chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Within 2 hours of receiving vaccination, arm and hand became swollen. Hand reddish/purple. Went to school nurse. Color has since resolved, current complaint includes pain from shoulder to fingers. She can move her fingers. 10/22/14 Mom states patient had hives last night that responded to BENADRYL. Today arm is still swollen and warm.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Pt has hives on arm between the shoulder and the elbow, reports itching. States it has been like this for "a few days". Sore for 2 days before it started itching.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Local swelling, Pruritus, Throat irritation
Clinical narrative: 400p gave injection. 430 patient came back with itching of the face and neck. BENADRYL 50mg po given. 505 neck swelling noted. No difficulty breathing. C/o scratchy throat. 520 911 called. 525 coughing, EPI PEN. Transferred at 545.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling
Clinical narrative: Had senior dose of flu shot on 10/08/14 at approx 4 pm. On morning on 10/09/14 woke up with swollen eyes. Used cold packs and BENADRYL. Lasted 4 days.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Urticaria
Clinical narrative: Severe hives - saw MD on following Monday prescribed prednisone treatment and BENADRYL. Took 5 days for hives to abate. Subsequent occasional outbreaks. Bruise at injection site one week later.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Fall, Headache, Hypoaesthesia
Clinical narrative: Numbness/tingling - seizure. Dizziness - fell. Extreme vomiting. Fever muscle aches - headache.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Numbness/tingling - seizure. Dizziness - fell. Extreme vomiting. Fever muscle aches - headache.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Nausea, Rash
Clinical narrative: Pt presents a red rash wrapping around the arm into the lymph nodes. The lymph nodes and arm is swollen. Pt was nauseous.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site reaction, Livedo reticularis
Clinical narrative: Pt came to clinic one day after receiving Influenza vaccine (L) deltoid site and red, indurated with some mottled ecchymosis. Pt afebrile.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Myelitis transverse
Clinical narrative: FLUMIST administered 01/24/2014. Hospitalized 02/09/2014 for ascending paralysis. Diagnosed 02/11/2014 with transverse myelitis. Received steroids. Positive pregnancy 02/16/2014. Multiple hospitalizations (4 total) and reoccurrences. Followed by high-risk pregnancy team.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging, Pregnancy test positive
Clinical narrative: FLUMIST administered 01/24/2014. Hospitalized 02/09/2014 for ascending paralysis. Diagnosed 02/11/2014 with transverse myelitis. Received steroids. Positive pregnancy 02/16/2014. Multiple hospitalizations (4 total) and reoccurrences. Followed by high-risk pregnancy team.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Hypopnoea, Loss of consciousness, Stridor
Clinical narrative: Shallow breathing - stridor. Lost of consciousness. .3 mg EPI-PEN given Intramuscular (R) thigh by Dr. at 12:14pm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Sciatica
Clinical narrative: Shot on 9/23/14. Since then I have had moderate to painful feelings in both shoulders front and back - on 10/09/14 I was nearly immobilized with acute left sided symptoms - left shoulder through left sciatica.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: 10/20/14 Administered vaccine. Arm sore that evening. 10/21/14 a.m. Below site arm red, swollen and hot to touch. Pt. called MD on 10/21. Told to apply warm compresses and report if it gets worse. 10/22 Redness spread. Still sore. Saw MD. Ordered KEFLEX 50mg 2 BID x 10 days.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 61 year old male patient. The patient's medical history included a splenectomy on unspecified date (prior to receiving PNEUMOVAX). On 09-OCT-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml intramuscular route in the left arm, (lot # K007773; Exp. Date: 01-MAY-2015) (strength not provided). Concomitant therapies included influenza virus vaccine (manufacturer unknown) applied on the same day in the right arm. On 09-OCT-2014, the patient experienced pain and problems with range of motion in his left arm and shoulder after receiving PNEUMOVAX 23. The patient was having difficulty doing his job due to the pain and limited range of motion in his left shoulder. The patient weighted 210 pounds and 1 inch long needle was used administered about 2 inches from the top of the patient's shoulder. Patient sought medical attention through an office visit. Patient received treatment with lipoderm patches and ibuprofen. Labs diagnostics studies were not performed. At the time of the report, the outcome of the events was reported as not recovered. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Urticaria
Clinical narrative: Developed urticarial rash and scratchy throat approx. 45 min after receiving flu vaccine. Has never received flu vaccine in the past.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site vesicles, Vaccination site swelling
Clinical narrative: Site where vaccine given turned red, then arm swelled down to elbow and then area blistered. Treated at urgent care and family doctor given anti-viral med (sulfatendthoxizole). Missed a week of work.
Age: 73.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old patient. On 17-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously, lot # K008885, expiry date: 20-SEP-2015, dose: 0.65 ml, in the left upper arm). In approximately October 2014 the patient developed a "half-dollar-sized" area of redness, warmth and firmness. The site also itched. No lab diagnostic was performed. The pharmacist did not know when the adverse experience was first noticed by the patient, or when the symptoms started to develop anxiety. The pharmacist observed the reddened area on the patient's left upper arm on 18-OCT-2014 and stated that there was no sign that the patient was developing a rash. The pharmacist recommended that the patient use ice, BENADRYL cream and ibuprofen for her injection-site swelling and itchiness. The outcome of redness, warmth, firmness, injection site swelling and itchiness was not reported. The relatedness between ZOSTAVAX and the events of redness, warmth, firmness, injection site swelling of itchiness was not reported. The reporting pharmacist was not the person who administered the dose of ZOSTAVAX to this patient on 17-OCT-2014. During the information collection for this report, the pharmacist reported the sight of administration as left upper arm. The pharmacist explained that she administered ZOSTAVAX in the fatty part of the back of the arm, not in the deltoid region. There was no adverse experienced associated with the pharmacist's mention on her routine route of administration of ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old patient. On 17-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously, lot # K008885, expiry date: 20-SEP-2015, dose: 0.65 ml, in the left upper arm). In approximately October 2014 the patient developed a "half-dollar-sized" area of redness, warmth and firmness. The site also itched. No lab diagnostic was performed. The pharmacist did not know when the adverse experience was first noticed by the patient, or when the symptoms started to develop anxiety. The pharmacist observed the reddened area on the patient's left upper arm on 18-OCT-2014 and stated that there was no sign that the patient was developing a rash. The pharmacist recommended that the patient use ice, BENADRYL cream and ibuprofen for her injection-site swelling and itchiness. The outcome of redness, warmth, firmness, injection site swelling and itchiness was not reported. The relatedness between ZOSTAVAX and the events of redness, warmth, firmness, injection site swelling of itchiness was not reported. The reporting pharmacist was not the person who administered the dose of ZOSTAVAX to this patient on 17-OCT-2014. During the information collection for this report, the pharmacist reported the sight of administration as left upper arm. The pharmacist explained that she administered ZOSTAVAX in the fatty part of the back of the arm, not in the deltoid region. There was no adverse experienced associated with the pharmacist's mention on her routine route of administration of ZOSTAVAX. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to approximately 34 year old female patient. Patient's present status was reported that the patient was pregnant. Medical history was reported as none. Drug reactions/allergies were reported as none. On 17-OCT-2014, the patient was vaccinated with GARDASIL (dose/ frequency-one dose, therapy route-injection). Concomitant medication was reported as none. Pregnant gestation was reported as 36 weeks. Estimated LMP (last menstrual period) of the patient was approximately 07-FEB-2014 (based on Gestational Age (36 weeks) of the fetus at the time of report) and EDD (estimated due date) was approximately 14-NOV-2014. The pregnancy outcome was unknown. Reporter stated that patient was inadvertently administered GARDASIL while in her physician's office while being pregnant. Caller further explained she was supposed to receive the DTAP vaccination, but was given GARDASIL. Patient seek medical attention while she was in office. Laboratory diagnostics studies performed was reported as none. The outcome of she was inadvertently administered GARDASIL while in her physician's office while being pregnant was unknown. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to approximately 34 year old female patient. Patient's present status was reported that the patient was pregnant. Medical history was reported as none. Drug reactions/allergies were reported as none. On 17-OCT-2014, the patient was vaccinated with GARDASIL (dose/ frequency-one dose, therapy route-injection). Concomitant medication was reported as none. Pregnant gestation was reported as 36 weeks. Estimated LMP (last menstrual period) of the patient was approximately 07-FEB-2014 (based on Gestational Age (36 weeks) of the fetus at the time of report) and EDD (estimated due date) was approximately 14-NOV-2014. The pregnancy outcome was unknown. Reporter stated that patient was inadvertently administered GARDASIL while in her physician's office while being pregnant. Caller further explained she was supposed to receive the DTAP vaccination, but was given GARDASIL. Patient seek medical attention while she was in office. Laboratory diagnostics studies performed was reported as none. The outcome of she was inadvertently administered GARDASIL while in her physician's office while being pregnant was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. The medical assistant informed that on an unspecified date in October 2014 the patients were vaccinated with improperly stored doses of ROTATEQ (route, lot number, expiration date and dosage were not reported). No symptoms 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: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site nodule
Clinical narrative: (R) thigh with 0.5 mm x 0.4 cm knot no erythema, no induration, no fluctuation.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (reported as in this last year; exact date unspecified), an unspecified number of patients were revaccinated with the second dose of PNEUMOVAX 23 (batch/lot#, dose and route were not reported), because the physician believed the serotypes for PNEUMOVAX 23 had changed. No adverse symptoms were reported. 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 healthcare worker referring to a patient of unknown age and gender. No concurrent conditions or medical history were provided. The reporter stated that on 07-OCT-2014, improperly stored PNEUMOVAX 23 injection (lot# J004196, expiration date 06-DEC-2014) (strength, dose, route of administration were not reported) was administered to the patient. No concomitant medications were reported. No adverse effects were reported. The outcome was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a patient's husband - pharmacist refers to a female patient of unknown age. The patient's concurrent condition included erythromycin allergy. On 24-OCT-2014, the patient was vaccinated with the single dose of ZOSTAVAX, (exact dose and anatomical location was not reported) subcutaneous. There were none concomitant medications reported. On 25-OCT-2014, the patient experienced red, raised, tender reaction at the injection site. The area of reaction was initially "the size of the baseball", but at the time of reporting, it was improving. The patient was not given any treatment. None lab diagnostic studies were performed. The outcome of the events was reported as recovering/resolving. The patient sought medical attention by informing her pharmacist. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, (lot # K010522, expiry date 25-FEB-2016) (dosing regimen, route and frequency unknown) that had been exposed to temperatures above 46 degrees Fahrenheit for an unspecified amount of time. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. This case is linked to case 1410USA016261 via same reporter link. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from an approximately 61 year old male patient regarding himself. The patient's medical history included heart murmur. The patient had no drug reaction or allergies. On 20-OCT-2014 the patient was vaccinated with ZOSTAVAX, 1 injection (route, lot# not provided). Concomitant therapies included influenza virus vaccine (manufacturer unknown) in different arm (left arm). On 20-OCT-2014, the patient experienced soreness, tenderness and saw that the injection site after receiving ZOSTAVAX was swollen and a little red. The patient says his arm has been feeling like this for three days, he first noticed this side effect when he was out for his morning run. He was treated with ibuprofen for the events. Lab diagnostic studies were not performed. The patient called pharmacist to inform about the events. No product quality complaints reported. The outcome of the events was reported as recovering. Causality of the events was not specified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J007208, expiration date 20-SEP-2014, dose, route not reported). The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 12-JUN-2014 the patient was vaccinated with first dose of PNEUMOVAX 23, inejction (dose and lot number unknown), intramuscular. On 17-OCT-2014 the patient was inadvertently received another dose of PNEUMOVAX 23 (intramuscular) (dose and lot number was unknown). No symptoms were reported. No product quality complaint was involved. The outcome of the event was unknown. Additional infomration has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. Nurse reported that on 27-OCT-2014 the patient was vaccinated with GARDASIL lot number J014295 (expiry date : 11-AUG-2016), intramuscular which underwent an unsupported temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot# reported as 1000AA, expiry date reported as 26-APR-2014, dose, route unknown). The patient called to inquire if she needed to restart the RECOMBIVAX HB series as she received a telephone call from her physician's office today that she had been administered an expired RECOMBIVAX HB. No adverse effects were reported. Additional information is not expected as contact details of reporter or the physician were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No current condition or medical history was reported. On 16-OCT-2014, the patient was vaccinated with an expired dose of ZOSTAVAX, subcutaneous injection (lot number: unknown, expiration date: 12-OCT-2014) 0.65 ml once subcutaneously. No concomitant therapy was reported. At the time of the report, the patient experienced no adverse effects. The outcome of the events was not reported. Action taken with the suspect product and causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from an unknown age female pharmacist refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date, the pharmacist was vaccinated by a fellow colleague with a dose of ZOSTAVAX (lot#, dose and frequency were not provided), intramuscularly rather than subcutaneously. The pharmacist also reported that since receipt of the ZOSTAVAX, the site was painful and "stingy" (date unspecified). The outcome of the events was not provided. 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 other health professional refers to unspecified number of patients (approximately less than 10 patients) of unknown age. No current condition or medical history was reported. On unknown dates the patients were vaccinated with GARDASIL intramuscular injection (dose, route and lot number not reported). No concomitant therapy was reported. On unknown dates, the patients received improperly stored GARDASIL. No adverse symptoms were reported. The temperature excursion for the GARDASIL was supported with in-house stability data. There was no product quality complaint involved. The outcome of the events was not reported. Action taken with the suspect product and the causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. It was reported that patient was administered a first dose of VARIVAX (Merck) on 20-OCT-2009 (18 days earlier that recommended age). Second dose of VARIVAX (Merck) was administered on 21-NOV-2013. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Pruritus, Rash
Clinical narrative: Rashes w/ intense itching in patches on torso and arms and legs. One area would begin to subside then another would break out - lasted 3 1/2 weeks.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, (lot # K009106, expiry date 25-FEB-2016) (dosing regimen, route and frequency unknown) that had been exposed to temperatures above 46 degrees Fahrenheit for an unspecified amount of time. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. There was no product quality issue reported. This case is linked to case 1410USA016183 via same reporter link. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 2 months old patient of an unknown gender. On 29-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and other previous drug allergic reactions were not reported. On 22-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength, dose and frequency unknown) lot # J010654 and expiry date 17-OCT-2014. No concomitant therapies were reported. No adverse effect was reported. The outcome of an expired dose of PNEUMOVAX 23, lot# J010654 expiry date 17-OCT-2014, was administered to an unspecified patient on 22-OCT-2014 was unknown. The causality of expired dose of PNEUMOVAX 23, lot # J010654 exp. 17-OCT-2014, was administered to an unspecified patient on 22-OCT-2014 and no adverse effect to be not related to PNEUMOVAX 23. No further information was provided. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 4 months old patient of an unknown gender. On 26-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, red, warm to touch, itchy, soreness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Injection site pruritus, Injection site urticaria
Clinical narrative: Pt. received ZOSTAVAX inj 10-23-14. Pt. called 10/27/14 c/o - "A welt" at inject site, headache, itching at inj site and slight shortness of breath.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever to 102 48-72 hrs after vaccines. Vomit, mild rash.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Monoplegia
Clinical narrative: Seen at ER evening Tdap administered. C/o arm feeling paralyzed. Several physicians consulted - no one has seen this reaction from Tdap.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 2 months old patient of an unknown gender. On 26-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. Patient's medical history included unspecified autoimmune disease. On 16-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection (lot # K010522, expiry: 25-FEB-2016), intramuscular in the right deltoid. On an unknown date in October 2014, the patient experienced red swollen band at injection site and it was further described as fluid filled sac like a saddle bag and area was painful. Sought medical attention. Patient was referred to urgent care or physician for further care beyond applying ice to site. No product quality complaint was involved. The outcome of red swollen band at injection site, area was painful and fluid filled sac like a saddle bag was reported as not recovered. The relatedness of the events with the therapy PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: 10-22-14 - fever, area red and raised. 10-23-14 - fever, area red and raised. 10-24-14 - area only red (size 5" x 2 1/2").
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: BENADRYL, cold compress, hydrocortisone. Redness in upper arm, warm to touch. FU if no better.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site warmth, Peripheral swelling, Rash, Swelling
Clinical narrative: Rash, raised red covered mid (rt) arm, neck, torso, 20 hours later: local reaction 3 days with redness, swelling and hot to touch (rt) deltoid. Torso raise rash in 6 hours took BENADRYL (OTC) 50 mg q 6 hr. for 4 days. I took pics available put in pt's chart. 3rd day felt very fatigue came to office today.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-OCT-2014 the patient was vaccinated with a dose of VARIVAX (Merck) lot # H019449, expiration date 25-OCT-2014, 0.5 ml) which were expired on 25-OCT-2014 subcutaneously. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was inadvertently administered a dose of M-M-R II injection (lot # H018948 with expiry date: 18-OCT-2014, albumin status HSA; 0.5 ml injected subcutaneously; strength and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the reporting nurse did not grant permission to contact her or physician.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, FLUN4, HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old male patient. The patient's medical history, past drug history and concomitant medications were unknown. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously, 0.65 ml dose in the back of the arm, lot # K000326, expiration date 27-FEB-2015). On 24-OCT-2014 the patient noticed a bump that became hard and welt forming at the injection site. On 25-OCT-2014, the patient's arm had a nice and red localized area that felt hot and warm. There was no relevant laboratory data reported. It was reported that as of the time of the report (25-OCT-2014) the patient no longer took ZOSTAVAX and the patient continued to experience a hard bump a welt forming at the injection site and the back of his arm had a nice and red localized area that felt hot and warm. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old male patient. The patient's medical history, past drug history and concomitant medications were unknown. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneously, 0.65 ml dose in the back of the arm, lot # K000326, expiration date 27-FEB-2015). On 24-OCT-2014 the patient noticed a bump that became hard and welt forming at the injection site. On 25-OCT-2014, the patient's arm had a nice and red localized area that felt hot and warm. There was no relevant laboratory data reported. It was reported that as of the time of the report (25-OCT-2014) the patient no longer took ZOSTAVAX and the patient continued to experience a hard bump a welt forming at the injection site and the back of his arm had a nice and red localized area that felt hot and warm. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Tenderness
Clinical narrative: 10/27/14 Pt told me that she had to go to the ER Saturday (10/25/14) evening because her arm had swelling, tenderness and itching. Began a steroid course as ordered by MD there. Her PCP added KEFLEX 10/27/14 to make sure infection is suppressed. Pt is OK.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with GARDASIL (dose, lot# were not reported) which were exposed to an unsupported temperature excursion of 59F for a cumulative total of 132 hours. On 05-SEP-2014, total excursion time was 63 hours. On 16-SEP-2014, total excursion time was 15 hours. On 18-SEP-2014, total excursion time was 24 hours. On 23-SEP-2014, total excursion time was 15 hours. On 29-SEP-2014, total excursion time was 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. 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 nurse refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 22-OCT-2014 and 29-OCT-2014, the patients were vaccinated with VARIVAX (Merck), 0.5 milliliter, subcutaneously once for an unknown indication. Concomitant medications were not reported. On an unknown date the patients received VARIVAX (Merck) that was improperly stored. VARIVAX (Merck) exposed to -10Celsius for 3 hours. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction to left upper arm. Redness, swelling and tenderness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with M-M-R II (dose, lot# were not reported) which were exposed to an unsupported temperature excursion of 59F for a cumulative total of 132 hours. On 05-SEP-2014, total excursion time was 63 hours. On 16-SEp-2014, total excursion time was 15 hours. On 18-SEP-2014, total excursion time was 24 hours. On 23-SEP-2014, total excursion was 15 hours. On 29-SEP-2014, total excursion time was 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient states she broke out with shingles 3 days after receiving vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 29-OCT-2014 the patient was inadvertently administered an expired dose of VARIVAX (Merck) (lot # H016600, expiry date: 05-SEP-2014), subcutaneous. No adverse effect was reported. Outcome of event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VARIVAX (Merck). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a currently 17 years old female patient with Last Menstrual Period (LMP) of 23-JUL-2014 and Estimated Date of Delivery (EDD) of 29-APR-2015. On 22-AUG-2014, when the patient was 4 weeks pregnant, the patient was vaccinated with a first dose of GARDASIL lot # J006850 and expiration date 31-MAR-2016 (dose and route not reported). The patient had not demonstrated or reported any adverse effects. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, intramuscular (lot number and expiration date not reported) and on the same date, the patient was also vaccinated with PREVNAR. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient (who was also a nurse) of unknown age. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with GARDASEIL (dose, frequency and lot # were not reported). Concomitant medications were not reported. It was reported that 2 weeks prior to her discovering that she was pregnant, the patient received GARDASIL vaccine. It was unspecified which dose with in the series the patient was received. The patient became pregnant. The LMP and EDD was not known. The pregnancy outcome was unknown. No product complaint was reported for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to herself. The pharmacist was reporting she inadvertently stuck the syringe needle into one of her fingers after withdrawing reconstituted ZOSTAVAX into a syringe on 23-OCT-2014. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. The medical assistant informed that on 30-OCT-2014 the patients were vaccinated with improperly stored doses of GARDASIL injection , lot # K006117, expiration date: 14-JAN-2017, (route and dosage were not reported). No symptoms 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with RECOMBIVAX (dose, lot number and frequency were not reported), intramuscular. Concomitant medications were not reported. The patients received RECOMBIVAX that was improperly stored. RECOMBIVAX was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Discomfort, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Flushed with slight hive-type rash about 15 minutes after injection. BENADRYL given with improvement. Discharged - increasing problem with redness and swelling with generalized rash late that night. Seen in ER with swelling. Given IV SOLUMEDROL w/ PEPCID. Discharged on oral prednisone. Lightheaded, achy joints and feeling foggy persisted with increased discomfort, pain in right hand persisting even 10 days after injection (carpal tunnel type).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Pain in extremity, Rash generalised, Swelling, Urticaria
Clinical narrative: Flushed with slight hive-type rash about 15 minutes after injection. BENADRYL given with improvement. Discharged - increasing problem with redness and swelling with generalized rash late that night. Seen in ER with swelling. Given IV SOLUMEDROL w/ PEPCID. Discharged on oral prednisone. Lightheaded, achy joints and feeling foggy persisted with increased discomfort, pain in right hand persisting even 10 days after injection (carpal tunnel type).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray limb normal
Clinical narrative: Flushed with slight hive-type rash about 15 minutes after injection. BENADRYL given with improvement. Discharged - increasing problem with redness and swelling with generalized rash late that night. Seen in ER with swelling. Given IV SOLUMEDROL w/ PEPCID. Discharged on oral prednisone. Lightheaded, achy joints and feeling foggy persisted with increased discomfort, pain in right hand persisting even 10 days after injection (carpal tunnel type).
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was given pneumo vaccine-23 at office visit on 10/28/14 in left deltoid. Pt had had flu vaccine at work 6 days prior same arm. Pt called the office 10/30/14 in AM to state having reaction. Redness and some swelling with pain in left upper bicep to antecubital. Redness to upper forearm this afternoon when exam by PCP.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with VAQTA (dose, lot# were not reported) which was improperly stored. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash macular, Skin lesion, Viral test
Clinical narrative: Generalized malaise, unbroken erythemic lesions on face, neck, body and extremities; over the course of 2 weeks.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with ROTATEQ (dose, lot# were not reported) which were exposed to temperature excursion of 59F for 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with VAQTA (dose, lot number and frequency were not reported). Concomitant medications were not reported. Patients received VAQTA that was improperly stored. VAQTA was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: After 4 days after injection pt. called pharmacy and mentioned hard lump and swelling at injection site. Pt reported 2 days later symptoms improved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with VARIVAX (dose, lot# were not reported) which were exposed to temperature excursion of 21F for 15 hours. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 26-OCT-2014 to 29-OCT-2014, the patients were vaccinated with ROTATEQ (dose, lot number and frequency were not reported), oral. Concomitant medications were not reported. The patients received ROTATEQ that was improperly stored. On an unknown date, ROTATEQ was exposed to 11.1 Celsius for 1 hour 18 minutes (all doses supported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient with no pertinent medical history and drug reactions or allergies. On 22-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot# K007824 and expiration validated as 05-NOV-2015) (dose/frequency reported as 0.5ml/once), intramuscularly. Concomitant therapies included PLAVIX. The reporter was calling to report that after a patient received the PNEUMOVAX 23 intramuscularly on 22-OCT-2014 the patient developed a "hard bulge under skin" at the injection site while the patient was still at the pharmacy. No diagnostic tests were reported. The patient did not seek medical attention. There was no treatment given for the event. The outcome of "hard bulge under skin at the injection site" was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age is also the patient. Patient's concurrent conditions included contact dermatitis. On an unknown date the patient was vaccinated with a dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced swelling at the injection site. The outcome of the event was reported as recovered/resolved (date unknown). Relatedness between the event and hepatitis A vaccine (manufacturer unknown) was not provided. This case is linked to MARRS# 1410USA014200 (same patient link). Additional information has been requested.