chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Red cell distribution width normal, Respiratory tract congestion, Rhinorrhoea, Salmonella test positive, Salmonellosis
Clinical narrative: Immunization Healthcare Branch was contacted by Occupational Health staff for assistance with VAERS for this patient and guidance on use of last oral typhoid dose in association with below symptoms. This 56 year old retired employee, received booster vaccinations on 3/10/2015 to include Yellow Fever and Meningococcal vaccines. He started his oral Typhoid vaccine on 3/11/2015 in compliance with employment immunization requirements. He advised he had received these same vaccines with IM Typhoid during his 23 year career without any reactions. Over the next few days he began to experience a runny nose, nasal congestion and fever noticing with 2nd and 3rd dose of oral typhoid (3/15/2015) his symptoms worsened (also day 5 after YF/MEN). He presented to PCP c/o persistent fever ranging 101-103.1F, chills, night sweats, generalized malaise, URI like symptoms (runny nose, congestion, post nasal drip, non-productive cough), body aches and episodic headaches (diffuse-facial). His complained urine was tea colored with first void but cleared after 4 liters water/Gatorade during the day. His wife reported he did not seem himself and was not "thinking clearly" as he did prior to his vaccinations. On 3/20/15 he continued alternating MOTRIN/TYLENOL for persistent recurrent fevers which would go down to 100 deg F. His PCP advised his CXR was normal and he had mild elevation in AST (53) and ALT (54) and low BUN/Creat (7/1.1) with BUN/Cr ratio low at 7.4. His WBC was normal at 7.4, H/H low 12.4/35.3, plt 189, RBC 3.95 (MCV/MCH/RDW all normal). Lab values suggest dehydration. Further labs were ordered for salmonella typhi, blood cultures, and viral studies (CMV, HSV, enterovirus, EBV). He reported being unable to work and was on personal sick leave greater than 24 hours. A VAERS will be filed by IHB. 3/23/2015: He advised his fevers were 99 degree F between MOTRIN doses; he uses NYQUIL at night, has stopped TYLENOL usage and has stopped using decongestants because it makes his mucus taste bad. No antibiotic therapy was initiated with normal WBC and he did not take the final dose of oral typhoid. He was eating well but had a queasy stomach at times due to post nasal drip, his night sweats were less and no headaches (last headache was 3/22/2015). 3/24/2015 he reported his temperature was stable at 98-99 deg F and he stopped use of MOTRIN. However, his temperature elevated to 101 degree F and he restarted use of his MOTRIN. He still has nasal congestion and post nasal drip with a mild cough, otherwise is doing fine. He advised his wife now has a cold. He is scheduled to see Infectious disease provider on Thursday 3/26/2015. 3/31/2015 he advised he no longer has a fever/temperature; however he continues with a mild cough. He advised he did return to work.
Age: 44.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Thinking abnormal, Upper respiratory tract infection, Upper-airway cough syndrome, White blood cell count normal
Clinical narrative: Immunization Healthcare Branch was contacted by Occupational Health staff for assistance with VAERS for this patient and guidance on use of last oral typhoid dose in association with below symptoms. This 56 year old retired employee, received booster vaccinations on 3/10/2015 to include Yellow Fever and Meningococcal vaccines. He started his oral Typhoid vaccine on 3/11/2015 in compliance with employment immunization requirements. He advised he had received these same vaccines with IM Typhoid during his 23 year career without any reactions. Over the next few days he began to experience a runny nose, nasal congestion and fever noticing with 2nd and 3rd dose of oral typhoid (3/15/2015) his symptoms worsened (also day 5 after YF/MEN). He presented to PCP c/o persistent fever ranging 101-103.1F, chills, night sweats, generalized malaise, URI like symptoms (runny nose, congestion, post nasal drip, non-productive cough), body aches and episodic headaches (diffuse-facial). His complained urine was tea colored with first void but cleared after 4 liters water/Gatorade during the day. His wife reported he did not seem himself and was not "thinking clearly" as he did prior to his vaccinations. On 3/20/15 he continued alternating MOTRIN/TYLENOL for persistent recurrent fevers which would go down to 100 deg F. His PCP advised his CXR was normal and he had mild elevation in AST (53) and ALT (54) and low BUN/Creat (7/1.1) with BUN/Cr ratio low at 7.4. His WBC was normal at 7.4, H/H low 12.4/35.3, plt 189, RBC 3.95 (MCV/MCH/RDW all normal). Lab values suggest dehydration. Further labs were ordered for salmonella typhi, blood cultures, and viral studies (CMV, HSV, enterovirus, EBV). He reported being unable to work and was on personal sick leave greater than 24 hours. A VAERS will be filed by IHB. 3/23/2015: He advised his fevers were 99 degree F between MOTRIN doses; he uses NYQUIL at night, has stopped TYLENOL usage and has stopped using decongestants because it makes his mucus taste bad. No antibiotic therapy was initiated with normal WBC and he did not take the final dose of oral typhoid. He was eating well but had a queasy stomach at times due to post nasal drip, his night sweats were less and no headaches (last headache was 3/22/2015). 3/24/2015 he reported his temperature was stable at 98-99 deg F and he stopped use of MOTRIN. However, his temperature elevated to 101 degree F and he restarted use of his MOTRIN. He still has nasal congestion and post nasal drip with a mild cough, otherwise is doing fine. He advised his wife now has a cold. He is scheduled to see Infectious disease provider on Thursday 3/26/2015. 3/31/2015 he advised he no longer has a fever/temperature; however he continues with a mild cough. He advised he did return to work.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: PREVNAR 13 given 4/13/15 (L) delt c/o itching x 2 days with redness. Came in 4/20/15 with large circular area with erythema, warm to touch below injection site. Dx with cellulitis and treated with KEFLEX.
Age: 82.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm had redness, swelling and warmth to injection site.  Patient came to PCP on 04/20/15 to report symptoms.  Advised to take Benadryl as needed.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Joint lock, Musculoskeletal pain
Clinical narrative: Swelling, large lump and pain at injection area. Shoulder pain and locking up in the joint during range of motion. Nerve pain almost as if shoulder is pinching a nerve. Still painful with lump at injection site on 4/20/2015.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Neuralgia
Clinical narrative: Swelling, large lump and pain at injection area. Shoulder pain and locking up in the joint during range of motion. Nerve pain almost as if shoulder is pinching a nerve. Still painful with lump at injection site on 4/20/2015.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Aphonia, Ear pain, Epistaxis, Erythema, Headache
Clinical narrative: Pain in ear, swollen left side face, redness left side of face, loss of voice, headaches, bloody nose.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: Pain in ear, swollen left side face, redness left side of face, loss of voice, headaches, bloody nose.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Client presented with LUE warm, swollen 5" diameter; client states she felt ill 4/16-17/2015, but did not call provider or CHD.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Patient said developed a bump and rash, originially the size of a silver dollar, some itching also.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Chills followed by fever 101. Took Advil, fever releived.  Felt chilled and as if having fever at 6AM 4/20/15 and took more Advil - fever relieved. Feels tired, slight nausea, no appetite.
Age: 1.31
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Eye swelling, Lacrimation increased, Lip swelling, Vomiting
Clinical narrative: Left eye swelling, vomiting, lower lip swelling, watery eyes.
Age: 18.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspepsia, Erythema, Fatigue, Flushing, Pruritus
Clinical narrative: This is a follow-up to a previously submitted VAERS report. 7/17/14 1300 hr received MMR and VAR vaccines- "15-30 min later" exam: c/o heartburn, hives to forearms and shoulder, +wheezing bilaterally. Treated with IM BENADRYL and EPIPEN x1 with resolution of itching and heartburn. Wheezing resolved during transport to ER where he was given IV SOLUMEDROL, monitored and discharged with diagnosis of urticarial rash. F/U exam 7/18/2014 reported all symptoms resolved without reoccurrence, just tired on BENADRYL. Also on ZANTAC po. Pt was healthy for next two weeks when given YF vaccine and BICILLIN shot on 9/8/2014 at 1300 hr. At 1620 he returned to medical c/o itching to back and arms, itchy throat similar to reaction 2 weeks ago. Exam: erythema welts/hives on back and arms, flushed face, audible wheezing on exhalation to LUL and LLL. Given IM BENADRYL and EPIPEN x2 and again transferred to ER where admitted for 24 hours and released on 9/9/14. F/U exam 9/10 was normal and given consult to allergy clinic. 10/22/2014 given 2nd BICILLIN shot IM without reaction. Began school in January 2015. 1/13/2015 shot call given Hep A/B and influenza vaccine w/o reaction and referred to allergy clinic for evaluation of past MMR/YF reactions. Seen by allergy clinic on 1/30/2015 and referred to another clinic. He denied any new food groups, detergents, deodorants, clothing, insect stings, dogs, cats, environmental allergies or recent travel (other than relocation). He was not exercising day of vaccination. He reported history of shellfish, fish and tree nut allergy that was cleared by allergies prior to work (completed skin testing to tree nuts (negative) with food challenge to tree nuts, tuna and shrimp asymptomatic and well tolerated). He does east hard boiled egg and uses a powdered egg protein in his workout shakes with no issues. He did have eggs over-easy while in high school and had problems with headaches, feeling bad so he stopped. He did get quadrivalent influenza vaccine (FLUARIX vs FLULAVAL) this year with no adverse reaction reported.
Age: 18.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Radioallergosorbent test positive, Throat irritation, Urticaria, Wheezing
Clinical narrative: This is a follow-up to a previously submitted VAERS report. 7/17/14 1300 hr received MMR and VAR vaccines- "15-30 min later" exam: c/o heartburn, hives to forearms and shoulder, +wheezing bilaterally. Treated with IM BENADRYL and EPIPEN x1 with resolution of itching and heartburn. Wheezing resolved during transport to ER where he was given IV SOLUMEDROL, monitored and discharged with diagnosis of urticarial rash. F/U exam 7/18/2014 reported all symptoms resolved without reoccurrence, just tired on BENADRYL. Also on ZANTAC po. Pt was healthy for next two weeks when given YF vaccine and BICILLIN shot on 9/8/2014 at 1300 hr. At 1620 he returned to medical c/o itching to back and arms, itchy throat similar to reaction 2 weeks ago. Exam: erythema welts/hives on back and arms, flushed face, audible wheezing on exhalation to LUL and LLL. Given IM BENADRYL and EPIPEN x2 and again transferred to ER where admitted for 24 hours and released on 9/9/14. F/U exam 9/10 was normal and given consult to allergy clinic. 10/22/2014 given 2nd BICILLIN shot IM without reaction. Began school in January 2015. 1/13/2015 shot call given Hep A/B and influenza vaccine w/o reaction and referred to allergy clinic for evaluation of past MMR/YF reactions. Seen by allergy clinic on 1/30/2015 and referred to another clinic. He denied any new food groups, detergents, deodorants, clothing, insect stings, dogs, cats, environmental allergies or recent travel (other than relocation). He was not exercising day of vaccination. He reported history of shellfish, fish and tree nut allergy that was cleared by allergies prior to work (completed skin testing to tree nuts (negative) with food challenge to tree nuts, tuna and shrimp asymptomatic and well tolerated). He does east hard boiled egg and uses a powdered egg protein in his workout shakes with no issues. He did have eggs over-easy while in high school and had problems with headaches, feeling bad so he stopped. He did get quadrivalent influenza vaccine (FLUARIX vs FLULAVAL) this year with no adverse reaction reported.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At injection site:  Swelling, redness, temperature = Hot to touch, reaction spread to the size of a softball.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling cold, Hypersomnia, Pyrexia
Clinical narrative: 4/15 day of injection went and worked out at gym per usual. 4/16 went to work but felt like she could not get warm, worked full day, home and to bed at 4:30 PM. Slept until next morning. Felt feverish for 2 full days. 4/20 Returned to clinic for assessment, erythema measures 18.5 cm by 11 cm; to be seen by Dr's partner.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test abnormal, Computerised tomogram head normal, Dehydration, Dizziness, Fall
Clinical narrative: Pt got out of his truck and walked across his yard. He got dizzy and fell to the ground. He was out for 15 min.  He had numbness in his face and lips.  he had a headache and vomited 3 - 4 times.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt got out of his truck and walked across his yard. He got dizzy and fell to the ground. He was out for 15 min.  He had numbness in his face and lips.  he had a headache and vomited 3 - 4 times.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Headache, Pruritus, Skin warm
Clinical narrative: Hep B (Engerix) vaccine administered to right deltoid. Employee returned to work, and reported warmth, erythema, and itchiness to entire right arm and right neck. 50mg Benadryl given orally, and employee observed in office for 30 minutes. Employee remained with stated symptoms 30 minutes into observation, erythema subsided slightly. Employee reported new onset of headache. No other symptoms reported. Employee was able to return to work. Followed up with employee 2 hours later (1430) all symptoms subsided with the exception of the headache.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Rash
Clinical narrative: Complained of difficulty breathing, dizziness, rash.
Age: 31.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: CLIENT WAS ADMINISTERED MMRV (PROQUAD) INSTEAD OF MMR TODAY. CLIENT INFORMED OF ERROR VIA PHONE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Somnolence, Vomiting
Clinical narrative: Severe vomiting and diarrhea, resulting in lack of appetite for about 2 days.  Very weak and sleeping for 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness on bilateral thighs located around injection sites.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Diarrhoea, Pyrexia, Rash, Rash macular
Clinical narrative: Rash (small erythematous raised macules around neck and extending to top of the back) and fever to 103.5 followed by diarrhea.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC, RV1
Symptoms: Eyelid rash, Rash, Rash erythematous
Clinical narrative: Red small rash on right forehead and bilateral eyelids, observation at clinic.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Injection site pruritus, Nausea, Vaccination site swelling
Clinical narrative: Itching at vaccination site followed by swelling then nausea and SOB - happenned after they left the office so they went to ER - treated with epinephrine, IV Solumedrol and discharged with oral prednisone x5 days.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Arthritis, Depression, Fatigue, Feeling abnormal
Clinical narrative: Chronic itchy Hives all over my body, Chronic Fatigue, mental fog, depression, anxiety, joint inflammation and pain, visual problems. Malaise.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Pruritus generalised, Urticaria, Visual impairment
Clinical narrative: Chronic itchy Hives all over my body, Chronic Fatigue, mental fog, depression, anxiety, joint inflammation and pain, visual problems. Malaise.
Age: 42.0
Sex: F
Vaccine: HEPAB, JEV1, PNC13, RAB, TDAP, TYP
Symptoms: Inflammation, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Large local reaction: 10X10 erythematous warm patch with discrete edges over deltoid (less erythematous) and medial to inner arm above olecranon. (+) mild edema and tender to touch. No lymphadenopathy to axilla or epitrochlear adenopathy. No papules, pustules, vesicles, or scale. 10 inch diameter to her left upper arm. She reports the onset was about 2 days after vaccine receipt. It is erythematous, edematous, and tender; when seen at day 7 she stated the site has improved. It is mildly pruritic and burning starting today. Her entire arm was sore. She had mild fever 99-101 the first 6 days. She was treated with ice, prn antihistamine for comfort, topical LIDEX, and ibuprofen. At telephone follow up on 20 APR 2015, reports pain resolved, local inflammation much improved in intensity and diameter of affected area.
Age: 42.0
Sex: F
Vaccine: HEPAB, JEV1, PNC13, RAB, TDAP, TYP
Symptoms: Injection site warmth, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Large local reaction: 10X10 erythematous warm patch with discrete edges over deltoid (less erythematous) and medial to inner arm above olecranon. (+) mild edema and tender to touch. No lymphadenopathy to axilla or epitrochlear adenopathy. No papules, pustules, vesicles, or scale. 10 inch diameter to her left upper arm. She reports the onset was about 2 days after vaccine receipt. It is erythematous, edematous, and tender; when seen at day 7 she stated the site has improved. It is mildly pruritic and burning starting today. Her entire arm was sore. She had mild fever 99-101 the first 6 days. She was treated with ice, prn antihistamine for comfort, topical LIDEX, and ibuprofen. At telephone follow up on 20 APR 2015, reports pain resolved, local inflammation much improved in intensity and diameter of affected area.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with MMR II (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Depression, Flushing, Hypersensitivity, Pruritus
Clinical narrative: Information was received regarding a case in litigation concerning a 39 year old male. Information received from the patient and medical records. The patient claims that in 20-DEC-2012, he was vaccinated with PNEUMOVAX 23 and experienced an allergic reaction. The patient stated that the effects of the allergic reaction severely discolored his face. As a result of the patient's allergic reaction, the patient reported "ongoing fear of public exposure, depression and mental stress." Information received from medical records concerning a 39 year old male (210 pounds, 71 inches) with penicillin allergy and history of asthma as a child. On 20-DEC-2012, the patient was vaccinated with PNEUMOVAX 23 (lot Number H014283, expiration date 17-APR-2014) via right deltoid. On 20-DEC-2012 at 1130 (approximately one hour after the vaccination), the patient was brought to the clinic with complaints of "upper body feeling itchy, feel a buzz in face and face feels red and hot." On examination the patient was noted to have some facial flushing, no shortness of breath noted and no rashes noted on his body. The physician noted that according to nursing assessment, the patient complained of tightness and itching of the chest as well. The physician reported the patient remained alert and oriented and appropriate vital signs were obtained. The patient was monitored for signs and symptoms of allergic reaction and also educated to report symptoms and return if needed. On 27-DEC-2012 examination, the patient felt improved and denied any shortness of breath, or feeling of flushing in his face. The physician explained to the patient that he may have had an allergic reaction. On examination, the physician reported the patient's skin showed no rashes or urticarial type lesions. The physician stated the patient with history of allergic reaction possible to PNEUMOVAX 23 on 20-DEC-2012 when he was given ZANTAC and hydroxyzine twice a day for the next five days. The physician reported this issue has been resolved. All available medical records will be provided upon request. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Skin discolouration, Social fear, Stress
Clinical narrative: Information was received regarding a case in litigation concerning a 39 year old male. Information received from the patient and medical records. The patient claims that in 20-DEC-2012, he was vaccinated with PNEUMOVAX 23 and experienced an allergic reaction. The patient stated that the effects of the allergic reaction severely discolored his face. As a result of the patient's allergic reaction, the patient reported "ongoing fear of public exposure, depression and mental stress." Information received from medical records concerning a 39 year old male (210 pounds, 71 inches) with penicillin allergy and history of asthma as a child. On 20-DEC-2012, the patient was vaccinated with PNEUMOVAX 23 (lot Number H014283, expiration date 17-APR-2014) via right deltoid. On 20-DEC-2012 at 1130 (approximately one hour after the vaccination), the patient was brought to the clinic with complaints of "upper body feeling itchy, feel a buzz in face and face feels red and hot." On examination the patient was noted to have some facial flushing, no shortness of breath noted and no rashes noted on his body. The physician noted that according to nursing assessment, the patient complained of tightness and itching of the chest as well. The physician reported the patient remained alert and oriented and appropriate vital signs were obtained. The patient was monitored for signs and symptoms of allergic reaction and also educated to report symptoms and return if needed. On 27-DEC-2012 examination, the patient felt improved and denied any shortness of breath, or feeling of flushing in his face. The physician explained to the patient that he may have had an allergic reaction. On examination, the physician reported the patient's skin showed no rashes or urticarial type lesions. The physician stated the patient with history of allergic reaction possible to PNEUMOVAX 23 on 20-DEC-2012 when he was given ZANTAC and hydroxyzine twice a day for the next five days. The physician reported this issue has been resolved. All available medical records will be provided upon request. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Redness at site of injection-treated for cellulitis.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness at site of injection. Treated for cellulitis.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with ROTATEQ oral, (dosage, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. 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 licensed practical nurse refers to an unknown number of patients of unknown ages with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX (Merck) (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. The nurse stated that there were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with GARDASIL, (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Along left side of back, she was getting itchy. Also on scalp, arms and legs. Red spots started appearing on these areas as well as torso and back. No pain associated with this.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a PEDIARIX as the 4th DTAP dose instead of just the DTAP.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra infuenza vaccine, 2 total for 2014-2015 season, had 2 doses of influenza vaccine last year as well.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at and around injection site. Stated within a couple of hours of injection.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Nasopharyngitis
Clinical narrative: Pain, redness and swelling at and around injection site. Stated within a couple of hours of injection.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Headache
Clinical narrative: Pt sitting on edge of exam table. Gave MCV4 (L) arm then HPV4 (R) arm approximately 30-45 seconds later pt fell to (L) and off table onto floor. Pt awake immediately but didn't know where was BP 100/60 AR 74 MD called to room. Left laying on floor approximately 15 min then sitting position x 15 min. Gave juice and granola bar. Pt c/o headache observed by MD for next 45 minutes.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Received varicalla vaccine 4-7 2015 in (R) arm. Fever that night. Leg pain 4-15; Still present 4-18-> red maculopapular erythema (L) chest. (R) ileam, (L) flank, (R) hip. No systemic sx.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, MMR
Symptoms: Extra dose administered
Clinical narrative: Child was given 2 doses of MMR vaccine at the same time (.5 ml) 1 ml in total administered. No reaction at this time.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Right arm pain started shortly after receiving the Tdap redness itching and increased warmth start yesterday injection on 4/8/15. Clindamycin 300 mg TID started on 4/15/15.
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Patient received TD vaccine earlier this morning. Patient presented with fever 101.2, headache, dizziness, and tired.
Age: 51.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Anger
Clinical narrative: TWINRIX, Tdap and inject typhoid given-two days later patient experienced 2hrs of extreme anger. Had issues in past which he has been working on. Last episode was 2 yrs ago.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. In 2011 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route were not provided). The patient came down with shingles recently (date unspecified). The pharmacist did not keep record of vaccination as far back as 2011 and could not provide lot # for ZOSTAVAX). The outcome of the event was unknown. The relationship between the event and ZOSTAVAX was not reported. It was unspecified whether the patient sought medical attention or not. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered wiht unknown number of doses of improperly stored GARDASIL (dose strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored measles, mumps and rubella (Wistar Ra 27-3) virus vaccine live (V@05C) (lot # K008202, EXP date: 05-JUNE-2016, dose and route not reported. No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with unknown number of doses of improperly stored PNEUMOVAX23 (dose strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same source.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: Information has been received from a medical assistant referring to an 11 year old female patient without pertinent medical history and drug reactions/allergies. On 16-FEB-2015, the patient was vaccinated with the first dose of GARDASIL in her right deltoid (dose not provided, lot number reported as K004204, expiration date 12-JAN-2017) while lying down. The patient also administered MCV4 (Sanofi) and TDAP (Sanofi) (dose, route and lot number not provided) on the same date in a different extremity. Before the patient sat up, she experienced minor seizure like activity in the office of physician. Treatment from physician was to keep patient lying down for an unspecified length of time, water, candy and observation for 30 minutes. No lab diagnostics were performed. The outcome of convulsion was reported as recovered/resolved on 16-FEB-2015. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored GARDASIL (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored ROTATEQ (dose, lot# were not reported, oral). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored COMVAX (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # K004921, EXP date 25-FEB-2016, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored VAQTA (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Reaction a couple hours after shots, purple, pink from hip to toes (B).
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. No medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose and frequency not provided). No concomitant therapy was provided. On an unknown date the patient was diagnosed with cervical cancer (medically significant). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Upon internal review the cervical cancer was considered as medically significant. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Malaise, Pharyngeal oedema, Throat irritation
Clinical narrative: Swelling of glands, felt rapidly sick, itchy throat, swelling of throat. Took two Benadryl and swelling gradually went down. Took a third Benadryl two hours later.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain, Pyrexia
Clinical narrative: Large, red, feverish, painful circle on the arm about 4 to 5 inches in diameter and increasing in size over a period of a couple of days. Also a hard knot beneath the surface of the skin.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Injection site bruising, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: The entire thigh of the left leg was swollen, very red and warm to the touch.  Less severe similar reaction on the right thigh.  Baby was also visibly upset and in pain based on his reactions to touching the area or moving the muscle in any way.  Baby received warm bath since he was visibly upset when warm compresses were attempted.  Bath seemed to calm baby.  An hour later area was still swollen, but less red.  Mom took pictures for documentation.  Around 3:30 pm baby developed low grade fever which ranged from 99.4-100.5 up until bed time.  Mom nursed baby on demand to ensure plenty of fluids were being received and wet/dirty diapers were monitored as well.  Baby continued to be monitored for any additional symptoms.  The following morning (4/21/15), the baby's fever was gone as was all redness.  As of this reporting, both thighs are still slightly swollen, there is bruising at both injection sites and in the right thigh there is a blueberry sized hard lump in the muscle.  Mom plans to massage the thigh in another warm bath today (4/21/15).
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: The entire thigh of the left leg was swollen, very red and warm to the touch.  Less severe similar reaction on the right thigh.  Baby was also visibly upset and in pain based on his reactions to touching the area or moving the muscle in any way.  Baby received warm bath since he was visibly upset when warm compresses were attempted.  Bath seemed to calm baby.  An hour later area was still swollen, but less red.  Mom took pictures for documentation.  Around 3:30 pm baby developed low grade fever which ranged from 99.4-100.5 up until bed time.  Mom nursed baby on demand to ensure plenty of fluids were being received and wet/dirty diapers were monitored as well.  Baby continued to be monitored for any additional symptoms.  The following morning (4/21/15), the baby's fever was gone as was all redness.  As of this reporting, both thighs are still slightly swollen, there is bruising at both injection sites and in the right thigh there is a blueberry sized hard lump in the muscle.  Mom plans to massage the thigh in another warm bath today (4/21/15).
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: Developed headache, arthralgias, myalgias, malaise, nausea and dizziness which lasted 2-3 weeks. Symptoms were reproduced with each subsequent anthrax dose. Since dose 2008 has had migratory arthralgias.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: Developed headache, arthralgias, myalgias, malaise, nausea and dizziness which lasted 2-3 weeks. Symptoms were reproduced with each subsequent anthrax dose. Since dose 2008 has had migratory arthralgias.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Within 1 hour of receiving vaccine had pounding headache, vomiting and body aches lasting 24 hrs. Had the exact same reaction after receiving a flu shot on 1-14-15 (FLULAVAL - ID Biomedical)
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria, Rash macular
Clinical narrative: Within seconds after giving IM injections, broke out in blotchy and purple rash with raised pink hives only on legs. Lesions faded without treatment.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of VAQTA (dose and route were not reported) lot number K009506, expiration date 22-SEP-2016; lot number K010579, expiration date 12-FEB-2017 and lot number K010577, expiration date 22-SEP-2016, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a 39-year-old female consumer reporting on herself. No information regarding the patient's medical history or concurrent conditions was reported. The patient reported that on separate unspecified dates in 2009, she received the first 2 doses of GARDASIL (doses, routes of administration, anatomical location, lot# and expiration dates were not provided). On an unspecified date, in 2015 (reported as "recently, this past week"), the patient received a dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Age: 0.56
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received form a clinical medical assistant regarding a currently 6 year old male patient with an allergy to azithromycin. The patient did not have pertinent medical history and concomitant medications. On 30-SEP-2008, the patient was vaccinated with the first dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported). On 06-FEB-2009, the patient was vaccinated with the second dose of RECOMVIBAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported). On 24-APR-2009, the patient was vaccinated with the third dose of RECOMBIVAX HB (route: intramuscular, dose, lot #, therapy type, expiration date were not reported). On an unspecified day in December 2014, unspecified infectious disease serologic testing was performed and showed no immunity to hepatitis B. Due to failure to produce antibodies after receiving the first RECOMBIVAX HB series, the patient received a fourth and fifth dose of RECOMBIVAX HB on an unspecified dates. The patient's outcome was unknown. The relatedness between the events and therapy was RECOMBIVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with VAQTA, lot # J016216 (expiration date- 18-AUG-2016) and lot # K012457 (expiration date- 04-JUN-2017) intramuscularly which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Right arm reddened, swollen and "felt some hard" 3/4 of below injection site per mom. Able to move arm and fingers, good sensation.  No fever.  Mom had been applying heat to reduce swelling and called HD 4/20 as did not have MD.  Instructed to give Children's Motrin per instructions on box, elevate arm and apply cool compresses. She did so and stated she continues to do so this morning with reduced swelling and redness "It looks much better." Has my cell# and I will check again tomorrow.  Instructed to go to ER if becomes worse or does not continue to improve, and she expressed understanding. In process of recovery at this time will monitor.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cyanosis, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: When another RN noticed child was on floor arms stiff and hands fisted, blue in color. Not responding to parent or nurse, although eyes were open.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash, diphenhydramine
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with RECOMBIVAX HB, lot # J007943 (expiration date- 05-FEB-2016) and lot # J005891 (expiration date- 20-SEP-2015) intramuscularly which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Aplastic anaemia, Platelet count decreased, Red blood cell count decreased, White blood cell count decreased
Clinical narrative: I took annual physical and 29 days later blood tests results were abnormally low (WBC 3.5; RBC 3.21; PLT 42K; etc.). For the next 3 months blood continued to drop until I was diagnosed with Aplastic Anemia I spent 6 days in hospital and I am still taking treatments.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Rash pruritic
Clinical narrative: Patient states on Saturday he developed a large red circle that eventually turned into an itchy knot at injection site. Itchy rash appeared from her shoulder to her elbow. No anaphylactic rxn. 4 days later and it is still itchy. She hasn't taken anything to treat the reaction.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Muscle soreness 3-26-15. Redness/itching 3-28-15. Bruising at site 3-28-15. Redness spread with swelling over upper arm saw Dr. 4-1-15 prescribed antibiotics 7 days.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cough, Myalgia, Rhinorrhoea, Syncope, Throat irritation
Clinical narrative: Day 1 - extreme pain in shoulder muscle 3 1/2 - 4 hrs. after injection. Fainted 2 times at 3:15 pm on day of injection due to excruciating pain in shoulder muscle. 3-30-15 most pain has gone, but still some pain on 4-3-15. 7 days later, 4-1-15 - slight cough and tickle in throat. Runny nose on 4-2-15. Cough has worsened and runny nose is still present.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complaining of left shoulder pain after TDAP injection DOS: 3/2/15, initially pain at site then after a week developed periodic pain in different areas on left arm. It varies in location, sometimes in triceps sometimes in hand, sometimes in bicep with w/radiation to hand.