chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Patient began experiencing severe insomnia.
Age: 69.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site rash, Injection site swelling, Paraesthesia
Clinical narrative: Swelling, redness, & rash at site of admin. of left upper arm. Also, pt says tingling/numbness of fingers of left arm.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Full blood count, Haptoglobin, Induration, Malaise
Clinical narrative: Rt arm edema, redness induration pain. Generalized malaise w nausea.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nausea, Oedema peripheral, Pain, Red blood cell sedimentation rate
Clinical narrative: Rt arm edema, redness induration pain. Generalized malaise w nausea.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Rash on the body that broke out on 2/23/13. Erythematous blanching macules all over body.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Swelling face, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of GARDASIL. On 02-MAR-2009 the patient developed a reaction similar to hives. The patient was fine within 24 hours. It is unknown if the patient sought medical attention. Follow up information was received from the nurse practitioner concerning the 17 year old female student with allergy to pollen who on 02-MAR-2009 at 12:49, was vaccinated with the first dose of GARDASIL (lot # 661846/1312X) into her left arm. There was no illness at the time of vaccination. On 02-MAR-2009 at 17:00 the patient experienced welts and itching on face and body. The patient was given BENADRYL and AVEENO lotion to face. No lab diagnostic studies were performed. Subsequently the patient resolved. Follow up information was received from a physician who reported that the patient with no known drug reactions/allergies developed hives and facial swelling within 1-2 hours after vaccination with GARDASIL. The physician stated that the patient would probably not continue the series. The patient sought medical attention via contacting office. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Muscles of facial expression on L side of face were dropping. Could not smile, close eye, furrow eyebrow, raise eyebrow, frown, kissing with lips. DX: Bell's Palsy at ER. Muscles of facial expression slight return at 1 month. Treatment: corticosteriod injection 11 am 1/17/13, prednisone 10 mg 2x/day 10 days started 1/17/13.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Crying, Eye pain, Fatigue, Nausea
Clinical narrative: First symptom nausea, then extreme fatigue, then extreme pain in nose and eyes. Extreme sensitivity to light. Fever on and off for 5 days up to 102.2. Dry hacking cough, runny nose. Incessent crying and  indescribable pain all over for 5 days. Finally back to normal after 8 days.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Photophobia, Pyrexia, Rhinalgia, Rhinorrhoea
Clinical narrative: First symptom nausea, then extreme fatigue, then extreme pain in nose and eyes. Extreme sensitivity to light. Fever on and off for 5 days up to 102.2. Dry hacking cough, runny nose. Incessent crying and  indescribable pain all over for 5 days. Finally back to normal after 8 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain, redness, swelling at and around injection site, fever, nausea, headache.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pain, redness, swelling at and around injection site, fever, nausea, headache.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt says she has sharp pains on injection site since she got vaccine in January.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to the mother. On 27-JAN-2013 the patient was vaccinated with live (Merck) VARIVAX (lot number, dose, route and site not reported) in error. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. This case was linked to case 1302USA007688 (same reporter). On 11-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # 671455/1256AA, expiration date 11-JAN-2012). On 11-FEB-2013 the patient received expired ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Injection site erythema, Skin warm, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient dev swelling at site, and subsequently severe infect. Which travel down entire upper/lower arm almost to wrist, skin discoloration, pain, severe swelling. Admitted to hospital and required IV abx for extensive cellulitis.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Injection site infection, Injection site swelling, Pain
Clinical narrative: Patient dev swelling at site, and subsequently severe infect. Which travel down entire upper/lower arm almost to wrist, skin discoloration, pain, severe swelling. Admitted to hospital and required IV abx for extensive cellulitis.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Patient dev swelling at site, and subsequently severe infect. Which travel down entire upper/lower arm almost to wrist, skin discoloration, pain, severe swelling. Admitted to hospital and required IV abx for extensive cellulitis.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a currently 74 year old female patient with hypertension, environmental allergies and no Drug reactions/allergies. On unspecified date, before the patient was 60 years old , she was vaccinated with the first dose of PNEUMOVAX23 (dose, lot # and route not reported). On 31-JAN-2013, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX23 25/0.5 Y, lot # H013399, Expire dose: 07-MAR-2014 (dose unknown). Concomitant therapies included MUCINEX, DIOVAN, SYSTOLIC, calcium (unspecified), VITAMIN B (UNSPECIFIED), loratadine (manufacturer unknown), vitamin e, vitamin d (unspecified) and ascorbic acid. On 01-FEB-2013, the patient experienced "significant redness and swelling up to the shoulder above where PNEUMOVAX23 was administered and down to the elbow". The Nurse Practitioner reported that the patient's symptoms resolved "almost completely" within 24 hours (outcome reported as recovering). The patient sought Medical Attention and placed ice as treatment. No lab tests were performed. Causality assessment was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a currently 74 year old female patient with hypertension, environmental allergies and no Drug reactions/allergies. On unspecified date, before the patient was 60 years old , she was vaccinated with the first dose of PNEUMOVAX23 (dose, lot # and route not reported). On 31-JAN-2013, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX23 25/0.5 Y, lot # H013399, Expire dose: 07-MAR-2014 (dose unknown). Concomitant therapies included MUCINEX, DIOVAN, SYSTOLIC, calcium (unspecified), VITAMIN B (UNSPECIFIED), loratadine (manufacturer unknown), vitamin e, vitamin d (unspecified) and ascorbic acid. On 01-FEB-2013, the patient experienced "significant redness and swelling up to the shoulder above where PNEUMOVAX23 was administered and down to the elbow". The Nurse Practitioner reported that the patient's symptoms resolved "almost completely" within 24 hours (outcome reported as recovering). The patient sought Medical Attention and placed ice as treatment. No lab tests were performed. Causality assessment was not provided. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient with no allergies or drug reactions. On 11-JAN-2013, the patient was vaccinated subcutaneously with live ZOSTAVAX (lot # H016766, expiration date: 10-DEC-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included diazepam (manufacturer unspecified) and testosterone (manufacturer unspecified). On an unknown date the patient experienced weakened muscles that is progressively worsening after receiving live ZOSTAVAX. The pharmacist mentioned the patient stated he was so weak he can't get out of his chair. No treatment information was reported. The patient sought unspecified medical attention. The outcome of weakened muscles that is progressively worsening was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient with no allergies or drug reactions. On 11-JAN-2013, the patient was vaccinated subcutaneously with live ZOSTAVAX (lot # H016766, expiration date: 10-DEC-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included diazepam (manufacturer unspecified) and testosterone (manufacturer unspecified). On an unknown date the patient experienced weakened muscles that is progressively worsening after receiving live ZOSTAVAX. The pharmacist mentioned the patient stated he was so weak he can't get out of his chair. No treatment information was reported. The patient sought unspecified medical attention. The outcome of weakened muscles that is progressively worsening was reported as not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Induration, Malaise, Nausea, Pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with osteoporosis and hyperlipidemia controlled by diet. The patient did not have drug reactions/allergies. On 07-FEB-2013 the patient was vaccinated with single dose of live ZOSTAVAX (lot number reported as H020683, expiration date 15-FEB-2014) subcutaneous in the left arm. Concomitant therapies included calcium (unspecified) and vitamins (unspecified). The patient had developed warmth, itching, and induration at the site of injection. The patient was experiencing intermittent shooting pain in the left arm, joint aching, nausea and malaise. The patient was evaluated in the office on 11-FEB-2013 and was prescribed KEFLEX to treat cellulitis. The patient was scheduled for a follow-up office visit on 13-FEB-2013. No lab diagnostics studies were performed. The patient had sought attention via office visit. The outcome of adverse event was unknown. The relatedness for the adverse event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with osteoporosis and hyperlipidemia controlled by diet. The patient did not have drug reactions/allergies. On 07-FEB-2013 the patient was vaccinated with single dose of live ZOSTAVAX (lot number reported as H020683, expiration date 15-FEB-2014) subcutaneous in the left arm. Concomitant therapies included calcium (unspecified) and vitamins (unspecified). The patient had developed warmth, itching, and induration at the site of injection. The patient was experiencing intermittent shooting pain in the left arm, joint aching, nausea and malaise. The patient was evaluated in the office on 11-FEB-2013 and was prescribed KEFLEX to treat cellulitis. The patient was scheduled for a follow-up office visit on 13-FEB-2013. No lab diagnostics studies were performed. The patient had sought attention via office visit. The outcome of adverse event was unknown. The relatedness for the adverse event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cellulitis, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with osteoporosis and hyperlipidemia controlled by diet. The patient did not have drug reactions/allergies. On 07-FEB-2013 the patient was vaccinated with single dose of live ZOSTAVAX (lot number reported as H020683, expiration date 15-FEB-2014) subcutaneous in the left arm. Concomitant therapies included calcium (unspecified) and vitamins (unspecified). The patient had developed warmth, itching, and induration at the site of injection. The patient was experiencing intermittent shooting pain in the left arm, joint aching, nausea and malaise. The patient was evaluated in the office on 11-FEB-2013 and was prescribed KEFLEX to treat cellulitis. The patient was scheduled for a follow-up office visit on 13-FEB-2013. No lab diagnostics studies were performed. The patient had sought attention via office visit. The outcome of adverse event was unknown. The relatedness for the adverse event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with osteoporosis and hyperlipidemia controlled by diet. The patient did not have drug reactions/allergies. On 07-FEB-2013 the patient was vaccinated with single dose of live ZOSTAVAX (lot number reported as H020683, expiration date 15-FEB-2014) subcutaneous in the left arm. Concomitant therapies included calcium (unspecified) and vitamins (unspecified). The patient had developed warmth, itching, and induration at the site of injection. The patient was experiencing intermittent shooting pain in the left arm, joint aching, nausea and malaise. The patient was evaluated in the office on 11-FEB-2013 and was prescribed KEFLEX to treat cellulitis. The patient was scheduled for a follow-up office visit on 13-FEB-2013. No lab diagnostics studies were performed. The patient had sought attention via office visit. The outcome of adverse event was unknown. The relatedness for the adverse event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: I GOT SHINGLES FROM THE ZOSTAVAX VACCINE.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I GOT SHINGLES FROM THE ZOSTAVAX VACCINE.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Rash erythematous, Skin lesion
Clinical narrative: Multiple <10mm reddened lesions on neck and face (shaving region) consistent with autoinoculation. No pus, or other erythema consistent with cellulitis.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Paranasal sinus hypersecretion, Rhinorrhoea, Vomiting
Clinical narrative: Copious mucus production and discharge from sinuses and nasal passages.  Mild nausea with a small amount of brief vomiting.  Entire episode lasted 2 hours.  Ended approximately 3:30 AM with no lasting effects.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Abnormal faeces, Flatulence, Irritability
Clinical narrative: Vaccines given on 2/19/13. By late afternoon she was "irritable & ornery" very gassy & has foul smelling BMs. Denies fever or redness at injection sites. Called back today, symptoms began to resolve Saturday & were gone on Sunday the 24th.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: 1/30/13 acute facial weakness. Peripheral 7th nerve palsy with classic facial nerve distribution involving upper & lower face. Rx: Prednisone x 6 day ZANTAC till gone
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Lip swelling
Clinical narrative: Parent reported that 1 1/2-2 hrs after immunization given swelling of lips.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Inflammation
Clinical narrative: After 45 min, inflammation, shortness of breath, patient went to ER.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: Born at 39 weeks gestation. Newborn screenings WNL. May have been a twin.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Swelling face
Clinical narrative: Patient got swelling on face, the next day, after receiving vaccine, next day - swelling around eyes. Advised to go to see MD right away. Patient got steroid medication from MD for treatment.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Decreased appetite, Diarrhoea, Dyspnoea, Molluscum contagiosum
Clinical narrative: 02 yom dependent with ongoing 1: DERM COMPLAINT: Pt has had multiple Sxs after receiving a Flu shot 05 weeks ago; the week of 08JAN2013. He first presented with N/V/D 01 week after his shot with loss of appetite and occasional irregular breathing pattern. However father and mother both deny any changes in bowel movements, urination, or dietary changes. 01 week later he began to develop a rash on the posterior aspect of bilat his elbows that has since spread to his lower extremities and is painful to the child. Parents deny any knowledge of allergies, or any family members with similar Sxs, any change in detergents. Parents also claim that all vaccinations are up to date and diet has since improved. Mother states that for home treatments they have tried Epsin salt baths, NEOSPORIN, Cortisone cream, and MOTRIN only seeing minor help with the Pt sleeping from the MOTRIN. Pt does not currently have N/V/D/F/C. Pt last seen on 07FEB2013 by and diagnosed with Molluscum. Pt was referred and told to follow up as needed.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Rash, Ultrasound abdomen, Urine analysis
Clinical narrative: 02 yom dependent with ongoing 1: DERM COMPLAINT: Pt has had multiple Sxs after receiving a Flu shot 05 weeks ago; the week of 08JAN2013. He first presented with N/V/D 01 week after his shot with loss of appetite and occasional irregular breathing pattern. However father and mother both deny any changes in bowel movements, urination, or dietary changes. 01 week later he began to develop a rash on the posterior aspect of bilat his elbows that has since spread to his lower extremities and is painful to the child. Parents deny any knowledge of allergies, or any family members with similar Sxs, any change in detergents. Parents also claim that all vaccinations are up to date and diet has since improved. Mother states that for home treatments they have tried Epsin salt baths, NEOSPORIN, Cortisone cream, and MOTRIN only seeing minor help with the Pt sleeping from the MOTRIN. Pt does not currently have N/V/D/F/C. Pt last seen on 07FEB2013 by and diagnosed with Molluscum. Pt was referred and told to follow up as needed.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 02 yom dependent with ongoing 1: DERM COMPLAINT: Pt has had multiple Sxs after receiving a Flu shot 05 weeks ago; the week of 08JAN2013. He first presented with N/V/D 01 week after his shot with loss of appetite and occasional irregular breathing pattern. However father and mother both deny any changes in bowel movements, urination, or dietary changes. 01 week later he began to develop a rash on the posterior aspect of bilat his elbows that has since spread to his lower extremities and is painful to the child. Parents deny any knowledge of allergies, or any family members with similar Sxs, any change in detergents. Parents also claim that all vaccinations are up to date and diet has since improved. Mother states that for home treatments they have tried Epsin salt baths, NEOSPORIN, Cortisone cream, and MOTRIN only seeing minor help with the Pt sleeping from the MOTRIN. Pt does not currently have N/V/D/F/C. Pt last seen on 07FEB2013 by and diagnosed with Molluscum. Pt was referred and told to follow up as needed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Feeling abnormal, Mobility decreased
Clinical narrative: Woke up 6 weeks ago and could not move (L) side. To Emergency Dept. Questionable stroke due to increased blood pressure. Stroke ruled out. Dr. did bloodwork. Pt was told she did not have Guillain-Barre but feels differently.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site swelling, Pain, Swelling
Clinical narrative: Pain, swelling at injection site. Patient still has pain with lifting arm. Redness/swelling was subsided.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Marked erythema, swelling on (R) arm with  body aches N / V / fever.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Marked erythema, swelling on (R) arm with  body aches N / V / fever.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: (R) arm red, warm to touch, tender, radiating pain, 4 inches by 3 inches in size. Instructed to ice area for 20 minutes and take ibuprofen every 6 hrs for pain & swelling.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient had a very large and swollen area approximately 6" in length around injection site the next day. It resolved in a couple of days with ice / cortisone treatment.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Pt had swelling of arm and hand. Referred pt to MD office. Advised to ice it down. RPh called on pt 3 days later & Pt was fine.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Bronchitis, Cough
Clinical narrative: Developed "bronchitis" diagnosed at Urgent Care with eye closed at that time but was seen in ER 3 days later and diagnosed with Bell's Palsy thereafter and also had rash at the time. Bell's Palsy improved but developed barking cough 3 weeks later, treated for possible pertussis but they found to have vocal cord dysfuntion.  Later developed shoulder and hand movements and now concerned and workup in progress and treatment for Tourette's Syndrome.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Full blood count normal, Metabolic function test normal, Movement disorder, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Developed "bronchitis" diagnosed at Urgent Care with eye closed at that time but was seen in ER 3 days later and diagnosed with Bell's Palsy thereafter and also had rash at the time. Bell's Palsy improved but developed barking cough 3 weeks later, treated for possible pertussis but they found to have vocal cord dysfuntion.  Later developed shoulder and hand movements and now concerned and workup in progress and treatment for Tourette's Syndrome.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Tourette's disorder, VIIth nerve paralysis, Vocal cord disorder
Clinical narrative: Developed "bronchitis" diagnosed at Urgent Care with eye closed at that time but was seen in ER 3 days later and diagnosed with Bell's Palsy thereafter and also had rash at the time. Bell's Palsy improved but developed barking cough 3 weeks later, treated for possible pertussis but they found to have vocal cord dysfuntion.  Later developed shoulder and hand movements and now concerned and workup in progress and treatment for Tourette's Syndrome.
Age: 63.0
Sex: M
Vaccine: PER, TD
Symptoms: Dyspnoea, Fatigue, Flushing
Clinical narrative: Extreme fatigue, shortness of breath, flushing - 2/21 went back to Dr. saw physician assistant - not sure if I am having a reaction to the 3 vaccines administered on 2/19 (pneumonia, pertussis, tetanus) or the flu.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Diplopia
Clinical narrative: Pt. tolerated inject well approx. 10 min after reported he had double vision, could see gray shadow 6 in around objects. Given water and juice for hydration. No other symptoms. Vital signs stable. After resting 40 min. shadow reduced to 3 inches around object. Total time in office 80 min. APRN checked pt sent home to rest. Mom reports vision issue gone upon waking from nap 3:30 pm.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, Rhinorrhoea
Clinical narrative: Had normal runny nose.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature increased, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: 103 temperature, weakness, trouble breathing, dizzy, tiredness, chest palpatations, weakness with standing, nerve pain in hands/arms.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Hepatic enzyme, Muscular weakness, Neuralgia, Pain in extremity
Clinical narrative: 103 temperature, weakness, trouble breathing, dizzy, tiredness, chest palpatations, weakness with standing, nerve pain in hands/arms.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: 103 temperature, weakness, trouble breathing, dizzy, tiredness, chest palpatations, weakness with standing, nerve pain in hands/arms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Area raised, red, itchy on left arm. No treatment given. Seen in office by Dr. on Monday 02/25/2013.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Dizziness, Headache, Neurological examination normal
Clinical narrative: Dizziness 2 days after shot with headache (bilateral).
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site cellulitis, Injection site nodule
Clinical narrative: 6 weeks after immunizations left thigh developed left thigh cellulitis - no other injuries, mom says "knot" from immunizations never healed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles left arm in C7 distribution.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Local reaction, Mass, Pain
Clinical narrative: Pt had localized reaction.  Golf ball size lump, hot, red, and sore.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: (L) deltoid approx. 4" diameter red "bullseye", swollen & very wm. to touch, c/o pain at site, h/a, tiredness, fogginess & diarrhea. Treated with ice & ibuprofen. Onset of S & S 2-23-13, no c/o fever. Temp in clinic 97.6.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid approx. 4" diameter red "bullseye", swollen & very wm. to touch, c/o pain at site, h/a, tiredness, fogginess & diarrhea. Treated with ice & ibuprofen. Onset of S & S 2-23-13, no c/o fever. Temp in clinic 97.6.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Localized hives immediately after MMR & Varicella vaccines bilateral arms.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Immediate post-injection reaction, Pain in extremity, Urticaria
Clinical narrative: Began having sore arm almost immediately. About 12 hour after injection, began having hives without respiratory symptoms. Responding to oral antihistamines. But hives continue today (2-25-13).
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a 65 year old pharmacist refers to himself. Patient had elevated cholesterol, hypertension and glaucoma. On 20-FEB-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml. Concomitant therapies included LIPITOR, COSOPT and AMLODIPINE. On 20-FEB-2013, immediately after receiving the ZOSTAVAX, the injection site was "puffed up" with fluid from the vaccine. The pharmacist stated that he pressed down on the injection site and the vaccine was eventfully absorbed. The pharmacist reported that the ZOSTAVAX was administered with an insulin syringe with a "5/16 inch" needle length and the vaccine may have been administered intradermally (wrong route of administration). The outcome of injection site was "puffed up" with fluid from the vaccine was reported as recovered on 20-FEB-2012. No other information was available at the time. The relatedness for the event was not reported for ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Inflammation
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. On 19-FEB-2013, the patient was vaccinated with ZOSTAVAX, (lot number reported as H020845, expiry date was 20-FEB-2014, route was subcutaneous). Concomitant therapy included PRAVASTATIN. On 20-FEB-2013, the patient was prescribed prednisone for inflammation because the patient's past injury on the leg had become exacerbated after receiving a dose of ZOSTAVAX. Laboratory diagnostics were not performed. Treatment rendered for the event was prednisone. The outcome of the event was reported as recovering. It was reported that the patient sought medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscular for prophylaxis. Dose and lot number were not provided. On an unknown date the patient received her second dose of GARDASIL. Dose and lot number were not provided. The nurse reported that the patient received her third dose of GARDASIL 12 days after her 27th birthday. Dose and lot number were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles, Rubella, Viral test positive
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot #, route and dose were unknown). The patient had positive titer for measles and rubuella on an unknown date. The outcome of event was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age (gender unspecified). On 20-FEB-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was reported) as opposed to VARIVAX (Merck). Concomitant medications were not reported. No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Viral titre increased
Clinical narrative: This spontaneous report as received from a physician refers to a 48 year old female patient with allergy to penicillin. The patient did not have any pertinent medical history. In January 1995 the patient was vaccinated with M-M-R II (lot # was reported as 1176A, expiration date on 15-DEC-1995, route and dose were unknown). The patient had positive titer for measles and rubella on 12-FEB-2013. The outcome of event was unknown. The patient sought medical attention via seeing the physician. This is one of several reports received from the same source. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Rash, Viral titre
Clinical narrative: Rash noted at trunk w/extension to (L) upper extremity; (+) low grade temp (Tmax < 102).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Cough, Fatigue, Gait disturbance
Clinical narrative: Coughing starting Saturday Sun - flu-like sx, joints achy, exhausted, Mon- not aching, increased energy but wobbly & weak, sweats when walks. Pt. to follow up physician. No SOB, no wheezing, remained conscious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Influenza like illness
Clinical narrative: Coughing starting Saturday Sun - flu-like sx, joints achy, exhausted, Mon- not aching, increased energy but wobbly & weak, sweats when walks. Pt. to follow up physician. No SOB, no wheezing, remained conscious.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling start about 5 cm below injection site. Proceeds distally to approx 2 cm above elbow, nearly circumferential. Pain at injection site. Pt received PNEUMOVAX previously without any effects.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Nodule, Pain, Swelling
Clinical narrative: Experienced immediate pain. Diffuse redness with a lump. Swelling & pain. (Couldn't sleep on that arm). Took TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypoaesthesia, Mental status changes, Muscular weakness
Clinical narrative: Muscle weakness, altered mental status, numbness of feet x 2 days, patient transferred to hospital. Was hospitalized x 3 days & discharged home.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site joint pain, Pain, Pain in extremity
Clinical narrative: Fever 102, headache, pain in right shoulder/joint of arm injection given, can't lift arm high, pain radiated to fingers, body aches.  Has been taking Aleve every 10 hours, using heat and ice to site.  States if she does not take the Aleve every 10 hours, she can not lift her arm. DENIES: swelling at site, redness, nodule, or warmth @ site.  Discussed taking Ibuprofen if pt can tolerate med. Pt consulted PMD.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 102, headache, pain in right shoulder/joint of arm injection given, can't lift arm high, pain radiated to fingers, body aches.  Has been taking Aleve every 10 hours, using heat and ice to site.  States if she does not take the Aleve every 10 hours, she can not lift her arm. DENIES: swelling at site, redness, nodule, or warmth @ site.  Discussed taking Ibuprofen if pt can tolerate med. Pt consulted PMD.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Back pain, Dizziness, Excoriation, Syncope
Clinical narrative: After receiving vaccines while checking out of office, he fainted. Came to very quickly, rested for 15 minutes, then mom took home. Small superficial abrasion left temple. Next day he began complaining of right sided lower back pain and feeling light-headed.  No other sx.  Sx subsiding as of 2/25/13.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Anticonvulsant drug level below therapeutic, Blood creatine phosphokinase increased, Computerised tomogram head normal, Condition aggravated, Grand mal convulsion
Clinical narrative: Witnessed grand-mal seizure at home, followed by another witnessed seizure at hospital several hours later.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Troponin I, Troponin normal
Clinical narrative: Witnessed grand-mal seizure at home, followed by another witnessed seizure at hospital several hours later.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Soft swelling in left and right arm.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever at 10 days 102.6 degrees. Rash at 2/17 on face & trunk.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age (gender unspecified). On 20-FEB-2013, the patient was inadvertently vaccinated with a dose of live ZOSTAVAX, (lot number, expiry date and route was reported) as opposed to live (Merck) VARIVAX. Concomitant medications were not reported. No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Tdap & MENACTRA : post administration (seen at 2d) erythema, induration, itching 13 x 8 cm to left arm.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Convulsion
Clinical narrative: About 11 PM on 2/8/13, had seizure and went to ER at hospital. Transferred to another hospital on 2/9/13 at 1330. Discharged 2/11/13 - records attached.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Multiple sclerosis, Weight increased
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not provided). Concomitant medications were not reported. On an unknown date, the patient experienced unspecified exacerbation of multiple sclerosis subsequently following administration of ZOSTAVAX and the patient also gained an unspecified amount of weight since receiving ZOSTAVAX. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Induration
Clinical narrative: Large 3" x 3.5" area of erythema, indurated, which resolved after 5 d without any treatment.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm red, swollen, warm on injection site. Denies other symptomatology post upper left arm-47 mm across 50 mm vertical.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician referred to a patient of unknown age. Physician reported that patient of another unspecified physician received the 1st dose in the GARDASIL series on 14-JUN-2011 ((Lot#, dose/frequency, route were unspecified) and the 2nd dose on 19-DEC-2012 (Lot#, dose/frequency, route were unspecified). No adverse effect reported. It was unspecified whether patient had sought medical attention. The outcome was unknown. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered varicella subque tech. to (L) upper arm. Approximately 15-20 minutes post vaccination it was observed that arm at vaccine site was red, raised and warm. The reddened area was approx 6 cm in diameter. Pt denied itching or pain. Ice pack applied to site and pt given BENADRYL 25 mg. IM injection to (R) gluteal. Pt released from office after an approx 20 minute observation. Rx for TAC steroid cream to affected area. F/U scheduled for 1/18/12.
Sex: U
Vaccine: BCG
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. Since 26-DEC-2012, at least one patient had received an improperly stored TICE (lot number and expiry date unspecified). No concomitant medications were reported. TICE was exposed to 50 degrees Fahrenheit (F). No adverse effect was reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Pyrexia, Vomiting
Clinical narrative: Admin - 2/12/13: vomiting with fevers 2/13/13 ice recommended, fever 2/14/13 PM 102.5; 2/15/13 IVF & antibiotics for cellulitis, sent to ED without improvement. Prescribed Clindamycin 300mg 2 tab Q8 hrs x 5 days.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Basophil percentage, C-reactive protein increased, Endocarditis, Eosinophil percentage, Fibrin D dimer increased
Clinical narrative: This case was reported in a literature article and described the occurrence of renal infarction in a 50-year-old male subject who was vaccinated with DTPa ((with small D + P), manufacturer unspecified). Concurrent medical conditions included Hodgkin's lymphoma, hyperlipidemia, hypothyroidism; migraine, prostatic hypertrophy, pulmonary fibrosis, pulmonary sarcoidosis and splenectomy. Historic vaccination included Hib; manufacturer unspecified; unknown given on an unspecified date; meningitis vaccine, strain not specified; manufacturer unspecified; unknown given on an unspecified date, SYNFLORIX; manufacturer unspecified, unknown given on an unspecified date. Historic medications included Doxorubicin, Bleomycin, Vinblastine and Dacarbazine. Concurrent medications included Calcium citrate, Enteric-coated aspirin, Simvastatin, Levothyroxine and Ergocalciferol. 21 months before vaccination, a stress echocardiogram showed normal left ventricular function at rest, mild aortic-root dilatation and trivial regurgitation of the other valves. The stress echocardiogram was negative for ischemia. The subject maintained a high-fiber low-fat diet, exercised, drank alcohol in moderation and didn't smoke. His mother had had breast cancer and she and a maternal aunt had had coronary artery disease. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). During the following 4 nights, the subject experienced mild nausea and fever (38.1 deg.C) without chills. 4 days after vaccination with DTPa (with small D + P), the subject experienced flank pain which was diagnosed as a thromboembolic renal infarction due to endocarditis. The subject was hospitalised. During hospitalisation, the subject had a methicillin-resistant Staphylococcus aureus. The subject was treated with Penicillin, ceftriaxone, vancomycin, Gentamicin, Ondansetron, Levothyroxine and simvastatin. At the time of reporting, the outcome of the events was unspecified. The authors considered that fever and nausea were almost certainly related to vaccination with DTPa (with small D + P).
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Flank pain, Lipoprotein (a) normal, Lymphocyte percentage decreased, Monocyte percentage, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of renal infarction in a 50-year-old male subject who was vaccinated with DTPa ((with small D + P), manufacturer unspecified). Concurrent medical conditions included Hodgkin's lymphoma, hyperlipidemia, hypothyroidism; migraine, prostatic hypertrophy, pulmonary fibrosis, pulmonary sarcoidosis and splenectomy. Historic vaccination included Hib; manufacturer unspecified; unknown given on an unspecified date; meningitis vaccine, strain not specified; manufacturer unspecified; unknown given on an unspecified date, SYNFLORIX; manufacturer unspecified, unknown given on an unspecified date. Historic medications included Doxorubicin, Bleomycin, Vinblastine and Dacarbazine. Concurrent medications included Calcium citrate, Enteric-coated aspirin, Simvastatin, Levothyroxine and Ergocalciferol. 21 months before vaccination, a stress echocardiogram showed normal left ventricular function at rest, mild aortic-root dilatation and trivial regurgitation of the other valves. The stress echocardiogram was negative for ischemia. The subject maintained a high-fiber low-fat diet, exercised, drank alcohol in moderation and didn't smoke. His mother had had breast cancer and she and a maternal aunt had had coronary artery disease. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). During the following 4 nights, the subject experienced mild nausea and fever (38.1 deg.C) without chills. 4 days after vaccination with DTPa (with small D + P), the subject experienced flank pain which was diagnosed as a thromboembolic renal infarction due to endocarditis. The subject was hospitalised. During hospitalisation, the subject had a methicillin-resistant Staphylococcus aureus. The subject was treated with Penicillin, ceftriaxone, vancomycin, Gentamicin, Ondansetron, Levothyroxine and simvastatin. At the time of reporting, the outcome of the events was unspecified. The authors considered that fever and nausea were almost certainly related to vaccination with DTPa (with small D + P).
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Neutrophil percentage increased, Pyrexia, Red blood cell sedimentation rate increased, Renal infarct, Renal vein embolism
Clinical narrative: This case was reported in a literature article and described the occurrence of renal infarction in a 50-year-old male subject who was vaccinated with DTPa ((with small D + P), manufacturer unspecified). Concurrent medical conditions included Hodgkin's lymphoma, hyperlipidemia, hypothyroidism; migraine, prostatic hypertrophy, pulmonary fibrosis, pulmonary sarcoidosis and splenectomy. Historic vaccination included Hib; manufacturer unspecified; unknown given on an unspecified date; meningitis vaccine, strain not specified; manufacturer unspecified; unknown given on an unspecified date, SYNFLORIX; manufacturer unspecified, unknown given on an unspecified date. Historic medications included Doxorubicin, Bleomycin, Vinblastine and Dacarbazine. Concurrent medications included Calcium citrate, Enteric-coated aspirin, Simvastatin, Levothyroxine and Ergocalciferol. 21 months before vaccination, a stress echocardiogram showed normal left ventricular function at rest, mild aortic-root dilatation and trivial regurgitation of the other valves. The stress echocardiogram was negative for ischemia. The subject maintained a high-fiber low-fat diet, exercised, drank alcohol in moderation and didn't smoke. His mother had had breast cancer and she and a maternal aunt had had coronary artery disease. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). During the following 4 nights, the subject experienced mild nausea and fever (38.1 deg.C) without chills. 4 days after vaccination with DTPa (with small D + P), the subject experienced flank pain which was diagnosed as a thromboembolic renal infarction due to endocarditis. The subject was hospitalised. During hospitalisation, the subject had a methicillin-resistant Staphylococcus aureus. The subject was treated with Penicillin, ceftriaxone, vancomycin, Gentamicin, Ondansetron, Levothyroxine and simvastatin. At the time of reporting, the outcome of the events was unspecified. The authors considered that fever and nausea were almost certainly related to vaccination with DTPa (with small D + P).