chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Trouble walking/joint pain after MMR and varicella vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Dermatitis bullous, Dyspnoea
Clinical narrative: This spontaneous report as received from a physician refers to a 16 or 17 year old female patient, with no prior medical history or notable family history. In late 2011 the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date and via not reported), without incident. An a period of time later, on 08-FEB-2012 the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date and via not reported). Concomitant therapies included hormonal contraceptives (unspecified). The reporter stated that subsequent to that second dose, a few days later the patient was hospitalized (also reported by the physician after additional information received as was seen in the emergency room (ER) three times for joint pain, shortness of breath, chest pain, overall fatigue and muscle aches which went away each time over a period of 3 weeks. In approximately 2012, the patient was noted to have an elevated Erythrocyte Sedimentation rate (ESR) and C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6. The patient was treated with MEDROL pack with subsequent resolution of her symptoms. The reporter also stated that over the last 8 weeks (also reported as about six weeks), the patient developed bullous lesions on the extensor surfaces of her arms and legs, diagnosed now as bullous pemphigoid. The physician noted that this was very unusual in a young female. The outcomes of joint pain, muscle aches, overall fatigue, chest pain, shortness of breath were reported as recovered/resolved. The outcome of bullous pemphigoid, elevated Erythrocyte Sedimentation rate (ESR), C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6 were unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Haemoglobin decreased, Myalgia, Pemphigoid, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a physician refers to a 16 or 17 year old female patient, with no prior medical history or notable family history. In late 2011 the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date and via not reported), without incident. An a period of time later, on 08-FEB-2012 the patient was vaccinated with the second dose of GARDASIL (lot number, expiration date and via not reported). Concomitant therapies included hormonal contraceptives (unspecified). The reporter stated that subsequent to that second dose, a few days later the patient was hospitalized (also reported by the physician after additional information received as was seen in the emergency room (ER) three times for joint pain, shortness of breath, chest pain, overall fatigue and muscle aches which went away each time over a period of 3 weeks. In approximately 2012, the patient was noted to have an elevated Erythrocyte Sedimentation rate (ESR) and C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6. The patient was treated with MEDROL pack with subsequent resolution of her symptoms. The reporter also stated that over the last 8 weeks (also reported as about six weeks), the patient developed bullous lesions on the extensor surfaces of her arms and legs, diagnosed now as bullous pemphigoid. The physician noted that this was very unusual in a young female. The outcomes of joint pain, muscle aches, overall fatigue, chest pain, shortness of breath were reported as recovered/resolved. The outcome of bullous pemphigoid, elevated Erythrocyte Sedimentation rate (ESR), C-reactive Protein (CRP) and a Haemoglobin (Hb) of 8.6 were unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Dermatitis bullous, Dyspnoea
Clinical narrative: This spontaneous report as received from a physician refers to a 16 or 17 year old female patient, with no prior medical history or notable family history. In late 2011 the patient was vaccinated with the first dose of GARDASIL, (lot number, expiration date and via not reported), without incident. An a period of time later, on 08-FEB-2012 the patient was vaccinated with the second dose of GARDASIL, (lot number, expiration date and via not reported). Concomitant therapies included hormonal contraceptives (unspecified). The reporter stated that subsequent to that second dose, a few days later the patient was hospitalized (also reported by the physician after additional information received as was seen in the emergency room (ER) three times) three times for joint pain, shortness of breath, chest pain, overall fatigue and muscle aches which went away each time over a period of 3 weeks. In approximately 2012, the patient was noted to have an elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) and a haemoglobin (Hb) of 8.6. The patient was treated with MEDROL pack with subsequent resolution of her symptoms. The reporter also stated that over the last 8 weeks (also reported as about six weeks), the patient developed bullous lesions on the extensor surfaces of her arms and legs, diagnosed now as bullous pemphigoid. The physician noted that this was very unusual in a young female. The outcomes of joint pain, muscle aches, overall fatigue, chest pain, shortness of breath were reported as recovered/resolved. The outcome of bullous pemphigoid, elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and a haemoglobin (Hb) of 8.6 were unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Haemoglobin decreased, Myalgia, Pemphigoid, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a physician refers to a 16 or 17 year old female patient, with no prior medical history or notable family history. In late 2011 the patient was vaccinated with the first dose of GARDASIL, (lot number, expiration date and via not reported), without incident. An a period of time later, on 08-FEB-2012 the patient was vaccinated with the second dose of GARDASIL, (lot number, expiration date and via not reported). Concomitant therapies included hormonal contraceptives (unspecified). The reporter stated that subsequent to that second dose, a few days later the patient was hospitalized (also reported by the physician after additional information received as was seen in the emergency room (ER) three times) three times for joint pain, shortness of breath, chest pain, overall fatigue and muscle aches which went away each time over a period of 3 weeks. In approximately 2012, the patient was noted to have an elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) and a haemoglobin (Hb) of 8.6. The patient was treated with MEDROL pack with subsequent resolution of her symptoms. The reporter also stated that over the last 8 weeks (also reported as about six weeks), the patient developed bullous lesions on the extensor surfaces of her arms and legs, diagnosed now as bullous pemphigoid. The physician noted that this was very unusual in a young female. The outcomes of joint pain, muscle aches, overall fatigue, chest pain, shortness of breath were reported as recovered/resolved. The outcome of bullous pemphigoid, elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and a haemoglobin (Hb) of 8.6 were unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) from an unspecified relative of the patient, concerning to a 5 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, frequency and route not reported). No concomitant medications were reported. On an unspecified date the patient experienced a high fever and abdominal distress after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 5 year old female patient. On 18-MAR-2013 the patient was vaccinated with a dose of (Merck) PROQUAD (lot no. 0404AA, expiration date 16-MAR-2013, dose no. not reported), 0.5 ml, subcutaneous in the left leg. The reporter stated child was vaccinated with expired (Merck) PROQUAD. No adverse effects reported. No other information provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old female patient. Pertinent medical history was reported as none. On 31-JAN-2013 the patient was vaccinated with ZOSTAVAX lot # H020683 (route and indication not specified). Concomitant therapies included ibuprofen. On 21-FEB-2013, 22 days a blood test was positive for hepatitis B surface antigen, negative for hepatitis B virus nucleic acid and negative for hepatitis B core antibody. On 28-MAR-2013 the above 3 blood tests were all negative. The physician requested a lot check. No further information was available. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Extreme, extreme muscle (deltoid) & joint pain to (R) arm 3 weeks s/p influenza injection began 3/28 to present.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Skin rash. Diphenhydramine 25 mg once.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient received ZOSTAVAX (dose, route and lot not reported) and developed shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. This is one report of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: Arm was red, warm and raised, also sore.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Employee came to office, asked for Flu shot. Without checking history of immunizations, Flu shot was given and discovered already had flu shot 9-28-12.
Age: 35.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Varicella vaccine given on 4/1/13 left upper deltoid SC. Pt reported localized redness and swelling at injection site on 4/2/13 at 5:02pm. Pt did not want to come in for eval. S/S of infection and anaphylaxis reviewed. Tx ice compress, elevation, and ibuprofen.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has swelling and redness the size of a CD on left leg after getting vaccines.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL (lot# and exp date not provided) (dose, route not reported), on an unknown date in 2011 the patient was vaccinated with a second dose of GARDASIL (lot# and exp date not provided) (dose, route not reported) and on 26-MAR-2013 the patient was vaccinated with the third dose of GARDASIL (lot# and exp date not provided) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Redness / hot induration at the site of TDAP and MENACTRA. Mom had to take him to ER as he started to have fever also. Reaction 2" circle around the site.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. On an unknown date, the patient received ZOSTAVAX (dose, route and lot not reported) and developed shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. This is one report of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Rash, fever. Bilateral legs erythematous rash, early vesicular rash.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Rash pruritic
Clinical narrative: Recvd vaccines on 3/29/13 and on 3/30/13 rash and itchiness on arm, spread down arm and on back. Rash was colorless, but very itchy.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Emotional distress, Irritability, Screaming
Clinical narrative: Fussy about 12 hours after vaccines. Screamed and inconsolable for 3 hours.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Red blotchy skin on trunk and at injection site (L) deltoid.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event, Product deposit
Clinical narrative: This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a pediatric 0.5mL RECOMBIVAX HB (lot number H011183, expiration date 31-JAN-2015; 0385AE, 08-NOV-2014) (dose, frequency and route not reported) that from 22-MAR-2013 to 26-MAR-2013 some vials of RECOMBIVAX HB had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS # 1303USA013510, 1304USA000422, 1304USA001054. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event, Product deposit
Clinical narrative: This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a pediatric dose of 0.5ml VAQTA (lot number H010437, expiration date 28-FEB-2015; H010187, 28-FEB-2015) (dose, frequency and route not reported) that from 22-MAR-2013 to 26-MAR-2013 some vials of VAQTA had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS # 1303USA013510, 1304USA000421, 1304USA000422. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown gender and possibly with 12 month old or 21 month old. On 26-MAR-2013 the patient received inadvertently a dose of PROQUAD and a dose of VARIVAX (Merck) (lot number and expiration date of both vaccines were not reported) (route of administration of both vaccines was not reported). Concomitant therapies were not reported. The reporter stated she was still in the process of identifying the patient involved, that was seen in the clinic on 26-MAR-2013. No adverse effects reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, regarding a 12 months old male patient with no pertinent medical history reported. On 26-MAR-2013 the patient was vaccinated with VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported) in the left arm. Other suspect therapies included PROQUAD (Merck) (lot number and expiration date not reported) (dose not reported), subcutaneous, in the right arm. The Registered nurse stated that the child was inadvertently vaccinated with VARIVAX (Merck) and PROQUAD (Merck) the same day. Staff error only. No adverse effects reported at that time. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event, Product deposit
Clinical narrative: This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received an adult dose of 1 ml of VAQTA (lot number H010269, expiration date 03-NOV-2014) (dose, frequency and route not reported) that from 22-MAR-2013 to 26-MAR-2013 some vials of VAQTA had been exposed to 9 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS # 1303USA013510, 1304USA000421, 1304USA001054. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event, Product deposit
Clinical narrative: This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a dose of GARDASIL (lot number H016238, expiration date not reported; H016238, 11-APR-2015, H020002, 08-AUG-2015) (dose, frequency and route not reported) that from 22-MAR_2013 to 26-MAR-2013 some vials of GARDASIL had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS #1304USA000421, 1304USA000422, 1304USA001054. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: 5-10 mins after receiving the flu shot, patient fell dead on Dr's floor.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Cough, Migraine, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I've been getting bad coughs, sore throat, running nose and migraine headaches. I've been getting these on a daily basis from Fall of 2012 on! My temperature was normal. My diagnosis is that I'm in good shape. I'm taking EQUATE mucus relief on a daily basis, and I still get bad coughs, but I'm trying to recover to the best that I can.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Musculoskeletal disorder
Clinical narrative: Initial case was received by a consumer on 18 March 2013. A two-year-old female patient, with past medical history not reported, received an injection of FLUZONE, sanofi pasteur Inc., lot number U4482BA, (route, site, side and dose in series not reported) on 05 September 2012 (reported as on or about 05 September 2012). On 07 September 2012, two days post vaccination, the patient was admitted to the hospital after losing all functioning of her lower extremities. According to reporter, the patient has lost permanent function of her lower extremities following her flu shot, believed as due to "Guillain Barre Syndrome" and the adverse reactions (unspecified) to the flu shot. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash
Clinical narrative: Case number PHHY2013US012237 is a spontaneous report received initially from the Vaccine Adverse Event Reporting System (VAERS reference number: 475464) website on 08 Feb 2013 with the follow-up received from Quality Assurance Department (reference number: 210521) on 26 Mar 2013: This report refers to a 63-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly to left arm, PNEUMOVAX (other manufacturer; batch number; 1706AA) subcutaneously to left arm and ZOSTAVAX (other manufacturer; batch number; H013017) subcutaneously to right arm on 16 Nov 2012. Patient noticed rash and redness at the injection site of PNEUMOVAX on 17 Nov 2012. On 18 Nov 2012 patient went to a walk in clinic, then emergency room and received antibiotics for a cellulitis reaction. On 20 Nov 2012 patient visited pharmacy because cellulitis reaction was getting worse and spreading. Outcome of the events injection site rash and redness were reported as condition unchanged. Seriousness and causality were not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1205301) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 26 Mar 2013: Updated batch review report.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Blood glucose normal, Diastasis recti abdominis, Dysaesthesia, Eosinophil percentage increased
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A 56-year-old male patient, had received a dose of ADACEL vaccine; (lot number, anatomical site and route of administration was not reported) on an unspecified date. Medical history and concomitant medications not reported. Illness at the time of vaccination included needle stick injury. Five days post vaccination patient came down with diffuse vesiculation on both arms and a leg, and had some paresthesias, but no muscle weakness. Corrective treatment was not reported and laboratory details were reported as unknown. The outcome of the events was reported as unknown. Follow-up information was received from a healthcare professional on 18 March 2013. Based upon follow-up information, this case has been upgraded to serious. The patient was seen on 15 November 2012 for muscle twitching possibly due to having ADACEL on 01 November 2012. The patient was giving an epidural injection to a patient and stuck his left hand with a contaminated needle. He and the patient he was administering the epidural to tested negative for all screenings. He was told he needed an ADACEL update. After having the vaccine, he started having twitches and diastasis which started five days post-vaccination. It first started in his right biceps and right forearm and later went to the left and major groups in his thighs and the calves. He has had some decrease in the right arm but not the other spots. He also developed some dysesthesias in his forearms and in his legs somewhat. No change in bowel or bladder function, no weakness and no headaches. Physical exam was normal. The assessment and plan was diffuse peripheral neuropathy possibly related to ADACEL injection. Treatment plan was to take magnesium and calcium pill daily and to discontinue ZOCOR until things improve. Abnormal laboratory values on 15 November 2012 included red blood cell count (RBC) 4.46 MLLNS/uL, eosinophils 11.2%, eosinophils 8% and glucose 107 mg/dL. All other values were normal. Past medical history included vitamin D deficiency, hyperlipidemia, eosinophilia, hypertension, back pain, external hemorrhoids without complication, right inguinal hernia, elevated c-reactive protein and abnormal TSH. Concomitant medications included aspirin, atorvastatin, B complex vitamins, calcium citrate-vitamin D, fish oil -omega-3 fatty acids, levothyroxine, multivitamin, and valsartan-hydrochlorothiazide. Outcome was not recovered. Documents held by sender: Medical records.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test normal, Muscle twitching, Neuropathy peripheral, Paraesthesia, Red blood cell count decreased
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A 56-year-old male patient, had received a dose of ADACEL vaccine; (lot number, anatomical site and route of administration was not reported) on an unspecified date. Medical history and concomitant medications not reported. Illness at the time of vaccination included needle stick injury. Five days post vaccination patient came down with diffuse vesiculation on both arms and a leg, and had some paresthesias, but no muscle weakness. Corrective treatment was not reported and laboratory details were reported as unknown. The outcome of the events was reported as unknown. Follow-up information was received from a healthcare professional on 18 March 2013. Based upon follow-up information, this case has been upgraded to serious. The patient was seen on 15 November 2012 for muscle twitching possibly due to having ADACEL on 01 November 2012. The patient was giving an epidural injection to a patient and stuck his left hand with a contaminated needle. He and the patient he was administering the epidural to tested negative for all screenings. He was told he needed an ADACEL update. After having the vaccine, he started having twitches and diastasis which started five days post-vaccination. It first started in his right biceps and right forearm and later went to the left and major groups in his thighs and the calves. He has had some decrease in the right arm but not the other spots. He also developed some dysesthesias in his forearms and in his legs somewhat. No change in bowel or bladder function, no weakness and no headaches. Physical exam was normal. The assessment and plan was diffuse peripheral neuropathy possibly related to ADACEL injection. Treatment plan was to take magnesium and calcium pill daily and to discontinue ZOCOR until things improve. Abnormal laboratory values on 15 November 2012 included red blood cell count (RBC) 4.46 MLLNS/uL, eosinophils 11.2%, eosinophils 8% and glucose 107 mg/dL. All other values were normal. Past medical history included vitamin D deficiency, hyperlipidemia, eosinophilia, hypertension, back pain, external hemorrhoids without complication, right inguinal hernia, elevated c-reactive protein and abnormal TSH. Concomitant medications included aspirin, atorvastatin, B complex vitamins, calcium citrate-vitamin D, fish oil -omega-3 fatty acids, levothyroxine, multivitamin, and valsartan-hydrochlorothiazide. Outcome was not recovered. Documents held by sender: Medical records.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash, Scab
Clinical narrative: Approximately 15 widely scattered crusty papular lesions upper trunk. No temp.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Approximately 15 widely scattered crusty papular lesions upper trunk. No temp.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Approximately 15 widely scattered crusty papular lesions upper trunk. No temp.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Biopsy, Chest pain, Dyspnoea, Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no pertinent medical history or drug allergies/reaction. On approximately an unspecified day in 2008 (reported as at age of 16 or 17 years of patient) the patient was vaccinated with the first dose of GARDASIL intramuscularly. And the patient was administered her second dose of GARDASIL an unspecified period time later. There was no concomitant therapy included. Subsequent to that second dose of GARDASIL, the patient was hospitalized (Dates of the three hospitalizations are unspecified) three times for joint pain, shortness of breath, chest pain, and overall fatigue and muscle aches which went away each time. About six weeks ago, approximately 14-FEB-2013 lesions were noted that had now been diagnosed as bullous pemphigoid". Patient sought medical attention and received treatment for adverse event but various things that had not worked. Biopsy result was pending. At the time of report the outcome of joint pain, shortness of breath, chest pain, and overall fatigue and muscle aches was recovered and bullous pemphigoid was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pemphigoid, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no pertinent medical history or drug allergies/reaction. On approximately an unspecified day in 2008 (reported as at age of 16 or 17 years of patient) the patient was vaccinated with the first dose of GARDASIL intramuscularly. And the patient was administered her second dose of GARDASIL an unspecified period time later. There was no concomitant therapy included. Subsequent to that second dose of GARDASIL, the patient was hospitalized (Dates of the three hospitalizations are unspecified) three times for joint pain, shortness of breath, chest pain, and overall fatigue and muscle aches which went away each time. About six weeks ago, approximately 14-FEB-2013 lesions were noted that had now been diagnosed as bullous pemphigoid". Patient sought medical attention and received treatment for adverse event but various things that had not worked. Biopsy result was pending. At the time of report the outcome of joint pain, shortness of breath, chest pain, and overall fatigue and muscle aches was recovered and bullous pemphigoid was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Cellulitis, Dizziness, Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a doctors office, via wholesaler, refers to a 62 year old female patient with thyroid medicine and hormone medicine. No known drug reactions or allergies. On 17-MAR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml (dosing information and route were not provided), lot # H014561. Concomitant therapies included SYNTHROID and PREMARIN. The patient had received this vaccine in the evening. The next day she was feeling very weak and had a low grade fever. The following morning she called the doctors office with complaints of redness around injection site, slight fever (temperature 102) and dizziness. The physician instructed the patient to go to ER. At the ER they confirmed it was cellulitis. While she was at ER she received Cephalexin. She was admitted to hospital after ER visit but she was discharged later on that same day (date unspecified). Date of incident was reported as 17-MAR-2013. It was reported that "as of today the patient feels fine". The relatedness for cellulitis, slight fever and dizziness is unknown for PNEUMOVAX23. It has been a little over five years since she had a pneumonia vaccine. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Cellulitis, Dizziness, Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a doctor's office, via wholesaler, refers to a 62 year old female patient with thyroid medicine and hormone medicine. No known drug reactions or allergies. On 17-MAR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml (dosing information and route were not provided), lot # H014561. Concomitant therapies included SYNTHROID and PREMARIN. The patient had received this vaccine in the evening. The next day she was feeling very weak and had a low grade fever. The following morning she called the doctors office with complaints of redness around injection site, slight fever (temperature 102) and dizziness. The physician instructed the patient to go to ER. At the ER they confirmed it was cellulitis. While she was at ER she received cephalexin. She was admitted to hospital after ER visit but she was discharged later on that same day (date unspecified). Date of incident was reported as 17-MAR-2013. It was reported that "as of today the patient feels fine". The relatedness for cellulitis, slight fever and dizziness is unknown for PNEUMOVAX23. It has been a little over five years since she had a pneumonia vaccine. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Splenectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patient had her spleen removed. Upon internal review spleen operation was considered medically significant based on the list of medically significant events. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional on 05 November 2012. A 68-year-old female patient, whose allergies included Amoxicillin, Erythromycin and Bactrium and concomitant medications and illness at the time of vaccination were not reported, had received an intramuscular dose of ADACEL vaccine in left deltoid (batch number: C4313AA) on 26 October 2012. The reporter stated that, after vaccination the patient returned to the office on 01 November 2012 with rash, redness, swelling at vaccination site and sore arm. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a health care professional on 18 March 2013. Based upon the new information provided, this case has been upgraded to serious due to diagnosis of cellulitis. The patient also received a dose of Influenza vaccine, Novartis, lot number 1204101, (route not reported) in the deltoid (side not reported) on 05 October 2012 (within four weeks date of ADACEL Vaccine). The patient had allergies reported as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as Bactrium) (reaction not reported). Concomitant medications included Aspir-Low, CRESTOR, Calcium, and CENTRUM SILVER ULTRA WOMEN'S vitamin. The patient was a non-smoker and denied alcohol use. The patient had an office visit on 01 November 2012 and she presented with rash on her left arm. According to medical record, the patient had received a dTap vaccine two days ago (date of ADACEL vaccine was reported as 26 October 2012), (which makes latency six days), but the redness and swelling was getting worse and arm was reported as swollen and itchy. The patient had no fever or systemic symptoms (sx) and denied pain. She did report some itchiness. The patient's height was reported as 59.75 inches (150 centimeters) and weight was reported as 155 pounds (lbs), (70 kilograms). The patient's vital signs were reported as: temperature 98.9 (37.1 degrees Celsius); blood pressure 130/80 and pulse 72. Review of symptoms was negative. Physical exam was normal, except for skin: 6 X 6 centimeter (cm), erythematous and warm macular lesion over left upper arm and elbow area, reported as exam consistent with a cellulitis. There was no open wound. The patient was diagnosed with cellulitis and abscess. Treatment included KEFLEX 500 milligram (mg) one tablet (tab) three times a day (tid) for seven days and ice. The patient was instructed to return to office (RTO), if not improving or systemic sx. The patient's outcome remained recovered on an unspecified date. List of documents held by sender: Medical Record.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash, Vaccination site rash
Clinical narrative: Initial report received from a non-healthcare professional on 05 November 2012. A 68-year-old female patient, whose allergies included Amoxicillin, Erythromycin and Bactrium and concomitant medications and illness at the time of vaccination were not reported, had received an intramuscular dose of ADACEL vaccine in left deltoid (batch number: C4313AA) on 26 October 2012. The reporter stated that, after vaccination the patient returned to the office on 01 November 2012 with rash, redness, swelling at vaccination site and sore arm. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a health care professional on 18 March 2013. Based upon the new information provided, this case has been upgraded to serious due to diagnosis of cellulitis. The patient also received a dose of Influenza vaccine, Novartis, lot number 1204101, (route not reported) in the deltoid (side not reported) on 05 October 2012 (within four weeks date of ADACEL Vaccine). The patient had allergies reported as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as Bactrium) (reaction not reported). Concomitant medications included Aspir-Low, CRESTOR, Calcium, and CENTRUM SILVER ULTRA WOMEN'S vitamin. The patient was a non-smoker and denied alcohol use. The patient had an office visit on 01 November 2012 and she presented with rash on her left arm. According to medical record, the patient had received a dTap vaccine two days ago (date of ADACEL vaccine was reported as 26 October 2012), (which makes latency six days), but the redness and swelling was getting worse and arm was reported as swollen and itchy. The patient had no fever or systemic symptoms (sx) and denied pain. She did report some itchiness. The patient's height was reported as 59.75 inches (150 centimeters) and weight was reported as 155 pounds (lbs), (70 kilograms). The patient's vital signs were reported as: temperature 98.9 (37.1 degrees Celsius); blood pressure 130/80 and pulse 72. Review of symptoms was negative. Physical exam was normal, except for skin: 6 X 6 centimeter (cm), erythematous and warm macular lesion over left upper arm and elbow area, reported as exam consistent with a cellulitis. There was no open wound. The patient was diagnosed with cellulitis and abscess. Treatment included KEFLEX 500 milligram (mg) one tablet (tab) three times a day (tid) for seven days and ice. The patient was instructed to return to office (RTO), if not improving or systemic sx. The patient's outcome remained recovered on an unspecified date. List of documents held by sender: Medical Record.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Initial report received from a non-healthcare professional on 05 November 2012. A 68-year-old female patient, whose allergies included Amoxicillin, Erythromycin and Bactrium and concomitant medications and illness at the time of vaccination were not reported, had received an intramuscular dose of ADACEL vaccine in left deltoid (batch number: C4313AA) on 26 October 2012. The reporter stated that, after vaccination the patient returned to the office on 01 November 2012 with rash, redness, swelling at vaccination site and sore arm. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a health care professional on 18 March 2013. Based upon the new information provided, this case has been upgraded to serious due to diagnosis of cellulitis. The patient also received a dose of Influenza vaccine, Novartis, lot number 1204101, (route not reported) in the deltoid (side not reported) on 05 October 2012 (within four weeks date of ADACEL Vaccine). The patient had allergies reported as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as Bactrium) (reaction not reported). Concomitant medications included Aspir-Low, CRESTOR, Calcium, and CENTRUM SILVER ULTRA WOMEN'S vitamin. The patient was a non-smoker and denied alcohol use. The patient had an office visit on 01 November 2012 and she presented with rash on her left arm. According to medical record, the patient had received a dTap vaccine two days ago (date of ADACEL vaccine was reported as 26 October 2012), (which makes latency six days), but the redness and swelling was getting worse and arm was reported as swollen and itchy. The patient had no fever or systemic symptoms (sx) and denied pain. She did report some itchiness. The patient's height was reported as 59.75 inches (150 centimeters) and weight was reported as 155 pounds (lbs), (70 kilograms). The patient's vital signs were reported as: temperature 98.9 (37.1 degrees Celsius); blood pressure 130/80 and pulse 72. Review of symptoms was negative. Physical exam was normal, except for skin: 6 X 6 centimeter (cm), erythematous and warm macular lesion over left upper arm and elbow area, reported as exam consistent with a cellulitis. There was no open wound. The patient was diagnosed with cellulitis and abscess. Treatment included KEFLEX 500 milligram (mg) one tablet (tab) three times a day (tid) for seven days and ice. The patient was instructed to return to office (RTO), if not improving or systemic sx. The patient's outcome remained recovered on an unspecified date. List of documents held by sender: Medical Record.
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Diarrhoea, Electrocardiogram, Erythema, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Local swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Tongue disorder, X-ray
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Adenotonsillectomy, Blood test, Electrocardiogram, Immunoglobulin therapy, Incorrect dose administered
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Sleep apnoea syndrome
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 1.25
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Overdose, Sleep apnoea syndrome
Clinical narrative: Kawasaki disease - Mucocutaneous lymph node syndrome, rash skin, red tongue, eyes red, back skin blood red spot, feet swell, neck swell, hands EKG, Xray fever 103 degrees - 105 degrees - 3 days diarrhea (IGIV).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Increase redness, swelling upper (L) arm including (L) shoulder area, warm to touch with erythema (L) deltoid / tx -warm compresses, BENADRYL Ibuprofen.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received BOOSTRIX at 4:30 pm 4-2-13 called HD 4-3-13 to report he developed itching and hives on Lt upper back 1-2 hrs after receiving the injection. He self treated with BENADRYL 25 mg 2 tabs and BENADRYL cream. Itching and hives resolved with 30 min. Subsequently pt. reported possibility of exposure to ant bite as he now remembers sitting in a chair with ants, but did not feel a bite at the time.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a male patient of unknown age. On 27-MAR-2012, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 26-MAR-2013, the patient was vaccinated with the second dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Child developed hives the morning after receiving vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Skin warm, Swelling
Clinical narrative: Swelling and flushed and hot around left eye and mouth, to lesser degree on right side.  Called doctors office on 4/03/2013 and told no relation to shingles vaccine.  No treatment given.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Back pain, Bone pain, Diplegia, Dizziness, Dyskinesia
Clinical narrative: Shortly after getting the vaccine, I came down with low grade flu symptoms (dizziness, fever, and extreme aching in the bones, particularly lower back). After a week, that subsided. However, the lower back pain has continued and I now suffer from shooting pains and temporary paralysis (loss of control) of my legs, often short enough to just invoke jerking movements while walking, running and bicycling (no falls yet). It hurts to sit, it hurts to stand, it hurts to move. Basically, I fidget to find a comfortable position all the time, then a few minutes later it hurts in my spine again and I have to move.  [[Vaccine Lot # UH745AB ]]
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Influenza, Loss of control of legs, Pain, Pyrexia, Spinal pain
Clinical narrative: Shortly after getting the vaccine, I came down with low grade flu symptoms (dizziness, fever, and extreme aching in the bones, particularly lower back). After a week, that subsided. However, the lower back pain has continued and I now suffer from shooting pains and temporary paralysis (loss of control) of my legs, often short enough to just invoke jerking movements while walking, running and bicycling (no falls yet). It hurts to sit, it hurts to stand, it hurts to move. Basically, I fidget to find a comfortable position all the time, then a few minutes later it hurts in my spine again and I have to move.  [[Vaccine Lot # UH745AB ]]