chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Metabolic function test, Pain in extremity, Rash pustular
Clinical narrative: Patient developed decreased appetite, increased fatigue, complaints of right lower leg pain, headache.  The following day patient developed a small cluster of pustules on right ankle with continued headache, fatigue, and loss of appetite.  The patient was seen by Dr. who ordered a CBC and CMP to rule out leukemia.  At the end of the week the patient developed several pustules along her L4 and L5 dermatome, which was diagnosed as shingles.  The patient was prescribed acyclovir.  The patient had no known chicken pox exposure other than the vaccine.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Bacterial test negative, Bilirubin urine, Blood glucose normal, Blood urine absent, Cerebellar ataxia
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Chest X-ray abnormal, Gait disturbance, Glucose urine absent, Granulocyte count, Granulocyte percentage
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage increased
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Nitrite urine absent, Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cells urine negative
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Streptococcus test negative, Tremor, Urinary sediment present
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Urine abnormality, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, Weight decreased
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: White blood cell count normal, White blood cells urine negative
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Encephalitis, Gait disturbance, Nystagmus, Tremor
Clinical narrative: 2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Age: 5.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient should have received a Dtap vaccine. Tdap vaccine was administered by mistake.  Patient did not experience any adverse reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt. came back few days after receiving treatment with a big red itchy patch so I recommended to go visit the Dr.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Injection site pain, Metabolic function test, Neck pain, Red blood cell sedimentation rate
Clinical narrative: Pt reports onset of h/o - neck/shoulder (L) pain 1 wk after receiving PREVNAR 13 vaccine. No fever and chills. No neuro deficit. Seen at my office 12/29/15.
Age: 1.02
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Cough, Rash generalised, Rhinorrhoea
Clinical narrative: Cough, runny nose, rash covering body.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Extreme pain at injection site upon injection, pain at injection 24/7 since injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Red, rashy, swollen from site to fingertips, heat present, painful patient did not seek treatment from physician because she had upcoming appointment.  It was at that time she showed her physician her arm.  Physician said to notify us of the reaction.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: Red, rashy, swollen from site to fingertips, heat present, painful patient did not seek treatment from physician because she had upcoming appointment.  It was at that time she showed her physician her arm.  Physician said to notify us of the reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient reported pain on 12/17/15.  She went to primary care physician on 12/22/15 and she was diagnosed with shingles.
Age: 50.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMR, MNQ, PNC13, TDAP, VARCEL
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Generalized rash and itching.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported sore throat, cough for over a week; redness, itchiness and swelling at the injection site. Patient used Benadryl gel at the injection site and was prescribed Medrol dose pack 4 mg.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Patient reported sore throat, cough for over a week; redness, itchiness and swelling at the injection site. Patient used Benadryl gel at the injection site and was prescribed Medrol dose pack 4 mg.
Age: 31.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Tenderness, redness, streaking into the arm pit, no treatment, person that gave vaccination notified.
Age: 0.8
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU4, PNC13
Symptoms: Pallor, Tremor
Clinical narrative: Per mother of patient: child was "pale and shaky," was taken to Emergency Department in the evening of the day the vaccine was administered; Child was observed at ER and then released. Per Mother, doing well the next day.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Pyrexia, Rash
Clinical narrative: Patient reported a rash around the neck, headache, fever, dizziness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: C/o edema, erythema, and warmth to (L) upper arm. Also has itching. Advised to place cool compresses to area, oral BENADRYL and apply HC cream to area PRN itching.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Pt's guardian came in and reported that patient had six Grand Mal seizures. Pt has a history of seizures, but has not had one in many months. Pt's guardian reports she is not sure if it is related to Immies, but wanted us to know. Pt has received care at Local ER following event.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Diarrhoea, Injection site inflammation, Pyrexia, Urticaria
Clinical narrative: Received shot 12/11/2015. Month earlier flu shot. 2 hrs later home diarrhea, hives, fever; Next day site of injection got inflamed and larger. Urgent care - 12/19. TYLENOL fever BENADRYL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Sore arm overnight then next day red and swollen below injection site and bump in the red area-soreness.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient had 11cm x 7 cm red, itchy, indurated area surrounding injection site on left arm.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Monoplegia
Clinical narrative: Paralysis in arm and leg. Mostly in first 48 hours, then symptoms decreased.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Patient complains of pain at the site of Flu shot injection, internally (muscular pain), sharp pain when lifting arm that began after injection on 11/20/15 and never went away and no pain, when arm is at rest. Went to urgent care 12/19/15.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: International normalised ratio increased, Peripheral swelling, Rash
Clinical narrative: INR 3.8 on 8/10/15. Dose decreased. Pt given PREVNAR 13 8/11/2015. Patient developed left arm swollen and rash. Seen in clinic 8/17/15 INR 1.8.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Haematoma, International normalised ratio increased, Peripheral swelling
Clinical narrative: Pt given PREVNAR 13 - arm swelled large hematoma extending from deltoid to wrist with erythema. Patient on coumadin INR 3.3. Son reports 24-48 hrs post called 12/20/15. Hematoma extending down arm. Treated for large hematoma 24 hours post and prophylactic for cellulitis.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Ultrasound scan normal
Clinical narrative: Pt given PREVNAR 13 - arm swelled large hematoma extending from deltoid to wrist with erythema. Patient on coumadin INR 3.3. Son reports 24-48 hrs post called 12/20/15. Hematoma extending down arm. Treated for large hematoma 24 hours post and prophylactic for cellulitis.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope, transient loss of consciousness.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: (R) upper exterior aspect of the arm red and painful (+3 x5). Developed fever (102.0) and chills on evening of 12/17 per mom.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's medical history, concurrent conditions and concomitant therapy provided. On 06-APR-2012, the patient was vaccinated with the first dose of RECOMBIVAX HB with strength 5 mcg/0.5 ml (lot number, expiration date, dose and route of administration were not reported). Subsequently, on 24-NOV-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported). This dosing schedule was outside the labeled recommendations in the RECOMBIVAX HB prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients were vaccinated with improperly stored doses of ROTATEQ (lot # L025598, expiration date 13-JAN-2017, route and dose not provided) on multiple unspecified dates after 17-NOV-2015. No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Petechiae
Clinical narrative: Information has been received from a 70 years old male patient with schizophrenia, seborrhoeic dermatitis and unspecified thyroid problem referring to himself. The patient had no drug allergies or reactions. In early 2015, the patient was vaccinated with a dose of ZOSTAVAX ("1 shot", route and lot# unknown). Concomitant therapies included "thyroxine", unidentified antipsychotics, several unidentified medications and corticosteroids lotion. In early 2015, the patient experienced shingles from the vaccine. He had redness in face and upper body with "minute blood spots all over the body", which tended to be aggravated by stress or excitement. The event had been persistent for several months. The patient did not have a regular physician to see and did not seek medical attention. He also did not receive any treatment and no lab test was performed. ZOSTAVAX was not re-introduced. The outcome of the events was not recovered. Additional information is not expected since there is no consent to contact the physician.
Age: 10.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 10 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-DEC-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J006365, expiration date: 05-DEC-2015, dose, route and strength were not reported). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015, the patient was inadvertently vaccinated with ZOSTAVAX lot # K009198, an expiry date 27-SEP-2015 (dose, and route of administration and frequency were not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with hypertension, hyperlipidaemia and type 2 diabetes mellitus and no known allergies. On 15-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX intramuscular in the left deltoid, lot # reported as L032184, expiration date: 25-NOV-2016. Concomitant therapies included PLAVIX and metformin, unspecified "cholesterol medications" and "hypertensive medications". On 16-DEC-2015, the patient experienced "a quarter sized" red and raised area at the injection site. The injection site was "slightly swollen" and the patient had a mild fever. No treatment was given for the events. No lab diagnostic tests have been performed. The patient did not seek medical attention. The outcome of the events was unknown. Relatedness between ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in 2015 (reported as "within the last month"), the patient was vaccinated with a dose of ZOSTAVAX, dose: 1 vial (strength, route of administration, lot number and expiry date were not reported). On an unknown date in 2015 (reported as "within the last month"), shortly after receiving the vaccine, the patient experienced shingles like rash. The patient sought medical attention (no details were provided). Product quality complaint (PQC) was not involved. The outcome of shingles like rash was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored MMRII lot # K024036, expiry date 26-NOV-2015 or lot # L024265, expiry date 01-JUL-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of MMR II lot # L000459, expiry date 06-JAN-2017, therapy type rHA (dose and route of administration were not provided). The vaccine was stored in temperature 46.8 F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored GARDASIL lot #L031245, expiry date 27-MAY-2017 or lot # K010215, expiry date 05-MAY-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were not reported. On 10-NOV-2015, the patient was vaccinated with improperly stored dose of M-M-R II lot # L000459, expiry date 06-JAN-2017, (dose and route of administration were not provided). The vaccine was stored in temperature 46.F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were reported. On 09-NOV-2015, the patient was vaccinated with improperly stored dose of MMRII lot # L000459, expiry date 06-JAN-2017, (dose and route of administration were not provided). The vaccine was stored in temperature 46.8 F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 27-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored oral, ROTATAEQ (lot # K020181, expiration date: 24-JUN-2016, dose was not reported, route of administration default to oral). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 15-DEC-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot# were unknown). No concomitant therapy was reported. On 16-DEC-2015, the patient accidentally received a second dose of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L018499 with expiration date of 25-FEB-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown demographics. On 10-DEC-2015 the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 (lot # K004207; expiry: 13-MAR-2015), intramuscularly (dose and frequency unspecified). No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 02-DEC-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Pruritus generalised, Rash
Clinical narrative: This spontaneous report was received from a 66 year old female patient, referring on herself. The patient's concurrent conditions included hypersensitivity (reported as allergy to CIPRO), gastrooesophageal reflux disease (reported as acid reflux) and asthma. On 08-DEC-2015 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous route, 1 shot, (dose, lot number, expiry date and administration site were unknown) (reported as "for shingles"). Concomitant therapies included NEXIUM. In December 2015, a few days after the vaccination with ZOSTAVAX, the patient experienced pruritus generalized (itchiness on the scalp ...spread to all over her body), rash (rash on her neck) and formication (similarly to the experience of skin crawling). The patient sought medical attention for the reported events and was prescribed with Prednisone as treatment (manufacturer unknown), but she was not satisfied with the results. At the time of this report, the outcome of pruritus, rash and formication was not recovered. The reporter did not provided a causality among the reported events and the ZOSTAVAX vaccination. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient received GARDASIL (dose, lot# and route were not reported) outside of schedule. The first dose was received in April 2014; second dose in series was received on 21-DEC-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 21-DEC-2015, the patient was vaccinated with expired dose of VAQTA, 50/1.0 U/mL, dose/frequency: the first dose in series/once, intramuscularly (lot # L001627, expiration date 11-NOV-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 12-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of GARDASIL 9 (lot # L016428 with expiration date of 30-JUL-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored GARDASIL 9 Lot# L007560, expiry date 15-JUN-2017 or Lot # L027282, expiry date 21-SEP-2017 (route and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored ROTATEQ (lot # L000433, expiry date 09-JUL-2016 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 2 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified 2 patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008577, expiry date 02-DEC-2016 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 5 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 24-AUG-2015 at 11:37 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of PROQUAD (Merck) (subcutaneously, in right thigh, lot # K008185; dose and expiration date were not reported) that was improperly stored. On 24-AUG-2015 at 1:37 a.m., the patient was also concomitantly vaccinated with the first dose of KINRIX (intramuscularly, in left thigh, lot # 5412R; dose and expiration date were not reported), the second dose of HAVRIX (intramuscularly, in left thigh, lot # NK747; dose and expiration date were not reported) and with the fourth dose of PREVNAR 13 (intramuscularly, in right thigh, lot # J90528; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose, strength and route were unknown, lot # reported as L034932, expiry date: 03-MAR-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 13-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (dose, strength and route were unknown, lot # L013193, expiry date: 20-JAN-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (dose, strength and route were unknown, lot # reported as L028276, expiry date: 28-JUL-2017 and lot#: L021216, expiry date: 10-JUN-2017). No adverse effects were reported. This case is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, strength and route were unknown, lot # K010535, expiry date: 27-AUG-2016 and lot #: K024552, expiry date: 22-OCT-2016). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored PEDVAXHIB lot # K008679, expiry date 05-MAR-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, strength and route were unknown, lot # L016428, expiry date: 30-JUL-2017 and lot # L016429, expiry date: 09-AUG-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product physical issue
Clinical narrative: Information has been received from a pharmacist referring to a 75 year old female patient. Information about patient's medical history, concurrent conditions and concomitant medications was not reported. The pharmacist reported that on an unknown date, while the patient was receiving ZOSTAVAX (lot#, dose and route not reported), there was difficulty withdrawing ZOTAVAX from vial after adding diluent. The product leaked out of the top portion of the vial and also "sprayed" from the top. As a result, the patient missed a dose. No adverse events were reported. Product quality complaint (PQC) was involved. The patient did not seek medical attention. Additional information is not expected because there was no consent for follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Information has been received from Abbvie (15K-163-1357325-00) on 08-DEC-2015. Spontaneous report by a consumer of a 60 year old female with an event of non-serious shingles vaccine administered with HUMIRA. There was no reported medical history. On 02-MAR-2015, the patient experienced shingles vaccine administered. On 02-MAR-2015, the patient administered a shingles vaccine. Later that evening the physician contacted the patient and stated that she should not have received a live vaccine because she was on HUMIRA. The patient was prophylactically treated with valacyclovir HCL. The patient denied adverse reactions since received the vaccine. Shingles vaccine (Varicella Zoster Vaccine) was also considered a suspect. The primary reporter did not provide lot number information because the product packaging was not in her possession. The patient was treated with valacyclovir HCL. The reporter stated that there was no reasonable possibility that the event of shingles vaccine administered was related to HUMIRA. No follow up information available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L010595 with expiration date of 12-NOV-2016; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a female patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. In approximately 2008 reported as "seven years ago", the patient was vaccinated with the first dose of GARDASIL injection (dose, route, lot# and expiration date were not provided). The nurse stated that on 21-DEC-2015; the patient received the second dose of the GARDASIL 9 injection (dose, route, lot# and expiration date were not provided) as she wanted complete the series. The reporter inquired if they had to start the series over. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. Concurrent conditions and pertinent medical history were not provided. The nurse reported that about two years ago (approximately in 2013) the patient was vaccinated with the first and second dose of GARDASIL (lot numbers, expiration dates, and routes were not reported). The nurse stated that the patient was in office on 21-DEC-2015 to receive her third dose of GARDASIL (lot number, expiration date and route were not provided for the administered dose). Concomitant therapies were not provided. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent condition and medical history was not reported. On 10-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 2.5/0.5 (units unspecified) lot # L029631, Expiry date: 14-AUG-2017 (dose, route, therapy type not reported). No adverse effects were reported. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Respiratory depression
Clinical narrative: Received PREVNAR shot, shortly afterwards felt SOA, chest pressure, dizzy and tired. Tremors. Diphenhydramine 25 mg once, methylprednisolone 125 mg Q week, aspirin 325 mg once.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: Received PREVNAR shot, shortly afterwards felt SOA, chest pressure, dizzy and tired. Tremors. Diphenhydramine 25 mg once, methylprednisolone 125 mg Q week, aspirin 325 mg once.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent condition and medical history was not reported. On 10-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 2.5/0.5 (units unspecified) lot # L029631, Expiry date: 14-AUG-2017 (dose, route, therapy type not reported). No adverse effects were reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010221, expiration date 12-MAY-2016 (strength, dose, route of administration and indication were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # K010221, expiration date 30-JUL-2017 (strength, dose, route of administration and indication were not reported). there was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.