chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, sub on 2017-12-13.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: On 1 Dec 2017, patient reported 4 day history of gradually worsening chest pain and shortness of breath. Pt was in significant distress and exam was notable for wheezes bilaterally. Albuterol inhaler was ineffective at relieving symptoms and patient was transferred to local ER where he was diagnosed with acute myocarditis, given a single dose of PO nitroglycerin with significant pain relief, and admitted to the cardiac unit. Medications started on admission were PO colchicine 0.6mg twice daily, IV methylprednisolone 62.5mg, PO Carol-F TID (Ibuprofen arginine 368.9mg, 200mg as ibuprofen), PO Dexlansoprazole 30mg, and PO Legalon 140mg. Symptoms had fully resolved by hospital day (HD)#2. Steroid dose stayed at 62.5mg IV for HD 1-3. On HD#4 he was tapered to prednisolone 30mg PO.  Patient was discharged on HD#5. Per Dr., 4 Dec 2017: Starting Colchicine 0.6mg po BID for 3 months, in addition to Ibuprofen 600mg by mouth TID for 2 weeks with plans to continue steroid taper but knowing his symptoms will likely recur due to steroid use. He should be on a restricted profile (no PT/ or exertional activities of any kind- desk duties) for 3 months. At the 3 months mark he should have a repeat inflammatory markers, cardiac enzymes, repeat TTE and a GXT to assess fitness for duty if his symptoms have not recurred for >6 weeks. On 19 Dec 2017, Patient remains asymptomatic. He is tapering off Prednisone (25 day taper); he continues on Colchicine 0.6 mg twice daily for a total of 3-month course; he is no longer taking Ibuprofen for pain. He is on limited duty and has scheduled Cardiology follow up for March 2018.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction decreased, Impaired work ability, Myocarditis
Clinical narrative: On 1 Dec 2017, patient reported 4 day history of gradually worsening chest pain and shortness of breath. Pt was in significant distress and exam was notable for wheezes bilaterally. Albuterol inhaler was ineffective at relieving symptoms and patient was transferred to local ER where he was diagnosed with acute myocarditis, given a single dose of PO nitroglycerin with significant pain relief, and admitted to the cardiac unit. Medications started on admission were PO colchicine 0.6mg twice daily, IV methylprednisolone 62.5mg, PO Carol-F TID (Ibuprofen arginine 368.9mg, 200mg as ibuprofen), PO Dexlansoprazole 30mg, and PO Legalon 140mg. Symptoms had fully resolved by hospital day (HD)#2. Steroid dose stayed at 62.5mg IV for HD 1-3. On HD#4 he was tapered to prednisolone 30mg PO.  Patient was discharged on HD#5. Per Dr., 4 Dec 2017: Starting Colchicine 0.6mg po BID for 3 months, in addition to Ibuprofen 600mg by mouth TID for 2 weeks with plans to continue steroid taper but knowing his symptoms will likely recur due to steroid use. He should be on a restricted profile (no PT/ or exertional activities of any kind- desk duties) for 3 months. At the 3 months mark he should have a repeat inflammatory markers, cardiac enzymes, repeat TTE and a GXT to assess fitness for duty if his symptoms have not recurred for >6 weeks. On 19 Dec 2017, Patient remains asymptomatic. He is tapering off Prednisone (25 day taper); he continues on Colchicine 0.6 mg twice daily for a total of 3-month course; he is no longer taking Ibuprofen for pain. He is on limited duty and has scheduled Cardiology follow up for March 2018.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging heart, Nuclear magnetic resonance imaging normal, Respiratory distress, Troponin I increased, Wheezing
Clinical narrative: On 1 Dec 2017, patient reported 4 day history of gradually worsening chest pain and shortness of breath. Pt was in significant distress and exam was notable for wheezes bilaterally. Albuterol inhaler was ineffective at relieving symptoms and patient was transferred to local ER where he was diagnosed with acute myocarditis, given a single dose of PO nitroglycerin with significant pain relief, and admitted to the cardiac unit. Medications started on admission were PO colchicine 0.6mg twice daily, IV methylprednisolone 62.5mg, PO Carol-F TID (Ibuprofen arginine 368.9mg, 200mg as ibuprofen), PO Dexlansoprazole 30mg, and PO Legalon 140mg. Symptoms had fully resolved by hospital day (HD)#2. Steroid dose stayed at 62.5mg IV for HD 1-3. On HD#4 he was tapered to prednisolone 30mg PO.  Patient was discharged on HD#5. Per Dr., 4 Dec 2017: Starting Colchicine 0.6mg po BID for 3 months, in addition to Ibuprofen 600mg by mouth TID for 2 weeks with plans to continue steroid taper but knowing his symptoms will likely recur due to steroid use. He should be on a restricted profile (no PT/ or exertional activities of any kind- desk duties) for 3 months. At the 3 months mark he should have a repeat inflammatory markers, cardiac enzymes, repeat TTE and a GXT to assess fitness for duty if his symptoms have not recurred for >6 weeks. On 19 Dec 2017, Patient remains asymptomatic. He is tapering off Prednisone (25 day taper); he continues on Colchicine 0.6 mg twice daily for a total of 3-month course; he is no longer taking Ibuprofen for pain. He is on limited duty and has scheduled Cardiology follow up for March 2018.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Brain natriuretic peptide normal, Differential white blood cell count, Dyskinesia, Electrocardiogram normal, Full blood count normal
Clinical narrative: Patient was given MENVEO and BEXSERO vaccines. While waiting during the 15 minute post immunization period, mom yelled for help. Dr. and CMA entered exam room and found patient sitting in chair. Dr. felt that patient was having syncopal episode with posturing. Patient was gotten up and had another episode with jerking and then left arm weakness. Vitals were taken and 911 was called. Patient was transferred to Hospital ED for assessment.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Metabolic function test normal, Muscular weakness, Posturing, Syncope, Troponin normal
Clinical narrative: Patient was given MENVEO and BEXSERO vaccines. While waiting during the 15 minute post immunization period, mom yelled for help. Dr. and CMA entered exam room and found patient sitting in chair. Dr. felt that patient was having syncopal episode with posturing. Patient was gotten up and had another episode with jerking and then left arm weakness. Vitals were taken and 911 was called. Patient was transferred to Hospital ED for assessment.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine.  No symptoms were experienced.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Oropharyngeal pain, Pyrexia, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Fever, vomiting, runny nose, sore throat decreased appetite, maculopapular rash.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, runny nose, sore throat decreased appetite, maculopapular rash.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Heart rate irregular
Clinical narrative: Patient had a cough started on 12/10/17 and 2 weeks later she was admitted to ER with irregular heartbeat.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PT RIGHT ARM SWELLING AND PAIN AT INJECTION SITE. HIS RIGHT ARM HAS REDNESS FROM UPPER ARM SPREADING TO LOWER ARM. HE COMPLAINED OF LOW GRADE FEVER, 99%. PT WAS PRESCRIBED CETIRIZINE 10MG, ZANTAC 150MG, HYDROXYZINE 25MG AND PREDNISONE 20MG TWO TABS DAILY FOR THREE DAYS.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 36 hours after vaccination the backs of my knees became bumpy, red, and extremely itchy. Over the course of the next 48 hours, the rash spread to my lower legs, arms, and trunk. Small raised red bumps resulted accompanied by extreme itch. Methylprednisone dose pack was prescribed, as well as topical triamcinolone. Some resolution from methylprednisone, but itch has returned after completion of dose pack.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber, and refers to a 19 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly for prophylaxis (dose, lot number and expiration date were not reported). On 06-DEC-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis, lot # N018273, expiration date 17-JUN-2019  (dose and route of administration were not reported). There was not product quality complaint or adverse event involved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Arthralgia, Blood test, Erythema, Gait disturbance
Clinical narrative: This spontaneous report was received from a 60 year old female patient refering to herself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. In May 2017, the patient was vaccinated with ZOSTAVAX injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). On an unspecifed date in 2017 after ZOSTAVAX vaccination, the patient experienced swelling, redness and warmth in an unspecified arm which lasted approximately 2 weeks. In June 2017, the patient began to feel ill. On an unspecified date in June or July 2017, she was seen in an emergency room and was diagnosed with vertigo and anemia but, she was not admitted to hospital. Addittionally, on an unspecified date in 2017, the patient experienced severe pain in all her major joints and took MOTRIN with little relief from pain. Consequently, in December 2017, the patient was diagnosed with polymyalgia rheumatica. Lab studies performed included "multiple blood tests" (results were not performed). At the reporting time, the outcome of polymyalgia rheumatica, anaemia and vertigo was reported as not recovered and the outcome of peripheral swelling, feeling hot and erythema was reported as recovered/resolved. The reporter did not assess the relatedness between ZOSTAVAX and the adverse events. The reporter stated that the polymyalgia rheumatica had caused her a significant disability as she was barely able to get out of bed or walk, and could barely leave the house. Additionally, she had had to stop working because of the pain. Upon internal review, the polymyalgia rheumatica was considered to be medically significant.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise, Mobility decreased, Peripheral swelling, Polymyalgia rheumatica
Clinical narrative: This spontaneous report was received from a 60 year old female patient refering to herself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. In May 2017, the patient was vaccinated with ZOSTAVAX injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). On an unspecifed date in 2017 after ZOSTAVAX vaccination, the patient experienced swelling, redness and warmth in an unspecified arm which lasted approximately 2 weeks. In June 2017, the patient began to feel ill. On an unspecified date in June or July 2017, she was seen in an emergency room and was diagnosed with vertigo and anemia but, she was not admitted to hospital. Addittionally, on an unspecified date in 2017, the patient experienced severe pain in all her major joints and took MOTRIN with little relief from pain. Consequently, in December 2017, the patient was diagnosed with polymyalgia rheumatica. Lab studies performed included "multiple blood tests" (results were not performed). At the reporting time, the outcome of polymyalgia rheumatica, anaemia and vertigo was reported as not recovered and the outcome of peripheral swelling, feeling hot and erythema was reported as recovered/resolved. The reporter did not assess the relatedness between ZOSTAVAX and the adverse events. The reporter stated that the polymyalgia rheumatica had caused her a significant disability as she was barely able to get out of bed or walk, and could barely leave the house. Additionally, she had had to stop working because of the pain. Upon internal review, the polymyalgia rheumatica was considered to be medically significant.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vertigo
Clinical narrative: This spontaneous report was received from a 60 year old female patient refering to herself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. In May 2017, the patient was vaccinated with ZOSTAVAX injection for prophylaxis (route, anatomical location, lot# and expiration date were not provided). On an unspecifed date in 2017 after ZOSTAVAX vaccination, the patient experienced swelling, redness and warmth in an unspecified arm which lasted approximately 2 weeks. In June 2017, the patient began to feel ill. On an unspecified date in June or July 2017, she was seen in an emergency room and was diagnosed with vertigo and anemia but, she was not admitted to hospital. Addittionally, on an unspecified date in 2017, the patient experienced severe pain in all her major joints and took MOTRIN with little relief from pain. Consequently, in December 2017, the patient was diagnosed with polymyalgia rheumatica. Lab studies performed included "multiple blood tests" (results were not performed). At the reporting time, the outcome of polymyalgia rheumatica, anaemia and vertigo was reported as not recovered and the outcome of peripheral swelling, feeling hot and erythema was reported as recovered/resolved. The reporter did not assess the relatedness between ZOSTAVAX and the adverse events. The reporter stated that the polymyalgia rheumatica had caused her a significant disability as she was barely able to get out of bed or walk, and could barely leave the house. Additionally, she had had to stop working because of the pain. Upon internal review, the polymyalgia rheumatica was considered to be medically significant.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Blood test, Dizziness, Loss of consciousness, Peripheral coldness
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 26-year-old female patient. The patient had a history of kidney stones, no previous history of reactions to vaccines or blood draws, concurrent condition of primary hyperparathyroidism and no concomitant medications. On 14-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection, lot # N017833 with expiration date on 16-NOV-2019 as a prevention of human papilloma virus (HPV). On the same day, about 2 minutes after the vaccine was administered, the patient started feeling dizzy and lightheaded. The medical assistant laid the patient back, as she was looking like she was near syncope. The reporter stated, the patient felt very cold to the touch at that time. Subsequently, the patient blacked out for about 3 seconds. When she woke up, she said it felt like it had been minutes since she blacked out and did not remember what happened. The patient stayed in the office until she felt better. The patient did not receive any treatment for the adverse events. The patient had unspecified bloodwork performed on 14-DEC-2017 (results were not provided). The outcome of dizziness, coldness to the touch and loss of memory was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of blacking out was considered to be medically significant.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 26-year-old female patient. The patient had a history of kidney stones, no previous history of reactions to vaccines or blood draws, concurrent condition of primary hyperparathyroidism and no concomitant medications. On 14-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection, lot # N017833 with expiration date on 16-NOV-2019 as a prevention of human papilloma virus (HPV). On the same day, about 2 minutes after the vaccine was administered, the patient started feeling dizzy and lightheaded. The medical assistant laid the patient back, as she was looking like she was near syncope. The reporter stated, the patient felt very cold to the touch at that time. Subsequently, the patient blacked out for about 3 seconds. When she woke up, she said it felt like it had been minutes since she blacked out and did not remember what happened. The patient stayed in the office until she felt better. The patient did not receive any treatment for the adverse events. The patient had unspecified bloodwork performed on 14-DEC-2017 (results were not provided). The outcome of dizziness, coldness to the touch and loss of memory was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of blacking out was considered to be medically significant.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Extra dose administered, Fatigue, Feeling cold, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of PREVNAR 13 (batch number requested) via an unspecified route of administration in upper arm on 11Nov2016 at a single dose for immunization. The patient's medical history was not reported. There were no concomitant medications. On 11Nov2016, the patient was supposed to be given pneumococcal 23 but was given with pneumococcal 13-valent conjugated vaccine. The patient stated that last 11Nov2016, when she went to her PCP, they gave her a pneumonia vaccine and then they said that this November (2017), when she went for her physical, that she would receive the other pneumonia vaccine. It was reported that what happened was that they gave her the same shot twice; they gave her the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) both in 2016 and this past year Nov2017. The patient stated when probed for the dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) administered in Nov2016 that she did not know and that it was whatever they gave her. Then on the same day of 11Nov2016, the patient had headache, kind of chills and felt kind of cold and stuff and was tired. The patient received no treatment for the events and had no lab works done. The patient recovered from all of the events within 24 hours (12Nov2016). The patient queried if the result of immunization diminished because she received the vaccine twice. The following information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient of an unspecified age and ethnicity received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first injection of TRUMENBA on an unspecified date, reported as 3Oct, for immunization. Two months later, the patient got the second dose and got the rash at the site, 8-10 cm, little swelling, mild tenderness, no difficulty swallowing or breathing. Therapeutic measures were taken as a result of got rash at the site, 8-10 cm, little swelling, mild tenderness and included treatment with BENADRYL and applied BENADRYL cream. A couple of days later, the patient felt it was getting worse, came in, but MD said it didn't look worse. It had resolved. NP states that he did not intend for the patient to get the 3 dose series, she was only supposed to get doses at 0 and 6 months. The information on the batch number and expiration date have been requested.
Sex: F
Vaccine: MENB
Symptoms: Chills, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Physician and a consumer (Office staff). A female patient of an unspecified age and ethnicity received TRUMENBA first dose via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen arm and chills on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Ear infection, Pneumonia, Sinus disorder
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (HCP) received via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, otitis and sinus. The outcome of the reported events was unknown. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded toward the occurrence of pneumonia and otitis.  Further information like confirmative pathological/serotype results and vaccination details including age, location and schedule are needed for full medical assessment.
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 13Dec2017 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that it made her really sore, very sore arm for a day and a half on an unspecified date. The patient experienced pain and swelling at the injection site on an unspecified date (patient thought it was a little swollen because it was painful), much more than when got the flu shot. It was reported that it was really uncomfortable to lay on that side. The next day (14Dec2017) the fatigue and headache lasted until 4pm. Patient had hardly had any joint pain. The patient hadn't lost appetite, no redness. The patient had a pretty good headache the day after and general fatigue, and had swelling in her left lymph node on an unspecified date which she thought meaning she was fighting something. The patient stated she was better, had a little bit of a headache on the top of head. The patient was feeling a little soreness around her shoulders on an unspecified date, but that may be from stress. The outcome of event headache was recovering, outcome of the other events was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 13Dec2017 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that it made her really sore, very sore arm for a day and a half on an unspecified date. The patient experienced pain and swelling at the injection site on an unspecified date (patient thought it was a little swollen because it was painful), much more than when got the flu shot. It was reported that it was really uncomfortable to lay on that side. The next day (14Dec2017) the fatigue and headache lasted until 4pm. Patient had hardly had any joint pain. The patient hadn't lost appetite, no redness. The patient had a pretty good headache the day after and general fatigue, and had swelling in her left lymph node on an unspecified date which she thought meaning she was fighting something. The patient stated she was better, had a little bit of a headache on the top of head. The patient was feeling a little soreness around her shoulders on an unspecified date, but that may be from stress. The outcome of event headache was recovering, outcome of the other events was unknown. No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age ethnicity and gender received PREVNAR 13 (LOT# and Expiration date not provided) (reported as Prevnar 23, pending clarification), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient had a flu shot and the PREVENAR 23 yesterday and the patient's arm was swollen, elbow clear up to shoulder, had fever and chills. The patient need to know if it was not a normal. The fact that the patient had never had a problem before. The outcome of the events was unknown.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test normal, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 82 years old male patient received PREVNAR 13 on an unknown date in Oct2017, at single dose, in arm, for immunization. Medical history included ongoing diabetes since 10 or 12 years and ongoing regular arthritis. Ongoing concomitant medications included insulin glargine (LANTUS) at 40 (unknown unit/frequency) in little syringe, for diabetes and insulin aspart (NOVOLOG) at unknown posology, depending on his blood sugar, for diabetes. On an unspecified date in Oct2017 in the morning, the very next day after vaccination, the patient could not raise his arm to put his shirt on, hands were swollen huge, big swollen hands, had pain and could not make a fist. The patient wife waited a day or 2 to call doctor because he said it might go away, it didn't. So for about 3 months nobody knew what it was and the patient tried some prednisone 2.5 mg (expiry date : 08Nov2018) that did not help. It will be finished in two days but he did not get relief and he had gone to a rheumatologist. It was not rheumatoid arthritis. Nobody knew how to treat this. The patient underwent blood work on an unspecified date, he just got  5 or 6 vials done and they send it to the rheumatologist who said his blood work was good and to come back in 6 weeks. He was still in pain at the time of report (still when he went to push himself out of the chair or move he had pain). The outcome of the other events was unknown. Information on the batch number has been requested.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (friend of parent of the patient). A 4-months-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. On the same date the patient received other unspecified vaccines. The patient medical history and concomitant medications were not reported.  The patient developed a very high fever within a few hours. In addition, later that evening he developed spots on his torso, which turned out to be a rash the following day. The outcome of the event was unknown. The patient experienced similar events with the third month shot (unspecified vaccine). Information on the batch number has been requested.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria chronic
Clinical narrative: Patient developed urticaria within 12 hours of the vaccine. Has subsequently developed chronic urticaria that has persisted through today's date. Urticaria is mild, easily treated with standard doses of antihistamines. No other systemic symptoms occurred.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient called 12.20.17 days after vaccine and said her arm was very sore, red, and warm to touch. I called patient on 12.21.17 to check on her and she said it was still sore and starting to itch.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Injection site warmth, Pain
Clinical narrative: Pt reports moderate arm pain at injection site. Said it was warm to the touch for several days after administration and that there is still a "knot" at the injection site. Pt reports her arm is still painful when she lifts it.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient described prolonged soreness and loss of range of motion in the arm used for vaccination. Seen doctor, recommended PT, assumed possible frozen shoulder.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71-year-old male patient with concurrent conditions of unspecified heart issues and unspecified prostate issue. On 07-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # N025656 with expiration date on 19-APR-2019 (dose was not reported). Concomitant drugs included unspecified blood pressure and prostate medications. On 08-DEC-2017, the patient experienced swelling below the injection site on his elbow and forearm area. The patient was prescribed cephalexin, prednisone (manufacturer unknown) and erythromycin and began the therapy on 08-DEC-2017. On 10-DEC-2017, the patient reported to the pharmacist that the swelling had travelled down to an unspecified area of his body (reported as "travelled down to his"). The patient did not recover from the events at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported (it was also reported that the pharmacist was unaware of the patient's status at the time of the report).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Functional gastrointestinal disorder, Headache, Pyrexia, Urinary incontinence
Clinical narrative: This spontaneous report was received from the patient's mother concerning to her 13 year old female daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, by intramuscular route (strength, dose, lot number and expiration date were not reported) to prevent HPV. The primary reporter stated that on 15-NOV-2017 to 09-DEC-2017, the patient kept having issues where she would "leak" or urinate onto her underwear. Also on 20-NOV-2017, the patient developed a high fever of 103 (units not reported). The fever decreased on 22-NOV-2017, but the reporter stated that the fever was on and off. Starting on 22-NOV-2017 to 23-NOV-2017, the patient also had headache. In approximately 2017, the patient was having issues with her bowels and could not got to the bathroom. Treatment was given for the adverse events. At the time of the report, the outcome of the events was reported as not recovered. The causality between the events and the GARDASIL 9 was not reported.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Ear pain, Headache, Nausea
Clinical narrative: Persistent ongoing head pain, nausea, dizziness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site indentation, Injection site nodule, Local reaction
Clinical narrative: First reported to provider on 11/03/2017- localized reaction to left thigh with small nodule and large area of dimpling/indentation to left thigh. Follow up 12/15 no improvement, no pain or weakness.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cardiac stress test, Confusional state, Diplopia, Disturbance in attention
Clinical narrative: This initial spontaneous case was received on 08-Nov-2017, from an consumer, concerning a 44-year-old, adult male patient. The patient's historical condition included small murmur in childhood, which was resolved. The patient's current condition included, unspecified mental disease disorder and the concomitant medications included EXCELL 300 mg, bupropion, escitalopram, clonazepam, estazolam, DEPAKOTE Extended release, TRIUMEQ, testosterone for unknown indications. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration, anatomical location batch number, expiry date). On the same day, within 2 minutes of vaccination, the patient's heart rate went up, had double vision, was unable to concentrate and felt like suffocating. The patient stayed for some time and drove home when he felt better. On 05-Nov-2017, the next day, when he woke up, was confused and really tired and had no energy. On the same day, the patient went to the hospital and there he collapsed on the floor and lost consciousness. The blood pressure was found to be 38, was hospitalised and kept under observation for 2 nights at cardiology department. The blood pressure was monitored and the physicians thought the BP would not raise above 50, hence insertion of pacemaker was considered. The patient underwent ECG (Electrocardiography), cardiogram, echogram, full blood panel, stress test for which result was not reported. The patient received unspecified medicines in the hospital. At the time of the discharge BP was found to be 75. At the time of the report, heart rate increased, double vision, unable to concentrate and suffocation was resolving and the outcome of other events was not reported. The reporter assessed the events as serious (hospitalization).
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Full blood count, Heart rate increased
Clinical narrative: This initial spontaneous case was received on 08-Nov-2017, from an consumer, concerning a 44-year-old, adult male patient. The patient's historical condition included small murmur in childhood, which was resolved. The patient's current condition included, unspecified mental disease disorder and the concomitant medications included EXCELL 300 mg, bupropion, escitalopram, clonazepam, estazolam, DEPAKOTE Extended release, TRIUMEQ, testosterone for unknown indications. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration, anatomical location batch number, expiry date). On the same day, within 2 minutes of vaccination, the patient's heart rate went up, had double vision, was unable to concentrate and felt like suffocating. The patient stayed for some time and drove home when he felt better. On 05-Nov-2017, the next day, when he woke up, was confused and really tired and had no energy. On the same day, the patient went to the hospital and there he collapsed on the floor and lost consciousness. The blood pressure was found to be 38, was hospitalised and kept under observation for 2 nights at cardiology department. The blood pressure was monitored and the physicians thought the BP would not raise above 50, hence insertion of pacemaker was considered. The patient underwent ECG (Electrocardiography), cardiogram, echogram, full blood panel, stress test for which result was not reported. The patient received unspecified medicines in the hospital. At the time of the discharge BP was found to be 75. At the time of the report, heart rate increased, double vision, unable to concentrate and suffocation was resolving and the outcome of other events was not reported. The reporter assessed the events as serious (hospitalization).
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Suffocation feeling, Syncope
Clinical narrative: This initial spontaneous case was received on 08-Nov-2017, from an consumer, concerning a 44-year-old, adult male patient. The patient's historical condition included small murmur in childhood, which was resolved. The patient's current condition included, unspecified mental disease disorder and the concomitant medications included EXCELL 300 mg, bupropion, escitalopram, clonazepam, estazolam, DEPAKOTE Extended release, TRIUMEQ, testosterone for unknown indications. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration, anatomical location batch number, expiry date). On the same day, within 2 minutes of vaccination, the patient's heart rate went up, had double vision, was unable to concentrate and felt like suffocating. The patient stayed for some time and drove home when he felt better. On 05-Nov-2017, the next day, when he woke up, was confused and really tired and had no energy. On the same day, the patient went to the hospital and there he collapsed on the floor and lost consciousness. The blood pressure was found to be 38, was hospitalised and kept under observation for 2 nights at cardiology department. The blood pressure was monitored and the physicians thought the BP would not raise above 50, hence insertion of pacemaker was considered. The patient underwent ECG (Electrocardiography), cardiogram, echogram, full blood panel, stress test for which result was not reported. The patient received unspecified medicines in the hospital. At the time of the discharge BP was found to be 75. At the time of the report, heart rate increased, double vision, unable to concentrate and suffocation was resolving and the outcome of other events was not reported. The reporter assessed the events as serious (hospitalization).
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Contusion, Immune thrombocytopenic purpura, Platelet count decreased, Viral infection
Clinical narrative: This initial spontaneous case was received from pharmacist on 07-Nov-2017, concerning a 11-year-old male child patient. The patient's medical history included ADHD and unspecified allergies (since an unspecified dates). The patient's concomitant medications included Clonidine, methylphenidate and ZYRTEC for an unknown indication. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: deltoid, batch number: 195218, expiry date: Apr-2018). It was reported that, the patient had no problem at the time of vaccination. On an unspecified date, the patient had bruising, which started about a week ago (as reported on hospitalization), which was worsened and popped up all over the body. On 06-Nov-2017, the patient was admitted to the hospital. The patient's platelets were below to 1000 (unit and normal range no reported) and he was diagnosed with idiopathic thrombocytopenia and no other symptoms were reported. The haematologist stated that, it was not from the clonidine but a viral infection (unspecified) that the virus attached to the platelets. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as serious due to hospitalization.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Peripheral swelling, Swelling, Temporal arteritis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster (onset date unknown). Shortly after receiving the ZOSTAVAX, the patient developed bulging veins, along with bulging temples and swelling arms. Thereafter, the patient was diagnosed with giant cell arteritis. The outcome of the giant cell arteritis and swelling arms is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Muscular weakness, Musculoskeletal disorder, Pain
Clinical narrative: Joint pain elbow, wrist, fingers left side throbbing/burning. Weakness in (L) arm prevented use of her left arm/hand for 2-3 weeks, over which time the weakness gradually faded and full use of the arm was restored.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Joint pain elbow, wrist, fingers left side throbbing/burning. Weakness in (L) arm prevented use of her left arm/hand for 2-3 weeks, over which time the weakness gradually faded and full use of the arm was restored.
Sex: M
Vaccine: FLUX
Symptoms: Deafness
Clinical narrative: This serious initial spontaneous case, was received from other health care professional on 10-Nov-2017, concerning a male patient of an unspecified age. The subject's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with Influenza vaccine (dose, batch number, manufacturer, trade name, route of administration and anatomical location: not reported). It was reported that, the patient experienced hearing loss after taking a flu shot. At the time of this report, the outcome of the event was not reported. Case Comment: A male patient had hearing loss after receiving flu vaccine. Company assesses the event causality as unassessable due to unavailability of information regarding vaccination, temporal latency, severity of the event, reversibility of the event and clinical status of the patient at the time of vaccination. The company assessed the event as serious (medically significant).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Child rec'd only the DTaP, IPV liquid portion of vaccine.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL was given instead of HIB.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site warmth, Pain, Peripheral swelling, Pyrexia
Clinical narrative: 18 hours post vaccine employee c/o redness and soreness with a low grade fever. Warmth at injection site.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Respiratory tract congestion
Clinical narrative: 18 hours post vaccine employee c/o redness and soreness with a low grade fever. Warmth at injection site.
Age: 27.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Seizure
Clinical narrative: Patient received the Tdap vaccine in office. patient stayed in our office 25 minutes after vaccine administration. At around 4:10 PM or 4:15 PM someone found the patient in the main entrance of the building having a seizure. 1st Aid was provided and EMS was called. Patient was transported via EMS to the nearest hospital.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Axillary pain, Differential white blood cell count normal, Full blood count normal, Lymph node pain
Clinical narrative: Swelling/pain L axilla started day after the Td vaccination in L deltoid. Had some pain radiating down L trunk to level of knee-this had resolved at time of my evaluation. Visible moderate edema of L axilla was noted on exam. Palpable, tender lymph node in area of swelling. Ordered labs (CBC and CMP that were unremarkable). Afebrile. US of L axilla completed-showed normal appearing LN's but fluid in soft tissue. Started patient on antibiotics and ibuprofen/TYLENOL and recommended warm packs and will follow up tomorrow.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Lymph node palpable, Metabolic function test normal, Oedema peripheral, Pain, Ultrasound scan normal
Clinical narrative: Swelling/pain L axilla started day after the Td vaccination in L deltoid. Had some pain radiating down L trunk to level of knee-this had resolved at time of my evaluation. Visible moderate edema of L axilla was noted on exam. Palpable, tender lymph node in area of swelling. Ordered labs (CBC and CMP that were unremarkable). Afebrile. US of L axilla completed-showed normal appearing LN's but fluid in soft tissue. Started patient on antibiotics and ibuprofen/TYLENOL and recommended warm packs and will follow up tomorrow.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Patient was seen by provider and directed to use OTC Tylenol and ice area.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Fatigue, Gait disturbance
Clinical narrative: Pt received PREVNAR at Public Health on 9-8-17, within a week had severe back and leg pain with leg swelling and difficulty walking. Was seen in ER, on 9-15-17, had ct scan unremarkable and u/a unremarkable, and sent home with rest and antiinflammatories.  Pt still feels pain and fatigue.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Peripheral swelling, Urine analysis normal
Clinical narrative: Pt received PREVNAR at Public Health on 9-8-17, within a week had severe back and leg pain with leg swelling and difficulty walking. Was seen in ER, on 9-15-17, had ct scan unremarkable and u/a unremarkable, and sent home with rest and antiinflammatories.  Pt still feels pain and fatigue.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Right upper extremity extremely swollen, reddened and extreme pain. Axilla lymph nodes enlarged and painful. Area hot to the touch.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Right upper extremity extremely swollen, reddened and extreme pain. Axilla lymph nodes enlarged and painful. Area hot to the touch.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Impaired driving ability, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: 11-13-17 brief episode of severe vertigo, then on 11-14-17 at 1045am had another episode of severe vertigo- patient went to emergency room that evening and got admitted for two nights, patient has not been symptom free yet. Patient's vertigo has decreased over the past month however not completely resolved- treatment has included physical therapy and meclizine, MD is also trying KLONOPIN. Patient currently not able to drive due to vertigo and effects daily movements.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Phlebitis
Clinical narrative: Patient received a pneumococcal vaccine on 12/6/17. Following the injection, the patient developed cellulitis of the right arm and was seen at a walk-in clinic where she was prescribed BACTRIM. Symptoms worsened and the following day she went to the hospital and was admitted for 3 days. During the hospital admission, pt developed phlebitis of the right arm. She received IV antibiotics and steroids while in the hospital and was discharged on AUGMENTIN and MEDROL DOSEPAK.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient said her arm hurts/pain/numbness after flu shot.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt is 3 years old and was administered influenza dose for age 6-35 months.