chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 27 year old female patient. The patient was seen in the office. On 28-JAN-2014 for a "post-partum" visit. At that time the patient received a dose of M-M-R II (lot # H016132, 31-AUG-2014) injection, 0.5 ml/once, subcutaneous. No concomitant medication was reported. The patient had a "pregnancy test" conducted. The pregnancy test showed "positive" and the nurse stated "we had already given the M-M-R II and then we learned she was pregnant". No treatment was given to the patient. The last menstrual period (LMP) and expected delivery of date (EDD) were unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician via company representative to a 74 year old male patient. On 25-SEP-2013, the patient was vaccinated with ZOSTAVAX lot # H013938, subcutaneous as directed. Concomitant medication included AFLURIA. On 05-NOV-2013, 42 days after onset of therapy, the patient experienced pain in his right thigh. On an unknown date in November 2013, the patient was seen in the ER and was diagnosed with shingles. On 18-NOV-2013, the patient sought medical attention and visited the office for treatment. The patient was treated with VOLTAREN Gel, acyclovir, LYRICA and CYMBALTA. The patient had multiple follow up visits on 18-DEC-2013 and on 22-JAN-2014 to proceed with the treatment. The outcome of the event shingles was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse via company representative refers to unknown number of patients of 6 months of age. On an unknown date, the patients were vaccinated with PEDVAXHIB,(dose unspecified) intramuscular injection at 2 months, 4 months and then 6 months. Concomitant therapy unspecified. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersomnia, Injection site erythema, Injection site reaction, Injection site swelling, Loss of consciousness
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a 11 year old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JUN-2008 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 658422/1030U, Exp date: 27-JUN-2009) (dose and route unspecified). No concomitant medication reported. On 20-JUN-2008, less than 24 hours later the patient started throwing up and became ill while at a soccer game. The consumer reported that her son left the soccer game and when her son got home he "passed out" and fell asleep. The consumer reported that her son slept for the next 24 hours. The consumer reported that when her son was sleeping she noticed that there was an injection site reaction at the site of the VARIVAX (Merck) vaccination that was described as a red, raised oval about 4 inches by 4 inches at the site of the VARIVAX (Merck) vaccination. The consumer reported that when her son woke up he felt better and within 4 or 5 days the injection site reaction resolved and her son was recovered (date unspecified). No treatment was given for the events and no lab diagnostics studies performed. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a 11 year old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JUN-2008 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 658422/1030U, Exp date: 27-JUN-2009) (dose and route unspecified). No concomitant medication reported. On 20-JUN-2008, less than 24 hours later the patient started throwing up and became ill while at a soccer game. The consumer reported that her son left the soccer game and when her son got home he "passed out" and fell asleep. The consumer reported that her son slept for the next 24 hours. The consumer reported that when her son was sleeping she noticed that there was an injection site reaction at the site of the VARIVAX (Merck) vaccination that was described as a red, raised oval about 4 inches by 4 inches at the site of the VARIVAX (Merck) vaccination. The consumer reported that when her son woke up he felt better and within 4 or 5 days the injection site reaction resolved and her son was recovered (date unspecified). No treatment was given for the events and no lab diagnostics studies performed. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu and pneumonia vaccines given in right deltoid 1" apart. Injections went well - no bleeding. He said later that evening was red, swollen and sore - went to express care 3 days later - swollen and red about 4" below injection. Received BACTRIM DS - 2 BID. Today - swollen down to elbow. Saw Infectious Disease Dr who ran CBC - waiting for results.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMRV, PNC13
Symptoms: Chills, Febrile convulsion, Nasopharyngitis, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 1 year old male patient. Pertinent medical history was reported as none. No known drug allergy was reported. On 23-JAN-2014, the patient was vaccinated with PROQUAD (Merck), dose (unspecified), frequency (unspecified), subcutaneous in the right thigh, Lot# J014237, expiry date 07-MAY-2015. Concomitant therapies included FLUZONE, PENTACEL and PREVNAR, on same visit (23-JAN-2014), separate sites. The nurse reported that on an unknown date, the patient developed chills, a fever and had a febrile seizure following administration of PROQUAD. Patient sought medical attention due to office contact. The patient informed (during the office visit on 31-JAN-2014) that on 30-JAN-2014, they went to the emergency room for treatment of febrile seizure (not admitted) and ibuprofen was provided at emergency room. During an office visit on 31-JAN-2014, the patient informed that they had cold symptoms with a fever for the last 3 days (estimated as 28-JAN-2014) and had a febrile seizure on January 2014 (estimated from the product administration date). The nurse reported that during the office visit on 31-JAN-2014. no fever was detected. No lab diagnostics studies were performed. Outcome of events was reported as recovered. Causality assessment was not provided. No product quality complaint was involved. No other information to report. Upon internal review, febrile seizure was considered serious due to other important medical event. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Nausea, Shock hypoglycaemic
Clinical narrative: This spontaneous report as received from a register nurse via Company Representative concerning a 14 year old patient of unknown gender with diabetes. Medical history was not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot number were not provided). Secondary and concomitant therapies were not reported. On an unknown date, the patient felt nauseous and may have suffered a diabetic shock after the first dose of GARDASIL was administered. The outcome of the events was not reported. Upon internal review diabetic shock was considered as an other important medical event. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Diabetic complication, Hypoglycaemia, Nausea, Shock
Clinical narrative: This spontaneous report as received from a register nurse via Company Representative concerning a 14 year old patient of unknown gender with diabetes. Medical history was not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot number were not provided). Secondary and concomitant therapies were not reported. On an unknown date, the patient felt nauseous and may have suffered a diabetic shock after the first dose of GARDASIL was administered. The outcome of the events was not reported. Upon internal review diabetic shock was considered as an other important medical event. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Nausea, Shock hypoglycaemic
Clinical narrative: This spontaneous report as received from a registered nurse via Company Representative concerning a 14 year old patient of unknown gender with diabetes. Medical history was not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot number were not provided). Secondary and concomitant therapies were not reported. On an unknown date, the patient felt nauseous and may have suffered a diabetic shock after the first dose of GARDASIL was administered. The outcome of the events was not reported. Upon internal review diabetic shock was considered as an other important medical event. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Diabetic complication, Hypoglycaemia, Nausea, Shock
Clinical narrative: This spontaneous report as received from a registered nurse via Company Representative concerning a 14 year old patient of unknown gender with diabetes. Medical history was not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot number were not provided). Secondary and concomitant therapies were not reported. On an unknown date, the patient felt nauseous and may have suffered a diabetic shock after the first dose of GARDASIL was administered. The outcome of the events was not reported. Upon internal review diabetic shock was considered as an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified amount of patients (ages not provided). The nurse practitioner stated that the patients had received their GARDASIL series for prophylaxis off-schedule on unspecified dates. Lot numbers were not provided. No adverse effects reported. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging, Oropharyngeal pain
Clinical narrative: Start to get sore throat then GBS.
Age: 41.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging, Oropharyngeal pain
Clinical narrative: Start to get a sore throat then GBS.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was vaccinated with M-M-R II (0.5 ml, lot # 671686/1874AA, expiration date 20-NOV-2013) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the patient received an expired dose of M-M-R II on 29-JAN-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date in May 2013, the patient was vaccinated with GARDASIL, first dose for prophylaxis. Nurse reported the patient is in the office now to receive second dose. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (route, dose, lot number and expiration date were not reported). There was no concomitant medication reported. The nurse stated that on an unspecified date the patient exhibited "Autism like behavior" for two weeks after the administration of the M-M-R II. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cheilitis, Erythema, Headache, Injection site discharge
Clinical narrative: Pt presented to urge center - received shingles vaccine Saturday 2/8/14 left arm has large lump c/o achy, fever headache and discharge at injection site. Assessed - Left posterior forearm draining vesicle, warm, edema, erythema, fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Pyrexia, Skin warm, Upper extremity mass
Clinical narrative: Pt presented to urge center - received shingles vaccine Saturday 2/8/14 left arm has large lump c/o achy, fever headache and discharge at injection site. Assessed - Left posterior forearm draining vesicle, warm, edema, erythema, fever.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception one day after receiving PO Rotavirus vaccine. Required air enema reduction and hospitalization.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Colectomy, Enema administration, Haematochezia, Intussusception
Clinical narrative: Went to ER due to vomiting and bloody stools, also lethargic on 12-12-13 was admitted. Abd. ultrasound and barium enema was done. Was diagnosed with intussusception. Was taken to surgery where he had 2 inches of colon removed.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Surgery, Ultrasound abdomen, Vomiting
Clinical narrative: Went to ER due to vomiting and bloody stools, also lethargic on 12-12-13 was admitted. Abd. ultrasound and barium enema was done. Was diagnosed with intussusception. Was taken to surgery where he had 2 inches of colon removed.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: CSF protein abnormal, CSF protein increased, Dysarthria, Electromyogram, Guillain-Barre syndrome
Clinical narrative: 9/3/13 loss muscle tone jaw, slurred speech onset, progressive neuro muscular weakness, diagnosed by L/P 9/14/13 w/Guillain Barre Syndrome.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Hypotonia, Muscular weakness
Clinical narrative: 9/3/13 loss muscle tone jaw, slurred speech onset, progressive neuro muscular weakness, diagnosed by L/P 9/14/13 w/Guillain Barre Syndrome.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Troponin increased
Clinical narrative: Pt received smallpox vaccine on 15Jan by medic. Pt noticed chest pain 23Jan and was flown to facility 26Jan. Labs were drawn and they showed that his troponin was elevated: .56ng/ml.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Pain in extremity, Pyrexia, Rash
Clinical narrative: Vaccine was given on 1-10-14, on 1-12-14 patient states arm was very sore. Had a low grade fever and a rash on arms an trunk. States lasted till 1-14-14 and rash and fever subsided. Presented requesting note stating she could return to work. I spoke with Dr and inst to write patient a note to return to work.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Cough, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Initial information received on 04 February 2014 from a consumer who is the patient's parent. A 19-month-old male patient received a fourth dose of DTaP (manufacturer, route, site of administration not reported) on 12-MAY-2010. The patient's concomitant medications were not reported. The patient had received 3 previous doses of DTaP, manufacturer unknown, in the past. Within a few minutes the patient started coughing, had tingling of tongue, lips and started swelling of throat. The patient was treated with an EPIPEN and steroids, date not reported. The patient was transferred to the hospital emergency room. The symptoms resolved and the patient was able to go home. The patient had no further symptoms. The patient outcome was recovered. Documents held by sender: None.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Aldolase normal, Areflexia, Asthenia, Blood creatine phosphokinase normal, Blood electrolytes normal
Clinical narrative: A 78-year-old man with a medical history of atrial fibrillation presented with complaints of 5 days of severe generalized weakness and difficulty walking. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. On further questioning, he also reported taking an influenza vaccine shot a few days prior to his weakness. He reported a history of similar illness with respiratory issues requiring tracheostomy after a simple upper respiratory infection when he was 10 years old. Physical exam showed significant proximal as well as distal muscle weakness in the bilateral upper and lower extremities. Sensations were preserved, and reflexes were absent. His laboratory workup including complete blood count, electrolytes, TSH, CPK, and aldolase levels were normal. MRI head was unremarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of chronic inflammatory demyelinating polyneuropathy triggered by influenza vaccination. The episode during childhood was presumably an episode of Guillain-Barre syndrome that developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness. He was subsequently sent to a physical rehabilitation center. The patient was advised not to repeat influenza vaccination in future." Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Electromyogram abnormal, Full blood count normal
Clinical narrative: A 78-year-old man with a medical history of atrial fibrillation presented with complaints of 5 days of severe generalized weakness and difficulty walking. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. On further questioning, he also reported taking an influenza vaccine shot a few days prior to his weakness. He reported a history of similar illness with respiratory issues requiring tracheostomy after a simple upper respiratory infection when he was 10 years old. Physical exam showed significant proximal as well as distal muscle weakness in the bilateral upper and lower extremities. Sensations were preserved, and reflexes were absent. His laboratory workup including complete blood count, electrolytes, TSH, CPK, and aldolase levels were normal. MRI head was unremarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of chronic inflammatory demyelinating polyneuropathy triggered by influenza vaccination. The episode during childhood was presumably an episode of Guillain-Barre syndrome that developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness. He was subsequently sent to a physical rehabilitation center. The patient was advised not to repeat influenza vaccination in future." Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Laboratory test normal, Mobility decreased, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: A 78-year-old man with a medical history of atrial fibrillation presented with complaints of 5 days of severe generalized weakness and difficulty walking. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. On further questioning, he also reported taking an influenza vaccine shot a few days prior to his weakness. He reported a history of similar illness with respiratory issues requiring tracheostomy after a simple upper respiratory infection when he was 10 years old. Physical exam showed significant proximal as well as distal muscle weakness in the bilateral upper and lower extremities. Sensations were preserved, and reflexes were absent. His laboratory workup including complete blood count, electrolytes, TSH, CPK, and aldolase levels were normal. MRI head was unremarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of chronic inflammatory demyelinating polyneuropathy triggered by influenza vaccination. The episode during childhood was presumably an episode of Guillain-Barre syndrome that developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness. He was subsequently sent to a physical rehabilitation center. The patient was advised not to repeat influenza vaccination in future." Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: A 78-year-old man with a medical history of atrial fibrillation presented with complaints of 5 days of severe generalized weakness and difficulty walking. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. On further questioning, he also reported taking an influenza vaccine shot a few days prior to his weakness. He reported a history of similar illness with respiratory issues requiring tracheostomy after a simple upper respiratory infection when he was 10 years old. Physical exam showed significant proximal as well as distal muscle weakness in the bilateral upper and lower extremities. Sensations were preserved, and reflexes were absent. His laboratory workup including complete blood count, electrolytes, TSH, CPK, and aldolase levels were normal. MRI head was unremarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of chronic inflammatory demyelinating polyneuropathy triggered by influenza vaccination. The episode during childhood was presumably an episode of Guillain-Barre syndrome that developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness. He was subsequently sent to a physical rehabilitation center. The patient was advised not to repeat influenza vaccination in future." Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site oedema, Nausea
Clinical narrative: Erythema, edema, induration at injection site (Lt leg). Systemic symptoms of headache, nausea, vomiting. Subjective fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Erythema, edema, induration at injection site (Lt leg). Systemic symptoms of headache, nausea, vomiting. Subjective fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Patient called today and stated next day c/o itching, swelling to ZOSTAVAX site with H/A and nausea. Received rx 2/1/14 for cellulitis.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Injection was very painful, I told the pharmacist the inj location was too high, close to shoulder. Since inj, I've experienced pain shooting down toward elbow and up toward shoulder and back.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Pt experiencing sharp pain in the muscle w/ stretching movements. Started at onset of flu shot and has continued since.
Age: 71.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Fine motor delay, Mobility decreased, Pain in extremity
Clinical narrative: First reported symptoms on 1/19 and again on 1/31/14. Symptoms of pain down arm, problem lifting, and decreased fine motor skill in hand. Slow improvement over 1/19 - 1/31 time frame. Tried icing and OTC pain meds. Has not seen physician yet.
Age: 71.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Mobility decreased, Motor dysfunction, Pain in extremity
Clinical narrative: First reported symptoms on 1/19 and again on 1/31/14. Symptoms of pain down arm, problem lifting, and decreased fine motor skill in hand. Slow improvement over 1/19 - 1/31 time frame. Tried icing and OTC pain meds. Has not seen physician yet.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: PNEUMOVAX administered at pharmacy Saturday 1/25 following morning developed redness, warmth at site, pain into axilla and down arm 3 of 5 pain scale.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Confusional state, Cough, Ear pain, Hallucination
Clinical narrative: Fever, cough, aching ear and throat, urine infection (the first 4 days).  Then I got tremors, nervousness, confusion, hallucination, stomach ache and nausea (1 week).  But I still have nervousness, nausea and stomach ache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Nausea, Nervousness, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, cough, aching ear and throat, urine infection (the first 4 days).  Then I got tremors, nervousness, confusion, hallucination, stomach ache and nausea (1 week).  But I still have nervousness, nausea and stomach ache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urinary tract infection
Clinical narrative: Fever, cough, aching ear and throat, urine infection (the first 4 days).  Then I got tremors, nervousness, confusion, hallucination, stomach ache and nausea (1 week).  But I still have nervousness, nausea and stomach ache.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX on 8-29-13 in her left deltoid. The area was sore that evening and by the following day it was better. Patient noticed pain and redness in the left arm the day after the vaccine was given but not in the area of the injection. Patient came to the ER on 8-31-13 at 12:05 p.m. for the pain and redness of the left arm. Patient was given 1 gm of ROCEPHIN at the ER and instructed to use heat carefully to the area, use TYLENOL or MOTRIN for pain and sent home.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: 1/17/14 at 13:28 PM received varicella vaccination in right ventral gluteal area subcutaneously per request - refused arm injection. 1/18/14 about 18:00 noted soreness/pain at injection site and then later in evening redness/swelling extending into groin area which then caused pain with hip movement. 1/20/14 at 6:55 AM contacted Employee Health sent to office (Worker's Comp provider) for further evaluation and treatment. Placed on Medical activity for 24 hours and requested to take TYLENOL every 6 hours for 24 hours. Requested to follow-up on 1/27/14. Employee did not make appointment, however on 1/24/2014 stated area was less sore and healing.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Varicella virus test negative
Clinical narrative: 1/17/14 at 13:28 PM received varicella vaccination in right ventral gluteal area subcutaneously per request - refused arm injection. 1/18/14 about 18:00 noted soreness/pain at injection site and then later in evening redness/swelling extending into groin area which then caused pain with hip movement. 1/20/14 at 6:55 AM contacted Employee Health sent to office (Worker's Comp provider) for further evaluation and treatment. Placed on Medical activity for 24 hours and requested to take TYLENOL every 6 hours for 24 hours. Requested to follow-up on 1/27/14. Employee did not make appointment, however on 1/24/2014 stated area was less sore and healing.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Arthralgia, Back pain, Blood test, Double stranded DNA antibody positive, Fatigue
Clinical narrative: 4/9/11 First symptoms - swollen finger, nodule on wrist next week pain in jaw and times when she called not straighten her finger. Increasing pain and swelling in knees, hands, feet, fingers and toes. Back and shoulder pain. Fatigue. Saw rheumatologist 6/8/11. Fever and rash all over body 6/19/11. Dx w/Lupus (SLE) 6/29/11, Tx prednisone and PLAQUENIL.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Joint swelling, Local swelling, Musculoskeletal pain, Nodule, Pain in jaw
Clinical narrative: 4/9/11 First symptoms - swollen finger, nodule on wrist next week pain in jaw and times when she called not straighten her finger. Increasing pain and swelling in knees, hands, feet, fingers and toes. Back and shoulder pain. Fatigue. Saw rheumatologist 6/8/11. Fever and rash all over body 6/19/11. Dx w/Lupus (SLE) 6/29/11, Tx prednisone and PLAQUENIL.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Pyrexia, Rash generalised, Systemic lupus erythematosus, Trigger finger
Clinical narrative: 4/9/11 First symptoms - swollen finger, nodule on wrist next week pain in jaw and times when she called not straighten her finger. Increasing pain and swelling in knees, hands, feet, fingers and toes. Back and shoulder pain. Fatigue. Saw rheumatologist 6/8/11. Fever and rash all over body 6/19/11. Dx w/Lupus (SLE) 6/29/11, Tx prednisone and PLAQUENIL.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, "single 0.65 ml", "subcutaneous injection". Lot number were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that the patient who had received ZOSTAVAX, later developed Shingles (approximately in 2013), which caused patient to be in "a lot of pain." The patient visited the healthcare office with the Shingles "within the last 2 months". At the time of this report the outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Mother states her face and tongue became swollen. Denied the baby having any trouble breathing or swallowing.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain
Clinical narrative: Swelling on upper arm and shoulder, pain Localized. Heat and anti inflammatory. Was told It would take a few days to get better.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: LIGHTHEADEDNESS, AND NAUSEA FOR APPROX 10 MIN THEN C/O SUBSIDED. NO TREATMENT INITIATED R/T SYMPTOM SUBSIDED. VR 02/11/14.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: LIGHTHEADEDNESS, NAUSEA AT ONSET, THEN PROGRESSED INTO HEADACHE WITH VOMITING APPROX 6 HOURS LATER. VR 02/11/2014.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Left arm (Pneumococcal vaccine) red, hot and painful to touch from injection site to elbow.  Right arm (Zostavax vaccine) hot and hard to touch. Generally did not feel well. Symptom free by AM 02/09/2014.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Left arm (Pneumococcal vaccine) red, hot and painful to touch from injection site to elbow.  Right arm (Zostavax vaccine) hot and hard to touch. Generally did not feel well. Symptom free by AM 02/09/2014.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Hypoaesthesia, Polymerase chain reaction, Rash generalised, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient. Diagnosed by Dermatology. MR#02404814. It started with 1 bump on her right hand in between her fingers, then turned into a cluster, then spread up her right arm and onto her chest. Some on leg and one on foot. No pain or itchiness, but numbness in hand. Treated with antiviral (unknown name). No underlying medical conditions. Lasted less than 4 weeks.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Quadriplegia
Clinical narrative: HE CAME HOME FROM SCHOOL LAID DOWN AND COULD GET UP ONCE HE WOKE UP.  HE WAS PARALYZED FROM THE NECK DOWN.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Radiculitis cervical, X-ray limb
Clinical narrative: Shoulder pain. Diagnosed with cervical radiculitis. Shoulder X-rays done and doctor felt that symptoms are unrelated to injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cardiac pacemaker insertion, Fatigue, Fluid retention, Gait disturbance
Clinical narrative: Information was received from a 54 year-old female patient who in September 2012, following a routine physical which resulted in a "clean bill of health," was vaccinated with a single dose of ZOSTAVAX (dosage and route of administration not provided). In September 2012, shortly after administration, the patient developed an enlarged red spot at the injection site. She followed with her healthcare provider twice and was advised that she had a local reaction to the vaccine and was advised to use BENADRYL. She developed a fever "shortly after." The following week, the patient "became very ill." She experienced severe fatigue, difficulty in walking and was hospitalized for one week. The patient had "gained 20 lbs. of water weight and her 'ES' was 'down to 15'." The patient reported that two weeks after receiving ZOSTAVAX, she received a diagnosis of congestive heart failure as a result of viral infection, "possibly brought on by the vaccine." At an unspecified time after, the patient had a pacemaker installed. Upon internal review, pacemaker installed was determined to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Malaise, Pyrexia, Viral infection
Clinical narrative: Information was received from a 54 year-old female patient who in September 2012, following a routine physical which resulted in a "clean bill of health," was vaccinated with a single dose of ZOSTAVAX (dosage and route of administration not provided). In September 2012, shortly after administration, the patient developed an enlarged red spot at the injection site. She followed with her healthcare provider twice and was advised that she had a local reaction to the vaccine and was advised to use BENADRYL. She developed a fever "shortly after." The following week, the patient "became very ill." She experienced severe fatigue, difficulty in walking and was hospitalized for one week. The patient had "gained 20 lbs. of water weight and her 'ES' was 'down to 15'." The patient reported that two weeks after receiving ZOSTAVAX, she received a diagnosis of congestive heart failure as a result of viral infection, "possibly brought on by the vaccine." At an unspecified time after, the patient had a pacemaker installed. Upon internal review, pacemaker installed was determined to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight increased
Clinical narrative: Information was received from a 54 year-old female patient who in September 2012, following a routine physical which resulted in a "clean bill of health," was vaccinated with a single dose of ZOSTAVAX (dosage and route of administration not provided). In September 2012, shortly after administration, the patient developed an enlarged red spot at the injection site. She followed with her healthcare provider twice and was advised that she had a local reaction to the vaccine and was advised to use BENADRYL. She developed a fever "shortly after." The following week, the patient "became very ill." She experienced severe fatigue, difficulty in walking and was hospitalized for one week. The patient had "gained 20 lbs. of water weight and her 'ES' was 'down to 15'." The patient reported that two weeks after receiving ZOSTAVAX, she received a diagnosis of congestive heart failure as a result of viral infection, "possibly brought on by the vaccine." At an unspecified time after, the patient had a pacemaker installed. Upon internal review, pacemaker installed was determined to be medically significant. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site erythema, Nausea, Pain, Pain in extremity
Clinical narrative: Initially, sore arm. Then progressed to full body aches and persistent nausea. 2-3 inch diameter red area around injection site.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient states he broke out in hives, noted redness and itching to neck, arms and back approximately 30 mins. after receiving the vaccine. TX. = BENADRYL 50mg IM, CELESTONE 6mg IM.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.08
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Small pox administered, patient at estimated 1 day gestation.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 16 year old male patient. Pertinent medical history and drug reactions/allergies were not reported. On 16-SEP-1998, the patient was vaccinated with a first dose of VARIVAX (Merck) (dose and route were not reported. Concomitant therapy was not reported. On 16-SEP-2010, the patient was given the second dose of VARIVAX (Merck) (lot number was reported as 0435Z, expiration date was unspecified) (dose and route were not reported) as catch up dose. On an unknown date, Nurse reporting a patient who received 2 doses of VARIVAX (Merck) was reporting shingles. The patient started with a rash on the middle lower back and down the left anterial lateral thigh which was painful and burning. The unspecified mother of the patient told the nurse the patient had no known history of chickenpox. The dermatologist told the mother of the patient, the patient must have had chickenpox to get shingles. The patient received two unspecified ointments as treatment. No lab diagnostics studies were performed. The outcome of the event was reported as recovering. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration, Local reaction, Skin warm
Clinical narrative: Patient it was hot and har - 8X11 cm.  ID physician stated it was a local reaction to the R deltoid with erythema, warmth and tenderness.  No evidence of cellulitis.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient it was hot and har - 8X11 cm.  ID physician stated it was a local reaction to the R deltoid with erythema, warmth and tenderness.  No evidence of cellulitis.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore shoulder and upper arm, red, fever.
Age: 1.57
Sex: F
Vaccine: FLU4
Symptoms: Full blood count normal, Gait disturbance, Injection site joint swelling, Synovitis, X-ray normal
Clinical narrative: Swelling of left knee and limping. Vaccine was administered in the left leg. She did have a cold at the onset of this as well.
Age: 1.09
Sex: F
Vaccine: HIBV, MENHIB, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: Nothing as of right now.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, warm area with pain and itching at injection site. Instructed to take Benadryl and return to clinic if not better.  If worsend, should report to ER.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema, Skin lesion
Clinical narrative: PATIENT DESCRIBED THE APPEARANCE OF ROUND, RED LESIONS ON TRUNK, LEFT AND RIGHT ARM OF BODY.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: Patient reported that site was initially swollen and itchy. She understood that was a possible reaction. However, over 2 months have passed and she still has a bump the size of a mosquito bite there, and it still itches. Reported no other problems.
Age: 1.72
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Heart rate increased, Productive cough, Pyrexia, Rash
Clinical narrative: High fever, rapid heartbeat, bumps on skin, junky cough, low energy.
Age: 1.72
Sex: M
Vaccine: VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: High fever, rapid heartbeat, bumps on skin, junky cough, low energy.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore Arm.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle spasms, Pain
Clinical narrative: My left/upper arm started to have spasms like a Charley horse, and my range of motion is limited I cannot fully straighten my arm without pain nor can I flex my arm. I am having radiating pain from my upper left arm down to my elbow. My left/upper arm feels as though I have been lifting weights and it is very sore to the touch. I have reported back to employee health at the hospital, I have seen a doctor at the Multispecialty Clinic, who has put me on muscle relaxers (Cyclobenzaprine 5mg) and for the pain (Naproxen 250mg) neither has helped me to recover.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT WAS LESS THAN 18 YO AND RECVD THE FLUCELVAX INJECTION THAT IS INDICATED FOR 18 AND OLDER. NO RETURN VISIT OF COMPLAINT FROM CUSTOMER.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Skin warm, Ultrasound scan, X-ray limb
Clinical narrative: Severe pain in left shoulder increased everyday horrible pain in mobility cant sleep went to chiropractor, had heat and TINS, then emergency room had shoulder injection and Tramadol neither  Stopped the pain then went to Orthopedist xrays and ultrasound; who recommended physical therapy I cant afford therapy so exercise with rubber straps but no help still unbearable pain with any arm movement. Constant pain and lack of use for two months and 3 days so far.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Axonal neuropathy, Electromyogram, Nerve conduction studies, Respiratory failure
Clinical narrative: Acute Demyelinating Axonal Neuropathy (similar to Guillain Barre), leading to diffuse weakness and respiratory failure.  Now has a tracheostomy, remains weak, and now is transferred to an LTAC.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tracheostomy
Clinical narrative: Acute Demyelinating Axonal Neuropathy (similar to Guillain Barre), leading to diffuse weakness and respiratory failure.  Now has a tracheostomy, remains weak, and now is transferred to an LTAC.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Movement disorder, Pain, Paraesthesia
Clinical narrative: Tingling and little pain initially. Having difficulty moving arm, wearing clothes. Saw orthopaedic who recommended physical therapy.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: 3 PM - Rash on face and neck. 430 P - Rash to chest, abdomen and scalp. Lg. hives (silver dollar) size. Consulted with N.P. BENADRYL 50mg PO at 630 P, 11 PM and 630 AM (2-11-14). Rash gone but still itchy.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Muscle arm/shoulder pain. Can't lift arm. Since the date of vaccination, pain has gotten worse rather than better. Have had flu shot previous years - no ill effects.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Breath holding, Erythema, Musculoskeletal stiffness, Respiratory arrest
Clinical narrative: Patient received ROTATEQ and PCV13 when pt began holding his breath for a few seconds and began breathing. Pt then was given HIB when he held breath again and stopped breathing. Pt face turned red and body was stiff when vigorous stimulus was applied and began breathing again. Code Blue was called prior to stimulus and doctors assessed pt when pt was transported to hospital.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye pain, Injection site erythema, Injection site induration, Injection site pain, Ocular hyperaemia
Clinical narrative: Ocular (red eyes) and eye pain of 24-48 hours duration. Local site redness, induration, pain and soreness, 24-48 hours.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fall, Tremor
Clinical narrative: Chills and shakes, got out of bed and fell down.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling at injection site. Some redness with itching. Sx seen after post injection: no tx - suggested ice pack and hydrocortisone cream.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria. Pruritus.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chapped lips, Injection site erythema, Injection site swelling, Injection site warmth, Oral herpes
Clinical narrative: This spontaneous report was received from a 56 year old female patient regarding on herself with migraine headaches and none drug allergies, who on 15-OCT-2013, was vaccinated with a dose of ZOSTAVAX (Lot no. J004266, exp. 12-JUL-2014), subcutaneous in the left arm for vaccination. Concomitant therapies included TOPAMAX. On 15-OCT-2013 the patient developed swelling, redness and warmth at the injection site 1 hour after administration of ZOSTAVAX. On 17-OCT-2013, the patient developed multiple fever blisters on her lip. The patient was evaluated by her unspecified physician who prescribed two courses of antiviral medication. On approximately 29-OCT-2013 (reported as 'within two weeks") injection site reaction resolved. The patient added that the corners of her mouth were cracked. The patient tried ABREVA and "lactinex". No lab diagnostic studies were performed. At the time of the report the patient had not recovered from fever blisters on her lip. Relationship between multiple fever blisters on her lip, swelling, redness, warmth of injection site and therapy ZOSTAVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oral herpes, Scar, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a 56 year old female patient regarding on herself with migraine headaches and none drug allergies, who on 15-OCT-2013, was vaccinated with a dose of ZOSTAVAX (Lot no. J004266, exp. 12-JUL-2014), subcutaneous in the left arm for vaccination. Concomitant therapies included TOPAMAX. On 15-OCT-2013 the patient developed swelling, redness and warmth at the injection site 1 hour after administration of ZOSTAVAX. On 17-OCT-2013, the patient developed multiple fever blisters on her lip. The patient was evaluated by her unspecified physician who prescribed two courses of antiviral medication. On approximately 29-OCT-2013 (reported as 'within two weeks") injection site reaction resolved. The patient added that the corners of her mouth were cracked. The patient tried ABREVA and "lactinex". No lab diagnostic studies were performed. At the time of the report the patient had not recovered from fever blisters on her lip. Relationship between multiple fever blisters on her lip, swelling, redness, warmth of injection site and therapy ZOSTAVAX was not reported. Additional information has been requested.