chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M042322 with expiration date of 21-FEB-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014483: US-009507513-1703USA014485: US-009507513-1703USA014486:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot # M036458 with expiration date of 02-MAR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014483: US-009507513-1703USA014484: US-009507513-1703USA014486.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L049316 with expiration date of 03-DEC-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014483: US-009507513-1703USA014484: US-009507513-1703USA014485.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: Patient had fever and chills that evening following getting  BEXERO vaccination.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Arm became swollen, warm to touch and hard.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Severe muscle pain starting in my low back, progressing down the muscles of both legs-front, sides and back to the lowest part of my calves; pain in the muscles of my abdomen began 3:31:2017 around 1:00 PM. Now I am developing muscle pain that is moderate to back of right arm. Vaccine was given in left deltoid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Rash, Swelling
Clinical narrative: Dizzy. Headache . Rash. Swelling.
Age: 74.0
Sex: F
Vaccine: PNC10
Symptoms: Erythema, Injection site bruising, Local swelling, Mass, Pain
Clinical narrative: She reports it hurting a lot. She develop "significant bruising" at the injection site. "Raised, red, lumpy" area pt describes as below injection site. warmth and pain.
Age: 74.0
Sex: F
Vaccine: PNC10
Symptoms: Skin warm
Clinical narrative: She reports it hurting a lot. She develop "significant bruising" at the injection site. "Raised, red, lumpy" area pt describes as below injection site. warmth and pain.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bruising at injection site, redness, swelling, discomfort, warmth. Pt reports redness is from injection site down to just above elbow.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: Patient walking to leave, felt like she was going to faint, mother returned her to chair.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Chills, Full blood count normal, Muscular weakness, Myopathy
Clinical narrative: Initial unsolicited report received from a physician on 17-Mar-2017. This case involves a 62-year-old male patient who was vaccinated with a dose of Fluzone QIV (batch number, expiry date, dsoe form, frequency route and site of administration not reported) on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not reported. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, two weeks following the vaccination, it was reported that the patient experienced high fever and muscle weakness. The patient was subsequently seen to the physician and was diagnosed with non-specific viral illness. Subsequently, the patient developed subsequently developed chills, rigors, further muscle weakness and was again referred to the emergency room (ER). It was reported the on an unspecified date, that the patient's creatinine Kinase (CK) level of 400 or 500 and with it, the patient developed muscle weakness of left arm and left leg. On an unspecified date, the patient's complete blood count was revealed as normal, however the sedimentation rate was elevated. Subsequently the patient was referred to a neurologist who thought that symptoms were related to myopathy following which the patient was seen by a neuro-rheumatologist. Other laboratory investigations and corrective treatment were not reported. On an unspecified date (reported as "patient had symptoms over next 4 weeks which then resolved") the patient recovered from the events. List of documents held by the sender: None.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Viral infection
Clinical narrative: Initial unsolicited report received from a physician on 17-Mar-2017. This case involves a 62-year-old male patient who was vaccinated with a dose of Fluzone QIV (batch number, expiry date, dsoe form, frequency route and site of administration not reported) on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not reported. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, two weeks following the vaccination, it was reported that the patient experienced high fever and muscle weakness. The patient was subsequently seen to the physician and was diagnosed with non-specific viral illness. Subsequently, the patient developed subsequently developed chills, rigors, further muscle weakness and was again referred to the emergency room (ER). It was reported the on an unspecified date, that the patient's creatinine Kinase (CK) level of 400 or 500 and with it, the patient developed muscle weakness of left arm and left leg. On an unspecified date, the patient's complete blood count was revealed as normal, however the sedimentation rate was elevated. Subsequently the patient was referred to a neurologist who thought that symptoms were related to myopathy following which the patient was seen by a neuro-rheumatologist. Other laboratory investigations and corrective treatment were not reported. On an unspecified date (reported as "patient had symptoms over next 4 weeks which then resolved") the patient recovered from the events. List of documents held by the sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial unsolicited report received from the literature on 18 March 2017. This case was linked to 2017SA047674 (same literature). The following is verbatim from the article: Background. Case reports have suggested that vaccines may trigger transverse myelitis (TM) or acute disseminated encephalomyelitis (ADEM), but the evidence for a causal association is inconclusive. We analyzed the association of immunization and subsequent development of TM or ADEM. Methods. We identified all cases of TM and ADEM in the Vaccine Safety Datalink population. Using a case-centered method, we compared vaccination of each case to vaccination of all matched persons in the study population, who received the same type of vaccine, with respect to whether or not their vaccination occurred during a predetermined exposure interval. We calculated a risk difference (excess risk) of TM and ADEM for each vaccine. Results. Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. Based on 2 exposed cases, the odds ratio for Tdap exposure 5-28 days prior to ADEM onset was 15.8 (95% confidence interval [CI], 1.2-471.6; P = .04), and the estimated excess risk was 0.385 (95% CI, .04 to 1.16) cases per million doses. Conclusions. We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tdap) (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date following the vaccination, the patient developed acute disseminated encephalomyelitis. Relevant laboratory test results and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event acute disseminated encephalomyelitis. The reporter assessed the causal relationship of event with Tdap as possible. Documents held by sender: none. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM), following TDAP VACCINE. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cough, Erythema, Injection site erythema, Injection site nodule, Rash generalised
Clinical narrative: Turned red and had rash all over. Developed cough. Large, red knot came up at injection site.  Benadryl IM, Epinephrine IM, and Prelone Syrup PO given in ER.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swelling and rash at injection site. Patient was seen at a urgent care facility. Description of visit was faxed to our office. Urgent care prescribed Prednisone.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RVX
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Developed petechaie and evidence of low platelets on blood testing. Diagnosed with idiopathic thrombocytopenic purpura suspected to be secondary to vaccination.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site swelling, Pruritus, Rash
Clinical narrative: Father reports bilateral extremity swelling from knees to groin as well as itching and rash.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, X-ray limb
Clinical narrative: Patient reported pain in her arm, shoulder, and neck the night of the injection. Patient sought treatment on 03/30/2017 and was given a Medrol dose pak, and Zanaflex. x-ray on the shoulder (or arm) was ordered according to patient. Meds are in day 2 and not even picked up.
Age: 75.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain
Clinical narrative: Sore, aching arm at site of injection only. Soreness reported by patient is "less than before" but still present as of 3/31/17.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Nausea, Pyrexia, Swelling
Clinical narrative: FEVER, NAUSEA, LETHARGY, MUSCLE ACHES, SWOLLEN WELT OF 3 INCH DIAMETER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: FEVER, NAUSEA, LETHARGY, MUSCLE ACHES, SWOLLEN WELT OF 3 INCH DIAMETER.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Biopsy kidney abnormal, Condition aggravated, Cytopenia, Glomerulonephritis membranous
Clinical narrative: Case number PHHY2017US046059, is an initial literature report received on 23 Mar 2017. The author discussed about a report of new onset lupus nephritis (LN) presenting as nephrotic syndrome in a formerly stable systemic lupus erythematosus (SLE) following influenza vaccination. This report refers to a 38-year-old female patient. Medical history included SLE. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in Nov 2015. On an unknown date, the patient was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in Nov 2015, at which time she had no protein on urinalysis (UA). In Feb 2016, UA showed new 300 mg/dL protein and 2 red blood cell count (RBC) (units not specified). Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. In Mar 2016, the renal biopsy showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) at a dose of 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) at an unknown dose in early Jul 2016. Her proteinuria improved to 3.9 g/day in late Jul 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in Sep 2016. Proteinuria remained at 2 g/day in Nov 2016, when she was started on azathioprine. Outcome of the event proteinuria was reported as condition improving. Outcome of the other events was not reported. Seriousness of all the events was not reported. Seriousness assessment of the event lupus nephritis (medically significant), glomerulonephritis membranous (medically significant) and nephrotic syndrome (medically significant) was upgraded based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza vaccination and new onset of lupus nephritis in a formerly stable SLE patient. There is a need for increased awareness that vaccinations might be potential triggers for lupus nephritis onset, and further research in this area is warranted.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Haematuria, Lupus nephritis, Nausea, Nephrotic syndrome, Oedema
Clinical narrative: Case number PHHY2017US046059, is an initial literature report received on 23 Mar 2017. The author discussed about a report of new onset lupus nephritis (LN) presenting as nephrotic syndrome in a formerly stable systemic lupus erythematosus (SLE) following influenza vaccination. This report refers to a 38-year-old female patient. Medical history included SLE. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in Nov 2015. On an unknown date, the patient was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in Nov 2015, at which time she had no protein on urinalysis (UA). In Feb 2016, UA showed new 300 mg/dL protein and 2 red blood cell count (RBC) (units not specified). Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. In Mar 2016, the renal biopsy showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) at a dose of 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) at an unknown dose in early Jul 2016. Her proteinuria improved to 3.9 g/day in late Jul 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in Sep 2016. Proteinuria remained at 2 g/day in Nov 2016, when she was started on azathioprine. Outcome of the event proteinuria was reported as condition improving. Outcome of the other events was not reported. Seriousness of all the events was not reported. Seriousness assessment of the event lupus nephritis (medically significant), glomerulonephritis membranous (medically significant) and nephrotic syndrome (medically significant) was upgraded based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza vaccination and new onset of lupus nephritis in a formerly stable SLE patient. There is a need for increased awareness that vaccinations might be potential triggers for lupus nephritis onset, and further research in this area is warranted.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Protein urine present, Proteinuria, Red blood cells urine positive, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Case number PHHY2017US046059, is an initial literature report received on 23 Mar 2017. The author discussed about a report of new onset lupus nephritis (LN) presenting as nephrotic syndrome in a formerly stable systemic lupus erythematosus (SLE) following influenza vaccination. This report refers to a 38-year-old female patient. Medical history included SLE. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in Nov 2015. On an unknown date, the patient was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in Nov 2015, at which time she had no protein on urinalysis (UA). In Feb 2016, UA showed new 300 mg/dL protein and 2 red blood cell count (RBC) (units not specified). Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. In Mar 2016, the renal biopsy showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) at a dose of 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) at an unknown dose in early Jul 2016. Her proteinuria improved to 3.9 g/day in late Jul 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in Sep 2016. Proteinuria remained at 2 g/day in Nov 2016, when she was started on azathioprine. Outcome of the event proteinuria was reported as condition improving. Outcome of the other events was not reported. Seriousness of all the events was not reported. Seriousness assessment of the event lupus nephritis (medically significant), glomerulonephritis membranous (medically significant) and nephrotic syndrome (medically significant) was upgraded based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza vaccination and new onset of lupus nephritis in a formerly stable SLE patient. There is a need for increased awareness that vaccinations might be potential triggers for lupus nephritis onset, and further research in this area is warranted.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Urine protein/creatinine ratio increased
Clinical narrative: Case number PHHY2017US046059, is an initial literature report received on 23 Mar 2017. The author discussed about a report of new onset lupus nephritis (LN) presenting as nephrotic syndrome in a formerly stable systemic lupus erythematosus (SLE) following influenza vaccination. This report refers to a 38-year-old female patient. Medical history included SLE. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in Nov 2015. On an unknown date, the patient was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in Nov 2015, at which time she had no protein on urinalysis (UA). In Feb 2016, UA showed new 300 mg/dL protein and 2 red blood cell count (RBC) (units not specified). Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. In Mar 2016, the renal biopsy showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) at a dose of 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) at an unknown dose in early Jul 2016. Her proteinuria improved to 3.9 g/day in late Jul 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in Sep 2016. Proteinuria remained at 2 g/day in Nov 2016, when she was started on azathioprine. Outcome of the event proteinuria was reported as condition improving. Outcome of the other events was not reported. Seriousness of all the events was not reported. Seriousness assessment of the event lupus nephritis (medically significant), glomerulonephritis membranous (medically significant) and nephrotic syndrome (medically significant) was upgraded based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza based on the NVS IME List. The author concluded the article stating that this case supports a potential association between influenza vaccination and new onset of lupus nephritis in a formerly stable SLE patient. There is a need for increased awareness that vaccinations might be potential triggers for lupus nephritis onset, and further research in this area is warranted.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Discomfort, Loss of personal independence in daily activities, Pruritus, Rash, Rash papular
Clinical narrative: 42yo F nurse recd primary smpx vaccine on 10 Mar 2017, in preparation for becoming a vaccine administrator. On 26 Mar, she first noticed itchy red papules on hands and feet. No fever, CP, or other systemic sxms, but itching and discomfort are impairing her activity. Additional information faxed with VAERS report, including photos. No history of having Eczema or Psoriasis. Received the Smallpox vaccine on 10MAR2017. On Monday, 27MAR2017 at 1100, I noticed 3 small bumps that I thought were the beginnings of palmar warts on my right palm. By 1300, I found 4 fluid filled bumps on my right index finger. By 1400, the soles of both my feet were itching tremendously. By 1600, both my thighs were itching and had broken out in hives. I applied Triamcinolone cream and CALMOSEPTINE ointment as directed by the Physician I saw earlier in the day. Tuesday, 28MAR2017, I noticed that the number of fluid filled bumps on my right hand had increased to 28 and I had 4 small bumps now on my left hand. Throughout the day the number of bumps on my left hand increased. My feet had small pink spots on the soles and were very itchy. My thighs still have raised bumps on them but not fluid filled like my hands, nor pink spots like my feet, more like itchy goosebumps. Wednesday, 29MAR2017, the number of fluid filled bumps on my hands seems to have stabilized at 42 on the right and 37 on the left, continue to be itchy and somewhat painful if bumped. The soles and sides of both my feet are covered with small pink spots; some you can see are fluid filled. My thighs have calmed down some with the use of Triamcinolone.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Rash vesicular, Tenderness, Urticaria
Clinical narrative: 42yo F nurse recd primary smpx vaccine on 10 Mar 2017, in preparation for becoming a vaccine administrator. On 26 Mar, she first noticed itchy red papules on hands and feet. No fever, CP, or other systemic sxms, but itching and discomfort are impairing her activity. Additional information faxed with VAERS report, including photos. No history of having Eczema or Psoriasis. Received the Smallpox vaccine on 10MAR2017. On Monday, 27MAR2017 at 1100, I noticed 3 small bumps that I thought were the beginnings of palmar warts on my right palm. By 1300, I found 4 fluid filled bumps on my right index finger. By 1400, the soles of both my feet were itching tremendously. By 1600, both my thighs were itching and had broken out in hives. I applied Triamcinolone cream and CALMOSEPTINE ointment as directed by the Physician I saw earlier in the day. Tuesday, 28MAR2017, I noticed that the number of fluid filled bumps on my right hand had increased to 28 and I had 4 small bumps now on my left hand. Throughout the day the number of bumps on my left hand increased. My feet had small pink spots on the soles and were very itchy. My thighs still have raised bumps on them but not fluid filled like my hands, nor pink spots like my feet, more like itchy goosebumps. Wednesday, 29MAR2017, the number of fluid filled bumps on my hands seems to have stabilized at 42 on the right and 37 on the left, continue to be itchy and somewhat painful if bumped. The soles and sides of both my feet are covered with small pink spots; some you can see are fluid filled. My thighs have calmed down some with the use of Triamcinolone.
Age: 43.0
Sex: F
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Arthralgia, Joint stiffness, Peripheral swelling
Clinical narrative: Received vaccines 3-8-17. Stated yesterday morning, 3-28-17 had pain in (L) knee. Stated around lunchtime, had (R) ankle pain and stiffness. Started by the afternoon, both wrists were hurting. Pt reported that pain and stiffness has continued today and has had (R) index finger and knee swelling. Stated hasn't had to seek medical attention.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Lymphadenopathy, Musculoskeletal pain, Sleep disorder, Vaccination site pain
Clinical narrative: Case number PHEH2016US030839, is a spontaneous report initially received from a pharmacist on 20 Nov 2016. This report refers to a 77 years old female patient. Historical condition was not reported. Current condition included chronic lymphoma leukemia. Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 166103, expiry date: Apr 2017) intramuscularly at a dose of 0.5 ml on 10 Nov 2016 at 18:00. On a same day after vaccination, the patient experienced pain at the vaccination site. On an unknown date, the patient lost range of motion, had a pain around the rotator cuff area, the patient reported that it was 30-40% better but the pain keeps her awake at night, it was reported as pain began a couple of days after injection. On an unknown date, the patient had swelling of lymph nodes in her neck. It was reported that, the patient's husband was a physician. The patient took ibuprofen for the symptoms reported. Upon follow up it was reported that, the patient said, was in a pain. The outcome of the events vaccination site pain and pain around the rotator cuff area was reported as condition unchanged (pain was still lingering/ was in a pain), and for other events it was reported as complete recovery. The seriousness of the events was reported as non serious. The causality of the event swelling of lymph nodes in her neck was reported as suspected (related to the FLUAD) and for other events it was not reported. Follow up report received from a pharmacist on 04 Jan 2017: Updated vaccination time, outcome of the events, seriousness as non serious and narrative.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHEH2016US031315, is an initial spontaneous report received from a pharmacist on 07 Oct 2016 (combined report). This report refers to an adult female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unknown date 04 years ago. After vaccination, the patient had reaction to flu vaccine (unknown reaction). The outcome of the event was reported as unknown. The seriousness and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US031955, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 04 Dec 2016. It was reported that, reporter did not think safety needle was locked to the syringe, some of the vaccine leaked on the patient's arm. Pharmacist did not think, syringe that had a problem, it was a safety needle that we used. No product complaint with syringe. No adverse event was reported following this medication errors (underdose and wrong technique in product usage process).
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Case number PHEH2016US032425, is an initial spontaneous report received from a physician on 08 Dec 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza virus vaccine INN (unknown whether seasonal or pandemic) intramuscularly on an unspecified date. On an unspecified date after vaccination, the patient experienced a metallic taste in her mouth. The patient was unsure which flu product it was. The outcome of the event was unknown. The seriousness and causality were not reported.
Age: 30.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US032437, is an initial spontaneous report received from a pharmacist on 08 Dec 2016. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 08 Dec 2016 when she was 30 years old. It was reported that, vaccine was administered to patient under the age of 65 years old on 08 Dec 2016. No adverse event reported following this medication error (drug administered to patient of inappropriate age). The case was assessed as non serious by the pharmacist.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site reaction, Joint crepitation, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Limited range of motion in left shoulder. Pain on exertion esp when abducting or pushing down. Pain in shoulder at night-wakes me up. Audible sound heard upon use of left shoulder.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Sleep disorder, X-ray
Clinical narrative: Limited range of motion in left shoulder. Pain on exertion esp when abducting or pushing down. Pain in shoulder at night-wakes me up. Audible sound heard upon use of left shoulder.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, Joint crepitation, Middle insomnia, Nuclear magnetic resonance imaging
Clinical narrative: Limited range of motion in left shoulder. Pain on exertion esp when abducting or pushing down. Pain in shoulder at night-wakes me up. Audible sound heard upon use of left shoulder.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, X-ray
Clinical narrative: Limited range of motion in left shoulder. Pain on exertion esp when abducting or pushing down. Pain in shoulder at night-wakes me up. Audible sound heard upon use of left shoulder.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Influenza A virus test negative
Clinical narrative: Light headed/dizzy shortly after vaccine in office - given juice and laid down briefly. Went to school = "out of it" and tired, almost like sleep state. After school went home and took 2 hr. nap. Work to 6p lacrosse game - was slow, tired and weak, still "out of it".
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Influenza B virus test, Influenza virus test negative, Slow response to stimuli, Somnolence
Clinical narrative: Light headed/dizzy shortly after vaccine in office - given juice and laid down briefly. Went to school = "out of it" and tired, almost like sleep state. After school went home and took 2 hr. nap. Work to 6p lacrosse game - was slow, tired and weak, still "out of it".
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Eye swelling, Hypoacusis, Lip swelling, Rash
Clinical narrative: Administer Pt. Tdap/MCV/HPV. A couple of minutes after pt. started feeling dizziness/swollen lips/swollen eyes/rash/hives and stated she couldn't see or hear. Gave pt. 10 ml of BENADRYL called EMS/started Neb Tx at 5:45, Oxygen at 5:50. EMS arrived at 5:55 took over pt. care.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria, Visual impairment
Clinical narrative: Administer Pt. Tdap/MCV/HPV. A couple of minutes after pt. started feeling dizziness/swollen lips/swollen eyes/rash/hives and stated she couldn't see or hear. Gave pt. 10 ml of BENADRYL called EMS/started Neb Tx at 5:45, Oxygen at 5:50. EMS arrived at 5:55 took over pt. care.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Diarrhoea, Fatigue, Nausea, Pallor, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea. Pale and fatigued on exam. No vomiting observed in office. Temp rectal=97 degree F.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: ROTATEQ vaccine was administered at the age of 9 months 26 days. No reactions and no further treatment.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Patient complained of skin to be tender to touch and high fevers.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA, HIBV
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Apparent death, Asthenia, Guillain-Barre syndrome, Immobile, Immunoglobulin therapy
Clinical narrative: Immobile morning of 12/11/16, went to ER. Dr. diagnosed problem as Guillain-Barre syndrome. Diagnosed near death, given 5 days 24/7 of IGG infusion-felt weak within a few days, tried resting, weakness continued.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Soreness within 2 hours. Redness, swelling proximal to injection site within 24 hours. Instructed to ice, take BENADRYL and ibuprofen.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Computerised tomogram, Dyspnoea, Injection site erythema, Pain
Clinical narrative: Red swollen at, above, and below site of administration. Pain, problems breathing.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash
Clinical narrative: After receiving vaccines (4 mth), patient developed a localized rash at the injection site (on her right thigh) where the HIB vaccine was administered. She also had this reaction after her 2 mth vaccines. SX resolved shortly thereafter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Patient experienced pain and swelling after administration RPH recommended IBU. Patient took it, did not work/relief pain or swelling. Patient advised to speak to MD and take additional IBU and add BENADRYL.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest pain, Cough, Dizziness, Feeling hot
Clinical narrative: 2/2 - immediate dizziness, pallor. 2/3 - next day chest pain - seen urgent care. 2/20 - urgent care - DX sinusitis. 3/3, 3/6 - still C/O chest pain and wheezing and cough - despite ABX for sinobronchitis from 3/3/17 visit, CXR (-). 3/9/17 - C/O feeling hot and flushed.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Immediate post-injection reaction, Pallor, Sinobronchitis, Sinusitis
Clinical narrative: 2/2 - immediate dizziness, pallor. 2/3 - next day chest pain - seen urgent care. 2/20 - urgent care - DX sinusitis. 3/3, 3/6 - still C/O chest pain and wheezing and cough - despite ABX for sinobronchitis from 3/3/17 visit, CXR (-). 3/9/17 - C/O feeling hot and flushed.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: 2/2 - immediate dizziness, pallor. 2/3 - next day chest pain - seen urgent care. 2/20 - urgent care - DX sinusitis. 3/3, 3/6 - still C/O chest pain and wheezing and cough - despite ABX for sinobronchitis from 3/3/17 visit, CXR (-). 3/9/17 - C/O feeling hot and flushed.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Approx 3 hrs after the PPSV23, extreme pain, radiating from the left upper arm (injection site) up the shoulder, up the left side of my neck to the base of head. The pain was at a level 10 (on a scale of 1-10). Unbearable pain if I moved my shoulder/neck. The pain got less for a few days and then re-occurred. I needed ER visit for pain - 1/5/2017. Same pain as 12/28/2016.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Continuance pain in upper left arm.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Sore stiff aching for 2 months plus in Lt. shoulder at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash
Clinical narrative: Rash after flu shot.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Warmth, redness, swelling, itching of entire (L) upper forearm.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: On 3/27/17- Rt arm swollen and erythematous, at the injection site tender/some pain. Local reaction area circle. Reviewed again on 3/30 less swelling.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Induration, Rash, Swelling, Tenderness
Clinical narrative: Pt received vaccine to right thigh. Developed localized rash with firm raised center. Tender to touch. Rash started on day 8 post injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness, erythema lateral to injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Local reaction
Clinical narrative: Local reaction started 1 hr after HPV/MENACTRA in left arm worsening to 12 X 14 cm 2 d later.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5 x 6 cm swelling and erythema anterior right thigh.
Age: 20.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Vaccine reaction after receiving meningitis and PPV23. 4 inch diameter in upper left arm with fever x 1 day after vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: BENADRYL 10 mL.
Age: 52.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2017US002218, is an initial spontaneous report received from a pharmacist on 17 Jan 2017. This report refers to a 52-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUAD (lot number: 166002, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly 17 Jan 2017. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
Age: 58.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2017US002456, is an initial spontaneous report received from a pharmacist on 20 Jan 2017. This report refers to a 58 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 19 Jan 2017 when he was 58 years old. It was reported that, FLUAD was administered to 58 years old on 19 Jan 2017. No adverse event reported following this medication error (drug administered to patient of inappropriate age).
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2016US032834, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a male patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine INN (unknown whether seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. The pharmacist stated that, the vaccine squirted on the husband of a female, sitting beside her and ran down her arm. No adverse event was reported following this administration error (inadvertent exposure to vaccine).
Age: 33.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US033368, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 33 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUAD (unknown whether seasonal or pandemic, bath number: 165803) at a dose of 0.5 ml intramuscularly on an unknown date when the patient was 33 years old. No adverse event reported following this medication error (inappropriate age at vaccine administration).
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Nervousness, Vaccination site pain
Clinical narrative: Case number PHEH2017US000576, is initial spontaneous report received from consumer on 03 Jan 2017. This report refers to a 73 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166101) intramuscular into left arm at dose of 0.5 ml on 22 Nov 2016. On the same day, the patient had consistently hurt (uncomfortable) where the vaccine was given. This was making her nervous. She was heart medication patient too. The outcome of the events was reported as unknown. The seriousness and causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Vaccination site bruising, Vaccination site nodule
Clinical narrative: Case number PHEH2017US001325, is an initial spontaneous report received from a pharmacist on 10 Jan 2017. This report refers to a 71 years old female patient. Medical history was not reported. Concomitant medication included PLAVIX. The patient was vaccinated with FLUAD (batch number: 165803, expiry date: Apr 2017) intramuscularly at a dose of 0.5 ml on 09 Dec 2016. On 10 Dec 2016 after vaccination, the patient experienced bruise (bruising of arm) and knot below deltoid on outer part of arm that the patient received the vaccine, it was reported that, could not tell if the events was at vaccination site. The bruising and knot lasted for one month, the knot was gone but bruise was slightly there still. The final outcome of the event bruise of arm was reported as condition improving and for event knot it was reported as complete recovery on 10 Jan 2017. The seriousness of the events was reported as non serious and causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case received PHEH2017US002001, is an initial spontaneous report received from a pharmacist on 16 Jan 2017. This report refers to a 29-year-old pregnant female patient. Patient's last menstrual date was not reported. It was reported that this 29 year old pregnant patient was vaccinated with one single dose of FLUAD (lot number: 166101, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly on 15 Jan 2017. No adverse event was reported following vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Back pain
Clinical narrative: About an hour after receiving the Flu vaccination I began having sharp pain in my upper back next to my left shoulder blade and within another half hour it also traveled to my lower left back. I received the shot in my left shoulder.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Blepharospasm, Eye pain, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Severe eye pain with eye twitching. generalized body aches and fatigue. pain swelling redness and warmth at injection site.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Severe eye pain with eye twitching. generalized body aches and fatigue. pain swelling redness and warmth at injection site.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Extremely Itchy, Spreading Rash.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Electroencephalogram, Motor developmental delay, Seizure like phenomena, Speech disorder developmental
Clinical narrative: Infant began having seizure-like episode upon waking, every time she woke from deep sleep. We saw the pediatrician about this and they then referred us to hospital. We also saw an ND, HmD, PhD several times. Patient received PT for motor delays and now is receiving speech therapy for language delays.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Cold Symptoms appeared after immunization given, patient is insisting it is due to vaccination despite education, counseling.