chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Skin reaction, Urticaria, Varicella
Clinical narrative: 6/14/13 patient came in pharmacy to report he stated noticing red rashes on shoulder, lower neck after receiving shingles vaccine (administered 3/12/13). Pt also stated he developed shingles in last week and was prescribed valacyclovir tablets on 6/13/13. Pt was informed shingles vaccine only decreases these evenly of the diseases.
Age: 1.01
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old female patient. The patient's medical history was unknown. On 06-JUN-2013, the patient was by mistake administered ZOSTAVAX instead of the first dose of VARIVAX (Merck). No other suspected medications or co-suspected medications were reported. No adverse events were reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. On 12-JUN-2013, the patient was vaccinated with the first dose of ROTATEQ (dose, route, lot number and indication were not specified). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to female patient in her 50s. Pharmacist states that on an unspecified date, patient had received ZOSTAVAX (dose, route and lot number were not provided) and later developed shingles. The outcome of the patient was not reported. The relationship between ZOSTAVAX and shingles was not reported. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report was received from a pharmacist refers to a approximately 52 years old male patient with no pertinent medical history and with drug reactions/allergies to penicillin and an anaphylactic reaction to unspecified flu vaccine (MARSS # 1306USA005758. In 2007 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number and expiration date not reported). No other co-suspect therapy was provided. Concomitant medications were not reported. The pharmacist reported that the patient received pneumonia vaccine (manufacturer unknown) approximately in 2007 which caused his arm to swell up. On an unknown date, the patient recovered from the event. No laboratory tests were performed. The outcome of the patient received an unspecified pneumonia vaccine which caused his arm to swell up was reported as recovered/resolved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a patient's husband, concerning his wife, a 69 year old female patient with no medication allergies reported. On 03-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (lot # and expiration date not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that the patient developed severe pain almost immediately after receiving the injection (unspecified whether the injection was subcutaneous or intramuscular). Her pain was reported to be concentrated at the injection site of the arm in which she received PNEUMOVAX 23 and about a "8" or "9" on a pain intensity scale of 1 to 10 with 10 being the most painful. The female patient was reported to be "more petite" than her husband. No laboratory tests were performed to the patient. At the time of the report, the patient was recovering from the pain. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 76 year old male patient reporting on himself, with no reaction/allergies reported who in 2003, ten years ago was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown), and had no reaction at all to that vaccine. On 03-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (lot # and expiration date not reported) for prevention of pneumonia. The patient reported that he developed significant pain in the arm where he received an injection of PNEUMOVAX 23. It was unspecified whether the injection was subcutaneous or intramuscular. The pain was developed 3 to 4 hours after the vaccination (on 03-JUN-2013). He described the pain as being felt throughout his arm and as about a 7 on a scale of 1 to 10 with 10 being the most painful. The patient did not receive any treatment for the event. Laboratory tests were not performed. At the time of reporting the patient was recovering from the event of significant pain in the arm. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Exposure during pregnancy, Syncope
Clinical narrative: Case number PHHY2012US111228 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number 465719) received on 04 Dec 2012. This report refers to a 25-year-old pregnant female patient. The patient was vaccinated with FLUVIRIN (batch number 1204101) intramuscularly in the left arm on 14 Sep 2012. On 14 Sep 2012, the same day after vaccination the patient fainted. She also felt lightheaded and dizzy. The condition improved slightly over the next 5 to 10 minutes. The patient visited her doctor. The outcome of the events was reported as not recovered as of 14 Sep 2012. Follow-up information received on 17 Jun 2013: Reporter was anonymous, this case is lost to follow-up.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Maternal exposure during pregnancy, Periarthritis
Clinical narrative: Case number PHHY2013US032451 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480518) website on 04 Apr 2013. This report refers to a 35-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1206501) intramuscularly into left arm on 15 Nov 2012. On 17 Nov 2012, two days after vaccination, she had severe pain at and around the injection site. She could not move her arm and had a frozen shoulder. She visited the emergency room but she could not receive X-ray as she was pregnant. The condition of the patient was not improved and outcome of the events was reported as not recovered as of 08 Jan 2013. The case was assessed as serious (permanent disability) by the reporter. The causality of the events was not reported. Follow-up received on 18 Jun 2013: No further follow-up will be pursued because the reporter was anonymous. This case is considered lost to follow-up.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Exposure during pregnancy, Injection site pain, Mobility decreased, Periarthritis
Clinical narrative: Case number PHHY2013US032451 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480518) website on 04 Apr 2013. This report refers to a 35-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1206501) intramuscularly into left arm on 15 Nov 2012. On 17 Nov 2012, two days after vaccination, she had severe pain at and around the injection site. She could not move her arm and had a frozen shoulder. She visited the emergency room but she could not receive X-ray as she was pregnant. The condition of the patient was not improved and outcome of the events was reported as not recovered as of 08 Jan 2013. The case was assessed as serious (permanent disability) by the reporter. The causality of the events was not reported. Follow-up received on 18 Jun 2013: No further follow-up will be pursued because the reporter was anonymous. This case is considered lost to follow-up.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Ear pain, Headache, Laboratory test abnormal, Lumbar puncture
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Nervous system disorder, Rhinitis perennial, Rhinoscopy, Sinusitis, Tendonitis
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Ear pain, Headache, Lumbar puncture, Nervous system disorder
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rhinitis perennial, Rhinoscopy, Sinusitis, Tendonitis, Vaccine positive rechallenge
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Alopecia, Anaemia, Back pain, Blood test
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Cognitive disorder, Computerised tomogram, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Feeling abnormal, Headache, Insomnia, Joint swelling, Lumbar puncture
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain, Paranasal sinus hypersecretion, Temperature intolerance, Tendonitis
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tilt table test, Vertigo, Vestibular function test
Clinical narrative: Daily headaches 24/7, stomach pains, tendonitis and swelling in the knees, unable to focus/concentrate, brain fog, fatigue, back pain, neck pain, sinus drainage, temperature sensitivity, insomnia, hair loss, dizzy spells, cognitive change, vertigo and anaemia.
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL, HEPAB, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Swelling
Clinical narrative: Local redness and swelling at injection site beginning within 24 hours.
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL, HEPAB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling at injection site beginning within 24 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and redness of arm of injection site. Tried diphenhydramine 1st - then antibiotics. SMZ TMPS DS and cephalexin 500 mg.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of arm of injection site. Tried diphenhydramine 1st - then antibiotics. SMZ TMPS DS and cephalexin 500 mg.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Laboratory test normal, Lumbar puncture normal, Meningitis, Musculoskeletal stiffness
Clinical narrative: Case number PHEH2013US010862 is an initial spontaneous report received from a nurse on 15 May 2013, with a combined follow-up received from a physician assistant on 11 Jun 2013 and 17 Jun 2013. This case refers to a 27-year-old male patient. His medical history was not reported and his concomitant medication included CONCERTA. He was vaccinated with MENVEO (batch number: X12025/A12025, expiry date: Jan 2015/Dec 2014) intramuscularly on 10 May 2013. On the same day, post vaccination, he developed fever. It was reported that within 24-48 hours after receiving vaccination, he developed high fever, neck stiffness, and headaches. He went to the hospital with headache, neck stiffness and fever greater than 103 degrees. He was hospitalized under the suspicion of meningitis where he was followed-up by an infectious disease physician. Lumbar puncture, spinal tap, x-rays, and laboratory testing were performed in ER, for which all results were negative for any infectious disease. The patient recovered from fever on 13 May 2013. The patient recovered completely from all the symptoms on unspecified date. He stayed in hospital for two to three days and was discharged in stable condition. Causality of fever was assessed as related to MENVEO. Combined follow-up was received on 11 Jun 2013 and 17 Jun 2013: Patient demographics, concomitant medication, events (neck stiffness and headache), hospitalization (tests performed in the hospital), outcome of the events and causality of fever were updated.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, X-ray normal
Clinical narrative: Case number PHEH2013US010862 is an initial spontaneous report received from a nurse on 15 May 2013, with a combined follow-up received from a physician assistant on 11 Jun 2013 and 17 Jun 2013. This case refers to a 27-year-old male patient. His medical history was not reported and his concomitant medication included CONCERTA. He was vaccinated with MENVEO (batch number: X12025/A12025, expiry date: Jan 2015/Dec 2014) intramuscularly on 10 May 2013. On the same day, post vaccination, he developed fever. It was reported that within 24-48 hours after receiving vaccination, he developed high fever, neck stiffness, and headaches. He went to the hospital with headache, neck stiffness and fever greater than 103 degrees. He was hospitalized under the suspicion of meningitis where he was followed-up by an infectious disease physician. Lumbar puncture, spinal tap, x-rays, and laboratory testing were performed in ER, for which all results were negative for any infectious disease. The patient recovered from fever on 13 May 2013. The patient recovered completely from all the symptoms on unspecified date. He stayed in hospital for two to three days and was discharged in stable condition. Causality of fever was assessed as related to MENVEO. Combined follow-up was received on 11 Jun 2013 and 17 Jun 2013: Patient demographics, concomitant medication, events (neck stiffness and headache), hospitalization (tests performed in the hospital), outcome of the events and causality of fever were updated.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Arthralgia, Blood immunoglobulin E increased, Burning sensation, Dysstasia
Clinical narrative: This spontaneous report as received from a female patient of unknown age with asthma, Gastrooesophageal reflux disease (GERD) and depression. Patient has allergy to KEFLEX, CELEXA and erythromycins. On an unknown date (reported as several months ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included bupropion hydrochloride (reported as Bupropion) and PREVACID. On an unknown date, immediately after receiving the ZOSTAVAX she developed flu-like symptoms. She did call and reported this to either her physician or the pharmacist (she could not remember which one), who told her that ZOSTAVAX would not cause these symptoms, so nothing further was done about this. The patient states that the symptoms lasted about 3-4 weeks and then resolved. The patient currently had developed on the inside of her right lower calf, muscle pain and joint pain, along with a small red rash that has a burning sensation. She contacted the pharmacist who administered her ZOSTAVAX and informed them about her current symptoms, and she stated that the pharmacist had told her that these were known side-effects that can occur after receiving ZOSTAVAX. These symptoms have resulted in the patient not being able to be on her feet as long as normal (disability). The patient also reported that on an unknown date, she developed a urinary tract infection at the same time she started developing the symptoms in her lower right calf. Patient sought medical attention. The patient recently saw an allergist who performed 'sensitivity testing' on her on an unknown date, and her pulmonologist performed a complete blood count on an unknown date and informed her that her IGE (immunoglobulin E) levels were in the 1500's. The outcome of small red rash that has a burning sensation, developed muscle pain and joint pain on the inside of her right lower calf, not being able to be on her feet as long as normal and developed a urinary tract infection was unknown. Upon internal review the event patient not being able to be on her feet as long as normal was considered to be disability. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Immediate post-injection reaction, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a female patient of unknown age with asthma, Gastrooesophageal reflux disease (GERD) and depression. Patient has allergy to KEFLEX, CELEXA and erythromycins. On an unknown date (reported as several months ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included bupropion hydrochloride (reported as Bupropion) and PREVACID. On an unknown date, immediately after receiving the ZOSTAVAX she developed flu-like symptoms. She did call and reported this to either her physician or the pharmacist (she could not remember which one), who told her that ZOSTAVAX would not cause these symptoms, so nothing further was done about this. The patient states that the symptoms lasted about 3-4 weeks and then resolved. The patient currently had developed on the inside of her right lower calf, muscle pain and joint pain, along with a small red rash that has a burning sensation. She contacted the pharmacist who administered her ZOSTAVAX and informed them about her current symptoms, and she stated that the pharmacist had told her that these were known side-effects that can occur after receiving ZOSTAVAX. These symptoms have resulted in the patient not being able to be on her feet as long as normal (disability). The patient also reported that on an unknown date, she developed a urinary tract infection at the same time she started developing the symptoms in her lower right calf. Patient sought medical attention. The patient recently saw an allergist who performed 'sensitivity testing' on her on an unknown date, and her pulmonologist performed a complete blood count on an unknown date and informed her that her IGE (immunoglobulin E) levels were in the 1500's. The outcome of small red rash that has a burning sensation, developed muscle pain and joint pain on the inside of her right lower calf, not being able to be on her feet as long as normal and developed a urinary tract infection was unknown. Upon internal review the event patient not being able to be on her feet as long as normal was considered to be disability. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Urinary tract infection
Clinical narrative: This spontaneous report as received from a female patient of unknown age with asthma, Gastrooesophageal reflux disease (GERD) and depression. Patient has allergy to KEFLEX, CELEXA and erythromycins. On an unknown date (reported as several months ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included bupropion hydrochloride (reported as Bupropion) and PREVACID. On an unknown date, immediately after receiving the ZOSTAVAX she developed flu-like symptoms. She did call and reported this to either her physician or the pharmacist (she could not remember which one), who told her that ZOSTAVAX would not cause these symptoms, so nothing further was done about this. The patient states that the symptoms lasted about 3-4 weeks and then resolved. The patient currently had developed on the inside of her right lower calf, muscle pain and joint pain, along with a small red rash that has a burning sensation. She contacted the pharmacist who administered her ZOSTAVAX and informed them about her current symptoms, and she stated that the pharmacist had told her that these were known side-effects that can occur after receiving ZOSTAVAX. These symptoms have resulted in the patient not being able to be on her feet as long as normal (disability). The patient also reported that on an unknown date, she developed a urinary tract infection at the same time she started developing the symptoms in her lower right calf. Patient sought medical attention. The patient recently saw an allergist who performed 'sensitivity testing' on her on an unknown date, and her pulmonologist performed a complete blood count on an unknown date and informed her that her IGE (immunoglobulin E) levels were in the 1500's. The outcome of small red rash that has a burning sensation, developed muscle pain and joint pain on the inside of her right lower calf, not being able to be on her feet as long as normal and developed a urinary tract infection was unknown. Upon internal review the event patient not being able to be on her feet as long as normal was considered to be disability. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion, Emotional distress, Haemorrhage intracranial, Haemorrhagic cerebral infarction, Irritability
Clinical narrative: Initial report was received on 10 June 2013 from a health care professional with additional information received on 11 June 2013 from a consumer who is also the patient's parent. A four month-old female patient with no past medical history had received on 05 June 2013 the following vaccines: dose 2 intramuscular right thigh injection of PENTACEL, lot number C4374AA; PREVNAR (manufacturer, lot number, route and site of administration not reported) and ROTATEQ (manufacturer, lot number, route and site of administration not reported) and the next day on 06 June 2013 the parent reported the child was irritable, inconsolable and was having "seizure like activity". The patient was taken for evaluation by the physician who reported the patient had a seizure and was immediately hospitalized (dates not reported). According to the parent, the patient was diagnosed with unspecified intracranial right hemorrhage and right cerebral arterial bleed with infarction. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Seizure like phenomena
Clinical narrative: Initial report was received on 10 June 2013 from a health care professional with additional information received on 11 June 2013 from a consumer who is also the patient's parent. A four month-old female patient with no past medical history had received on 05 June 2013 the following vaccines: dose 2 intramuscular right thigh injection of PENTACEL, lot number C4374AA; PREVNAR (manufacturer, lot number, route and site of administration not reported) and ROTATEQ (manufacturer, lot number, route and site of administration not reported) and the next day on 06 June 2013 the parent reported the child was irritable, inconsolable and was having "seizure like activity". The patient was taken for evaluation by the physician who reported the patient had a seizure and was immediately hospitalized (dates not reported). According to the parent, the patient was diagnosed with unspecified intracranial right hemorrhage and right cerebral arterial bleed with infarction. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age. The nurse noted the patient was inadvertently administered a dose of VARIVAX (Merck) (lot # and dose not reported) subcutaneously instead of ZOSTAVAX on 14-JUN-2013. No adverse effect was reported. At the time of reporting, the patient had no known adverse effect. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Teen received GARDASIL on 17 June 13 (2nd vaccine in series). Teen had fever to 102.3 degrees F on 19 Jun13. Teen had myalgias, dizziness on 19, 20 Jun 13.
Sex: U
Vaccine: HPV4, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (also reported as healthcare worker) refers to an unspecified number of unspecified patients. The office manager reported that GARDASIL (lot number, strength, dose, route and site unspecified) and MMR II (lot number, strength, dose, route and site unspecified) might have been stored at temperature outside of the prescribing information since an unspecified date in March 2013 and administered to an unspecified number of patients. No adverse effects reported. It was unspecified if the patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 26 year old female patient with no pertinent medical history and no drug reactions or allergies. On 08-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H018976, expiration date 24-OCT-2014) 0.5 ml, once, subcutaneous for company requirement. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL TABLETS, desogestrel,RECLIPSEN and simvastatin (manufacturer unknown). The Registered Nurse reported that on 09-JUN-2013, patient went to work stating she had sore throat. The next day, on 10-JUN-2013 the patient had cellulitis at the injection site. The Registered Nurse reported that an unspecified physician in the office gave the patient a shot of ROCEPHIN and oral sulfamethoxazole and BACTRIM. Registered Nurse reported that two other patients, experienced adverse reactions after receiving a dose of VARIVAX (Merck) from this lot # (MARRS # 1306USA009129 and 1306USA009130). Nurse was requesting a lot check for this VARIVAX (Merck). At the time of the report the outcome sore throat and cellulitis at the injection site was unknown. This one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) deltoid with 6 x 5 cm red, hot area at injection site.
Sex: F
Vaccine: FLUX
Symptoms: Visual acuity reduced
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-Jun-2013) concerns a female patient with a medical history of diabetes and allergies to amoxicillin, carisoprodol and sulfa. On an unspecified date 'years ago', the patient received a influenza vaccine (batch and brand unspecified). After this, on an unspecified date, the patient almost went blind. Then the patient took a medicine which restored her sight. The event outcome was recovered.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: 4 cm area of redness, swelling, heat, and tenderness consistent with cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling from left shoulder to left elbow, pain, redness, hot to touch.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Macule, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Per documentation, fever for 3 days a week before 6/17/2013 office visit. Rash developed 6/16/2013. Macule, papule rash covering body including palms, soles, and diaper area.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Cold sweat, Dyspnoea, Erythema, Feeling hot, Rash erythematous
Clinical narrative: Hot and clammy, some SOB, red blotchy flat rash over chest/trunk with pink face.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Rash macular
Clinical narrative: Hot and clammy, some SOB, red blotchy flat rash over chest/trunk with pink face.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Rash, Temperature intolerance
Clinical narrative: Started getting a rash at injection site and on side of neck associated with injection. C/O pain at injection site, T100 (F) P112.  No wheezing, respiratory difficulty.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Arthritis, Asthenia, Asthma, Blood culture
Clinical narrative: Flu like symptoms, weakness, paralysis, anemia, persistent weakness, severe pain, numbness and tingling in fingers and toes. Unstable BP, sugar level and worsening asthma and arthritis. Diagnosis of GBS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose, Blood glucose fluctuation, Blood iron, Blood pressure fluctuation, Blood test
Clinical narrative: Flu like symptoms, weakness, paralysis, anemia, persistent weakness, severe pain, numbness and tingling in fingers and toes. Unstable BP, sugar level and worsening asthma and arthritis. Diagnosis of GBS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: CSF test, Computerised tomogram, Condition aggravated, Guillain-Barre syndrome, Haemoglobin
Clinical narrative: Flu like symptoms, weakness, paralysis, anemia, persistent weakness, severe pain, numbness and tingling in fingers and toes. Unstable BP, sugar level and worsening asthma and arthritis. Diagnosis of GBS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza like illness, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Flu like symptoms, weakness, paralysis, anemia, persistent weakness, severe pain, numbness and tingling in fingers and toes. Unstable BP, sugar level and worsening asthma and arthritis. Diagnosis of GBS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Paralysis, X-ray
Clinical narrative: Flu like symptoms, weakness, paralysis, anemia, persistent weakness, severe pain, numbness and tingling in fingers and toes. Unstable BP, sugar level and worsening asthma and arthritis. Diagnosis of GBS.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Eyelid oedema, Lethargy, Pallor, Rash macular, Retching
Clinical narrative: Baby gagged and forcefully vomited copious milk-like contents through mouth and nose. She was wiped and washed clean of emesis and wet diaper was changed (no diarrhea) over the next 10 min (face and trunk were almost completely covered with emesis), then appeared pale and sleepy/lethargic with pink blotchy swollen upper eyelids R>L. (She was responsive to voice but only briefly stirred and then seemed sleepy). No sz activity was observed before/during/right after emesis. She remained like this for 5-10 min without wheezing/resp distress/sz/apnea/cyanosis as we observed her.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Somnolence, Vomiting projectile
Clinical narrative: Baby gagged and forcefully vomited copious milk-like contents through mouth and nose. She was wiped and washed clean of emesis and wet diaper was changed (no diarrhea) over the next 10 min (face and trunk were almost completely covered with emesis), then appeared pale and sleepy/lethargic with pink blotchy swollen upper eyelids R>L. (She was responsive to voice but only briefly stirred and then seemed sleepy). No sz activity was observed before/during/right after emesis. She remained like this for 5-10 min without wheezing/resp distress/sz/apnea/cyanosis as we observed her.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: Peeling and itching rashes.
Age: 34.0
Sex: M
Vaccine: HEPAB, TDAP, YF
Symptoms: Asthma, Condition aggravated, Dyspnoea, Urticaria
Clinical narrative: Had just arrived home after receiving immunizations. Sudden onset of asthma and he used his inhaler.  Was having a little difficulty breathing. Called RN at Health Dept, was advised to go to ER. By the time he to to the ER he had developed hives and was having more difficulty breathing.
Age: 0.43
Sex: F
Vaccine: 6VAX-F
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Asthenia, Flatulence, Headache, Hypotonia, Muscle rigidity
Clinical narrative: Four to five minutes after receiving immunizations child became limp and unresponsive lasting 30 secs.  Then body became rigid, arching back, extremities, shaking and passing gas.  Lasting 30 to 40 seconds.  Patient was responsive to sharp pain to head and weak.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Opisthotonus, Tremor, Unresponsive to stimuli
Clinical narrative: Four to five minutes after receiving immunizations child became limp and unresponsive lasting 30 secs.  Then body became rigid, arching back, extremities, shaking and passing gas.  Lasting 30 to 40 seconds.  Patient was responsive to sharp pain to head and weak.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flushing, Oedema peripheral, Urticaria
Clinical narrative: Developed flushing, swelling of both legs and feet. Later had some urticarial rash on legs and abdomen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Need vax on Monday IIA. Injection site is now red and itchy and getting worse instead of better. She is going to call her Dr.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: Number 3 MMR was given this day (6/14/13). Patients 1st MMR recorded in EMR #2 was hot. Nurse did not check state registry prior to administration.
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness left arm - elbow to shoulder (reaction to KINRIX).
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Chills, Erythema, Headache, Injection site erythema
Clinical narrative: 5/8/13 (pm) fever 100-102.9. Chills, body aches, headache, cellulitis, redness and tenderness at injection site. Macular rash Tx = KEFLEX and TYLENOL.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pain, Pyrexia, Rash macular
Clinical narrative: 5/8/13 (pm) fever 100-102.9. Chills, body aches, headache, cellulitis, redness and tenderness at injection site. Macular rash Tx = KEFLEX and TYLENOL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Dizziness, headache, neck stiffness started day of immunization and has increased in severity since then. Also reporting sweating, heavy for 10 min about 3 x day.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Dyskinesia, Fall, Head injury
Clinical narrative: Client rec'd Tdap, HPV4, MCV4, approx. 3 min after while sitting in waiting area she fainted, fell to side hitting head on floor. Placed feet up, laid on back, clammy, cool cloths to neck and forehead. 5 min sat client up, still seemed lightheaded. Brought in to nurse area sat in chair to watch, talking to staff, and fainted again, this time having jerking movements for few seconds, laid on floor. BP 102/68 P 62, clammy. No breathing difficulty noted, just pale skin color. 911 called and client left with paramedics at 10:03, to be checked at hospital.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Client rec'd Tdap, HPV4, MCV4, approx. 3 min after while sitting in waiting area she fainted, fell to side hitting head on floor. Placed feet up, laid on back, clammy, cool cloths to neck and forehead. 5 min sat client up, still seemed lightheaded. Brought in to nurse area sat in chair to watch, talking to staff, and fainted again, this time having jerking movements for few seconds, laid on floor. BP 102/68 P 62, clammy. No breathing difficulty noted, just pale skin color. 911 called and client left with paramedics at 10:03, to be checked at hospital.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Oedema peripheral, Pain, Platelet count normal
Clinical narrative: < 24 hours after injection developed significant arm swelling, fever 103 degrees and pain.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: < 24 hours after injection developed significant arm swelling, fever 103 degrees and pain.
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pruritus, Rash erythematous
Clinical narrative: About 6 hours after injection both my arms started itching and I got a red rash on upper chest, both arms and face.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Patient's son called to report his mom had swelling/inflammation below injection site on left arm.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site bruising
Clinical narrative: Had TWINRIX Hep A-B vaccine administered to (R) deltoid IM on 4-10-13. Client presented today (6-19-13) and reported "a bruise on that arm since then". On (R) later upper arm 2-3" above elbow there is a quarter sized deep green/black bruise. Client reports that this bruise appears within days of the injection. Denies other injury.
Age: 1.06
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site oedema, Papule
Clinical narrative: Edema and erythema in right thigh. Red papules scattered throughout body. - likely normal VARIVAX reaction.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Lethargy, Pyrexia
Clinical narrative: Fever tx with TYLENOL. Lethargy. Dizziness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, raised, warm circular area approx 7 cm in diameter. Rx: clindamycin x 10 days
Age: 46.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Myalgia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a  46 year old female patient with penicillin allergy (patient got hives) and RELAFEN allergy (she has an anaphylactic reaction on an unspecified date). Patient has no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H018796, expiration date 24-OCT-2014) 0.5 ml, once, subcutaneous for company requirement. There were no concomitant medications reported. The Registered Nurse reported that patient experienced cellulitis at the injection site and myalgia on 12-JUN-2013, after receiving a dose of VARIVAX (Merck). Registered Nurse reported that patient was seeing on 13-JUN-2013, by an unspecified physician in the office who prescribed BACTRIM and MOTRIN. The Registered Nurse also stated that two other patients (MARRS cases 1306USA006664 and 1306USA009130), experienced adverse reactions after receiving doses of VARIVAX (Merck) from this lot. Nurse was requesting a lot check for this VARIVAX (Merck). Laboratory tests were not performed. At the time of the report, the outcome of cellulitis at the injection site and myalgia was reported as not recovered/not resolved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX  VIAL 19400 PFU, 0.65 ml, subcutaneous for prophylaxis. On an unknown date, the patient developed a cold sore 10 to 14 days after receiving ZOSTAVAX. VALTREX was given as treatment. The outcome of cold sore was reported as recovering/resolving. The pharmacist could not specify whether the patient had ever had a cold sore previously. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no medical history or drug allergies. On 10-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot#J001009, expire date: 24-APR-2014), subcutaneous injection, subcutaneous, 0.65 ml. Concomitant therapies included potassium chloride USP, tizanidine hydrochloride, furosemide, doxepin hydrochloride, folic acid, VIVELLE-DOT, SYNTHROID and acetaminophen, hydrocodone bitartrate and omeprazole. On 12-JUN-2013, the patient experienced swelling and redness that was 2x3 inches at the injection site and the area was very painful, mainly painful to the touch and "the pain has worsened in the last day". The patient had sought medical attention via phone call. No lab test was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count abnormal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Pt was admitted on 2/19/12 with ITP and treated. Vaccine was given on 1-26-12. Pt has been in remission for 1 yr now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pallor, Skin warm
Clinical narrative: IPV given to left deltoid. 9 cm x 9 cm warm erythematous area. Blanchable. Diphenhydramine, ibuprofen and cephalexin prescribed.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness and shortness of breath.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient states that red, itchy rash developed at injection site during evening of 6-13-13. Became progressively larger to diameter of baseball as of 6-16-13. Patient saw MD 6-17-13, rash improving.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Given shots Hep #1, Hep #3 310 pm June 18 - at Bedtime June 19 (8 pm), 1 pink 'bump' noted on (L) upper arm/shoulder - slept ok - awoke with hives all over, torso, face, arms itchy. Lungs clear.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient is experiencing minor redness, very mild tenderness at the injection site (or close to it). There is no swelling in the area. She says it's a little bit sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Small, quarter-sized red spot at injection site.  Patient returned to pharmacy on 6/20/13, and showed pharmacist that spot had grown to about the size of a silver dollar.  Pharmacist instructed patient to take Diphenhydramine 25mg 1 po q4-6h, and add ice to the injection site.   Further instructed patient if no improvement noticed within 24 hours, check with physician.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient has erythema and swelling to left upper arm. There are 2 small water blisters to area. Patient has had diarrhea, headache and fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: Patient has erythema and swelling to left upper arm. There are 2 small water blisters to area. Patient has had diarrhea, headache and fever.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Fever 101.9, chills, extreme pain, redness, warmth, and swelling to the size of a soft ball.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Skin warm
Clinical narrative: Fever 101.9, chills, extreme pain, redness, warmth, and swelling to the size of a soft ball.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Mild fever, body aches, sore joints, tiredness, nausea, chills. Lasted from 12:00am on 06/19/2013 through 06/20/2013. Aspirin (one 500mg tablet) was taken every 4 hours and it relieved almost all symptoms.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Mild fever, body aches, sore joints, tiredness, nausea, chills. Lasted from 12:00am on 06/19/2013 through 06/20/2013. Aspirin (one 500mg tablet) was taken every 4 hours and it relieved almost all symptoms.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: Was given Tdap HPV (Gardasil) and MCV Menveo.
Age: 65.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fevers to 104.1 degrees F; headaches; 9x6 cm area of warmth, erythema and tenderness on left deltoid; myalgias; fatigue.
Age: 65.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fevers to 104.1 degrees F; headaches; 9x6 cm area of warmth, erythema and tenderness on left deltoid; myalgias; fatigue.
Age: 26.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient needed the Tdap adult dose but was given the Dtap peds dose. Patient received correct vaccine. No reaction or symptom.
Age: 1.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site cellulitis, Injection site nodule
Clinical narrative: Approx 3x4cm area of cellulitis with 2 1cm nodules on anterior and lateral left thigh x10 days.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site reaction, Injection site warmth, Muscle tightness
Clinical narrative: (L) arm - (?) reaction to MENACTRA red, warm, tense over deltoid.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation from shoulder to fingers. Started 3-4 weeks after immunization, comes and goes, not constant.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lethargy, Pyrexia
Clinical narrative: Admin dose 6/14/13 in PM. Pt reported fever (< 101 degrees F) on 6/15 and 6/16/13 with injection site pain. Remained in bed all day 6/15 with lethargy. Returned to normal on Tues 6/8/13. Still some arm soreness.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oedema peripheral, Pain
Clinical narrative: Pt was administered HPV, MENACTRA vaccine in right deltoid 6/19/13. Seen 6/20/13 for swelling in arm about 4-5 cm big. Dr then gave 15 mLs of MOTRIN by mouth due to pain.