chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker and refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date in June 2014, the patient was vaccinated with the first dose of VAQTA and on an unknown date in September 2014, the patient was vaccinated with the second dose of VAQTA (lot number and expiry date were not reported) intramuscularly (the second doses was administered in less than the recommended interval). There were no concomitant medications reported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Baby received PENTACEL, PREVNAR and ROTATEQ on 3/10/15. Next day on 3/11/15- hives all over no treatment.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt called reporting pain in left arm at injection area. Pt stated she couldn't lift her arms out straight w/out pain, or behind her back. Arm is achy and throbbing.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Pt called reporting pain in left arm at injection area. Pt stated she couldn't lift her arms out straight w/out pain, or behind her back. Arm is achy and throbbing.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a dentist refers to a 75 year old male patient with macular degeneration, arteriosclerosis and high blood pressure. The patient's medical history included aortic stent insertion. In approximately 2013 reported as about two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. In approximately February 2015 reported as 3-4 weeks ago, the patient developed shingles of the eyes. The patient sought medical attention, went to see the physician and an ophthalmologist and was prescribed with unspecified eye drops for the shingles on an unspecified date. None laboratories studies were performed. The outcome of the shingles of the eyes was reported as not recovered at the time of the report. The relatedness between the shingles of the eyes and ZOSTAVAX was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Pt stated she had diarrhea, chills, slight temp, vomiting. Symptoms for 24 hrs.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pt was given PNEUMOVAX in right deltoid on 3-6-15. Pt started having myalgia in right arm. Pt seen by doctor 3-11-2015.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Immediate post-injection reaction, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 23 year old female patient. The patient's medical history included hay fever. On 28-JAN-2015, the patient was vaccinated with first dose of GARDASIL (intramuscular, dose/frequency: 1 shot, lot # K006191, expiry date: 02-FEB-2017). Concomitant therapies included SINGULAIR (dose and frequency unknown) and ALLEGRA (dose and frequency unknown). On 28-JAN-2015, the patient became lightheaded immediately after receiving the vaccine. On 06-FEB-2015, the patient experienced weakness and soreness in both of her arms which had caused difficulty in lifting and moving objects with her arms. The patient had visited an unspecified primary care physician. No hospitalization or prolongation and significant disability or incapacity was reported. The outcome of the events was unknown. The Causal relationship between the events and GARDASIL 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 licensed vocation nurse on 13-MAR-2015 refers to unspecified patients. Nurse reported that probably up to 20 to 30 doses of improperly stored (Oka/Merck) VARIVAX were exposed to defrost cycle temperatures and administered to patients since 02-FEB-2015. No adverse events were reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On unspecified dates between 01-NOV-2014 and 13-MAR-2015, patients received improperly stored PROQUAD (Merck) (dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No Product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Since 06-NOV-2014 the patients were vaccinated with doses of GARDASIL (lot #, expiration date, dose and route unspecified) that were improperly stored. No adverse effects were known. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself with not known case of chickenpox. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, lot # and expiration date were not provided). On an unknown date, after receiving ZOSTAVAX, the patient experienced 3 separate cases of herpes zoster as shingles in her throat. The patient also experienced, dysphagia as she had difficult swallowing and post herpetic neuralgia (PHN). At the time of the report, the outcome of herpes zoster, dysphagia and post herpetic neuralgia was unknown. Additional information is not expected because the reporter did not provided contact details.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of MMR II (dose, frequency, lot# and route were not reported). On an unknown date the patient had negative titers after receiving unspecified vaccines. The outcome of the event was unknown. The relationship between the event and MMR II was not reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender on 03-MAR-2015. The patient had no drug reactions/allergies and had "issues with left arm (Unspecified). On 01-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010648, expiration date October 2015, 0.65 ml, once) subcutaneously in right arm. Concomitant therapies included tizanidine hydrochloride (muscle relaxer), unspecified patch for muscle pain, levothyroxine sodium and sertraline hydrochloride. In March 2015 the patient developed itching, redness, swelling at injection site. The patient used hydrocortisone cream (manufacturer unspecified) on site as self care. The patient had not had many vaccinations and sought medical attention via contacting the pharmacist. The outcome of these events was reported as not recovered/not resolved. The relationship between these events and ZOSTAVAX was not reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, patients received improperly stored GARDASIL (dose strength and route was unknown). No adverse effect was reported.No concomitant medication was reported. No Product Quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 4 month old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medication provided. On 21-JUL-2007, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type, lot # and expiration date were not reported). On 29-AUG-2007, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type, lot # and expiration date were not reported). On 30-OCT-2007, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose 0.5 ml, route, therapy type lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a 10 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route, lot# and expiration dates were not provided) that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information is not expected, because there was no consent to contact the reporter.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative referring to a currently 15 year old female patient who on 10-MAR-2015, was vaccinated with a booster dose of (Oka/Merck) VARIVAX, subcutaneously (lot # reported as K006133, dose unspecified). No pertinent medical history, concurrent conditions and other co-suspect or concomitant medications were reported. In March 2015, the patient experienced injection site swelling and injection site erythema (reported as swelling and redness at the injection site respectively) after receiving the booster dose of (Oka/Merck) VARIVAX. Patient was seen by the physician, but no treatment was provided for the events, and the patient was sent home. The outcome of injection site swelling and injection site erythema was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative referring to a currently 15 year old female patient who on 10-MAR-2015, was vaccinated with a booster dose of (Oka/Merck) VARIVAX, subcutaneously (lot # reported as K006133, dose unspecified). No pertinent medical history, concurrent conditions and other co-suspect or concomitant medications were reported. In March 2015, the patient experienced injection site swelling and injection site erythema (reported as swelling and redness at the injection site respectively) after receiving the booster dose of (Oka/Merck) VARIVAX. Patient was seen by the physician, but no treatment was provided for the events, and the patient was sent home. The outcome of injection site swelling and injection site erythema was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Since 06-NOV-2014 the patients were vaccinated with doses of ROTATEQ (lot #, expiration date and dose unspecified, oral) that were improperly stored. No adverse effects were known. This is one of several reports received from same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 38 year old adult female patient. The patient's concurrent condition included allergy to penicillin. On 18-FEB-2010, the patient was vaccinated with M-M-R II (lot #, expiry date, route of administration not reported) (0.5 ml dose) as she was health care worker. No concomitant medication was reported. The physician reported that the patient's titer drawn on 12-SEP-2014 showed that the patient was not immune to mumps. On 24-SEP-2014, the patient was administered another 0.5ml dose of M-M-R II (Lot# J014876, unspecified expiry date). The patient sought medical attention and consulted the physician. The outcome of event was unknown. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 GARDASIL (dose, route, lot # and expiration date were not provided) that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information is not expected, because there was no consent to contact the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a 62 years old female Registered Nurse refers to herself. No medical history, drug allergy and concurrent condition was reported. On 26-JAN-2015, the patient was vaccinated with ZOSTAVAX 1 single shot, subcutaneous (Strength and lot number were not specified) for the prevention of shingles. Concomitant therapy included multiple unspecified medications. Approximately on an unknown date in January 2015, the nurse reported that after received ZOSTAVAX she experienced pain in the left shoulder blade, injection site was warm to touch and red. She had also developed post herpetic neuralgia (PHN). The patient was treated with ibuprofen. No intervention to prevent serious criteria was reported. No lab diagnostic studies were performed. Patient sought medical attention by spoken with physician. No product quality complaint (PQC) involved. The outcome of events was reported as not recovered/not resolved. Reporter causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Since 06-NOV-2014 the patients were vaccinate with doses of PEDVAXHIB (lot #, expiration date, dose and route unspecified) that were improperly stored. No adverse effects were known. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, patients received improperly stored MMR II (therapy type, dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No Product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Erythema, Flushing, Injection site erythema
Clinical narrative: On 3/13 went to bed early, by midnight diarrhea and nausea started. Arm was swollen and red at site of vaccination. On Saturday lost appetite had diarrhea all day and was running a low grade fever. Sunday felt a little better and recovered by the afternoon (3pm). On Friday face was red and flushed. Called doctor on Saturday and quit taking antibiotic when got sick as well.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: On 3/13 went to bed early, by midnight diarrhea and nausea started. Arm was swollen and red at site of vaccination. On Saturday lost appetite had diarrhea all day and was running a low grade fever. Sunday felt a little better and recovered by the afternoon (3pm). On Friday face was red and flushed. Called doctor on Saturday and quit taking antibiotic when got sick as well.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On unspecified dates between 01-NOV-2014 and 13-MAR-2015, patients received improperly stored VARIVAX (Merck) (dose strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No Product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. 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 healthcare worker refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, (dose route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 17 year old female patient. No medical history, drug allergy and concurrent conditions was reported. On 10-MAR-1998, the patient was vaccinated with VARIVAX (Merck) dose 1 (Strength, route and lot number were unspecified). Patient's mother told the reporter that her child broken out chickenpox (varicella) on an unknown date in April 2004. It was unspecified whether treatment was given for the event. Nurse then stated that antibody titers were drawn for the patient on 03-MAR-2015, but the results were negative. Patient sought medical attention. No product quality complaint (PQC) involved. The outcome of events were unknown. Reporter causality assessment was not provided. Additional information has been requested.
Age: 99.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 99 year old male patient. On 09-MAR-2015 the patient was vaccinated with expired dose of ZOSTAVAX lot # K003595, expiration date 07-FEB-2015 (dose and route of administration were not reported). No adverse events were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Respiratory tract congestion, Sinus congestion, Vaccination complication
Clinical narrative: Patient had reaction to ZOSTAVAX. She stated her arm was swollen 6 inches in diameter. Complained of sinus/chest congestion. Provider prescribed hydroxyzine.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site irritation, Injection site warmth, Peripheral swelling
Clinical narrative: Left arm, fist sized reddened and raised area. Irritation and heat to the site.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient was given a PREVNAR 13 injection on 3/12/15. On 3/13, her arm began to get red, warm, swollen, itchy where vaccine was administered.
Age: 0.06
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 3 week old male patient concerning her son. The patient's current condition, drug allergic reactions and medical history were unkonwn. On 25-NOV-1997 the patient was vaccinated with first dose of RECOMBIVAX HB 5 microgram/0.5 ml (dose, route, lot number and expiry date unknown). On 17-DEC-1997, the patient was vaccinated with second dose of Hepatitis B vaccine which was less than 1 month after the first dose and third dose was vaccinated on 20-AUG-1998. No adverse event was reported. The outcome of event was unknown. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site inflammation
Clinical narrative: Patient says area near vaccination site is inflammed and itchy.
Age: 39.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Tenderness
Clinical narrative: Redness, tenderness, growing area of involvement.
Age: 1.58
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Blood culture negative, C-reactive protein increased, Culture throat negative, Decreased appetite, Laboratory test normal
Clinical narrative: Rash which eventually became significant morbilliform reaction. Low grade fever to 100 degrees F. Rhinorrhea. Decreased appetite.
Age: 1.58
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Liver function test normal, Measles antibody negative, Pyrexia, Rash morbilliform, Red blood cell sedimentation rate increased
Clinical narrative: Rash which eventually became significant morbilliform reaction. Low grade fever to 100 degrees F. Rhinorrhea. Decreased appetite.
Age: 1.58
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Rhinorrhoea, Streptococcus test negative, Viral test negative, White blood cell count increased
Clinical narrative: Rash which eventually became significant morbilliform reaction. Low grade fever to 100 degrees F. Rhinorrhea. Decreased appetite.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Dry skin, Haemorrhage, Injection site erythema, Pruritus, Rash
Clinical narrative: Left arm site of shot - red all around site. Looked like he was bitten? Itchy, after 1 wk small areas appeared slowly on his upper back - 2 weeks after rash all over back - 4 wks - went to nurse practitioner, treated him for dry skin - put on 5mg prednisone for 1 wk. Jan. 13, 2015 calmed itching, came back worse - dark red spots like measles. Saw dermatologist, diagnosed as reaction to PREVNAR 13. (Patient had diphtheria when he was 10 yrs old). Now put on prednisone 20mg for 2 wks. Saw his family Dr. nurse practitioner - diagnosed him as "dry skin". Gave prednisone 5mg - 1 wk Dec. 2014. Later saw another Dr Jan. 27, 2015 when she diagnosed him (increased Prednisone 20 mg for 2 wk) and treated him. Rash calmed down with itching. Still visual under his skin. Rash continued and began to appear on his sides and stomach. His left side had a big red circle ? unusual. Never had pain. Just itching and redness, bled at times. Dr ordered - betamethasone topical cream. Began Feb. 20 -2x/day. Important - Note: patient had diphtheria when he was 10 yrs old. Side effects written state anyone having a diphtheria toxoid vaccine should not have this shot PREVNAR 13. He had pneumonia twice and had other pneumonia vaccine shots that did not affect him.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous, Rash morbilliform
Clinical narrative: Left arm site of shot - red all around site. Looked like he was bitten? Itchy, after 1 wk small areas appeared slowly on his upper back - 2 weeks after rash all over back - 4 wks - went to nurse practitioner, treated him for dry skin - put on 5mg prednisone for 1 wk. Jan. 13, 2015 calmed itching, came back worse - dark red spots like measles. Saw dermatologist, diagnosed as reaction to PREVNAR 13. (Patient had diphtheria when he was 10 yrs old). Now put on prednisone 20mg for 2 wks. Saw his family Dr. nurse practitioner - diagnosed him as "dry skin". Gave prednisone 5mg - 1 wk Dec. 2014. Later saw another Dr Jan. 27, 2015 when she diagnosed him (increased Prednisone 20 mg for 2 wk) and treated him. Rash calmed down with itching. Still visual under his skin. Rash continued and began to appear on his sides and stomach. His left side had a big red circle ? unusual. Never had pain. Just itching and redness, bled at times. Dr ordered - betamethasone topical cream. Began Feb. 20 -2x/day. Important - Note: patient had diphtheria when he was 10 yrs old. Side effects written state anyone having a diphtheria toxoid vaccine should not have this shot PREVNAR 13. He had pneumonia twice and had other pneumonia vaccine shots that did not affect him.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid is swollen and warm to touch. It is also painful. Swelling and pain started at 12:00AM on 3/12/15. Mother iced left deltoid. BENADRYL 25mg and Ibuprofen 300mg given in office.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Vaccines administered 11:44 am, MMR in (L) vastus lateralis, PCV 13 upper (R) vastus lateralis, Hep A bottom (R) vastus. Premedicated with 3/4 tsp BENADRYL, 3/4 tsp ADVIL at 11:35 am. At 11:53 am, significant swelling and redness to (R) vastus worse around upper site. 3" diameter. Circular induration. Gone at 12:05p after 1/4 tsp BENADRYL given at 12:00p.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Eosinophil percentage increased, Epstein-Barr virus antibody negative, Erythema nodosum, Fatigue
Clinical narrative: Had Hep B vaccine - 3 days later developed erythema nodosum with corresponding fatigue, body aches, headaches, stomach aches and LE swelling.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count, Haematocrit normal, Haemoglobin normal, Headache, Lymphocyte percentage
Clinical narrative: Had Hep B vaccine - 3 days later developed erythema nodosum with corresponding fatigue, body aches, headaches, stomach aches and LE swelling.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Monocyte percentage, Neutrophil percentage, Pain, Peripheral swelling, Platelet count normal
Clinical narrative: Had Hep B vaccine - 3 days later developed erythema nodosum with corresponding fatigue, body aches, headaches, stomach aches and LE swelling.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: White blood cell count normal
Clinical narrative: Had Hep B vaccine - 3 days later developed erythema nodosum with corresponding fatigue, body aches, headaches, stomach aches and LE swelling.
Age: 16.0
Sex: M
Vaccine: HPVX, MNQ, VARCEL
Symptoms: Peripheral swelling
Clinical narrative: (R) Arm swelling within 2 after imm. administered
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Rash, Skin warm
Clinical narrative: Rash making arm hot to touch and causing pain radiating from injection site (left arm SQ injection).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care worker regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, patients received improperly stored PNEUMOVAX 23 (dose, strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: (3/11/15) within a few hours of receiving vaccination, developed headache, pain at site of injection and general fatigue and chills. Subsided by 3/12/15. Took TYLENOL and rested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old female patient. The patient's concurrent conditions or medical history were not reported. In April 2008, in December 2012, February 2013, August 2013 and on 11-FEB-2015 the patient received the first, second, third, fourth and fifth doses, respectively, of GARDASIL, (dose, anatomical location, route. lot number and expiration date not reported). No adverse effects were reported. Additional information is not expected as the reporter did not give consent to follow up contact.
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 year old patient of unknown gender. The patient concurrent conditions and medical history was not reported. On 02-MAR-2015 the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # H018689 and expiry date: 07-NOV-2014) 0.5 ml intramuscularly in the right thigh. No adverse effects reported. Additional information is not expected as the reporter did not wish to contact.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Started with a rash 3 days after receiving Hep A vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: Maculopapular rash over MMRV site, perhaps 4x4. No nodal involvement, no cellulitis.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Malaise, Pallor
Clinical narrative: Pt. told mom didn't feel well approximately 2-3 min after adm. Hep A and HPV (pt standing with mom at check out window) pt assisted to chair and given granola bar. Appeared pale. Pt assisted to exam room to lay down - given fruit juice BP 90/68 at 9:45/AM. Color returned - juice taken. DC 10AM with mom assisting. BP 94/48 at 8:30/AM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt received ZOSTAVAX on 3/4/15. Pt said that on 3/7/15 she noticed a red, itchy, rash on her hands, face and neck. Pt did not go to the doctor as of 3/16/15 when I spoke with her and she said her symptoms were better.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling itching site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and raised area where administered for days after and is still black and blue.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Altered state of consciousness, Asthenia, Autonomic neuropathy, Blood test, Chills
Clinical narrative: Presented to clinic on 2/11/15 with c/o HA/nausea since 2/8/15. Also c/o neck/shoulder pain since 2/6/15. Prescribed NSAIDS, heat, rehab exercises bland diet. Returned later 2/11/15 and 1/12/15 with same complaints went home before labs could be drawn. Meningeal signs (-).
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Dizziness, Fatigue, Feeling cold, Headache, Muscle tightness
Clinical narrative: Presented to clinic on 2/11/15 with c/o HA/nausea since 2/8/15. Also c/o neck/shoulder pain since 2/6/15. Prescribed NSAIDS, heat, rehab exercises bland diet. Returned later 2/11/15 and 1/12/15 with same complaints went home before labs could be drawn. Meningeal signs (-).
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Paraesthesia, Photophobia
Clinical narrative: Presented to clinic on 2/11/15 with c/o HA/nausea since 2/8/15. Also c/o neck/shoulder pain since 2/6/15. Prescribed NSAIDS, heat, rehab exercises bland diet. Returned later 2/11/15 and 1/12/15 with same complaints went home before labs could be drawn. Meningeal signs (-).
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Radicular pain, Skin discolouration, Tinnitus, Vertigo
Clinical narrative: Presented to clinic on 2/11/15 with c/o HA/nausea since 2/8/15. Also c/o neck/shoulder pain since 2/6/15. Prescribed NSAIDS, heat, rehab exercises bland diet. Returned later 2/11/15 and 1/12/15 with same complaints went home before labs could be drawn. Meningeal signs (-).
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Headache, Nausea
Clinical narrative: Presented to clinic on 2/11/15 with c/o HA/nausea since 2/8/15. Also c/o neck/shoulder pain since 2/6/15. Prescribed NSAIDS, heat, rehab exercises bland diet. Returned later 2/11/15 and 1/12/15 with same complaints went home before labs could be drawn. Meningeal signs (-).
Age: 1.65
Sex: F
Vaccine: MMR
Symptoms: Gianotti-Crosti syndrome, Rash morbilliform
Clinical narrative: Measles like rash on body that lasted about 10 days. One month after MMR vaccination was diagnosed with GianottiCrosti syndrome.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain, X-ray limb normal
Clinical narrative: Deep ache around site of injection, numbness radiating down arm to fingers. Severe pain in upper arm and shoulder presented next day, make my it very difficult to move or use arm. As of today, 3/18/15, pain is lessened but ever-present as a deep ache. Certain movements or activities still bring sharp pain.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, X-ray normal
Clinical narrative: Deep ache around site of injection, numbness radiating down arm to fingers. Severe pain in upper arm and shoulder presented next day, make my it very difficult to move or use arm. As of today, 3/18/15, pain is lessened but ever-present as a deep ache. Certain movements or activities still bring sharp pain.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Localized erythema reaction to right upper arm. 3/17/2015 3 1/2 inches x 3 1/2 inches. 3/18/2015 3 1/2 inches x 7 inches.
Age: 25.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Abdominal pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Evening of receiving vaccines pt had subj fever, chills, and headache.  By the next morning she had severe nausea, vomiting and some abdominal pain.
Age: 25.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Vomiting
Clinical narrative: Evening of receiving vaccines pt had subj fever, chills, and headache.  By the next morning she had severe nausea, vomiting and some abdominal pain.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hunger, Hyperhidrosis, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: Received HPV vaccine. Standing at check in desk and indicated he felt hungry. Began to go down to floor and was eased to floor by staff. Per a person responding the patient was unresponsive so he requested a code blue adult be called. Called immediately. Patient unresponsive for 2-3 seconds. Woke with a sternal rub. When woke indicated he did not know how he got down to floor. Skin diaphoretic. Skin pale. BP 98/62. HR 88. Code Blue team on site within 2 minutes.
Age: 34.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Rash pruritic, Swelling
Clinical narrative: Had itchy rash, swollen; no fever; no lip or tongue tingling, or sob/wheezing, throat sx; no abdominal pain, n/v, diarrhea; no hiking or bug bites, partner in bed without this rash; no prior reaction to vaccination.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: Awoke next AM with rash upper arm and thigh - disappeared in one hour. Didn't feel well for 1 wk: nausea, headache, (R) upper arm ache x 1 day. 1-2 wks after injection, entire upper (R) arm started to ache and has continued ever since, keeping me awake at night. Went to Dr on Nov. 10, she prescribed Gabapentin, but I was afraid of its side effects so I have not taken it. I've had to rely on TYLENOL and massage for temporary relief.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Awoke next AM with rash upper arm and thigh - disappeared in one hour. Didn't feel well for 1 wk: nausea, headache, (R) upper arm ache x 1 day. 1-2 wks after injection, entire upper (R) arm started to ache and has continued ever since, keeping me awake at night. Went to Dr on Nov. 10, she prescribed Gabapentin, but I was afraid of its side effects so I have not taken it. I've had to rely on TYLENOL and massage for temporary relief.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 28.0
Sex: U
Vaccine: TDAP
Symptoms: Back pain, Chills, Musculoskeletal pain, Nausea, Pain
Clinical narrative: She had pain in left arm that radiated into left shoulder and back and ten into whole body x 48 hours after receiving the injection. She also had nausea, chills, and slight fever. The symptoms occurred 7 hours after receiving TDaP.
Age: 28.0
Sex: U
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: She had pain in left arm that radiated into left shoulder and back and ten into whole body x 48 hours after receiving the injection. She also had nausea, chills, and slight fever. The symptoms occurred 7 hours after receiving TDaP.
Age: 51.0
Sex: F
Vaccine: TDAP
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 52-year-old female patient who received BOOSTRIX (batch number P39A2, expiry date 15th February 2015). On 16th February 2015, the patient received BOOSTRIX .5 ml. On 16th February 2015, an unkonwn time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Death
Clinical narrative: None stated.
Age: 1.38
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Second influenza vaccine given on 12/11/14 was not sent to ER by nurse that entered and gave it. ER on 3/16/15 reflected pt was due for influenza so above nurse administered. When filling out parents imm record realized the 2nd dose of influenza was already ginve. No reaction to this vaccine given on 3/16/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (lot/batch#, expiration dates, dose and dose numbers were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: The location where the shot was administered swelled up the size of a softball. The lump was filled with fluid, bright red, and the bump itched a lot.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The location where the shot was administered swelled up the size of a softball. The lump was filled with fluid, bright red, and the bump itched a lot.
Age: 1.52
Sex: M
Vaccine: HIBV
Symptoms: Blood glucose decreased, Coma, Hypoglycaemia, Metabolic function test normal
Clinical narrative: After no illness or abnormal behavior the day before, I found him almost comatose in his crib. We found out eventually his blood sugar was 32 and he was "diagnosed" with idiopathic ketotic hypoglycemia.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Crying, Disorientation, Emotional distress, Eye movement disorder, Movement disorder
Clinical narrative: Child upset, crying flailing could not comfort 15 minutes. Gave Motrin and she fell asleep. Later she was in car seat and was disengaged, disoriente, trembling head bobbing and shaky. Her eye turning out to the side.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: Child upset, crying flailing could not comfort 15 minutes. Gave Motrin and she fell asleep. Later she was in car seat and was disengaged, disoriente, trembling head bobbing and shaky. Her eye turning out to the side.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site was hot and red. The area kept getting larger by the hour. I woke up about every 2 hours because of the pain. When I awoke at 4 AM I felt nauseous and started dry heaving. I also had a headache and a low grade temp (99.5). The area of swelling, redness, and pain encircled my whole arm from shoulder to elbow.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nausea, Pain, Retching
Clinical narrative: Injection site was hot and red. The area kept getting larger by the hour. I woke up about every 2 hours because of the pain. When I awoke at 4 AM I felt nauseous and started dry heaving. I also had a headache and a low grade temp (99.5). The area of swelling, redness, and pain encircled my whole arm from shoulder to elbow.
Age: 18.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Slow response to stimuli
Clinical narrative: Patient was slow response after receiving two vaccines. HEP A AND VARICELLA. Nurse assisted patient to floor. C/o of light headedness and numbness with some confusion.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drooling, Mental status changes, Seizure like phenomena, Vomiting
Clinical narrative: Patient developed drooling, altered mental status and emesis hours after receiving immunizations.  Had total of 3 episodes concerning for seizure like activity.
Age: 16.0
Sex: F
Vaccine: MEN, VARCEL, MNQ, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: The area of injection became very hard.  It was stinging, burning, itching, hot, and turned red. It swelled quite a bit and was painful to the touch.  Fatigue was also brought on by the vaccine.
Age: 16.0
Sex: F
Vaccine: MEN, VARCEL, MNQ, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The area of injection became very hard.  It was stinging, burning, itching, hot, and turned red. It swelled quite a bit and was painful to the touch.  Fatigue was also brought on by the vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt came to clinic and received Tdap, MCV4, and HPV #1. Pt fainted after administration. did not lose conscious. Pt was alerted and oriented X3. BP 125/71, P 72, BP 114/73, P73, BP 108/65, P87. Pt left the clinic walking in stable condition. Advised mom to see pcp for further evaluation.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Feeling cold, Headache, Tremor
Clinical narrative: Patient received Hepatitis B vaccine on the morning of 3/18/15 at our clinic. She reports she went to the grocery store shortly after and about 30 minutes after receiving vaccine she began shaking vigorously, she felt very cold, and developed a severe headache.   Patient presented to our clinic with this symptoms. Vitals all within normal limits. 1000 mg of Tylenol were administered to patient orally. Symptoms subsided within an hour.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain, Rash erythematous
Clinical narrative: Red rash localized around the site of injection.  Rash is warm to the touch. Patient also claims to have achiness.
Age: 0.44
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Asthenia, Fatigue, Lethargy, Nausea, Pallor
Clinical narrative: Fever, vomiting, forgetting to breathe, lethargic, fatigued, pale, nausea, weak. Once hospitalized required IV fluids and no food for 5 days, oxygen for 2 days, and slow progression back into eating just Pedialyte with a little formula.
Age: 0.44
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Respiratory disorder, Vomiting
Clinical narrative: Fever, vomiting, forgetting to breathe, lethargic, fatigued, pale, nausea, weak. Once hospitalized required IV fluids and no food for 5 days, oxygen for 2 days, and slow progression back into eating just Pedialyte with a little formula.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Middle insomnia, Mobility decreased, Pain, Poor quality sleep
Clinical narrative: Sharp pains and Limited movement.  Restless sleep awakened at night.  Difficulty dressing.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Pain, Poor quality sleep
Clinical narrative: Sharp pains and Limited movement.  Restless sleep awakened at night.  Difficulty dressing.
Age: 48.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthropathy, Streptococcus test positive
Clinical narrative: Pt hosp with ifx (R) sh arthr 11/20-27/12.
Age: 48.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthropathy, Guillain-Barre syndrome, Infection, Streptococcal infection
Clinical narrative: Pt hosp with ifx (R) sh arthr 11/20-27/12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Condition aggravated, Cough, Wheezing
Clinical narrative: Approx 30 min after immunizations, pt noted to be coughing more by mom and had wheezing. Was in lab for blood draw and sent back to our office to evaluated. Had wheezing bilat - resolved with albuterol nebulization.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Hyperhidrosis, Hypersensitivity, Presyncope
Clinical narrative: Allergic reaction/lightheaded/sweaty. Near syncope.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dehydration, Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Rpt LOC in chair - LOC post injection. Pale, diaphoretic, warm, vagal reaction and mild dehydration.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Rpt LOC in chair - LOC post injection. Pale, diaphoretic, warm, vagal reaction and mild dehydration.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Urticaria
Clinical narrative: Rapid onset of hives/redness on arms following injection-hives bilaterally down arms, (-) torso or lower extrem. No lip, tongue or face swelling.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: Rapid onset of hives/redness on arms following injection-hives bilaterally down arms, (-) torso or lower extrem. No lip, tongue or face swelling.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Urticaria
Clinical narrative: Hives within 10 min down both arms.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: Hives within 10 min down both arms.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Erythema, Injection site induration, Pruritus, Skin warm, Swelling
Clinical narrative: Patient started itching around 8:30 pm last night (2/24/15). Mother gave MOTRIN and child went to sleep. Then today after school mom noticed redness and swelling, warm to touch. Also area where vaccine given was hard. Measured 30 x 35mm. Left deltoid.