chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PENUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (office visit) and was prescribed Keflex for what the physician thought looked like cellulitis. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014075). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site warmth, Local swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PENUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (office visit) and was prescribed Keflex for what the physician thought looked like cellulitis. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014075). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 11-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 11-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014074). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 11-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 11-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014074). Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old patient (gender unknown). On 06-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# J003798, expiry: 28-JUN-2014), subcutaneously and developed rash soon after receiving ZOSTAVAX. On 12-SEP-2013, the patient was diagnosed with chicken pox. Pharmacist states she reported to VAERS when she learned of rash and noted VAERS confirmation number. The patient went to see an unspecified infectious Disease physician for antiviral treatment. The patient has been receiving antiviral therapy for near 10 days. The outcome of chicken pox was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 05-SEP-2013 the patient received an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous. Lot number 0068AEM is not a valid lot number for ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 17-MAR-2008, the patient was vaccinated with a first  dose of VARIVAX (Merck)(lot number, expiry date and route was not reproted). On 29-MAR-2012, the patient was vaccinated with a second dose of VARIVAX (Merck), (lot number, expiry date and route was not reported). No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: At night felt cold, like chills, run fever of 1 degree. Yesterday felt fine. Today feels fine but has red and hot patch on left arm. It extends from 1 1/2 inch above injection site down the arm. It is a 4 1/2 long by 3 1/2 wide area. Patch is not a complete circle, irregular. Patch gets narrow and wider as go down. Went to doctor and they asked her to go to ER if redness extends outside area they drew on arm. Currently she is icing it but it is tender and sore.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Tenderness
Clinical narrative: At night felt cold, like chills, run fever of 1 degree. Yesterday felt fine. Today feels fine but has red and hot patch on left arm. It extends from 1 1/2 inch above injection site down the arm. It is a 4 1/2 long by 3 1/2 wide area. Patch is not a complete circle, irregular. Patch gets narrow and wider as go down. Went to doctor and they asked her to go to ER if redness extends outside area they drew on arm. Currently she is icing it but it is tender and sore.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 year old female patient. On 19-SEP-2013, the patient was vaccinated with a doe of 0.5 ml VARIVAX (Merck), (lot number, expiry date was unknown), subcutaneous instead of ZOSTAVAX. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 21 year old female patient. The patients concomitant medications were none. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date in 2011, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number, expiry date, and route was not reported). On an unknown date in 2011, the patient developed a varicella like syndrome with rash. She stated that it was like chicken pox. She stated it may have been reported at that time. The outcome of varicella like syndrome with rash is recovered. The patient sought medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Heart rate decreased, Pallor, Respiratory arrest, Syncope
Clinical narrative: Pt collapsed at service desk of local store, nurse called to scene, found lying on floor, not moving, no apparent breathing, face pale and lips blue. Nurse immediately gave Epinephrine 1:1000 0.5 ml into left deltoid. Pt aroused, turned onto side and the paramedics arrived to stabilize pt for transport to local hospital.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Pyrexia
Clinical narrative: Began with shortness of breath.  Then came extreme rapid heartbeat which lasted approximately one hour followed by a brief 15 period of fever.  The next 24 hours were a period of extreme tiredness.
Age: 0.35
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Very large hive at the shot site.  Continued to grow in size until several doses of allergy medication were taken. Hive is no longer warm to the touch and has started going down in size.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Lymphadenitis, Pain
Clinical narrative: Inflammation of lymph node on right side of neck causing extreme pain, duration 10 days.  Severe headache, duration 10 days.  Fatigue, duration 5 days.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Dyspnoea, Erythema, Headache, Hypersensitivity, Local swelling
Clinical narrative: Fever, headache, nausea vomiting, problems breathing, swollen red itchy arms.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Nausea, Pruritus, Pyrexia, Vomiting
Clinical narrative: Fever, headache, nausea vomiting, problems breathing, swollen red itchy arms.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Started with mild body hives, continued hives until entire body covered in hives.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever (101.8), chills, joint pain, rash, general fatigue, headache once fever resolved. I called the doctor's office.  They stated that my symptoms could not have been due to the vaccine, that I must have the flu.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Fever (101.8), chills, joint pain, rash, general fatigue, headache once fever resolved. I called the doctor's office.  They stated that my symptoms could not have been due to the vaccine, that I must have the flu.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site red and warm.  Redness had spread to a large spot.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 1 year old patient. On 25-SEP-2013, the patient was vaccinated with a dose of 0.5 ml VARIVAX (lot number, expiry date was unknown), subcutaneously and PROQUAD (Merck) (lot number, expiry date was unknown) on the same day and no adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh with redness and swelling at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, hot, painful. Redness extended from inj site on shoulder to elbow of left arm.
Sex: U
Vaccine: HPV4
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 and gender. On an unknown date, the unspecified number of patients might have been vaccinated with GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB that went out of temperature range and range is not supported by our in house stability data. No adverse effects reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer's mother regarding her 15 year daughter. On 16-AUG-2012, the patient was vaccinated with a first dose of GARDASIL (lot number was reported as H063645, expiry date was not reported) 0.5 milliliter (ml), intramuscular. On 19-OCT-2012, the patient was vaccinated with a second dose of GARDASIL (Lot # H012973, expiry date was not reported), 0.5 ml, intramuscular. Approximately on an unknown date in 2012, the patient experienced pain at the injection site following administration of GARDASIL, but the pain has since subsided. Patient sought medical attention. No treatment was given. No lab diagnostic test was performed. On an unknown date, the event pain was recovered. The reporter stated that the patient was late in receiving her third dose in the series of GARDASIL, which is other-than-indicated. The patient was scheduled to receive her third injection of GARDASIL on 19-SEP-2013 at an unspecified physician's office. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 11-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # 672556/1602AA, subcutaneous. No co-suspected or concomitant medications were reported. The vaccine that the patient received on 11-SEP-2013 had expired on 13-JAN-2013. No adverse effects were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Pt presented 48 hrs post vaccination with erythema extending in a 3" diameter around injection site. Pt monitoring.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pain, Vomiting
Clinical narrative: About 7 hrs after receiving vaccine felt tired, vomited x 1, chills, body aches-felt better around 2p next day.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Chills, Diarrhoea, Eye pruritus
Clinical narrative: Approx 1 hr after vaccine developed flu like symptoms chills, body aches, abd pain, diarrhea, eye's itchy and red, fever. Had to leave work. Symptoms improved 10 hrs post onset.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Approx 1 hr after vaccine developed flu like symptoms chills, body aches, abd pain, diarrhea, eye's itchy and red, fever. Had to leave work. Symptoms improved 10 hrs post onset.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 33 year old male patient with no pertinent medical history or drug reaction/allergies. On unspecified dates in 1998, the patient was vaccinated with a complete series of Hepatitis B vaccine (manufacturer unknown), 10 mcg injection (lot#s, dose and route not reported). Anti-Hepatitis B antibody serologic testing that was performed on 29-AUG-2013 showed that the patient did not have immunity to Hepatitis B. There was no treatment for the event. At the time of reporting, the patient had not recovered from the event. On an unknown date, the patient sought medical attention that he went to the physician's office. Additional information is not expected.
Age: 95.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 95 year old female patient. On 19-SEP-2013, the patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was unknown), subcutaneous instead of ZOSTAVAX. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient who is between 60 and 69 year old. About one year ago (approximately November 2012) the patient was vaccinated with ZOSTAVAX. Dose and route were not reported. On an unknown date, after being vaccinated with ZOSTAVAX, the patient developed a bad case of shingles on the thoracic region of the body. The patient sought medical attention by an office visit on an unspecified date. The outcome of developed a bad case of shingles on the thoracic region of the body is unknown. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Rash, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 55 year old male patient. The patient had no pertinent medical history or drug reactions or allergies. On 11-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003806, expiry date 03-JUL-2014, subcutaneous). Concomitant therapies included testosterone injection. On 12-SEP-2013, the patient experienced large rash, approximately four inches in height and two inches in width with extreme pain, burning, itching and hot to touch after received ZOSTAVAX. The physician stated that hte patient should have been four fingers below shoulder, the patient was seen in the pharmacy on 14-SEP-2013 and there ws improvement demonstrated by decrease in size of reaction. The patient was treated with KEFLEX and triamcinolone. There was no lab tests performed. The outcom eof the events were reported as recovering, the patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Death, Haematocrit normal, Haemoglobin normal, Haemoptysis
Clinical narrative: Initial report was received from a healthcare professional on 20 September 2013. A 67-year-old female had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the emergency room (ER) and was seen by her oncologist. She presented with coughing up blood, bruising and a fever. The patient died four hours after arrival to the ER. There was no bleeding or bruising at the injection site after vaccination and a 1 inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9, hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN, acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide (HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems. Outcome was fatal. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: International normalised ratio decreased, Platelet count decreased, Pyrexia, White blood cell count normal
Clinical narrative: Initial report was received from a healthcare professional on 20 September 2013. A 67-year-old female had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the emergency room (ER) and was seen by her oncologist. She presented with coughing up blood, bruising and a fever. The patient died four hours after arrival to the ER. There was no bleeding or bruising at the injection site after vaccination and a 1 inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9, hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN, acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide (HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems. Outcome was fatal. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Hives; Swelling in throat; Treated in ER for 4-5 hours then released; Given Benadryl and Solumedrol in ER, released with Medrol Dose Pak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Vaccine given on 9/26/13. ON 9/30/13 patient showed me the injection site. Red, hard, not/warm to touch, itchy and site of injection was very visible.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Cough, Eye pruritus, Feeling abnormal, Ocular hyperaemia
Clinical narrative: Initial report was received from a healthcare professional on 19 September 2013. A 50-year-old female patient had received a dose two intramuscular injection in the right deltoid of FLUZONE, lot number UH899AC, on 09 September 2013. On her way home the same day, the patient reported feeling "funny". She developed a mild cough, runny nose and red itchy eyes. The cough progressed over the next five hours and she was evaluated by a physician. The patient had a heart rate of 109 and was treated with intravenous BENADRYL 50mg and TAGAMET 800mg. The diagnosis was "anaphylactic reaction to serum". The patient was re-evaluated on 10 September 2013 and condition was improved, the symptoms had resolved. The patient had an allergy to latex and a history of plantar fasciitis. At the time of the vaccination, the patient was being evaluated for chest discomfort to rule out (r/o) pleurisy. The patient had a previous dose of influenza vaccine in 2012. Outcome was recovered. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Initial report was received from a healthcare professional on 19 September 2013. A 50-year-old female patient had received a dose two intramuscular injection in the right deltoid of FLUZONE, lot number UH899AC, on 09 September 2013. On her way home the same day, the patient reported feeling "funny". She developed a mild cough, runny nose and red itchy eyes. The cough progressed over the next five hours and she was evaluated by a physician. The patient had a heart rate of 109 and was treated with intravenous BENADRYL 50mg and TAGAMET 800mg. The diagnosis was "anaphylactic reaction to serum". The patient was re-evaluated on 10 September 2013 and condition was improved, the symptoms had resolved. The patient had an allergy to latex and a history of plantar fasciitis. At the time of the vaccination, the patient was being evaluated for chest discomfort to rule out (r/o) pleurisy. The patient had a previous dose of influenza vaccine in 2012. Outcome was recovered. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Bradycardia, Convulsion, Hypoglycaemia, Mental status changes, Nausea
Clinical narrative: Initial information received from a healthcare professional (physician) on 18 September 2013. An 82 year old male patient was administered FLUZONE HD, lot U4714AA on 15 September 2013. In the evening on 15 September 2013, the patient developed intractable nausea and vomiting as well as a fever of 101.2. The patient was taken to the hospital, date not reported and was found to be hypoglycemic, bradycardic with unspecified mental status changes. The patient had a history of Addisons' and Brittle Diabetes. During hospitalization the patient developed a seizure and was transferred to a critical care unit. He remains in the hospital at the time of the report. Concomitant medications and laboratory reports were not reported. No further details were available at the time of this report. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial information received from a healthcare professional (physician) on 18 September 2013. An 82 year old male patient was administered FLUZONE HD, lot U4714AA on 15 September 2013. In the evening on 15 September 2013, the patient developed intractable nausea and vomiting as well as a fever of 101.2. The patient was taken to the hospital, date not reported and was found to be hypoglycemic, bradycardic with unspecified mental status changes. The patient had a history of Addisons' and Brittle Diabetes. During hospitalization the patient developed a seizure and was transferred to a critical care unit. He remains in the hospital at the time of the report. Concomitant medications and laboratory reports were not reported. No further details were available at the time of this report. Documents held by sender: None.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (lot# reported as H020254, EXP date 08-NOV-2013; lot#J000153, EXP date: 07-JAN-2015) exposed to 56 F for 8 hours. VARIVAX doses were evaluated and were supported. No adverse events were reported. At the time of report, the status of patient was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Pain, Pyrexia, Tremor
Clinical narrative: Skin puffed up at injection site; at about 5 and 1/2 hours after shot, had chills and achiness that progressed to trembling; then fever; trembling made it hard to take medicine.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no drug reactions or allergies and no concomitant medication. In January 2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, injection, intramuscularly, lot number #H010649. expiration date: 20-FEB-2015. In 2013 reported as after receiving of GARDASIL, the patient experienced hives. The patient did not seek medical attention. The patient's mother, of her own accord, gave the patient over-the-counter BENADRYL. No lab diagnostics studies were performed. No additional adverse events were reported. The outcome of hives was unknown. Relatedness between vaccination and GARDASIL and hives was not reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Pain, Pyrexia, Tremor
Clinical narrative: -Tender at injection site. - About 5 and 1/2 hours after injection, had chills and achiness that progressed to trembling; had to put on thermal underwear, then fever. Had to take medicine due to trembling.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling cold, Pyrexia, Tremor
Clinical narrative: Approximately 5 hours after vaccine began having symptoms; struggled to go upstairs for bed; very cold and trembling; was burning up - had fever.
Sex: U
Vaccine: MMR
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 (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On 23-SEP-2013, the unspecified number of unspecified patients may have been administered doses of MMR II after it was stored improperly. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site mass
Clinical narrative: Subcutaneous lump on right thigh. No erythemas edema.No treatment. 9/30/12 Recheck lump gone.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Heart rate increased
Clinical narrative: Chest discomfort 24 hrs post injection #1. Chest discomfort, rapid heart beat within one hour of injection #2 (8/30/13) and (9/27/13).
Age: 73.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approx. 6" x 6" warm red patch on shoulder injected with PNEUMOVAX 23.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test, Pyrexia, Visual impairment
Clinical narrative: HPV #3 at 09:00 hrs, by 18:00 hrs in ER with 102 degree F fever, visual changes, numbness in hands and feet. Kept in ER overnight - no cause found.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Induration, Pyrexia
Clinical narrative: (approx .10 cm) Received VARIVAX (L) upper arm SQ on 9/26/2013, Larg area of induration (R) upper arm. Diag w/cellulitis 9/28/13. Developed fever after vaccines. Started Clindamycin Palmitate 75mg/5ml TID.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Nodule, red and swollen.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Underdose
Clinical narrative: Case number PHEH2013US020264, is an initial spontaneous report received from a physician on 25 Sep 2013. This case refers to a 62 years old female patient. The patient had hypoglycaemia. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 25 Sep 2013. Reported stated that, during vaccination, the patient slumped over. Only half dose of prefilled syringe was administered due to the fall. The seriousness and outcome of the event was not reported. The physician reported that it was not a reaction to the medicine but that she had hypoglycemia. No more information was available.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram normal, Laboratory test normal, Palpitations
Clinical narrative: Palpitations developed 3 to 4 hours after vaccine, associated with lightheaded.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Pt c/o fever, body aches (extremely bad), chills, runny nose, nasal congestion, headache, nausea, dry heaves.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Retching, Rhinorrhoea
Clinical narrative: Pt c/o fever, body aches (extremely bad), chills, runny nose, nasal congestion, headache, nausea, dry heaves.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: -Redness/swelling of left, upper arm - Generalized pain, felt ill - Patient took diphenhydramine and ibuprofen.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Fall
Clinical narrative: Pt. was given flu shot at approximately 10:30 AM. Pt was ambulatory and showed no problem after vaccination. Pt did not complain at any problem at the flu shot. I received a call from facility that at approximately at 11:45 after exercising the patient fell and was taken to hospital. I do not believe that the flu shot vaccination had anything to do with the patient's fall.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chemotherapy, Chest X-ray abnormal, Lung consolidation, Malaise
Clinical narrative: This spontaneous report as received from a nurse refers to a 76 year old male patient. Medical history was not specified. On 05-SEP-2013 the patient was vaccinated with ZOSTAVAX. After vaccination patient experienced being increasingly sick, weak, chest consolidation (onset date interpreted as 05-SEP-2013) and elevated white blood counts (onset date interpreted as September 2013). Patient was being treated at oncology clinic for myelodysplastic syndrome. Patient had been to emergency room three times since he received ZOSTAVAX. Since 05-Sep-2013, patient was treated with a ten day course of Valacyclovir. Patient was actively undergoing chemotherapy and received VIDAZA on 06-SEP-2013. White blood count was reported as 0.5 (units not provided), prior to vaccination of ZOSTAVAX, and 7.9 on 23-SEP-2013, 7.1 on 25-SEP-2013 and 6.6 on 26-SEP-2013. Chest x-ray on 26-SEP-2013 showed possible developing hazy infiltrate left lung base. The reporter considered the adverse events to be life threatening and serious due to disability. The outcome of chest consolidation, x-ray showed possible developing hazy infiltrate left lung base, myelodysplastic syndrome, elevated white blood counts, weak and increasingly sick was unknown. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Myelodysplastic syndrome, White blood cell count increased
Clinical narrative: This spontaneous report as received from a nurse refers to a 76 year old male patient. Medical history was not specified. On 05-SEP-2013 the patient was vaccinated with ZOSTAVAX. After vaccination patient experienced being increasingly sick, weak, chest consolidation (onset date interpreted as 05-SEP-2013) and elevated white blood counts (onset date interpreted as September 2013). Patient was being treated at oncology clinic for myelodysplastic syndrome. Patient had been to emergency room three times since he received ZOSTAVAX. Since 05-Sep-2013, patient was treated with a ten day course of Valacyclovir. Patient was actively undergoing chemotherapy and received VIDAZA on 06-SEP-2013. White blood count was reported as 0.5 (units not provided), prior to vaccination of ZOSTAVAX, and 7.9 on 23-SEP-2013, 7.1 on 25-SEP-2013 and 6.6 on 26-SEP-2013. Chest x-ray on 26-SEP-2013 showed possible developing hazy infiltrate left lung base. The reporter considered the adverse events to be life threatening and serious due to disability. The outcome of chest consolidation, x-ray showed possible developing hazy infiltrate left lung base, myelodysplastic syndrome, elevated white blood counts, weak and increasingly sick was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cutis laxa, Erythema, Feeling hot, Swelling
Clinical narrative: -One day later patient had swelling, noticed warmth and redness - Two days later pt had swelling that caused skin sagging, still red and warm
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling - soreness. Patient followed up with Urgent Care Walk-in clinic.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Pt came into pharmacy about 30 hrs after vaccine administration with swollen arm, red. I advised ice pack and TYLENOL for discomfort. Not severe symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. Pertinent medical history, drug reactions or allergies were not reported. On 09-MAY-2013 the patients were vaccinated with GARDASIL (lot# was not reported). Dose, duration and route of administration were not reported. It was also reported that an unknown number of patients received previously two doses of GARDASIL on 23-APR-2013. (WAES 1308USA009208). Concomitant medications were not reported. The nurse reported that the patients might have received improperly stored GARDASIL, exposed to 34.1 Fahrenheit degrees for 60 days in March 2013 to April 2013. No adverse event reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Rash macular, Rash papular
Clinical narrative: Wide spread rash starting 9/7/13 numerous red papules with occasional central cloudy vesicles few erythematous macules on (B) palms & soles of feet lasting approx 1 week.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Throat tightness
Clinical narrative: At approx 1219 pt presents with coughing dry, complaints of "throat closing". Pt attests to recent treatment of bronchitis via PRN albuterol, "ZPAK", and SYMBICORT. Pt also attests to severe environmental allergies to grass, pollen. Pt recently treat for hives through allergist with BENADRYL, epinephrine approx 4 weeks ago. Vitals recorded below. She refused ambulance also refused PO BENADRYL due to "esophageal stretching". Pt administered IM BENADRYL at 1235, voiced immediate relief. Coworkers drove her home.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Injection site discolouration, Injection site induration, Injection site warmth, Laboratory test
Clinical narrative: Large area of discoloration and induration and warm 90x110 cm over L deltoid.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Prothrombin time
Clinical narrative: Large area of discoloration and induration and warm 90x110 cm over L deltoid.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness, Dysarthria, Feeling cold, Hyperhidrosis, Hypotension
Clinical narrative: Patient was administered Fluvirin. Sat down in waiting room. After approximately 5 min, was pale, loss of vision, sweating, cold, slurred speech, low blood pressure. Called 911 and evaluated by paramedics. Came to but went to hospital for further evaluation as advised by paramedics.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pallor
Clinical narrative: Patient was administered Fluvirin. Sat down in waiting room. After approximately 5 min, was pale, loss of vision, sweating, cold, slurred speech, low blood pressure. Called 911 and evaluated by paramedics. Came to but went to hospital for further evaluation as advised by paramedics.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose, Cardiac monitoring, Chills, Hyperhidrosis, Hypotension
Clinical narrative: Patient was administered Fluvirin. Sat down in waiting room. After approximately 5 min, was pale, loss of vision, sweating, cold, slurred speech, low blood pressure. Called 911 and evaluated by paramedics. Came to but went to hospital for further evaluation as advised by paramedics.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Syncope, Vision blurred
Clinical narrative: Patient was administered Fluvirin. Sat down in waiting room. After approximately 5 min, was pale, loss of vision, sweating, cold, slurred speech, low blood pressure. Called 911 and evaluated by paramedics. Came to but went to hospital for further evaluation as advised by paramedics.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest discomfort, Feeling hot, Nasal congestion, Pain
Clinical narrative: Chest tightness 5 hours later when laid down in bed, generalized achy body, back ache, stuffy nose, congested throat, feels hot and warmer.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract congestion
Clinical narrative: Chest tightness 5 hours later when laid down in bed, generalized achy body, back ache, stuffy nose, congested throat, feels hot and warmer.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Hives bilaterally left and right arms and hands.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Nausea, Syncope, Vomiting
Clinical narrative: Employee had syncopal episodes times 2 - she reported she has vaso-vagal syndrome with injections. Employee called to report that after she returned to work she had nausea and vomiting times 2 and left work because of this - she also reported feeling weakness all over.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Measles, Pyrexia
Clinical narrative: Fever, irritability, measles rash
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Evening of shots, extreme nausea from 8:00 to 10:00 PM. Then uncontrollable violent shaking, cont 'd thru night, around 1:00 AM 99.8 fever, 5:00 AM 99.3 fever, still shakes, 8:00 AM 98.6 fever and ok.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: Received flu shot at 07:30 - 08:00 both eyes red and c/o nausea. 08:45 to Employee Health - shivering nausea vomit. Zofran 4 mg orally, went home.
Age: 37.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: Redness in arm, sore, swollen glands and didn't feel well.
Age: 1.02
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Patient was given the varicella vaccine and contracted chicken pox. Pt presented with fever and blister like rash when we checked on patient on 9-5-13 patient was recovering well.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Dry throat, Eye pain, Eye pruritus, Heart rate increased
Clinical narrative: Patient reported initial reaction - itchy, painful (non-swollen) eyes about 2.5 hrs after vaccine. This progressed into dry throat/mouth and eventually increased heart rate and vomiting.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient reported initial reaction - itchy, painful (non-swollen) eyes about 2.5 hrs after vaccine. This progressed into dry throat/mouth and eventually increased heart rate and vomiting.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: No problems at vaccine administration later 10 days shingles rash developed with neuropathics throughout body. Pt saw Dr to verify active shingles outbreak. Started on left side body.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Herpes zoster
Clinical narrative: No problems at vaccine administration later 10 days shingles rash developed with neuropathics throughout body. Pt saw Dr to verify active shingles outbreak. Started on left side body.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Feeling hot, Flushing
Clinical narrative: A few minutes after vaccines, pt's face became red and seemed flushed. He said he felt hot and dizzy. We called 911. After 2 minutes he was perfect, and rescue said he was fine. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: Right upper thigh cellulitis
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling on arm where injection was given. Pt took benadryl 50 mg x 1 dose then 25 mg x 2 doses.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Contusion, Injection site swelling, Injury, Pain, Rash
Clinical narrative: 3.5 hrs after shots - rash. Increased swelling to thighs, pain. Urgent care (bumps and bruises) noted entire leg swollen. Tx: TYLENOL and BENADRYL.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Throat irritation, Throat tightness
Clinical narrative: Dizzy, scratchy tight throat, cough. ER visit 9/20/13.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Erythema, Local swelling, Myalgia, Urticaria
Clinical narrative: Pt had a red, swollen spot on the back of her left arm 3 1/2" long and wide with a 13/4" inch raised welt, a sore left trapezoid muscle and sore left breast on 9/6/13.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dizziness, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, rash, joint pains, dizziness, nausea, sore throat.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Fever, rash, joint pains, dizziness, nausea, sore throat.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Loss of consciousness, Presyncope
Clinical narrative: Pt passed out and had seizure while resting on the chair 9/6 Pt. has vaso reaction per mom - doing ok today.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Bacterial infection, Cellulitis
Clinical narrative: Acquired bacterial infection, lasted for 8 days and as per patient chart, was diagnosed with local cellulitis.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Grand mal convulsion, Skin warm
Clinical narrative: Patient's representative stated that the patient was having grand mal seizures and felt hot to the touch. He is currently being treated in the emergency room.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling cold, Myalgia, Tremor
Clinical narrative: Uncontrollable shivering, deep muscle aches, trembling limbs, cold and could not get warm. Symptoms hit in early evening and lasted a few hours; took 2 Advil and mercifully fell asleep at about 11 PM; exhausted the next day but better.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Pyrexia, Tremor, Vomiting
Clinical narrative: Sx occurred 11:00pm uncontrolled shaking, feeling cold, chills. Used aspirin x2 doses. Vomited. Fever - unknown temp.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Rash macular, Throat tightness
Clinical narrative: Shortness of breath, blotchy skin, nausea "throat tight" - started at 10:30-sought help at 11:30. Epi 0.3 ml of 1:1000 dilution given. Paramedics called.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Patient developed a raised bump at the administration site immediately following the injection. Applied ice pack to raised bump and swelling went down.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Eye discharge, Headache, Pain, Purulent discharge
Clinical narrative: 104 degree fever, difficulty swallowing, yellow discharge from eyes, body aches, headache.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 104 degree fever, difficulty swallowing, yellow discharge from eyes, body aches, headache.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain in extremity, Tenderness
Clinical narrative: Redness, warmness, and arm pain and tenderness radiating down her shoulder and back. This pain is still present 19 days later.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt called day after receiving both vaccines and reported pain, swelling and heat at Pneumovax injection site within 1hr of injection. Recommended she contact her MD to follow-up for treatment.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Diarrhoea, Hypersomnia, Moaning, Pain
Clinical narrative: Patient was administered his first vaccine on 9-6-13. Within 30 minutes he was sleeping and proceeded to sleep for 3 hours. Mother woke him for dinner. (approx 6:30 pm). Marked decreased appetite was observed. He fell asleep again approx 7:00 pm and slept for 15 hours. He had previously been a frequent night waker, nursing 2-3 times per night. The following day the vaccine injection he developed a low grade fever. Additionally, beginning this day, he would scream and scream and scream. He would double over in pain and continued to scream. This was sometimes accompanied by explosive diarrhea. When he was not screaming, mother and father attempted to engage him in play. He would stare into space. He would not smile, he would not laugh, in contrary to his usually bright and bubbly personality. He was again very sleepy this day following the vaccine and showed marked disinterest in solid food. Continued to breastfeed. At night and for the next several days and nights, he would moan and whimper in his sleep. - all night long. His sleep was restless and accompanied by much tossing and turning. Close contact was kept with the Pediatrician throughout the weekend who agreed increasing probiotics may be helpful. He was also brought to a Naturopathic Physician who prescribed 1/4 tsp probiotic 1 x daily, 5 drops Thuja 1 x daily and 5 drops of Anticromian Crudum 3 x daily. Follow up visit was done with Pediatrician on Sept 10th. The above symptoms lasted nearly a week and a half with symptoms peaking between 1-4 days following the injection and slowly beginning to taper off. He appears to be recovered as of the writing of this form.