chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable physician assistant (other health care professional). A 28-year-old female patient received TRUMENBA, via an unspecified route of administration in the left deltoid, on 05Mar2015, at single dose. Relevant medical history included ongoing congenital bicornuate uterus, ongoing congenital absent R kidney, ongoing congential duplicate L ureter, ongoing asthma, ongoing bipolar disorder and ongoing migraines. Concomitant medications included NORCO from 05Mar2015 and 12Mar2015, for joint pain; TOPAMAX, from 05Mar2015, at 100 mg at bedtime; sumatriptan (unspecified trade name), from 05Mar2015, at 100 as needed; gabapentin (unspecified trade name), from 05Mar2015, at 300 mg 2x/day; CYMBALTA, from 05Mar2015, as needed; FLONASE, from 05Mar2015, as needed; PRO AIR, from 05Mar2015, as needed; IMPLANON IUD, from 05Mar2015. On unknown date the patient experienced pain at the site, fatigue, joint pain, fever, headache, chills, injection site pain, rash and rash turned out to be shingles. The outcome of the events was unknown. The reporter considered there was a reasonable possibility that the events were related to TRUMENBA, and mentioned that the patient will not receive the rest of series vaccinations with TRUMENBA. Follow-up (13Mar2015): New information received from the same contactable other health care professional includes: events updated. Follow-up (29Apr2015): new information received from a contactable other health care professional includes: events updated/added, indication updated, causality assessment, relevant medical history, concomitant medications.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 40 year old female patient received on 17JUL2015 TRUMENBA (lot J29203, expiry date JUN2016, NDC number: 30050100102) at 0.5 ml single, in arm,. Medical history was not provided. The patient was not taking any medication. On 18JUL2015 the patient arm that was administered with vaccine]= was very red, swollen, hot, the patient experienced fever, headache, chills.  By 19JUL2015 the patient felt better but her arm was still red but smaller and then on 20JUL2015 there was no redness or swelling but the area that had been red and swollen was very "rough" and bumpy. The patient did not took any medication. The patient recovered from redness and swelling in JUL2015. Outcome of the other reported events was unknown.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse. A 40 year old female patient received on 17JUL2015 TRUMENBA (lot J29203, expiry date JUN2016, NDC number: 30050100102) at 0.5 ml single, in arm,. Medical history was not provided. The patient was not taking any medication. On 18JUL2015 the patient arm that was administered with vaccine]= was very red, swollen, hot, the patient experienced fever, headache, chills.  By 19JUL2015 the patient felt better but her arm was still red but smaller and then on 20JUL2015 there was no redness or swelling but the area that had been red and swollen was very "rough" and bumpy. The patient did not took any medication. The patient recovered from redness and swelling in JUL2015. Outcome of the other reported events was unknown.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse. A 40 year old female patient received on 17JUL2015 TRUMENBA (lot J29203, expiry date JUN2016, NDC number: 30050100102) at 0.5 ml single, in arm,. Medical history was not provided. The patient was not taking any medication. On 18JUL2015 the patient arm that was administered with vaccine]= was very red, swollen, hot, the patient experienced fever, headache, chills.  By 19JUL2015 the patient felt better but her arm was still red but smaller and then on 20JUL2015 there was no redness or swelling but the area that had been red and swollen was very "rough" and bumpy. The patient did not took any medication. The patient recovered from redness and swelling in JUL2015. Outcome of the other reported events was unknown.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Dry skin, Erythema, Headache, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 40 year old female patient received on 17JUL2015 TRUMENBA (lot J29203, expiry date JUN2016, NDC number: 30050100102) at 0.5 ml single, in arm,. Medical history was not provided. The patient was not taking any medication. On 18JUL2015 the patient arm that was administered with vaccine]= was very red, swollen, hot, the patient experienced fever, headache, chills.  By 19JUL2015 the patient felt better but her arm was still red but smaller and then on 20JUL2015 there was no redness or swelling but the area that had been red and swollen was very "rough" and bumpy. The patient did not took any medication. The patient recovered from redness and swelling in JUL2015. Outcome of the other reported events was unknown.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse. A 40 year old female patient received on 17JUL2015 TRUMENBA (lot J29203, expiry date JUN2016, NDC number: 30050100102) at 0.5 ml single, in arm,. Medical history was not provided. The patient was not taking any medication. On 18JUL2015 the patient arm that was administered with vaccine]= was very red, swollen, hot, the patient experienced fever, headache, chills.  By 19JUL2015 the patient felt better but her arm was still red but smaller and then on 20JUL2015 there was no redness or swelling but the area that had been red and swollen was very "rough" and bumpy. The patient did not took any medication. The patient recovered from redness and swelling in JUL2015. Outcome of the other reported events was unknown.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Chest discomfort, Dyskinesia, Electroencephalogram normal, Eye movement disorder, Fall
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (Lot# L13514, Exp Date 31Jul2016), intramuscular in the right arm, on 04Sep2015, at 0.5 ml single, and MENACTRA, via an unspecified route of administration in the left arm, on 04Sep2015, at standard dose. Relevant medical history included unspecified other problems in the past. Concomitant medications were not reported. The patient experienced photosensitivity, psycho seizures and couldn't walk right now very well on an unspecified date. The patient was hospitalized in response to the events. As of 09Sep2015 the patient was still in the hospital, it was unknown if she was discharged.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Headache, Hyperaesthesia, Hypoaesthesia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (Lot# L13514, Exp Date 31Jul2016), intramuscular in the right arm, on 04Sep2015, at 0.5 ml single, and MENACTRA, via an unspecified route of administration in the left arm, on 04Sep2015, at standard dose. Relevant medical history included unspecified other problems in the past. Concomitant medications were not reported. The patient experienced photosensitivity, psycho seizures and couldn't walk right now very well on an unspecified date. The patient was hospitalized in response to the events. As of 09Sep2015 the patient was still in the hospital, it was unknown if she was discharged.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Pain, Pain in extremity, Paralysis, Photophobia, Tremor
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (Lot# L13514, Exp Date 31Jul2016), intramuscular in the right arm, on 04Sep2015, at 0.5 ml single, and MENACTRA, via an unspecified route of administration in the left arm, on 04Sep2015, at standard dose. Relevant medical history included unspecified other problems in the past. Concomitant medications were not reported. The patient experienced photosensitivity, psycho seizures and couldn't walk right now very well on an unspecified date. The patient was hospitalized in response to the events. As of 09Sep2015 the patient was still in the hospital, it was unknown if she was discharged.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Psychogenic seizure
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (Lot# L13514, Exp Date 31Jul2016), intramuscular in the right arm, on 04Sep2015, at 0.5 ml single, and MENACTRA, via an unspecified route of administration in the left arm, on 04Sep2015, at standard dose. Relevant medical history included unspecified other problems in the past. Concomitant medications were not reported. The patient experienced photosensitivity, psycho seizures and couldn't walk right now very well on an unspecified date. The patient was hospitalized in response to the events. As of 09Sep2015 the patient was still in the hospital, it was unknown if she was discharged.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Seizure
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA (Lot# L13514, Exp Date 31Jul2016), intramuscular in the right arm, on 04Sep2015, at 0.5 ml single, and MENACTRA, via an unspecified route of administration in the left arm, on 04Sep2015, at standard dose. Relevant medical history included unspecified other problems in the past. Concomitant medications were not reported. The patient experienced photosensitivity, psycho seizures and couldn't walk right now very well on an unspecified date. The patient was hospitalized in response to the events. As of 09Sep2015 the patient was still in the hospital, it was unknown if she was discharged.
Sex: U
Vaccine: MMR
Symptoms: Paralysis, Seizure
Clinical narrative: This spontaneous report as received from a consumer refers to her child - a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, after receiving the vaccine, the patient experienced convulsions and paralysis. The outcome of convulsions and paralysis was unknown. The relatedness between adverse events and M-M-R II was not reported. Upon internal review the events of convulsions and paralysis were considered to be medically significant. Additional information is not expected as the reporter refused to provide any further details regarding the experience.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Joint stiffness, Joint swelling, Pyrexia, Vomiting
Clinical narrative: High fever, joint stiffness and swelling, vomiting and diarrhea.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO SYMPTOMS.  KINRIX (DTAP/IPV) VACCINE GIVEN TO A CHILD LESS THAN 4 YEARS OF AGE. NO ADVERSE EFFECT.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bone pain, Erythema, Middle insomnia, Muscular weakness
Clinical narrative: 1st 3 mths. swelled and red with fever touch..now servere pain in muscle rotary cup joints bone and arm wakes me from solid sleep at night..fells like it's coming out of socket..weak and no strength as far as using it.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: 1st 3 mths. swelled and red with fever touch..now servere pain in muscle rotary cup joints bone and arm wakes me from solid sleep at night..fells like it's coming out of socket..weak and no strength as far as using it.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Asthenia, Pallor
Clinical narrative: Post vaccination approx 5 min, client became weak and change of color (pale) . Lgs checked, ice pack applied to nape of neck. Once chest began to return to nroaml and color, juice given. Client recovered and left with family.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Flu vaccine administered to (R) deltoid 9/18/15 and (R) submandibular ln swelling-pain noted 9/19/15.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Pt reported initial iching at site of injection that spread to other arm & then broke out in hives on arms, chest & back. Also reports tingling of face & tongue. Pt took 50mg BENADRYL and saw medical provider, given Epinephrine and SOLU-MEDROL in route to hospital. Vaccine given approximately 12:40. Received call from hospital about 2pm.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness across arm, about 2in x 3in slight pain at area of injection swelling for 2 days now. Patient was told by pharmacist to apply cold compress and hydrocortisone. She said it seem better now.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: 9/20/15..7:00PM-MUSCLE ACHES. 9/20/15..8:00PM-CHILLS. 7/21/15..7:30AM-LIGHTHEADNESS. 9/21/15..7:30AM-FEVER.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: THIS WAS REPORTED TO ME SECOND HAND ON 9/21/15- PATIENT REPORTED TO PHARMACY WHEN I WAS OFF WITH EXTENSIVE BRUISE AT INJECTION SITE.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Severe pain in shoulder area with difficulty to move and very stiff upon trying to move. Still present on 09/21/2015 at 10:00 AM and no treatment performed.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Within four hours after vaccinated developed redness, erythema, induration, swelling, pain extending 5-6 inches around and below injection site. Very Painful injection site and surrounding area.  Unable to sleep. Headache, myalgia, fatigue, abnormal weakness and lack of engery. Asthenia.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Insomnia, Myalgia
Clinical narrative: Within four hours after vaccinated developed redness, erythema, induration, swelling, pain extending 5-6 inches around and below injection site. Very Painful injection site and surrounding area.  Unable to sleep. Headache, myalgia, fatigue, abnormal weakness and lack of engery. Asthenia.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: EXTENSIVE BRUISING TO BICEP MUSCLE.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle atrophy, Musculoskeletal pain, Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe pain in shoulder down arm. Muscle atrophy and nerve damage. Seeked several doctors and came to the conclusion the cause was from flu vaccine. I have recovered since then, but would like to know if it is safe to take the flu vaccine as I get older?
Age: 49.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swollen area over injection site left arm.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Abscess drainage, Atrial fibrillation, Blood calcium decreased, Blood chloride decreased
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional via a sales representative. A 94-year-old female patient received PREVNAR 13 (Lot # L77780, Exp Date Jan2017), intramuscular in the left deltoid at 15:00 on 14Aug2015 at 0.5 ml, single. No other vaccines were given on 14Aug2015 along with PREVNAR 13. Medical history included osteoporosis from Aug2014 and ongoing, ongoing glaucoma, ongoing chronic rhinitis and ongoing corneal transplant. Concomitant medications included dorzolamide hydrochloride, COSOPT (2-0.5% eye drops) one drop to right eye twice a day, SENNA PLUS ( 8.6-50 mg tablet) two tablet by mouth at bedtime, famotidine (40 mg tablet) one tablet by mouth daily, SOPTO CARPINE (1% eye drops) one drop three times a day, aspirin (81 mg) one day by mouth daily, carvedilol (6.25 mg tablet) one tablet by mouth at bedtime, amlodipine besylate (5 mg tablet) one tablet by mouth daily, PHOSPHOLINE IODIDE (0.125% eye drops) one drop in right eye once a week, MUCINEX as needed for chronic rhinitis and multivitamin capsule, one capsule by mouth daily. The patient received the vaccine in the HCP's office and she experienced cellulitis and abscess on an unspecified date which lead to hospitalization. A family member called and informed the HCP's office that the patient had to have surgery due to the reaction she had due to vaccine. The abscess was surgically incised and drained; a wound vac was applied to the left upper extremity wound. After discharge from the hospital, the patient was admitted to the Skilled Nursing Rehab Unit on 25Aug2015. While at the Skilled Nursing Rehab Unit, the patient was re-admitted to the hospital for hyponatremia on 01Sep2015. This hospital course complicated by management of a UTI (Urinary Tract Infection) with CIPRO 500 mg. The patent was treated at the hospital and discharged back to the Skilled Nursing Rehab Unit on 10Sep2015 with a diagnosis of hyponatremia. It is unknown if the patient still had the wound vac in place. Left upper extremity wound in healing. The patient cannot take FLONASE due to her glaucoma. She had bad reactions to antihistamines. The patient cannot take decongestants. Cultures drawn during the first hospital admission were negative. The patient underwent lab tests and procedures on 31Aug2015 which included calcium serum 8.1, chloride serum 78, glucose 111, osmolality 235 and sodium 113. It was also reported that the patient had atrial fibrillation (A fib) and hypertension both in Aug2015, gastrooesophageal reflux disease (GERD) on 14Aug2015, antidiuretic hormone secretion on 10Sep2015, unsteady gait on 28Aug2015 and sepsis on 26Aug2015, and she still had these problems. Therapeutic measures were taken as a result of abscess. The outcome of the events was unknown.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose normal, Blood osmolarity decreased, Blood sodium decreased, Cellulitis, Culture negative
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional via a sales representative. A 94-year-old female patient received PREVNAR 13 (Lot # L77780, Exp Date Jan2017), intramuscular in the left deltoid at 15:00 on 14Aug2015 at 0.5 ml, single. No other vaccines were given on 14Aug2015 along with PREVNAR 13. Medical history included osteoporosis from Aug2014 and ongoing, ongoing glaucoma, ongoing chronic rhinitis and ongoing corneal transplant. Concomitant medications included dorzolamide hydrochloride, COSOPT (2-0.5% eye drops) one drop to right eye twice a day, SENNA PLUS ( 8.6-50 mg tablet) two tablet by mouth at bedtime, famotidine (40 mg tablet) one tablet by mouth daily, SOPTO CARPINE (1% eye drops) one drop three times a day, aspirin (81 mg) one day by mouth daily, carvedilol (6.25 mg tablet) one tablet by mouth at bedtime, amlodipine besylate (5 mg tablet) one tablet by mouth daily, PHOSPHOLINE IODIDE (0.125% eye drops) one drop in right eye once a week, MUCINEX as needed for chronic rhinitis and multivitamin capsule, one capsule by mouth daily. The patient received the vaccine in the HCP's office and she experienced cellulitis and abscess on an unspecified date which lead to hospitalization. A family member called and informed the HCP's office that the patient had to have surgery due to the reaction she had due to vaccine. The abscess was surgically incised and drained; a wound vac was applied to the left upper extremity wound. After discharge from the hospital, the patient was admitted to the Skilled Nursing Rehab Unit on 25Aug2015. While at the Skilled Nursing Rehab Unit, the patient was re-admitted to the hospital for hyponatremia on 01Sep2015. This hospital course complicated by management of a UTI (Urinary Tract Infection) with CIPRO 500 mg. The patent was treated at the hospital and discharged back to the Skilled Nursing Rehab Unit on 10Sep2015 with a diagnosis of hyponatremia. It is unknown if the patient still had the wound vac in place. Left upper extremity wound in healing. The patient cannot take FLONASE due to her glaucoma. She had bad reactions to antihistamines. The patient cannot take decongestants. Cultures drawn during the first hospital admission were negative. The patient underwent lab tests and procedures on 31Aug2015 which included calcium serum 8.1, chloride serum 78, glucose 111, osmolality 235 and sodium 113. It was also reported that the patient had atrial fibrillation (A fib) and hypertension both in Aug2015, gastrooesophageal reflux disease (GERD) on 14Aug2015, antidiuretic hormone secretion on 10Sep2015, unsteady gait on 28Aug2015 and sepsis on 26Aug2015, and she still had these problems. Therapeutic measures were taken as a result of abscess. The outcome of the events was unknown.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Gastrooesophageal reflux disease, Hypertension, Hyponatraemia, Inappropriate antidiuretic hormone secretion
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional via a sales representative. A 94-year-old female patient received PREVNAR 13 (Lot # L77780, Exp Date Jan2017), intramuscular in the left deltoid at 15:00 on 14Aug2015 at 0.5 ml, single. No other vaccines were given on 14Aug2015 along with PREVNAR 13. Medical history included osteoporosis from Aug2014 and ongoing, ongoing glaucoma, ongoing chronic rhinitis and ongoing corneal transplant. Concomitant medications included dorzolamide hydrochloride, COSOPT (2-0.5% eye drops) one drop to right eye twice a day, SENNA PLUS ( 8.6-50 mg tablet) two tablet by mouth at bedtime, famotidine (40 mg tablet) one tablet by mouth daily, SOPTO CARPINE (1% eye drops) one drop three times a day, aspirin (81 mg) one day by mouth daily, carvedilol (6.25 mg tablet) one tablet by mouth at bedtime, amlodipine besylate (5 mg tablet) one tablet by mouth daily, PHOSPHOLINE IODIDE (0.125% eye drops) one drop in right eye once a week, MUCINEX as needed for chronic rhinitis and multivitamin capsule, one capsule by mouth daily. The patient received the vaccine in the HCP's office and she experienced cellulitis and abscess on an unspecified date which lead to hospitalization. A family member called and informed the HCP's office that the patient had to have surgery due to the reaction she had due to vaccine. The abscess was surgically incised and drained; a wound vac was applied to the left upper extremity wound. After discharge from the hospital, the patient was admitted to the Skilled Nursing Rehab Unit on 25Aug2015. While at the Skilled Nursing Rehab Unit, the patient was re-admitted to the hospital for hyponatremia on 01Sep2015. This hospital course complicated by management of a UTI (Urinary Tract Infection) with CIPRO 500 mg. The patent was treated at the hospital and discharged back to the Skilled Nursing Rehab Unit on 10Sep2015 with a diagnosis of hyponatremia. It is unknown if the patient still had the wound vac in place. Left upper extremity wound in healing. The patient cannot take FLONASE due to her glaucoma. She had bad reactions to antihistamines. The patient cannot take decongestants. Cultures drawn during the first hospital admission were negative. The patient underwent lab tests and procedures on 31Aug2015 which included calcium serum 8.1, chloride serum 78, glucose 111, osmolality 235 and sodium 113. It was also reported that the patient had atrial fibrillation (A fib) and hypertension both in Aug2015, gastrooesophageal reflux disease (GERD) on 14Aug2015, antidiuretic hormone secretion on 10Sep2015, unsteady gait on 28Aug2015 and sepsis on 26Aug2015, and she still had these problems. Therapeutic measures were taken as a result of abscess. The outcome of the events was unknown.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Incisional drainage, Sepsis, Urinary tract infection, Wound, Wound closure
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional via a sales representative. A 94-year-old female patient received PREVNAR 13 (Lot # L77780, Exp Date Jan2017), intramuscular in the left deltoid at 15:00 on 14Aug2015 at 0.5 ml, single. No other vaccines were given on 14Aug2015 along with PREVNAR 13. Medical history included osteoporosis from Aug2014 and ongoing, ongoing glaucoma, ongoing chronic rhinitis and ongoing corneal transplant. Concomitant medications included dorzolamide hydrochloride, COSOPT (2-0.5% eye drops) one drop to right eye twice a day, SENNA PLUS ( 8.6-50 mg tablet) two tablet by mouth at bedtime, famotidine (40 mg tablet) one tablet by mouth daily, SOPTO CARPINE (1% eye drops) one drop three times a day, aspirin (81 mg) one day by mouth daily, carvedilol (6.25 mg tablet) one tablet by mouth at bedtime, amlodipine besylate (5 mg tablet) one tablet by mouth daily, PHOSPHOLINE IODIDE (0.125% eye drops) one drop in right eye once a week, MUCINEX as needed for chronic rhinitis and multivitamin capsule, one capsule by mouth daily. The patient received the vaccine in the HCP's office and she experienced cellulitis and abscess on an unspecified date which lead to hospitalization. A family member called and informed the HCP's office that the patient had to have surgery due to the reaction she had due to vaccine. The abscess was surgically incised and drained; a wound vac was applied to the left upper extremity wound. After discharge from the hospital, the patient was admitted to the Skilled Nursing Rehab Unit on 25Aug2015. While at the Skilled Nursing Rehab Unit, the patient was re-admitted to the hospital for hyponatremia on 01Sep2015. This hospital course complicated by management of a UTI (Urinary Tract Infection) with CIPRO 500 mg. The patent was treated at the hospital and discharged back to the Skilled Nursing Rehab Unit on 10Sep2015 with a diagnosis of hyponatremia. It is unknown if the patient still had the wound vac in place. Left upper extremity wound in healing. The patient cannot take FLONASE due to her glaucoma. She had bad reactions to antihistamines. The patient cannot take decongestants. Cultures drawn during the first hospital admission were negative. The patient underwent lab tests and procedures on 31Aug2015 which included calcium serum 8.1, chloride serum 78, glucose 111, osmolality 235 and sodium 113. It was also reported that the patient had atrial fibrillation (A fib) and hypertension both in Aug2015, gastrooesophageal reflux disease (GERD) on 14Aug2015, antidiuretic hormone secretion on 10Sep2015, unsteady gait on 28Aug2015 and sepsis on 26Aug2015, and she still had these problems. Therapeutic measures were taken as a result of abscess. The outcome of the events was unknown.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Acoustic stimulation tests normal, Decreased appetite, Dysphemia, Ear infection, Laboratory test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A 3-year-old female patient received PREVNAR 13, via an unspecified route of administration in the leg, on 12Aug2014, at single dose. Relevant medical history included ear infection until a week before (she had never been on antibiotics) and house dust allergy. Concomitant medications were not reported. No vaccines given on the same day or eight weeks prior to PREVNAR 13. Before vaccination the doctor did a basic language test and all looked great, so patient got the vaccine. On 17Aug2014 the patient started stuttering and experienced trouble moving legs. On an unspecified date she experienced a reaction to vaccine, would throw her head forward trying to get the words out, didn't eat for 2 days and started screaming for two days. In Apr2015 she experienced ear infection. Clinical course was as follows: four to five days after vaccination the patient started stuttering. For a few weeks it seemed the stuttering was getting worse. As she was trying to speak, she would throw her head forward trying to get the words out. The patient's mother went back to the doctor and was referred for language therapy. Since Sep2014 her daughter has been going to a center, stuttering lasted 6 months and recovered completely a month and a half before. The patient underwent lab tests and procedures which included hearing and language test done on an unspecified date which showed it wasn't a hearing issue. The patient was hospitalized for the events would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward and she received speech therapy. The patient recovered from stuttering in 2015; recovered from didn't eat for 2 days, trouble moving  legs, screaming for two days and would throw her head forward trying to get the words out an unspecified date. Outcome of event ear infection was recovered. Patient's mother stated that this was not the first time she had a reaction to vaccines. The patient's doctor considered stuttering and would throw her head forward trying to get the words out as unrelated to PREVNAR 13. Follow-up (10Jul2015): new information received from a contactable consumer (patient's mother) includes: event "started stuttering/stuttering to the point of throwing her head forward" start date updated. Follow-up (10Sep2015): Follow-up attempts completed. No further information expected. Follow-up (14Sep2015): New information obtained from a contactable consumer includes: hospitalization for would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward, treatment, outcome updated for ear infection. Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Movement disorder, Screaming, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A 3-year-old female patient received PREVNAR 13, via an unspecified route of administration in the leg, on 12Aug2014, at single dose. Relevant medical history included ear infection until a week before (she had never been on antibiotics) and house dust allergy. Concomitant medications were not reported. No vaccines given on the same day or eight weeks prior to PREVNAR 13. Before vaccination the doctor did a basic language test and all looked great, so patient got the vaccine. On 17Aug2014 the patient started stuttering and experienced trouble moving legs. On an unspecified date she experienced a reaction to vaccine, would throw her head forward trying to get the words out, didn't eat for 2 days and started screaming for two days. In Apr2015 she experienced ear infection. Clinical course was as follows: four to five days after vaccination the patient started stuttering. For a few weeks it seemed the stuttering was getting worse. As she was trying to speak, she would throw her head forward trying to get the words out. The patient's mother went back to the doctor and was referred for language therapy. Since Sep2014 her daughter has been going to a center, stuttering lasted 6 months and recovered completely a month and a half before. The patient underwent lab tests and procedures which included hearing and language test done on an unspecified date which showed it wasn't a hearing issue. The patient was hospitalized for the events would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward and she received speech therapy. The patient recovered from stuttering in 2015; recovered from didn't eat for 2 days, trouble moving  legs, screaming for two days and would throw her head forward trying to get the words out an unspecified date. Outcome of event ear infection was recovered. Patient's mother stated that this was not the first time she had a reaction to vaccines. The patient's doctor considered stuttering and would throw her head forward trying to get the words out as unrelated to PREVNAR 13. Follow-up (10Jul2015): new information received from a contactable consumer (patient's mother) includes: event "started stuttering/stuttering to the point of throwing her head forward" start date updated. Follow-up (10Sep2015): Follow-up attempts completed. No further information expected. Follow-up (14Sep2015): New information obtained from a contactable consumer includes: hospitalization for would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward, treatment, outcome updated for ear infection. Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, TDAP
Symptoms: Cough, Pyrexia
Clinical narrative: Pt received Tdap, PREVNAR and Flu (high potency) f/u 9/4/15. Developed fvr, residual cough.
Age: 45.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site swelling
Clinical narrative: Swelling around injection site.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, little pain (not debilitating but aware of it) on 9/13/15 in the morning.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient received flu and pneumonia vaccine. Developed cellulitis at both sites of injection. Treated at hospital with antibiotics and steroids.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: 15 minutes after admin. of vaccine she began to have tingling/itchiness in the face and scalp followd by hands. 24 hours later scalp still itchy and red and has only been controlled by BENADRYL. Told to see doctor if persists.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Flushing, Inflammation, Pruritus generalised
Clinical narrative: 15 minutes after admin. of vaccine she began to have tingling/itchiness in the face and scalp followd by hands. 24 hours later scalp still itchy and red and has only been controlled by BENADRYL. Told to see doctor if persists.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Confusional state, Dizziness, Dysarthria, Erythema
Clinical narrative: Vaccine administered at 16:00. At 16:35 c/o dizziness, nausea, then loss of consciousness. Increased BP R 197/131, (L) 170/30 (+) tachycardia, slurred speech, confusion. Confirmed increased BP. 911 called and patient transported to local ED. Given ATIVAN and IV fluids. to f/u with neurology. 9/17 (+) erythema. warmth, numbness to (L) arm. (+) pain to (L) arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Loss of consciousness, Nausea, Pain in extremity, Skin warm
Clinical narrative: Vaccine administered at 16:00. At 16:35 c/o dizziness, nausea, then loss of consciousness. Increased BP R 197/131, (L) 170/30 (+) tachycardia, slurred speech, confusion. Confirmed increased BP. 911 called and patient transported to local ED. Given ATIVAN and IV fluids. to f/u with neurology. 9/17 (+) erythema. warmth, numbness to (L) arm. (+) pain to (L) arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Vaccine administered at 16:00. At 16:35 c/o dizziness, nausea, then loss of consciousness. Increased BP R 197/131, (L) 170/30 (+) tachycardia, slurred speech, confusion. Confirmed increased BP. 911 called and patient transported to local ED. Given ATIVAN and IV fluids. to f/u with neurology. 9/17 (+) erythema. warmth, numbness to (L) arm. (+) pain to (L) arm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash on left lower abdomen and left upper leg.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The area surrounding where the shot was given became red and swollen. The swelling on 09/17/15 measured 3 1/4" wide and 2" long. The area was tender to touch and warm.  I encouraged her to visit with her HCP about reaction especially since she is needing another for nursing school and they may want to wave that dose.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rubber sensitivity
Clinical narrative: Patient reported a rash on his arm from latex, but the vaccinator did not use any latex product. He went to his physician on 9/17/15 and was diagnosed with latex allergy and given a prescription for a steroid.  The latex exposure came from a different source but he wanted to report the reaction as being attributed to his vaccination.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Rash, Ulcer
Clinical narrative: First noticed 09/21 but obviously older.  Redness, rash, weeping sores that are healing, approximately 6 inches x 3 inches in area.  No soreness. Prevnar 13 for Adults
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pronounced heat, swelling and redness at site.  Symptoms continue for more that 72 hours past injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, painful, warm-to-touch around site of injection.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to an approximately 11 to 12 year old male patient. The patient's concurrent conditions and medical history were no provided. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL intramuscular injection (anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, the patient developed Guillain-Barre syndrome. On an unspecified date, the patient visited the physician's office for medical attention. There was no product quality issue involved. The outcome of Guillain-Barre syndrome was not reported. The reporter physician stated that the patient's parents believed that the child had developed Guillain-Barre, as result of GARDASIL injection, but, the physician did not assess the relatedness of Guillain-Barre syndrome with GARDASIL. Upon internal review Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: In 24 hours after flu vaccine-stomach cramps diarrhea-lasting for 48 hours. Slowly improving-large red raised area on arm at injection site -arm hor to touch and painful.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: In 24 hours after flu vaccine-stomach cramps diarrhea-lasting for 48 hours. Slowly improving-large red raised area on arm at injection site -arm hor to touch and painful.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Bone pain, Chills, Decreased appetite, Hyperhidrosis, Muscular weakness
Clinical narrative: Friday-midnight reports lung congestion; No treatment. Saturday morning: body aches, bones ache; Saturday 11am: chills, violent shaking, weakness in extremities sweating, N/V, and decrease appetite/ Sunday: still weak and achy all over; Monday-still weak but better.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pulmonary congestion, Tremor
Clinical narrative: Friday-midnight reports lung congestion; No treatment. Saturday morning: body aches, bones ache; Saturday 11am: chills, violent shaking, weakness in extremities sweating, N/V, and decrease appetite/ Sunday: still weak and achy all over; Monday-still weak but better.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 54 year old female patient. Patient's concurrent condition and medical history were not reported. On 15-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX vial , lot # K010630, expiration date on 30-OCT-2015 (dose, route of administration, anatomical location were not reported). When the patient received the dose of ZOSTAVAX, she also received FLUARIX (manufactured by GlaxoSmithKline) (strength, dose, anatomical location, route of administration, lot # an expiration date were not reported) at a different anatomic site. There was not concomitant medication reported. On 17-SEP-2015, the patient experienced an "apple-sized itchy rash" at the injection site. She had not sought any medical attention at this time. A product quality complain was not involved. At the time of the report, the outcome of "apple-sized itchy rash" was reported as not recovered. The relatedness of the adverse event and suspect therapy was not provided . Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain, Rash
Clinical narrative: Pt said had big rash and pain and soreness and said pain in armpit and pt said it is getting better will call Dr and she will call Dr as well.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: ARM PAIN, REDNESS AND SWELLING AROUND INJECTION SITE, THEN BLISTERS. BLISTERS STARTED TO GO AWAY THE NEXT MORNING. NOW (4 DAYS POST-INJECTION) REDNESS AND PAIN CONTINUES TO A LESSER EXTENT AND LINE WHERE BLISTERS WERE IS STILL VISIBLE. RASH APPEARS TO BE RESOLVING ON ITS OWN.
Age: 10.0
Sex: M
Vaccine: FLUN4, HEPA, IPV
Symptoms: Altered state of consciousness, Feeling hot, Pallor
Clinical narrative: Client started feeling warm. Felt like he was going to pass out. Client became pale. Helped the patient into a lying position with legs up, gave client orange juice and blood pressure was 110/70. Client quickly regained color and felt better.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Adverse event
Clinical narrative: Pharmacist counseled patient on the adverse event with the imz. Physician prescribed antibiotics and prednisone. Pharmacy suggested taking Benadryl and that patient is allergic to a component of the immunization.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Rash, redness, and itching around the injection site. Rash and redness is spreading around the arm.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: I've thrown up three times I feel tired and dizzy.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Haematochezia, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain, and significant swelling at injection site. Systemic swelling with 15lbs fluid gain. Bloody stool. Fever persisting >48 hours.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Weight increased
Clinical narrative: Redness, pain, and significant swelling at injection site. Systemic swelling with 15lbs fluid gain. Bloody stool. Fever persisting >48 hours.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 70 yo F was given Prevnar (pneumococcal 13) vaccine in right upper deltoid (lot #I82219) and high dose influenza vaccine (UI430AA) in her left upper deltoid on 09/10/2015.  On 09/20/2015, pt noticed redness in the right upper arm with mild warmth to the skin in this area.  The reaction is circumferential and mildly indurated.  The area is not particularly painful to palpation.  MD assessed this as mild self limited reaction to the Prevnar injection.  Pt to be treated with ice and antihistamines.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Flank pain, Headache, Inflammation, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, left side hurt, hands hurt.  Felt like everything is inflamed.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Abscess, Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Sore and swollen arm that persists, was seen today and cellulitis and abscess was diagnosed and Cephalixin and warm compresses prescribed.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches that worsens over 10 hrs; fever of 103; down to 99 by 12M, then back up to 103 at 3AM.  Took ibuprofen 2 x for that period. Also took Benadryl at 7PM and 3AM. Remained achy throughout next 2 days, fever slowly down; normal by 9/20 AM.  Rested all weekend (9/19 and 9/20). Body aches resolved by 9/20 AM.  No problem since.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Upper extremity mass
Clinical narrative: Whooping cough vaccine given 9/15/15 and about 1 week later customer had reaction left arm with hard lump.
Age: 52.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Body temperature increased, Feeling of body temperature change, Nausea, Respiratory tract congestion
Clinical narrative: DONOR REPORTED SHE WOKE UP FEELING CONGESTED NAUSEATED HOT AND COLD CHECK TEMPERATURE 100.5 DEGREE. REPORTED TOOK OTC TYLENOL S/S RESOLVED LATER THAT DAY.
Age: 52.0
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Feeling of body temperature change, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: DONOR REPORTED SHE WOKE UP FEELING CONGESTED NAUSEATED HOT AND COLD CHECK TEMPERATURE 100.5 DEGREE. REPORTED TOOK OTC TYLENOL S/S RESOLVED LATER THAT DAY.
Age: 52.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Body temperature increased, Feeling of body temperature change, Nausea, Respiratory tract congestion
Clinical narrative: NEXT MORNING AFTER VACCINE WAS ADMINISTER DONOR STATED SHE WOKE UP CONGESTED NAUSEATED HOT AND COLD WITH A FEVER 100.5 REPORTED SHE TOOK OTC TYLENOL ALL S/S RESOLVED LATER THAT DAY NO ER VIST OR HEALTHCARE PROVIDER VISIT.
Age: 52.0
Sex: M
Vaccine: TTOX, TTOX
Symptoms: Feeling of body temperature change, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: NEXT MORNING AFTER VACCINE WAS ADMINISTER DONOR STATED SHE WOKE UP CONGESTED NAUSEATED HOT AND COLD WITH A FEVER 100.5 REPORTED SHE TOOK OTC TYLENOL ALL S/S RESOLVED LATER THAT DAY NO ER VIST OR HEALTHCARE PROVIDER VISIT.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Injection site is very red and inflamed. Patient did not notice this until today. No pain or itching, just redness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction of right arm at injection site.