sitting on the floor. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2014US001058 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508336) website on 06 Jan 2014: This report refers to a 75-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309001) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: J004196) intramuscularly in to the left arm on 14 Oct 2013. On an undetermined date after vaccinations, her arm was swollen and painful. She visited the emergency room (ER) following these events. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Ear pain, Pain in jaw
Clinical narrative: Case number PHHY2014US001060 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 508348) on 06 Jan 2014. This report refers to a 60 year old male patient. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly to his left arm on an 17 Oct 2013. On the same day (17 Oct 2013), the patient reported difficulty swallowing and pain in jaw bone radiating to his ear (right side of face). He was started feeling symptoms within 1 hour of injection. No trouble breathing or throat swelling reported. Outcome of the events were reported as condition unchanged as of 19 Oct 2013. Seriousness and causality were not reported.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Contusion, Injection site pain
Clinical narrative: Case number PHHY2014US001063 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508360) web site on 06 JAN 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309201) intramuscularly, along with PNEUMOVAX (batch number: J006242)intramuscularly and with ZOSTAVAX (other manufacturer batch number: J005720) subcutaneously on 10 OCT 2013. She came back to the pharmacy on 18 OCT 2013 complaining of bruising. She claimed to be painful at the time ZOSTAVAX was administered. She was advised to take Motrin and apply cold compress. Final outcome of the events was reported as condition unchanged. No further information about seriousness and causality was provided.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site bruising, Local swelling, Myalgia
Clinical narrative: Case number PHHY2014US001182 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508534) website on 06 JAN 2014. This report refers to a 78-year-old female patient. Her medical history was not reported. Her concomitant medications included PLAVIX , benazepril and hydrochlorothiazide. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601) intramuscularly in to the left arm on an undetermined date. On an unknown date after vaccination, she experienced muscle aches, back pain, neck swelling and injection site bruising. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injection site erythema, Injection site warmth, Myalgia, Swelling
Clinical narrative: Case number PHHY2014US001193 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508749) website on 06 JAN 2014. This report refers to an 80-year-old female patient. Her medical history was not reported. Her concomitant medications included Tegretol. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13373P) intramuscularly in to the left arm on 10 OCT 2013. On 13 OCT 2013, she experienced pain in muscle and redness and heat at injection site. Her reaction improved by 15 OCT 2013. She then developed pain in bone on 18 OCT 2013. On 21 OCT 2013, she still reported some pain and swelling. She had an appointment with her physician on 24 OCT 2013. She was alternating cold/hot compress every 15 minutes up to 12 times daily. Final outcome of the events was reported as condition unchanged as on 18 OCT 2013. No further information about seriousness and causality was provided.
Age: 67.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2014US001196 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS number: 508760) web site on 06 JAN 2014. This report refers to a 67-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIIN 2013/2014 (batch number: 1309201) intramuscularly in to the left arm along with BOOSTRIX (other manufacturer, batch number: N435Z) intramuscularly in to the right arm on 16 OCT 2013. On 17 OCT 2013, he experienced swelling and pain across top right of foot. He was recommended to follow-up with his physician. Final outcome of the events was reported as condition unchanged as on 21 OCT 2013. No further information about seriousness and causality was provided.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Photophobia
Clinical narrative: Case number PHHY2014US001197 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508766) website on 06 JAN 2014. This report refers to a 33-year-old female patient. Her medical history included recurring migraines and her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309501) in to the left arm on 16 OCT 2013. On the same day after vaccination, several hours later she experienced a sudden onset of light-headedness, dizziness and nausea. She was sensitive to light. She had not eaten just that day and was working on her feet. She gradually felt stronger and by 15 OCT 2013, she felt normal. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was provided.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia
Clinical narrative: Case number PHHY2014US001069, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509283) website on 06 Jan 2014. This report refers to 90-year-old male patient. His medical history included chronic atrial fibrillation. His concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: 1309201) intramuscularly in the left arm on 23 Oct 2013 between 11:00 AM and 11:30 AM. On the same day at 18:00 PM, his wife stated that he complained of double vision when both eyes were open. His wife monitored for signs of stroke and no other symptoms. The event outcome was reported as condition unchanged as of 23 Oct 2013. The seriousness and causality was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Middle insomnia, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2014US001082, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 509377) website on 06 JAN 2014. This report refers to a 35-year-old female patient. Her current condition included  hypothyroidism and treated with Armour (thyroid). She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13442P) intramuscularly in the left arm on 14 OCT 2013. On 15 OCT 2013, she experienced left arm pain which spread into left shoulder, upper back and left side of neck. It was reported that there was a little soreness in the night before bed and pain woke her up during the night and it continued to increase. She took Motrin and using topical muscle cream without relief. She also had  intermittent vertigo. The final outcome of the events reported as not recovered.