chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. The patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Blister, Dysphonia, Headache, Pain, Pruritus
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash erythematous, Rash generalised, Secretion discharge
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash, Rubella antibody negative
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Blister, Blood pressure increased, Crying, Dysphonia, Feeling hot
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Headache, Hyperhidrosis, Pain, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash generalised, Rubella antibody test, Scab, Urticaria
Clinical narrative: Information has been received from a nurse referring to a 50 year old female patient with allergy to azithromycin (reaction unspecified). On an unspecified date, the patient had titers drawn which showed no immunity to rubella. No past vaccination history available. In response to negative titers, on 18-MAR-2015 the patient was vaccinated with M-M-R II HSA, lot # K010318, expiration date: 22-JUL-2015, 0.5 ml, subcutaneously. On 20-MAR-2015, the patient developed rash on her hands, face and arms. The patient was sent to the Emergency Room for evaluation and no treatment information was available. The patient was not admitted to the hospital. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Thyroid disorder, X-ray normal
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Pain, X-ray normal
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Limb discomfort, Musculoskeletal pain
Clinical narrative: Reported pain 10/6/14 and evaluated in ER. Prednisone x3 days. Occupational health on 10/8/14. Follow with our pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative ending 1/30/15. (2) X ray 12/18/14=negative. (3) MRI show small disc problem, joint hypertrophy and thyroid lesion. 1/20/15 she is refusing PT. Has not missed work. Continues to have complaints of pain. No clear diagnosis. VAERS completed today.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Angioedema, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Swelling to face on 3/26. Swelling to lips, eyelids, and hives on subsequent days.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Eyelid oedema, Lip swelling, Swelling face, Urticaria
Clinical narrative: Swelling to face on 3/26. Swelling to lips, eyelids, and hives on subsequent days.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Aplastic anaemia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of about 64 years of age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced aplastic anaemia (medically significant). The patient sought medical attention from physician (unspecified). The outcome of aplastic anaemia was reported as not recovered. Causality assessment was not reported. No further information was reported. Upon internal review the event aplastic anaemia was considered as medically significant. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness around injection site.  Scratching noted at injection site.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Sore, swollen arm. Rash. Itchy skin, headache.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Pink, solid rash on back of neck for first four days.  On 3/12/15 I noticed distinct red spots on his neck, head, and upper chest.  The spots lasted for 3 days.  Also had a low-fever (101 F) with the spots.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Rash generalised
Clinical narrative: Patient presented to Physicians office with Rash/Spots on 3/31/15 that began the previous day (3/30/2015), and family noticed that the spots began to spread through out the body. Physician treated patient with calamine lotion and Benadryl.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient presented to Physicians office with Rash/Spots on 3/31/15 that began the previous day (3/30/2015), and family noticed that the spots began to spread through out the body. Physician treated patient with calamine lotion and Benadryl.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Neck pain, Pain in extremity
Clinical narrative: Redness extending from arm to neck, pain from arm to neck to back. Treatment Decadron 8mg IM.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gaze palsy, Irritability, Pyrexia, Respiratory arrest, Rhinovirus infection
Clinical narrative: Fever, fussiness, eyes rolled in back of head briefly. Family reports patient stopped breathing momentarily.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever, maculopapular rash.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial medication error report received on 09-OCT-2013 from a pharmacist. An under 7 years old child whose gender, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Pharmacist stated reported that Tdap inadvertently administered instead of Dtap to a child under 7 years. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very swollen, warm, slightly red and very painful.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Biopsy skin, Psoriasis, Rash
Clinical narrative: Patient received 3 doses of GARDASIL vaccine, shortly after third dose developed psoriasis HPV#1-3/26/13, HPV#2 6/3/13, HPV#3 10/24/13. Patient 1st seen for rash 2/4/14, mom reports it was there for a while before that.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Tremor
Clinical narrative: Fever within 12 hours of vaccine. Fever 102.4 3 days rash 2 days after vaccine. Has some shakiness as well.
Age: 39.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Large, swollen, red inflamed area surrounding injection site measuring about 6" x 8" in diameter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with ROTATEQ lot # K008140 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electromyogram normal, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging normal
Clinical narrative: Pain in left arm at point of flu vaccine and shoulder.  Reduced range of motion in shoulder/arm. On 2/17/15, received diagnosis of Adhesive Capsulitis or Frozen Shoulder from Orthopedic Specialist.  On 2/19/15, started Physical Therapy and OTC Pain Meds (Acetaminophen and Ibuprofen) as prescribed.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray limb, X-ray limb normal
Clinical narrative: Pain in left arm at point of flu vaccine and shoulder.  Reduced range of motion in shoulder/arm. On 2/17/15, received diagnosis of Adhesive Capsulitis or Frozen Shoulder from Orthopedic Specialist.  On 2/19/15, started Physical Therapy and OTC Pain Meds (Acetaminophen and Ibuprofen) as prescribed.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Culture urine, Full blood count normal, Irritability, Pyrexia
Clinical narrative: Fever 101-102, fussy behavior after vaccines admin.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis
Clinical narrative: Fever 101-102, fussy behavior after vaccines admin.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Oedema, Skin warm
Clinical narrative: PT Reported to clinic 1 April 2015 at 1520 with complaints of redness, induration, edema, and warm to touch.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Immune thrombocytopenic purpura, Laboratory test abnormal, Petechiae
Clinical narrative: Patient developed petechial rash following the MMRV and influenza and hepatitis B Vaccines on 3/19/15. Patient was admitted to the hospital and labs showed thrombocytopenia, likely cause ITP.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Blood culture negative, Computerised tomogram abnormal, Culture urine negative, Dizziness
Clinical narrative: Severe stomach pain, dizziness, blurry vision.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Vision blurred
Clinical narrative: Severe stomach pain, dizziness, blurry vision.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV4
Symptoms: Blood test, Central nervous system function test, Chest X-ray, Decreased appetite, Dizziness
Clinical narrative: Constant headache, fatigue, brain fog, dizziness, orthostatic intolerance, anorexia, poor sleep. Diagnosed with POTS Feb 19, 2015.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Constant headache, fatigue, brain fog, dizziness, orthostatic intolerance, anorexia, poor sleep. Diagnosed with POTS Feb 19, 2015.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV4
Symptoms: Orthostatic intolerance, Poor quality sleep, Postural orthostatic tachycardia syndrome
Clinical narrative: Constant headache, fatigue, brain fog, dizziness, orthostatic intolerance, anorexia, poor sleep. Diagnosed with POTS Feb 19, 2015.
Age: 1.37
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Mother reports about 30 minutes status post injection the patient's left upper thigh started swelling and getting warm. Thought it was a mild reaction, was rubbing on it and bathed child. 2 days later leg progressively getting more swollen, was warm to touch the night prior and now the thigh is hard and the patient keeps itching it. Patient will not walk or crawl on leg,so mother brought in child. Tx: Ranitidine BID and Benadryl every 6 hours for itch. Tylenol or Ibuprofen for pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Androgenetic alopecia
Clinical narrative: Hair loss; thinning hair.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy
Clinical narrative: Case number PHEH2015US006026, is an initial spontaneous report received from a consumer (patient) on 25 Mar 2015. This report refers to a 52-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 14650) intramuscularly on 21 Oct 2014. On an unknown date after the vaccination he was diagnosed with Parsonage-Turner syndrome. The outcome of the event was unknown. The seriousness and causality assessment of the event was not reported. Seriousness assessment of Parsonage-Turner syndrome was upgraded based on available information in the source document.
Age: 0.82
Sex: M
Vaccine: MMR
Symptoms: Ecchymosis, Epistaxis, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Developed ITP with platelets decreased 1,000/L. Presented with epistaxis, ecchymosis and petechiae of extremities and face 11 days after the vaccine. MMR given because of the travel to another country which was cancelled because of hospitalization. Had IV dexamethasone and IV immunoglobulin.
Age: 0.82
Sex: M
Vaccine: MMR
Symptoms: Platelet count decreased
Clinical narrative: Developed ITP with platelets decreased 1,000/L. Presented with epistaxis, ecchymosis and petechiae of extremities and face 11 days after the vaccine. MMR given because of the travel to another country which was cancelled because of hospitalization. Had IV dexamethasone and IV immunoglobulin.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified MMR II that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant referring to a 19 year old patient who on an unspecified date was inadvertently administered a pediatric dose of VAQTA (dose and route not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with M-M-R II with lot # K002816 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified (Oka/Merck) VARIVAX that were improperly stored. No adverse effects reported. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 16-MAR-2015, the patient was vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously, (anatomical location, lot number and expiration date were not reported), which underwent a supported temperature excursion. No adverse experiences were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a patient who received KINRIX (batch number 95ZT7, expiry date October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to KINRIX.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist from a pharmacist concerning a patient of unknown age and gender. Information regarding the concurrent conditions and medical history was not reported. On 15-MAR-2015 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # H015833, expiration date 24-AUG-2014; route and dose not reported). No adverse effect was reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous report as received from a physician refers to a 78 year old female patient. Concurrent or medical conditions were not reported. In 2008, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route and lot were not reported). Secondary suspects and concomitant therapies were not reported. The physician reported that about a year later, in 2009, after receiving ZOSTAVAX, the patient started having a burning pain without rash in the right lateral abdomen. The outcome of burning pain without rash in the right lateral abdomen was not reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Erythema, Genital erythema, Injection site erythema, Urticaria
Clinical narrative: Red area below shot site 11 x 12 cm red areas on both arms, face and genital area, red, raised whelp areas.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm, Swelling
Clinical narrative: Warm to touch. Swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. No information on concurrent and historical condition was reported. On 02-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot number: K016320, expiry date: 24-DEC-2015, subcutaneously in the left arm. On an unknown date (in March 2015, specified date unknown), the patient experienced adverse reaction. The patient had redenss, swelling, warmth at the injection site of left arm. On 04-MAR-2015 (reported as today), the patient sought medical attention by calling the pharmacy. The outcome the events reported as not recovered. The causality between events and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness on left inside of upper arm. Called Dr. Instructed client to ice red area for 30 minutes 3 x per day. Marked border of redness. Client came to PH office 3/30/2015 and redness had resolved and he did not seek any medical treatment for reaction.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and egnder who on 09-MAR-2015 was vaccinated with a unsupported temperature excursion dose of PNEUMOVAX23 (lot # reported as J49842, expiration date March 2016) (dose not reported), intramusuclar (incorrect product storage). No adverse effects were3 reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with PROQUAD lot number K022445 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Initial medication error report received on 07 September 2013 from a Nurse. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Patient used ADACEL twice in a two month period. A woman administers a dose of Tdap vaccine to pregnant women during each pregnancy ideally at between 27 and 36 weeks. Patient did not have any adverse events. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Redness. Hot to touch. 3 1/2 x 3 in.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as receivd from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with GARDASIL lot number K023435 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with M-M-R II lot number J014872 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with VARIVAX (Merck) with lot # K007781 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to her pregnant female friend of unknown age. Date of last menstrual period was on approximately on 22-SEP-2014, date of conception was on approximately 06-OCT-2014 and estimate delivery date would be on approximately 29-JUN-2015. On 09-MAR-2015 at six month pregnant, the patient was inadvertently vaccinated with a dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with MMR II with lot # J014876 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with GARDASIL lot # K006124 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well/ There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with GARDASIL lot # K007264 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 23-MAR-2015 the patient was inadvertently vaccinated subcutaneously with an expired dose of ZOSTAVAX (0.65 ml; lot # J012657, expiration date 10-JAN-2015). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with VARIVAX (Merck) lot # K010338 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with VARIVAX (Merck) lot # K008819 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt mentioned to staff Rph approximately 3/17 that his arm was still sore. Rx M tried to call pt. Left message pt. came in Mon 3/23 and said arm was sore after injection and has been sore since. Also when hold arm out to side and elevates it. Also when he sleeps at night. I advised him to seel medical attention as that is not a normal side effect.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient noticed rash 30 hrs after vaccine and the next day it got worse so the day after that-3/20-patient went to MD to get it checked. Rash went from elbow up towards back of shoulder. It was itchy, red, swollen and hot to touch. MD gave cefadroxil. Pt started cefadroxil 3/20 at 6pm. Rash was getting better by 3/21 12pm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The vaccine was given in left outer lower arm and it really hurt. That evening my arm at inj. site was red, itchy, hot and sore. Swollen red area was size of a fist and lasted 2 wks. Only Rx I did was put ice on it. I am a retired R.N.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date an unspecified patients received improperly stored PROQUAD (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Disorientation, Dizziness, Fatigue, Full blood count, Hyperhidrosis
Clinical narrative: Extremely tired, disoriented, after moderate exercise experienced sweating, shakiness, light headed.
Age: 43.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Tremor
Clinical narrative: Extremely tired, disoriented, after moderate exercise experienced sweating, shakiness, light headed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 23-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K024031, expiration date; February 2016 (dose and route of administration were not reported). On 23-MAR-2015, the patient experienced red spot which looked "like the size of a nickel" at the injection site and could possibly be a rash. The patient sought medical attention: spoke to the pharmacist. No treatment was given for the adverse event. The outcome of the event was reported as not recovered. Relatedness between the event and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with ROTATEQ with lot number K016279 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Red 3" band around arm, warm, tender to touch at injection site. Nausea, dizziness.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-DEC-2002, one day after the patient's first birthday, the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Erythema of arm (upper) deltoid 3 days post shot, continuing to be erythematous, decreasing in warmth when seen in office.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date an unspecified patients received improperly stored RECOMBIVAX HB (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female nurse practitioner of unknown age, refers to herself. On an unknown date, the nurse was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number were not reported). The nurse practitioner reported that she found out afterwards that she was pregnant. The Last Menstrual Period (LMP) date and Estimate Date of Delivery (EDD) were not known. The pregnancy outcome was lost to follow-up, the fetus outcome was unknown. Vaccine exposure during pregnancy outcome was unknown (also reported as not recovered). Additional information is not expected because the reporter's contact details were incomplete.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Extensive swelling of vaccinated limb, Hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received FLUARIX. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included ankylosing spondylitis, allergic reaction to antibiotics and allergy. On an unknown date, the patient received the 1st dose of FLUARIX (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX, the patient experienced allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration. On an unknown date, the outcome of the allergic reaction and condition aggravated were recovered/resolved and the outcome of the extensive swelling of vaccinated limb, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration to be related to FLUARIX. Additional information received: The reporter called to ask RN in office (the patient) can receive BOOSTRIX and if it has anything in common with FLUARIX TIV. to the best of their knowledge, FLUARIX TIV caused the patient to have an allergic reaction of local swelling and induration to 2-3 inches at site of injection on first dose 2-3 years ago when she was 56-57 year-old. A repeat dose of FLUARIX TIV the next year resulted in her whole arm swelling, which required doctor's office attention (see case US2015GSK043064).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received FLUARIX. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included ankylosing spondylitis, allergic reaction to antibiotics and allergy. On an unknown date, the patient received the 1st dose of FLUARIX (intramuscular) .5 ml. On an unknown date, unknown after receiving FLUARIX, the patient experienced allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration. On an unknown date, the outcome of the allergic reaction and condition aggravated were recovered/resolved and the outcome of the extensive swelling of vaccinated limb, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the allergic reaction, condition aggravated, extensive swelling of vaccinated limb, injection site swelling and injection site induration to be related to FLUARIX. Additional information received: The reporter called to ask RN in office (the patient) can receive BOOSTRIX and if it has anything in common with FLUARIX TIV. to the best of their knowledge, FLUARIX TIV caused the patient to have an allergic reaction of local swelling and induration to 2-3 inches at site of injection on first dose 2-3 years ago when she was 56-57 year-old. A repeat dose of FLUARIX TIV the next year resulted in her whole arm swelling, which required doctor's office attention (see case US2015GSK043064).
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-MAR-2014 the patient was vaccinated with RECOMBIVAX HB strength reported as: 2.5mcg/0.5ml (dose, route and lot # not provided). Later on 27-MAY-2014, 07-AUG-2014 and 25-SEP-2014 the patient received doses of PEDIARIX (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 9-year-old female patient who received Influenza vaccine unspecified. On an unknown date, the patient received Influenza vaccine unspecified. In February 2015, an unknown time after receiving Influenza vaccine unspecified, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to Influenza vaccine unspecified. Additional information was provided: No other events were noted or reported.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient came in 4/1/15 to say her arm where injection site was given was still painful off and on since 3/17/15 no swelling or redness just pain indicated patient was to have doctor appointment 4/1/15 to check it out.