chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored VARIVAX (lot # M009764 23-FEB-2018, L040422 15-OCT-2017, L019124 27-MAY-2017) for prophylaxis. The vaccine were exposed to a temperature of 21F at a time frame of 8 hours. No adverse effects reported. Additional information has been requested. This is one of the two cases received form the same reporter.; Sender's Comments: US-009507513-1612USA010514:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vaccination complication
Clinical narrative: Information has been received on 22-DEC-2016 from a third party claims management company representing a pharmacy for a case in litigation concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 17-NOV-2016, the patient was vaccinated with PNEUMOVAX23 (lot number and expiration not reported) for prophylaxis. Allegedly, the patient was given the pneumonia vaccine on 17-NOV-2016 but the patient suffered an adverse reaction after leaving the store (pharmacy) which required ambulance transport and an overnight stay in the hospital. The patient experienced but is not limited to a spike in fever of 103.5 and some swelling and redness around the injection area. The patient was released from the hospital on 16-DEC-2016 and it is unknown if additional medical treatment will be required at this time. 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 licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with doses of ROTATEQ for prophylaxis, (orally; dose, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013204: US-009507513-1612USA013205: US-009507513-1612USA013206: US-009507513-1612USA013207:
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient with high blood pressure and seasonal allergies. The patient had no drug reactions. Concomitant therapies included olmesartan medoxomil (BENICAR), metoprolol succinate (TOPROL XL TABLETS, reported as TOPROL XL) and olopatadine hydrochloride (PATADAY). On 25-OCT-2016, the patient received a dose of ZOSTAVAX (lot # L029481, expired date November 2016, dose 0.65ml, frequency once) subcutaneous in her left arm for preventing shingles. The pharmacist stated that immediately after receiving the ZOSTAVAX, the patient developed itching and a bump under the skin at the injection site. The pharmacist stated the patient came into the pharmacy on 22-DEC-2016 (also reported as today) in regards to the reaction. When asked present status the pharmacist stated "the itching has resolved but the bump is still there". No treatment was given and no lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. Since 21-DEC-2016, the patients were each vaccinated with a dose of improperly stored PROQUAD (dose and route were unknown, lot # reported as M036158 with expiration date 12-FEB-2018, lot # M033908 with expiration date 16-JAN-2018, lot # M032496 with expiration date 02-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 41 Fahrenheit for 9 hours and 15 minutes and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012911.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. Since 21-DEC-2016, the patients were each vaccinated with a dose of improperly stored VARIVAX (dose and route were unknown, lot # M034583 with expiration date 27-JUL-2018, lot # M031970 with expiration date 30-JUN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 41 Fahrenheit for 9 hours and 15 minutes and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1612USA012899:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored doses of GARDASIL 9 injection, for prophylaxis. (Strength, dose number, lot number and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA011668: US-009507513-1612USA013214.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 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 VARIVAX lot # M033904, expiration date 20-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 through -10 degrees Celsius for 20 minutes and 15 through 46 degrees Fahrenheit for 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014069:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 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 PROQUAD lot # M034692, expiration date 24-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 through -10 degrees Celsius for 20 minutes and 15 through 46 degrees Fahrenheit for 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013984.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Computerised tomogram, Gait disturbance, Laboratory test
Clinical narrative: Initial unsolicited report received from other non-health care professional on 19-Dec-2016. This case involves 58-year-old male patient who was vaccinated with fourth dose of FLUZONE QIV (batch number: UI441AC, expiry date: 30 Jun 2016) via intramuscular route in right (unspecified date) on 11-Oct-2016. The patient's ongoing illness, medical history, risk factors were revealed that patient had HTN (Hypertension) and Hyperlipidemia. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were denied. Concomitant medications were not reported. On 17-Oct-2016, six days following the vaccination, the patient experienced pain to hip and had severe muscle aches and pain. On an unspecified date, approximately two weeks following the vaccination, the patient had syncopal episode. On an unspecified date, post vaccination, the patient had experienced difficulty in walking and extreme weakness. After receiving corrective treatment, patient continued having difficult with severe lethargy and muscle weakness. On an unspecified date, post vaccination, the patient's arms and legs feeling extremely heavy. On an unspecified date, the patient was diagnosed with myalgia. It was reported that, on an unspecified date, post vaccination the Tumor was found on spinal cord but physician stated it was incidental finding and not related to his current symptoms. Patient required ER or doctor visit. Laboratory investigations include CT scan and MRI of brain and spinal column. It was reported that, many other lab test was also done. Corrective treatment includes Prednisone and LYRICA. Patient was given prescription for therapy. The outcome of events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event spinal cord neoplasm and syncopal attack. It was reported that neurologist felt diagnosis was secondary to flu vaccine. List of documents held by sender: none. Sender's Comments: This case concerns 58 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed pain to hip, muscle aches and pain, syncopal episode, difficulty walking, extreme weakness, severe lethargy, muscle weakness, arms and legs feeling extremely heavy, pain continues and myalgia. CT and MRI revealed spinal cord tumor which might be incidental finding. Time to onset is compatible for pain in hip, muscle pain. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Limb discomfort, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain
Clinical narrative: Initial unsolicited report received from other non-health care professional on 19-Dec-2016. This case involves 58-year-old male patient who was vaccinated with fourth dose of FLUZONE QIV (batch number: UI441AC, expiry date: 30 Jun 2016) via intramuscular route in right (unspecified date) on 11-Oct-2016. The patient's ongoing illness, medical history, risk factors were revealed that patient had HTN (Hypertension) and Hyperlipidemia. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were denied. Concomitant medications were not reported. On 17-Oct-2016, six days following the vaccination, the patient experienced pain to hip and had severe muscle aches and pain. On an unspecified date, approximately two weeks following the vaccination, the patient had syncopal episode. On an unspecified date, post vaccination, the patient had experienced difficulty in walking and extreme weakness. After receiving corrective treatment, patient continued having difficult with severe lethargy and muscle weakness. On an unspecified date, post vaccination, the patient's arms and legs feeling extremely heavy. On an unspecified date, the patient was diagnosed with myalgia. It was reported that, on an unspecified date, post vaccination the Tumor was found on spinal cord but physician stated it was incidental finding and not related to his current symptoms. Patient required ER or doctor visit. Laboratory investigations include CT scan and MRI of brain and spinal column. It was reported that, many other lab test was also done. Corrective treatment includes Prednisone and LYRICA. Patient was given prescription for therapy. The outcome of events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event spinal cord neoplasm and syncopal attack. It was reported that neurologist felt diagnosis was secondary to flu vaccine. List of documents held by sender: none. Sender's Comments: This case concerns 58 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed pain to hip, muscle aches and pain, syncopal episode, difficulty walking, extreme weakness, severe lethargy, muscle weakness, arms and legs feeling extremely heavy, pain continues and myalgia. CT and MRI revealed spinal cord tumor which might be incidental finding. Time to onset is compatible for pain in hip, muscle pain. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal, Spinal cord neoplasm, Syncope
Clinical narrative: Initial unsolicited report received from other non-health care professional on 19-Dec-2016. This case involves 58-year-old male patient who was vaccinated with fourth dose of FLUZONE QIV (batch number: UI441AC, expiry date: 30 Jun 2016) via intramuscular route in right (unspecified date) on 11-Oct-2016. The patient's ongoing illness, medical history, risk factors were revealed that patient had HTN (Hypertension) and Hyperlipidemia. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were denied. Concomitant medications were not reported. On 17-Oct-2016, six days following the vaccination, the patient experienced pain to hip and had severe muscle aches and pain. On an unspecified date, approximately two weeks following the vaccination, the patient had syncopal episode. On an unspecified date, post vaccination, the patient had experienced difficulty in walking and extreme weakness. After receiving corrective treatment, patient continued having difficult with severe lethargy and muscle weakness. On an unspecified date, post vaccination, the patient's arms and legs feeling extremely heavy. On an unspecified date, the patient was diagnosed with myalgia. It was reported that, on an unspecified date, post vaccination the Tumor was found on spinal cord but physician stated it was incidental finding and not related to his current symptoms. Patient required ER or doctor visit. Laboratory investigations include CT scan and MRI of brain and spinal column. It was reported that, many other lab test was also done. Corrective treatment includes Prednisone and LYRICA. Patient was given prescription for therapy. The outcome of events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event spinal cord neoplasm and syncopal attack. It was reported that neurologist felt diagnosis was secondary to flu vaccine. List of documents held by sender: none. Sender's Comments: This case concerns 58 year old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and developed pain to hip, muscle aches and pain, syncopal episode, difficulty walking, extreme weakness, severe lethargy, muscle weakness, arms and legs feeling extremely heavy, pain continues and myalgia. CT and MRI revealed spinal cord tumor which might be incidental finding. Time to onset is compatible for pain in hip, muscle pain. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016566258) on 19 Dec 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE) (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient relevant medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient had swelling local and redness at injection site. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited case received from a physician on 19 Dec 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5489AA, Expiry date, dose, route and site of administration was not reported) on 01 Dec 2016. The patient illness at the time of vaccination, preexisting physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On an unknown date, after the vaccination (reported as of today 19 Dec 2016) the patient had right arm pain and due to pain he is not able to abduct right arm and it was reported as the patient will be coming to see the physician on 20 Dec 2016, for evaluation and treatment as needed. The patient lab tests and corrective treatment was not reported. The outcome of the events was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 19 Dec 2016. Manufacturer report number: 2016563870. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had sickness. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none
Age: 1.5
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Respiratory tract congestion
Clinical narrative: Sudden redness and swelling at injection site with later onset of 103 fever, congestion.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Oedema, Swelling
Clinical narrative: Swelling on opposite side from injection site (bicep and lower arm had edema, erythema-but nothing around injection site, no pain or redness just on opposite side of arm and lower arm near elbow also swollen).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling on opposite side from injection site (bicep and lower arm had edema, erythema-but nothing around injection site, no pain or redness just on opposite side of arm and lower arm near elbow also swollen).
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Noticed tenderness at site followed by mild redness and mild warmth to the area.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Drooling, Dyskinesia, Electrocardiogram normal
Clinical narrative: Patient was walking out of clinic and felt dizzy, saw blackness, brief loss of consciousness for less then one minute. Parents witnessed.  fell to ground.  Hit head.  Eyes rolled back, upper arms jerked and drooling.  loss of urine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Head injury, Laboratory test normal, Loss of consciousness
Clinical narrative: Patient was walking out of clinic and felt dizzy, saw blackness, brief loss of consciousness for less then one minute. Parents witnessed.  fell to ground.  Hit head.  Eyes rolled back, upper arms jerked and drooling.  loss of urine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Patient was walking out of clinic and felt dizzy, saw blackness, brief loss of consciousness for less then one minute. Parents witnessed.  fell to ground.  Hit head.  Eyes rolled back, upper arms jerked and drooling.  loss of urine.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Chills, vomiting, possible fever for one day. right arm sore, "couldn't move it".
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male patient. The patient's concurrent conditions included seasonal allergy and high cholesterol. There were no drug reactions. No pertinent medical history was reported. Concomitant therapies included CRESTOR and FLONASE. On 11-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not reported). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and he was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from  the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is a Corrected report. The field Potential Lot Check was marked as Yes, as the case meets the criteria for Adverse Event Quality Investigation Process. Follow up information has been received from the reporting nurse on 20-DEC-2016. On 11-OCT-2016 at 10:59, the patient was vaccinated with a dose of PNEUMOVAX23 via intramuscular in the right deltoid. On 13-OCT-2016 at 11:37, the patient experienced cellulitis, red and hot to touch. The patient was administered ZPACK as treatment. On 18-OCT-2016, the patient recovered from the event. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information was sent and received. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007088: US-009507513-1611USA007096: US-009507513-1611USA007131: MERCK 1611USA007077: Mfr number.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an  approximately 83 year old female patient. The patient's concurrent conditions included hypertension, thyroid issue, Atrial fibrillation (AFIB) and allergy to quinapril hydrochloride. No pertinent medical history was reported. Concomitant therapies included an unspecified thyroid medicine and an unspecified  high blood pressure medicine. On 10-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not  reported). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from  the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is a Corrected report. The field Potential Lot Check was marked as Yes, as the case meets the criteria for Adverse Event Quality Investigation Process. Follow up information has been received from the reporting nurse on 20-DEC-2016, concerning a 83 year old female patient. On 10-OCT-2016 at 10:38, the patient was vaccinated with a dose of PNEUMOVAX23 via intramuscular in the left deltoid. On 11-OCT-2016 at 16:45, the patient experienced cellulitis on the left arm. The patient received AUGMENTIN 125 mg tablet, 875 mg bid for 10 days as treatment. On 21-OCT-2016, the patient recovered from cellulitis. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information had been sent and received. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007088:US-009507513-1611USA007096: MERCK 1611USA007131: Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, injection (lot # L032395, expiration date: 26-AUG-2017; lot# L042267, expiration date: 27-OCT-2017; lot# M002062, expiration date 21-JAN-2018; dose and route of administration were not provided). No adverse events were reported. Administered doses of vaccine experienced the following temperature excursion: 9.9 F for 15 mins 7.3 F for 15 mins 9.0 F for 15 mins 7.9 F for 15 mins 9.9 F for 15 mins 11.7 F for 15 mins 10.2 F for 15 mins 6.8 F for 15 mins 7.3 F for 15 mins 10.9 F for 15 mins 14.9 F for 15 mins 6.1 F for 15 mins 5.9 F for 15 mins 6.4 F for 15 mins 6.3 F for 15 mins 6.3 F for 15 mins 12.6 F for 15 mins 7.3 F for 15 mins 6.3 F for 15 mins 6.6 F for 15 mins 6.3 F for 15 mins 6.3 F for 15 mins 13.6 F for 15 mins 7.7 F for 15 mins 6.4 F for 15 mins 6.6 F for 15 mins 7.3 F for 15 mins 6.3 F for 15 mins 6.6 F for 15 mins 6.3 F for 15 mins 6.6 F for 15 mins 6.3 F for 15 mins 6.6 F for 15 mins 6.4 F for 15 mins 6.8 F for 15 mins There were no previous temperature excursions. Digital data logger was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site inflammation, Injection site swelling, Pruritus
Clinical narrative: This spontaneous report was received from a health care professional concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-OCT-2016 at 16:00, the patient was vaccinated on her right arm with a first dose of PNEUMOVAX 23 (lot # M038216), (strength, dose, route and expiration date were not provided) for prophylaxis. The patient did not have any illness at the time of vaccination. On 27-OCT-2016, one day post vaccination, the patient experienced inflamed and raised around the injection site described as the size of a tennis ball (injection site inflammation), and also she experienced redness and itching which was advised her to take BENADRYL. At time of the report, the patient had recovered from the events. The causality between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician via Pfizer, Inc. in the format of a medical record refers to a female patient who is currently 62 years old. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (the dose, dosage number, anatomical location, lot # and expiration date were unknown) for prophylaxis. No concomitant therapies were reported. Subsequently, on an unknown date, the patient developed an allergic reaction to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The outcome of the event was unknown but it was considered to be related to the vaccination with the suspect vaccine. All medical records will be provided upon request. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (dose and route of administration were not reported); lot # M031568 with expiry date 24-DEC-2017 and lot # M031945 with expiry date 27-DEC-2017. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013636.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an eight patients of unknown age and gender. On 29-NOV-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M026306, expiry date 30-APR-2018) (dose and route were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014070: US-009507513-1612USA014071: US-009507513-1612USA014072.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a six patients of unknown age and gender. On 30-NOV-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M026306, expiry date 30-APR-2018) (dose and route were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014072: US-009507513-1612USA014071: US-009507513-1612USA011604.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender, who on unspecified dates were vaccinated with improperly stored doses of GARDASIL 9 (lot# M030380, expiry date 30-APR-2018) (dose and route were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014070: US-009507513-1612USA011604: US-009507513-1612USA014072.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender (reported as "up to 20"), who between 01-SEP-2016 and 28-SEP-2016 were vaccinated with improperly stored doses of GARDASIL 9 (lot # reported as 040459, expiry date 06-APR-2017) and "Gardasil 4" (doses and routes were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014070: US-009507513-1612USA011604: US-009507513-1612USA014071.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 10/5/16 pm-Arm extremely sore. 10/6/16 am-Unable to lift arm for several days. Ongoing-Pain in arm when sleeping, still hard to lift arm over head.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness postural
Clinical narrative: Dizziness with change in position . Continued for 7 days.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Erythema, Hypoaesthesia oral, Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site then redness spread to both arms, chest  & neck.  Approximately 45 Min to 1 hour later lips and tough were numb and became hoarse.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test
Clinical narrative: Redness and itching at site then redness spread to both arms, chest  & neck.  Approximately 45 Min to 1 hour later lips and tough were numb and became hoarse.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported). On 26-OCT-2016, she was vaccinated with the second dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported).  On an unknown date in 2016, the patient became pregnant with last menstrual period (LMP) in November 2016. Estimated date of delivery (EDD) was not known. She discovered that she was pregnant on an unknown date in 2016 (reported as "recently"). The patient sought medical attention - she was seen at clinic. No product quality complaint (PQC) was involved. No other information was available at the time of reporting, as the patient did not see her physician yet. The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This solicited report has been received from a 44 year old female patient with chronic obstructive pulmonary disease (COPD) who participated in a market research and was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient was vaccinated with a doses of PNEUMOVAX 23 for respiratory disease (reported as resp dis) (doses, frequency, route of administration, anatomical location, lot# and expiration date were not reported). According to the patient, every time she received PNEUMOVAX 23 for respiratory disease she ended up with symptoms of that disease which set off her COPD, (dates unspecified). She stated also: "the cure was worse than her disease". The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected as there was no consent to contact provided.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a nurse refers to an un patient of unknown age. The patient's medical history and concurrent conditions were not provided. The nurse reported that an unknown number of unspecified patients on unspecified dates reported contracting mumps after having a prior history of vaccination with either properly stored M-M-R II or properly stored PROQUAD (vaccination date, dose, route of administration, lot numbers, expiration dates were not reported for both vaccines) or both. The nurse confirmed that the vaccinations were historical in these cases, not necessarily recent. The nurse reporter also stated that there was a mumps outbreak in an unspecified geographic area affecting these particular patients. The outcome of mumps was unknown. Causality assessment was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-DEC-2016, the patient was vaccinated with a dose of expired PNEUMOVAX 23 (strength, dose, frequency, route and lot# were not provided, expiration date: 03-NOV-2016) for prophylaxis. There was no known adverse effects reported. The outcome of the event was unknown. Additional information is not expected because the physician refused to provide the contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 1.0ml, intramuscularly, with lot # L006229 and expiration date of 17-AUG-2017 for prophylaxis. It was reported that, RECOMBIVAX HB was exposed to a temperature excursion of 27°F for 9 hours. However, no adverse effects were noted and no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician, via other company (manufacturer control# 2015341229), refers to a currently 57-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route, lot# and expiry date were not reported). On an unknown date, the patient experienced allergy to zoster vaccine. The outcome of the event was not reported. The reporter considered allergy to zoster vaccine to be related to zoster vaccine live (manufacturer unknown). This is one of several reports received from the same source concerning the same patient. Additional information has been requested. Sender's Comments: US-009507513-1612USA011443: US-009507513-1612USA012215.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 13-NOV-2016, the patients were vaccinated with improperly stored doses of M-M-R II lot # L043704, expiration date 04-NOV-2017 and lot# L032182, expiration date: 25-AUG-2017 for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014190: US-009507513-1612USA014191: US-009507513-1612USA003501:
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Diarrhoea, Dizziness, Encephalitis, Pyrexia, Rash
Clinical narrative: Fever, rash, dizziness, diarrhea, screaming much like he was experiencing encephalitis.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Screaming
Clinical narrative: Fever, rash, dizziness, diarrhea, screaming much like he was experiencing encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastroenteritis, Intussusception, Rectal haemorrhage, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Patient was seen on 11/15/16 and 11/16/16 for Gastroenteritis and vomiting. Patient had normal pyloric ultrasound on 11/16/16. Illness was resolved by 12/8/16 well child and shot appointment. Received all listed vaccine on 12/8/16. Returned to clinic on 12/15/16 for vomiting and rectal bleeding. Sent for abdominal US which revealed intussusception. Patient sent to hospital ER where surgery was performed.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting, X-ray
Clinical narrative: Patient was seen on 11/15/16 and 11/16/16 for Gastroenteritis and vomiting. Patient had normal pyloric ultrasound on 11/16/16. Illness was resolved by 12/8/16 well child and shot appointment. Received all listed vaccine on 12/8/16. Returned to clinic on 12/15/16 for vomiting and rectal bleeding. Sent for abdominal US which revealed intussusception. Patient sent to hospital ER where surgery was performed.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia, Rash follicular, Rash macular, Red blood cell sedimentation rate increased, Streptococcus test positive
Clinical narrative: Ten days of fever within two weeks of vaccine associated with antibiotic treatment for Rapid Strep + test and an intermittent/wandering macular/follicular rash. Pediatric ID rec. VAERS report.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: White blood cell count increased
Clinical narrative: Ten days of fever within two weeks of vaccine associated with antibiotic treatment for Rapid Strep + test and an intermittent/wandering macular/follicular rash. Pediatric ID rec. VAERS report.
Sex: U
Vaccine: HEPAB
Symptoms: Therapy non-responder, Viral titre decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a patient  who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult. On an unknown time after receiving TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that following a series of TWINRIX the patient did not develop an adequate titer following vaccination. This led to therapy non responder. The healthcare professional was unsure which titers were drawn (Hepatitis A, Hepatitis B, or both). The healthcare professional did not have vaccine information or dates of vaccination, date the titer was drawn, which titers were drawn or patient demographics.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Some discoloration and swelling just distal to injection site (L) UA.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received FLUARIX Quadrivalent (batch number 4GX4F, expiry date 30th June 2017. Concomitant products included PNEUMOVAX. On 17th November 2016, the patient received FLUARIX Quadrivalent. On 24th November 2016, 7 days after receiving FLUARIX Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in the arm to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The pharmacy student reported that one of their patients received FLUARIX Quadrivalent (unknown arm) and about a week after vaccination the patient started having pain at the injections site and pain in the arm. The patient also received PNEUMOVAX on other arm. The patient did not have any side effects on the arm where PNEUMOVAX was injected.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash developed very soon after administration on Influenza vac. Rash at the site on vaccine adm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Malaise, Mobility decreased, Renal pain
Clinical narrative: Experienced back pains, suspected to be kidney pains, left side pain. Generally felt sick and could not move.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Are still sore from shot, hard time raising arm and buckling seat belt. He felt shot going in at time.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: Pain at site given x 30 days. Bursitis. Recovery 3-4 weeks with provider recommendations.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chills, Chromaturia, Erythema
Clinical narrative: Evening of immunization had nausea and could not eat. Next evening face was red, had chills, stiffness and lower back/knee pain next evening sweaty face, red and puff, dark color to urine - acidic smell went to Dr. next day.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Feeding disorder, Hyperhidrosis, Laboratory test normal, Musculoskeletal stiffness, Nausea
Clinical narrative: Evening of immunization had nausea and could not eat. Next evening face was red, had chills, stiffness and lower back/knee pain next evening sweaty face, red and puff, dark color to urine - acidic smell went to Dr. next day.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face, Urine odour abnormal
Clinical narrative: Evening of immunization had nausea and could not eat. Next evening face was red, had chills, stiffness and lower back/knee pain next evening sweaty face, red and puff, dark color to urine - acidic smell went to Dr. next day.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Muscle contractions involuntary, Pyrexia
Clinical narrative: 12 hrs. after PENTACEL had fever. Later, during sleep developed muscle fasciculations. Resolve with waking. No seizures. Fevers resolved after 36 hours. Fasciculations continue during sleep.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See attached note.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has complained of arm pain following vaccination-symptoms have dulled but persisted for months.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Skin lesion, Skin warm, Swelling
Clinical narrative: Skin is warm. Capillary refill takes less than 3 seconds. Blanchable, erythematous lesion that is 6 cm in greatest diameter noted overlying the left anterior thigh. Increased warmth and swelling but no fluctuance. No streaking or purulent drainage. No tenderness with palpitation.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Fatigue, Lethargy
Clinical narrative: Mom called stating that she has been acting tired and lethargic. Not acting herself. No treatment just told to watch and if not improved then needs to be seen.