chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Pain in extremity, Rash erythematous, Rash macular
Clinical narrative: Entire thigh became very swollen, hot, and red. Very painful. Swelling lasted approximately 72 hours, but blotchy red rash persists 9 days later.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Entire thigh became very swollen, hot, and red. Very painful. Swelling lasted approximately 72 hours, but blotchy red rash persists 9 days later.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Area of redness around injection site, approximately 1.5 inches x 2 inches. Area is sore. Not seeking treatment at this time.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising at and below injection site.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Diarrhoea, Injection site rash, Rash
Clinical narrative: Pt. called on 10/7/13 and stated she had a prickly rash on her shin/knee and under arm/shoulder area that following a line. She also states she had diarrhea and told her she could have a rash around the injection site but since it had spread she should she her PCP in the morning to access the rash.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: No adverse reaction happened that we know, we just wanted to report it in case anything came up. Pt had a flu shot at pulmonology on 9/27/13 and we didn't know. She was revaccinated on 10/4/13.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Neck pain when turning head to the right. 75% of the time turning to the right there is pain no pain other times.
Age: 1.22
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Mild swelling, induration and erythema at vaccine injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Sensation of foreign body
Clinical narrative: Within about an hour after receiving her flu shot at work, pt felt like something was in her throat that she couldn't swallow - went to ER - treated with IV SOLUMEDROL, BENADRYL, albuterol neb.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling
Clinical narrative: Swelling of left arm since about 10/6/13. Treatment: BENADRYL (Given by aunt not given by doctor).
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox rash - on legs and arms. Being treated by MD.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Rash, Varicella
Clinical narrative: Chicken pox rash - on legs and arms. Being treated by MD.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising
Clinical narrative: Pt has a 2" across bruise at injection site which appeared the next day. Also had a 3"x3" red area 2-3" below injection site which went away 2 days later. Pt has no plain with bruise, takes daily aspirin.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Red welt on back of left arm. Approximately 3 inches in diameter at ZOSTAVAX injection site.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Red welt on back of left arm. Approximately 3 inches in diameter at ZOSTAVAX injection site.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Erythema, Localised oedema
Clinical narrative: 15 mo. Imm. given at WCE on 10-04-13. Mom called office on 10-07-13 and spoke with phone triage nurse. Mom reports s/s to (Lt) as 2-2 1/2" area of redness and edema beginning after imm. on 10/4/13. Mom reports decreased s/s 10-07-13; afebrile, no streaking or dischg. (No tx or O.V. - call report only; s/s resolving spontaneously at time of report).
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Infection, Pain, Pyrexia
Clinical narrative: Had allergic reaction, redness, soreness, high fever, then got infected.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm swelled up from elbow to shoulder and got warm. Lasted 3 days.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Feeling of body temperature change, Rash, Skin irritation
Clinical narrative: Pt. reports receiving flu vaccine in (L) DM 10/3/13. On 10/4/13 pt complains of (R) arm irritation with rash from wrist to elbow. Pt experienced hot/cold flashes 10/4-10/5/13. On 10/5/13, pt reports feeling of increased anxiety with possible rapid heart rate lasting till 10/6/13. Both rash and anxiety reaction resolved 10/6/13.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Diffuse pruritus. Diffuse urticarial rash.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Following AM after vaccine admin arm at site was red swollen sore to touch, localized to arm no pus or discharge at inj. site. Called pt 10/8/13 states arm still looks red and like inj site is bruised. Pt has not as of 10/8/13 seen PCP. I suggested having inj site looked at by PCP.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Neck pain, Pain
Clinical narrative: Pt's daughter called pharmacy to inform manager about adverse event. 40 mins following shot pt experienced excruciating pain. Was advised to ice area. 3 days later pain persists and worsening and radiating to neck. Pt cannot lift arm.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Large red, round, swollen lump at the site of injection. ZOSTAVAX given 10/5/13.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis reported by family physician where injection was given (both FLUVIRIN and PNEUMOVAX given same arm 1" apart).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Exposure during pregnancy, Headache, Human chorionic gonadotropin positive, Respiratory tract congestion
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to an 18 year old female patient with no drug reaction/allergies. The patient's medical history included Bell's palsy. The patient became pregnant with LMP of 25-AUG-2013 and EDD of 01-JUN-2014. The first 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 17-MAY-2007 and the second 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 13-SEP-2007. The physician reported that a third 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered to the patient on 25-SEP-2013 while she was pregnant. The next day, 26-SEP-2013, the patient reported having a headache and on 28-SEP-2013 the patient reported having a runny nose, cough and congestion. Laboratory studies performed included Beta serum HCG pregnancy confirmation. Patient sought medical attention by calling physician's office and was treated with TYLENOL and ROBITUSSIN. The outcome of events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to an 18 year old female patient with no drug reaction/allergies. The patient's medical history included Bell's palsy. The patient became pregnant with LMP of 25-AUG-2013 and EDD of 01-JUN-2014. The first 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 17-MAY-2007 and the second 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 13-SEP-2007. The physician reported that a third 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered to the patient on 25-SEP-2013 while she was pregnant. The next day, 26-SEP-2013, the patient reported having a headache and on 28-SEP-2013 the patient reported having a runny nose, cough and congestion. Laboratory studies performed included Beta serum HCG pregnancy confirmation. Patient sought medical attention by calling physician's office and was treated with TYLENOL and ROBITUSSIN. The outcome of events was unknown. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Nausea, Neck pain
Clinical narrative: This spontaneous report was received from a 52 year old male consumer reporting on himself. The patient's medical history included chickenpox twice. On 18-SEP-2013the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided) "one time shot" injection, for prevention of shingles. Concomitant therapies included ibuprofen. On 20-SEP-2013, patient developed a welt of the size of a lemon that turned red and itched badly; he also developed hives, felt nauseous, and had extreme pain in his lower back, hips, and neck. The patient also stated he gets nauseous after taking some unspecified pain pills. Patient was treated with Benadryl (manufacturer unknown) and an unspecified cortisone cream. The outcome of welt the size of a lemon that turned red and itched badly, hives, extreme pain in neck, hips and lower back, and felt nauseous was reported as recovering/ resolving. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Patient contacted physician by phone. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 52 year old male consumer reporting on himself. The patient's medical history included chickenpox twice. On 18-SEP-2013the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided) "one time shot" injection, for prevention of shingles. Concomitant therapies included ibuprofen. On 20-SEP-2013, patient developed a welt of the size of a lemon that turned red and itched badly; he also developed hives, felt nauseous, and had extreme pain in his lower back, hips, and neck. The patient also stated he gets nauseous after taking some unspecified pain pills. Patient was treated with Benadryl (manufacturer unknown) and an unspecified cortisone cream. The outcome of welt the size of a lemon that turned red and itched badly, hives, extreme pain in neck, hips and lower back, and felt nauseous was reported as recovering/ resolving. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Patient contacted physician by phone. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient with none medical history and none drug allergies. On 23-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004747, exp 20-JUL-2013). There was none concomitant medication. Pharmacist reported that the patient experienced an injection site reaction hours after receiving the PNEUMOVAX23. Pharmacist stated that the patient experienced itchiness and swelling at the injection site which spread on the arm. There was no lab diagnostic studies performed. The patient was treated with Ice, unspecified antihistamine. Pharmacist stated that patient reported that the area was much better as of 26-SEP-2013. The outcome of the adverse events was reported as recovering/resolving. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, who reported that on 02-AUG-2013, two patients of unknown age and gender received a dose of GARDASIL (lot # J004197, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA010552, 1309USA004737, 1309USA004746, and 1309USA004747 via same reported link. Follow up information as received from a Licensed Practical Nurse refers to a 13 year old patient received a dose of GARDASIL (lot # J004197, expiration date 27-NOV-2015) (dose, location and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age. On an unknown date the patient was a dose of vaccinated with ZOSTAVAX (dose, route, indication and lot # not reported). On an unknown date the patient developed shingles after receiving the ZOSTAVAX vaccine. The outcome of shingles was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On 25-SEP-2013 the patient was vaccinated with one shot of ZOSTAVAX by injection  (route and lot # not reported). On 25-SEP-2013 or 26-SEP-2013, the patient experienced itching and swelling of the injection site after receiving ZOSTAVAX. The patient spoke with an unspecified pharmacist for medical attention. The outcome of itching and swelling of the injection site was unknown. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Erythema multiforme, Streptococcus test negative
Clinical narrative: Dx with erythema multiforme on 10/8/13. FLUMIST was administered 7 days ago per staff.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Dysphagia, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Case number PHHY2013US097170 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494297) website on 05 Sep 2013, with a non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013 and another follow-up received from the quality assurance department on 03 Oct 2013. This report refers to a 17-year-old poly-medicated female patient. Medical history of this patient includes hypothyroidism, bipolar disorder, GERD (gastroesophageal reflux disease), anaphylaxis, hyperlipidemia, environmental allergies, constipation, asthma - mild intermittent, depression; BMI (body mass index; pediatric 99% for age); smoking. She was vaccinated with MENVEO (batch number: A11078/M11078, Expiry date: Feb 2014) intramuscularly in the left arm on 07 Jun 2013. Approximately 7 minutes after vaccination she started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent to home. On 08 Jun 2013 she woke up at 12:35 am feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and was sent back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 1:30 pm and she was taken to an urgent care. After reaching, patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS (emergency service) for suspected allergic reaction to vaccine. In the emergency room she had several labs drawn (CBC, UA, CMP and Urine Pregnancy Test) which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER (emergency room). By 15.15 she was "feeling better" and released from the ER. She was told to follow up in PCP office. Causality and seriousness were not reported. The quality assurance department stated that, based on the review performed, MENVEO batch number: A11078, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013: Reference number was updated. Follow-up received from the Quality Assurance department (reference number: 251463) on 03 Oct 2013: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Metabolic function test normal, Pregnancy test urine negative, Tachycardia, Throat tightness
Clinical narrative: Case number PHHY2013US097170 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494297) website on 05 Sep 2013, with a non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013 and another follow-up received from the quality assurance department on 03 Oct 2013. This report refers to a 17-year-old poly-medicated female patient. Medical history of this patient includes hypothyroidism, bipolar disorder, GERD (gastroesophageal reflux disease), anaphylaxis, hyperlipidemia, environmental allergies, constipation, asthma - mild intermittent, depression; BMI (body mass index; pediatric 99% for age); smoking. She was vaccinated with MENVEO (batch number: A11078/M11078, Expiry date: Feb 2014) intramuscularly in the left arm on 07 Jun 2013. Approximately 7 minutes after vaccination she started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent to home. On 08 Jun 2013 she woke up at 12:35 am feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and was sent back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 1:30 pm and she was taken to an urgent care. After reaching, patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS (emergency service) for suspected allergic reaction to vaccine. In the emergency room she had several labs drawn (CBC, UA, CMP and Urine Pregnancy Test) which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER (emergency room). By 15.15 she was "feeling better" and released from the ER. She was told to follow up in PCP office. Causality and seriousness were not reported. The quality assurance department stated that, based on the review performed, MENVEO batch number: A11078, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013: Reference number was updated. Follow-up received from the Quality Assurance department (reference number: 251463) on 03 Oct 2013: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Urine analysis normal
Clinical narrative: Case number PHHY2013US097170 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494297) website on 05 Sep 2013, with a non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013 and another follow-up received from the quality assurance department on 03 Oct 2013. This report refers to a 17-year-old poly-medicated female patient. Medical history of this patient includes hypothyroidism, bipolar disorder, GERD (gastroesophageal reflux disease), anaphylaxis, hyperlipidemia, environmental allergies, constipation, asthma - mild intermittent, depression; BMI (body mass index; pediatric 99% for age); smoking. She was vaccinated with MENVEO (batch number: A11078/M11078, Expiry date: Feb 2014) intramuscularly in the left arm on 07 Jun 2013. Approximately 7 minutes after vaccination she started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent to home. On 08 Jun 2013 she woke up at 12:35 am feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and was sent back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 1:30 pm and she was taken to an urgent care. After reaching, patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS (emergency service) for suspected allergic reaction to vaccine. In the emergency room she had several labs drawn (CBC, UA, CMP and Urine Pregnancy Test) which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER (emergency room). By 15.15 she was "feeling better" and released from the ER. She was told to follow up in PCP office. Causality and seriousness were not reported. The quality assurance department stated that, based on the review performed, MENVEO batch number: A11078, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from the quality assurance department (reference number: 251463) on 10 Sep 2013: Reference number was updated. Follow-up received from the Quality Assurance department (reference number: 251463) on 03 Oct 2013: Updated batch review report.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Arthralgia, Guillain-Barre syndrome, Lethargy, Pain in extremity, VIIth nerve paralysis
Clinical narrative: A report has been received from a physician concerning a 3 year old male patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. On 16-Aug-2013, the patient received nasal FLUMIST (intranasal). On 25-Aug-2013, the patient started to have viral symptoms with fever and did not want to move his legs and vomited numerous times (5). On 27-Aug-2013, patient was seen back in the clinic and was diagnosed with viral illness. Vomiting had stopped at this time. On 02-Sep-2013, mother of the patient called at night reporting patient had facial droop and could not lift his head so we sent the family to the emergency room. On 02-Sep-2013, patient was hospitalized and was diagnosed by doctors at hospital as possible viral/FLUMIST induced Guillain Barre. Patient was discharged from hospital to rehab but date of discharge from hospital unknown. Action taken with influenza virus vaccine live, intranasal was unknown and the outcome of the event of viral illness and Guillain-Barre like symptoms was unknown. The reporter assessed the events of viral illness and Guillain-Barre like symptoms to be serious due to hospitalised criterion. The reporter assessed the causality between the events of viral illness and Guillain-Barre like symptoms with the suspect drug FLUMIST to be related.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Guillain-Barre syndrome, Mobility decreased, Posture abnormal, Pyrexia, VIIth nerve paralysis
Clinical narrative: A report has been received from a physician concerning a 3 year old male patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. On 16-Aug-2013, the patient received nasal FLUMIST (intranasal). On 25-Aug-2013, the patient started to have viral symptoms with fever and did not want to move his legs and vomited numerous times (5). On 27-Aug-2013, patient was seen back in the clinic and was diagnosed with viral illness. Vomiting had stopped at this time. On 02-Sep-2013, mother of the patient called at night reporting patient had facial droop and could not lift his head so we sent the family to the emergency room. On 02-Sep-2013, patient was hospitalized and was diagnosed by doctors at hospital as possible viral/FLUMIST induced Guillain Barre. Patient was discharged from hospital to rehab but date of discharge from hospital unknown. Action taken with influenza virus vaccine live, intranasal was unknown and the outcome of the event of viral illness and Guillain-Barre like symptoms was unknown. The reporter assessed the events of viral illness and Guillain-Barre like symptoms to be serious due to hospitalised criterion. The reporter assessed the causality between the events of viral illness and Guillain-Barre like symptoms with the suspect drug FLUMIST to be related.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Viral infection, Vomiting
Clinical narrative: A report has been received from a physician concerning a 3 year old male patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. On 16-Aug-2013, the patient received nasal FLUMIST (intranasal). On 25-Aug-2013, the patient started to have viral symptoms with fever and did not want to move his legs and vomited numerous times (5). On 27-Aug-2013, patient was seen back in the clinic and was diagnosed with viral illness. Vomiting had stopped at this time. On 02-Sep-2013, mother of the patient called at night reporting patient had facial droop and could not lift his head so we sent the family to the emergency room. On 02-Sep-2013, patient was hospitalized and was diagnosed by doctors at hospital as possible viral/FLUMIST induced Guillain Barre. Patient was discharged from hospital to rehab but date of discharge from hospital unknown. Action taken with influenza virus vaccine live, intranasal was unknown and the outcome of the event of viral illness and Guillain-Barre like symptoms was unknown. The reporter assessed the events of viral illness and Guillain-Barre like symptoms to be serious due to hospitalised criterion. The reporter assessed the causality between the events of viral illness and Guillain-Barre like symptoms with the suspect drug FLUMIST to be related.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Chest discomfort, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: Received vaccination around 0930; started feeling dizzy & nauseated around 1030 and got worse as day went on (chest pressure, shortness of breath, fatigue). Didn't take AM meds and ate little breakfast. Seen by EMS; skin cool and clammy to touch. Dextrose stick- 67 V/S 162/104-72-18. EMS V/S 160/87 - 81-18. Refused to go to ER.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Received vaccination around 0930; started feeling dizzy & nauseated around 1030 and got worse as day went on (chest pressure, shortness of breath, fatigue). Didn't take AM meds and ate little breakfast. Seen by EMS; skin cool and clammy to touch. Dextrose stick- 67 V/S 162/104-72-18. EMS V/S 160/87 - 81-18. Refused to go to ER.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Nausea
Clinical narrative: Received vaccination around 0930; started feeling dizzy & nauseated around 1030 and got worse as day went on (chest pressure, shortness of breath, fatigue). Didn't take AM meds and ate little breakfast. Seen by EMS; skin cool and clammy to touch. Dextrose stick- 67 V/S 162/104-72-18. EMS V/S 160/87 - 81-18. Refused to go to ER.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Paraesthesia, Pruritus, Rash
Clinical narrative: Sudden onset tingling to face and head then intense heat with redness to face/ears. Rash to neck throat chest and arms. Hives to arms and back with itchiness.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Sudden onset tingling to face and head then intense heat with redness to face/ears. Rash to neck throat chest and arms. Hives to arms and back with itchiness.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Vomiting
Clinical narrative: Violent stomach cramps with severe vomiting and diarrhea along with chills.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site rash
Clinical narrative: Large raised red area surrounding vaccine site that remains two days later. Have had flu shot for many years without a previous reaction.
Age: 30.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Stuffy nose, sore throat.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, Aches, Sore Throat. By 8:00 PM fever was 102 F. Took Tylenol. Felt much better next morning, but not 100% well.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Blood pressure systolic increased, Dizziness, Feeling abnormal, Gastrointestinal pain
Clinical narrative: Patient received B12 shot the same day. By 1pm felt lips numb and tingly, was not feeling good. Site of injection, red, tender, swollen. Called doctor, pt asked to go back to the doctor office. Nurse observed and sent her back home. By 3P face was numb so went to ER. Felt very dizzy, heart pounding, systolic BP was high around 158. Then felt itchy, heart palpitations, whole body numb and tingly, felt nauseous, then went into shaking. Nurse put IV for blood tests but did not get IV started until 1 hour later which exacerbated GI pain issues. Given phenergan and DILAUDID to help with nausea and pain a bit. Admitted to the hospital because legs were still numb and tingly. By 9PM Friday, dry heaving, potassium was very low, had a charley horse on leg. Given oral BENADRYL and phenergan. By 1PM on Saturday felt a bit better still a little tingly and numb, had bowel movement and they stopped IV fluids since was able to drink ginger ale. Patient who is a nurse was very upset with care at hospital so she left even if she was not feeling well completely. Today still feels lips and face a little tingly and numb.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received B12 shot the same day. By 1pm felt lips numb and tingly, was not feeling good. Site of injection, red, tender, swollen. Called doctor, pt asked to go back to the doctor office. Nurse observed and sent her back home. By 3P face was numb so went to ER. Felt very dizzy, heart pounding, systolic BP was high around 158. Then felt itchy, heart palpitations, whole body numb and tingly, felt nauseous, then went into shaking. Nurse put IV for blood tests but did not get IV started until 1 hour later which exacerbated GI pain issues. Given phenergan and DILAUDID to help with nausea and pain a bit. Admitted to the hospital because legs were still numb and tingly. By 9PM Friday, dry heaving, potassium was very low, had a charley horse on leg. Given oral BENADRYL and phenergan. By 1PM on Saturday felt a bit better still a little tingly and numb, had bowel movement and they stopped IV fluids since was able to drink ginger ale. Patient who is a nurse was very upset with care at hospital so she left even if she was not feeling well completely. Today still feels lips and face a little tingly and numb.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nausea, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient received B12 shot the same day. By 1pm felt lips numb and tingly, was not feeling good. Site of injection, red, tender, swollen. Called doctor, pt asked to go back to the doctor office. Nurse observed and sent her back home. By 3P face was numb so went to ER. Felt very dizzy, heart pounding, systolic BP was high around 158. Then felt itchy, heart palpitations, whole body numb and tingly, felt nauseous, then went into shaking. Nurse put IV for blood tests but did not get IV started until 1 hour later which exacerbated GI pain issues. Given phenergan and DILAUDID to help with nausea and pain a bit. Admitted to the hospital because legs were still numb and tingly. By 9PM Friday, dry heaving, potassium was very low, had a charley horse on leg. Given oral BENADRYL and phenergan. By 1PM on Saturday felt a bit better still a little tingly and numb, had bowel movement and they stopped IV fluids since was able to drink ginger ale. Patient who is a nurse was very upset with care at hospital so she left even if she was not feeling well completely. Today still feels lips and face a little tingly and numb.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Retching, Tremor
Clinical narrative: Patient received B12 shot the same day. By 1pm felt lips numb and tingly, was not feeling good. Site of injection, red, tender, swollen. Called doctor, pt asked to go back to the doctor office. Nurse observed and sent her back home. By 3P face was numb so went to ER. Felt very dizzy, heart pounding, systolic BP was high around 158. Then felt itchy, heart palpitations, whole body numb and tingly, felt nauseous, then went into shaking. Nurse put IV for blood tests but did not get IV started until 1 hour later which exacerbated GI pain issues. Given phenergan and DILAUDID to help with nausea and pain a bit. Admitted to the hospital because legs were still numb and tingly. By 9PM Friday, dry heaving, potassium was very low, had a charley horse on leg. Given oral BENADRYL and phenergan. By 1PM on Saturday felt a bit better still a little tingly and numb, had bowel movement and they stopped IV fluids since was able to drink ginger ale. Patient who is a nurse was very upset with care at hospital so she left even if she was not feeling well completely. Today still feels lips and face a little tingly and numb.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling hot, Headache, Injection site erythema, Skin infection
Clinical narrative: 24 hours later at about 2 PM red mark around injection site. It was large as big as silver dollar. Did not itch, felt tired and had a headache. By next morning spot was larger, tender, hot. Went by clinic and PA said it was a little skin infection that would go away. 10/5 Went by clinic again and they said that it was a skin infection that required prescription so was given cephalexin but it did not help. 10/6/13 Went to ER. Red area was getting larger, doctor gave new medication clindamycin. Today it doesn't look as red but tender. Red area migrating towards elbow. 2 different red spots, looks like bad sunburn.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: 24 hours later at about 2 PM red mark around injection site. It was large as big as silver dollar. Did not itch, felt tired and had a headache. By next morning spot was larger, tender, hot. Went by clinic and PA said it was a little skin infection that would go away. 10/5 Went by clinic again and they said that it was a skin infection that required prescription so was given cephalexin but it did not help. 10/6/13 Went to ER. Red area was getting larger, doctor gave new medication clindamycin. Today it doesn't look as red but tender. Red area migrating towards elbow. 2 different red spots, looks like bad sunburn.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Breast mass, Cancer in remission, Chemotherapy, Mammogram abnormal
Clinical narrative: This spontaneous report as received from a 66 year old female registered nurse refers to herself. On 09-MAY-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). On an unknown date in August 2012 the patient was diagnosed with a lump in her breast during her yearly mammogram. Her mammogram the previous year had demonstrated no signs of any abnormality. After her diagnosis of breast cancer, she received radiation and chemotherapy treatments in "September and November of 2012". The patient stated that the breast condition was currently in remission. The outcome of the event was reported as recovered. The reporter considered breast cancer to be not related to ZOSTAVAX. Upon internal review, breast cancer was considered as medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Radiotherapy
Clinical narrative: This spontaneous report as received from a 66 year old female registered nurse refers to herself. On 09-MAY-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). On an unknown date in August 2012 the patient was diagnosed with a lump in her breast during her yearly mammogram. Her mammogram the previous year had demonstrated no signs of any abnormality. After her diagnosis of breast cancer, she received radiation and chemotherapy treatments in "September and November of 2012". The patient stated that the breast condition was currently in remission. The outcome of the event was reported as recovered. The reporter considered breast cancer to be not related to ZOSTAVAX. Upon internal review, breast cancer was considered as medically significant. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Lethargy, Oral herpes, Rash
Clinical narrative: Case number PHEH2013US020776 is an initial spontaneous report received from a health care professional on 04 Oct 2013. This report refers to a 92-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) on 25 Sep 2013. On an unspecified date, her whole arm became red and broke out in rash that spread onto her back after FLUVIRIN was administered. She also had fever blisters around her mouth. She needed to be taken to emergency room (ER) because she was lethargic and was kept in ER (hospitalization) for observation overnight. Reporter stated that physician did not want to use FLUVIRIN anymore and would like to return the remaining FLUVIRIN vaccines. Outcome and causality of the events were not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2013US020873 is a combined initial and follow-up spontaneous report received from a medical assistant and nurse on 04 Oct 2013 and 07 Oct 2013: This report refers to an 18-year-old male patient. He was vaccinated with 0.5 ml of MENVEO (batch number: A12114 and expiry date: 31 Aug 2014) intramuscularly on 30 Sep 2013. On an unknown date after vaccination, he fainted and had to go to the hospital. It was reported that he fainted from the shot, not the vaccine. He was seen by a physician and completely recovered on an unknown date. No further information about seriousness was reported.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Local swelling, Pain in extremity, Rash
Clinical narrative: Case number PHEH2013US020760 is an initial spontaneous report received from a consumer on 03 Oct 2013. This report refers to a 68-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with flu vaccine (manufacturer and batch number: unknown) intramuscularly in 1999. After vaccination, her arm was swollen, red and she had a rash. She also stated she had pain in her arm and shortness of breath. Her physician told her not to take flu shot again. She stated that she also had the same reaction in the past with tetanus shot (other manufacturer, batch number: unknown) and therefore received the antidote to tetanus shot. Outcome, seriousness and causality of the events were not reported.
Sex: M
Vaccine: MNQ
Symptoms: Fall, Lip injury, Loss of consciousness, Tooth fracture
Clinical narrative: Case number PHEH2013US020576 is an initial spontaneous report received from the consumer on 01 Oct 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11074, expiry date: Feb 2014) on 26 Dec 2012. On the same day, he passed out striking the floor. He sustained a comminuted fracture in the extra osseous portion of the right upper center incisor and displacement of minor fragments anteriorly to the upper lip soft tissue. The event outcome, seriousness and causality were not reported. No additional information was available.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Antibody test negative, Antinuclear antibody negative, Areflexia, Asthenia, Balance disorder
Clinical narrative: Case number PHHY2013US110239 is an initial literature report received on 26 Sep 2013: In this article, authors have described a case of distal acquired demyelinating symmetric neuropathy (DADS-I) after influenza vaccination. This report refers to a 31-year-old male patient. He was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unknown date. Two months after vaccination he developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following four months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toes extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction study (NCS) showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30% - 50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin Gruber anastomosis was not present. Limb temperature was more than 32 degree Celsius. Two grams per kilogram of IVIG was initiated four months after symptom onset. One gram per kilogram of IVIG was repeated every three weeks. Over the following six months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running three consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. The authors commented that vaccine-associated DADS-I may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, they suspected that vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy in the form of DADS-I.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, Decreased vibratory sense, Demyelinating polyneuropathy, Gait disturbance, Hypoaesthesia
Clinical narrative: Case number PHHY2013US110239 is an initial literature report received on 26 Sep 2013: In this article, authors have described a case of distal acquired demyelinating symmetric neuropathy (DADS-I) after influenza vaccination. This report refers to a 31-year-old male patient. He was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unknown date. Two months after vaccination he developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following four months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toes extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction study (NCS) showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30% - 50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin Gruber anastomosis was not present. Limb temperature was more than 32 degree Celsius. Two grams per kilogram of IVIG was initiated four months after symptom onset. One gram per kilogram of IVIG was repeated every three weeks. Over the following six months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running three consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. The authors commented that vaccine-associated DADS-I may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, they suspected that vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy in the form of DADS-I.