chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old male patient. The patient's medical history was not reported. On 22-SEP-2014 (reported as yesterday), the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (Dose: 0.5 ml, Route: subcutaneous in the left arm) (lot # K002927 and expiry date: 16-FEB-2016) instead of ZOSTAVAX. Staff error only. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is linked to 1409USA013863 (same repoter link). Additional information is not expected as the reporter did  not wish to contact.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Pyrexia, Throat tightness, Vomiting
Clinical narrative: About 4 hrs after vaccination, patient felt throat tight, itchy, mucousy eyes, vomiting and fever. Took BENADRYL (Fever 101 degrees). Patient no better/no worse 7PM and 9PM.
Age: 33.0
Sex: M
Vaccine: VARZOS, TDAP
Symptoms: Expired drug administered, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 11-SEP-2014 the patient was inadvertently administered ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that had been reconstituted with expired sterile water diluent, lot number 0575AE, expiration date 31-MAY-2014 (dose, route and anatomical location were unspecified). No concomitant therapies were reported. The outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 33.0
Sex: M
Vaccine: VARZOS, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 11-SEP-2014 the patient was inadvertently administered ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that had been reconstituted with expired sterile water diluent, lot number 0575AE, expiration date 31-MAY-2014 (dose, route and anatomical location were unspecified). No concomitant therapies were reported. The outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patient were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ oral solution, (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL, (lot #, strength, dose, frequency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was inadvertently vaccinated with expired PNEUMOVAX 23, injection, 0.5 ml, intramuscular (IM), lot # J009827 that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Large amount of swelling, redness and itchiness at the site of the injection. Additional hives on back.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Myalgia, Pain of skin, Pyrexia
Clinical narrative: All of my muscles were sore, my skin was extremely sensitive to touch, severe headache, and felt feverish - though my actual temperature was only 0.6 above my normal.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Around 3 became fatigued with headache; by 7 still fatigued with muscle aches; chills with normal temp at 9; temp up to 101.5 over night and gradually returned to normal by 7am next day.
Age: 0.6
Sex: F
Vaccine: DTPHEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2.5 inch erythematous raised site reaction.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Asthma, Dizziness, Headache
Clinical narrative: High blood pressure, dizziness, blurry vision, nose throat, asthma attack, headaches, weakness, body aches, nauseas, stomach pain. Still sick after 4 days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Malaise, Nausea, Pain, Vision blurred
Clinical narrative: High blood pressure, dizziness, blurry vision, nose throat, asthma attack, headaches, weakness, body aches, nauseas, stomach pain. Still sick after 4 days.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Right side of face swelled up, about 2" from ear to jaw, worse when eating, so I stopped. No pain when not eating.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Injected limb mobility decreased, Injection site pain, Malaise, Pain
Clinical narrative: Fever of 100.8 (fluctuated but that was the high), body aches, pain at injection site (couldn't lift arm over shoulder), general malaise, slight cough.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever of 100.8 (fluctuated but that was the high), body aches, pain at injection site (couldn't lift arm over shoulder), general malaise, slight cough.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatomyositis, Muscular weakness, Myalgia, Rash generalised
Clinical narrative: Dermatomyositis. Rash on face, chest, neck, hands. Generalized muscle aches and weakness (head to toe).
Age: 37.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Painful redness, swelling and itching at site. Patient giver Bactrim ds 800 mg one bid x 7 days and advised to apply moist heat 4-6 times a day. Advised to follow up in 2 days.
Age: 0.51
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Screaming
Clinical narrative: Woke up screaming, fever of 102.7, screamed for over 1 hour, both legs were red, swollen and hot to the touch.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on vaccine arm (left) and underarm - lasted ~5 days given antihistamine by RPh.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient states she had a fever for 6 hours that started 4 hours after her vaccine was given.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pruritus, Rash generalised
Clinical narrative: Rash, redness, tenderness at injection site. Small lesion like rash across the body. Not very itchy.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: Redness about the size of an orange near injection site & very slight itching occurred morning after vaccine received. Redness & itching completely resolved by 09/27/14. Nausea & mild headache occurred on morning of 09/27/14.
Age: 0.53
Sex: M
Vaccine: DTPHIB, FLUX, IPV, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Insomnia, Irritability
Clinical narrative: High Temperature 102. 7, red marks where shot was given, skin was raised where shot was given, excessive crying and fussing and wasn't able to sleep without parent next to him. Yes he did recover but very scary for a young 6 month old, shouldn't have happened.
Age: 0.53
Sex: M
Vaccine: DTPHIB, FLUX, IPV, RVX
Symptoms: Pyrexia
Clinical narrative: High Temperature 102. 7, red marks where shot was given, skin was raised where shot was given, excessive crying and fussing and wasn't able to sleep without parent next to him. Yes he did recover but very scary for a young 6 month old, shouldn't have happened.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Pain, Pyrexia, Respiratory disorder
Clinical narrative: The evening after receiving the flu shot, the night after, and the following day, the guest had fever, severe chills and body aches, and respiratory symptoms (coughing).  He said that the same thing has happened to him the last couple of years that he received the vaccine, but it seems to keep getting worse each year.  Patient received Fluzone High Dose vaccination.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: The evening after receiving the flu shot, the night after, and the following day, the guest had fever, severe chills and body aches, and respiratory symptoms (coughing).  He said that the same thing has happened to him the last couple of years that he received the vaccine, but it seems to keep getting worse each year.  Patient received Fluzone High Dose vaccination.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound antenatal screen, Uterine dilation and evacuation
Clinical narrative: Fetal demise within 24 hours of vaccination. Required emergency D&E 1 week later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported swelling, redness, and itching at and around the site of injection on left arm. She reported some improvement in symptoms on 9/28/2014, but still has some swelling, redness, and itching. She will report back to the pharmacy and her doctor if symptoms don't improve.
Age: 77.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Local swelling, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient stated that her arm became very sore, stiff, and swollen the evening of the vaccination, and she lost mobility in her arm.  Also reported pain in back/neck. At time of report, pt stated that the pain was beginning to improve and had decided not to seek medical attention.
Age: 77.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient stated that her arm became very sore, stiff, and swollen the evening of the vaccination, and she lost mobility in her arm.  Also reported pain in back/neck. At time of report, pt stated that the pain was beginning to improve and had decided not to seek medical attention.
Age: 16.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Inflammation
Clinical narrative: Inflammation and redness.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms -fever, bodyaches.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure; temp 100.6 F rectal.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to 3 patients of unknown age and gender. On 14-AUG-2014, GARDASIL vials were improperly exposed to 34F for 24 hours. During the time frame of 19-AUG-2014 to 27-AUG-2014, each of 3 patients was vaccinated with one dose of this improperly stored GARDASIL (lot # J010668, expiration date 29-APR-2016, dose was unknown) intramuscular. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. None of pertinent medical history was reported. None of drug reactions/allergies was reported. On 15-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K003600, expiry date: 10-MAR-2015), subcutaneous in the arm for vaccination (dose and dose number not reported). None of concomitant medication was reported. On 16-SEP-2014, the patient came back to the pharmacy and presented with an injection site reaction in the arm where she received the ZOSTAVAX. The reporting pharmacist reported that the patient stated that the site was painful, warm and tender, and the injection site reaction was about 6 inches across the injection site. Patient sought medical attention by returning to pharmacy and ice packs was given as treatment. None of lab diagnostics studies were performed. Therapy with ZOSTAVAX was reported as continued. The outcome of events was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a M-M-R II lot # reported as J014875 (therapy type, dose, route, and expiration date were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On 08-SEP-2014 the patients were vaccinated with improperly stored PROQUAD (lot #, expiration date, dose and route unspecified). No adverse symptoms reported. The temperature excursion was found to be supported by in-house stability data. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a child patient of unknown age and gender. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route and lot # unknown). On an unknown date in 2013, (also reported as "in the last year") the patient fainted after receiving the dose of GARDASIL. It was unspecified if patient sought medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date. The causality was not reported. This is one of several reports received from the 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 health care worker refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with (Oka/Merck) VARIVAX (dose: 0.5 ml, subcutaneous) that had continued to undergo defrost cycling in which the temperature has risen above the proper parameters. No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is linked to case # 1406USA004630 and 1409USA004711 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expired date were not reported). Concomitant medications were not reported. No adverse symptoms reported. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Bronchitis, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Injected limb mobility decreased
Clinical narrative: Case number PHHY2014US121092, is an initial spontaneous report from a consumer received via Vaccine Adverse Event Reporting System (VAERS reference number: 538631) website on 16 Sep 2014. This report refers to female patient of unknown age. Concurrent conditions included chronic obstructive pulmonary disease. Family history (aunt) included breast cancer. No concomitant medication was reported. She was on treatment with ADVAIR for chronic obstructive pulmonary disease and Albuterol for unknown indication at unknown dosing. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and pneumococcal polyvalent vaccine (unknown manufacturer, batch number: not reported) on an unknown date in Oct 2013. It was reported that she received one vaccine in her left arm and the other in her right arm. However, she does not know which vaccine was given in which arm. Less than a week after vaccination in Oct 2013, she could hardly move her right arm and did not sleep for two nights. On an unknown date in 2013 (sometime around Thanksgiving and Christmas) she experienced difficulty breathing and bronchitis. Also it was reported that her last COPD (chronic obstructive pulmonary disease) checkup was scheduled for 13 Jun 2013 and her other doctors are concerned that her lungs are worsening and are stressing her to go to her Pulmonologist. She was trying to coordinate a visit that was so badly needed. She was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) in the first part of the month (every three months) for her cancer and that was not done either, so she will have to work on that as well. It was reported that she had no problems with ADVAIR when she got her flu shot. The final outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Insomnia, Lung disorder, Neoplasm malignant
Clinical narrative: Case number PHHY2014US121092, is an initial spontaneous report from a consumer received via Vaccine Adverse Event Reporting System (VAERS reference number: 538631) website on 16 Sep 2014. This report refers to female patient of unknown age. Concurrent conditions included chronic obstructive pulmonary disease. Family history (aunt) included breast cancer. No concomitant medication was reported. She was on treatment with ADVAIR for chronic obstructive pulmonary disease and Albuterol for unknown indication at unknown dosing. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and pneumococcal polyvalent vaccine (unknown manufacturer, batch number: not reported) on an unknown date in Oct 2013. It was reported that she received one vaccine in her left arm and the other in her right arm. However, she does not know which vaccine was given in which arm. Less than a week after vaccination in Oct 2013, she could hardly move her right arm and did not sleep for two nights. On an unknown date in 2013 (sometime around Thanksgiving and Christmas) she experienced difficulty breathing and bronchitis. Also it was reported that her last COPD (chronic obstructive pulmonary disease) checkup was scheduled for 13 Jun 2013 and her other doctors are concerned that her lungs are worsening and are stressing her to go to her Pulmonologist. She was trying to coordinate a visit that was so badly needed. She was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) in the first part of the month (every three months) for her cancer and that was not done either, so she will have to work on that as well. It was reported that she had no problems with ADVAIR when she got her flu shot. The final outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Insomnia
Clinical narrative: Case number PHHY2014US121092, is an initial spontaneous report from a consumer received via Vaccine Adverse Event Reporting System (VAERS reference number: 538631) website on 16 Sep 2014. This report refers to female patient of unknown age. Concurrent conditions included chronic obstructive pulmonary disease. Family history (aunt) included breast cancer. No concomitant medication was reported. She was on treatment with ADVAIR for chronic obstructive pulmonary disease and Albuterol for unknown indication at unknown dosing. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and pneumococcal polyvalent vaccine (unknown manufacturer, batch number: not reported) on an unknown date in Oct 2013. It was reported that she received one vaccine in her left arm and the other in her right arm. However, she does not know which vaccine was given in which arm. Less than a week after vaccination in Oct 2013, she could hardly move her right arm and did not sleep for two nights. On an unknown date in 2013 (sometime around Thanksgiving and Christmas) she experienced difficulty breathing and bronchitis. Also it was reported that her last COPD (chronic obstructive pulmonary disease) checkup was scheduled for 13 Jun 2013 and her other doctors are concerned that her lungs are worsening and are stressing her to go to her Pulmonologist. She was trying to coordinate a visit that was so badly needed. She was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) in the first part of the month (every three months) for her cancer and that was not done either, so she will have to work on that as well. It was reported that she had no problems with ADVAIR when she got her flu shot. The final outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2014US121107 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 539028) on 16 Sep 2014. This report refers to a male patient of an unspecified age. His past medical history and concomitant medications were not reported. On an unspecified date, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). After an unspecified interval after the vaccination, he developed a near anaphylactic reaction. The outcome of the event was not reported. The event was reported as non serious but was reassessed as serious (medically significant) by the agency and causality of the event was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chills, Oedema mouth, Oropharyngeal pain, Swelling face
Clinical narrative: Had vaccine at 3:45 P per patient. 7:30 PM started with fever, chills, low grade fever, achy joints then face swelling, painful mouth with lesions inside and swollen tongue. Denied SOB. 7P Took TYLENOL. 10P BENADRYL 25mg. Was still swollen this AM at 6:30 AM - 9/26/14 jaw, lips and tongue, but was better, but felt achy.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Had vaccine at 3:45 P per patient. 7:30 PM started with fever, chills, low grade fever, achy joints then face swelling, painful mouth with lesions inside and swollen tongue. Denied SOB. 7P Took TYLENOL. 10P BENADRYL 25mg. Was still swollen this AM at 6:30 AM - 9/26/14 jaw, lips and tongue, but was better, but felt achy.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Chills, Lip swelling, Oral disorder, Oral pain
Clinical narrative: Had vaccine at 3:45 P per patient. 7:30 PM started with fever, chills, low grade fever, achy joints then face swelling, painful mouth with lesions inside and swollen tongue. Denied SOB. 7P Took TYLENOL. 10P BENADRYL 25mg. Was still swollen this AM at 6:30 AM - 9/26/14 jaw, lips and tongue, but was better, but felt achy.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Swelling, Swelling face, Swollen tongue
Clinical narrative: Had vaccine at 3:45 P per patient. 7:30 PM started with fever, chills, low grade fever, achy joints then face swelling, painful mouth with lesions inside and swollen tongue. Denied SOB. 7P Took TYLENOL. 10P BENADRYL 25mg. Was still swollen this AM at 6:30 AM - 9/26/14 jaw, lips and tongue, but was better, but felt achy.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Rash generalised, Rash macular
Clinical narrative: Vaccine given in morning approx 10 Am 9/24/2014 patient stated she developed itching on torso and rash about 5 pm same day - noted on 9/26/2014 pt visited EH office - rash over body more concentrated on front torso.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Vaccine given in morning approx 10 Am 9/24/2014 patient stated she developed itching on torso and rash about 5 pm same day - noted on 9/26/2014 pt visited EH office - rash over body more concentrated on front torso.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe chills, body aches, headache, mild fever, 9PM to 11PM, Motrin 400mg.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II (dose not reported, lot # H015833, expiration date 24-AUG-2014, subcutaneously. No known adverse effects. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: Pt described somewhat raised rash about the size of the palm of ones hand that felt warm to the touch.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Pain, Skin warm, Swelling
Clinical narrative: Patient received vaccine on Fri Sept 26 and reported Mon Sept 29 of swelling, redness, warm to the touch and patient had trouble sleeping on it bc it was painful.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Hives, itchiness, headache.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 1 week after receiving the varicella vaccine, my daughter reported that the injection site was itchy. We applied some Benadryl cream several times. By the next day, there was a 2' raised red circle around the site. I called the Dr's office and was advised to give ibuprofen and apply ice. The area continued to worsen, to the point my daughter was limping from pain in her upper leg. Her lymph nodes in the area were also swollen. By Friday of the same week, the area around the injection site had doubled in size and was spreading. It was hot to the touch, swollen and painful. We returned to the Dr and my daughter was prescribed an antibiotic and steroid. Now, 3 days after beginning the antibiotic, the swelling and redness are almost gone.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Lymphadenopathy
Clinical narrative: 1 week after receiving the varicella vaccine, my daughter reported that the injection site was itchy. We applied some Benadryl cream several times. By the next day, there was a 2' raised red circle around the site. I called the Dr's office and was advised to give ibuprofen and apply ice. The area continued to worsen, to the point my daughter was limping from pain in her upper leg. Her lymph nodes in the area were also swollen. By Friday of the same week, the area around the injection site had doubled in size and was spreading. It was hot to the touch, swollen and painful. We returned to the Dr and my daughter was prescribed an antibiotic and steroid. Now, 3 days after beginning the antibiotic, the swelling and redness are almost gone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Large 8 inch by 5 inch red, swollen, area from 3 inches above the injection site to the elbow, hard lump under injection site, Itching, hot,  then progressed to blisters, area about 2 inches square, fluid filled.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Large 8 inch by 5 inch red, swollen, area from 3 inches above the injection site to the elbow, hard lump under injection site, Itching, hot,  then progressed to blisters, area about 2 inches square, fluid filled.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Haemoptysis, Malaise, Tongue disorder
Clinical narrative: EXCESSIVE COUGHING TO WHERE SHE SAW BLOOD (NOT A LOT, MAYBE DUE TO THE EXCESSIVE COUGHING, IT HAD STOPPED SOMEWHAT) SHORTNESS OF BREATH, TONGUE HAD TURNED RED AND SHE FELT VERY ILL. SHE SAW HER DOCTOR ON MONDAY AND WAS GIVEN A ZPAK.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy Sunday 9/28 approxiamtely 3pm with chief complaint of warmth, swelling and redness in left bicep area. There was bruising in left deltiod where high dose flu shot was given Friday 9/26, but no redness or swelling in that region. Advised pt to contact dr Monday morning and seek medical help if rash spread, fever, or dizziness occured. I will follow up with PCP and oversight physicain.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count abnormal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: 2nd GARDASIL adm 7-11-14 - pt had physical with another office a routine CBC showed a platelet CT 50 - pt referred to Hematologist Dx with ITP rec. prednisone with improvement in CBC.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Malaise, Platelet count decreased
Clinical narrative: 2nd GARDASIL adm 7-11-14 - pt had physical with another office a routine CBC showed a platelet CT 50 - pt referred to Hematologist Dx with ITP rec. prednisone with improvement in CBC.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: 2nd GARDASIL adm 7-11-14 - pt had physical with another office a routine CBC showed a platelet CT 50 - pt referred to Hematologist Dx with ITP rec. prednisone with improvement in CBC.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Cough, Nausea, Pyrexia
Clinical narrative: Pt received 2 vaccines, ZOSTAVAX and FLUZONE HIGH DOSE. A short time later pt developed symptoms including cough, fever, chills and nausea. Pt reported to emergency room and was admitted to hospital.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Extreme cramping and vomiting on first day of menstrual cycle.  Still occurs on first day of menstrual cycle each month.  Had never happened prior to receiving vaccine.
Age: 5.0
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: ActHib and Prevnar were the vaccines that were given after maximum age.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Itch, rash, fever, hives.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain; difficult to roll over in bed or lift arm over shoulder height; it is not getting any better, but is getting worse.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Feeling abnormal, Oropharyngeal pain, Pain, Rash
Clinical narrative: Client reports on 9/27/14 he felt a little bad and had a small sore throat and some aching.  On Sunday 9/28/14 client reports feeling worse and the sore throat and achiness was worse and notices rash on right arm.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Started as bad sore throat and low grade fever. 12 hours later it is a 102 fever with congestion and cough.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Rash/hive developed on ankles, legs first.  Spread to waist, chest, by 9PM same day.  09/29/14 0500 AM - spread to arms, wrist and palm of hands. Red dots varying between 1/16" and 1/4" diameter. Itching accompanies rash/hives.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site rash
Clinical narrative: Unsure of onset date/time, pt reports she developed a rash around vaccine site shortly after receiving vaccine on 09/15/14.  Rash still present at in-office visit today 09/29/14.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm of injection site became very swollen, red and hot to touch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema
Clinical narrative: 11*11 CM REDNESS RA.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of pain in the area. Step father looked at area of injection, patients leg was swollen, bright red, and site was hot.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Started with small red spot which continued to grow.  Fever began the evening of 9/26.  Area was hot, tender, and began feeling queasy.  Went to doctor on 9/27 and diagnosed with cellulitis.  Prescribed 100MG  Doxycycline twice a day and returned for check up on 9/29.  Prescribed Sulfamethoxazole  tmp ds, valacyclovir hcl 1 gram, ranitidine 150 mg, and hydroxyzine pam 50 mg.  Return to Dr. daily until cleared.  Taking Tylenol for pain.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Started with small red spot which continued to grow.  Fever began the evening of 9/26.  Area was hot, tender, and began feeling queasy.  Went to doctor on 9/27 and diagnosed with cellulitis.  Prescribed 100MG  Doxycycline twice a day and returned for check up on 9/29.  Prescribed Sulfamethoxazole  tmp ds, valacyclovir hcl 1 gram, ranitidine 150 mg, and hydroxyzine pam 50 mg.  Return to Dr. daily until cleared.  Taking Tylenol for pain.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis staphylococcal, Injection site pruritus, Injection site swelling
Clinical narrative: Started with small red spot which continued to grow.  Fever began the evening of 9/26.  Area was hot, tender, and began feeling queasy.  Went to doctor on 9/27 and diagnosed with cellulitis.  Prescribed 100MG  Doxycycline twice a day and returned for check up on 9/29.  Prescribed Sulfamethoxazole  tmp ds, valacyclovir hcl 1 gram, ranitidine 150 mg, and hydroxyzine pam 50 mg.  Return to Dr. daily until cleared.  Taking Tylenol for pain.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Patient reported swelling and itching at injection site and continued to become more swollen 2 days later. Went to doctor. MD told pt cellulitis cuased by MRSA. Prescribed doxycycline.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Patient reported swelling and itching at injection site and continued to become more swollen 2 days later. Went to doctor. MD told pt cellulitis cuased by MRSA. Prescribed doxycycline.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis staphylococcal, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported swelling and itching at injection site and continued to become more swollen 2 days later. Went to doctor. MD told pt cellulitis cuased by MRSA. Prescribed doxycycline.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Headache, Malaise, Pyrexia
Clinical narrative: Bad headache over entire forehead, slight fever, general malaise for 1.5 days. Headache itself was the main symptom. Missed work the day after getting shot.
Age: 74.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Local swelling, Pain in extremity, Skin warm
Clinical narrative: Left arm sore, hot and swollen.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Flushing
Clinical narrative: "Pt felt flushed, difficulty swallowing- similar to sx from allergic reactions in the past. no sob. no angioedema" -- from ER report  pt called 9-1-1, given IV benadryl and sub-q Epinephrine en route to hospital. Treated at ER. Pt given Pepcid 20m IV and Solu-medrol 40mg IV x1 in ER. Stable and discharged home on 9/22/14 at approx 15:31
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Tremor
Clinical narrative: Pt reported "itching" several hours after receiving....self-admin diphenhydramine..similar symtoms 09/28/2014, plus "shaking"  took diphenhydramine...went to local ER..no additional therapy/effects.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives to left arm, neck, face.
Age: 1.38
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A few hours after the immunizations, he developed swelling of the right leg (where vaccines were given). It became red. The swelling had extended beyond his hip and down to the knee.  He was admitted for IV steroids, antibiotics, and oral antihistamines.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Flushing, Hyperhidrosis, Palpitations, Throat irritation
Clinical narrative: ITCHY THROAT/FLUSHING OF THE SKIN/HEART PALPATION, SWEATING.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood creatine phosphokinase increased, C-reactive protein increased, Condition aggravated, Double stranded DNA antibody
Clinical narrative: Extreme pain (increase in chronic right leg/hip pain), pain much worse after 3rd HPV vaccination (1st and 2nd may have been related to increase in pain over previous months also), hospitalized 9 days after 3rd vaccination, also hospitalized in 7/2012 for 6-7 days with pain, pt now diagnosed w/ undifferentiated connective tissue disease (possibly Lupus) and responding to Plaquenil. Vaccine dates: 9/8/11, 11/10/11, 6/12/12.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Undifferentiated connective tissue disease
Clinical narrative: Extreme pain (increase in chronic right leg/hip pain), pain much worse after 3rd HPV vaccination (1st and 2nd may have been related to increase in pain over previous months also), hospitalized 9 days after 3rd vaccination, also hospitalized in 7/2012 for 6-7 days with pain, pt now diagnosed w/ undifferentiated connective tissue disease (possibly Lupus) and responding to Plaquenil. Vaccine dates: 9/8/11, 11/10/11, 6/12/12.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: Burning rash with appearance of shingles on lower back (same side of body) with flu-like symptoms and low fever (100-101).  Rash worsened over the course of a week.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient. Patient's concurrent condition includes asthma, penicillin and environmental allergies. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004542, expiry date 19-AUG-2015, 0.5 ml, intramuscular in the right arm. The patient was also administered FLUVIRIN concomitantly in her left arm at the same time. Post vaccination, on the same day (23-SEP-2014) the patient developed eight inch swelling of the right arm that extended to the elbow, her arm was itchy, painful and she could not bend it (disability). The patient sought medical attention and called the pharmacy. Treatment was over the counter BENADRYL and ice pack. The pharmacist indicated that during the patient's call back she reported that her right arm was little less swollen now but she still could not bend it. Patient did not have any problem in the left arm where the FLUVIRIN was injected. The pharmacist indicated that the patient was unsure if she ever had PNEUMOVAX 23 injection before or not. Action taken with the suspect therapy was not reported. The outcome was events were reported as not recovered. Causal relationship of the events with suspect drug was not reported. The reporter considered the event she cannot bend it serious due to disability. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Patient complaint of vertigo 24hr post vaccination. Complaint of not walking straight.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza like illness, Urticaria
Clinical narrative: Flu like symptom, and hives throughout body.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: HIVES ON ARMS AND LEGS.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat in area around injection site, possible soft tissue infection.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Myopathy
Clinical narrative: Patient reported severe myopathy/ myalgia resulting in the need of an emergency room visit/ referral to an orthopedic specialist.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reports "tingly" fingers and numbness through thumb.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES- FACE, NECK AND R FOREARM. HAD VACCINE ON 9/25 AT 1 PM. WOKE IN THE AM ON 9/26 WITH ITCHING AND HIVES. TAKING BENADRYL 25 MG Q 4 HRS WHILE AWAKE. STILL HAVE HIVES AS OF 9/29/2014.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Hypotension, Nausea, Visual acuity reduced
Clinical narrative: Patient stated that 4 hours after he received the flu vaccine (he received the shot at 3:55pm), he felt nausea and had trouble seeing.  He stated his blood pressure became low and and he was dehydrated. He was taken to the emergency room by his daughter and was released about midnight.  His blood pressure was 70/43 when he first arrived, but was brought up to 111/57 before discharge.  He also stated the emergency room staff let him know that the flu shot causes red blood cells to dilate and significantly lower the blood pressure.
Age: 50.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Cough, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Day after "felt like I had razor blades in my throat"; "cough was excrutiating"; "everything in my body hurt"; "just knew I was not going to get out of bed"; lasted two days; today still feels a bit sick, but markedly better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Less than one week after recieving her influenza vaccine for the 2013/2014 flu season, she developed an intensely pruritic rash of hives that lasted approximately 3 months.  No shortness of breath or anaphylaxis symptoms.  Treated successfully with Benadryl.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Child had inconsolable, high pitch cry for nearly 24 hours. Spiked fever of 104.9 for 48 hours with Tylenol give every 4-6 hours. Child appeared extremely irritable with any stimulation or movement regardless of where she was touched.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Gingival pain, Lip pain, Lip swelling
Clinical narrative: Patient felt dizzy starting at midnight. She then said the roof of her mouth became extremely painful (burning pain). Her teeth and gums hurt and she developed a sinus type migraine. She said her lips became swollen and were tingling and painful. Her mouth also became so dry that her tongue would stick to the roof of her mouth.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Oral discomfort, Oral pain, Paraesthesia oral, Toothache
Clinical narrative: Patient felt dizzy starting at midnight. She then said the roof of her mouth became extremely painful (burning pain). Her teeth and gums hurt and she developed a sinus type migraine. She said her lips became swollen and were tingling and painful. Her mouth also became so dry that her tongue would stick to the roof of her mouth.