chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: This spontaneous report as received from a medical assistant via a field representative refers to a 13 year old female patient with no drug reactions or allergies, the medical assistant's daughter. On 19-SEP-2012, 14-NOV-2012 and 21-MAR-2013, the patient was vaccinated with the three doses of GARDASIL because patient's mother wanted her to have it, respectively. It was reported that the patient experienced stomach cramps and diarrhea within 24 hours of receiving each GARDASIL dose. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The representative reported that the adverse events experienced lasted 24 hours. The outcome of diarrhea and stomach cramps was reported as recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot number not provided). On an unknown date, the patient experienced tenderness and pain around the injection site. The patient was given an unspecified antibiotic on an unspecified date by an unspecified healthcare provider. The outcome of tenderness and pain around the injection site was unknown. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous report as received from a mother regarding her 50 years old son with Williams Syndrome. On 16-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On 16-APR-2013, the patient developed a pin size brown spot at the site of the injection. The patient had no pain at the site. The patient sought no medical attention. Diagnostic test performed was none. No treatment was given. The outcome of the event was not recovered/not resolved. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 66 year old male pharmacist regarding himself. The patient has sulfa allergy and psoriasis. The patient's medical history included heart attack 8 months ago. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included aspirin, TOPROL XL TABLETS, COZAAR, EFFIENT, LIPITOR, DOVONEX, DIPROLENE, UV light treatments daily, multivitamins (vitamins unspecified), Vitamin B Complex, Ascorbic Acid, Vitamin D(UNSPECIFIED), Vitamin E and OMEGA-3 MARINE TRIGLYCERIDES. On 20-APR-2013, the patient developed shingles. The patient was treated with VALTREX. There were no laboratory tests performed. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 66 year old male patient regarding himself. The patient's medical history included bladder cancer. Patient had no allergies or drug reactions. On 02-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as J000927, expiry: 10-APR-2009) in the left arm. Concomitant therapies included ZOLOFT, NEXIUM and LIPITOR. On 04-APR-2013 (reported as 2 days after the shot), the patient experienced constant ache in his left shoulder. Whenever he lifts his shoulder 90 degrees or more or when he lifts something heavy, he has a constant pain in his left shoulder. No treatment was received. No laboratory tests were performed. Patient sought medical attention (called pharmacist). The outcome of constant ache in shoulder was reported as not recovered. This is 1 of 2 reports
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female. On 10-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number not reported). On 17-APR-2013, the patient experienced tenderness and pain around the injection site. The outcome of tenderness and pain around site was unknown. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 18 year old female patient. On an unknown date in the beginning of January 2011, the patient who was vaccinated with a first dose of GARDASIL (Lot number and expiry date was not reported), received the second dose on 29-OCT-2012 and the third dose of GARDASIL (Lot number H016238 and expiry date was 11-APR-2014) 0.5 milliliter (ml) intramuscularly on 03-JAN-2013. No adverse events reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Nausea, Throat tightness, Uvulitis, Vomiting
Clinical narrative: Initial report received from a consumer on 23 January 2013. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a FLUZONE HD (lot number U4537AA, route, number in series and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, patient had allergic reaction after vaccination. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Follow-up information was received from a consumer on 15 April 2013. Based upon the new information, this case has been upgraded to serious. The patient was a 71-year-old male who received FLUZONE HIGH-DOSE on 23 January 2013 at 3:00 PM. Three hours later at 6:00 PM, the patient developed nausea, vomiting and a sensation of throat closing. The patient was diagnosed with uvulitis at the emergency room and treated with steroids. Outcome was recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-005251, 2013-005253 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230, 1995-00224 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 36-year-old male patient who had received Combination tetanus and reduced diphtheria vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and eight days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05262 and 2013-05268-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 57-year-old male patient who had received Combination tetanus and reduced diphtheria vaccine (manufacturer, lot number, route, site and date of administration not reported) and 41 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might were vaccinated with a dose of PROQUAD (Merck) (lot# not reported) stored as high as 9F for about 2 months. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 59 year old female patient with arthritis, asthma and hypertension. The patient was allergic to Penicillin, Amoxicillin, Neomycin eye drops and Polytran eyedrops (Reactions were unspecified). On 19-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000783, expiry date 30-APR-2014) 0.65 milliliter (ml), subcutaneously. Concomitant therapies included pantoprazole sodium, FLOVENT, potassium (unspecified), triamterene, calcium (unspecified), glucosamine, omega-3 marine triglycerides (fish oil) and ACTANENE. On 20-APR-2013 the next day, the patient experienced 6.5 inch by 4.5 inch welt that was red with white dots. The patient reported that the white spots went away quickly and the rash itches and burns. The patient sought medical attention (was seen in the office) and was given Hydrocortisone creme which had provided relief. On 20-APR-2013 (reported the day after vaccination), the patient had a small red spot, mid abdomen that resolved on an unknown date in April 2013 (reported as very quickly) without treatment. Diagnostic test performed was none. The outcome of 6.5 inch by 4.5 inch welt that was red with white dots and rash itches and burns was recovering/resolving. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient had a history of dermatologic issue on the skin. No current conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency not reported) (lot # and exp. Date not reported). No co suspects or concomitant medications were reported. A pharmacist told the representative that on an unknown date the patient developed big red swollen spot after received a dose of ZOSTAVAX. The outcome of big red swollen spot is unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-MAR-2013, the patient was vaccinated with a dose of improperly stored PROQUAD (Lot number as H020140, expiry date was 07-MAY-2014, route and dose were not reported) at around 9 am. No adverse effect was reported. Follow up information was received from the medical assistant regarding the 5 year old male patient. Reporter details and patient details were updated. Patient's birth weight was reported as 38 (units unknown). The patient received the improperly stored dose of (Merck) PROQUAD subcutaneously on 26-MAR-2013 08:30 AM. This is one of the three reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might were vaccinated with a dose of ZOSTAVAX (lot # not reported) stored as high as 9F for about 2 months. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might was vaccinated with a dose of VARIVAX (Merck) (lot # not reported) stored as high as 9F for about 2 months. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Full blood count normal, Pain, Swelling
Clinical narrative: Redness and swelling, blisters, rt thigh area, blisters formed first, very sore to touch no fever noted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Patient had pain and swelling at the injection site and was seen by an urgent care doctor who stated she had cellulitis. He indicated it was due to the vaccine.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Headache, Pain in extremity, Paraesthesia
Clinical narrative: Pt. c/o minor HA, arm pain and tingling into hand on 4-22-13. Started with back pain on 4/23/13. Much worse 4-24-13 and 4/25/13. Back pain unknown etiology developing within 48 hours of GARDSIL.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Developed redness, some edema at injection site then fever 104 between 24-48 hours after vaccine.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: Received call from mom. Child crying uncontrollably for 2 hours. Unable to sooth child.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient with penicillin allergy and no pertinent medical history. On 19-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020844, expiration date 20-FEB-2014) (subcutaneous, dose and anatomical site not reported). No other suspect therapies were reported. There was no concomitant medications. The pharmacist reported that the patient developed a rash at the injection site, immediately following vaccination with ZOSTAVAX, which spread to the other arm. Pharmacist stated that the rash was starting to go away (had faded) and the patient left the pharmacy after an unspecified timeframe. At the time of the report the patient's present status was reported as recovering. No treatment was given for the rash at the injection site which spreaded to the other arm. No laboratory diagnostic studies were performed. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom called office 4/24/13 to report right thigh redness, warmth, swelling and pain after shot received 4/22/13. Mom advised to return to office for evaluation ASAP, mark borders of redness to track extension, give ibuprofen for pain relief. Go to urgent care facility or ER of fever develops, pus oozing from site or further extension of redness. Assessment 4/24/13 went to U.C. Dx: Cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Mom called office 4/24/13 to report right thigh redness, warmth, swelling and pain after shot received 4/22/13. Mom advised to return to office for evaluation ASAP, mark borders of redness to track extension, give ibuprofen for pain relief. Go to urgent care facility or ER of fever develops, pus oozing from site or further extension of redness. Assessment 4/24/13 went to U.C. Dx: Cellulitis.
Age: 1.26
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Skin mass
Clinical narrative: Child developed quarter-sized, firm, subcutaneous mass (presumed hematoma) after injection. Overlying skin pink. No evidence of infection.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Laboratory test normal, Lymphadenopathy
Clinical narrative: Ipsilateral axillaroadenopathy within 3 days post Tdap. Adenopathy resolved in 2 weeks. Then 3 weeks after Tdap sudden onset of profound weakness and dizziness lasting almost 3 month. No residual after episode resolved spontaneously.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Swelling face, Urticaria, Vaccination complication
Clinical narrative: Reaction to vaccine, hives, itchy body, face swollen.
Age: 15.0
Sex: F
Vaccine: TYP, YF
Symptoms: Asthenia, Chills, Dizziness postural, Vomiting
Clinical narrative: Pt's mthr. reports pt. awoke in the early hours of 4-23-13 with "chills", "weakness", "dizziness" upon standing and emesis x 1. Mthr. states other household members have "head cold" sxs only. Mthr. said she will just watch her closely and take her to pediatrician only if sxs/condition worsen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: In 24 hrs has large, red, warm to touch local reaction - 5 1/2" x 2 1/2". No c/o systemic reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Swelling, redness, itchy on right arm where vaccines were administered.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: She had 2 red hives around the injection site. Prescriber treated her with BENADRYL and ice packs. Her hives have almost disappeared today (4/26/13).
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: The mother of patient called the morning of the 24th, 12-14 hrs after receiving the vaccination of GARDASIL. She said that he had awoken in the am with "hives all the way around his waist and on his knees". She gave him BENADRYL and sent him off to school She was asked if there was any redness or swelling around the injection site. There was none. Patient has allergies to pollen, but nothing else of which she knows. She was advised to let her medical provider know about the rash. The mom was contacted again on Thursday. She said that the rash was resolving and patient just had a small amount of rash remaining.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema and painful swelling at injection site, patient self-treated with OTC diphenhydramine and ibuprofen, duration of symptoms > 1 hr (exact duration unknown).
Age: 43.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Donor states he had nausea and vomiting, slight dizziness.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Eating disorder, Fluid intake reduced, Irritability, Pyrexia, Rash generalised
Clinical narrative: Rash over entire body, fever 101, not eating or drinking, crankyness.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia, Rash
Clinical narrative: Rash over entire body, fever 101, not eating or drinking, crankyness.
Age: 49.0
Sex: F
Vaccine: DTP
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Oedema peripheral
Clinical narrative: Left arm completed swollen, pain/soreness/tenderness unable to move arm without pain. Fatigue fever headache nausea loss of appetite.
Age: 49.0
Sex: F
Vaccine: DTP
Symptoms: Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Left arm completed swollen, pain/soreness/tenderness unable to move arm without pain. Fatigue fever headache nausea loss of appetite.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: Patient developed dizziness, shortness of breath, weakness and headache, that lasted about 2 hours, then subsided.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Pt. had hives, pain, redness on injection arm.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein increased, Chest X-ray normal, Headache, Pyrexia, Urine analysis normal
Clinical narrative: Bad headache and spiking fevers 103.7 deg F through Tylenol and Ibuprofen for 3 days.  On and off low grade temps with headaches without meds for 4 days. Then 101.7 deg F temps with significant headaches for 3 more days.  Occasional headache with low grade temps no meds for 2 more days. CXR, UA, WBC normal.  CRP elevated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Bad headache and spiking fevers 103.7 deg F through Tylenol and Ibuprofen for 3 days.  On and off low grade temps with headaches without meds for 4 days. Then 101.7 deg F temps with significant headaches for 3 more days.  Occasional headache with low grade temps no meds for 2 more days. CXR, UA, WBC normal.  CRP elevated.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Headache, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal
Clinical narrative: Persistent severe headache, started about 4 days after injection and have continued. He has had a negative LP and MRI.  Normal ophthalmologic exam.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 2cm red area around vaccine site on right leg.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, induration, erythema, warmth and tenderness of thigh at site of Kinrix administration. Induration/dark erythema 3.5 x 4 cm, lighter erythema 8.5 x 9 cm.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Neuralgic amyotrophy
Clinical narrative: Left brachial plexus neuritis; neuralgic amyotrophy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site induration, Skin warm, Swelling
Clinical narrative: Pt noticed redness, swelling, warm to touch this morning, at about 8:00AM (4/25/13). Came into clinic, induration measured at 9x9 cm on left deltoid area. Mother instructed by PA to apply cold compresses and administer MOTRIN until swelling and redness subsides. Mother ok with instructions. Advised to come into clinic if symptoms worsen.
Age: 0.85
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site granuloma
Clinical narrative: Granuloma at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain, Skin warm
Clinical narrative: Local symptoms started day after vaccines red, warm to touch, sore. Told by MD to use cold compress and BENADRYL.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm over area of varicella vaccine raised, hot to touch, painful approx 3" x 1". MENACTRA site above this area small red raised with ecchymosis. Hx mult food allergies.
Age: 43.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site joint pain, Injection site warmth, Vaccination complication
Clinical narrative: Exam of the right shoulder. Shows area of erythema upper lateral shoulder which is warm to touch shoulder motion is markedly limited to 50 degrees abduction secondary to pain. Neurovascular is intact distally. Adverse reaction to vaccine. Given 125 g methyl prednisone IM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: 4/25/13 at 4:45 PM Pt. came in for PPD reading and mentioned to us that she had gotten reaction to vaccine in her (L) deltoid. There is a wheal with erythema about 20mm x 18mm. Dr. advised cold compress 3x's a day for about 10 minutes and a Rx for BENADRYL given.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called Friday am saying he developed a raised rash at injection site. 1-2 days after receiving inj. Patient will call his physician and seek medical attention; per phone call with patient. Have not heard frm patient since.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythematous, warm area (R) deltoid measuring 8 x 10 cm.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Haemoglobin normal, Pallor
Clinical narrative: After pt received Tdap and GARDASIL today, pt became lightheaded (about 5 min after vaccines were given). Pt was helped to the floor by RN and pt's mother. Pt was pale, pt c/o vision closing in on her LOC?. Pt's eyes remained open however did not respond to questions for less than 1 min, pt began to feel better was observed in office after 5-10 min pt walked out with mother.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: After pt received Tdap and GARDASIL today, pt became lightheaded (about 5 min after vaccines were given). Pt was helped to the floor by RN and pt's mother. Pt was pale, pt c/o vision closing in on her LOC?. Pt's eyes remained open however did not respond to questions for less than 1 min, pt began to feel better was observed in office after 5-10 min pt walked out with mother.
Age: 1.14
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Classic exanthem appearing on 7th day after receiving the MMR vaccine. No pruritus. No fever. Did receive at the same time via separate doses DTaP; Hep A #1; PREVNAR #4; Varicella #1.
Age: 50.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fevers, chills, headaches 8 hrs after vaccine.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. It was reported that in May 2012 the patient received the first dose in the GARDASIL (Lot number and expiration date not provided) (dose not provided, route intramuscular) vaccination series and the second dose in the GARDASIL vaccination series will be administered on 22-APR-2013. No adverse effect reported. Concomitant medications were not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: The patient was given Tdap vaccination in left deltoid per clinic guidelines. About one minute after the injection the pt states that her arm was itchy. The ARNP imediately retrieved the Epipen and called 911. The pt was place prone on the examination table and feet elevated. Her VS were obtained (HR 65, BP 110/65, SpO2 98%) Pt left arm was red and itchy around injection site. She denied SOB or any difficulty breathing. She denied any chest tightness, difficulty swallowing, itchy chest, nausea, or back pain. Approx. 2-3 minutes after 911 was called the EMS providers arrived. ARNP stayed with pt. After about 15 minutes with EMS. EMS worked on pt in clinic for approx 15-25 minutes. They placed an IV and gave her IV Benadryl. They did an EKG and transported her via stretcher from clinic to ambulance to go to the hospital. PTs father was present for entire encounter. Pt has NKA and has never had a vaccine reaction before.
Age: 34.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Arthralgia, Back pain, Chills, Feeling hot, Influenza like illness
Clinical narrative: Began with feeling sick, like from a cold/flu around 5 pm. Around 7 pm felt achy joints. From 7-8 chills and still sick. From 8 pm on into the night, fever. Hot spells very very achy in back, neck, and legs. Unable to sleep.
Age: 34.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Insomnia, Malaise, Nasopharyngitis, Neck pain, Pain in extremity
Clinical narrative: Began with feeling sick, like from a cold/flu around 5 pm. Around 7 pm felt achy joints. From 7-8 chills and still sick. From 8 pm on into the night, fever. Hot spells very very achy in back, neck, and legs. Unable to sleep.
Age: 34.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Pyrexia
Clinical narrative: Began with feeling sick, like from a cold/flu around 5 pm. Around 7 pm felt achy joints. From 7-8 chills and still sick. From 8 pm on into the night, fever. Hot spells very very achy in back, neck, and legs. Unable to sleep.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Fatigue, Injection site pain, Irritability, Lethargy
Clinical narrative: She became very tired and cranky, complained leg still hurt where she got shot. That night came down with high fever, vomiting. Fever lasted 4 days, very high, continued w/ vomiting and diahrrea and developed a rash, and was very lethargic the whole time. Was very lethargic and generally feeling sick w/ no specific complaint of throat, headache, etc. Fevers went up to 103.9, which were causing her to shake/twich.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Muscle twitching, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: She became very tired and cranky, complained leg still hurt where she got shot. That night came down with high fever, vomiting. Fever lasted 4 days, very high, continued w/ vomiting and diahrrea and developed a rash, and was very lethargic the whole time. Was very lethargic and generally feeling sick w/ no specific complaint of throat, headache, etc. Fevers went up to 103.9, which were causing her to shake/twich.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Tremor, Vomiting
Clinical narrative: She became very tired and cranky, complained leg still hurt where she got shot. That night came down with high fever, vomiting. Fever lasted 4 days, very high, continued w/ vomiting and diahrrea and developed a rash, and was very lethargic the whole time. Was very lethargic and generally feeling sick w/ no specific complaint of throat, headache, etc. Fevers went up to 103.9, which were causing her to shake/twich.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The nurse reported that the patient received 1st and 2nd dose of GARDASIL (lot # not reported) intramuscularly 5 years ago on an unspecified dates. The patient came into the office on an unspecified date this year, 2013, and received the 3rd dose of GARDASIL (lot # not reported) intramuscularly. No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Area pain, finger numbness.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Received ZOSTAVAX 4/8/13. Reported 4/28 as "rash" on areas of lower legs, also sm. area on back appeared sometime after shot given, shingles like in appearance pt told to take BENADRYL/ZYRTEC and have MD check.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Crying, Lethargy, Pallor, Syncope, Vomiting
Clinical narrative: On 4/18/13 patient vomited then became pale & lethargic, O2 sat was 97%, HR 117, BP 90/42, BG 82, patient was lethargic for several minutes then began crying when BP was taken. Patient was sent to ED. Per mom, patient had similar episode on 3/13/13 when she received the following vaccines: Hib, flu, PCV13, Rota. Mom did not bring her in on 3/13 & patient did better without intervention. Patient was admitted with dx of syncope.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 86 year old female patient with history of having fever blisters and no known drug reactions or allergies. On 17-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # H019999, expiration date 02-FEB-2014, subcutaneously. On 18-APR-2013, the patient experienced flare up of fever blisters on her lips after receiving a dose of ZOSTAVAX. The patient received mineral oil, oxybenzone, BLISTEX as treatment. There were no laboratory diagnostics studies performed. The outcome of flare up of fever blisters on her lips was reported as not recovered/not resolved. The patient sought medical attention by calling the nurse. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Blood culture positive, Chills, Injection site cellulitis, Pain in extremity, Pyrexia
Clinical narrative: Cellulitis at injection site left deltoid, fever, chills, arm pain.
Age: 65.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: White blood cell count increased
Clinical narrative: Cellulitis at injection site left deltoid, fever, chills, arm pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Hyperbaric oxygen therapy, Malaise, Pain, Pyrexia
Clinical narrative: Severe pain, fever, increased heart rate feeling ill. In the hospital now. On antibiotics. Undergoing hyperbaric oxygen therapy 90 minutes a day. It is very painful!
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Soreness, redness, swelling around vaccine injection site, followed by generalized muscle aches in shoulders, neck.  Also with fevers up to 102F.  Treatment just supportive with Tylenol, cold packs, observation.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Immediate post-injection reaction, Infection, Injected limb mobility decreased, Injection site cellulitis
Clinical narrative: First of all, my arm was immediately very sore following the vaccine. The next morning, I woke up and fainted in the shower.  I was unconscious for 5 seconds.  Later on that day, I developed a fever and severe chills, and muscle cramps...and the soreness on my arm grew unbearable.  It was a challenge to even lift my arm at this point because the site of the injection was so painful.  At this point, I went to the Emergency Room, and they gave me fluids (iv) because my white blood count was high due to fighting an infection which they believed was cellulitis at the site of the vaccine in my arm.  So, I was given antibiotics to treat the infection.  I am on my first day of antibiotics now.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Laboratory test, Loss of consciousness, Muscle spasms, Pain in extremity
Clinical narrative: First of all, my arm was immediately very sore following the vaccine. The next morning, I woke up and fainted in the shower.  I was unconscious for 5 seconds.  Later on that day, I developed a fever and severe chills, and muscle cramps...and the soreness on my arm grew unbearable.  It was a challenge to even lift my arm at this point because the site of the injection was so painful.  At this point, I went to the Emergency Room, and they gave me fluids (iv) because my white blood count was high due to fighting an infection which they believed was cellulitis at the site of the vaccine in my arm.  So, I was given antibiotics to treat the infection.  I am on my first day of antibiotics now.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Syncope, White blood cell count increased
Clinical narrative: First of all, my arm was immediately very sore following the vaccine. The next morning, I woke up and fainted in the shower.  I was unconscious for 5 seconds.  Later on that day, I developed a fever and severe chills, and muscle cramps...and the soreness on my arm grew unbearable.  It was a challenge to even lift my arm at this point because the site of the injection was so painful.  At this point, I went to the Emergency Room, and they gave me fluids (iv) because my white blood count was high due to fighting an infection which they believed was cellulitis at the site of the vaccine in my arm.  So, I was given antibiotics to treat the infection.  I am on my first day of antibiotics now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative refers to an approximately 60-year-old (reported as "in her 60s) female patient. On 16-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in April 2013, the patient developed an injection site reaction with a large area of redness which was swollen and warm. The patient was treated with an unspecified antibiotics for the events. It was unspecified whether lab diagnostic studies were performed for the event. The events resolved on an unknown date in April 2013. The patient sought medical attention by visiting the physician. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender. Approximately on 09-APR-2013 the patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). On 10-APR-2013, (1 day after administration) the patient experienced local injection site reaction, baseball sized lump, swollen and hard. The outcome of the reported events was unknown. Causality was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 55 year old female patient with penicillin allergy. Approximately in 2003 (reported as "about 10 years ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported). Approximately in 2003, the patient developed lymphadenopathy one hour after receiving PNEUMOVAX 23 about 10 years ago. The patient sought medical attention via seeing a physician. The patient received the unspecified treatment for the event. There were no lab diagnostics studies performed. Subsequently, the patient recovered from lymphadenopathy. The outcome of lymphadenopathy was reported as recovered/resolved. The patient also had the same reaction lymphadenopathy after receiving streptomysin sulfate (manufacturer unknown) (Case# 1304USA016347). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Contusion, Joint swelling, Muscular weakness, Oedema peripheral, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old female patient with no pertinent medical history or drug reactions/allergies. On 15-APR-2013 the patient was vaccinated with first dose of GARDASIL (lot number reported as H01555, expire date: 13-APR-2015). Concomitant therapies included HAVRIX on 15-APR-2013. On 15-APR-2013, the patient experienced fainted in the office after the vaccine was administered. The healthcare worker reported the patient did not hit the ground, however she presented in the office 2 days later with a swollen and bruised wrist and hand. The healthcare worker stated the patient reported that her hand felt very weak. The healthcare worker stated "the patient did not eat much prior to her appointment". At the time of the report, the patient was not recovered from the events. The causality was not provided. H01555 is not a valid lot number for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 113 patients of demographics. Since an unknown date in August 2012, the patients were vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). It was unknown as to how many patient received just GARDASIL and how many received just PEDVAXHIB or how many patients had received both. Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated 19 children received PEDVAXHIB. This is one of the several reports from the same source.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Follow-up report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-05251-05255, 2013-05257-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, and 2006-03086. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a hospitalized 60 year-old male patient who had received what was previously reported as INFLUENZA SPLIT TRITON VACCINE - U, but also reported in the article as Influenza Vaccine (manufacturer name, lot number, route, site and date of administration not reported) and 24 days later (previously reported as 13 days after vaccination on 30 November 1995) reported the onset of GBS. No further information was provided. Update to the outcome not received. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Eye pruritus, Lacrimation increased
Clinical narrative: Pt had difficulty swallowing, shortness of breath and itchy watery eyes 45 minutes after vaccine administered pt was given Diphenhydramine 25 mg po and taken to urgent care. There she was given an IM steroid and epinephrine.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site pain
Clinical narrative: Rt anterior thigh tender nodule approximately dime size. Was about quarter size per mother.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Patient has been dx with rotavirus twice within 18 months of vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Surgery
Clinical narrative: This spontaneous report was received from a 82 year old female patient regarding herself. The patient has drug allergies with BIAXIN, trazodone, statin drugs. She also has arthritis in knee and diabetes type 2. The patient had shingles three times before vaccination. On an unknown date in November 2006, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported) subcutaneously (under the skin) in the right arm. Concomitant therapies included oxycodone, OXYCONTIN, insulin and gabapentin. The patient stated that she got ZOSTAVAX and had got shingles twice. The patient was in the hospital for a surgery and On 18-OCT-2011, the patient broke out in the shingles while inpatient (hospitalization) and was kept her admitted at least 2 days longer than it should have. There was no laboratory tests performed. The patient was treated with VALTREX and hydroskin. The outcome of the event was reported as unknown. The patient sought medical attention. Additional information has been requested.