chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Guillain-Barre syndrome, Muscle spasms, Nerve injury
Clinical narrative: Initial unsolicited report received from the literature on 10-AUG-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787 and 2016SA148885. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a 47-year-old female patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had Guillain-Barre Syndrome (GBS) and presented with neurological symptoms characterized mainly by increasing weakness, numbness, and/or tingling in extremities and difficulty walking. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This is poorly documented case as patient presented with multiple symptoms and diagnosed with Guillain Barre syndrome (GBS) following IMOVAX RABIES vaccine. Time to onset is unknown, as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, complementary medical history, concomitant medication history, results of investigations (cytoalbuminologic dissociation, EMG, NCS, MRI) and etiological work-up (infection) are needed to assess the case. Based on available information role of vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: 7/11 830 pm patient started with a cough, crying and uncomfortable feeling, and slight wheezing. She slept that evening upright in a chair on my chest. She immediately developed a injection site reaction on both legs. 7/12 patient had a cranky day, she still had a slight cough, and at one point cried for a hour straight which is not her normal behavior. Complained that her injection sites hurt. 7/13 Continue not feeling well. 7/14 patient broke out in hives and rash all over her arms, legs, face and, abdomen. She had swelling around the eyes as well as a rash on her cheeks. This continued off and on for almost three weeks and was treated with benadryl, and prednisdone. She continues to have slight out breaks of hives and had one 8/11 they were on her back, as well as complained on tingly toes. Her right injection site on her leg is still visible.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Cough, Crying, Discomfort, Eye swelling
Clinical narrative: 7/11 830 pm patient started with a cough, crying and uncomfortable feeling, and slight wheezing. She slept that evening upright in a chair on my chest. She immediately developed a injection site reaction on both legs. 7/12 patient had a cranky day, she still had a slight cough, and at one point cried for a hour straight which is not her normal behavior. Complained that her injection sites hurt. 7/13 Continue not feeling well. 7/14 patient broke out in hives and rash all over her arms, legs, face and, abdomen. She had swelling around the eyes as well as a rash on her cheeks. This continued off and on for almost three weeks and was treated with benadryl, and prednisdone. She continues to have slight out breaks of hives and had one 8/11 they were on her back, as well as complained on tingly toes. Her right injection site on her leg is still visible.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site urticaria, Irritability
Clinical narrative: 7/11 830 pm patient started with a cough, crying and uncomfortable feeling, and slight wheezing. She slept that evening upright in a chair on my chest. She immediately developed a injection site reaction on both legs. 7/12 patient had a cranky day, she still had a slight cough, and at one point cried for a hour straight which is not her normal behavior. Complained that her injection sites hurt. 7/13 Continue not feeling well. 7/14 patient broke out in hives and rash all over her arms, legs, face and, abdomen. She had swelling around the eyes as well as a rash on her cheeks. This continued off and on for almost three weeks and was treated with benadryl, and prednisdone. She continues to have slight out breaks of hives and had one 8/11 they were on her back, as well as complained on tingly toes. Her right injection site on her leg is still visible.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Malaise, Paraesthesia, Rash, Urticaria, Wheezing
Clinical narrative: 7/11 830 pm patient started with a cough, crying and uncomfortable feeling, and slight wheezing. She slept that evening upright in a chair on my chest. She immediately developed a injection site reaction on both legs. 7/12 patient had a cranky day, she still had a slight cough, and at one point cried for a hour straight which is not her normal behavior. Complained that her injection sites hurt. 7/13 Continue not feeling well. 7/14 patient broke out in hives and rash all over her arms, legs, face and, abdomen. She had swelling around the eyes as well as a rash on her cheeks. This continued off and on for almost three weeks and was treated with benadryl, and prednisdone. She continues to have slight out breaks of hives and had one 8/11 they were on her back, as well as complained on tingly toes. Her right injection site on her leg is still visible.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: Evening of his 4 mo. shots: was nursing near bedtime, had arm/leg jerks x 10sec. Then normal. Had a few jerks again early feeding 5:30 am next day.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia
Clinical narrative: Evening of his 4 mo. shots: was nursing near bedtime, had arm/leg jerks x 10sec. Then normal. Had a few jerks again early feeding 5:30 am next day.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: This spontaneous report has been received from a nurse regarding to a 14 year old female patient. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 10-AUG-2016, the patient was administered with first dose of GARDASIL 9, 0.5 ml (lot# M020103) (Exp: 15-FEB-2016) intramuscularly (frequency not reported). The patient was not on any concomitant medications. On 10-AUG-2016, 10 minutes after the vaccination the patient felt lightheaded, was pale and vomited. The nurse stated that the patient's mother called the office on 11-AUG-2016 to report that on 11-AUG-2016, the patient had "5 to 6 episodes of tunnel vision (medically significant), dizziness, nausea and lightheadedness which required her to lie down for most of the day". On 11-AUG-2016 the patient had 2 additional episodes with the same symptoms which occurred again after the call with the mother of the patient on 11-AUG-2016 (these were reported to the nurse by the patient when the nurse spoke to the patient on 15-AUG-2016). The patient did not undergo any lab diagnostic studies. The patient did not receive any treatment for the events. On 12-AUG-2016, patient was fine and fully recovered, hence the outcome of the events were reported as recovered. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Upon internal review the event tunnel vision considered to be serious due to medically significant. Lot number (M020103) is an invalid lot number for GARDASIL 9 Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Nausea, Pallor, Tunnel vision, Vomiting
Clinical narrative: This spontaneous report has been received from a nurse regarding to a 14 year old female patient. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 10-AUG-2016, the patient was administered with first dose of GARDASIL 9, 0.5 ml (lot# M020103) (Exp: 15-FEB-2016) intramuscularly (frequency not reported). The patient was not on any concomitant medications. On 10-AUG-2016, 10 minutes after the vaccination the patient felt lightheaded, was pale and vomited. The nurse stated that the patient's mother called the office on 11-AUG-2016 to report that on 11-AUG-2016, the patient had "5 to 6 episodes of tunnel vision (medically significant), dizziness, nausea and lightheadedness which required her to lie down for most of the day". On 11-AUG-2016 the patient had 2 additional episodes with the same symptoms which occurred again after the call with the mother of the patient on 11-AUG-2016 (these were reported to the nurse by the patient when the nurse spoke to the patient on 15-AUG-2016). The patient did not undergo any lab diagnostic studies. The patient did not receive any treatment for the events. On 12-AUG-2016, patient was fine and fully recovered, hence the outcome of the events were reported as recovered. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Upon internal review the event tunnel vision considered to be serious due to medically significant. Lot number (M020103) is an invalid lot number for GARDASIL 9 Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP, HEPAB
Symptoms: Disorientation, Gaze palsy, Loss of consciousness, Seizure, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of convulsive seizure in a 55-year-old male patient who received TWINRIX adult (batch number L5SH5, expiry date 27th September 2018). Concomitant products included Typhoid vaccine. On 2nd August 2016, the patient received the 1st dose of TWINRIX adult. On 2nd August 2016, less than a minute after receiving TWINRIX adult, the patient experienced convulsive seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope. On an unknown date, the outcome of the convulsive seizure was recovering/resolving and the outcome of the syncope was recovered/resolved. The reporter considered the convulsive seizure and syncope to be possibly related to TWINRIX adult. Additional details were provided as follows: This case was reported by a medical assistant. On the same day, after few seconds, the patient experienced syncope and seizure or convulsions. The healthcare professional was not sure if the patient exhibited a seizure or convulsions.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP, HEPAB
Symptoms: Seizure, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of convulsive seizure in a 55-year-old male patient who received TWINRIX adult (batch number L5SH5, expiry date 27th September 2018). Concomitant products included Typhoid vaccine. On 2nd August 2016, the patient received the 1st dose of TWINRIX adult. On 2nd August 2016, less than a minute after receiving TWINRIX adult, the patient experienced convulsive seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope. On an unknown date, the outcome of the convulsive seizure was recovering/resolving and the outcome of the syncope was recovered/resolved. The reporter considered the convulsive seizure and syncope to be possibly related to TWINRIX adult. Additional details were provided as follows: This case was reported by a medical assistant. On the same day, after few seconds, the patient experienced syncope and seizure or convulsions. The healthcare professional was not sure if the patient exhibited a seizure or convulsions.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Rash
Clinical narrative: Initial unsolicited report received from health care professional via other company (Pfizer) (Manufacturer Report Number: 2016196323) on 11 April 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient developed rash and allergy to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of events rash and allergy to tetanus vaccine were not reported. List of documents held by sender: none
Sex: F
Vaccine: HPVX
Symptoms: Headache, Visual impairment
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old female patient (also reported as granddaughter of the reporter). The patient did not have any pertinent medical history and no drug allergies or reactions. On 10-OCT-2011 the patient was vaccinated with first dose of unspecified HPV vaccine (GARDASIL could not be ruled out) (dosing regimen and frequency unknown) (lot number and expiry date unknown). The patient was not taking any medications concomitantly. On 04-DEC-2011 the patient was vaccinated with second dose of the unspecified HPV vaccine (GARDASIL could not be ruled out). On an unknown date approximately in July 2016 (also reported within the last month or so) the patient experienced headaches and black spots in her vision (visual impairment) (medically significant). The nurse also reported that her granddaughter had an appointment with a physician in September to address these adverse events. No treatment was given for the events. No lab diagnostic studies were performed. There was no product quality complaint reported. The action taken with the therapy was unknown. The outcome of headache and visual impairment was reported as not recovered. The relatedness of the events to the suspect therapy was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Faint.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling -size of  orange/grapefruit, painful - at site of injection.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-AUG-2016, the patient was vaccinated intramuscularly with 0.5 ml dose of expired PNEUMOVAX 23 (lot# K021881, expiration date 30-JUL-2016. No adverse effects were reported. No further information was given. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 27-JUL-2016, the patient was inadvertently vaccinated with two doses (0.5 ml, twice) PROQUAD lot # L047305 (expiry date: 23-MAY-2017) subcutaneously, instead of receiving one dose of PROQUAD and one dose of KINREX.(extra dose of administered and Wrong vaccine administered). No adverse effects were reported. No product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 1.56
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 18 months old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 16-AUG-2016, the patient was vaccinated with an expired (wistar ra 27-3) M-M-R II lot # K010318, expiry date: 22-JUL-2016 (dosing details were not reported). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Pt felt dizzy, nauseated s/p vaccination.  Placed in supine position and given water, symptoms subsided.  Pt left clinic with mother in ambulatory condition. Mother called the next day stating pt still felt nauseated/dizzy/headache & was experiencing some diarrhea.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: About 6 inches around injection site VERY swollen, red, hot.  Lasted one week before subsiding. Took antihistamine with no effect.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiry date: 20-JUL-2017). Medical assistant reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 14 hours. There were no previous temperature excursion. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from an unknown reporter regarding patients of unknown age and gender who had enrolled in a Market Research program. The patient's concurrent condition, medical history and concomitant medication was unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported). It was reported that, the reporter or his/her hospital had decided to administer PREVNAR 13 at least some adult patients. The key reasons for the decision was the patients were allergic to PNEUMOVAX 23. Action taken with the suspect vaccine was unknown. The outcome of the event allergic to PNEUMOVAX 23 was unknown. The reporter did not provide any causal relationship between the event and PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received 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 as received from a physician refers to a patient of unknown age and gender, who on an unknown date, was vaccinated with improperly stored VARIVAX (lot # M000998, expiration date 07-JAN-2018; dosage and route of administration not provided). Excursions were reported as 9.9F for 10 hours, 15F for 20 hours, 6F for 17 hours, and new excursions of 6F for 15 hours. No adverse effects were reported. Additional information was received from the physician on 20-JUL-2016. The physician reported that an unspecified patient received the improperly stored VARIVAX dose #2, 0.5 ml subcutaneously, on an unspecified date in June 2016. Lot # M000998 has been determined to be a valid lot number for VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 08-AUG-2016, the patient was vaccinated with one dose of ZOSTAVAX (dose and route of administration were not reported, lot # L003218) which expired on 30-APR-2016. Concomitant therapy was unknown. It was unknown if the lab diagnostics studies were performed. The patient's current status was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 24-year-old female patient who received BOOSTRIX (batch number X2444, expiry date 8th October 2017). Co-suspect products included TWINRIX adult. Concomitant products included TWINRIX adult. On 14th July 2016, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On 21st July 2016, the patient received the 2nd dose of TWINRIX adult 1 ml. On 26th July 2016, 12 days after receiving BOOSTRIX and 5 days after receiving TWINRIX adult, the patient experienced generalized rash (serious criteria other: As per reporter). On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to BOOSTRIX and TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The pharmacist reported that the patient received travel prophylaxis of TWINRIX adult. The patient's grandmother stated that her granddaughter broke out in a head to toe rash. At the time of reporting, the rash was getting better and resolving according to the grandmother. The reported lot number (X2444) for BOOSTRIX and (DX793) for 1st and 2nd dose of TWINRIX adult were not exist and was updated to XZ444 and DX7D3, according to sales database. The doses of vaccines were administered by 2 different people. It was not clear who administered which dose of the vaccines.
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site rash, Pain in jaw, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of jaw pain in a female patient who received MEN B NVS. On an unknown date, the patient received Meningococcal B vaccine. On 7th AUGUST 2016, 7 days after receiving Meningococcal B vaccine, the patient experienced injection site rash. On an unknown date, the patient experienced jaw pain, rash and headache. In August 2016, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the jaw pain and injection site rash were not recovered/not resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the jaw pain, rash, headache and injection site rash to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's mother. The patient was administered with a Meningitis B Vaccination at 10 AM about a week ago. By noon, the patient experienced hurting in her jaw. At the time of reporting there was a lot of pain in her jaw. Later, the patient experienced a rash which seemed to move around, headache for about three days and rash that appeared on lower face, neck and chest. The patient did not complain about the headache after it had been recovered. At the time of reporting, 7 days after vaccination, the patient experienced rash was on the patient's arm where she received the vaccine. The reporter was inquiring about, was it related to vaccination and if they should be concerned about it and what should be done.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a nurse, a female patient of unknown age (via company representative) reporting on herself. The patient's medical history and concurrent conditions were unknown. ON 02-AUG-2016, the patient was subcutaneously vaccinated with the single dose of ZOSTAVAX (dose, frequency were not reported, lot # M013377 with expiration date: 25-MAY-2017). Concomitant therapy was unknown. On an unknown date in August 2016, the patient experienced local reaction of redness, warmth and there was slightly raised area of 30 Millimeters. The patient sought medical attention. It was unknown if the patient had any lab diagnostic studies performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC was not filed) This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L027733, expiry date: 13-SEP-2017 and lot # L044694, expiry date: 04-FEB-2018. Medical assistant reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 14 hours. There were no previous temperature excursion. No adverse effects were reported. This is one of the two 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 was received from a medical assistant refers to three unspecified patients of unknown age and gender. Three unspecified patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, three unspecified patients were vaccinated with improperly stored (at a maximum 49.1 F for total 66 hours and 37 minutes) ROTATEQ vial, lot # L033694 (16-JUN-2017) (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to five unspecified patients of unknown age and gender. Five unspecified patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, five unspecified patients were vaccinated with improperly stored (at a maximum 49.1 F for total 66 hours 37 minutes) PEDVAXHIB, lot # M001814 (expiry date: 15-OCT-2018) (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Flushing, Urticaria, Wheezing
Clinical narrative: 8/18/16 MMR and varicella vaccine administered 607pm. At 6:21pm pt began coughing and wheezing. Face was flushed chest with a few hives. Resp 36 HR 96. No lip or tongue swelling pulse ox 100%. Epinephrine given (1:1000) 0.15 ml. Albuterol 0.083% via neb. 635pm BP 110/50 - clear lungs except for slight exp wheeze. Ambulance called. 648pm transported to hosp.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: 3 small raised itchy red bumps on area of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Patient experienced a hard bump the size of an egg mostly under the skin. It was red, warm to touch and swollen around the area. The patient notified the pharmacy where the vaccine was administered on 8/18/16 and reported that it has decreased in size and subsided since onset. The pharmacy called the pcp to notify the same day and followed up with patient on 8/19/16. She said it was getting better still and she doesn't feel sick but she will call her pcp as well.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Frequent bowel movements, Irritability, Vomiting
Clinical narrative: 08/16/2016 Brown watery stool, irritability, increased number of bowel movements, elevated temperature 99.7 under arm reading 08/17/2016 Watery stool, 20+ bowel movements (usually 1-2 per day). Fussiness, vomitting . 08/18/2016 Loose stool, 10-15 bowel movements, regurgitated 1x .
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Myalgia, Pyrexia, Rash, Rash papular
Clinical narrative: Developed myalgias, subjective fevers, redness at injection site (L deltoid), then erythematous papular rash across upper back without vesicles or pruritis.
Sex: U
Vaccine: PNC13
Symptoms: Adverse event, Wrong drug administered
Clinical narrative: Information has been received from an unknown reporter regarding an adult patient of unknown age and gender who had enrolled in a Market Research program. The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date the patient was vaccinated with PREVNAR 13 (dose, frequency and route were not reported) instead of PNEUMOVAX 23. It was reported that "changes by CMS, no longer assessing". On an unknown date the patient experienced unspecified safety events due to wrong vaccine administration. Action taken with the suspect vaccines was unknown. The outcome of wrong vaccine administration and adverse event (unspecified) was unknown. The reporter did not provide any causal relation between the events and the suspect vaccines. This is one of several reported received from the same reporter. Additional information has been registered.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with several doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # K008931 with expiration date: 04-MAR-2017. The doses were improperly stored with a temperature excursion to 33 Fahrenheit degrees for 2 hours on an unknown date. No adverse effects were reported. Additional information is not expected, because reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from physician refers to multiple unknown patients of unknown age and gender. The patients relevant medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the multiple unknown patients were vaccinated with PNEUMOVAX 23 injection (lot number/expiry date and dosage not reported). On an unknown dates, multiple unknown patients experienced unspecified (muscle aches) following the administration of PNEUMOVAX 23. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not provided. ON 15-AUG-2016 the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L036851, expiration date 03-SEP-2017, (concentration, dosage and therapy route were unknown). Concomitant therapies were not provided. No adverse effects were reported. The vaccine was exposed to 55.6 F for 2 hours and 24 minutes and the call was made because of digital data logger. No product quality complain (PQC) was involved. This is one of two reports from the same source (MARRS # WAES1608USA008369). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, induration, warmth, swelling around injection site. Reaction site is approximately 5 inches in diameter (a circle). Very painful and tender.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a 57-year-old female patient who received FLUARIX Quadrivalent 2015-2016 season. On 1st October 2015, the patient received FLUARIX Quadrivalent 2015-2016 season .5 ml. On an unknown date, less than a year after receiving FLUARIX Quadrivalent 2015-2016 season, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was recovered/resolved. The reporter considered the numbness facial to be unlikely related to FLUARIX Quadrivalent 2015-2016 season. Additional details were provided as follows: The patient received a dose of FLUARIX Quadrivalent 2015-2016 season in left arm and experienced facial numbness. The reporter would like to know if there were any reports associated with facial numbness.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Hypotension, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 53-year-old male patient who received (Reduced antigen) BOOSTRIX (batch number AH4LF, expiry date 8th July 2018). Concurrent medical conditions included fasting. On 3rd August 2016, the patient received BOOSTRIX. In August 2016 several hours after receiving BOOSTRIX, the patient experienced syncope, dehydration and low blood pressure. On an unknown date, the outcome of the syncope, dehydration and low blood pressure were unknown. It was unknown if the reporter considered the syncope, dehydration and low blood pressure to be related to BOOSTIX. Additional details were provided as follows: The pharmacist stated that the patient received a dose of BOOSTRIX and was fine when she administered the vaccine and observed him after. Then the patient went home and did 3 hours of yard work in the hot heat. He said he fainted when he was doing yard work also had been fasting and was dehydrated. He dto go to the emergency room because of the fainting, where they stated he had low blood pressure. No further information was provided.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site vesicles in an unspecified number of patients who received KINRIX. On an unknown date, the patients received KINRIX .5 ml. On an unknown date, less than a day after receiving KINRIX the patients experienced injection site vesicles. On an unknown date, the outcome of the injection site vesicles was unknown. It was unknown if the reporter considered the injection site vesicles to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the reporter read on web site that some children were reported to develop vesicles after receiving KINRIX immunization. One of the patients of the reporter developed vesicles after vaccination with KINIRX. The reporter was inquiring about any special advice to give to the parents or any need to apply local antibiotic at the site to prevent bacterial infection. This was an ICC pop request. The reporter did not answer for additional adverse event information.
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a 30-year-old patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult 1 ml. On 7th July 2016, an unknown time after receiving TWINRIX adult, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. Additional details were provided as follows: The age at vaccination was not reported. The sale representative called on behalf of healthcare professional and did not have any additional information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding three patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Improperly stored ROTATEQ with Lot# L029617 and Expiry date:19-MAY-2017 were administered to three different patient on 07-JUL-2016, 12-JUL-2016 and on 21-JUL-2016 (dose and route of administration information was not reported). No adverse effects were reported. Temperature and time frame: 8.6 C for 3 hours and 41 minutes; -10.1 C for 1 hour and 10 minutes and 9.8 C for 4 hours and 5 minutes. Previous temperature excursion: 8.8 C for 43 minutes; -0.1 for 3 hours and 18 minutes. The temperature was adjusted back to range. The call was because of data logger. No product quality complaint was reported. This is one of the two reports (Same reporter link : WAES1608USA10262). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Product quality issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX lot # M013377, expiration date: 25-MAY-2017 (dose and route were not reported). The pharmacist reported that as she was administering a dose of ZOSTAVAX some of the vaccine leaked out of the needle and patient did not received full dose. The pharmacist also stated that it was due to a defective needle (also reported as product quality complaint (PQC): no). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Muscular weakness, Myalgia, Pain
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 years old male patient. The patient's pertinent medical history and concurrent conditions were not provided. In 2016, reported as "sometime in June or July 2016", the patient was vaccinated with GARDASIL (lot #, expiration date, concentration, dose and therapy route were not indicated). Concomitant therapies were not provided. The physician stated that in 2016, reported as "an unspecified amount of time after the dose of GARDASIL was administered", the patient was complaining of generalized muscle aches, pains and lower extremity weakness. The outcome of generalized muscle aches, pains and lower extremity weakness was unknown. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008986). Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding two patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. One patient received improperly stored (Wistar RA 27-3) M-M-R II with lot# K020188 and expiry date: 22-OCT-2016 on 25-JUL-2016 and the second patient received improperly stored (Wistar RA 27-3) M-M-R II with lot# L011528 and expiry date: 03-APR-2017 on 26 JUL-2016 (dose and route of administration information was not reported). No adverse effects were reported. Temperature and time frame: 8.6 C for 3 hours and 41 minutes; 10.1 C for 1 hour and 10 minutes and 9.8 C for 4 hours and 5 minutes. Previous temperature excursion: 8.8 C for 43 minutes; -0.1 for 3 hours and 18 minutes. The temperature was adjusted back to range. The call was because of data logger. No product quality complaint was reported. This is one of two reports (Same reporter link: WAES1608005052). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Narrative: Pneumonia vaccination today states swelling, redness to site, itching, pain to left upper arm, no fever, no n/v, no other complaints. Symptoms: Erythema Multiform and Urticaria Pruritus.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Narrative: Pneumonia vaccination today states swelling, redness to site, itching, pain to left upper arm, no fever, no n/v, no other complaints. Symptoms: Erythema Multiform and Urticaria Pruritus.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, X-ray limb normal
Clinical narrative: Initial unsolicited report received from a pharmacist on 08 Aug 2016. This case involves a 55-year-old female patient who was vaccinated with ADACEL (batch number: U1558AA, expiry date: 10 Apr 2018) (dose, dose in series not reported) (route: intramuscular) in right deltoid on 08 July 2016. Patient had medical history of allergy to erythromycin. Concomitant medications were not reported. On 08 July 2016, on the same day following the vaccination, the patient experienced severe pain in right arm. It was also reported that, pain has continued to today. 08 Aug 2016, one month later and patient was also experiencing decreased mobility of that right arm which limits her activity. Patient required ER/doctor visit. X-ray of arm was done and result was negative. Other lab test was not reported. Patient had been treated with Ibuprofen. The outcome of the events was reported as not recovered. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: Initial unsolicited report received from non-health care professional (Medical assistant) on 10-Aug-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA (batch number: U5259AA, expiry date: 13-May-2017, dose was not reported) intramuscularly in the left deltoid on 03-Aug-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies to Ceftin. Patient had no other vaccinations within 4 weeks of vaccinations. On 03-Aug-2016, same day "ever since received vaccination" following vaccination, the patient experienced numbness in different parts of her body. On an unspecified date, following vaccination patient also has started having twitching. Lab test and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by the sender: None.