chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Local swelling
Clinical narrative: Dnr has redness and swelling to arm, warm to the touch at injection site and surrounding area occured approx 9pm.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: I began to feel the typical side effects of the flu vaccine however 6 days later I continue to feel the symptoms and feel they are getting worse.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth at/around injection site.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Incorrect storage of drug, Mobility decreased, Monoplegia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no pertinent medical history and no drug reactions or allergies. On 22-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as J000388 and 06-AUG-2014 respectively) which was improperly stored. There were no concomitant medications. Since 22-SEP-2013, the arm of the patient from the shoulder down was paralyzed and numb and could not move it. The patient felt the administration of the PNEUMOVAX23 a little high on her arm. It was unspecified if the patient sought any medical attention. The patient put her arm up on pillow. No lab tests were performed. The patient was recovering from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. On 04-SEP-2013, the patient was vaccinated with a dose of FLUZONE. Upon internal review, arm from the shoulder down was paralyzed was considered as medically significant and could not move it as disability. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Incorrect storage of drug, Mobility decreased, Monoplegia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no pertinent medical history and no drug reactions or allergies. On 22-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as J000388 and 06-AUG-2014 respectively) which was improperly stored. There were no concomitant medications. Since 22-SEP-2013, the arm of the patient from the shoulder down was paralyzed and numb and could not move it. The patient felt the administration of the PNEUMOVAX23 a little high on her arm. It was unspecified if the patient sought any medical attention. The patient put her arm up on pillow. No lab tests were performed. The patient was recovering from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. On 04-SEP-2013, the patient was vaccinated with a dose of FLUZONE. Upon internal review, arm from the shoulder down was paralyzed was considered as medically significant and could not move it as disability. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: 9-15-13: Spiked high fever, severe chills and fatigue. 9-16-13: fatigue, fever, chills. 9-17-13: Patient developed facial swelling, hives, chest pains, difficulty breathing. Went to ER.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: 9-15-13: Spiked high fever, severe chills and fatigue. 9-16-13: fatigue, fever, chills. 9-17-13: Patient developed facial swelling, hives, chest pains, difficulty breathing. Went to ER.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood creatine phosphokinase increased, Hypokinesia, Liver function test abnormal, Rhabdomyolysis
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female, non pregnant patient with no medical history and no drug reactions or allergies. On 24-SEP-2013 the patient was vaccinated with a third dose of GARDASIL (lot number, dose, route and site of administration were not reported). The dates of administration of the first two doses of GARDASIL were unspecified. No concomitant medications were reported. The patient presented to the hospital on 29-SEP-2013 with increased liver function tests, increased creatinine kinase levels and rhabdomyolysis. The physician reported that the patient had been given extra fluids to treat rhabdomyolysis, and the patient's liver function tests were worsening. The patient was very weak and couldn't move around a lot. The outcome of adverse events was reported as not recovered. The relatedness between vaccination with GARDASIL and adverse events was not reported. Upon internal review rhabdomyolysis was considered to be medically significant. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lethargy, Vomiting
Clinical narrative: 9:30 AM Flu vac L-59YY4 Ex. 6/30/13 Rt deltoid c/o at 10AM. Headache - VS taken 10 AM 200/120 P170. 911 called - pt responsive, lethargic, vomited. 10:10 - VS 200/170 P170 - 10:15 180/100; P100; 10:20 Rescue came.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth in area 5 cm diam medial upper arm, but not surrounding injection site (deltoid) coincides with arm in which PNEUMOVAX was given.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Gaze palsy, Loss of consciousness
Clinical narrative: Almost immediately after administration of FLUZONE, pt passed out for about 15 sec. He regained consciousness but had one jerky movement and rolled his eyes back for a couple of seconds. He was observed for 30 min offered Gatorade and pt was ok so he walked back with his dad.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right upper medial arm with 6 cm diam of redness, warmth and pain. (R) deltoid (injection site) was not involved with these changes.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient received Flu HD vaccine approx 11:00 AM. Patient went home and had vomiting/diarrhea around 2:00pm, there was no pain or signs of reaction at injection site, symptoms resolved at 3:00pm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: SEP 10, around injection site - hot, swollen, pain. SEP 11 hot, swollen, pain, during the day developed discoloration/rash 8x9" above and below inj. site to within 2 1/2" above bend of elbow at emergency room before midnight. SEP 12 examined, took Cetirizine and SINGULAIR and ALEVE during this time.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Glossodynia, Pruritus, Throat irritation
Clinical narrative: Loss of muscle control in throat, was not able to swallow, tongue and throat had burning feeling, body had itchy feeling (slight).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient rec'd vaccine on 9/17 and on 9/21 experienced vomiting on 4 occasions and reports "feeling feverish". Patient went to ER 9/21 and was prescribed ondansetron for nausea and released. No other tests given. Patient presented to pharmacy 9/28 inquiring whether or not this could've been vaccine related. Claims NOT dx with Guillain-Barre in past. Patient feeling well since 9/21.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Antinuclear antibody negative, Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulins absent, Double stranded DNA antibody
Clinical narrative: This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Glomerulonephritis membranoproliferative, Haemodialysis, Hepatitis B test negative, Hepatitis C test negative, Nephrotic syndrome
Clinical narrative: This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Renal failure, Toxicity to various agents
Clinical narrative: This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Glomerulonephritis membranoproliferative, Hepatitis B test negative, Hepatitis C test negative, Nephrotic syndrome, Renal failure
Clinical narrative: This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: FLUX, HIBV, IPV, TDAP, FLUX, HIBV, IPV, TDAP
Symptoms: Serology negative, Toxicity to various agents
Clinical narrative: This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Difficulty breathing. Weakness. Hoarseness. Dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Little swelling at injection site, warm to touch; itching; mild rash. Advise patient to take diphenhydramine 25 mg x 2 STAT and monitor closely.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Local swelling, Pain in extremity
Clinical narrative: On 9/25/13, she was given Zostavax, flu shot and Pneumovax at the same time and on one arm. Now each arm was painful and swollen and "disabled".
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Right arm cellulitis in arm that had vaccination.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exploratory operation, Immediate post-injection reaction, Injected limb mobility decreased, Nerve injury, Nervous system disorder
Clinical narrative: Upon receiving the vaccination, pt experienced immediate pain that continuously got worse. She underwent surgical exploration and treatment and has been diagnosed with nerve and neurological damage with scarring and impairment of the (L) arm.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Scar
Clinical narrative: Upon receiving the vaccination, pt experienced immediate pain that continuously got worse. She underwent surgical exploration and treatment and has been diagnosed with nerve and neurological damage with scarring and impairment of the (L) arm.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Myalgia
Clinical narrative: Temp 101 - next am after receiving Tdap joint muscle aches.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Aggression, Decreased appetite, Diet refusal, Fatigue, Hypersomnia
Clinical narrative: Mom called. Says child last eve -no appetite. This Am would not eat breakfast (very unusual), sleeping "a lot" , threw fit (behavioral, not seizure) in floor. Exhausted. Mom states same kind of behavior if gets gluten. Went to school but still tired.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Decreased appetite, Fatigue, Insomnia, Irritability
Clinical narrative: Mom called. Says child last eve -no appetite. This Am would not eat breakfast (very unusual), sleeping "a lot" , threw fit (behavioral, not seizure) in floor. Exhausted. Mom states same kind of behavior if gets gluten. Went to school but still tired.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Pt called on 9/30/13 - she received vaccine on 9/23/13. She has felt fine until today when she experienced redness and swelling in upper arm - no fever or fatigue reported.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Injection site pain, Pyrexia
Clinical narrative: Very high fever 101.6 and severe chills. Very weak. Lasting 10 hours then just as quick as it came on started to feel better. Injection site very sore.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Hypoaesthesia, Respiratory tract inflammation, Tachycardia
Clinical narrative: Pt. went home and took nap after vaccination. Woke up several hours later with throat closing. Went to ER with severe allergic reaction including numbness from waist-up, blurry vision, tachycardia, inflamed airway and extreme shortness of breath. Was treated with BENADRYL and IV steroids. Was released when symptoms resolved.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vision blurred
Clinical narrative: Pt. went home and took nap after vaccination. Woke up several hours later with throat closing. Went to ER with severe allergic reaction including numbness from waist-up, blurry vision, tachycardia, inflamed airway and extreme shortness of breath. Was treated with BENADRYL and IV steroids. Was released when symptoms resolved.
Age: 7.0
Sex: M
Vaccine: FLU3, MNQ, TYP, YF
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: MCV4 and influenza vaccines into right deltoid. Patient noticed mild pain in right arm starting that night, then more pain, swelling of right arm from shoulder to forearm, and erythema and warmth over the next 1.5 days.
Age: 7.0
Sex: M
Vaccine: FLU3, MNQ, TYP, YF
Symptoms: Local swelling, Pain in extremity, Skin warm
Clinical narrative: MCV4 and influenza vaccines into right deltoid. Patient noticed mild pain in right arm starting that night, then more pain, swelling of right arm from shoulder to forearm, and erythema and warmth over the next 1.5 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat irritation
Clinical narrative: Facial swelling, throat scratchy.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder joint. Tendinitis/bursitis?
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site pruritus, Throat tightness, Urticaria
Clinical narrative: Started with itching on injection site arm, hives developed, face flushed, tightening on right side of throat.  Benadryl 25 mg given PO.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: Fever, severe migraine, nausea, diarrhea, fatigue, treated with Reglan and fluids at ER, on 09/16/2013.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Raised, red, hard, and rash development at injection site. 22 hours later: continued raised and red with rash improvement.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: No fever, felt very cold, shaking. Had to put extra clothes on. Was in bed with extra blankets. Room 72 degrees (not cold). Event lasted about 1 1/2 hr - until I had put on enough layers. When I woke up during the night I took off extra layers and had no recurrence.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Nausea, Pyrexia, Vomiting, Wheezing
Clinical narrative: Wheezing, Nausea, Vomiting, Chills, Fever. 6 hours. Took a tendril, and used inhaler. Thought a trip to the ER might be needed but not.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Eyelid oedema, Lip swelling, Oedema mouth, Pharyngeal oedema, Swollen tongue
Clinical narrative: Took the vaccine shot at 3 PM By 6:30 I had some swelling on eye lids, lips, throat and even tongue and inside mouth. By 08:00 PM, I was in the emergency room. I was in the Hospital till 02:30 next day.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Swollen tongue
Clinical narrative: Rash to bilateral arms, tongue swelling and itching.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Ear discomfort, Eyelid oedema, Hypersensitivity, Injection site erythema
Clinical narrative: Temp 100-101>started 8/21/13 thru 8/25/13 a long with fussiness, pulling at ears. To Dr on 8/22/13 told was probably due to teething. 8/25/13 fine red rash chest, back. L side of neck and face also puffiness of face and eyes to ER and given oral steroid. Rx for Benadryl. Also had quarter size  red whelp L thigh. Starting evening 8/22 thru 8/29/13.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Irritability, Rash, Rash erythematous, Swelling face
Clinical narrative: Temp 100-101>started 8/21/13 thru 8/25/13 a long with fussiness, pulling at ears. To Dr on 8/22/13 told was probably due to teething. 8/25/13 fine red rash chest, back. L side of neck and face also puffiness of face and eyes to ER and given oral steroid. Rx for Benadryl. Also had quarter size  red whelp L thigh. Starting evening 8/22 thru 8/29/13.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Teething, Urticaria
Clinical narrative: Temp 100-101>started 8/21/13 thru 8/25/13 a long with fussiness, pulling at ears. To Dr on 8/22/13 told was probably due to teething. 8/25/13 fine red rash chest, back. L side of neck and face also puffiness of face and eyes to ER and given oral steroid. Rx for Benadryl. Also had quarter size  red whelp L thigh. Starting evening 8/22 thru 8/29/13.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: 6 x 7 cm red indurated raised local reaction - noted approximately 24 hrs after vaccine BENADRYL, ice.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Erythema, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: 6 inches of swelling and redness on back of arm starting on 9/23/13 A.M. Patient reported fever, low grade on 9/24/13. Vomiting in morning on 9/24/13 as well. Pain, burning on arm and more vomiting later in day on 9/24/13. Patient seen and told to watch. No treatment given.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Vomiting
Clinical narrative: 6 inches of swelling and redness on back of arm starting on 9/23/13 A.M. Patient reported fever, low grade on 9/24/13. Vomiting in morning on 9/24/13 as well. Pain, burning on arm and more vomiting later in day on 9/24/13. Patient seen and told to watch. No treatment given.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: About after receiving FLUVIRIN, patient experienced itching and hives on left side of body - arm, neck, chest and back areas. Hydrocortisone cream alleviated symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Local skin infection, warmth and redness at site of injection 3" x 1.5". Given antibiotic BACTRIM and MEDROL dose pak.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm above elbow red, warm and swollen since 10-3-13. Advised pt to alternate heat and cold compresses to affected area.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Mouth ulceration
Clinical narrative: Sx's started on 9/27/10. Examination revealed multiple small ulcers on left soft palate, no lesions on right side - Dx's Herpes Zoster CN x 11. Rx-Lidocaine 2% mucosal solution (swish and spit) Valacyclovir 1 gr - 1 tab tid x 7 days.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythma and edema of proximal (L) upper extremity. Tx with prednisone 1mg/kg burst x 3 days.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Local swelling
Clinical narrative: Swollen arm.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Pain, Pain in extremity, Swelling
Clinical narrative: Swollen arm.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Dry eye, Pain, Throat irritation
Clinical narrative: Pain in left shoulder joint (severe), dry eyes, low grade temp, body aches, itchy throat.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm to touch, itchy, swelling at site of injection.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test, Neck pain, Pain in jaw, VIIth nerve paralysis
Clinical narrative: On 9/25/13, patient woke up with pain in her jaw/neck on the right side.  Then on 9/26 she developed an eye droop and then later in the day her mouth began to droop as well.  She went to the ER and was dx'd with Bell's Palsy.  She was treated with Amox for 14 days for presumptive Lyme and a Prednisone taper for 12 days.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pyrexia, Tremor
Clinical narrative: FEVER OF 102 DEGREES, CHILLS, SHAKING, JOINT PAIN.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Swelling face, Throat irritation
Clinical narrative: Dyspnea/facial swelling/throat swelling and itchy. Has been recieving the flu shot every year without difficulty until this year.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: Headache, fever, dizziness, generalized achiness. Redness at injection site developed 3 days later.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Flu-like symptoms: Chest congestion, Coughing, Wheezing, Head/sinus congestion, Muscle aches, Joint aches, Sore throat, Fatigue, Headache, Runny nose, Loss of appetite. Patient has continued taking his seasonal allergy medication (Zyrtec). Started Emergen-C supplements. Got additional bed rest (slept unusually long  12.5 hours from 10/03/13 to 9:30AM 10/04/13). Continues to take plenty of fluids.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersomnia, Influenza like illness, Myalgia, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Flu-like symptoms: Chest congestion, Coughing, Wheezing, Head/sinus congestion, Muscle aches, Joint aches, Sore throat, Fatigue, Headache, Runny nose, Loss of appetite. Patient has continued taking his seasonal allergy medication (Zyrtec). Started Emergen-C supplements. Got additional bed rest (slept unusually long  12.5 hours from 10/03/13 to 9:30AM 10/04/13). Continues to take plenty of fluids.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sinus congestion, Wheezing
Clinical narrative: Flu-like symptoms: Chest congestion, Coughing, Wheezing, Head/sinus congestion, Muscle aches, Joint aches, Sore throat, Fatigue, Headache, Runny nose, Loss of appetite. Patient has continued taking his seasonal allergy medication (Zyrtec). Started Emergen-C supplements. Got additional bed rest (slept unusually long  12.5 hours from 10/03/13 to 9:30AM 10/04/13). Continues to take plenty of fluids.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Nausea, Skin warm
Clinical narrative: Patient complained of shortness of breath, heat to neck area, nauseated, patient appeared flushed. First set of v/s taken by Dr. at 2:45. BP checked by nurse at 150/80, rep at 22, O2 was administered 2.5 liters. Patient stated she felt better. Patient complained of dyspnea, patient looked flushed at this point EMS was called. Patient taken to hospital for further evaluation. last v/s taken at 2:55 pm bp @130/80, apical pulse at 68, resp at 22.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Wheal - 2 - 2 1/2" diameter. Inflamed - hot to touch. Left arm pain.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Decreased appetite, Dizziness, Fatigue, Local swelling, Pain
Clinical narrative: Symptoms: no appetite, tired, dizzy, aches, feverish, arm hot and swollen (left). Patient took TYLENOL, BENADRYL.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Symptoms: no appetite, tired, dizzy, aches, feverish, arm hot and swollen (left). Patient took TYLENOL, BENADRYL.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cold sweat, Dizziness, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: 9/30 at 4:30pm became dizzy at bedtime felt achy on arm. Wednesday noon, cold sweats took 2 ADVIL. Headaches and pressure along with hot and cold sweats. Took 2 more ADVIL. Called Doctor Thursday.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Headache, Hypokinesia, Pain in extremity
Clinical narrative: 9/30 at 4:30pm became dizzy at bedtime felt achy on arm. Wednesday noon, cold sweats took 2 ADVIL. Headaches and pressure along with hot and cold sweats. Took 2 more ADVIL. Called Doctor Thursday.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: 9/30 at 4:30pm became dizzy at bedtime felt achy on arm. Wednesday noon, cold sweats took 2 ADVIL. Headaches and pressure along with hot and cold sweats. Took 2 more ADVIL. Called Doctor Thursday.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus
Clinical narrative: Left distal wrist soreness started 10/3/13 am then 10/4/13 am right distal wrist soreness. Over the counter ASA taken. Pinkness slightly and a bit itchy at injection site mild.
Age: 5.0
Sex: F
Vaccine: FLUN4, MMRV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Maculopapular rash on cheeks and all over body.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Fainted within 3 minutes after HPV injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Feeling hot, Pain, Pyrexia
Clinical narrative: Date of injection 10/1/13. Pt states 3 hrs after PPV23 injection (R) arm "Felt hot" and small redden area". Next day migraine headache (unrelieved by TYLENOL, but relief with EXCEDRIN Migraine) acute generalized body aches and fatigue x 2 dys.? Fever. Today (10/4) T = 97.9, site clear (injection).
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a claims administrator, concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (LOT # J001700, expiration date 18MAY2014) (dose and route not reported). The patient had an adverse reaction (not further specified) to the ZOSTAVAX (Merck) vaccine. It was unknown if the patient sought medical attention. Treatment and outcome of the adverse reaction was unknown. Additional information requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear congestion, Pyrexia
Clinical narrative: Pt. received FLUZONE influenza vaccine on 10-02-13, as part of our volunteer program. On 10-03-13, she notified our employee health dept that one hour after receiving the vaccine she developed a cough and ears felt plugged. She then felt feverish and used an oral thermometer and found her fever to be 103.5. She did not seek medical attention.
Sex: F
Vaccine: MMRV
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner for PROQUAD (Merck), a Pregnancy Registry product, refers to a female patient of unknown age. On an unknown date the pregnant patient was vaccinated with the dose of PROQUAD (Merck) (dose, route of administration and lot number were not reported). The last menstruation period (LMP) and estimated delivery date (EDD) were not known. The pregnancy outcome was pending. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear discomfort, Headache, Pyrexia, Throat tightness
Clinical narrative: Pt. left voicemail this AM of 10-04-12 that after receiving flu vaccine on 10-03-13 at 08:30, she bean to feel constriction in her throat, used inhaler to reduce constriction. At 6 PM that day she had a fever of 100.6 orally, cough, ears felt plugged and irritated, and headache. Only took Nyquil to alleviate sx. 10/03/13 - Today only headache remains at 12:00 PM.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 23-SEP-2013, the patient was vaccinated with a dose of 0.5ml ZOSTAVAX (lot # J003798, expiry date 28-JUN-2014, subcutaneous). No adverse effect was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling right upper arm site of vaccine injection.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information had been received regarding a case for PNEUMOVAX 23 (MARRS# 1309USA014552). A female reported, "Following these events we have come to realize that serious reactions and pulmonary infection are more common than the vaccine information implies. Several people that I have met have had similar reactions." This is one of several reports from the same source. No further information is anticipated.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Gait disturbance, Inflammation
Clinical narrative: This spontaneous report as received from a 69 year old female patient reporting herself. The patient's concurrent condition included high blood pressure and no drug reactions/allergies. On 27-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, injection site and lot # not provided). Concomitant medication included "ZAFERTIZ" (unspecified dose, frequency and manufacturer). On 10-SEP-2013, she experienced debilitating joint and muscle pain, trouble walking, trouble sleeping, and severe inflammation after being administered ZOSTAVAX. On 18-SEP-2013, the patient had office visit and extensive blood tests were performed, and as a result of those blood tests, she was diagnosed with polymyalgia rheumatica. The patient stated, "The doctor informed to take ADVIL (unspecified dose/frequency and manufacturer) and TYLENOL (unspecified dose/frequency and manufacturer)." The outcome of adverse events was reported as not recovered. The causality between vaccine ZOSTAVAX and adverse events were not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Myalgia, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a 69 year old female patient reporting herself. The patient's concurrent condition included high blood pressure and no drug reactions/allergies. On 27-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, injection site and lot # not provided). Concomitant medication included "ZAFERTIZ" (unspecified dose, frequency and manufacturer). On 10-SEP-2013, she experienced debilitating joint and muscle pain, trouble walking, trouble sleeping, and severe inflammation after being administered ZOSTAVAX. On 18-SEP-2013, the patient had office visit and extensive blood tests were performed, and as a result of those blood tests, she was diagnosed with polymyalgia rheumatica. The patient stated, "The doctor informed to take ADVIL (unspecified dose/frequency and manufacturer) and TYLENOL (unspecified dose/frequency and manufacturer)." The outcome of adverse events was reported as not recovered. The causality between vaccine ZOSTAVAX and adverse events were not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test abnormal, C-reactive protein increased, Myalgia, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a 69 year old female patient reporting herself. The patient's concurrent condition included high blood pressure and no drug reactions/allergies. On 27-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, injection site and lot # not provided). Concomitant medication included "ZAFERTIZ" (unspecified dose, frequency and manufacturer). On 10-SEP-2013, she experienced debilitating joint and muscle pain, trouble walking, trouble sleeping, and severe inflammation after being administered ZOSTAVAX. On 18-SEP-2013, the patient had office visit and extensive blood tests were performed, and as a result of those blood tests, she was diagnosed with polymyalgia rheumatica. The patient stated, "The doctor informed to take ADVIL (unspecified dose/frequency and manufacturer) and TYLENOL (unspecified dose/frequency and manufacturer)." The outcome of adverse events was reported as not recovered. The causality between vaccine ZOSTAVAX and adverse events were not provided. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Hypoaesthesia, Local swelling, Pain in extremity, Tenderness
Clinical narrative: He came in on 9/28 and said he had swelling and pain in his left arm. He said it hurt a lot when he got his shot in the left arm. Still tender and numbness. Swelling went down 10/4/13.
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two medical assistants concerning a patient of unknown gender and age. On an unknown date the patient was vaccinated with an adult dose of RECOMBIVAX HB (route, injection site and lot # not provided). It was reported that the RECOMBIVAX HB was improperly stored. No adverse effects reported. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 month old patient. The patient's mother reported that the patient was vaccinated with a dose of PROQUAD and a dose of VARIVAX in the same vaccination session. No adverse effects had occurred. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cold sweat, Feeling abnormal, Injection site pain, Insomnia
Clinical narrative: This spontaneous report as received from a field employee, an acquaintance with the patient. The report refers to a 74 year old female patient with drug reactions/allergies for Beta Blockers. The patient received her first pneumonia vaccination (manufacturer unknown) at age 64 years of age (assumed in 2003). On 13-SEP-2013 at 12PM the patient was vaccinated with PNEUMOVAX 23 (dosing information and route are unknown). Concomitant therapies included WARFARIN and Calcium Channel Blocker. The field employee reported that the patient told her she had received a PNEUMOVAX 23 injection and afterward her arm was very sore and painful. The patient told her she felt "lousy" and had to stay in bed for three days. Follow up information was received from the patient. The patient reported that she developed a "total knock down reaction" to PNEUMOVAX 23 injection. She stated that later that evening, on 13-SEP-2013, her arm had begun to feel very heavy. The patient then stated that by that afternoon the arm had developed intense pain from the injection site and spread into her tendons. The patient attempted to treat the pain with TYLENOL with was unsuccessful. The patient then stated that by that night the pain was so intense it became hard to sleep, and afterward she also developed ice-cold sweats and nausea. The patient explained that the entire reaction occurred over a 4 day period with 1.5 days of intense pain, and the remaining time with lingering pain in her tendons and forearm. The patient present status was reported as recovering/resolving. No reporter causality provided. Additional information has been requested.