chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received meningococcal vaccine/HPV #1 and FLUMIST 3/4/14. States on 3/5/14 she developed redness, warmth-to-touch and swelling from top of (L) deltoid, halfway down to elbow. Pt tried applying ice/hot salt water to site. (L) arm was still red and swollen on 3/7/14 but 3 1/2 x 3 1/2 inches. Advised to apply ice and take Ibuprofen - not to apply hot water.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash over abdomen and chest bilateral. Rash resolved with steroid application after 7 day trx.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Tremor
Clinical narrative: Approx. 5 minutes after receiving vaccines, patient noted by father and immunization tech, to have body shaking that lasted for < 10 seconds. No postictal state, patient placed in trendelenburg position and given supplemental O2. He was pale, but responsive. No LOC. Vital signs were stable.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Pyrexia
Clinical narrative: 2-3 days after administration, patient had fever, felt burning sensation on right back, some blisters developed; mild pain. Capsaicin cream was prescribed by Dr. Patient was fine and said he did not need to use any pain med.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: RA was rashed and raised. It was about 2" wide by 3" length and warm to touch. No induration.
Age: 0.26
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 300 pm 3/7/14 - Inconsolable crying starts. Right lower thigh red, tender, and swollen. No fever. 3:35 pm - PCP instructed to give infant TYLENOL. 4:30 pm. Infant TYLENOL given. 4:50 - Crying stops. 3/10/14 - 9:30 am - Right leg normal. No further episodes of crying.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 24 hours after administration, red and raised 2-3", 48 hours - red, arm, and raised 4-5", 4 days later, redness, warm but no longer raised. No pain. Pt started KEFLEX and VISTORIL at 48 hours.
Age: 1.32
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Symptoms developed over days following vaccine.  Unusual arm soreness, followed by "pain" that moved from neck to shoulder to back, then chest per pain.  Patient was concerned and asked to report the symptoms.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Symptoms developed over days following vaccine.  Unusual arm soreness, followed by "pain" that moved from neck to shoulder to back, then chest per pain.  Patient was concerned and asked to report the symptoms.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LEFT DELTOID/INJECTION SITE "VERY PAINFUL, SWOLLEN, RED AND HOT".
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema, Skin warm, Urticaria
Clinical narrative: Onset of redness and swelling that extended from below the injection site to almost the elbow.  Was 4 in x 6 in size, visible edema on lower edges and appearance of hives on arm and chest the next two days.  No fever.  Warm to touch, not particularly painful. Treated with ibuprofen and ice without success.  Then with Benadryl, no change.  Referred to medical care provider.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Joint range of motion decreased, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: FIRM, ERYTHEMATOUS, PAINFUL AREA SURROUNDING VACCINE SITE EXTENDING DOWN TO ELBOW. UNABLE TO MOVE UPPER ARM.  STARTED ON AUGMENTIN 875MG BID   RESOLVED 2 DAYS LATER.
Age: 51.0
Sex: F
Vaccine: DTP
Symptoms: Cough, Fatigue, Headache, Increased bronchial secretion
Clinical narrative: Persistent, deep cough, heavy mucous in lungs and sinuses, headache, fatigue. Treatment: Zinc and cough suppressant.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Mobility decreased, Pruritus
Clinical narrative: JOINT PAIN, BODY ITCHING, PATIENT WAS NOT ABLE TO MOVE HER HANDS.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Blood sodium decreased, Fall, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of Guillain-Barre syndrome in a 76-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. On 28 October 2013 the subject received a dose of Influenza vaccine unspecified (details unknown). It was reported that "two vaccines in the flu shot mixed". On 19 January 2014, 83 days after vaccination with Influenza vaccine unspecified, the subject experienced fell. The patient's symptoms began on 19 January 2014 when she fell three times. On 20 January 2014, 84 days after vaccination with Influenza vaccine unspecified, the patient went to the emergency room and was first treated for low sodium. On an unknown date in 2014, months after vaccination with Influenza vaccine unspecified, the subject experienced "numbness of hands, feet and arms", "paralysis of whole body", arm paralysis and Guillain-Barre syndrome. The subject was hospitalised. The subject was discharged from the hospital on 10 February 2014 when transferred to transitional rehab facility. The patient was treated with plasmapheresis five times. The patient underwent acute physical therapy. Relevant test results included sodium of 117 on 20 January 2014 and spinal tap in 2014 that "confirmed it" [diagnosis]. At the time of reporting the arm paralysis and Guillain-Barre syndrome were unresolved, but the whole body paralysis was considered resolved; the fell was resolved and the outcome for the low sodium and numbness was unknown. At the time of the report, the patient was still at the rehab facility because she was "not able to function on own".
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Monoplegia, Paralysis, Plasmapheresis
Clinical narrative: This case was reported by a consumer and described the occurrence of Guillain-Barre syndrome in a 76-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. On 28 October 2013 the subject received a dose of Influenza vaccine unspecified (details unknown). It was reported that "two vaccines in the flu shot mixed". On 19 January 2014, 83 days after vaccination with Influenza vaccine unspecified, the subject experienced fell. The patient's symptoms began on 19 January 2014 when she fell three times. On 20 January 2014, 84 days after vaccination with Influenza vaccine unspecified, the patient went to the emergency room and was first treated for low sodium. On an unknown date in 2014, months after vaccination with Influenza vaccine unspecified, the subject experienced "numbness of hands, feet and arms", "paralysis of whole body", arm paralysis and Guillain-Barre syndrome. The subject was hospitalised. The subject was discharged from the hospital on 10 February 2014 when transferred to transitional rehab facility. The patient was treated with plasmapheresis five times. The patient underwent acute physical therapy. Relevant test results included sodium of 117 on 20 January 2014 and spinal tap in 2014 that "confirmed it" [diagnosis]. At the time of reporting the arm paralysis and Guillain-Barre syndrome were unresolved, but the whole body paralysis was considered resolved; the fell was resolved and the outcome for the low sodium and numbness was unknown. At the time of the report, the patient was still at the rehab facility because she was "not able to function on own".
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 5-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Historic vaccination included FLUZONE (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date 2012-2013 season. On 4 March 2014 the subject recevied unspecified dose of FLUARIX QUADRIVALENT (unknown). On 4 March 2014, immediately after vaccination with FLURAIX QUADRIVALENT, the subject experienced seizure. The healthcare professional reported the subject experienced a seizure immediately after administration of FLUARIX QUADRIVANELT; no other information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure was unspecified.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Myelitis
Clinical narrative: This case was reported by a physician (also subject) and described the occurrence of myelitis in an adult female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included foreign travel. Concurrent vaccination included typhoid vaccine (non-gsk); non-GSK manufacturer; unknown given on 9 November 2013. On 9 January 2013 the subject received a dose of HAVRIX (unknown details). On 19 January 2013, 10 days after vaccination with HAVRIX, the subject experienced myelitis. The physician stated that she was "recently diagnosed with myelitis probably due to the vaccine I got before" travel. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with HAVRIX.
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a child subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced possible allergic reaction. The healthcare professional inquired about information on allergy testing for neomycin and later stated that a child subject had a possible allergic reaction to HAVRIX. The reporter did not want to provide additional information or contact information stating this had already been reported. A search in the GSK database did not locate the possible allergic reaction with HAVRIX, therefore case A1014504A was databased. At the time of reporting the outcome of the event was unspecified.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Muscular weakness, Pyrexia
Clinical narrative: Headaches, fevers, chills, pain at the site of vaccination. Weakness of the legs.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase decreased, Blood glucose normal, Blood lactate dehydrogenase increased
Clinical narrative: 2-3 headaches per week, lethargy, rash.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Dermatomyositis, Electrocardiogram T wave abnormal, Electrocardiogram normal, Headache, Laboratory test
Clinical narrative: 2-3 headaches per week, lethargy, rash.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Lethargy, Nuclear magnetic resonance imaging abdominal, Nuclear magnetic resonance imaging abnormal, Rash, Supraventricular extrasystoles
Clinical narrative: 2-3 headaches per week, lethargy, rash.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Von Willebrand's factor activity test
Clinical narrative: 2-3 headaches per week, lethargy, rash.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Presyncope, Syncope
Clinical narrative: Vasovagal reaction/syncopal episode.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of (r) leg numbness in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 May 2012 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm) On 9 May 2012, 1 hour after vaccination with HAVRIX, the subject experienced (r) leg numbness. The right leg numbness "lasted a couple of hours and resolved." Per the pharmacist, the subject did not seek medical attention and returned to receive her second shot. At the time of reporting, it was unknown if the subject received the second shot. On 9 May 2013, the event was resolved.
Age: 1.02
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blood glucose normal, Carbon dioxide decreased, Chest X-ray abnormal, Febrile convulsion, Full blood count normal
Clinical narrative: Fever, simple febrile seizure, and pneumonia for which patient was seen at Hospital / Emergency Department and discharged home.
Age: 1.02
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pneumonia, Protein urine absent, Pyrexia, Urine analysis normal
Clinical narrative: Fever, simple febrile seizure, and pneumonia for which patient was seen at Hospital / Emergency Department and discharged home.
Age: 1.52
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Hives, redness and swelling.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Excessive eye blinking, Grimacing, Pyrexia
Clinical narrative: This case was reported by a consumer (friend of subject's mother) and described the occurrence of fever in a 2-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of Hepatitis A vaccine (unknown details). One day after vaccination with Hepatitis A vaccine, the subject experienced fever. Three days after vaccination with Hepatitis A vaccine, the subject experienced grimacing  and repetitive eye blinking. No additional details were available at the time of reporting. The reporter will encourage the subject's mother to contact GSK directly to provide additional details. At the time of reporting the outcome of the events were unspecified. The reporter also reported another case. See case A1017127A for details on the other case.
Sex: U
Vaccine: HEPA
Symptoms: Discomfort, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm (injection site) in a subject of unspecified age and gender who was vaccinated with HAVIRX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given in February 2013. In March 2013 the subject received 2nd dose of HAVRIX (unknown, right arm) and experienced sore arm (injection site) and drug dose administration interval too short. In late March 2013, the subject was administered a 2nd dose of HAVRIX one month after receiving the 1st vaccination. The reporter felt the clinic must have made a mistake. The subject felt uncomfortable after the second vaccination, clarified as soreness on the right arm that was different compared to the first vaccination. The reporter declined to provide specific details but authorized to be contacted for follow-up. At the time of reporting the outcome of the sore arm (injection site) was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Injection site swelling, Pyrexia, Rash erythematous, Swelling
Clinical narrative: This case was reported by a consumer via Merck and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced swelling injection site, fever, red swollen bumps [red bumps and swelling]. The consumer, who is the subject's parent, reported that her child was administered HAVRIX, and experienced injection site swelling, fever, and red swollen bumps. At the time of the report no other information was available. At the time of reporting the outcome of the events were unspecified.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Headache, Lacrimation increased
Clinical narrative: This case was reported by a physician and described the occurrence of diarrhea in a 45-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. On 10 May 2013 at 09:30 the subject received 1st dose of HAVRIX (unknown, left arm), Lot number reported as GX2LA. Within days of vaccination with HAVRIX, the subject experienced diarrhea, headache and watery eyes. The physician reported that an adult subject received HAVRIX on 10 May 2013 and reported a headache, watery eyes and diarrhea. The headache resolved but the diarrhea was still being reported (twice daily). At the time of reporting the outcome of the headache resolved; diarrhea was unresolved and the watery eyes was unspecified.
Age: 52.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Blister, Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site blisters in a 52-year-old male subject who was vaccinated wiht HAVRIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. Concurrent vaccination include yellow fever vaccines (non-gsk) ;manufacturer unspecified;unknown given on 16 May 2013. On 16 May 2013 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm). On 17 May 2013, 1 day after vaccination with HAVRIX, the subject experienced injection site blisters and blister on arm. The reporter stated that the subject "developed 1 blister overnight on the left arm and found them the next morning." The subject then "developed 1 blister on right arm today (day after vaccination)." The reporter was considering whether to continue the HAVRIX series. At the time of reporting, the subject had not received "medical condition" but will be "determined based on progression" of the adverse evens. The reporter stated that the HAVRIX lot number was AHAVBJ97AA which is not a valid lot number. An unsuccessful attempt was made to clarify the lot number. At the time of reporting the outcome of the events were unspecified.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Overdose
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of overdose in a 14-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline). On 20 May 2013 at 17:57 the subject received a dose of HAVRIX ADULT (1.0ml, left arm) and experienced overdose. The nurse reported that a "14 year old patient received an adult dose of HAVRIX." No adverse events were reported at the time of reporting. Follow up was received from nurse on 18 June 2013. The nurse documented that on 21 May 2013, 1 day after vaccination with the 1st dose of HAVRIX ADULT, the subject also experienced injection site soreness. The event resolved on 21 May 2013 and was probably related to HAVRIX ADULT. The nurse did not consider this case to be serious. The nurse documented that erroneous administration of HAVRIX ADULT to be adolescent could have been associated with the event. The subject was also vaccinated with a booster dose of "Tdap" (0.5ml, intramuscularly) on 20 May 2013. The nurse documented that the subject's mother was notified and a "variance incident report form" was completed. Per the nurse, the immunization series was not delayed or discontinued. It was unknown if the symptoms recurred following subsequent administration. The subject had not experienced any adverse events following previous vaccinations.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a pharmacist and described the occurrence of Hepatitis A infection in a currently 58-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline). The subject's medical history included foreign travel. The subject recently traveled. The pharmacist stated that the subject reported "eating frozen berries that have recently been recalled from [retailer] due to Hepatitis A contamination." In 2006 the subject received 1st dose and 2nd dose of HAVRIX (unknown details). On 4 June 2013, 7 years after vaccination with HAVRIX, the subject experienced Hepatitis A infection and vaccination failure. The pharmacist stated that the subject was "not usually a customer of that [retailer] and the vaccine was not administered here." The pharmacist also stated that the subject reported "eating frozen berries that have recently been recalled from [retailer] due to Hepatitis A contamination." The subject's wife, who was a doctor, stated that the subject had "all the signs and symptoms of Hepatitis A." Relevant laboratory results: The pharmacist reported that the subject stated that in 2013 (described as "now"), the subject had "now tested positive for active Hepatitis A infection." This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Gait disturbance, Influenza like illness, Joint swelling, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 June 2013 the subject received a dose of HAVRIX (1 ml, unknown route, left arm). In June 2013, less than one week after vaccination with HAVRIX, the subject presented to the physician having experienced fever, joint pain, joint swelling, rash, flu like symptoms and walking difficulty. At the time of reporting the events were unresolved. The physician reported another case with HAVRIX. See case A1031798A for details on the other case.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 June 2013 the subject received a dose of HAVRIX (1 ml, unknown route, left arm). In June 2013, less than one week after vaccination with HAVRIX, the subject presented to the physician having experienced fever, joint pain, joint swelling, rash, flu like symptoms and walking difficulty. At the time of reporting the events were unresolved. The physician reported another case with HAVRIX. See case A1031798A for details on the other case.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a physician and described the occurrence of bubbles under skin at site of injection in a 57-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 17 May 2013 at 15:00 the subject received 2nd dose of HAVRIX (1 ml, unknown, right arm) and experienced bubbles under skin at site of injection. The subject had a round bubble under the skin at injection site. The subject was noted to have small arms. At the time of reporting the event was unresolved. Follow up received from pharmacist (initial reporter) on 18 June 2013. Previously, the reporter was documented as a physician; however, on follow up, the reporter noted that they were a pharmacist. According to the pharmacist, on 18 May 2013 (described as "24 hours after shot") the subject experienced bubbles under the skin. The onset date was previously reported as 17 May 2013. The pharmacist documented that the adverse event had resolved. The pharmacist did not consider the event to be serious. According to the pharmacist, the event could have been associated with erroneous administration "subcutaneously rather than intramuscularly" and "side effect for patient." The pharmacist documented that the subject had received the vaccine before and had "no side effects from 1st set of immunizations." The immunization series was not discontinued. It was unknown if the series was delayed. The pharmacist noted that the subject "had not had final shot as of yet and patient will have physician do a titer test in 1 month and report to us if physician wants her to be reinjected."
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Gait disturbance, Influenza like illness, Joint swelling, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 38-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Relevant medical history included history of hepatitis b, hepatitis b carrier. On 9 June 2013 the subject received a dose of HAVRIX (1 ml, unknown route, left arm). In June 2013, less than one week after vaccination with HAVRIX, the subject presented to the physician having experienced fever, joint pain, joint swelling, rash, flu like symptoms and walking difficulty. At the time of reporting the events were unknown. The physician reported another case with HAVRIX. See case A1031781A for details on the other case.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 38-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Relevant medical history included history of hepatitis b, hepatitis b carrier. On 9 June 2013 the subject received a dose of HAVRIX (1 ml, unknown route, left arm). In June 2013, less than one week after vaccination with HAVRIX, the subject presented to the physician having experienced fever, joint pain, joint swelling, rash, flu like symptoms and walking difficulty. At the time of reporting the events were unknown. The physician reported another case with HAVRIX. See case A1031781A for details on the other case.
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer (friend of subject) and described the occurrence of hive in a female subject of unspecified age who was vaccinated with HAVRIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of HAVRIX (unknown details). At an unspecified time after vaccination with HAVRIX, the subject experienced hive and itching. The reporter stated that a female he had spoken with experienced hives and itching after vaccination with HAVRIX. At the time of reporting the outcome of the events were unspecified. The reporter documented another case with HAVRIX. See case A1034117A for details on the other case.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Inflammation, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm rash in a 23-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 2 August 2013 the subject received a dose of HAVRIX (1 cc, unknown route, right arm). On 4 August 2013, 2 days after vaccination with HAVRIX, the subject experienced arm rash and arm inflammation. The reporter stated that "both of the patient's arm having a rash and becoming inflamed." No other details were known at the time of reporting. The subject was treated with BENADRYL after evaluation from a doctor. At the time of reporting the events were worse. The healthcare professional considered the events were related to vaccination with HAVRIX. Per the reporter, "it was not certain whether the reaction was from the HAVRIX but it was assumed to be since it only started after receiving the vaccine."
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of flu-virus in a 30-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included influenza vaccine unspecified; non-GSK manufacturer; CSL Biotherapies; unknown; unknown given in October 2013. Concurrent medications included ALESSE. On 14 November 2013 at 12:00 the subject received 2nd dose of HAVRIX (a "unit dose syringe", unknown details, left arm). On 24 November 2013, 10 days after vaccination with HAVRIX, the subject experienced flu-virus, fever, chills and body pain. The nurse reported that the subject woe up on 24 November 2013 with fever, chills and body aches. The subject "continued to feel worse during 25 November 2013" and sought medical attention at an urgent care facility. Per the nurse "urgent care confirmed the flu" but the nurse was unsure if "that was based upon symptoms or lab tests." The subject was treated with TAMIFLU on 25 November 2013. At the time of reporting the events were worse.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender who on 12-MAR-2014, was vaccinated with a dose of PROQUAD, 0.5 ml, subcutaneously, expiration date 24-FEB-2014. No adverse effects reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoeic attack, Body temperature increased, Cyanosis
Clinical narrative: Apneic, cyanotic episode the evening of the vaccines (6-8 hrs after vaccine). Tactile stimulation was the only intervention 911 called. Exam only showed temp of 100.8 (R) otherwise well by the time of exam.
Age: 4.0
Sex: F
Vaccine: DTPIPV, MMR, TTOX, VARCEL
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swollen area around tetanus injection site.  Area grew to 5 inches in dia.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: TEMP 102.5, REDNESS, SWELLING, WARMTH OF RIGHT UPPER ARM INJECTION SITE.
Age: 33.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Headache
Clinical narrative: Mild Headache, No SOB, No rashes, NO tingling sensation/ Per RN. Advice pt to wait for another 30 mins for further symptoms of adverse reactions. No other adverse reactions noted p 30 mins. Pt discharge to home.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Herpes zoster, Pruritus, Rash
Clinical narrative: RASH, ITCH, NO PAIN ON HIS WAIST AND THIGH. LOOKS SIMILAR TO SHINGLES BUT NO BLISTERS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash 2" wide x 4" long extending down inner arm from injection area and very sore.  Reddened skin 3" wide x 6" long extending down inner arm starting below rash almost to elbow, and very hot to the touch.  Symptoms subsided after 7 to 8 days.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Induration, Local swelling, Pain in extremity
Clinical narrative: Left arm hard, swollen, pain of "10", ice applied, Tylenol given, pharm and MD informed.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES AT BASE OF NECK IN THE BACK AND AT THE BACK OF THE NECK AT BASE OF HEAD.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Injection site rash, Malaise, Tenderness
Clinical narrative: Rash extending from injection site to elbow, tender arm, malaise, cough.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Diplegia, Herpes zoster, Myalgia
Clinical narrative: Information has been received from a 75 year old female consumer with a history of shingles who on 12-MAY-2010, was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included "pain pills". The consumer stated that the ZOSTAVAX (Merck) shot did not relieve her pain. The consumer also reported that her myalgia remained after getting the ZOSTAVAX (Merck) shot. She received a dose of ZOSTAVAX (Merck) on the advice of a physician. At the time of the report the consumer was recovering. The consumer sought unspecified medical attention. Additional information has been received from consumer. The patient reported that she had developed shingles on an unspecified date in 2008. The patient was completely free of pain for 2 years after receiving the ZOSTAVAX. However she developed shingles again on an unspecified date in September 2013 and again on 27-FEB-2014. The patient stated that her legs became paralyzed and then she took VALTREX (also reported as manufacturer unknown) and then realized that she is getting shingles again. The patient sought medical attention for the events. The outcome of events was recovering. The causality of the events with the suspect product was unknown. No product quality complaint was reported. Upon internal review the event legs paralysis was considered as medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: After administering the vaccines, the patient presented abdominal pain, nausea, dizziness and vomit. He was pale, sweaty and cool to touch. B/P 80/50 P-62.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Peripheral coldness, Vomiting
Clinical narrative: After administering the vaccines, the patient presented abdominal pain, nausea, dizziness and vomit. He was pale, sweaty and cool to touch. B/P 80/50 P-62.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: (L) shoulder swelling - MCV4 vs TDAO. Swelling = (14/16 cm) T and R + ice pack on swelled area. BENADRYL 125/5 sig 2 tsp po q 8 hours #200 cc.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Allergy to vaccine, Pruritus generalised, Rash
Clinical narrative: Pt came in 3/3/14 due to body itch Dr. prescribed BENADRYL. 3/14/14 pt came in due to rash to hands. Dr. Dx: allergic to HPV prescribed BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, redness and mild tenderness of deltoid. Cool cloth.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching, subcutaneous recommended antihistamine regime ice if really itchy,
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 3/13/14 Am mom noticed swelling and redness. Redness better and swelling better on 3.14.14 no fever, no fatigue.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Proximal (L) shoulder/deltoid pain; started w/in week of receiving flu shot.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient was given Hep A and MCV4. Next day, arm red, warm to touch and swollen. Treated with warm compresses and cephalexin 500 mg cap by mouth 2 times a day for 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 60 year old female patient who on 09-OCT-2012, was vaccinated with a dose of ZOSTAVAX (lot no. H011048, exp. 05-SEP-2013), 0.65 ml, subcutaneous. On an unknown date the patient developed an "outbreak" along her jaw line. The "outbreak" was itchy and painful. The "outbreak" resolved within a few days. These "outbreak" occurred repeatedly and lasted for a few days. No lab diagnostic tests were performed. Relationship between "outbreak" along the jaw itchy, painful and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. The patients current conditions or medical history were reported as none. On 05-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose and route were not reported) (lot number reported as J011828 expiry 26-DEC-2020). Concomitant therapies included HAVRIX administered at the same time as ZOSTAVAX in the patient's opposite arm. On 06-MAR-2014, the patient developed a 2 inch, red rash at the ZOSTAVAX injection site. The pharmacist reported that the patient went to the pharmacy on 07-MAR-2014 and the 2 inch red rash was still present at the injection site. At the time of the report the patient was not recovered from 2 inch red rash at the injection site. The patient did not receive treatment for the event. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with hypertension and no drug reaction/allergies. On 17-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). Concomitant therapies included DIOVAN. The pharmacist reported that the patient had experienced soreness at the injection site since she was administered ZOSTAVAX at her physician's office on 17-FEB-2014. The patient had not recovered from soreness at the injection site. The patient called pharmacy for medical attention. The causal relationship was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 25 year old female consumer, refers herself. The patient had no medical history or concurrent conditions. On 28-FEB-2014, the patient was vaccinated with the first dose of (oka/merck) VARIVAX (dose not reported), route reported as injection. No co-suspect therapies were reported. Concomitant therapies included unspecified prenatal vitamins. The patient reported that she received (oka/merck) VARIVAX while being pregnant. The patient became pregnant with Last menstrual Period (LMP) of 26-FEB-2014 and Estimated Date of Delivery (EDD) of 03-DEC-2014. It was reported that no treatment was given for the event and no lab diagnostic studies were performed. At the time of the report, the pregnancy outcome and the outcome of vaccine exposure during pregnancy were unknown. It was reported that (oka/merck) VARIVAX was not reintroduced and that the patient sought medical attention (office visit). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Blood test normal, Chest pain, Hypoaesthesia
Clinical narrative: Same day, skipped a few days, and pains/aches started happening all over inside body.  Not growing pain feelings, but electric type pinched nerve feelings, random and off and on continuously for nearly two weeks so far incuding chest pain, numb feelings, and weakness.  Lots of hip and leg and elbow pain.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pain in extremity, Paraesthesia, Urine analysis normal
Clinical narrative: Same day, skipped a few days, and pains/aches started happening all over inside body.  Not growing pain feelings, but electric type pinched nerve feelings, random and off and on continuously for nearly two weeks so far incuding chest pain, numb feelings, and weakness.  Lots of hip and leg and elbow pain.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal tenderness, Blood test, Bowel movement irregularity, CSF test, Dyspnoea
Clinical narrative: Numbness on legs, tenderness on abdemen, then, breathing difficulty, can't urinate and no bowel movement.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging, Urine output decreased
Clinical narrative: Numbness on legs, tenderness on abdemen, then, breathing difficulty, can't urinate and no bowel movement.
Age: 32.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Back pain, Musculoskeletal pain, Neuralgic amyotrophy, Winged scapula
Clinical narrative: Extreme pain in my right shoulder and upper right back began while I was sleeping.  Pain continued for about 1 week then I had a loss of strength in the arm and shoulder and winging of my right shoulder blade.  The condition was diagnosed as Parsonage Turner Syndrome.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site joint movement impairment, Injection site movement impairment, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm (near injection site) radiating down arm. Pain has worsened and is still present as of today, 03/15/2014.  I have limited range of motion in left shoulder.  Severe 9/10 pain with certain movements such as extending arm out to the side, or back.  Putting clothing on is very painful. Shoulder cracks and 'pops'.  When it 'pops' I nearly double over with pain. The pain awakens me in the night.  Motrin reduces the pain but does not relieve it.  A heating pad makes the pain worse. Called nurse practitioner who gave the injection and she recommended warm moist compress.  It did nothing. I do not feel pain when touching my arm.  It is not like a bruise type of pain.  All the pain is a constant shoulder upper arm, radiating to the wrist pain and severe pain with movement.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Poor quality sleep
Clinical narrative: Severe pain in left arm (near injection site) radiating down arm. Pain has worsened and is still present as of today, 03/15/2014.  I have limited range of motion in left shoulder.  Severe 9/10 pain with certain movements such as extending arm out to the side, or back.  Putting clothing on is very painful. Shoulder cracks and 'pops'.  When it 'pops' I nearly double over with pain. The pain awakens me in the night.  Motrin reduces the pain but does not relieve it.  A heating pad makes the pain worse. Called nurse practitioner who gave the injection and she recommended warm moist compress.  It did nothing. I do not feel pain when touching my arm.  It is not like a bruise type of pain.  All the pain is a constant shoulder upper arm, radiating to the wrist pain and severe pain with movement.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever and rash all over body.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, Brain stem auditory evoked response, CSF test, Diplopia, Hypoaesthesia
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Sensory loss
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urine analysis, Visual evoked potentials
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test abnormal, Brain stem auditory evoked response abnormal, Diplopia, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Sensory loss
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urine analysis abnormal, Visual evoked potentials abnormal
Clinical narrative: Woke up in the morning and had numbness/ no sensation below the waist. I also had double vision. I went the next day and saw a physician at the health center. She referred me immediately to Dr. for a neurology consult. Testing quickly revealed multiple sclerosis. I was treated and still an under treatment with daily Copaxone injections.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Extremely swollen right thigh. Right thigh almost twice the size of normal. Redness of thigh extending past knee. Right thigh hot to the touch. Patient fussy. 24 hours later exact same symptoms persist in spite of alternating Tylenol and Motrin and giving Benadryl.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 46 year old female patient. No pertinent medical history or drug reactions/allergies were reported. On 14-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 VIAL (lot # J014401; expiry date 26-NOV-2014), 0.5 ml, subcutaneously in the arm (dose number not provided). No co-suspect or concomitant therapies were reported. After receiving PNEUMOVAX 23, approximately on 14-FEB-2014, the patient developed swelling and redness on her arm, at the injection site. The reporter did not known if the patient had received PNEUMOVAX 23 in the past. At the time of the report, the outcome of the events was unknown. It was reported that the patient may had been using an unspecified cream to treat the injection site symptoms. The patient sought medical attention by calling the office. The reporter requested a lot check. This is case in linked to case MARRS # 1403USA007283 (same reporter link). Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: DTP, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Urticaria
Clinical narrative: 30 hrs after immuniz dev fever, then febrile seizure 9 days after immz dev. urticarial rash.