chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 31-year-old female patient who received FLUARIX (batch number H99B5, expiry date 30th June 2016). On 20th October 2015, the patient received FLUARIX. In 2015, less than a month after receiving FLUARIX, the patient experienced pain in arm and bursitis. On an unknown date, the outcome of the pain in arm and bursitis were unknown. It was unknown if the reporter considered the pain in arm and bursitis to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a health department. The patient had extreme left arm pain since receiving the FLUARIX. The patient reported the pain to her primary care physician. The primary care physician told the patient that the pain was a result of the Flu shot and wound require physical therapy. The patient reported her physician's findings to health department. The reporting nurse from health department described it as bursitis in the upper left arm. The patient reported that the pain felt like a torn rotator cuff.
Age: 28.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Local reaction redness, swelling, pain.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Left arm pain side where injection was administered. Pain on lifting at shoulder, towards the front of arm & near shoulder joint, cannot sleep on left side. Pain is still present after 9 days of injection.
Age: 26.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Full blood count normal, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Patient turned pale, started sweating and felt dizzy; had severe headache on right side of the head and neck; felt weak in legs. Reaction started immediately as HPV (Gardasil 9) vaccine was administered. Patient was kept in the injection room for about 2 hours and given Juice to increase blood sugar level; cold towels were used to bring body temp down.
Age: 26.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Metabolic function test normal, Muscular weakness, Neck pain, Pallor
Clinical narrative: Patient turned pale, started sweating and felt dizzy; had severe headache on right side of the head and neck; felt weak in legs. Reaction started immediately as HPV (Gardasil 9) vaccine was administered. Patient was kept in the injection room for about 2 hours and given Juice to increase blood sugar level; cold towels were used to bring body temp down.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Itching, hives, facial swelling.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Balance disorder, Blood test, Diplegia, Herpes zoster
Clinical narrative: Information had been received on 17-NOV-2015 from an 88 year old male with history of high blood pressure, bladder control, fluid retention and thyroid with allergies to neomycin, penicillin, sulfa, common aspirin, all inflammatory drugs for arthritis, statin drugs, ZETA, nonsteroidal anti-inflammatory drugs (NSAIDS), niacin, amiloride hydrochlorothiazide, ibuprofen, CELEBREX and cefpodoxime. Patient was treated with ZOSTAVAX one time vaccine in the right hip "7 years ago" (dose and date of vaccination were not provided). Concomitant medications included metoprolol, warfarin, OXYBUTIN, fish oil and LASIX (dates of use, dose and indication not reported). Patient reported he had become "paralyzed in both legs" (onset not reported). Patient stated that four days after getting the vaccine he developed the shingles (date not reported). He said that over the next three months, he continued to lose his balance and "became unable to walk" (onset not reported). Patient also stated that he had outbreaks of "hives" and had been diagnosed with vitamin deficiencies after getting ZOSTAVAX (onset not reported). Patient sought medical treatment and underwent blood tests (dates and results not provided). Treatment included a series of steroids and a medicated salve. Outcome of events was not reported. Patient was currently proceeding with legal action to recover medical costs. Patient declined to be transferred with the legal issue. No other information was provided for documentation. Upon internal review, paralyzed in both legs was determined to be medically significant. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypovitaminosis, Urticaria
Clinical narrative: Information had been received on 17-NOV-2015 from an 88 year old male with history of high blood pressure, bladder control, fluid retention and thyroid with allergies to neomycin, penicillin, sulfa, common aspirin, all inflammatory drugs for arthritis, statin drugs, ZETA, nonsteroidal anti-inflammatory drugs (NSAIDS), niacin, amiloride hydrochlorothiazide, ibuprofen, CELEBREX and cefpodoxime. Patient was treated with ZOSTAVAX one time vaccine in the right hip "7 years ago" (dose and date of vaccination were not provided). Concomitant medications included metoprolol, warfarin, OXYBUTIN, fish oil and LASIX (dates of use, dose and indication not reported). Patient reported he had become "paralyzed in both legs" (onset not reported). Patient stated that four days after getting the vaccine he developed the shingles (date not reported). He said that over the next three months, he continued to lose his balance and "became unable to walk" (onset not reported). Patient also stated that he had outbreaks of "hives" and had been diagnosed with vitamin deficiencies after getting ZOSTAVAX (onset not reported). Patient sought medical treatment and underwent blood tests (dates and results not provided). Treatment included a series of steroids and a medicated salve. Outcome of events was not reported. Patient was currently proceeding with legal action to recover medical costs. Patient declined to be transferred with the legal issue. No other information was provided for documentation. Upon internal review, paralyzed in both legs was determined to be medically significant. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Local reaction on right arm. Arm began to swell up and was very warm. Pt went to ER for cephalexin 500 and PERCOCET on 11/9/15. She called to follow up on 11/14/15 that she's doing much better. She says it's clearing up good.
Sex: M
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from an unspecified reporter on a digital media via SPMSD on 18-NOV-2015, referring to a boy of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date the patient died after vaccination. The cause of death was not reported. It was unknown if autopsy had done. The causality between the events and GARDASIL was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Malaise
Clinical narrative: Elevated temperature, general malaise.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Body temperature increased, Chills, Eye swelling, Fatigue
Clinical narrative: At 5:30 pm: very bad chills, that continued with entire body feeling extremely weak, achy, and tired. Temp a little over 102. The next day 11/11:  body still weak, achy, tired.  Face and eyes swollen. On 11/12: eyes still swollen underneath the eyes, but less weak and achy. On 11/13: eyes less swollen, felling a little stronger.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Swelling face
Clinical narrative: At 5:30 pm: very bad chills, that continued with entire body feeling extremely weak, achy, and tired. Temp a little over 102. The next day 11/11:  body still weak, achy, tired.  Face and eyes swollen. On 11/12: eyes still swollen underneath the eyes, but less weak and achy. On 11/13: eyes less swollen, felling a little stronger.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swollen are from elbow up, moving fine, no temp, acting fine.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Dizziness, Dyspnoea, Injection site erythema
Clinical narrative: For first three days after vaccine, patient experienced dizziness, difficulty breathing, and redness on the arm that Zostavax was given  that extended to elbow.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Information has been received from a physician via Pfizer (manufacturer report number# 2015332296) referring to a 60 year old male patient. The patient's medical history included relapsing-remitting multiple sclerosis, hypertension, vitamin D deficiency and gastrooesophageal reflux disease. At around 11:00 on 15-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K021030, expiration date were unknown, 0.5 ml) intramuscularly in the left deltoid. Concomitant therapies included AVONEX, hydrochlorothiazide, PRILOSEC and cholecalciferol. On 16-JUN-2015, the patient started experiencing left arm red, tender and swollen. The patient had rash. It was also reported that on 18-JUL-2015 the patient experienced rash that was red on left arm and hurt all over body. The patient saw the doctor on 18-JUN-2015 and taken antibiotic and MEDROL DOSEPAK. The outcome of left arm red rash, tender and swollen was reported as recovered/resolved on 26-JUN-2015. The outcome of body hurt was unknown. The reporter considered left arm red rash, tender and swollen to be related to PNEUMOVAX 23. The causality between the body hurt and PNEUMOVAX 23 was not reported. Left arm red rash, tender and swollen were considered to be disability by the reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician via Pfizer (manufacturer report number# 2015332296) referring to a 60 year old male patient. The patient's medical history included relapsing-remitting multiple sclerosis, hypertension, vitamin D deficiency and gastrooesophageal reflux disease. At around 11:00 on 15-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K021030, expiration date were unknown, 0.5 ml) intramuscularly in the left deltoid. Concomitant therapies included AVONEX, hydrochlorothiazide, PRILOSEC and cholecalciferol. On 16-JUN-2015, the patient started experiencing left arm red, tender and swollen. The patient had rash. It was also reported that on 18-JUL-2015 the patient experienced rash that was red on left arm and hurt all over body. The patient saw the doctor on 18-JUN-2015 and taken antibiotic and MEDROL DOSEPAK. The outcome of left arm red rash, tender and swollen was reported as recovered/resolved on 26-JUN-2015. The outcome of body hurt was unknown. The reporter considered left arm red rash, tender and swollen to be related to PNEUMOVAX 23. The causality between the body hurt and PNEUMOVAX 23 was not reported. Left arm red rash, tender and swollen were considered to be disability by the reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Rash erythematous, Tenderness
Clinical narrative: Information has been received from a physician via Pfizer (manufacturer report number# 2015332296) referring to a 60 year old male patient. The patient's medical history included relapsing-remitting multiple sclerosis, hypertension, vitamin D deficiency and gastrooesophageal reflux disease. At around 11:00 on 15-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K021030, expiration date were unknown, 0.5 ml) intramuscularly in the left deltoid. Concomitant therapies included AVONEX, hydrochlorothiazide, PRILOSEC and cholecalciferol. On 16-JUN-2015, the patient started experiencing left arm red, tender and swollen. The patient had rash. It was also reported that on 18-JUL-2015 the patient experienced rash that was red on left arm and hurt all over body. The patient saw the doctor on 18-JUN-2015 and taken antibiotic and MEDROL DOSEPAK. The outcome of left arm red rash, tender and swollen was reported as recovered/resolved on 26-JUN-2015. The outcome of body hurt was unknown. The reporter considered left arm red rash, tender and swollen to be related to PNEUMOVAX 23. The causality between the body hurt and PNEUMOVAX 23 was not reported. Left arm red rash, tender and swollen were considered to be disability by the reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself via Pfizer Sales Representative. A 60-year-old male patient received on an unknown date a single dose of PREVNAR 13 parenteral on left arm and on 15Jun2015 at 11:00 a dose of PNEUMOVAX 23 (Batch/Lot K021030) at 0.5 ml intramuscular on left deltoid. Medical history included relapsing remitting multiple sclerosis (MS) from 2005, hypertension from 2005, vitamin D deficiency from 2012 and gastrooesophageal reflux disease (GERD) from 1995. Concomitant medications included AVONEX from 2005 for multiple sclerosis intramuscular at 30mcg weekly, HCTZ from 2005 for hypertension oral at 25mg daily, PRILOSEC from 1995 for GERD oral at 20mg daily and Vitamin D3 from 2012 for Vitamin D deficiency oral at 2000 units daily. On 16Jun2015 patient's left arm was red, tender and swollen; on 18Jun2015 he saw a physician who prescribed Rx, antibiotic and MEDROL. The events were serious as medically significant and due to disability/incapacity. On 18Jun2015, the patient experienced rash that was red (rash on left arm) and his body hurt all over, and he took antibiotics. Events left arm was red, tender and swollen recovered on 25Jun2015, the outcome of the other events was unknown. The physician stated there was a reasonable possibility that left arm was red, tender and swollen was related to pneumococcal vaccine. Follow-up (02Oct2015): New information obtained from a contactable physician who reported for himself includes: ethnicity, onset and details of the events, additional suspect vaccine. Follow-up (13Nov2015): New information received from the same contactable physician includes: patient and vaccination details, clinical course, events, seriousness, concomitants and medical history updated.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself via Pfizer Sales Representative. A 60-year-old male patient received on an unknown date a single dose of PREVNAR 13 parenteral on left arm and on 15Jun2015 at 11:00 a dose of PNEUMOVAX 23 (Batch/Lot K021030) at 0.5 ml intramuscular on left deltoid. Medical history included relapsing remitting multiple sclerosis (MS) from 2005, hypertension from 2005, vitamin D deficiency from 2012 and gastrooesophageal reflux disease (GERD) from 1995. Concomitant medications included AVONEX from 2005 for multiple sclerosis intramuscular at 30mcg weekly, HCTZ from 2005 for hypertension oral at 25mg daily, PRILOSEC from 1995 for GERD oral at 20mg daily and Vitamin D3 from 2012 for Vitamin D deficiency oral at 2000 units daily. On 16Jun2015 patient's left arm was red, tender and swollen; on 18Jun2015 he saw a physician who prescribed Rx, antibiotic and MEDROL. The events were serious as medically significant and due to disability/incapacity. On 18Jun2015, the patient experienced rash that was red (rash on left arm) and his body hurt all over, and he took antibiotics. Events left arm was red, tender and swollen recovered on 25Jun2015, the outcome of the other events was unknown. The physician stated there was a reasonable possibility that left arm was red, tender and swollen was related to pneumococcal vaccine. Follow-up (02Oct2015): New information obtained from a contactable physician who reported for himself includes: ethnicity, onset and details of the events, additional suspect vaccine. Follow-up (13Nov2015): New information received from the same contactable physician includes: patient and vaccination details, clinical course, events, seriousness, concomitants and medical history updated.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Rash erythematous, Tenderness
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself via Pfizer Sales Representative. A 60-year-old male patient received on an unknown date a single dose of PREVNAR 13 parenteral on left arm and on 15Jun2015 at 11:00 a dose of PNEUMOVAX 23 (Batch/Lot K021030) at 0.5 ml intramuscular on left deltoid. Medical history included relapsing remitting multiple sclerosis (MS) from 2005, hypertension from 2005, vitamin D deficiency from 2012 and gastrooesophageal reflux disease (GERD) from 1995. Concomitant medications included AVONEX from 2005 for multiple sclerosis intramuscular at 30mcg weekly, HCTZ from 2005 for hypertension oral at 25mg daily, PRILOSEC from 1995 for GERD oral at 20mg daily and Vitamin D3 from 2012 for Vitamin D deficiency oral at 2000 units daily. On 16Jun2015 patient's left arm was red, tender and swollen; on 18Jun2015 he saw a physician who prescribed Rx, antibiotic and MEDROL. The events were serious as medically significant and due to disability/incapacity. On 18Jun2015, the patient experienced rash that was red (rash on left arm) and his body hurt all over, and he took antibiotics. Events left arm was red, tender and swollen recovered on 25Jun2015, the outcome of the other events was unknown. The physician stated there was a reasonable possibility that left arm was red, tender and swollen was related to pneumococcal vaccine. Follow-up (02Oct2015): New information obtained from a contactable physician who reported for himself includes: ethnicity, onset and details of the events, additional suspect vaccine. Follow-up (13Nov2015): New information received from the same contactable physician includes: patient and vaccination details, clinical course, events, seriousness, concomitants and medical history updated.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Acute onset of right shoulder pain with severe decrease in range of motion.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: Acute onset of right shoulder pain with severe decrease in range of motion.
Age: 39.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Injection site infection, Injection site reaction, Neuralgia
Clinical narrative: Injection site infection. Nerve involvement/pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, indurated band of skin on L arm above elbow, measuring 6.5" x 3". Rash resolved within 72 hours. Stiff neck/limited ROM x 1 day after vaccinatino. Light-headed and stomach discomfort x 1 day. All symptoms resolved within 72 hours.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Rash
Clinical narrative: Red, warm, indurated band of skin on L arm above elbow, measuring 6.5" x 3". Rash resolved within 72 hours. Stiff neck/limited ROM x 1 day after vaccinatino. Light-headed and stomach discomfort x 1 day. All symptoms resolved within 72 hours.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Abnormal behaviour, Chills, Decreased appetite, Delusion, Pain
Clinical narrative: Fever, chills, body aches, delusions, anorexia, behavior changes started appx 24 hours after vaccine - lasted 12 hours.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Pyrexia
Clinical narrative: Fever, chills, body aches, delusions, anorexia, behavior changes started appx 24 hours after vaccine - lasted 12 hours.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Macule, Nasopharyngitis, Papule, Rash, Scab
Clinical narrative: Developed a cold a few days ago, then parents noticed 2 spots on chest on Sat, 5 more by Sunday, and a large amount today. Inchal spots are scabbed Sat parents not see any blisters. Today there were macules, papules and scabbed spots.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Received vaccine on 10-16-15. Developed "cellulitis" (L) injection site extending to lower arm. Treated with KEFLEX PO.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: 4 days after receiving PNEUMOVAX, noticed pain in right upper lateral arm with redness and swelling. Also had sweats and chills, and felt feverish. There is erythema circumferentially around injection site and mild warmth. Placed on cephalexin x 10 days for dx of cellulitis.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 4 days after receiving PNEUMOVAX, noticed pain in right upper lateral arm with redness and swelling. Also had sweats and chills, and felt feverish. There is erythema circumferentially around injection site and mild warmth. Placed on cephalexin x 10 days for dx of cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (R) thigh - area of redness, warmth and tenderness measuring 10 x 8 cm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at injection site.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Drug administered at inappropriate site, Injection site bruising, Injection site pain
Clinical narrative: Shot was given too high up on left shoulder resulting in a dark bruise.  About a week later when bruise finally went away, began noticing pain and loss of strength in left shoulder.  Today, 11/23 I am having extreme pain and loss of strength.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Limb discomfort, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, fatigue, Patient described arm and being very heavy had a hard time moving it.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Arthropathy, Autoimmune disorder, Borrelia test negative, Culture negative
Clinical narrative: The patient is a 69-year-old male who, it turns out, has a prior history of an adverse reaction to influenza vaccine manifesting as fever and myalgias. He received the Prevnar 13 vaccine on September 18, 2015. The next day he had the onset of fever followed by a bullous rash in the mouth and on the hands and on the feet accompanied by night sweats and joint symptoms. I was contacted by Dr at the time and suggested that he be seen by Dermatology. He was seen by Dermatology and started on doxycycline for possible cellulitis. He has been on doxycycline now for a month. The vesicular rash has resolved, as has his fevers. He has not had any fever since early October. He still has some mild joint symptoms at the base of his ring finger and had some sore ankles a couple weeks ago, but in general he is improving. He was seen in the emergency room on October 9 where it was noted that he did not have a fever for one week. His workup included negative Lyme serology, tick panel, culture of the lesion, CBC, comprehensive panel, RPR and blastomyces EIA. Provider states: it is most likely that he had an immune reaction to his Prevnar 13 given the temporal sequence of events. It is possible that he had a hand, foot and mouth disease syndrome due to a coxsackievirus, though based on the temporal association with the Prevnar 13 administration and his prior similar reaction to an influenza shot I think an autoimmune reaction to his vaccine is most likely.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Dermatitis bullous, Full blood count normal, Immunology test normal, Metabolic function test normal, Night sweats
Clinical narrative: The patient is a 69-year-old male who, it turns out, has a prior history of an adverse reaction to influenza vaccine manifesting as fever and myalgias. He received the Prevnar 13 vaccine on September 18, 2015. The next day he had the onset of fever followed by a bullous rash in the mouth and on the hands and on the feet accompanied by night sweats and joint symptoms. I was contacted by Dr at the time and suggested that he be seen by Dermatology. He was seen by Dermatology and started on doxycycline for possible cellulitis. He has been on doxycycline now for a month. The vesicular rash has resolved, as has his fevers. He has not had any fever since early October. He still has some mild joint symptoms at the base of his ring finger and had some sore ankles a couple weeks ago, but in general he is improving. He was seen in the emergency room on October 9 where it was noted that he did not have a fever for one week. His workup included negative Lyme serology, tick panel, culture of the lesion, CBC, comprehensive panel, RPR and blastomyces EIA. Provider states: it is most likely that he had an immune reaction to his Prevnar 13 given the temporal sequence of events. It is possible that he had a hand, foot and mouth disease syndrome due to a coxsackievirus, though based on the temporal association with the Prevnar 13 administration and his prior similar reaction to an influenza shot I think an autoimmune reaction to his vaccine is most likely.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash vesicular, Treponema test negative
Clinical narrative: The patient is a 69-year-old male who, it turns out, has a prior history of an adverse reaction to influenza vaccine manifesting as fever and myalgias. He received the Prevnar 13 vaccine on September 18, 2015. The next day he had the onset of fever followed by a bullous rash in the mouth and on the hands and on the feet accompanied by night sweats and joint symptoms. I was contacted by Dr at the time and suggested that he be seen by Dermatology. He was seen by Dermatology and started on doxycycline for possible cellulitis. He has been on doxycycline now for a month. The vesicular rash has resolved, as has his fevers. He has not had any fever since early October. He still has some mild joint symptoms at the base of his ring finger and had some sore ankles a couple weeks ago, but in general he is improving. He was seen in the emergency room on October 9 where it was noted that he did not have a fever for one week. His workup included negative Lyme serology, tick panel, culture of the lesion, CBC, comprehensive panel, RPR and blastomyces EIA. Provider states: it is most likely that he had an immune reaction to his Prevnar 13 given the temporal sequence of events. It is possible that he had a hand, foot and mouth disease syndrome due to a coxsackievirus, though based on the temporal association with the Prevnar 13 administration and his prior similar reaction to an influenza shot I think an autoimmune reaction to his vaccine is most likely.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chest discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Pt stated having a "bruised" feeling that radiated down his back and across his chest to his left shoulder. He said the soreness also radiated down his back to his belt line. Pt stated that the soreness was unilateral to the right side of body except his left shoulder. Pt stated soreness went away after about 1 and 1/2 weeks.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Patient given pediatric Influenza. Parent notified and encouraged to bring patient back for correct dosage of Influenza.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Pyrexia
Clinical narrative: Bad headache, fever, severe chills, weakness, rapid heartbeat  This lasted until approximately 8:00 PM.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination complication
Clinical narrative: Rash started on feet and then worked its way up her body to trunk.  Patient visited local urgent care who diagnosed adverse reaction to Zostavax and initiated Medrol Dosepak course.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dyspnoea
Clinical narrative: BODY SUDDENLY FELT WEAK, TIGHTNESS IN CHEST, SHORTNESS OF BREATH.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Underdose
Clinical narrative: Patient given pediatric influenza. Parent notified and encouraged to bring patient back for correct dosage of influenza.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, X-ray limb normal
Clinical narrative: Left upper arm persistent pain and weakness. Currently treated with NSAIDs and physical therapy.
Age: 20.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 11/4/15 Patient walk into clinic on 11/4/15 stating that since the day of the vaccine he has been on pain on his left shoulder and is having difficulty moving. 11/20/15 patient returned stating that he unable to move his left shoulder.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blindness, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 18-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on unspecified date single dose and MENACTRA, via an unspecified route of administration on an unspecified date. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient experienced could not see, face was pale, sweaty, dizzy, cold hands and nauseous. The outcome of the events was reported as unknown.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Peripheral coldness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 18-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on unspecified date single dose and MENACTRA, via an unspecified route of administration on an unspecified date. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient experienced could not see, face was pale, sweaty, dizzy, cold hands and nauseous. The outcome of the events was reported as unknown.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cardiac arrest, Cardiac disorder, Injection site haemorrhage, Injection site mass, Vagus nerve disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer colleague. A 72-years-old male patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration on 30Oct2015 at single dose in arm and high dose influenza vaccine, via an unspecified route of administration on 30Oct2015 in arm. The patient medical history and concomitant medications were not reported. Approximately a week later patient reported bleeding at injection site, and injection site reaction described as a lump the size of a goose egg, reporter thinks it was 06Nov2015, but was unsure. The patient was admitted 2 weeks later to the hospital. He suffered a vagal nerve response and 'weird heart things'. Vagal response did not start on date of injection. The patient stated his heart stopped 4 times in the ambulance. He was still in the hospital. The outcome of 'weird heart things' and injection site reaction described as a lump the size of a goose egg was not recovered. The outcome of vagal nerve response, bleeding at injection site, and heart stopped was unknown.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia streptococcal, Streptococcus test positive, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient. The patient was enrolled in a patient support program. In approximately June 2015 (referred as like in June), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not provided) instead of PREVNAR. In 2015 (unspecified date), the patient experienced pneumonia streptococcal referred as "strep pneumonia bacteremia, and her serotype was 23F". The physician stated that the patient was at the hospital at that time (hospitalization could not be ruled out). At the time of the report, the patient was in there in both vaccines. The outcome of pneumonia streptococcal was unknown. Additional information is not expected as the reporter refused additional contact.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Dizziness, Malaise, Nausea, Pain in extremity
Clinical narrative: Started with arm being sore and tender next day 11/19/15 also started having a little dizziness around 4:30p and worsened that evening, also arm started swelling and getting hot.  11/20/15 - (Friday) continued with above listed symptoms of arm being swollen, hot not feeling well and also started getting nauseated and vomited.  Patient went to ER on Saturday 11/21/15 - treated for cellulitis - put on antibiotics and meclizine for dizziness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin warm, Tenderness, Vomiting
Clinical narrative: Started with arm being sore and tender next day 11/19/15 also started having a little dizziness around 4:30p and worsened that evening, also arm started swelling and getting hot.  11/20/15 - (Friday) continued with above listed symptoms of arm being swollen, hot not feeling well and also started getting nauseated and vomited.  Patient went to ER on Saturday 11/21/15 - treated for cellulitis - put on antibiotics and meclizine for dizziness.
Age: 87.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abasia, Fatigue, Hypersomnia, Mobility decreased
Clinical narrative: Unable to get out of bed.  Intense tiredness.  Slept for 36 hours.  When awoke could not walk.  Taken by ambulance to hospital.  Admitted to hospital for 5 days.  Then spent 4 weeks in Rehab learning to walk again.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Pain in extremity, Peripheral swelling, Rash, Urticaria
Clinical narrative: Patient came to health dept on 11/12/15 and received MMR in right subcutaneous. MOC stated she wanted to only do one vaccine at a time. Child then seen at primary MD provider on 11/13/15 and received HBV, HAV, Dtap and IPV. The site of vaccination was not indicated on IZ record. Child began having symptoms on 11/15/15 of pain and swelling on upper left arm. On 11/16/16, child awoke with full hives/blisters. MOC took child to PCP, was prescribed Benadryl and Prednisone. MOC took child to ER to get second opinion. She stated she was told that it was a vaccine reaction, but MOC could not remember which vaccine they stated could have been the cause. Patient was prescribed Benadryl and Prednisone. Mother discontinued medication on 11/18/15 with the result that the rash recurred, looking like "mosquito bites". Mother then began administering medication again. Child did not have a fever at any time during these events.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was given 2 doses of Hep B in December of 2014 and 1 was an extra shot too close in proximity of the previous shot (one was given 12/4/14 and the other 12/22/14). There are currently no known adversities but I would like to have a record of this in case there are any long term side effects.
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Initial report received from a healthcare professional on 01 October 2014. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of Flu vaccine (manufacturer: unknown, batch number, expiration date, dose in series, route and site of vaccination was not reported, on an unspecified date. On an unspecified date, the patient reported that following flu vaccine she experienced a metallic taste in her mouth. At the time of this report, the patient had not recovered from the event. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 19 September 2014. A 62-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UI196AD, intramuscular in left deltoid) having expiry date 30 June 2015 on 17 September 2014. The patient has no illness at the time of vaccination and is allergic to sulfa drugs, statin drugs and latex. It was reported that on 17 September 2014, on the same day after receiving FLUZONE QIV vaccine, the patient experienced left arm pain and nausea. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 23 December 2014. The patient had received 0.5 ml dose of FLUZONE QIV.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Gait disturbance, Peripheral swelling, Pneumonia, Rash
Clinical narrative: Initial report received from a consumer on 19 September 2014. A 46-year-old female patient, had received a dose of INFLUENZA VACCINE (Manufacturer-unknown, lot number, dose number, route and anatomical site of administration not reported) on an unknown date and had received a dose of PNEUMOCCAL VACCINE (Manufacturer- unknown, lot number, dose number, route and anatomical site of administration not reported) on an unknown date. The patient previously received COPAXONE from 1 Jan 1997 to 1 Jan 2004 and AVENOX from 1 Jan 20104 to 1 Aug 2014 as a previous MS therapy. On an unknown date after vaccination patient had experienced her arm was swollen and has a rash and also states, "I am hardly able to walk". It was reported that patient had not started on AUBAGIO yet. It was reported that patient experienced pneumonia every year; however patient physician wanted to vaccinate with pneumonia vaccine. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 23 September 2014. A 66-year-old female patient, who has no relevant medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5019AA, intramuscular in left deltoid) having expiry date 4 October 2015 on 22 September 2014. It was reported that on 22 September 2014, in the evening after receiving FLUZONE HD vaccine, the patient's fingers of left hand were swollen. The patient was going to take BENADRYL as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 24 September 2014. A 76-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5019AA, intramuscular in left deltoid) on 19 September 2014. The patient has no known allergies and illness at the time of vaccination was unknown. It was reported that on 23 September 2014, 4 days after receiving FLUZONE HD vaccine, the patient experienced stabbing pain at the arm lasting 30 minutes and goes on and off for 5 seconds each time. It was reported that, once she gets up the pain goes away and did not come back until the next morning. The patient's corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Dysphemia
Clinical narrative: Initial report received from a healthcare professional on 24 September 2014. A 25-month-old female patient, had received a dose of FLUZONE QIV, (batch number U4990CA, expiry date: 30 June 2015, dose in series, route and site of vaccination were not reported) on 15 September 2014. The patient's illness at the time of vaccination was not reported and had no known allergies. The patient's concomitant medications were not reported. On 15 September 2014, same day after vaccination, the patient began stuttering and involuntary head movements. Laboratory tests and corrective treatments were not reported. The patient was taken to emergency room visit for doctor visit. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Cognitive disorder, Condition aggravated, Epstein-Barr virus infection, Fatigue, Headache
Clinical narrative: Initial case received from a consumer who is the patient on 23 September 2014. A 56 year old male patient, was vaccinated with a Flu Vaccine (manufacturer, batch, route and site of administration not reported) last year in "2013?" on an unspecified date. The patient has a history of previous Epstein-Barr infection. A couple of days after vaccination, he felt achy with generalized pain as if he had the flu. He was extremely tired. He reported that a couple of months later he was diagnosed with recurrence for Epstein-Barr virus. He is continuing to experience extreme tiredness and continues with Epstein-Barr infection. Laboratory tests and concomitant medications were not reported. Treatments were not reported. He received the flu vaccine at his own healthcare provider. The patient outcome is not recovered. Documents held by sender: None. Follow-up pregnancy report received from a non-healthcare professional on 01 Dec 2014. Date of vaccination was reported as 11-Oct-2013. Batch number of INFLUENZA VACCINE was reported as UN900AE and the site of vaccination was right deltoid. Date of event onset for recurrence of Epstein-Barr infection, altered cognitive function/ altered mental status, disturbance of skin sensation/ arm paresthesia, headache, extreme tiredness/malaise and fatigue, generalized pain as if he had the flu and he also felt achy on 13-Oct-2013. Any other vaccination within 4 weeks prior to date listed and adverse event following prior vaccination was reported as none. Illness at the time of vaccination was reported as CFIOS. Asthma and Anxiety was reported since 2006. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise, Mental status changes, Pain, Paraesthesia
Clinical narrative: Initial case received from a consumer who is the patient on 23 September 2014. A 56 year old male patient, was vaccinated with a Flu Vaccine (manufacturer, batch, route and site of administration not reported) last year in "2013?" on an unspecified date. The patient has a history of previous Epstein-Barr infection. A couple of days after vaccination, he felt achy with generalized pain as if he had the flu. He was extremely tired. He reported that a couple of months later he was diagnosed with recurrence for Epstein-Barr virus. He is continuing to experience extreme tiredness and continues with Epstein-Barr infection. Laboratory tests and concomitant medications were not reported. Treatments were not reported. He received the flu vaccine at his own healthcare provider. The patient outcome is not recovered. Documents held by sender: None. Follow-up pregnancy report received from a non-healthcare professional on 01 Dec 2014. Date of vaccination was reported as 11-Oct-2013. Batch number of INFLUENZA VACCINE was reported as UN900AE and the site of vaccination was right deltoid. Date of event onset for recurrence of Epstein-Barr infection, altered cognitive function/ altered mental status, disturbance of skin sensation/ arm paresthesia, headache, extreme tiredness/malaise and fatigue, generalized pain as if he had the flu and he also felt achy on 13-Oct-2013. Any other vaccination within 4 weeks prior to date listed and adverse event following prior vaccination was reported as none. Illness at the time of vaccination was reported as CFIOS. Asthma and Anxiety was reported since 2006. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 25 September 2014. A 75-year-old male patient, whose medical history and concomitant were not reported, had received an intramuscular dose of FLUZONE HD (batch number U5024CA, expiration ate 12 May 2015, and dose in series not reported) in to the deltoid right, and a dose of PNEUMOVAX (manufacturer MSD) (batch number, expiration date, route, and dose in series not reported) in to the arm left on 23 September 2014. The patient had experienced pain in the arm down to the elbow and does not know if it was the right or the left arm on 23 September 2014. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional on 25 September 2014. This is a cluster case of 25 patients (demographics unknown). 25 patients had received a dose of FLUZONE QIV, (batch number UI196AA, expiry date: 30 June 2015, dose in series and site of vaccination were not reported) intramuscularly on an unspecified date. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date, after vaccination, patients experienced "more pain upon administration of this vaccine than any other vaccinations ever received". It was stated that all patients reported pain, after needle placed, when vaccine was being administered into site. In addition, of those 25 patients about 10-15 had swelling, red, rash at injection site. It was also stated that most of the 25 patients reporting the pain upon injection were under the age of 64 years. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up report received from a physician on 28 April 2015. It was reported that reporter did not have any additional information to provide or each patient's identifier. Corrected report: The coding of event was updated to vaccination site pain. Coded events of about 10-15 patients had swelling and red rash at injection site. Documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Dizziness, Influenza like illness, Pain
Clinical narrative: 15 MINUTES AFTER, PT STARTED FEELING DIZZY.  PT WENT HOME AND TOOK MECLIZINE.  SHE WAS WEAK, ACHY AND HAD LOW GRADE FEVER, FELT FLU-LIKE SYMPTOMS FOR 7 DAYS.  SHE HAD SEVERE DIARRHEA ON THE 7TH DAY AND IT SEEMED TO GET BETTER AFTER THAT.  PT WAS DRINKING A LOT OF FLUIDS AT THE TIME.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 15 MINUTES AFTER, PT STARTED FEELING DIZZY.  PT WENT HOME AND TOOK MECLIZINE.  SHE WAS WEAK, ACHY AND HAD LOW GRADE FEVER, FELT FLU-LIKE SYMPTOMS FOR 7 DAYS.  SHE HAD SEVERE DIARRHEA ON THE 7TH DAY AND IT SEEMED TO GET BETTER AFTER THAT.  PT WAS DRINKING A LOT OF FLUIDS AT THE TIME.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: My arm/shoulder (injection site) became visibly bruised, sore, and itchy.  It remained itchy and sore for about 2 weeks.  I've never had a reaction like this before to the flu vaccine.