chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 18-JUN-2012, the patient was vaccinated with a first dose of VAQTA 25 U Injection (lot #, dose and route not reported). On 14-NOV-2012, the patient received a second dose of VAQTA 25 U Injection. No other co-suspects were reported. No concomitant medications were reported. The patient received two doses of VAQTA less than 6 months apart. No adverse effects. No additional information provided. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypoaesthesia, Lip blister, Paraesthesia
Clinical narrative: This spontaneous report as received from a 61 years old male patient regarding himself. The patient current conditions included glaucoma. No concomitant medications were taken by the patient. There was no drug reactions or allergies reported. The patient's medical history included shingles on approximately June 2010 (reported as about 2 and a half years ago). After experiencing pain involved with shingles, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and dose were not reported) on December 2010 (reported as 2 years ago). No concomitant medications were reported. The patient reported that he still had some numbness and tingling sensation on the left side of his face. He occasionally gets some blisters on the inside of his lips. The numbness, tingling and blisters had never gone away completely from the initial case of shingles which occurred about 2 and a half years ago (June 20100. But they did get a little worse approximately on an unknown date in December 2011 (reported as about one year) after getting the vaccine. The patient sought medical attention (saw the health care professional) and was treated with cremes (unspecified for rash). The outcome of numbness and tingling on the left side of his face and blisters on the inside of his lips was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dyspnoea, Feeling hot, Flushing
Clinical narrative: Case number PHEH2012US024590 is an initial spontaneous report received from a consumer on 11 Dec 2012. This report refers to a 20-year-old female patient. The patient's current condition included anemia and controlled asthma. The patient received FLUVIRIN (batch number: unknown) intramuscularly in one arm and PNEUMOVAX 23 (batch number unknown) in the other arm on 25 Oct 2012. Within 5 seconds post vaccination, she felt her stomach was hot, her face was red, she had a high fever, her airway closed up, and air was not going into her blood. She received EPIPEN by the pharmacist. She was taken to emergency room, where she received steroids and antibiotics. On 26 Oct 2012, her doctor referred her to an allergist "who did not want to do testing". According to allergist, it was not an anaphylactic reaction. Over the weekend (date unspecified), she developed a fever of 103 degree F and she wasn't able to hold anything down, and her airway continued closing up. She was hospitalized on 30 Oct 2012 for 9 days. During hospitalization, her heart stopped twice, for the first time it was for 5 minutes and the second time duration was unknown. She also experienced pseudo-seizures. She had fever the whole time when she was in the hospital and highest temperature noted was 103.5 degree F. She was discharged on 07 Nov 2012. After discharge, on around 15 Nov 2012, she developed flu and pneumonia. Her liver enzymes were "all over the place". Her white blood cell count has been high, and she was still receiving antibiotics and steroids. She received some medicines from hospital "2 days before". She was taking ROBITUSSIN and MUCINEX. She experienced fever and vomiting "this weekend". Seriousness, outcome and causality were not reported.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cardiac arrest, Erythema, Feeling hot, Hepatic enzyme abnormal, Influenza
Clinical narrative: Case number PHEH2012US024590 is an initial spontaneous report received from a consumer on 11 Dec 2012. This report refers to a 20-year-old female patient. The patient's current condition included anemia and controlled asthma. The patient received FLUVIRIN (batch number: unknown) intramuscularly in one arm and PNEUMOVAX 23 (batch number unknown) in the other arm on 25 Oct 2012. Within 5 seconds post vaccination, she felt her stomach was hot, her face was red, she had a high fever, her airway closed up, and air was not going into her blood. She received EPIPEN by the pharmacist. She was taken to emergency room, where she received steroids and antibiotics. On 26 Oct 2012, her doctor referred her to an allergist "who did not want to do testing". According to allergist, it was not an anaphylactic reaction. Over the weekend (date unspecified), she developed a fever of 103 degree F and she wasn't able to hold anything down, and her airway continued closing up. She was hospitalized on 30 Oct 2012 for 9 days. During hospitalization, her heart stopped twice, for the first time it was for 5 minutes and the second time duration was unknown. She also experienced pseudo-seizures. She had fever the whole time when she was in the hospital and highest temperature noted was 103.5 degree F. She was discharged on 07 Nov 2012. After discharge, on around 15 Nov 2012, she developed flu and pneumonia. Her liver enzymes were "all over the place". Her white blood cell count has been high, and she was still receiving antibiotics and steroids. She received some medicines from hospital "2 days before". She was taking ROBITUSSIN and MUCINEX. She experienced fever and vomiting "this weekend". Seriousness, outcome and causality were not reported.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pneumonia, Psychogenic seizure, Pyrexia, Respiratory gas exchange disorder, Throat tightness
Clinical narrative: Case number PHEH2012US024590 is an initial spontaneous report received from a consumer on 11 Dec 2012. This report refers to a 20-year-old female patient. The patient's current condition included anemia and controlled asthma. The patient received FLUVIRIN (batch number: unknown) intramuscularly in one arm and PNEUMOVAX 23 (batch number unknown) in the other arm on 25 Oct 2012. Within 5 seconds post vaccination, she felt her stomach was hot, her face was red, she had a high fever, her airway closed up, and air was not going into her blood. She received EPIPEN by the pharmacist. She was taken to emergency room, where she received steroids and antibiotics. On 26 Oct 2012, her doctor referred her to an allergist "who did not want to do testing". According to allergist, it was not an anaphylactic reaction. Over the weekend (date unspecified), she developed a fever of 103 degree F and she wasn't able to hold anything down, and her airway continued closing up. She was hospitalized on 30 Oct 2012 for 9 days. During hospitalization, her heart stopped twice, for the first time it was for 5 minutes and the second time duration was unknown. She also experienced pseudo-seizures. She had fever the whole time when she was in the hospital and highest temperature noted was 103.5 degree F. She was discharged on 07 Nov 2012. After discharge, on around 15 Nov 2012, she developed flu and pneumonia. Her liver enzymes were "all over the place". Her white blood cell count has been high, and she was still receiving antibiotics and steroids. She received some medicines from hospital "2 days before". She was taking ROBITUSSIN and MUCINEX. She experienced fever and vomiting "this weekend". Seriousness, outcome and causality were not reported.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Case number PHEH2012US024590 is an initial spontaneous report received from a consumer on 11 Dec 2012. This report refers to a 20-year-old female patient. The patient's current condition included anemia and controlled asthma. The patient received FLUVIRIN (batch number: unknown) intramuscularly in one arm and PNEUMOVAX 23 (batch number unknown) in the other arm on 25 Oct 2012. Within 5 seconds post vaccination, she felt her stomach was hot, her face was red, she had a high fever, her airway closed up, and air was not going into her blood. She received EPIPEN by the pharmacist. She was taken to emergency room, where she received steroids and antibiotics. On 26 Oct 2012, her doctor referred her to an allergist "who did not want to do testing". According to allergist, it was not an anaphylactic reaction. Over the weekend (date unspecified), she developed a fever of 103 degree F and she wasn't able to hold anything down, and her airway continued closing up. She was hospitalized on 30 Oct 2012 for 9 days. During hospitalization, her heart stopped twice, for the first time it was for 5 minutes and the second time duration was unknown. She also experienced pseudo-seizures. She had fever the whole time when she was in the hospital and highest temperature noted was 103.5 degree F. She was discharged on 07 Nov 2012. After discharge, on around 15 Nov 2012, she developed flu and pneumonia. Her liver enzymes were "all over the place". Her white blood cell count has been high, and she was still receiving antibiotics and steroids. She received some medicines from hospital "2 days before". She was taking ROBITUSSIN and MUCINEX. She experienced fever and vomiting "this weekend". Seriousness, outcome and causality were not reported.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Pt developed rash on chest. Reported to MD who prescribed MEDROL Dosepak 9/28/12.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pt developed rash on chest. Reported to MD who prescribed MEDROL Dosepak 9/28/12.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy skin abnormal, Impaired healing, Injection site haemorrhage, Injection site scab, Injection site swelling
Clinical narrative: Lesion on site of injection. It is a weeping wound. It bleeds and scabs over, cycle repeating for over a year. Biopsy done recently are will be removed on Tuesday. Site redness, sore, not raised. Had weeping wound with last flu vaccine on other arm but healed after awhile.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Precancerous skin lesion
Clinical narrative: Lesion on site of injection. It is a weeping wound. It bleeds and scabs over, cycle repeating for over a year. Biopsy done recently are will be removed on Tuesday. Site redness, sore, not raised. Had weeping wound with last flu vaccine on other arm but healed after awhile.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Biopsy, Injection site discharge, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Lesion on site of injection. It is a weeping wound. It bleeds and scabs over, cycle repeating for over a year. Biopsy done recently are will be removed on Tuesday. Site redness, sore, not raised. Had weeping wound with last flu vaccine on other arm but healed after awhile.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site scab, Skin lesion
Clinical narrative: Lesion on site of injection. It is a weeping wound. It bleeds and scabs over, cycle repeating for over a year. Biopsy done recently are will be removed on Tuesday. Site redness, sore, not raised. Had weeping wound with last flu vaccine on other arm but healed after awhile.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Musculoskeletal discomfort, Pain, Pruritus
Clinical narrative: This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2012US134820 refers to an approximately 70 years old male patient. The patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. About a year ago, in approximately December 2011, the patient experienced reactions to the zoster vaccine live (manufacturer unknown). The patient felt he had shingles after getting the vaccine. At the time of the report, the patient's outcome was unknown. The relatedness for felt he had shingles after getting the vaccine was unknown for zoster vaccine live (manufacturer unknown). This was originally reported by a consumer. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2012US134820 refers to an approximately 70 years old male patient. The patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. About a year ago, in approximately December 2011, the patient experienced reactions to the zoster vaccine live (manufacturer unknown). The patient felt he had shingles after getting the vaccine. At the time of the report, the patient's outcome was unknown. The relatedness for felt he had shingles after getting the vaccine was unknown for zoster vaccine live (manufacturer unknown). This was originally reported by a consumer. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Bone densitometry, Bone scan normal, Full blood count, Hypoaesthesia
Clinical narrative: Onset of pain in both left and right shoulders and weakness in both legs.  Saw internist on 10/29/2012 when pain became more severe and spread to include right and left wrist, and area from buttock to back of knees. X rays showed inflamation of left shoulder.  On 11/16/2012, an NM body bone scan showed many area of inflamation.  On 11/20/2012, treated with prednidone 30 mg q d X 8 days.  Saw rheumatologist on 11/29/2012, at which time she had muscle weakness in both legs.  "Rheumatoid" test were positive and she was diagnosed as possibly having rheumatoid arthrits or a "polio" arthritis." Prednisone dose was adjusted and over time she improved to the point that she was being tapered off prednisone at the time of this report.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Movement disorder, Musculoskeletal pain, Musculoskeletal stiffness, Nerve conduction studies
Clinical narrative: Onset of pain in both left and right shoulders and weakness in both legs.  Saw internist on 10/29/2012 when pain became more severe and spread to include right and left wrist, and area from buttock to back of knees. X rays showed inflamation of left shoulder.  On 11/16/2012, an NM body bone scan showed many area of inflamation.  On 11/20/2012, treated with prednidone 30 mg q d X 8 days.  Saw rheumatologist on 11/29/2012, at which time she had muscle weakness in both legs.  "Rheumatoid" test were positive and she was diagnosed as possibly having rheumatoid arthrits or a "polio" arthritis." Prednisone dose was adjusted and over time she improved to the point that she was being tapered off prednisone at the time of this report.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Onset of pain in both left and right shoulders and weakness in both legs.  Saw internist on 10/29/2012 when pain became more severe and spread to include right and left wrist, and area from buttock to back of knees. X rays showed inflamation of left shoulder.  On 11/16/2012, an NM body bone scan showed many area of inflamation.  On 11/20/2012, treated with prednidone 30 mg q d X 8 days.  Saw rheumatologist on 11/29/2012, at which time she had muscle weakness in both legs.  "Rheumatoid" test were positive and she was diagnosed as possibly having rheumatoid arthrits or a "polio" arthritis." Prednisone dose was adjusted and over time she improved to the point that she was being tapered off prednisone at the time of this report.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Arthritis, Bone scan abnormal, Injection site pain, Muscular weakness
Clinical narrative: Onset of pain in both left and right shoulders and weakness in both legs.  Saw internist on 10/29/2012 when pain became more severe and spread to include right and left wrist, and area from buttock to back of knees. X rays showed inflamation of left shoulder.  On 11/16/2012, an NM body bone scan showed many area of inflamation.  On 11/20/2012, treated with prednidone 30 mg q d X 8 days.  Saw rheumatologist on 11/29/2012, at which time she had muscle weakness in both legs.  "Rheumatoid" test were positive and she was diagnosed as possibly having rheumatoid arthrits or a "polio" arthritis." Prednisone dose was adjusted and over time she improved to the point that she was being tapered off prednisone at the time of this report.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Rheumatoid factor positive, X-ray limb abnormal
Clinical narrative: Onset of pain in both left and right shoulders and weakness in both legs.  Saw internist on 10/29/2012 when pain became more severe and spread to include right and left wrist, and area from buttock to back of knees. X rays showed inflamation of left shoulder.  On 11/16/2012, an NM body bone scan showed many area of inflamation.  On 11/20/2012, treated with prednidone 30 mg q d X 8 days.  Saw rheumatologist on 11/29/2012, at which time she had muscle weakness in both legs.  "Rheumatoid" test were positive and she was diagnosed as possibly having rheumatoid arthrits or a "polio" arthritis." Prednisone dose was adjusted and over time she improved to the point that she was being tapered off prednisone at the time of this report.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Disability, Mitochondrial myopathy, Upper extremity mass
Clinical narrative: Case number PHEH2012US024700 is an initial spontaneous report received from a consumer who was also a nurse on 13 Dec 2012. This report refers to a 53-years-old female patient. She experienced tinnitus with cephalosporins, penicillin and streptomycin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 17 Nov 2008. On the same day, she had a huge lump on her arm. It was reported that she was disabled for a month after the vaccine and was diagnosed with mitochondrial myopathy in 2010. The outcome of the event was not reported. No further information was provided.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Discomfort, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Recipient of influenza vaccine reports that vaccine administered into the very top of the deltoid muscle, causing immediate discomfort/mild pain.  The discomfort/pain has continued for two and a half weeks, ranging between mild discomfort to pain.  Left shoulder range of motion has been affected and this has limited reciepients life style. No treatment given by a practitioner yet, though she has an appt. for an evaluation.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever, fussiness.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node in arm pit on left/right that disappeared then appeared on opposite arm, then disappeared again.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: My arm began to get very sore about an hour after the shot and then my neck on the same side as the shot started to hurt all the way through my shoulder about an hour an a half after the shot. I went to bed around 9 p.m. and then got the chills and shivers. I took Advil and Tylenol, threw on another blanket and turned up the heat and went to sleep. I did not have a fever. When I got up this morning, all symptoms were gone, except the sore arm.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Back pain, Headache, Malaise, Nausea
Clinical narrative: After the flu and pneumonia shots my arm started to hurt, I became VERY nauseous, developed painful headache, mild fever, pain from my arm spread through my head, neck, back, and joints, and the pain increase throughout the next 24 hours and did not subside until after 48 hours. I could not get out of bed on 12/10/2012 and had to stay home from work again on 12/11/2012. I would have gone to the doctors on 12/10/2012 if I wasn't so sick!
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: After the flu and pneumonia shots my arm started to hurt, I became VERY nauseous, developed painful headache, mild fever, pain from my arm spread through my head, neck, back, and joints, and the pain increase throughout the next 24 hours and did not subside until after 48 hours. I could not get out of bed on 12/10/2012 and had to stay home from work again on 12/11/2012. I would have gone to the doctors on 12/10/2012 if I wasn't so sick!
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Respiratory disorder, Tremor
Clinical narrative: Acute respiratory problem.  Could not catch my breath, rapid feeling pulse, shaking.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: Chills, Fever, Headache, Joint Pain, Muscle Aches, Nausea, Intestinal Cramping, Fatigue.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, Fever, Headache, Joint Pain, Muscle Aches, Nausea, Intestinal Cramping, Fatigue.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Oedema peripheral, Rash, Tenderness, Urticaria, Vaccination complication
Clinical narrative: Pt reported to the E.R on 9/08/12 at 10:19 a.m. w/skin rash, swollen and tender Left upper extremity.  Dx w/hives, identified cause was his immunizations.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came in to pharamcy on 12/20/12 to state that since her vaccination she had had soreness in her left upper arm (near injection site.) This has also caused a limitation in her range of motion in that arm.  The soreness and limited range of motion of the arm has not yet ceased.  She will follow up with her Doctor in January and inform us of any updates.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Bruise, swelling, no redness, tender and swollen lymph node on neck, left side.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lymph node pain, Urticaria
Clinical narrative: Chills, hives, pain in lymph nodes BENADRYL.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Redness and swelling moving out and away from injection site. Cellulitis dx. Rx cephalexin 500 mg.
Age: 19.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, Chest pain, Electrocardiogram abnormal, Myopericarditis
Clinical narrative: Myopericarditis marked by chest pain, ECG abnormalities and elevated troponin (max 6.6). Normal coronary angiogram.
Age: 19.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: Myopericarditis marked by chest pain, ECG abnormalities and elevated troponin (max 6.6). Normal coronary angiogram.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: States all of left upper arm aches & has difficulty holding a book or a hair dryer. Symptoms started shortly after getting flu shot. Advised to consult physician.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Mass, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Vaccine given 8/8/2012, 11/21/2012. 1st shot - had a fever and sore throat - negative for strep. Noticed lump on side of neck below ear in the same spot approx 2-4 weeks following vaccine. Plans to see doctor to assess the lump.
Age: 5.0
Sex: F
Vaccine: FLUN3, MMRV
Symptoms: Abdominal pain upper, Arthralgia, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Vaccine administered on 12/17/12. Rash developed on leg noticed on 12/18/12. 12/19 leg hurt, neck, stomach, knees hurting 100 fever, mildly tender throughout leg. 17 x 8 cm erythema left lateral leg.
Age: 5.0
Sex: F
Vaccine: FLUN3, MMRV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Vaccine administered on 12/17/12. Rash developed on leg noticed on 12/18/12. 12/19 leg hurt, neck, stomach, knees hurting 100 fever, mildly tender throughout leg. 17 x 8 cm erythema left lateral leg.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Joint swelling, Urticaria
Clinical narrative: Patient given her 3rd flu shot ever on 12-7-12 around 3 pm - parent reported on 12-17-12 8 days later 12-15-12 child woke up with rash (hive like) near injection site on left arm deltoid area - By Mon. AM hive like rash on both arms, trunk area c/o joint swelling - hands, wrists & elbows. Follow up PC to family scheduled 12-20-12 - BENADRYL given per PHN 12-17-12 around noon - 3 p parent reports - child doing fine - no wheezing at this time or anytime. 12-20-12 10:00 AM PC with parent of patient she is fine - rash (hives) and joint swelling completely gone by Wed AM - parent reports joint swelling hands, wrists, elbows with hives on arms, trunk - itchy rash. No respiratory stress responded well to BENADRYL it was started lunch time 12-17-12 1 dose at HS; 1 dose AM, HS 12-18-12 1 dose BENADRYL AM 12-19-12. Rash swelling completely gone; symptoms appeared 8 days later after Flu shot. Child had had 1 seasonal Flu 3-29-10 and 1 H1N1 dose 3-29-10 prior to Flu vaccine on 12-7-2012.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Urticaria
Clinical narrative: Pt got hives on trunk within 24. Took BENADRYL and ZYRTEC. Got flu like symptoms Day 2 for approximately 1 week.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Mother reported a fever of 102.4 all day on Tuesday 2/18 along with nasal congestion, vomiting and a bloody nose once.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Musculoskeletal pain, Oedema peripheral, Tenderness
Clinical narrative: Adverse event reported to our office on 12/13/12. Patient reported redness & swelling in the right arm following the injection. As of 12/13/12, patient states swelling, redness improved but she has pains in right shoulder when raising her arm & reaching behind her, occasional numbness in finger tips. (+) tenderness with abduction & external rotation of right shoulder after (2 weeks) immunization. On 12/13/12, no point tenderness or subcu masses on palpation of (R) deltoid area. Not better after 4 days of ALEVE 2 po bid.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: No known problems, parent did not return phone calls.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Itching at site of inj. & down to elbow 2 days after inj. (flu) given. Continues to itch at deltoid down to elbow area. Some soreness at site 2 -3 days but no soreness now.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling- very red about 3 inch circle around shot 24 hour.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: The patient presents with right, arm swelling. The onset was 1 days ago. The course/duration of symptoms is worsening. Type of injury: unknown. The location where the incident occurred was at home. Location: Right posterior proximal arm. Radiating pain: none. The character of symptoms is pain, redness, swelling and tingling. The degree of pain is moderate. The degree of swelling is moderate. Exacerbating factors consist of activity, movement palpation. There are relieving factors including immobilization and position. Risk factors consist of recent hospitalization and recently immunized in that arm
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node. Area around lymph node also swollen.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Pain and soreness at injection site, skin hot to the touch with redness and swelling.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MEN, TDAP
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: On initial reaction patient was ok has never had a reaction in the past from other vaccines. Patient was out in the waiting room with mom and sister making an appoitnment for next vaccine. Patients stated that she started feeling dizzy and stated blacking out pt fell nausea. Mom took her to the restroom where she did not vomit. Pt told mom that she felt better, then I walked in and assisted pt to a room to lay down pt vital I gave pt 2x163mls of apple juice and a cup of water. Pt only had a cup of milk for breakfast. After 20min pt felt better I called Dr. to come and take a look at pt after his assessment pt was ok to go home.
Age: 9.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to the touch, required antibiotics.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Pruritus, Pulmonary congestion, Rash, Urticaria
Clinical narrative: Rash/Hives, itching, chest congestion, increase in pulse.  EMT called.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Right side of face numbness. Described as if had received novacaine. Progressed to neck and head. This lasted about 2 hours.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Injection site warmth, Local reaction, Rash erythematous
Clinical narrative: Localized reactions at site, hot to touch. Some red spots that is growing bigger.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Culture negative, Full blood count normal, Influenza virus test negative, Injection site erythema
Clinical narrative: Left injection site was red and swollen, warm and painful to touch.  Difficult to lift arm.  Redness and swelling increased over the next 4 days and became the front half of the upper arm.  Also started with a temp 100-101 with chills, body aches, sore throat. This lasted 5 days.  Then on day 4 got petechiae like itchy rash on roof of mouth and discoid fluid filled pustules on upper back that were itchy.  Flu swab on 12/15/2012 was negative.  Had received flu shot in fall 2012.  Took Tylenol 1000 mg Q 6-8 hrs with naproxen in between Tylenol doses for fever and body aches.  After rash and itching started also took Benadryl 25 mg that night.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Metabolic function test normal, Mobility decreased
Clinical narrative: Left injection site was red and swollen, warm and painful to touch.  Difficult to lift arm.  Redness and swelling increased over the next 4 days and became the front half of the upper arm.  Also started with a temp 100-101 with chills, body aches, sore throat. This lasted 5 days.  Then on day 4 got petechiae like itchy rash on roof of mouth and discoid fluid filled pustules on upper back that were itchy.  Flu swab on 12/15/2012 was negative.  Had received flu shot in fall 2012.  Took Tylenol 1000 mg Q 6-8 hrs with naproxen in between Tylenol doses for fever and body aches.  After rash and itching started also took Benadryl 25 mg that night.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain, Petechiae, Pyrexia, Rash
Clinical narrative: Left injection site was red and swollen, warm and painful to touch.  Difficult to lift arm.  Redness and swelling increased over the next 4 days and became the front half of the upper arm.  Also started with a temp 100-101 with chills, body aches, sore throat. This lasted 5 days.  Then on day 4 got petechiae like itchy rash on roof of mouth and discoid fluid filled pustules on upper back that were itchy.  Flu swab on 12/15/2012 was negative.  Had received flu shot in fall 2012.  Took Tylenol 1000 mg Q 6-8 hrs with naproxen in between Tylenol doses for fever and body aches.  After rash and itching started also took Benadryl 25 mg that night.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: Left injection site was red and swollen, warm and painful to touch.  Difficult to lift arm.  Redness and swelling increased over the next 4 days and became the front half of the upper arm.  Also started with a temp 100-101 with chills, body aches, sore throat. This lasted 5 days.  Then on day 4 got petechiae like itchy rash on roof of mouth and discoid fluid filled pustules on upper back that were itchy.  Flu swab on 12/15/2012 was negative.  Had received flu shot in fall 2012.  Took Tylenol 1000 mg Q 6-8 hrs with naproxen in between Tylenol doses for fever and body aches.  After rash and itching started also took Benadryl 25 mg that night.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Axillary pain, Body temperature increased, Chills, Eye pain
Clinical narrative: Raised rash around injection site 5x5 inches that migrated into axilla.  Rash was streaky - streaks from injection site to axilla.  Moderate to severe pain on arm and axilla.  Temp 102 F.  Eye aches, head ache, malaise, weakness, body/back aches, chills.  Treated with Advil which decreased fever to 100 F.   Temperature lasted 48 hours.  Rash took 7 days to go away.  Malaise and weakness subsided after 3 days.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Injection site rash, Malaise, Pain, Pain in extremity
Clinical narrative: Raised rash around injection site 5x5 inches that migrated into axilla.  Rash was streaky - streaks from injection site to axilla.  Moderate to severe pain on arm and axilla.  Temp 102 F.  Eye aches, head ache, malaise, weakness, body/back aches, chills.  Treated with Advil which decreased fever to 100 F.   Temperature lasted 48 hours.  Rash took 7 days to go away.  Malaise and weakness subsided after 3 days.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Raised rash around injection site 5x5 inches that migrated into axilla.  Rash was streaky - streaks from injection site to axilla.  Moderate to severe pain on arm and axilla.  Temp 102 F.  Eye aches, head ache, malaise, weakness, body/back aches, chills.  Treated with Advil which decreased fever to 100 F.   Temperature lasted 48 hours.  Rash took 7 days to go away.  Malaise and weakness subsided after 3 days.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Myalgia, Pain, Urticaria
Clinical narrative: Muscle ache/pain starting evening of day shots were given. Pt. complains of hot, aching sensation. Bumps that are hive-like were also seen/developed. Pain not relieved by ibuprofen use. On 12/15/12 evening patient said her pain is subsiding and she is not going to Dr's office.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash surrounding vaccine area, with warmth.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swelling & tenderness (L) deltoid/pain radiating down (L) arm/reduced ROM (L) arm. No erythema. Pt seen 12/17/12. Symptoms improves approx 50%. 12/20/12 patient called & arm much better - cancelled appt for 12/20/12.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Probable intraarticular injection with increased pain & immediate redness. 12/15/12 had cellulitis along AC & bicep groove. Resolved 12/17/12 with antibiotic & steroids.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Probable intraarticular injection with increased pain & immediate redness. 12/15/12 had cellulitis along AC & bicep groove. Resolved 12/17/12 with antibiotic & steroids.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Pharyngeal oedema
Clinical narrative: Patient received PNEUMOVAX in afternoon, & by evening was experiencing "throat swelling" & needed to go to ER due to anaphylaxis.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: NDC 0006-4827-00 Pt says these symptoms have improved today but redness is still present. Redness around injection site measuring 3.75inx2.75in, previously itchy and hot to the touch.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Client received PNEUMOVAX 23 to right upper arm on Monday December 17, 2012. Client presents today with c/o reddened, swollen, warm, painful area to under side of upper arm. Client reports taking ibuprofen ATC for discomfort. Denies running any fever. Dr examined client. Dx of local reaction to PNEUMOVAX 23.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Erythema, Papule, Skin plaque
Clinical narrative: Bright red plaques and papules at face, neck, trunk and arms. Area were confluent on face. No ulcers or pustules.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Pain, Vomiting
Clinical narrative: 8AM - received vaccines. 12N - achy all over. 2PM - 2 aspirin. 5PM - extreme shivering till 12 midnight. 8 PM - vomited. 12 MN - TYLENOL. Next day - joints achy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Burning sensation
Clinical narrative: 48 hours after receiving Intradermal FLUZONE pt noted blisters between all fingers on both hands also blisters noted on top of hands. Small in size with a burning feeling when touched. Rx for: Prednisone 50 mg sent 12-20-12.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm hot, swollen, tender to touch at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Local swelling
Clinical narrative: Local swelling with erythema and pruritus at injection site.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, warm, allergic reaction at the site of administration (5 x 4.5 cm) within 24 hours.
Age: 32.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given 2nd Hepatitis A vaccine 2 months after first dose normal interval 6 months.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event that I am aware of at this point. Pt received FLULAVAL which is for 18 year old and older. Trying to contact parent currently. Messages left.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Hard "knot" at site of shot underarm, with redness radiating to elbow at left arm. Instructed patient to take anti-inflammatory and BENADRYL, called today, 12/20/12, swelling & redness was almost.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, X-ray
Clinical narrative: 5 days after injection of FLUVIRIN pt experienced pain at site of injection which then migrated to shoulder on day & after injection of FLUVIRIN.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Auricular swelling, Erythema, Skin warm, Swelling
Clinical narrative: Appeared with redness, warmth - arms, neck, chest, around mouth, swelling noted to right ear = angioedema. No SOB.
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Apnoea, Vomiting
Clinical narrative: Pt received 2nd flu vaccine (11/20/12 and 12/20/12) about 10 min later pt vomited and had an apnea episode. Pt did feed prior to the visit.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a patient's mother concerning to an 11 years old female patient. The patient received her first dose of GARDASIL intramuscular (dose and lot not reported) in JUN-2012 6 months ago. No other co-suspects were reported. No concomitant medications were reported. The patient had not received her second dose at this time. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with improperly stored doses (exposed to 31.1 F for 8 hours 10 minutes) of GARDASIL (Lot # not reported) on an unspecified date. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a doctor in pharmacy concerning to a patient of unknown age and gender. On 07-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot reported). On 21-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). On 07-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient received a compressed schedule for GARDASIL. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Dyspnoea, Swelling face, Wheezing
Clinical narrative: Swollen face, shortness of breath, wheezing, cough, hoarseness. Reported by patient. Per patient given steroids & BENADRYL at ER. Not yet re-evaluated in office. Patients states having persistent difficulties.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Meningitis, Musculoskeletal stiffness
Clinical narrative: Patient received vaccine 10/23/12 & said she started feeling ill that evening. The next day she was stiff all over. She went to her MD and was turned away & then went to a walk in clinic where she was diagnosed with meningitis. She will have to have vertebrae fused per patient. Patient had blood work approximately one week before vaccination and everything looked fine.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-NOV-2012 at 06:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to a 77 years old patient. Pharmacist reported that on 06-NOV-2012, the patient may had been vaccinated with ZOSTAVAX Lot reported as H012519; Exp date: 09-OCT-2013 (dose not reported) by the intramuscular route. No other co-suspects were reported. Concomitant medications included: FLUVIRIN at the same visit on 06-NOV-2012 but opposite arm from ZOSTAVAX. The patient continued to had pain in the arm vaccinated with ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 52 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # H013943; exp date 25-OCT-2013) (dose and route not reported) on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 09-DEC-2012 the patient went back to the pharmacy, to pick up MEDROL dosepack. The reason for use of MEDROL dosepack was unspecified. No lab diagnostic tests were performed the outcome of the unspecified event was unknown. The relatedness for the event was not provided for ZOSTAVAX, Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age with no spleen with no pertinent medical history and drug reactions reported. On 12-DEC-2012, the patient was vaccinated intramuscular with 0.5 ml PEDVAX HIB (lot # not provided). No concomitant medications were reported. The Nurse stated that on 12-DEC-2012, the patient was administered an improperly stored dose of PEDVAX HIB. Nurse noted that the PEDVAX HIB was drawn up in a syringe and not immediately administered but stored in the refrigerator for 1 to 2 hours before being administered to the patient. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified date, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received from pharmacist considering a 60 years old patient of unknown gender, who on 03-OCT-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005677, 1212USA005679, 1212USA005680, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.